Movement of Certain Genetically Engineered Organisms, 29790-29838 [2020-10638]

Download as PDF 29790 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Parts 330, 340, and 372 [Docket No. APHIS–2018–0034] RIN 0579–AE47 Movement of Certain Genetically Engineered Organisms Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. AGENCY: We are amending the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered organisms in response to advances in genetic engineering and our understanding of the plant pest risk posed by genetically engineered organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. This final rule, which marks the first comprehensive revision of the regulations since they were established in 1987, provides a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of genetically engineered organisms that are unlikely to pose plant pest risks. DATES: Effective August 17, 2020. Sections 340.4 and 340.5 are applicable beginning April 5, 2021. FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Assistant Deputy Administrator, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 98, Riverdale, MD 20737– 1238; (301) 851–3944. SUPPLEMENTARY INFORMATION: SUMMARY: jbell on DSKJLSW7X2PROD with RULES2 Background The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) administers the regulations in 7 CFR part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests’’ (referred to below as ‘‘the regulations’’). These regulations govern the introduction (importation, interstate movement, or release into the environment) of certain genetically engineered (GE) organisms. Along with the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA), APHIS is responsible for the oversight and review of GE organisms. In 1986, the VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) 1 was published by the Office of Science and Technology Policy. It describes the comprehensive Federal regulatory policy for ensuring the safety of biotechnology research and products and explains how Federal agencies use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework explains the regulatory roles and authorities for APHIS, EPA, and the FDA. The Coordinated Framework was updated in 2017 in light of advances that had occurred since 1986 in the field of biotechnology. APHIS first issued these regulations in 1987 under the authority of the Federal Plant Pest Act of 1957 and the Plant Quarantine Act of 1912, two acts that were subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with other provisions. Since 1987, APHIS has amended the regulations six times, in 1988, 1990, 1993, 1994, 1997, and 2005, to institute exemptions from the requirement for permits to conduct activities for certain microorganisms and Arabidopsis, to institute the current notification process and petition procedure, and to exclude plants engineered to produce industrial compounds from the notification process. While the regulations have been effective in ensuring the safe introduction of GE organisms during the past 30 years, they do not reflect the findings from APHIS’ three decades of experience in evaluating GE organisms for plant pest risk or account for developments in genetic engineering over that period. APHIS’ evaluations to date have provided evidence that genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not result in a GE plant that presents a plant pest risk. Further, genetic engineering techniques have been developed that do not employ plant pests as donor organisms, recipient organisms, vectors, or vector agents, yet may result in organisms that do pose a plant pest risk. Given these developments, as well as legal and policy issues discussed below, it has become necessary, in our view, to update our regulations accordingly. 1 To view the 1986 framework, go to https:// www.aphis.usda.gov/brs/fedregister/coordinated_ framework.pdf. To view the 2017 revision to the framework, go to https://www.aphis.usda.gov/ biotechnology/downloads/2017_coordinated_ framework_update.pdf. PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 On January 19, 2017, we published in the Federal Register (82 FR 7008–7039, Docket No. APHIS–2015–0057) a proposed rule 2 intended to revise our regulatory approach from ‘‘regulate first before analyzing risks’’ to ‘‘analyze plant pest and noxious weed risks of GE organisms prior to imposing regulatory restrictions.’’ Under the January 2017 proposed rule, a stakeholder could request that we conduct a risk assessment to determine whether a GE organism would pose plant pest or noxious weed risks and thus need to be regulated. Regulated GE organisms could be imported, moved interstate, or released into the environment under a flexible, risk-based permitting procedure. APHIS received 203 comments on the proposal during the comment period. Commenters expressed concerns about many provisions of the proposed rule. Many stated that the proposed requirements would be too burdensome and had the potential to stifle innovation. After reviewing the comments, APHIS subsequently withdrew the proposed rule. Following the withdrawal, APHIS conducted extensive outreach. Our outreach efforts took place in all regions of the United States and encompassed all sectors of the agriculture supply chain, as well as academic researchers, growers of various crops, and advocacy groups. Organizations ranged in size from small laboratories to larger scale businesses. APHIS also took proactive steps to meet with organizations both supportive and skeptical of agricultural biotechnology. In total, APHIS met with more than 80 organizations, including 17 universities, State departments of agriculture, and farmer organizations. Much of the feedback received during this process centered on the need to focus regulatory efforts and oversight upon risk, rather than the method used to develop GE organisms. Stakeholders also expressed a desire for flexible and adaptable regulations so that future innovations do not invalidate the regulations. We also received feedback urging us to keep international trade objectives in mind when proposing new regulations and ensuring that new regulatory requirements are transparent and clearly articulated. The feedback we received led us to update APHIS’ regulatory framework, in a manner that further focuses our regulatory efforts on the properties of the GE organism itself rather than on the 2 To view the 2017 proposed rule, the subsequent withdrawal, all supporting documents, and comments APHIS received, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2015-0057. E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 method used to produce it. We believed that this regulatory approach would better reflect our current knowledge of the field of biotechnology and would therefore enable us to evaluate GE organisms for plant pest risk with greater precision than the existing framework allowed. The regulatory framework was also intended to enable APHIS to avoid conducting repetitive analyses, to utilize its staff time more efficiently than before, and to provide better stewardship of taxpayer dollars. On June 6, 2019, we published in the Federal Register (84 FR 26514–26541, Docket No. APHIS–2018–0034) a proposal 3 to amend the regulations in accordance with the Secretary of Agriculture’s March 28, 2018, statement on plant breeding innovations. The Secretary’s statement and the accompanying explanatory details provided clarification on the USDA’s oversight over plants produced through innovative, new breeding techniques, including genome editing techniques. (The statement and further details are available at: https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology/brs-news-andinformation/2018_brs_news/plant_ breeding.) We would note also that the June 2019 proposed rule and this final rule are consistent with the President’s ‘‘Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products’’ (June 11, 2019, Executive Order 13874). Executive Order 13874 directs the Federal Government to adopt regulatory approaches for the products of agricultural biotechnology that are proportionate to the risks such products pose, and that avoid arbitrary or unjustifiable distinctions across like products developed through different technologies. Among other things, Executive Order 13874 states that regulatory decisions should be scienceand evidence-based, taking economic factors into account as appropriate and consistent with applicable law; that regulatory reviews should be conducted in a timely and efficient manner; and that biotechnology regulations should be transparent, predictable, and consistent. We solicited comments on our proposed rule and its supporting 3 To view the proposed rule, the comments we received, and supporting documents, go to http:// www.regulations.gov/#!docketDetail;vD=APHIS2018-0034. Additionally, please note that within the body of this document, that rule and this final rule are referred to at times as the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The SECURE rule is the nomenclature used by USDA to discuss the rule with stakeholders. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 analyses until August 6, 2019. We received 6,150 comments by that date. They were from developers of GE organisms; growers of GE plants for food crops and other uses; trade associations representing both of those groups and sellers of such commodities as corn, soybeans, and grain; scientists representing academic institutions; organic farmers and trade associations representing their interests; consumer and public interest groups; and individuals. Most of the comments, while not form letters, expressed a generalized, similarly themed opposition to GE products. Of the comments that specifically addressed the provisions of the rule, approximately 25 expressed some support for the rule. The comments are discussed below by topic. Applicability of the Regulations Exemptions The June 2019 proposed rule exempted from the regulations certain categories of plants that have been modified. Specifically, § 340.1(b)(1) through (4) proposed to exempt such plants if: • The genetic modification is solely a deletion of any size; or • The genetic modification is a single base pair substitution; or • The genetic modification is solely introducing nucleic acid sequences from within the plant’s natural gene pool or from editing nucleic acid sequences in a plant to correspond to a sequence known to occur in that plant’s natural gene pool; or • The plant is an offspring of a GE plant and does not retain the genetic modification in the GE plant parent. In addition to above-listed categories, proposed § 340.1(c) stated that modified plants would not be subject to the regulations if they have plant-traitmechanism of action (MOA) combinations that are the same as those of modified plants for which APHIS has conducted a regulatory status review (RSR) and found not to be subject to the regulations under part 340. The above-listed exemptions elicited a broad spectrum of comments. Some commenters welcomed the regulatory relief offered by the exemptions as written, while others viewed them as too broad and still others as excessively restrictive. Among the commenters who viewed the exemptions as excessively broad, several commenters stated that APHIS did not provide the ‘‘necessary scientific justifications’’ for the exemptions from regulation listed in proposed § 340.1(b)(1) through (3). PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 29791 The exemptions in § 340.1(b)(1) through (3) are based on the principles listed below. (For reasons discussed later in this document, we are removing from this final rule the exemption contained in § 340.1(b)(4) of the proposed rule, which would have pertained to ‘‘null segregants,’’ or the offspring of a GE plant that does not retain the genetic modification in the GE plant parent; while there is still a paragraph (b)(4) in this final rule, it serves a different purpose which we discuss later in this document.) 1. Plants created through conventional breeding have a history of safe use related to plant pest risk; 2. The types of plants that qualify for these exemptions can also be created through conventional breeding; and 3. There is no evidence that use of recombinant deoxyribonucleic acid (DNA) or genome editing techniques necessarily and in and of itself introduces plant pest risk, irrespective of the technique employed. When a plant meets one of the abovelisted exemptions, therefore, it is not expected to pose plant pest risks greater than the plant pest risks posed by plants modified by conventional breeding methods and thus should rightly not be subjected to regulation under part 340. (The term ‘‘conventional breeding’’ may generally be used interchangeably with ‘‘traditional breeding.’’ In the June 2019 proposed rule, APHIS used both terms, with ‘‘traditional breeding’’ appearing more frequently in the text. Based in part on dialogue with other agencies involved in regulating biotechnology, we have elected to use the term ‘‘conventional breeding’’ throughout this final rule and its supporting documents, except when the need to quote directly indicates otherwise. For purposes of this rule and its supporting documents, ‘‘conventional breeding’’ has the meaning it is understood to have within the context of part 340, based on the examples provided immediately below. Other Federal or State regulations may use the term ‘‘conventional breeding’’ in the context of their regulations and attribute slightly different meanings.) We noted in the preamble to the June 2019 proposed rule that conventionally bred crops have a long history of safe use with respect to plant pest risk and that the long history of conventional plant breeding gives us extensive experience in safely managing any associated plant pest risks. Conventional breeding techniques generally involve the deliberate selection of plants with desirable traits from existing population genetic variation or from new genetic variation E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29792 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations created through artificial hybridization or induced mutagenesis. As we noted in the June 2019 proposed rule, such techniques include marker-assisted breeding, tissue culture, protoplast, cell, or embryo fusion, and chemical or radiation-based mutagenesis. Products generated solely using such techniques have never been regulated under the part 340 regulations. Although conventional breeding is not risk free, the risks associated with it are, according to a 1989 National Research Council (NRC) report,4 ‘‘manageable by accepted standards.’’ In other words, the types of traits that can be introduced through conventional breeding have not led to plant pest risk concerns. The types of DNA modifications that occur through conventional breeding by mutagenesis are well characterized (Oladosu, et al., 2016; Kharkwal, et al., 2012). Among the common outcomes that result from mutagenesis are deletions, insertions, inversions, or translocations of DNA and base pair substitutions (Oladosu, et al., 2016) which often result from double strand breaks in the DNA followed by natural DNA repair. Base-pair substitution also results from chemical modification of a base followed by natural DNA repair. These types of modifications occur at a low rate from naturally occurring environmental exposure to ionizing radiation, radical oxygen, chemical compounds, or biological agents such as viruses, or at an elevated rate in response to radiation and chemicalinduced mutagenesis. In conventional breeding, these types of DNA modifications are introduced randomly. Individual plants possessing a mutation conferring a useful phenotype are isolated by screening, and random mutations that are introduced and do not convey a useful phenotype are addressed during backcrossing. New plant breeding technologies, such as those used in genome editing, can be used to create targeted double strand breaks in specific parts of the genome that when repaired result in deletions and small insertions, just as from natural environmental exposure or radiation mutagenesis (Chen, et al., 2019). Likewise, new plant breeding technologies can also be used, in a specific, targeted manner, to create base pair substitutions that are similar to the modifications that can be created by random chemical mutagenesis. In other words, the same types of DNA 4 National Research Council (NRC) 1989. Field Testing Genetically Modified Organisms: Framework for Decisions. Washington DC. National Academy Press. 185 pp. Retrieved from http:// www.nap.edu/catalog/1431.html. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 modifications that occur in conventional breeding can also be constructed precisely using new plant breeding technologies (Custers, et al., 2019). We are exempting plants generated using plant breeding technologies that have non-templated insertions and deletions and that have a single base pair substitution, because they could otherwise be created by conventional breeding and pose no increased plant pest risk relative to their conventionally bred counterparts. The exemption in proposed § 340.1(b)(3) applies to the use of new plant breeding technologies to recreate the introduction of a gene, allele of a gene, or structural variation that could otherwise be introduced by crosses. APHIS notes that conventional methods of plant breeding and new plant breeding technologies often share the same goals with similar results. Human selection of plants has been used for thousands of years; and crossing has been used to introduce alleles into breeding populations since at least the early 18th century (Goulet, et al., 2017). More recently, plant breeders have expanded the source of genetic material that can be used to introduce genetic changes into breeding populations through wide crosses, embryo rescue, and protoplast fusion (Bravo, et al., 2011; De Filippis, 2014; Singh, 1990), as well as the rate of introduction of genetic material through marker-assisted and genomic selection; all of these approaches are considered conventional breeding methods and are used to expand and guide changes in the gene pool available within a population. Genetic engineering can be used to introduce a genetic sequence from any donor source into plants, which cannot be accomplished through conventional breeding. To limit the exemption in paragraph (b)(3) to what is possible in conventional breeding, the third exemption applies only to the introduction of a gene, allele, or structural variant known to occur from a donor source (1) in the same species as the recipient, or (2) in a species compatible via wide crosses, embryo rescue, or protoplast fusion with the recipient species. The NRC has concluded in multiple studies 5 that there was no evidence of 5 National Academies of Sciences, Engineering, and Medicine (NAS) 1987. Introduction of Recombinant DNA-engineered Organisms into the Environment: Key Issues. Washington, DC National Academy Press. 24 pp. Retrieved from https:// www.nap.edu/read/18907/chapter/1. National Research Council (NRC) 1989. Field Testing Genetically Modified Organisms: Framework for Decisions. Washington DC. National Academy Press. 185 pp. Retrieved from http:// www.nap.edu/catalog/1431.html. PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 unique hazards inherent in the use of recombinant DNA techniques with respect to plants, and that crops modified by molecular and cellular methods should pose risks no different from those modified by conventional breeding methods for similar traits. Moreover, new molecular methods for editing genomes have been developed since the NRC studies that can be more specific and precise than those evaluated by the NRC studies, and plants modified by these new methods should also pose plant pest risks that are no different from plants that are modified for similar traits by conventional breeding methods. For all of the foregoing reasons, we consider the exemptions to be based on the best available science. Some commenters stated that APHIS did not adequately consider risk when developing the exemptions. It was stated that the proposed exemptions do not consider potential pest risks or human, environmental, or agricultural impacts on nontarget organisms. A commenter claimed that APHIS regulates risks other than plant pest risks, such as inadvertent introduction to the food supply and economic impacts from gene flow, so there should be scientific evidence that plants exempted from regulations do not pose any of the full range of risks. We do not agree with these comments. With regard to the commenters who stated that the exemptions failed to consider impacts on non-target organisms, APHIS considers impacts on non-target organisms that are beneficial to plants to be indirect plant pest impacts. It is not accurate to say that APHIS has previously regulated risks other than plant pest risks. Under the current regulations prior to the effective date of this final rule (referred to below as ‘‘the current regulations’’), APHIS has imposed measures to limit gene flow from GE plants that already met the definition of a regulated article. (Please see the ‘‘Implementation Table’’ on Regulations.gov regarding the dates when various provisions of this rule become applicable.) In these cases, APHIS considered the GE plants to be regulated articles because they had used a plant pest as the donor organism, recipient organism, or vector or vector agent, and therefore could pose a plant pest risk. As noted in the proposed rule, APHIS’ evaluations to date have provided evidence that genetically National Academies of Sciences, Engineering, and Medicine (NAS) 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC National Academy Press. 420 pp. doi:10.17226/ 23395. Retrieved from http://www.nap.edu/23395. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations engineering a plant with a plant pest does not in and of itself result in a plant that presents a plant pest risk, however. In cases where GE crops were not subject to regulation, no ‘‘other risks’’ such as inadvertent introduction to the food supply or economic impacts from gene flow have been regulated by APHIS insofar as they were outside the scope of the regulations. A commenter opposed the exemptions listed in proposed § 340.1(b)(1) through (3) on the basis that plants produced through most methods that would be used for genome editing are regenerated from single cells in tissue culture, resulting in somaclonal variation with unpredictable consequences, and that off-target mutations caused by genome editing are more likely than chemical and radiation mutagenesis to be non-random. A second commenter asked that the exemptions be limited so that they apply only to plants produced using techniques that minimize off-target mutations. A third commenter asked whether off-target mutations are considered when determining eligibility for an exemption. Somaclonal variation has been utilized extensively for breeding purposes, and the resultant new plant variety is not subject to the APHIS regulations in part 340 that we are replacing with this final rule (Krishna, et al., 2016; Neelakandan and Wang, 2012). APHIS is not aware of a reason to mandate government oversight over new plant varieties resulting from somaclonal variation. Background mutation occurs naturally in plants and does not raise plant pest risk concerns in conventional breeding programs. APHIS does not believe it is necessary to regulate off-target effects of genome editing in plants because (1) the off-target mutation rate from genome editing is low relative to the background mutation rate that occurs in conventional breeding, and (2) whatever changes do occur are likely to be segregated away from the target mutation during the breeding process. Comprehensive CRISPR/Cas off-target analysis on a genome-wide scale has been performed in rice, maize, tomato, and Arabidopsis (Feng, et al., 2014; Feng, et al., 2018; Peterson, et al., 2016; Nekrasov, et al., 2017; Lee, et al., 2018; Tang, et al., 2018). In these cases where the frequency of off-target mutation was measured in CRISPR/Cas expressing lines and their progeny, the authors concluded that the rate of off-target mutation was below the level of background mutation induced during seed amplification or tissue culture (Hahn and Nekrasov, 2019). Although VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 there can be variation in off-target mutation rates due to the nature of the technique used and the biological system to which it is applied, the mutation rates in such conventional breeding techniques as chemical and irradiation-based mutagenesis dwarf the rate associated with such methods. Due to the nature of plant breeding— in which populations are created and evaluated, and individual plants are selected for the intended modifications—off-target changes are likely to be lost unless they are genetically linked to the targeted modification that is introduced. APHIS wishes to clarify that, for these reasons, off-target mutations are not considered when determining eligibility for an exemption. This is also consistent with APHIS’ approach regarding conventional breeding techniques. As noted above, these techniques often have a high mutation rate, but have a history of safe use with respect to plant pest risk. APHIS has modified the regulatory text in § 340.1(b) to indicate that we are considering only targeted modifications when determining eligibility for an exemption. Some commenters stated that the scope of the exemptions listed in proposed § 340.1(b)(1) through (3) should be broadened to encompass the range of genetic modifications that are accessible to plant breeders through conventional breeding methods, and proposed alternative language that would allow an unlimited number of genetic modifications to be made and exempt from the regulations. The commenters appear to have interpreted our references in the June 2019 proposed rule and its preamble to plants that could otherwise have been developed through ‘‘traditional breeding methods’’ to mean any type and extent of genetic change that is theoretically possible through conventional breeding methods. There are many biological and practical factors that affect a plant breeder’s ability to develop a new crop variety by introducing genetic variation and intentionally selecting for desired traits. These include the number of targeted loci and type of desired genetic changes, the genetic distance between the desired changes, generation time, breeding system (sexual or asexual, selfcompatibility), ploidy level and genomic complexity, resource availability (time, money, labor, and genomic resources), and other factors. These factors, and thus the extent of intentionally selected genetic variation that can be introduced, vary widely among plant species. Moreover, new plant breeding techniques can make possible more complex combinations of PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 29793 genetic modifications than can practically be achieved through conventional breeding methods (Custers, et al., 2019; Wolter, et al., 2019; Najera, et al., 2019). Currently, APHIS lacks sufficient familiarity to develop a risk-based exemption for products containing complex combinations that might be produced in the future. APHIS is clarifying that the exemptions listed in § 340.1(b)(1) through (3) are based on types of modifications that are easily recognizable to the developers of the organism and on genetic changes that could be practically achieved by conventional breeding methods in any plant species. However, over time, APHIS expects to gain more familiarity with the products of these new plant breeding innovations. Accordingly, we are revising § 340.1(b) to establish a process for listing additional modifications that plants can contain while still being exempted from the regulations. This process is specified in paragraph (b)(4) of § 340.1 in this final rule. Some commenters inquired how the exemptions in proposed § 340.1(b)(1) through (3) pertain to combinations of genetic modifications or to sequential edits. For example, would a deletion and a single base substitution made at the same time in a plant qualify for exemption? If a single change is made to a plant, when could another change be made that qualified for an exemption? Some commenters argued that there is no valid scientific reason that the exemptions should not allow multiple simultaneous genomic changes to be made. Other commenters asked us to reaffirm that the exemptions are limited to only a single genome editing change, and that a plant containing multiple changes made at the same or different times would not be exempt, or that we delete the exemptions altogether, since genome edits could be made sequentially such that each intermediate organisms would be exempt, cumulatively resulting in a final organism with many targeted changes that would also be exempt. Several commenters requested that APHIS include a process for adding new categories of exemptions and revising exemptions in order to ensure that the regulatory system stays up to date and keeps pace with advances in scientific knowledge, evidence, and experience. APHIS seeks to clarify that exemptions listed in § 340.1(b)(1) through (3) apply to plants containing single targeted modifications. The exemptions were formulated to apply to what could otherwise be achieved through conventional plant breeding E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29794 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations techniques in any species. As discussed above, the plants that are eligible for exemption would have no increased plant pest risk than conventionally bred plants. APHIS realizes that in some species, a single targeted modification is often less than what could otherwise be developed through conventional breeding. However, as noted above, the extent of intentionally selected variation that could otherwise be introduced through conventional breeding varies depending on the plant species. To establish clear and unambiguous exemptions that could apply to any plant species while enabling for variation in what can be achieved through conventional breeding, APHIS has revised the regulatory text in § 340.1(b). Initially, the exemptions will apply only to plants containing a single targeted modification in one of the categories listed. APHIS anticipates scientific information and/or experience may, over time, allow APHIS to list additional modifications that plants can contain and still be exempted from the regulations so that the regulatory system stays up to date and keeps pace with advances in scientific knowledge, evidence, and experience. This may include multiple simultaneous genomic changes. If the Administrator determines that it is appropriate to list additional modifications, APHIS will notify the public in the Federal Register and will take public comment. After reviewing the comments, APHIS will issue a subsequent notice announcing its determination. This process is provided in new paragraph (b)(4) in § 340.1. One commenter requested that APHIS document examples of deletions of any size that could be made by conventional breeding. The first exemption allows a single deletion of any size because radiation can create any size deletion. As mutations are typically detrimental to the organism, what is achievable in practice is limited by the viability and fertility of the organism. Large mutations can be maintained in a heterozygous state but do not tend to undergo homozygous inheritance (Naito, 2005). For example, in Arabidopsis, which has a genome size of 135 Mb (Arabidopsis Genome Initiative, 2000), a radiation-induced deletion of 3.1 Mb was obtained that disrupted 852 genes and was maintainable only as a heterozygote presumably because genes essential for survival are present in the deleted region (Kazama, et al., 2017). Polyploid plants and those with large genomes are better able to accommodate even larger deletions (Men et al., 2002). VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 For example, in hexaploid wheat, X-ray mutagenesis was used to create a mutant, Ph1-, widely used in breeding programs, that has a 70 Mb deletion (Sears, 1977). To put the size of this deletion in perspective, it is larger than half of the entire genome of Arabidopsis. Some commenters recommended that the exemption in § 340.1(b)(1) be broadened to allow for insertions that occur during the natural DNA repair mechanism after double-strand break of the DNA. In the proposed rule, the exemption in paragraph (b)(1) mentions only deletions. APHIS agrees with the comment. Deletions, small insertions, and combinations of deletions and insertions are all possible outcomes resulting from the cellular mechanisms used to repair DNA breaks that occur naturally or that are induced during conventional plant breeding, and all have been used in conventional plant breeding (Manova and Gruszka, 2015; Wang, et al., 2016). The exemption in § 340.1(b)(1) has been revised to reflect all of the possible outcomes of natural DNA repair mechanisms that occur in the absence of a deliberately provided repair template. A commenter asked that APHIS eliminate the exemptions for deletions and single base pair substitutions, arguing that any type of change in a gene sequence can potentially cause phenotypic changes that have significant consequences. APHIS disagrees with this argument. Naturally occurring single base pair substitutions and deletions are commonly induced and are widely used to generate new crop varieties in conventional mutation breeding, which includes both chemically induced and irradiation-based mutagenesis (Oladosu, et al., 2016; Kharkwal, 2012; Ahloowalia and Maluszynski, 2001). The targeted single base pair substitutions or deletions covered by these exemptions are the same in kind as, and do not pose any increased plant pest risks than, the substitutions or deletions introduced through conventional breeding. Thus, they should not be subject to the regulations. Many commenters argued that limiting the exemption in proposed § 340.1(b)(1) to a single deletion and the exemption in § 340.1(b)(2) to a single base pair substitution does not take into account that multiple base pair substitutions and/or deletions are routinely and safely introduced into plants using conventional breeding methods, including mutagenesis. The argument that multiple substitutions or deletions can occur PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 through conventional breeding methods, including mutagenesis, seems to be conflating the specific targeted changes that can be made via genome editing techniques with the multiple random changes that occur during conventional breeding, only one or few of which might contribute to the desired phenotype. In the case of random chemical or radiation mutagenesis, thousands of mutations are introduced into the plant but most are detrimental, or neutral at best. The fact that multiple mutations exist in the plant is a negative feature that needs to be overcome by laboriously self-fertilizing or backcrossing the mutated plant for multiple generations. Even then, a developer may not find an agronomically suitable phenotype. By applying selection, it is possible, though at a very low frequency, to get two desirable mutations in a single mutated line if the mutations are unlinked. It is improbable to get two linked mutations in a single line, particularly if the mutations are sought within the same gene. In contrast, genome editing can easily introduce multiple beneficial changes in one generation, leading to phenotypes that we have not seen by conventional breeding. The exemptions listed in § 340.1(b) are based on measures that are easily defined, are based on familiarity, and thus are meant to be limited to genetic changes that could practically be achieved by conventional breeding methods in any plant. It is not possible to define a number of such changes greater than one which could practically be achieved by conventional breeding methods in all plant species. The number of changes that can practically be achieved through conventional breeding methods can vary widely from one species to another. For this reason, APHIS is retaining the limitation of a single modification, as this approach ensures that we can identify those plants that pose a plant pest risk. We anticipate that most plants that are not eligible for the exemption and do not pose a plant pest risk will pass through the RSR process quickly. In addition, as noted above, we are revising § 340.1(b) by adding a new paragraph (b)(4) that establishes a process for listing additional modifications that plants can contain while being exempted from the regulations, based on what could be achieved through conventional plant breeding. Thus, while the exemptions in § 340.1(b)(1) through (3) will initially apply only to plants containing a single modification in one of the categories listed, APHIS anticipates that scientific information and/or experience will, E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations over time, allow multiple and sequential changes in some species after public notice and comment. The introductory text of § 340.1(b)(4) provides that the Administrator may propose to exempt plants with additional modifications, based on what could be achieved through conventional breeding. Such proposals may be APHIS-initiated, or in response to a request. Paragraph (b)(4)(i) sets forth the process for APHIS-initiated proposals. APHIS will publish a notice in the Federal Register of the proposal by the Administrator to exempt plants with additional modifications. The notice will make available any supporting documentation, and will request public comment. After reviewing the comments, APHIS will publish a subsequent notice in the Federal Register announcing its final determination and responding to the comments received. Under paragraph (b)(4)(ii), any person may request that APHIS exempt plants developed with additional modifications that could be achieved through conventional breeding. The request will have to include the following supporting information, in writing: • A description of the modification(s); • The factual grounds demonstrating that the proposed modification(s) could be achieved through conventional plant breeding; • Copies of scientific literature, unpublished studies, or other data that support the request; and • Any information known to the requestor that would be unfavorable to the request. Paragraph (b)(4)(iii) provides the timeframe for Agency review of such requests. It provides that, after APHIS receives all the information required for a request, APHIS will complete its review of the request and render a final determination within 12 months, except in circumstances that could not reasonably have been anticipated. Under paragraph (b)(4)(iv) if, after review of the request, APHIS disagrees with the conclusions of the request or determines that there is insufficient evidence that the modification could be achieved through conventional breeding methods, APHIS will deny the request and notify the requestor in writing regarding this denial. Paragraph (b)(4)(v) provides for Agency actions when we agree with a request. It states that, if APHIS initially determines that the modification could be achieved through conventional breeding methods, APHIS will publish a VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 notice in the Federal Register in accordance with the process set forth in § 340.1(b)(4)(i). Under paragraph (b)(4)(vi), a list specifying the additional modifications allowed will be posted on the APHIS website at https://www.aphis.usda.gov/ aphis/ourfocus/biotechnology. This list would include both those additional modifications originally proposed by the Administrator and those that originate with a request. Some commenters suggested a change to the exemption in proposed § 340.1(b)(2) so that it would allow a limitless number of synonymous base pair changes. Synonymous base pair changes, it was stated, do not alter the amino acid composition of the encoded protein. One commenter suggested changing the exemption to allow however many specific and known base pair changes are needed to achieve the intended MOA. APHIS rejects the first suggestion because synonymous changes can lead, and indeed have been made, to generate significant phenotypic changes, e.g., by altering mRNA splice sites, promoters, and regulatory RNAs. APHIS acknowledges that these types of phenotypic changes could, in principle, also occur through a single deletion, insertion, or base pair change in conventional breeding. However, these types of phenotypic changes are unlikely to be possible in all or perhaps even most genes through deletion or single base pair changes. Moreover, multiple targeted changes within a single gene are generally not likely to be achieved in conventional breeding. Therefore, the exemption will not be broadened to include multiple synonymous base pair changes. However, as discussed below under this same subheading of comment responses, we have revised the exemption in § 340.1(b)(3) to clarify that if multiple sequence changes are needed to generate an allele that will result in the intended phenotype and if those changes are known to occur in the plant’s gene pool, the GE plant would qualify for the exemption. One commenter stated that APHIS should eliminate the exemption in paragraph (b)(3), regarding introducing variation known to occur in the gene pool, because sequences found naturally in closely related, sexually compatible organisms do not necessarily have acceptable risks when introduced into other species. The commenter offered an example, stating that ‘‘the introduced nucleic acids can direct the synthesis of toxins, change metabolism in harmful ways, turn on or off genes and metabolic pathways in the genetically engineered PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 29795 host, and make the genetically engineered organism more susceptible to pests and pathogens, or more fit in the wild and more weedy.’’ APHIS disagrees with the comment. The commenter is pointing out harms that potentially could occur, and are no less likely to occur, in conventional breeding programs. However, such harms have not materialized in conventional breeding programs because they rarely occur and are intentionally eliminated during the evaluation and selection process (NRC, 1989). One commenter wished to know whether the exemption in proposed § 340.1(b)(3) supersedes the exemption in § 340.1(b)(1) and (b)(2). Another commenter felt that the exemptions in paragraphs (b)(1) and (b)(2) were too narrow because polymorphisms, insertions, inversions, and multiple megabase deletions and translocations are abundant in nature and frequently induced in breeding programs through mutagenesis. APHIS seeks to clarify that § 340.1(b)(3) does supersede § 340.1(b)(1) and (b)(2) in the number of changes that can be made under the exemption. APHIS also seeks to clarify that paragraphs (b)(1) and (b)(2) pertain to products of mutagenesis which have not been observed in the gene pool, whereas paragraph (b)(3) applies only to variation already known to occur in the gene pool. Therefore, the exemption in paragraph (b)(3) allows the introduction of a gene, i.e., a functional unit of DNA that encodes an RNA or protein, or of an allele (a variant form of a gene or, for the purposes of this regulation, a genetic sequence) containing multiple sequence changes as long as the allele is known to occur in the gene pool of the plant. With regard to the comment that the exemptions in paragraphs (b)(1) and (b)(2) are unnecessarily restrictive because there are changes abundant in nature not covered by these exemptions, APHIS wishes to clarify that the duplications, inversions, translocations, and transpositions already known to occur in the gene pool would qualify under the exemption in paragraph (b)(3). Some commenters suggested deleting ‘‘natural’’ from § 340.1(b)(3) because the gene pool of a plant may include variation that has been previously induced through chemical or radiation mutagenesis or that could be introduced via human-assisted wide crosses. Further comments on the exemption in paragraph (b)(3) recommended substituting the phrase ‘‘known to occur’’ with some variation of E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29796 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations ‘‘otherwise accessible through traditional plant breeding methods.’’ APHIS agrees with the first comment and disagrees with the second. APHIS considers the known and accessible gene pool of a plant to include not only genetic sequences that can be introduced to a plant via crosses that can take place without human assistance, but also genetic sequences that can be introduced to a plant via human-assisted wide crosses between distantly related species. In systems for which breeding techniques such as bridging and embryo rescue have been developed to enable wide crosses, distantly related plants are also considered part of the gene pool. However, these categories may not be considered ‘‘natural,’’ so APHIS is in favor of deleting this term. APHIS is retaining the phrase ‘‘known to occur,’’ however. As discussed above, when we refer to GE plants that could otherwise have been developed through conventional breeding methods, we do not mean any genetic changes that are theoretically possible. Almost any genetic change is theoretically possible, given enough time. APHIS’ intention in § 340.1(b)(3) is to exempt from regulation a product that could be practically expected to be pursued and achieved in a conventional breeding program. To qualify for an exemption based on occurrence in the gene pool, the genetic change must be known to occur. We do not intend the exemption to apply to limitless possibilities that are theoretically possible but not currently known to occur in the gene pool. Consequently, the exemption in paragraph (b)(3) has been slightly modified for accuracy and clarity. Some commenters asked that the exemption in paragraph (b)(3) be expanded to include plants in which an allele has been modified to align with a similar known allele found in a close relative, or in a more distant relative beyond the family level of taxonomy, or that we exempt plants containing any sequence from a plant that is known not to be a plant pest and is routinely used for food. APHIS considers the known and accessible gene pool of a plant to include not only genetic sequences that can be introduced to a plant via crosses that can take place without human assistance, but also human-assisted wide crosses between more distantly related species. In systems for which breeding techniques such as bridging and embryo rescue have been developed to enable wide crosses, more distantly related plants are also considered part of the known gene pool. APHIS agrees in principle that exchange of genetic VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 information between unrelated species is likely to be safe in most cases. However, APHIS does not have the experience to definitively state that exempting all exchange of DNA between plants will not lead to increased plant pest risk. In cases where genetic material from a more distantly related plant species is introduced into the plant, developers can request an RSR. A commenter stated that their understanding is that the exemption in § 340.1(b)(3) would include any insertion or other sequence modification of less than 20 base pairs. APHIS disagrees and seeks to clarify that even an insertion or sequence modification smaller than 20 base pairs that does not otherwise qualify for exemptions § 340.1(b)(1) or (b)(2) still has to meet the criteria of paragraph (b)(3) to qualify for exemption under paragraph (b)(3). The exemption does not apply to what is theoretically possible. The genetic variation must be known to occur in the plant’s gene pool in order to qualify for the exemption. A commenter stated that the regulation could clarify that exemption under paragraph (b)(3) covers the introduction of natural or chemically synthesized copies of nucleic acid sequences from one plant species into the same or a crossable plant species, including (a) the targeted insertion or replacement of sequences exceeding 20 base pairs in length (e.g., the insertion or replacement or a promoter, terminator, exon, intron, or small open reading frame, excluding complete genes), (b) the targeted replacement of a cisgenic allele (i.e., perfect allelic replacement), (c) the targeted insertion of a cisgenic sequence at the same or a different location in the genome of the recipient species, and (d) the targeted insertion of a cisgene with a new combination of genetic elements, as plants containing such changes could have occurred naturally or could result from conventional breeding since they fall under exemption under paragraph (b)(3). A second commenter stated that some genetic engineering experiments will replace promoters, altering gene expression patterns in ways that are not attainable by today’s breeders. APHIS does not intend to modify the regulation text per the commenter’s suggestion. Exemption under paragraph (b)(3) will exempt from regulation plants that have been modified to introduce a gene known to occur in the plant’s gene pool, or that make changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool. Some of the examples provided by the first commenter may PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 thus not be eligible for exemption under paragraph (b)(3). For instance, (b)(3) will not exempt from regulation a plant containing an insertion of a gene that is known to occur in the gene pool if the insertion results in the creation of a gene not known to occur in the gene pool, e.g., a gene that results in the production of a protein or RNA, or a loss or gain of function, that is not known to be produced by plants within the gene pool. However, if a specific modification can be demonstrated to be present in the plant’s gene pool, then it can be exempted under paragraph (b)(3). If a developer has a question about whether its plant is exempt from the regulation, the developer can contact APHIS for a consultation. Some commenters asked how the deletion exemption in § 340.1(b)(1) pertains to diploid and polyploid plants. For example, if a deletion is made to both alleles of a diploid or all four or six alleles in tetraploid and hexaploid plants, respectively, would those plants qualify for the exemption? APHIS seeks to clarify that exemptions in § 340.1(b)(1) through (3) apply to modifications made to one pair of homologous chromosomes. It is very straightforward in conventional breeding to identify a single allele in a diploid line and then convert the heterozygote to a homozygote in the next generation. However, it is very difficult through conventional breeding to create the same allele in all homoeologous genomes in polyploid plants. Therefore, for polyploid plants, the exemptions would initially apply only to modifications made to one pair of homologous chromosomes. As an example, consider a change to a gene in common wheat (bread wheat). Common wheat has three sets (AA BB DD) of homoeologous chromosomes. A developer can qualify for the exemption if modifying the A genome through a change that qualifies for exemption (b)(1), (b)(2), or (b)(3). If the developer wanted to make the same corresponding changes to the B and D genomes, the developer would go through the RSR process (as described below). Once APHIS determines that this A/B/D plant is unlikely to pose an increased plant pest risk, it will go on the list of planttrait-MOAs that do not require regulation (i.e., the § 340.1(c) exemption list). At that point, this developer, and any others, would be able to make the same plant-trait-MOA combination and be exempt from regulation under part 340. Some commenters noted that the exemption in proposed § 340.1(b)(4), i.e., the exemption of null segregants derived from GE plants, is superfluous E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations because the definition of genetic engineering applies only to organisms whose DNA sequence has been modified. APHIS agrees with these commenters. According to our definition of genetic engineering, the genome of null segregants has not been created or modified. Therefore, null segregants do not need an exemption from regulation, and APHIS is removing this exemption from the final rule. Some commenters stated that the exemption in proposed § 340.1(c) for a GE plant with a plant-trait-MOA combination that has previously undergone an analysis in accordance with § 340.4 and has been found by the Administrator to be unlikely to pose a plant pest risk should be eliminated. One commenter stated that the impact of releasing new GE plants into the environment cannot be accurately predicted or assessed without case-bycase analysis and controlled field experiments. Another commenter stated that every transformation event is unique, and thus potentially has a novel phenotype that must be assessed to determine appropriate regulation. The commenter further stated that the National Academy of Sciences (NAS) has also advocated the use of genetic engineering [i.e., transformation] as ‘‘both a useful and scientifically justifiable regulatory trigger’’ because ‘‘there is no scientific basis’’ on which to exclude GE organisms from regulatory review prior to evaluation of data on the interactions between ‘‘trait, organism and environment.’’ APHIS disagrees with these points. Based on the risk assessments we have performed in accordance with the petition process over 30 years, we have determined that, in many cases, we would have been able to evaluate the plant pest risks associated with a GE organism without field-test data. Rather, APHIS has discovered that the introduced trait of the GE organism provides the most reliable indicator of the organism’s potential for deleterious effects on plants and plant products. These observations are expected and are consistent with the findings of reports of NAS (NRC, 1989; NAS, 2016). APHIS will seek additional information, potentially including data from controlled field experiments, in cases where APHIS identifies a plausible pathway to increased plant pest risk. The same NAS study (NRC, 2002) cited by the commenter stated the following: ‘‘Transgenic organisms have potential environmental risks, but the committee expects that most of them will not produce significant actual environmental risks. Consequently, the VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 committee also suggests that for environmental risk regulatory oversight should be designed to winnow the potentially riskier transgenic crops from the less risky ones before a substantial regulatory burden is imposed on the less risky ones.’’ APHIS has designed a system where organisms that pose a plausible plant pest risk are rapidly distinguished from those that do not, based on the RSR process described below under the subheading ‘‘Regulatory Status Review,’’ focusing regulation on the former. The exemption that we proposed in § 340.1(c) will apply only to those GE plants that have undergone a risk assessment in the RSR process. The revised regulations are proportionate to risk and are therefore consistent with the recommendation of NAS’s study. Several comments were received on the definition and application of the term MOA as it relates to the exemption in § 340.1(c). The issues raised by the commenters are discussed in detail below. Two commenters stated that the categories of trait (defined in the June 2019 proposed rule as ‘‘an observable (able to be seen or otherwise identified) characteristic of an organism’’) and MOA (defined as ‘‘the biochemical process(es) through which genetic material determines a trait’’) could be interpreted so broadly that new GE plants that have a plant-trait-MOA combination similar to that of a nonregulated plant, yet contain unique features with unknown impacts on nontarget organisms and the surrounding ecosystem, would not require review by APHIS. They stated that, for example, the ‘‘Cry 6 protein MOA’’ could include dozens of possibilities with unknown effects, and that it could even be the case that APHIS review would not be required when any gene encoding a Cry protein that targets broad orders of insect pests is inserted into a plant that had previously been engineered with any other trait and had been found by APHIS not to pose a plant pest risk. APHIS disagrees with the suggestion that the proposed definition of MOA is too broad. The suggestion is based on a misreading of the definitions and the preamble of the June 2019 proposed rule. As described in the preamble, the MOA refers to the specific manner by which the genetic modification confers the intended trait on the plant. We noted that the same trait can be obtained by different MOAs that would thus be 6 A Cry protein is a crystalline protein toxic to certain species of insects primarily produced by the bacterium Bacillus thuringiensis (Bt). Genes for Cry proteins have been widely used to confer resistance to insect pests in several types of crop plants. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 29797 subject to distinct RSRs. In the example cited, the preamble was clear that nontarget impacts related to Cry proteins depend on whether the non-target insect has the correct receptor in its gut to bind the Cry protein; thus, for each new Cry protein it will be important to evaluate the potential for non-target impacts. Similarly, the preamble provided an example of RNA interference-based resistance, where it would be important to consider the specific target RNA and its corresponding protein in order to determine whether there could be nontarget effects. Moreover, the regulatory text and preamble were clear that it is the specific plant-trait-MOA combination that is the subject of the RSR and decision. Developers could not qualify for exemption under § 340.1(c) by inserting any cry gene that encodes a protein targeting a broad order or orders of insects into a plant with any other trait and MOA that was previously reviewed by APHIS. Another commenter stated that reasonably broad MOA categories should be established that would cover broad protein functional classes, account for all normal polymorphisms found in nature at the DNA and protein levels at the genus level, and account for the normal wide variation in expression seen among transgenic events and backgrounds. An additional commenter recommended that the definition of MOA refer to the biochemical process(es) through which the gene, rather than the genetic material, determines a trait, stating that it is a gene product and not the genetic material that determines the resulting biochemical process. Finally, a commenter requested that the final rule clarify which products would qualify for the exemption in § 340.1(c), noting that APHIS alternately used the terms ‘‘same’’ and ‘‘similar’’ to describe products that could qualify based on their use of a crop-trait-MOA combination that has already been assessed by APHIS and determined unlikely to pose a plant pest risk than the appropriate comparator(s). APHIS agrees that in most cases, the MOA could cover all normal polymorphisms of a gene found in nature, even at levels broader than the genus. For example, the outcome of an RSR would apply to genetic material encoding an enzyme that catalyzes a specific biochemical reaction regardless of whether the genetic material is sourced from a plant or a microbe, as long as the enzyme catalyzes the same biochemical reaction regardless of the organism from which the genetic material encoding the enzyme is obtained, and does not catalyze any E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29798 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations additional biochemical reactions that differ among the source organisms. APHIS does not agree that the MOA would be so broad as to cover broad functional classes, since broad functional classes could encompass many different proteins that have multiple differences in the biochemical processes in which they participate. Typically, an RSR would be conducted at the level of the MOA of individual genes. If those genes when stacked produce a new phenotype, such as a new biochemical pathway, APHIS will consider the interaction of the gene products in the RSR. Regarding variation in expression, in most cases APHIS anticipates that variation in expression should not affect the outcome of an RSR. However, as we noted in the preamble to the June 2019 proposed rule, there may be cases where it is important to consider where, when, or at what level the genetic material is expressed in the plant. In those cases, APHIS will specify whether and in what way variation in expression limits the outcome of the review. APHIS will not revise the definition of MOA in response to these additional comments, because some MOAs may not involve changes in gene products but rather changes in genetic material that affect the expression of gene products. As this discussion makes clear, a plant-trait-MOA combination may qualify for the exemption only if the combination is the same as a previously reviewed plant-trait-MOA combination that has been found to be unlikely to pose a plant pest risk. To be clear, a merely ‘‘similar’’ combination does not qualify as a ‘‘same’’ combination, but a ‘‘similar’’ product may qualify for the exemption if it has the same combination as a previously reviewed combination. One commenter urged that in addition to mutated products of genome editing, the concept of exemptions due to familiarity should be broadened to include plants with transgenic traits that are familiar in type and inherently unlikely to give a significant advantage to wild plants. Examples would be sterility traits, stature reduction traits, and quality traits relevant to industrial processing (e.g., modified lignin in alfalfa and trees). According to the commenter, another class of strong candidates for plant kingdom-wide exemption are the widely used marker genes, such as nptII for kanamycin resistance, T–DNA borders, and widely used promoters such as 35S and NOS. APHIS appreciates these comments. The commenter did not provide any scientific evidence or explanation that VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 would make the comments actionable at this time, however. Several commenters asked that APHIS clarify the regulation of plants containing stacked traits. One commenter requested that APHIS codify in the regulations that plants developed through conventional breeding that are derived from products determined to not be regulated (either because of an exemption or as a result of an RSR) would themselves be unlikely to pose increased plant pest risk and therefore would not be subject to regulation. Other commenters argued that APHIS should assess the risks of stacked traits, particularly plants containing multiple herbicide resistance traits, using the noxious weed authority. A discussion of our noxious weed authority in the context of these regulations is presented later in this document. APHIS notes that in accordance with § 340.1(c), the regulations under part 340 do not apply to a GE plant with a plant-trait-MOA combination that has previously undergone an analysis in accordance with § 340.4 and is not subject to the regulations. APHIS notes that the word ‘‘combination’’ used in the regulation text is deliberately enumerated as singular and not plural in order to denote that the exemption applies to a single plant-trait-MOA combination and not a molecular stack of multiple plant-trait-MOA combinations. Plant-trait-MOA combinations that have undergone an analysis in accordance with § 340.4 and are not subject to the regulations may be stacked by conventional breeding methods and would still qualify for the exemption. However, this is not the case for plant-trait-MOAs stacked molecularly; today stacked traits typically have independent MOAs. In the future, we anticipate seeing more interactions between or among the products of genes in molecular stacks, potentially including new MOAs that were not evident in the review of individual traits. For this reason, APHIS anticipates that plants that are the genetically engineered product of more than one previously evaluated combination will be subject to evaluation under § 340.4. In cases where there is no interaction between traitMOA combinations, we expect to be able to use the results of previous reviews to quickly reach a regulatory status determination. Finally, several commenters requested clarity on the regulatory status of planttrait-MOA combinations that were previously deregulated under part 340 or deemed to be not regulated under the ‘‘Am I Regulated’’ (AIR) process. PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 To provide the clarity the commenters requested, we are amending paragraph (c) to exempt from these regulations a GE plant that has a plant-trait-MOA combination contained in a GE plant determined by APHIS to be deregulated under a petition submitted prior to October 1, 2021 pursuant to § 340.6 of the current regulations in part 340. We are also adding a new paragraph (d) to § 340.1, stating that all GE plants determined not to require regulation pursuant to the AIR process will retain their nonregulated status under these regulations. As we have noted, APHIS will publish a list (referred to earlier in this document as the § 340.1(c) exemption list) of plant-trait-MOA combinations that have been evaluated under our new RSR process and found not to require regulation under part 340. That list may be used by a developer to determine whether its novel GE plant would qualify for exemption under § 340.1(c). GE plants previously evaluated under the petition process will be included on the § 340.1(c) exemption list because such plants will have effectively been evaluated at the MOA level and determined not to pose a plant pest risk. Plants that have been determined not to require regulation pursuant to the previous AIR process will not be included on the § 340.1(c) exemption list because they will not have been evaluated at the MOA level or by analogous criteria. Such plants will be identified at a separate list, at https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology. Because the plants to be identified on this separate AIR list were not evaluated under the petition process or under the RSR process, developers will not be able to use the AIR list in determining whether new GE plants they develop should be subject to or exempt from the regulations. At the same time, we have multiple reasons for concluding that the specific plants on the AIR list should retain their nonregulated status under these regulations. Not only do we lack a basis for overturning our prior individualized determinations reached pursuant to the AIR process, we also believe that it is appropriate for us to take into account the importance of preventing potential market disruptions, including potential trade disruptions, and providing regulatory certainty for developers, third parties, and the general public. Self Determination Under the June 2019 proposed rule, developers would have the option to determine whether their plants belong to one of the categories listed under § 340.1(b) or (c) and are therefore E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations exempt from the regulations. As stated in the preamble to that proposed rule, allowing for such ‘‘self-determinations’’ would provide developers with regulatory relief and would open more efficient and predictable pathways for innovators to get new modified plants that do not require regulation to market, in turn supporting further innovation. Eliminating the need for redundant evaluations of products would allow APHIS to devote more attention to assessing and regulating GE organisms that are likely to be associated with potential plant pest risks. While many commenters agreed with the rationale discussed above and welcomed the regulatory relief that allowing for developer ‘‘selfdetermination’’ would provide, others either opposed the concept entirely or expressed reservations. Many in the latter category cited what they believed to be potential risks that could result from allowing developers to determine whether their products are eligible for exemption from the regulations. Some industry commenters questioned whether allowing developers to make such determinations would actually relieve regulatory burden and incentivize innovation to the extent that we anticipated. The comments are discussed in detail in the paragraphs that follow. Many commenters opposed ‘‘selfdetermination’’ on the ground that allowing developers to regulate themselves could result in conflicts of interest. It was stated that developers of GE products with a financial stake in the outcome should not be allowed to determine which products should be subject to regulatory review. According to these commenters, such an approach would fatally undermine the integrity, rigor, and credibility of what must be an independent regulatory process, weakening Agency ability to protect the public interest, and furthering mistrust in the U.S. Federal regulatory system in the public’s eye and among key trading partners. By avoiding the RSR or permitting process, these commenters believed, the developer could get its new product to market without its ever having undergone an objective, thirdparty review. In allowing developers to determine whether their products are eligible for exemption, according to these commenters, we are effectively abdicating our regulatory authority and not carrying out our mission to protect U.S. agriculture. We do not agree with these comments. The revised regulations in part 340 recognize that plant products that are the result of modifications that coincide with conventional plant VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 breeding do not pose additional plant pest risk and should not be regulated under these regulations. Products that do not fall within the regulatory scope of part 340 have not been subject to compulsory regulation in the past, and developers have always been able to act accordingly to determine whether their products are subject to the regulations. It was further argued that allowing developers to determine the regulatory status of their products will result in less transparency and greater risk of commingling with organic and other non-GE crops and will damage consumer confidence. Allowing developers to determine the regulatory status of their products, it was claimed, will result in an overall loss of transparency in that the public would not have access to the data used by developers to make their determinations. Organic farmers would have less information about modified crops grown near their fields than they do now, because the information that informed developers’ determinations would remain proprietary, and their ability to take preventive measures would be hindered. Some commenters cited the recent finding in Washington of unapproved GE glyphosate-resistant wheat 7 as an example of risks posed by allowing developers to determine whether their products are eligible for exemption and by reducing our regulatory oversight over GE products more broadly. We do not agree with these comments. With regard to transparency, we anticipate that many developers whose products fall within an exemption will request confirmation letters because the letters will help them market their products domestically and overseas. Those letters will be posted on the APHIS website and will be available to the general public, including organic and other growers of non-GE crops. Information from previous RSRs will also be available to the public. We do not agree that self-determinations will limit organic growers from learning whether their neighbors are growing GE crops. This information principally comes from conversation with neighbors 7 On June 7, 2019, APHIS confirmed the discovery of GE wheat plants growing in an unplanted agricultural field in Washington State. The GE wheat in question was resistant to glyphosate, commonly referred to as Round Up. On July 12, 2019, APHIS announced that the GE wheat plants in question were developed by Monsanto (now owned by Bayer CropScience (BCS)) and referred to as MON 71300 and MON 71800. APHIS also announced that there is no evidence that any GE wheat entered commerce or is in the food supply. https://www.aphis.usda.gov/aphis/ ourfocus/biotechnology/brs-news-andinformation/ 2019_brs_news/wheat_update_jul2019. PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 29799 and from other voluntary interactions and arrangements, and is not based on USDA decisions on regulatory status. We also do not agree that the finding of GE wheat in Washington fields is relevant to the regulatory changes made in this final rule. Under the new regulations set forth in this final rule, the GE wheat involved in the incident would not be eligible for an exemption and would need to go through the RSR process. The commenters are generally confusing a fact-specific compliance issue, which could arise under any number of regulatory schemes, with broader questions about the appropriate regulatory approach. If APHIS were to find that a plant was unlikely to pose an increased plant pest risk, APHIS would make information publicly available regarding the plant, trait, and a general description of the MOA. In cases where GE crops are not subject to regulation because they are unlikely to pose a plant pest risk, no other risks are regulated by APHIS insofar as they are outside the scope of the regulations. In the preamble to the June 2019 proposed rule, we stated that a developer who made a determination of regulatory status that APHIS found not to be valid would be subject to remedial measures or penalties in accordance with the compliance and enforcement provisions contained in § 340.6 of the June 2019 proposed rule. Some commenters stated that there is a need for a plan for detection and enforcement in cases where developers incorrectly determine their products to be non-regulated, or where changes in evidence may call a developer’s determination into question. Without a record of what plants are being released, according to these commenters, it will be impossible to conduct any kind of periodic surveillance or audit to ensure compliance. These commenters believe that this difficulty may be partly addressed by having a compulsory reporting mechanism whereby a responsible party fills out a form to declare its modification and assert its exempt status. This would create a searchable record. According to such commenters, a database compiled from self-reported data would not offer complete protection against bad actors, but when combined with penalties that are proportional to the degree of harm done by a developer incorrectly making a determination, such a database may aid in correcting incorrect determinations by developers. APHIS disagrees with the proposal for a mandatory process and the data base proposals associated with it and has instead included provisions in part 340 for a voluntary confirmation process for E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29800 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations products exempted from the regulation. Voluntary confirmation will be public information, however, and interested parties could search for it of their own volition. Under APHIS’s long-standing regulations, APHIS regulates articles based only upon a narrow and limited plant pest mechanism. The products that commenters are concerned will be ‘‘missed’’ or ‘‘overlooked’’ in the ‘‘future’’ have no current regulatory trigger. Under this rule, APHIS’ focus will be on plant pest risk associated with the product, consistent with our legal authority. Consistent with longstanding practices, we will continue to offer voluntary confirmation of regulatory status to those who seek it. APHIS agrees with comments expressing concern that a mandatory process may trigger confusion among both consumers and the international trading partners, by unnecessarily hindering global acceptance of products of biotechnology. That said, if the market demands confirmation of regulatory status, APHIS has created a mechanism for developers to request such confirmation, and for us to provide it. APHIS also notes that a large number of commenters supported the kind of voluntary confirmation process contained in this final rule for regulatory exemptions, noting public access to the confirmation letters. Those comments noted that a voluntary process would provide domestic and international transparency, be beneficial for marketing of new products, support deregulation processes in other countries, facilitate exports, facilitate the development of new genome edited plant varieties, encourage the continued domestic and global adoption of new traits, and enhance harmonization of global trait approvals. If a plant pest issue arises from a plant that is exempt from these regulations, APHIS has mechanisms to address such risks subsequently and has a wealth of experience in dealing with such instances. As under the current regulations, a developer could knowingly or unknowingly violate APHIS regulations by transporting, importing, or releasing into the environment a regulated plant without APHIS authorization. The PPA contains authority for the Administrator of APHIS at any point to place such articles under regulation. If a determination made by a developer should be found to be invalid, however, APHIS does have the authority to enforce sanctions. As noted in the preamble to the June 2019 proposed rule, pursuant to sections 7714 and 7731 VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 of the PPA, APHIS may seize, quarantine, treat, destroy, or apply other remedial measures to an organism covered under the regulations that is new to or not widely prevalent or distributed in the United States to prevent dissemination of the organism. Enforcement provisions are also included in § 340.6 of this rule. APHIS has many years of experience in initiating and coordinating enforcement action as appropriate, in cases where compliance issues exist. Even in cases where we would impose penalties for invalid determinations by developers, some commenters expressed skepticism that those penalties would be efficacious in remediating harm or preventing further harm. In the view of these commenters, if the movement or release of a GE product that had already reached the market based on a faulty determination by a developer resulted in commingling with other crops or the dissemination of plant pests, whatever penalties or remedial actions APHIS would impose would likely neither prove adequate to address injuries to innocent parties nor provide sufficient disincentives to discourage bad actors from making invalid determinations. Elaborating on the latter point, one commenter stated that penalties imposed by APHIS after the fact may not even be legally defensible if we have allowed a developer to determine whether its product is eligible for exemption. Another commenter stated that APHIS, lacking a post-commercialization monitoring program, has little capacity to recall the products of invalid determinations by developers. We do not agree with these comments. In the event that APHIS discovers that a developer makes an invalid determination, the specific penalties and/or remedial action will be applied case by case, as appropriate. Similarly, whether the discovery of an invalid determination is too late will also be decided on a case-by-case basis. In regard to legal defensibility, the PPA provides ample flexibility and broad civil penalty authority to deter violations of the PPA. For example, the PPA provides statutory maximum penalties of $1,000,000 per violation for any person who willfully violates the PPA. Other commenters feared that the penalties could be excessive. It was stated that any such penalty applied to a developer must be based on a demonstration of significant economic harm to another entity from the error, and not on technical or minor errors in interpretation. The commenters further stated that in such situations, the PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 penalties must be proportional to that harm. We agree that penalties must be proportional to the severity of violations and the harms that may result from them, and we will enforce the regulations accordingly. Furthermore, the harms must fall within the harms considered under the PPA. Congress has outlined the factors for consideration in assessing penalties under the PPA. These factors include ‘‘the nature, circumstance, extent, and gravity of the violation or violations,’’ as well as the violator’s ability to pay, the effect of the penalties on the violator’s ability to continue to do business, and any history of prior violations. (See 7 U.S.C. 7734.) In the preamble to the June 2019 proposed rule, we stated that one of the benefits of ‘‘self-determination’’ is that it would enable APHIS to focus its regulatory resources and risk analyses on unfamiliar products and thereby to avoid conducting repetitive analyses on GE products that are very similar to those that we have already evaluated for regulatory status. APHIS would thus be able to utilize its staff time more efficiently, and provide better stewardship of taxpayer dollars than it could under the existing regulations. One commenter viewed allowing developer-made determinations as evading APHIS’ regulatory responsibilities rather than enabling APHIS to use its resources more efficiently. The commenter stated that if GE developers are concerned about delays in getting their products to market because, in their view, APHIS does not have sufficient resources to conduct all reviews in a timely manner, then those developers should lobby Congress to provide more funding to enable APHIS to perform its duties in a more timely manner, as opposed to having APHIS reduce its oversight role. APHIS disagrees with this comment. The plants that qualify for exemption under part 340 fall into three categories: (1) Those that could otherwise have been developed through conventional breeding methods and have a history of safe use related to plant pest risk that does not require regulation (§ 340.1(b)(1) through (3)); (2) those that have the same plant-trait-MOA combination as other plants that have already been evaluated by APHIS and have been found to be not subject to the regulations (§ 340.1(c)); or (3) those determined to be not subject to the regulations under the AIR process. It should be noted that plants that qualify for exemption under § 340.1(c) are very similar to plants that have been evaluated previously by APHIS. APHIS can utilize its resources most efficiently E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations by evaluating GE plants that do not fall into these categories and therefore may pose a level of plant pest risk that requires regulation. Many other commenters expressed skepticism from an opposing perspective about the efficacy of allowing developers to determine whether their products are eligible for exemption. These commenters doubted that such ‘‘self-determination’’ would provide the regulatory relief that we claimed in the preamble to the June 2019 proposed rule. One reason given was that most developers would seek certification or confirmation from APHIS that their determinations were valid, given the possible liabilities associated with making incorrect determinations. Such certification would therefore become a de facto requirement. One commenter expressed the concern that in order to receive such confirmation, developers would need to provide the information described in proposed § 340.4, which contains information requirements for RSRs. It was further suggested that while academics, startups, and small developers could see some benefit from ‘‘self-determination,’’ companies with existing portfolios of GE crops will be in a better position to benefit. We do not agree with these comments. If innovators choose to forgo the regulatory relief provisions offered by our revision of the regulations in part 340 for any reason, they are welcome to do so. In this final rule, APHIS focuses on plant protection, while also easing regulatory burdens. Accordingly, we also aim to be responsive to repeated concerns raised by small businesses, academic-based researchers, and other innovators who have reported past difficulty successfully seeing products through to commercialization. The approach APHIS has taken is fully consistent with the priorities and direction provided by Executive Order 13874, which we have discussed earlier. In § 340.1(d) 8 of the June 2019 proposed rule, we indicated that developers may request confirmation from APHIS that the plant is not within the scope of the regulations in part 340. A developer may find a confirmation letter useful in marketing its products domestically or overseas because the letter would serve as verification to an importing country or other party that APHIS concurs with the developer’s determination. Confirmation is not required, however, and for developers 8 Due to the addition of a new paragraph (d) in § 340.1, as described earlier, provisions related to confirmation letters are contained in § 340.1(e) of this final rule. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 not seeking confirmation letters, no submission of information to APHIS is required, nor is any response from APHIS. Guidelines for the information that would need to be submitted to enable APHIS to respond to a request for confirmation are discussed below under this same subheading of comment responses. Some commenters expressed doubt that developers would even be able to employ the ‘‘self-determination’’ option due to what they perceived as a lack of clarity surrounding it. It was stated that decisions on a product’s regulatory status would be based on APHIS’ assessment of plant pest risk, but that because APHIS would define plant pest risk and because APHIS did not provide a list of traits for identification of a plant pest in the proposed rule, a developer would lack the guidance to make a determination safely. APHIS disagrees with this comment. This rule clearly outlines the kinds of information needed to successfully navigate the APHIS regulatory system, as well as the protection goals and criteria that APHIS will consider as part of this process. Plants that meet the exemptions listed under § 340.1 will not require regulatory oversight under the regulations in part 340. The exemptions in § 340.1(b) are based not on the trait, but on whether the plant could have otherwise been produced through conventional plant breeding techniques. The exemption in § 340.1(c) is based on whether the plant-trait-MOA combination is the same as one that APHIS has previously determined to be nonregulated. APHIS will publish a list of such combinations, which developers may use in determining whether their GE plants qualify for exemption under § 340.1(c). As more GE plants undergo RSRs to determine their regulatory status, that list will grow. A list of traits for identification of a plant pest is not needed in order for developers to determine whether their products meet one of these exemptions in § 340.1(b) or (c). Several commenters recommended that we provide more certainty about the process by issuing guidance documents to aid developers in making their determinations. Such documents, it was stated, could include, among other things, information requirements and timelines, including timelines for APHIS responses to requests for confirmation. Many commenters stated that, in general, defined timeframes for APHIS regulatory actions are important to improve predictability and to support the planning needed to conduct seasonally based field research, and therefore should be included in the PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 29801 regulations. Most commenters who provided specific timeframes for confirmation requests suggested that APHIS should respond to such requests within 60 days. It was further suggested that to provide developers with additional guidance for making determinations, APHIS should maintain a database of products that have undergone RSRs and been found not to be subject to the regulations. APHIS has had a longstanding practice of providing guidance to aid the regulated community in complying with the regulations. APHIS will provide guidance to developers regarding the confirmation process. We will also maintain on our website requests for and results of RSRs. That information will aid developers in making their determinations. Regarding timeframes, in the preamble to the proposed rule, APHIS noted that we anticipate a timely turnaround time in providing confirmation letters. APHIS agrees that providing a more specific timeframe for responses to confirmation requests would improve predictability. Based on our experience with the current AIR process, which is functionally similar to the confirmation process, APHIS has amended § 340.1(e) by adding a sentence indicating that, except in unforeseen circumstances, written responses will be provided within 120 days of receiving a confirmation request containing sufficient detail to determine whether the plant meets one of the exemptions in § 340.1. One commenter stated that the type of information provided to APHIS by developers should be a description of the crop and the justification for meeting the exclusion, which would be similar to the information submitted for the ‘‘Am I Regulated’’ Process. APHIS agrees with the sentiment expressed in this comment and is therefore setting out guidelines for parties requesting confirmations to submit to APHIS in support of their requests. The guidelines are listed below and will also be posted on the APHIS website at https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology. In addition, developers who have specific concerns may consult with APHIS. In communications with APHIS requesting confirmation of exemption from the regulations, requestors will be expected to submit the following: 1. A description of the plant, trait(s), and modification(s). 2. A clear statement of which regulatory exemption the biotechnology developer is claiming for the plant and E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29802 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations why the plant qualifies for that exemption. 3. Details about the scientific method used to validate that the plant met the exemption criterion. APHIS expects that the description of the plant will include both the scientific and common names. The trait information should include a description of the intended and any observed phenotype(s) of the plant. Details about the modification(s) must provide APHIS with a clear understanding of the genetic change in the plant. In the case of § 340.1(c) exemptions, requestors must submit the MOA. Many commenters advocated that we establish a mandatory process for developers to notify APHIS of their determinations and for APHIS to issue confirmations. (We would note here, however, that there was considerable divergence of opinion on this issue, with 25 commenters expressing support for maintaining a voluntary confirmation process.) Some commenters requested that confirmation be mandatory for all determinations made by developers, while others stated that confirmation should be mandatory only for developer-made determinations of products that will be commercialized. Many requested that the process be streamlined and include information and self-reporting requirements and timelines. It was recommended by some commenters that developers be required to provide notice to APHIS 90 days before putting a product on the market. We will not be making any changes to this final rule in response to these comments. The confirmation process laid out in the June 2019 proposed rule was voluntary, and switching over to a ‘‘mandatory’’ confirmation and/or notification process in this final rule would run counter to the spirit of regulatory relief underlying our new regulatory framework. A voluntary confirmation process allows the market to drive the demand for new plants, avoids codifying a process that may grow antiquated as technology develops, provides developers with a method to obtain confirmation that their products are in fact exempt from the regulations, and avoids differential treatment for genome-edited products that are otherwise equivalent to conventionally bred and/or developed products. Commenters did not persuasively explain how developers of products that are not subject to the regulations could be compelled to comply with a requirement for mandatory participation in a confirmation process. APHIS notes that even if the commenters had provided a sufficient regulatory VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 mechanism to impose such a requirement, a mandatory process would likely trigger the emergence of trade concerns, as products that are scientifically justified to be exempt would also appear on lists of GE organisms–essentially creating a third category of products that are required to be listed but are otherwise exempt from regulation (in addition to two other categories: (1) Organisms that were subject to RSR and determined not to be regulated by APHIS, and (2) regulated organisms). APHIS further notes that a mandatory process would likely disadvantage the very small-scale, midsize, and university researchers and innovators that the rule was intended to aid. Lastly, APHIS notes that the proposal for a mandatory confirmation provides no added benefit in plant protection. Some of the commenters who favored a formal or mandatory confirmation process did so because they questioned the utility of a voluntary process. It was stated that an APHIS confirmation that a determination made by a developer is valid, as provided for in the June 2019 proposed rule, will be a formulaic letter without an accompanying risk assessment. Some trading partners may not view such confirmation letters as sufficient to meet their own requirements for admission of U.S. GE products. It was stated that to keep export markets running smoothly, industry needs an official U.S. attestation that the new traits do not pose a plant pest risk. We do not agree with these comments. The confirmation letters will state that the product in question meets a regulatory exemption or has a planttrait-MOA combination that has already been reviewed by APHIS. APHIS currently works with, and is committed to continuing to work with, international trading partners and exporters to resolve trade concerns. International trade issues are discussed in greater detail later in this document. Some commenters addressed the issue of whether, or how much, information pertaining to determinations made by developers and APHIS confirmations should be made public. Some commenters, citing the need for transparency and certainty, recommended that we post confirmation inquiries and confirmation letters on our website. Others, however, thought that such information should be treated as confidential business information (CBI) and therefore not be made publicly available. One commenter suggested that we use a process similar to that of the existing ‘‘Am I Regulated’’ process, under which CBI exemptions PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 could be claimed in the request for confirmation submitted to APHIS, and a non-CBI version of the submission could be made publicly available. In the interest of transparency, APHIS will post the confirmation letters online. APHIS notes, however, that confirmation letters are subject to claims of CBI and will proceed in implementation of such posting in accordance with all applicable laws and procedures. In accordance with USDA regulations, 7 CFR 1.8(a) through (c), a submitter of confidential commercial information must use good-faith efforts to designate, at the time of submission, any portion of its submission that it considers to be protected from disclosure under Exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. 552). When making discretionary releases of records, as is the case with the posting of the confirmation letters online, APHIS follows the FOIA, USDA, and APHIS implementing regulations (7 CFR subpart A and 7 CFR 370.5, respectively), and guidance from the U.S. Department of Justice’s Office of Information Policy relating to the handling of confidential business information. Finally, there were a few comments on proposed § 340.1 that did not fall into any of the categories discussed above. One commenter suggested that the exemptions should focus on plant species, not variety, as well as the purpose and type of application of genome editing. The commenter stated that genome editing can be used both to produce or improve on a specific characteristic or phenotype, such as by silencing a disease sensitive gene, and to improve existing breeding processes themselves, such as by using gene editing to more efficiently induce double haploids. The ‘‘purpose and type of application of genome editing’’ is just another way of describing the plant-trait-MOA combination. In the example given above where genome editing is used to improve an existing breeding process by more efficiently inducing double haploids, genomic modifications will be made to a specific plant, with a specific trait, having a specific MOA. Recently a widely used haploid inducer in corn was identified to be a defective allele (matL) of the gene named Matrilineal (Kelleher, 2017). A haploid induction trait was shown to work in rice by genome editing the matL allele (Yao, 2018). APHIS considers this new process to be an example of a plant (rice), trait (haploid induction), MOA (defective pollen specific phospholipase) combination. Upon E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations completion of an RSR for this plant trait MOA combination, the § 340.1(c) exemption would apply to all varieties of rice, not just the variety it was introduced into. Another commenter thought that there was a possible conflict between §§ 340.1(c) and 340.2(a). The latter paragraph of the proposed rule stated that a plant with a plant-trait-MOA combination that has not been evaluated by APHIS for regulatory status in accordance with § 340.4 would have to move under permit. According to the commenter, the conflict arises because products we would allow to move without permits based on developers’ determinations would not have been evaluated by APHIS. We do not see such a conflict. When a developer determines that a GE plant falls under § 340.1(c), it is not subject to the regulations in part 340 and therefore does not require a permit for movement. We are making an editorial change to § 340.2(a), however, to clarify that a GE plant will be subject to the regulations: (1) If it has not undergone an RSR in accordance with § 340.4; or (2) if it has undergone an RSR and, as a result of the evaluation, is subject to the regulations. Such GE plants will require permits for movement. One commenter stated that by allowing developers to determine whether their products are eligible for exemption, we would not be in compliance with the requirement of the Cartagena Protocol on Biosafety that countries list all GE organisms released into the environment in the Biosafety Clearing House. APHIS notes this comment, and wishes to clarify that the United States is not a signatory to the Cartagena Protocol on Biosafety. APHIS also notes that Article 3 of the Cartagena Protocol on Biosafety does not reference ‘‘GE organisms.’’ Instead, Article 3 (g) states that ‘‘living modified organism means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.’’ Many international efforts are underway to align regulatory approaches and to seek compatibility for emerging technologies that were not in existence when existing policies were developed. Two commenters requested that APHIS develop and issue guidance for developers of non-plant GE organisms to give them an opportunity to determine for themselves whether their products are subject to the regulations and to apply to APHIS for confirmation of regulatory status. APHIS does not agree that such a new process needs to be developed. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 Currently, the Agency responds to the developers’ questions about whether a specific GE organism, including a nonplant organism, is subject to the regulations. APHIS will continue that practice after this final rule becomes effective. Scope of the Regulations Section 340.2 of the June 2019 proposed rule delineated the scope of the regulations. We proposed to regulate, i.e., require a permit for the movement of, any GE organism that: 1. Is a plant that has a plant-traitMOA combination that has not been subject to RSR; or 2. Meets our proposed definition of a plant pest; or 3. Is not a plant but has received deoxyribonucleic acid (DNA) from a plant pest, and the DNA from the donor organism either is capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or 4. Is a microorganism used to control plant pests or an invertebrate predator or parasite (parasitoid) used to control invertebrate plant pests and could pose a plant pest risk. As was the case with the proposed exemptions, commenters expressed a wide range of views regarding the scope of the proposed regulations. While some supported our overall approach, others expressed the view that the proposed rule would either narrow or broaden our regulatory oversight excessively. Some commenters who favored a broader scope stated that a regulatory approach that provides for regulations of only those GE organisms that are plant pests or pose a plant pest risk is too narrow. Such an approach, it was stated, isolates the GE organism from the environment in which it is used and the process by which it is developed, thereby impeding science-based risk assessment. According to these commenters, other hazards potentially associated with GE organisms and not accounted for in the June 2019 proposed rule need to be addressed. Some concepts discussed in these submissions included the increased potential for commingling with non-GE crops; the potential for contributing to the creation of herbicide-resistant weeds; pesticide overuse; habitat destruction; reductions in insect populations; and increased herbicide use, which, according to the commenters, has been associated with GE crops and may have additional deleterious effects on the environment and on human health. While we recognize commenters’ interests in addressing these concerns, many of these comments are outside the PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 29803 scope of this rulemaking and APHIS’s statutory authority under the PPA. Commingling between GE and non-GE crops is generally a market issue unrelated to plant pest risk. Herbicide use is regulated by EPA, not USDA, so is not within the scope of this regulation. The basis for the commenter’s claim that GE crops result in habitat destruction is not clear; however, we note that APHIS does not regulate farming practices. USDA’s National Resources Conservation Service does have incentive programs to promote more sustainable farming. The current rule includes an RSR process that considers, as appropriate, impacts (if any) of a GE crop on populations of beneficial insects and other non-target organisms beneficial to agriculture. Some commenters questioned the scientific justifications for the above listed categories of GE organisms that would fall under the regulations. It was stated that APHIS needs to re-cast its entire proposal and frame it around the identification of the characteristics of the organism or phenotypes of concern for which a plausible case can be made, based not on speculation but data and experience, that they present an unreasonable risk to American agriculture. It was further argued that there is no scientific justification for regulating by plant-trait-MOA instead of phenotype associated with the trait. In order for the regulations under part 340 to enable future innovation while simultaneously protecting American agriculture from potential risks to plant health, it is vital that the regulations be prospective rather than retrospective, while being appropriately tailored to risk. A regulation that enumerated specific phenotypes that APHIS is concerned with would not only be impractical, since a phenotype may be of concern in one plant species but not in another (including depending on whether the plant has sexually compatible relatives, an attribute important for considering the distribution of a phenotype introduced into a plant), but would become immediately obsolete upon issuance. As articulated clearly in numerous studies, including those by the National Academy of Sciences, no entity has the foresight to identify only those phenotypes that present concerns decades into the future. Moreover, the MOA utilized by the developer matters when determining if there is a plant pest risk. The same intended phenotype can result from multiple different MOAs, but each MOA may differ in other phenotypes and thus may differ in their ability to present a plant pest risk and E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29804 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations in the types of plant pest risk they may present. APHIS thus does not consider the approach of regulating solely by phenotype to be feasible. Instead, APHIS has articulated a regulatory approach that is adaptable to future innovation and continues to protect against risk, even in cases where it is not possible to envision the kinds of products being developed in the future. In particular, we have developed the RSR process in order to determine, based on scientific knowledge and information, if a GE plant contains a plant-trait-MOA combination that could plausibly present an increased plant pest risk than the appropriate comparator plant(s). We will regulate a GE plant only when we identify and are unable to rule out a plausible pathway to increased plant pest risk. In this way, when sufficient data and experience are lacking to rule out a plausible risk identified by APHIS, we have a mechanism to acquire more information to test the specific plausible risk hypothesis before decision making. The risk-based system APHIS has developed in part 340 appropriately provides entrance for genetically engineered organisms into the regulatory framework and provides appropriate off-ramps from regulation for those products that do not pose plant pest risks. Conversely, a narrowly focused characterization of an intended phenotype, regardless of the plant species or MOA by which the phenotype is conferred, would not provide a sound scientific basis for an entire regulatory program. Many commenters expressed support for our scientific and risk-based regulatory process that evaluates plants based on their plant-trait-MOA combination. A commenter stated that the restriction in § 340.2(c) covering a nonplant GE organism that has received DNA from a plant pest is unclear and lacking in scientific justification. The commenter questioned whether receiving DNA from a plant pest would likely make the recipient into a plant pest. The commenter misconstrues § 340.2(c), which states that non-plant GE organisms that receive DNA from a plant pest will be regulated if that DNA is capable of producing an infectious agent that causes plant disease or if the DNA encodes a compound that is capable of causing plant disease. Such non-plant GE organisms could pose a plant pest risk, justifying their regulation under part 340. Some commenters stated that organisms and microorganisms used to control plant pests should not require VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 regulation if they are not plant pests themselves or do not pose a plant pest risk. One commenter stated that there appears to be a conflict between § 340.2(d) and EPA’s regulatory authority under the Federal Insecticide, Fungicide, and Rodenticide Act for microbial pesticides. The commenter further stated that the intent of the PPA for biological control organisms is to facilitate their development, but that APHIS is proposing to require additional regulatory requirements without indicating a need for these extra requirements in terms of protecting against plant pests. We agree with the first comment (i.e., that organisms and microorganisms used to control plant pests should not require regulation if they are not plant pests themselves or do not pose a plant pest risk), and this rulemaking does not provide for the regulation of biological control organisms if they are not plant pests themselves or do not pose a plant pest risk. As we noted in the preamble to the June 2019 proposed rule, ‘‘GE non-plant organisms that do not pose a plant pest risk would not fall under the scope of the regulations and therefore would not require permits for movement.’’ We disagree with the remaining comments. As we noted in the preamble to the proposed rule, while biological control organisms are generally not plant pests, some biological control organisms could be plant pests because their potential effects on organisms beneficial to agriculture could indirectly affect plant health. The PPA provides the authority to regulate such biological control organisms used to control plant pests to ensure that they do not pose a plant pest risk. As with non-GE biological control organisms, the types of GE biological control organisms that APHIS would regulate include organisms that could pose a plant pest risk by lacking sufficient specificity for the target pest and thereby harming beneficial nontarget organisms, such as other invertebrate predators or parasites (parasitoids), pollinators, or microbes that promote plant health. Because biological control organisms are almost always intended for eventual release into the environment, it is not sufficient for us to consider only their use in controlling their target plant pest. We must also take into consideration the indirect plant pest risks that the organism may pose due to harmful impacts on non-target organisms that are beneficial to agriculture (e.g., harm to natural enemies of plant pests). If the GE organism is known to have harmful impacts on beneficial non-target PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 organisms, it is consistent with APHIS’ authority under the PPA to prohibit or restrict its release. To the extent that we do not know whether a GE biological control organism is sufficiently specific to avoid harming beneficial non-target organisms, it is also prudent for us to place regulatory controls on the movement and release of the GE biological control organism until the impacts on beneficial non-target organisms and any resulting direct or indirect plant pest effects are better understood. In addition, we will exempt biological control organism-containing microbial pesticide products that are currently registered with EPA as microbial pesticide products that are not plant pests. Definitions In this final rule, we have revised the definition of article to provide greater clarity. The definition in the June 2019 proposed rule was drawn from that provided in the PPA. However, while the PPA indicates that an article may be an object that could harbor noxious weeds, upon review of the provisions of the proposed rule, we have determined that it is not appropriate to consider such an object an article under these revised part 340 regulations. The proposed definition could have been interpreted to suggest that APHIS intends to regulate GE organisms, and require permits for their movement, under the revised regulations based solely on their noxious weed potential. As discussed elsewhere in this document, however, this is inconsistent with APHIS’ intent. The revised definition reads as follows: ‘‘[a]ny material or tangible object that could harbor plant pests.’’ A commenter stated that we need to define environment, because movement under permit includes release into the environment. Environment was defined in the proposed rule, however, and we are retaining that definition in this final rule. In the June 2019 proposed rule, we defined environment as ‘‘[a]ll the land, air, and water; and all living organisms in association with land, air, and water.’’ We are retaining that proposed definition without modification in this final rule. Numerous commenters stated that the proposed definition of genetic engineering requires greater clarity. Several commenters asked APHIS to clarify that ‘‘synthetic’’ nucleic acids, for the purposes of this regulation, are those that are non-naturally occurring. Some commenters requested that APHIS clarify what is meant by both ‘‘recombinant’’ and ‘‘synthetic’’ nucleic E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations acids and cited the definitions and exemptions in the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules’’ (https:// osp.od.nih.gov/wp-content/uploads/ NIH_Guidelines.pdf). One commenter stated that they understood the term ‘‘synthetic nucleic acid’’ to refer to a sequence that was created ‘‘new from scratch,’’ and not to a plant’s nucleic acid sequence that was modified. APHIS does not agree that the term ‘‘recombinant’’ requires further definition in these regulations. After nearly half a century of research and development involving recombinant nucleic acids, the term ‘‘recombinant nucleic acids’’ is well understood. The definition that APHIS proposed was based on the definition of ‘‘recombinant and synthetic nucleic acids’’ contained in Section I–B of the NIH Guidelines. Accordingly, by ‘‘synthetic’’ nucleic acids we mean nucleic acids that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules. Such nucleic acids are not limited to those that are non-naturally occurring. They could also include nucleic acids with sequences identical to those that are naturally occurring, but which have been synthesized or amplified, rather than constructed by joining nucleic acid molecules (nucleic acids that have been so constructed are recombinant nucleic acids). APHIS agrees that greater clarity regarding the term ‘‘synthetic’’ would provide developers and other stakeholders with a clearer picture of the products that are included within the scope of the regulations. Therefore, we are changing the definition of ‘‘genetic engineering’’ to ‘‘techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.’’ This change is consistent with the objectives of the Coordinated Framework, in that it aligns our usage of the term ‘‘synthetic’’ with that of the NIH. One commenter believes that the definition for genetic engineering should include changes to the epigenome. APHIS does not agree. Epigenetic changes are caused by endogenous regulatory processes, such as DNA methylation and histone modifications through naturally occurring enzymes. Epigenetic changes are also caused by small naturally occurring RNA molecules. Epigenetic changes reflect an interaction of the genome with the environment that leads to changes in gene expression without changing the VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 sequence of DNA. Epigenetic engineering differs from genetic engineering in that the former merely adjusts the innate potential of the genome of an existing organism, whereas genetic engineering has the potential to create organisms that could not exist but for the technology. Some commenters recommended that we add a definition of genetically engineered organism to provide greater clarity relating to which organisms would be regulated. The following language was a suggested definition: ‘‘An organism developed using genetic engineering, excluding those offspring that do not retain the genetic modification of the parent. For the purposes of this part, a plant will not be considered a genetically engineered organism if it meets any of the criteria outlined in § 340.1(b)(1)(3).’’ We do not agree with this comment. At the forefront, the SECURE rule establishes clear exemptions for products that are not subject to regulatory oversight under part 340, and, thereafter, sets forth definitions for genetic engineering and for organism. Although we are able to offer regulatory relief in part 340 by excluding those products of biotechnology that mimic what can be achieved though plant breeding, APHIS has not, in this rulemaking or prior rulemakings involving part 340, taken the position that genome editing does not constitute genetic engineering. Taking such a position would be inconsistent with the generally accepted scientific characterization of genome editing technology (Knott and Doudna, 2018). While some commenters have asked APHIS to revisit its proposed definition of ‘‘genetically engineered organism’’ from the 2017 proposed rule involving part 340, even in that rulemaking APHIS did not take the position that genome editing was outside the scope of genetic engineering. Instead, APHIS explained it was defining ‘‘genetically engineered organism’’ for the purpose of establishing regulatory exemptions from part 340, including exemptions for certain organisms created using techniques that fall within the scope of genetic engineering, as follows: APHIS ‘‘would also exclude, from its definition of GE organism, certain organisms that are created using techniques that fall within the scope of genetic engineering, but that could otherwise have been produced using traditional breeding techniques . . . .’’ (82 FR pp.7008 and 7015, January 19, 2017). As discussed above, the SECURE rule establishes regulatory exemptions at the forefront, which promotes clarity regarding the scope of part 340, and avoids adopting PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 29805 a confusing characterization of techniques of biotechnology. A couple of commenters stated that the proposed rule lacked a definition of natural gene pool and a discussion of its relevance in terms of safety. The term was used in the regulatory text in § 340.1(b)(3). As discussed above, we have removed ‘‘natural’’ from that paragraph. We discussed the relevance of exemption under paragraph (b)(3) to plant pest risk above. We are, however, adding a definition of the term gene pool to the regulations in this final rule in response to these comments. Gene pool is defined as germplasm within which sexual recombination is possible as a result of hybridization, including via methods such as embryo culture or bridging crosses. One commenter viewed our proposed definition of person as potentially problematic in that it could open APHIS to legal challenges. The commenter expressed concern that because the definition includes not only individuals, business entities, and associations but also any other ‘‘organized group,’’ the argument could be made that APHIS falls under the definition. If so, according to the commenter, there might be the possibility of a conflict if decisions under these regulations are taken by the Administrator of APHIS. The commenter requested clarification on this issue. The definition of person would apply to individuals or entities regulated by APHIS, including APHIS. Under the law, a company is an entity that is recognized as a legal person that exists independently, with rights and liabilities. APHIS has, in the past, issued itself permits in conjunction with enforcement of the regulations so that plant products could move legally across state lines. This practice is not inconsistent with the PPA or with the prior or new regulations. Therefore, regulation by APHIS under part 340 will not create conflict or otherwise be adversely impacted. A commenter stated that the proposed definition of plant pest is too broad and could be construed to cover model organisms, such as Drosophila melanogaster, that do not have significant negative effects on agriculture. The commenter stated that an overly broad definition is of concern to biomedical researchers because some invertebrates they use could be classified as plant pests. Noting the lack of a mechanism to acknowledge that an organism that consumes plant material is not detrimental to agriculture, the commenter recommended that APHIS establish a mechanism for classifying an E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29806 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations organism as ‘‘agriculturally unimportant within the plant pest category’’ and that such a classification have influence on APHIS’ regulatory processes. APHIS appreciates the comment, but does not believe that it is necessary for APHIS to establish such a mechanism. The definition of plant pest is based directly on, and does not exceed, the definition of the term in the PPA. The proposed regulations contained an exemption from the requirement for permit for interstate movement for Arabidopsis thaliana. In this final rule, we are adding an exemption from some permitting requirements for GE Drosophila melanogaster, which we will discuss in more detail below, under the subheading ‘‘Permits.’’ Another commenter stated that by adopting a definition of plant pest that aligns with the definition provided in the PPA, APHIS would regulate a broad range of GE animals, including those used in medical research, thereby imposing large, new, and unwarranted regulatory burdens on researchers in medical research and other fields. APHIS disagrees with the comment. As we stated in the preamble to the proposed rule, while the PPA gives APHIS authority to regulate any nonhuman animal as a plant pest, it is longstanding APHIS policy not to regulate vertebrate animals as plant pests. In the absence of such a policy, all herbivores and omnivores could be considered plant pests, and thus subject to regulation, an untenable position since this would require APHIS to consider livestock, such as cows, sheep, and horses, as well as many laboratory research animals, to be plant pests. In the June 2019 proposed rule, we defined plant pest risk as ‘‘[t]he possibility of harm to plants resulting from introducing or disseminating a plant pest or exacerbating the impact of a plant pest.’’ Many commenters viewed the proposed definition as vague and potentially problematic due to the terminology we used. Commenters expressed concern that the words ‘‘possibility of’’ in the proposed definition are vague and uncharacteristic of standard risk assessment terminology and methodology, which characterizes risk as either a likely or probable adverse outcome. Some commenters requested that the definition of plant pest risk be defined in terms of the likelihood and magnitude of harm. Commenters also expressed concern that the word ‘‘harm’’ in the proposed definition is inconsistent with the PPA, and that the regulatory end-point should be risk of causing injury to, damage to, or disease in any plant or plant product. It was VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 stated that the inconsistency and lack of precision in the terminology used in the proposed definition could leave riskbased decisions made by APHIS open to criticism or challenge for not addressing all possibilities for harm, no matter how unlikely. APHIS agrees with the commenters that greater clarity and consistency in the definition of plant pest risk would be useful. APHIS is revising the definition accordingly. We agree that the words ‘‘possibility of’’ could be construed in a manner that is inappropriate. Numerous scenarios could be put forward as the basis for events that represent the ‘‘possibility’’ of harm without any plausible basis for concluding that such scenarios have any likelihood of occurring. The glossary of the Society for Risk Analysis (SRA), which is available at https:// www.sra.org/sites/default/files/pdf/ SRA_glossary_20150622.pdf, defines risk as, among other things, ‘‘the potential for realization of unwanted, negative consequences of an event.’’ The SRA glossary makes clear the distinction between the qualitative definition of risk and the metrics that are used to measure or characterize risk, which are framed in terms of likelihood and magnitude of an adverse outcome. We view a qualitative definition as more appropriate for defining risk, and use likelihood and consequence to evaluate scientifically plausible risks identified in the RSR process discussed below under the subheading ‘‘Regulatory Status Review.’’ We also find the SRA terminology to be more useful than ‘‘possibility of’’ and are revising our definition of plant pest risk accordingly. We are also revising the definition to refer to injury to, damage to, or disease in any plant or plant product. Accordingly, this final rule defines plant pest risk as ‘‘[t]he potential for direct or indirect injury to, damage to, or disease in any plant or plant product resulting from introducing or disseminating a plant pest, or the potential for exacerbating the impact of a plant pest.’’ Importantly, while APHIS defines plant pest risk in this rule in reference to the potential for direct or indirect injury, damage, or disease, the RSR process itself is based on standard risk assessment practices and uses a methodology that focuses on a likelihood and magnitude assessment of plausible risks. Since the RSR process will require that a plausible risk be identified in order to proceed with further risk assessment, it will not be an open-ended evaluation of any conceivably ‘‘possible’’ scenario that could be imagined. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 One commenter stated that the term plant-trait-MOA is not defined as a combination, though the individual terms are defined in the proposed rule, and that if the combination has its own meaning, APHIS should clarify that. The term plant-trait-MOA refers to three individual terms/factors for analyzing whether certain GE organisms may present a plausible pathway to plant pest risk and by which we determine whether a product actually poses a plant pest risk. Under the definition of responsible person in the June 2019 proposed rule, responsibility for maintaining control over a GE organism under permit during its movement and assuring compliance with all permitting conditions could be given to an individual or an institution. A commenter stated that individuals should not be included under the definition. According to the commenter, responsibility should reside only with the institution with which the signatory or any other individual bearing such responsibility is affiliated. The commenter pointed out that staff often move among jobs well before permit conditions are fulfilled. As discussed in the preamble to the June 2019 proposed rule, attributing responsibility for a GE organism moved under permit to only an institution may be problematic for enforcement of the regulations, because such responsibility can be diffused, resulting in no individual’s being held responsible for compliance with the permit conditions, the regulations in part 340, and the PPA. Our definition ensures that for each permit, there is a single individual who is responsible for ensuring an institution’s compliance with permit conditions, regulatory requirements, and the PPA. If this individual moves to a different job or otherwise leaves an institution, responsibility for any permits can be officially transferred, subject to APHIS’ approval, to another qualified individual, as described in § 340.5(i)(10) of this final rule (‘‘permit conditions’’). A commenter stated that there is no justification for the requirement, contained in the proposed definitions of both agent and responsible person, that they be legal U.S. residents, and that there is no means of verifying such a requirement. We are retaining the requirement, as it would be a stronger mechanism for ensuring accountability in the regulatory program than the existing definition. We have learned through administration of the program that the existing definition is not adequate, and has not provided the necessary framework to hold noncompliant E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 developers responsible (e.g., academic researchers who returned to their native countries without taking steps to destroy their GE-test material prior to departure). Finally, we have revised the definition of State to read as follows: ‘‘[a]ny of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territories or possessions of the United States.’’ This definition aligns with that contained in the PPA. Regulatory Status Review Section 340.4 of the June 2019 proposed rule set out the RSR process, under which developers may request that APHIS evaluate their novel plants and determine whether or not they fall within the scope of the regulations, i.e., under one or more of the categories in § 340.2. The section contained requirements for submitting requests for reviews and re-reviews, including supporting information; listed the factors that APHIS would consider in the course of its reviews; described the review process; and provided for public notice of RSR determinations. Commenters addressed all these topics. As noted in the preamble to the June 2019 proposed rule, the RSR process applies only to GE plants. APHIS specifically solicited comments on whether the scope of the RSR should be expanded to include non-plant GE organisms as well as GE plants, whether some equivalent process for evaluating such organisms for regulatory status should be developed instead, and, if so, what factors APHIS should consider in its analyses. Several commenters did request that APHIS develop a process to evaluate the regulatory status of non-plant GE organisms, based on the subject organism’s potential plant pest risk; however, the commenters did not provide specifics on what factors APHIS should consider in its analyses. APHIS believes that further discussion and outreach with impacted developers and other stakeholders on this issue is required before pursuing rulemaking. We received several comments pertaining to the re-review process. Some commenters stressed the need to consider whether our requirements adequately address the risk of requests for spurious reviews. Noting that we proposed to require that any request for a re-review be supported by ‘‘new, scientifically valid evidence bearing on plant pest risk,’’ commenters urged us to clarify what we mean by ‘‘scientifically VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 valid evidence’’ in order to ensure that trivial evidence or conjecture, or publications in non-credible online ‘‘scientific’’ journals, cannot form the basis of a request. Clarification was also requested as to whether re-reviews can be initiated for all products for which RSRs have been completed or only for those found after an initial RSR to be subject to the part 340 regulations. One commenter stated that in cases of rereviews initiated by APHIS, APHIS needed to provide for due process by allowing developers adequate time to respond. APHIS agrees that requests for rereview must be based on ‘‘scientifically valid evidence’’ that relates to plant pest risk. APHIS has experience dealing with such requests and will conduct an objective analysis of re-review requests to determine whether re-reviews are warranted. A valid re-review request would apply only to those GE plants or plant products that were previously found to be subject to the regulations after an initial RSR was conducted. In the June 2019 proposed rule, § 340.4(a)(4) specified information requirements for persons submitting a request for APHIS to conduct an RSR of a GE plant and stated that additional guidance on how to meet the requirements would be found on the APHIS website. A few commenters requested that APHIS either (1) incorporate the additional guidance into the regulations; (2) commit not to change the guidance without public notice and comment procedures; or (3) make clear that the additional guidance is non-binding because any changes made to it would not otherwise be subject to formal notice and comment. After reviewing these comments, APHIS has decided to pursue the second of the three recommended options. When APHIS seeks to make a substantive change to the information provided on our website, we will indicate the proposed change, provide an explanation for it, and take public comment on it. We will then review the comments and make a determination as to whether to implement the change. In this final rule, we are revising § 340.4 to incorporate the notice-and-comment process. The revised § 340.4 also uses the term ‘‘detailed information’’ rather than ‘‘guidance,’’ which was used in the proposed rule. We are making this change, which we have placed in a new paragraph (a)(4)(iv), to clarify that in order to satisfy the broad requirements contained in the regulations for information on the comparator plant(s), the genotype of the modified plant, and the new trait(s) of the modified plant, the developer must provide the detailed PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 29807 information indicated on the website. We anticipate that this change will provide more consistency and predictability regarding information requirements than would have been afforded by the June 2019 proposed rule. Such predictability is important for ensuring that developers can adequately comply with the regulations and can plan their product development activities accordingly. A number of commenters expressed concerns about specific details of how to meet the detailed information requirements for the RSR process that will be maintained on APHIS website. Some commenters were concerned that the requirement for information on the genotype of the modified plant was unclear and could be interpreted as requiring sequence information comparing the entire genome of the modified plant with that of the unmodified plant. Commenters stated that sequence information should be limited to sequence information for the specific genetic modification(s) in the plant. One commenter noted that some gene-edited products could have had genetic material inserted during development that was subsequently segregated away, and that we could clarify that the whole genome sequence information is not required by specifying that the required sequence information pertains to the targeted modified sequence. APHIS agrees with these comments. It was not our intent to request whole genome sequence information. Rather, we are requesting sequence information on the specific targeted genetic modification(s) in the plant. We have revised the information that will be published on the APHIS website to clarify the sequence information that must be provided. Some commenters stated that sequence information is not needed to determine whether a GE plant poses a plant pest risk, as long as developers provide the type of modification and describe the genotype by providing information on the insertion, deletion, and/or expressed gene product, and that if sequence information is required, it should be limited only to sequences that confer the trait(s) and should exclude vector sequences that are not in the final plant. APHIS largely disagrees with these comments. The specified sequence information is needed by APHIS in order to confirm the intended trait(s) at the molecular/genetic level; to understand the MOA for purposes of assessing the plant pest impact(s), if any, of the modification(s); and to assess similarity with previously reviewed GE E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29808 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations plants. For inserted genetic material, APHIS requires the sequence of the entire insert for molecular characterization. All genetic elements integrated into the plant genome need to be described; therefore, vector sequence information is not required if vector sequences are not inserted. For genome editing, the sequence of the entire edited gene or functional motif of a regulatory region (e.g., a transcription factor binding site in a promoter region) is required to understand the targeted sequence modification(s). The characteristics imparted by inserted or edited regulatory sequences (such as expression levels, patterns, and timing) are necessary to verify the full extent of the engineered genetic changes as part of understanding the plant pest risk associated with the modification(s). Commenters raised concerns about how to meet the information requirements concerning the MOA. One commenter stated that while there may be information on a specific gene product, the precise mechanism of action may not be elucidated. APHIS recognizes that the MOA may not always be well characterized. As we indicated in the preamble to the June 2019 proposed rule, we are requiring information on the MOA to the extent that it is known. We have revised the detailed information provided on the APHIS website to clarify this point. Other commenters stated that certain information categories appear to exceed what APHIS has historically asked for when reviewing petitions for nonregulated status under the current regulations, and that RSR information requirements should align with the information APHIS has required previously, should not increase a developer’s data submission burden, and should be sufficiently flexible to accommodate the nature of the particular product being evaluated. A commenter stated that gene expression data are unnecessary in many cases and that APHIS should clarify when such data would be required, such as when the intent is to change the expression pattern of a gene. Another commenter stated that information on the production, creation, or enhancement of a reservoir for a plant pest goes beyond the type of information currently submitted by developers in support of petitions for nonregulated status. APHIS largely disagrees with these comments but recognizes that the preamble to the June 2019 proposed rule lacked sufficient clarity regarding information requirements that apply at various stages of the RSR process. The information developers must submit, as specified in § 340.4(a) of this final rule VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 and on the APHIS website, generally aligns with information APHIS has been seeking previously, will reduce rather than increase a developer’s data submission burden, and is intended to be sufficiently flexible to accommodate the nature of the plant being evaluated. Under the petition process, developers have had to submit data and information regarding a broad range of possible harms for evaluation by APHIS, regardless of whether the plant could plausibly pose a plant pest risk. The RSR process differs from the petition process in that APHIS is requesting much less information for the initial review, with no requirement for laboratory or field-test data. If APHIS is unable to identify a plausible pathway by which the GE plant could pose an increased plant pest risk in the initial review, developers will not be required to submit any additional information to APHIS. When there is a plausible pathway to plant pest risk identified, developers will receive feedback about the type(s) of information that APHIS would need to assess the identified plausible pathway and complete a plant pest risk assessment. This information could include field-test data, gene expression data, or other data relevant to assessing whether the GE plant could have increased importance as a host for plant pests. The preamble to the proposed rule discussed some of the types of information that might be required in this situation, but incorrectly made it appear as if this information would be required for all initial reviews. We now clarify that such information could be submitted during the initial review stage, but that any such submission would be optional. To clarify that additional data would be requested on the basis of identified plausible pathways to plant pest risk, APHIS has added the following language to the existing text in § 340.4(b)(3)(i): ‘‘APHIS may request additional information as needed to evaluate the factor(s) of concern.’’ We are revising the detailed information that will be published on the APHIS website to make this distinction clear. One commenter found it difficult to understand how plant-trait-MOA could be adequately evaluated without field trials. Data from field trials do not provide information about the plant-trait-MOA. As we noted in the preamble to the proposed rule, APHIS’ experience in preparing risk assessments in accordance with the petition process indicates that field trial data are generally not necessary unless they address an identifiable plausible pathway to plant pest risk. The PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 introduced trait and MOA provide the most reliable indicators of the organism’s potential for plant pest risk. As we also noted in the June 2019 preamble, our conclusions are consistent with findings of reports of NAS.7 8 By having an understanding of the biology and any existing impacts of the plant, the genetic trait to be inserted into the plant, and the MOA, APHIS is able to conduct a review based upon a large body of scientific publications, as well as APHIS’ knowledge and experience. Information from field tests would be unnecessary, in most cases, for a determination of regulatory status under these regulations. Accordingly, field test information would not be a generally applicable requirement for the initial RSR and would be requested only as needed when further analysis is required. This approach would not preclude developers from providing information from field tests that they consider pertinent to our analysis. For example, if a developer requested a reevaluation of a GE plant that APHIS had previously considered to be subject to regulation, field test information demonstrating a lack of plant pest risk could be provided in support of that request. Nor would the provisions preclude APHIS from asking for field test information if APHIS considers it necessary in order to conclude review of a particular request. The revised detailed information requirements that will appear on the APHIS website are listed below. 1. A description of the comparator plant(s), to include common name(s), genus, species, and any relevant subspecies information that would distinguish the plant. 2. The genotype of the modified plant, including a detailed description of the differences in genotype between the modified and unmodified plant, specifically: a. If genetic material is inserted into the genome, provide information on all inserted genetic material, including: i. For genetic sequences, the name of the sequence, the donor organism(s) or source, the function of the sequence, the nucleotide sequence, and if applicable, the publicly available sequence identification, protein accession 7 National Research Council (NRC) 1989. Field Testing Genetically Modified Organisms: Framework for Decisions. Washington, DC. National Academy Press. 185 pp. Retrieved from http:// www.nap.edu/catalog/1431.html. 8 National Academies of Sciences, Engineering, and Medicine (NAS) 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: National Academy Press. 420 pp. doi: 10.17226/ 23395. Retrieved from http://www.nap.edu/23395. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations number, and enzyme commission number. If inserted genetic sequences have been modified (e.g., codon usage efficiency, gene shuffling), a statement regarding the nature and purpose of the modification, and identification of the modifications by submitting an alignment of the modified sequence with the unmodified sequence. ii. For regulatory sequences, the function of each regulatory sequence as it relates to the gene sequence and the donor organism(s) or source of each regulatory sequence. Identify promoters as constitutive, inducible, developmental, or tissue specific. If developmental/tissue specific, describe the stage(s)/tissue(s) at/in which the promotor is intended to be active. b. If genetic material is not inserted into, or was inserted and is no longer present in, the genome, and the genome is modified in a way that does not fall under the exemptions in § 340.1(b), provide: i. The nature of the modification(s) and the gene(s) and function(s) being modified; ii. For substituted based pairs, the number of substitutions; iii. The original unmodified sequence aligned to the targeted modified sequence. 3. A detailed description of the new trait(s) of the modified plant, including: a. The purpose and intended phenotype of the new trait and available information on the MOA by which the intended trait is conferred; b. Any expected changes in metabolism, physiology, and development due to the trait/genetic modification, to the extent known; c. Optional: Any additional experimental data, publications, and other science-based assessments that may be helpful for APHIS’ evaluation of the potential of the plant to pose plant pest risks. Such information could include, to the extent that it is known, information about any new enzymes or other gene products produced; where, when, and at what level the introduced or modified genetic material is expressed in the plant; the biochemical action of the genetic material or its product; and how the genetic material or its product participates in or interacts with metabolic, physiological, or developmental processes in the engineered plant or in other organisms. (APHIS does not intend to require submitters to generate experimental data specifically for an RSR. However, if a submitter is aware of information or experimental data in the public domain that may support our assessment, the submitter may include the data.) VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 The June 2019 proposed rule specified, in § 340.4(b)(1)(i) through (iii), the factors that APHIS would consider when conducting an initial review of the plant pest risk posed by the GE plant and any sexually compatible relatives that could acquire the engineered trait, relative to that posed by their respective non-GE or other appropriate comparator(s). To provide context for the discussion that follows, we are listing those factors below, as they appeared in the proposed rule. 1. The biology of the comparator plant(s) and its sexually compatible relatives; 2. The trait and mechanism-of-action of the modification(s); and 3. The effect of the trait and mechanism-of-action on: a. The distribution, density, or development of the plant and its sexually compatible relatives; b. The production, creation, or enhancement of a plant pest or a reservoir for a plant pest; c. Harm to non-target organisms beneficial to agriculture; and d. The weedy impacts of the plant and its sexually compatible relatives. Commenters had concerns and questions about some of the factors. One commenter stated that APHIS should clarify that a comparator could be a GE plant, even though Codex Food Safety Guidelines do not allow a GE crop to be a comparator, because the majority of certain crops, such as corn and soybean, are already GE. APHIS agrees that in some circumstances a GE plant could be an appropriate comparator for the purpose of evaluating plant pest risk, and notes that the Codex Guidelines address food safety and do not address plant pest risk. Typically, a comparator plant is the non-GE plant from which the GE plant is derived. In some cases it may be appropriate to use another GE variety of the plant as a comparator. This could occur if, for example, a developer is using genetic engineering to add a new trait to an existing GE plant. To date, APHIS has not generally seen the use of a GE plant as a comparator, but this could change in the future as products of genetic engineering become more complex. One commenter requested that APHIS define how it intends to determine ‘‘distribution, density, or development of the plant and its sexually compatible relatives and weediness across plant types.’’ Another suggested that we add a definition of weediness because it is mentioned in the context of the RSR. APHIS is making no changes to the rule in response to these comments. The PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 29809 plant pest risk assessment framework document that accompanied the proposed rule described how the distribution (including density) of the GE plant and its sexually compatible relatives can be predicted by the biological properties of the plant compared with the known distribution and properties of the comparator(s), in the context of the receiving environment. The development of the GE plant and its sexually compatible relatives can similarly be predicted. Assessment of these factors is important for determining whether the GE trait(s) could increase the prevalence or alter the distribution of the plant or its sexually compatible relative(s) in such a way that they could have increased importance as hosts for plant pests. It is also important to point out that consideration of weediness in this manner has long been a part of the plant pest risk assessments conducted in response to petitions for nonregulated status since the 1990s, under the regulations that we are replacing in this final rule. This final rule does not change this analysis, and does not expand the scope of APHIS’ consideration of weediness in evaluating plant pest risks as compared with the scope of consideration that was present in APHIS’ exercise of its authority under the regulations that we are replacing. Some commenters had concerns about the factor ‘‘harm to non-target organisms beneficial to agriculture,’’ and asked us to shift our focus to adverse effect on trophic functional groups beneficial to agriculture and to articulate a scientific rationale as to how a plant, whether GE or not, could pose a plant pest risk on the basis of its potentially harming an insect predator or pollinator. Beneficial organisms such as predators and pollinators fall squarely under APHIS’ authority because predators and pollinators are essential to plant health, and harm to these organisms may result in greater injury or damage to plants. APHIS analyses are based on whether a GE trait introduced into a plant will had adverse impacts on non-target organisms beneficial to agriculture. Non-target organisms beneficial to agriculture encompass a broad range of organisms that provide ecosystem services. Focusing on certain trophic guilds is not adequate to address all aspects of plant pest risk to nontarget organisms beneficial to agriculture. For example, some GE traits may have greater effects on closely related groups of insects, regardless of the trophic guild of members of that group. Focusing on trophic levels may also expand the scope to impacts E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29810 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations outside of agriculture. When there is a scientifically plausible link to harm to non-target organisms beneficial to agriculture, the information needed for a plant pest risk analysis would be determined on a case-by-case basis, accounting for the particular biology of the GE plant, the MOA of the GE trait, and the environment. In addition to listing the factors discussed above, proposed § 340.4(b) set out the components of the RSR process, including making determinations and providing public notice of such determinations. Proposed paragraph (b)(1) stated that when APHIS receives a request for an RSR, APHIS will conduct an initial review of the potential plant pest risk posed by the GE plant and any sexually compatible relatives that could acquire the engineered trait, relative to the plant pest risk posed by their respective nonGE or other appropriate comparator(s), based on the factors discussed above. Proposed paragraph (b)(2) stated that if APHIS is unable to identify potential plant pest risks in the initial review, the GE plant will not be subject to the regulations. Proposed paragraph (b)(3)(i) stated that if APHIS does identify potential plant pest risks in the initial review, APHIS will conduct an evaluation of the factor(s) of concern to determine the likelihood and consequence of the potential plant pest risk posed by the GE plant. Proposed paragraph (b)(3)(iii) stated that if the GE plant is found unlikely to pose a plant pest risk and, therefore, not to require regulation under part 340, then APHIS will post the finding on its website. Proposed paragraph (b)(3)(iv) stated that if APHIS is unable to find the GE plant unlikely to pose a pest risk, then the plant will require regulation, and its movement will be allowed only under permit in accordance with § 340.5. Commenters expressed numerous concerns about this process as we described it in the proposed rule. Some thought that we provided insufficient detail, especially concerning the distinction between the initial review and the additional evaluation that some GE plants would need to undergo. Others took issue with some of the terminology that we used, stating that it lacked clarity and could lead to confusion about our regulatory focus and decision making process. Numerous commenters proposed alternative language, in some cases arguing that their proposed alternatives were more consistent with standard risk assessment terminology and the PPA than what we had proposed. Commenters also stated that in order for regulation to be appropriately calibrated VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 with actual risk, our decision-making criteria should incorporate the concept that the plant pest risk posed by the GE plant should be greater than that posed by the plant from which it was derived. APHIS agrees with many of these comments. In this final rule, we have amended § 340.4(b) to provide additional detail and clarity and to incorporate the concept that in order for regulation to be appropriate, the plant pest risk posed by the GE plant or its sexually compatible relatives must pose an increased plant pest risk relative to the comparator(s). Regarding terminology, we have revised § 340.4(b) to indicate that in the initial reviews, we will make determinations concerning whether further review is necessary based on a finding of ‘‘plausible,’’ rather than ‘‘potential,’’ plant pest risks. We view the former term as more precise and more in keeping with standard risk assessment terminology. Further, since the RSR process will require that a scientifically plausible risk be identified in order to proceed with further risk assessment, the revision will ensure that the initial review will not be an openended evaluation of any conceivably possible scenario that could be imagined. As noted earlier in this document, in connection with the discussion on confirmation letters, some commenters saw a need for timeframes for APHIS regulatory processes for purposes of predictability and business planning. Commenters raised the issue in connection with the RSR as well. We agree with the commenters on the need for timeframes and are adding them to paragraphs (b)(2) and (3), as discussed below. Revised § 340.4(b)(1) contains provisions related to the initial review. The introductory text states that when APHIS receives a request for an RSR of a GE plant, APHIS will conduct an initial review to determine whether there is any plausible pathway by which the GE plant, or any sexually compatible relatives that can acquire the engineered trait from the GE plant, would pose an increased plant pest risk relative to the plant pest risk posed by the respective non-GE or other appropriate comparator(s), based on the factors listed in paragraphs (b)(1)(i) through (iii) (also listed above), which remain the same as those in the proposed rule. Revised § 340.4(b)(2) provides that except in unforeseen circumstances, APHIS will complete the initial review within 180 days of receiving a request that meets the requirements specified in this section. If APHIS does not identify a plausible pathway by which the GE PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the GE plant will not be subject to the regulations. APHIS will post information on the plant and trait and a general description of the MOA on its website. Regarding the timeframe, while the RSR process is new to APHIS, we anticipate that in many cases the initial review may be completed rapidly (that is, within 60 to 90 days). However, for plants that APHIS has infrequently authorized in the past, we anticipate that additional time may be required to compile information on the appropriate comparator(s) needed to conduct the initial review. In addition, we anticipate that additional time may be required to compile the information on less familiar or more complex MOAs needed to conduct initial reviews. Based on our experience, we anticipate that we will generally be able to complete reviews of less familiar plants and MOAs within 180 days, barring unforeseen circumstances. Revised § 340.4(b)(3)(i) states that if APHIS does identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the requestor may apply for a permit and/or request that APHIS conduct an evaluation of the factor(s) of concern to determine the likelihood and consequence of the increased plant pest risk. Revised paragraph (b)(3)(ii) states that for those GE plants for which such an evaluation is conducted, APHIS will publish the results of the evaluation in the Federal Register and will solicit and review comments from the public. Soliciting public comments will allow APHIS to collect information we might have missed and receive additional comment. Except in circumstances that could not reasonably have been anticipated, APHIS will complete these steps within 15 months of receiving a request for an RSR that meets our requirements. This evaluation will be similar to the current petition process, and will include, in addition to public notice and comment, preparation of any applicable National Environmental Policy Act (NEPA) analysis; hence, the longer timeline. Revised paragraph (b)(3)(iii) states that if APHIS finds that the GE plant and its sexually compatible relatives are unlikely to pose an increased plant pest risk relative to their comparator(s), the GE plant is not subject to part 340 and APHIS will announce the final determination in a subsequent Federal E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 Register notice and post the finding on its website. If APHIS does not make such a finding, the GE plant will remain regulated, and its movement will be allowed only under permit in accordance with § 340.5. Due to the changes made in § 340.4(b)(2) and (b)(3)(iii), we are not finalizing proposed paragraph (c), as it is no longer necessary. (There is a paragraph (c) in § 340.4 of this final rule, but it discusses when the section becomes applicable, and is discussed later in this document.) APHIS does not agree with other changes to the regulatory text suggested by some commenters. Specifically, the commenters recommended that we predicate our decisionmaking on whether the GE plant poses an ‘‘unacceptable plant pest risk’’ or an ‘‘unacceptable’’ or ‘‘unreasonable’’ ‘‘increase in plant pest risk.’’ APHIS appreciates these comments and has given them full consideration. APHIS does not find these terms to be necessary for purposes of our decisionmaking, nor have we concluded that such terms would provide the necessary precision to become the foundation for regulatory analysis and decisionmaking. For example, these terms could be interpreted to take into account considerations unrelated to plant pest risk and, if used as a regulatory benchmark, could be used to attempt to place APHIS risk assessors in the position of deemphasizing scientific considerations. As such, APHIS does not make changes to the regulatory text under in part 340 as suggested by the commenters. A commenter stated that just as the MOA for achieving a phenotypic trait in a GE organism should be taken into account, the MOA for achieving the genotype changes used to achieve those phenotypic traits should be taken into account as well. According to the commenter, the reason why APHIS regulations have historically been ‘‘event-specific’’ 9 is that genetic material is inserted into recipient plants in an essentially random manner during the genetic engineering process which can create mutations in recipients at rates of ∼30–60 percent, and that uncharacterized genetic material/DNA can unintentionally become 9 Event-specific is used to distinguish the genome position of the same DNA insertions after transformation. As noted by the commenter, the same DNA introduced into a plant by transformation will insert randomly in the genome. To distinguish the fact that the position of the same inserted DNA varies between transformations, each transformation is referred to as an event. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 incorporated into recipients about 20 percent of the time. We do not agree with this comment. As noted above, we have not seen evidence in the scientific literature that there are unique hazards that arise solely from the use of recombinant DNA techniques, as compared with more conventional plant breeding techniques. One commenter stated that putting RSR results on the web would encourage copycats rather than innovators. We do not agree with this comment. As discussed later in this document, certain sensitive RSR information will be eligible for CBI exemptions and, therefore, protected. Permits Paragraphs (a) and (b) of proposed § 340.5 contained, respectively, permit issuing and application requirements. Proposed § 340.5(f) contained requirements for APHIS review of permit applications. In the June 2019 proposed rule, APHIS proposed to remove timeframes for review of permit applications so as to ensure that APHIS has the appropriate time to evaluate each permit application based upon the plant pest risk posed by the GE organism and the complexity of the application. Some commenters opposed the change and requested that we retain those requirements in the regulations or otherwise incorporate into this final rule ‘‘reasonable’’ timeframes to provide greater certainty for developers about the length of the process. Commenters had various suggestions as to the length of the timeframe(s). One commenter, for example, recommended that APHIS be allowed 10 days to review applications for permits for interstate movement and 30 days for release permit applications. It was also recommended that we establish timeframes for making determinations on permit amendments and for review and comment by State and Tribal officials on permit applications. Although we recognize the need for certainty about the length of the process, our experience has been that some permit and notification applications take a minimal amount of time and others take longer, and we anticipate this to continue. A review of our experience over the last 2 years demonstrates that 45 days is currently sufficient to authorize import and interstate movement permits, while up to 120 days are often needed to authorize release permits. Therefore, PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 29811 APHIS is adding a new § 340.5(h)(5) 10 containing timeframes for review of permit applications. New paragraph (h)(5)(i) states that except in circumstances that could not reasonably have been anticipated, interstate movement and import permits will be approved or denied within 45 days of receipt of a complete permit application. New paragraph (h)(5)(ii) states that except in circumstances that could not reasonably have been anticipated, release permits will be approved or denied within 120 days of receipt of a complete permit application. New paragraph (h)(5)(iii) states that in cases where an environmental assessment or environmental impact statement is necessary to issue the permit, the 120day period will be extended. Paragraph (h)(3) of § 340.5 contains requirements for inspections related to permitted activities. The paragraph states that all premises associated with the permit are subject to inspection before and after permit issuance, and that all materials associated with the movement are subject to sampling after permit issuance. In addition, the responsible person and agents must provide inspectors access to premises, facilities, release locations, storage areas, waypoints, materials, equipment, means of conveyance, documents, and records related to the movement of organisms permitted under part 340. A commenter stated that APHIS should define waypoint in a manner that accounts for the fact that applicants for permits may not be able to legally guarantee access to all waypoints, such as those that may be the sole property of a third-party shipping company. APHIS will work cooperatively with the permit holder if there is need to gain access to a waypoint not under the permit holder’s control. A permit holder will not be held responsible for providing access that is outside the permit holder’s power to grant or deny. In § 340.5(h)(3), APHIS mandates that all materials associated with activities conducted under permit would be subject to sampling. One commenter questioned the need to include this requirement in the regulations. According to the commenter, the PPA gives APHIS authority to conduct investigations, including sampling, when required. The commenter stated that sampling has never been done outside the scope of an investigation, 10 As explained below, we are adding new paragraphs (e), (f) and (g) to § 340.5. As a result, except where otherwise indicated by a specific reference to the proposed rule, for purposes of this discussion, paragraphs will be referred to by their designation in the regulatory text of this final rule. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29812 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations and that practice should remain. The commenter said that if APHIS decides to move forward with inclusion of a sampling requirement, it should clearly describe how those samples will be handled, the level of confidentiality that they will be subject to, and the specific uses for which samples may be taken in order to protect confidential business information. The commenter further stated that such samples are of proprietary research materials and valuable enough to be targets of misappropriation if not handled appropriately. APHIS appreciates the comment and wants to reassure the regulated community that sampling will be done only when necessary. APHIS accepts that regulated material is proprietary property of the regulated entity and will ensure the taking only of quantities of samples required for diagnostic evaluation. The language in § 340.5(h)(3) is consistent with APHIS’ authority under the PPA to conduct inspections. When sampling is done, APHIS follows strict chain of custody protocols. APHIS will protect all proprietary information and CBI associated with sampling, and APHIS will share results only within USDA (marking documents containing CBI to ensure protection of such information) and with the regulated entity. Paragraphs (c) and (d) of proposed § 340.5 contained, respectively, exemptions from permitting requirements for interstate movement for GE Arabidopsis thaliana and Agrobacterium tumefaciens, subject to certain conditions. Some commenters suggested that we consider additional exemptions. One such commenter requested that in addition to A. thaliana, APHIS should exempt specialty crops, in which an allele has been edited to align with a similar, known allele in a close relative. Another commenter pointed out that disarmed versions of Agrobacterium rhizogenes have a record for transformation that is equally useful and safe as the record for disarmed versions of A. tumefaciens. The commenter requested that the exemption for ‘‘disarmed Agrobacterium tumefaciens’’ be broadened to ‘‘disarmed Agrobacterium strains’’ or ‘‘disarmed members of the Rhizobiales’’, such as Ochrobactrum haywardense. Using the same reasons and arguments, the commenter stated that APHIS should consider exempting Nicotiana benthamiana. It was also suggested that because disarmed viruses are commonly used in plant molecular biology studies, any pathogen with the pathogenicity demonstrably removed could be exempted. Some commenters VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 favored even broader exemptions, stating that most types of transgenic plants should also be exempted when shipments are small or in a form in which persistence in the environment is very unlikely. The lack of such exemptions, according to these commenters, impedes collaborative research and breeding substantially. We agree with these comments in part. Historically, A. thaliana and A. tumefaciens have been exempted from permitting requirements for interstate movement because interstate movement of the organisms has not resulted in the dissemination of plant pests within the United States. A. thaliana has been a research model plant species, and the research community is very familiar with the biological and ecological characteristics of the species. We have had extensive experience assessing the plant pest risks associated with the interstate movement of both organisms. In both cases, the plant pest risks are very low, and safeguards exist that can adequately mitigate those risks. APHIS agrees that other disarmed Agrobacterium species can be exempted from the requirement of permits for importation or interstate movement and has revised 340.5(d) accordingly. While some strains of disarmed Agrobacterium species may cause mild plant disease symptoms in some cases, importing them or moving them interstate presents very low plant pest risk given their specific usage in transforming plants, their lack of persistence in the newly transformed plants, and existing practices for shipping Agrobacterium strains. We do not have sufficient experience with the order Rhizobiales to further broaden this exemption at this time. Other GE organisms, such as specialty crops, have not been exempted before, and APHIS does not have extensive experience assessing their plant pest risks. Therefore, APHIS does not think it is appropriate to exempt such GE plants at this time in the same way as A. thaliana and A. tumefaciens. As noted earlier in the discussion of the definition of plant pest, we are adding to this final rule an exemption from the requirement for permits for import and interstate movement for GE Drosophila melanogaster in response to public comments that this organism does not have significant negative impacts on agriculture. This exemption is contained in a new paragraph (e) of § 340.5. This exemption excludes strains that have been engineered to propagate through a population by biasing the inheritance rate (e.g., gene drives), because such strains could be designed to persist in the environment and we do not have sufficient experience to PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 conclude that such strains would not pose a significant plant pest risk. We have also revised the exemption text for Arabidopsis thaliana and Agrobacterium strains in § 340.5(c) and (d), respectively, to conform with the revised definition of genetic engineering, which is not limited to the insertion of ‘‘cloned’’ genetic material into an organism. In response to comments about interagency coordination, which are discussed in detail below under the subheading ‘‘Statutory Authority, Jurisdiction, and Interagency Coordination,’’ we are adding a new paragraph (f) to § 340.5, which contains an exemption from permitting requirements for any microbial pesticide that is currently registered with the EPA as a microbial pesticide, so long as the microorganism is not a plant pest as defined in § 340.3. The addition of this exemption ensures that these organisms will not be subject to duplicative regulation. Also in the interest of interagency coordination, as well as other considerations discussed in detail later in this document in the section pertaining to plant incorporated protectants (PIPs), we are also adding a new paragraph (g) to § 340.5 that exempts from the permitting requirement for movement of any GE plant modified solely to contain a PIP that is currently registered with EPA as a pesticide product pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) or that is currently exempted from FIFRA pursuant to 40 CFR 174.21. Numerous commenters expressed concerns about our proposed permit conditions. Those issues are discussed individually in the paragraphs that follow. One commenter viewed the permit conditions in general as excessively strict. The commenter stated that the conditions strive toward zero risk, as opposed to the Coordinated Framework criterion of unreasonable risk. It is important to maintain measures commensurate to risk, according to the commenter. We do not agree with this commenter’s suggestion that our permit conditions are too strict or are striving toward zero risk. Our permit conditions are set to ensure containment and confinement of the organism under permit. They are designed to be commensurate with the risk posed by the GE organism. The commenter did not offer specific guidance on how we should apply the ‘‘unreasonable risk’’ standard. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations Some commenters requested that we clarify the distinction between standard permit conditions that apply to all GE organisms and those that apply only to GE plants or to GE microorganisms or insects. We believe that the standard permit requirements, as listed in § 340.5(i)(1) through (10) of this final rule, make this distinction clear. As written, all the standard conditions listed in § 340.5(i) of this final rule, except for paragraph (i)(6)(ii) (which pertains specifically to GE plant volunteer monitoring), are applicable to all GE organisms. Therefore, we are not making any changes in response to these comments. One commenter recommended that we adopt a hybrid permit system under which performance standards are primarily used as the enforcement mechanism. According to the commenter, specific permit conditions should be added only when scientifically justified. We will not be making any changes to the final rule as a result of this comment. Some of the standard permit conditions in § 340.5(i) are, in fact, performance standards, consistent with the commenter’s recommendation. For example, paragraph (i)(1) states that ‘‘[t]he organism under permit must be maintained and disposed of in a manner so as to prevent its unauthorized release, spread, dispersal, and/or persistence in the environment.’’ Under paragraph (i)(6), records related to permit activity by the responsible person must ‘‘be of sufficient accuracy, quality, and completeness to demonstrate compliance with all permit conditions and requirements under this part.’’ Nonetheless, we do not believe that a sole or primary regulatory focus on performance standards would be desirable for the regulations in part 340. As noted in the preamble to the June 2019 proposed rule, Office of Inspector General (OIG) audits conducted in 2008 and 2015 recommended, among other things, that APHIS generally reduce its reliance on performance-based standards in the regulations in part 340. APHIS agrees with the OIG recommendations. While performance standards offer the advantages of administrative streamlining for APHIS and flexibility for regulated parties, there are also significant disadvantages to a performance-standard-based regulatory approach. The absence of specific measures that constitute compliance with the regulations in performance-based standards introduces an element of uncertainty into the process of determining whether a regulated party is in compliance with VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 the regulations. Enforcing the regulations, and thereby protecting U.S. agriculture from plant pest risks, would thus be made more difficult than it is when compliance measures are clearly enumerated in specific permit conditions, as they always have been under the regulations in part 340 and will continue to be as a result of this rulemaking. Because permit conditions specify which actions need to be taken by the responsible person to be in compliance with the regulations and do not rely as much on subjective determinations (by both the responsible person and APHIS personnel) as do performance standards, the permitting system can provide more riskappropriate oversight, better regulatory enforcement, and transparency. A commenter questioned the necessity of the requirement in § 340.5(i)(6) for the submission of a report of no environmental release for all authorized locations in which an environmental release of a GE organism did not occur. It was stated that this provision is inconsistent with the policy approach of the Coordinated Framework and represents regulatory overreach that should be set aside. The commenter saw no risk mitigation value in this requirement. APHIS appreciates the commenter’s concern but disagrees with the commenter’s arguments. A permit authorization often covers many sites, and planting may never occur at some sites. Similar to the need for a postplanting report (PPR) to indicate which sites are planted and when, APHIS needs to know which sites were not planted, so as to provide efficient and appropriately focused oversight. APHIS thinks that the submission of a report of no release can help APHIS track the status of all authorized test field locations in order to account for and sufficiently monitor all such locations, thereby preventing the accidental release of GE organisms into the environment. Additionally, this requirement addresses recommendations issued by USDA’s OIG, following audits performed in 2015. One commenter stated that developers may operate under multiple permits for multiple plant-trait-MOA combinations at one time. The commenter stated that plant lines within these multiple permits are planted in proximity to one another to facilitate comparative science and to utilize resources in the most efficient way possible, and that if APHIS were to issue each permit with different conditions, of which the developer may learn only weeks before planting, these materials may have to be physically PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 29813 separated from each other or research would need to be abandoned, inhibiting innovation and increasing the cost to develop new products. APHIS does not consider such scenarios to be likely. The permit conditions for non-plant-made pharmaceutical and industrial (PMPI)producing plants are based on the reproductive ecology of each species and the receiving environment. APHIS anticipates that such permit conditions will generally be consistent across multiple permits for the same species. The timeframes for the issuance of permits that have been added to the regulations will enable developers to plan adequately to meet the specified permit conditions. One commenter stated that APHIS should specify in the regulations timeframes for the submission by the responsible person of reports of activities under permit that are required under § 340.5(i)(6). We do not agree with this comment. The types of reports to be submitted and the timing of their submission will vary by species and, therefore, will be included in each permit in the supplemental permit conditions, rather than in the regulations. One commenter recommended that we allow for changes in the designation of a responsible person via a notification process. We do not agree with this comment. In § 340.3, we define responsible person as the person responsible for maintaining control over a GE organism under permit during its movement and for ensuring compliance with all conditions contained in any applicable permit as well as other requirements in part 340. In § 340.5(i)(10), we state that the responsible person for a permit remains responsible unless a transfer of responsibility is approved by APHIS. The requirement for APHIS approval is necessary to ensure that, in the event a transfer becomes necessary, the new responsible person is aware, prepared, and equipped to work with APHIS. That provision does not apply, however, to an agent, a term defined in the June 2019 proposed rule as someone designated by the responsible person to act on behalf of the permittee to maintain control over an organism under permit during its movement and to ensure compliance with permit conditions. A change in agent may be effected through a notification. One commenter requested that we not require Global Positioning Satellite (GPS) coordinates in permit-related records, a requirement that, according to the commenter, is effectively a permit condition, though it is actually E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29814 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations contained in § 340.6, the section covering recordkeeping. The commenter stated that information on actual acreage shortly after planting would suffice. APHIS disagrees with this comment. GPS coordinates allow APHIS to fully utilize Geographic Information System capabilities to oversee what will be released within the defined authorized area. For example, APHIS uses GPS coordinates information to determine whether a proposed release site happens to be on Federal land or critical habitat. Paragraph (j) of § 340.5 addresses permit denials and withdrawals. One commenter stated that APHIS must make it clear that denial should occur only to prevent an unreasonable risk to U.S. agriculture. The commenter further suggested that APHIS should include assurances that a permit will be presumptively issued unless APHIS can present a plausible argument that failure to comply with the permitting conditions would result in such an unreasonable risk. Another commenter suggested that the rule should be clarified to indicate that a permit application may be withdrawn by the applicant as well as the Administrator. We will not be making any changes to the final rule as a result of these comments. Under § 340.5(j)(1), the Administrator may deny a permit application if he or she concludes that the proposed actions under permit may not prevent the unauthorized release, spread, dispersal, and/or persistence in the environment of the GE organism; if the responsible person or agent has materially failed to comply with any provision of these regulations; or if the responsible person or agent has failed to comply with any other regulations issued pursuant to the PPA or the PPA itself. Permits will also be denied if the responsible person or agent does not agree in writing to comply with permit conditions or to allow inspection by APHIS. These conditions are necessary to protect U.S. agriculture. Regarding withdrawal, the existing regulations do not specify that a permit application may be withdrawn by the applicant. Nonetheless, under current regulations, applicants may request withdrawal of permit applications prior to the issuance of the permit. This will continue to be the case when the revised regulations become effective. One commenter stated that developers may operate by covering multiple planttrait-MOA combinations under a single permit. According to the commenter, permits may be requested by location, with many experiments, containing multiple plant-trait-MOA combinations, planted in the same location. The commenter submits that if a permit is VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 terminated due to a completed RSR, the termination should not apply to the entire permit, but only to the individual plant-trait-MOA which was reviewed. APHIS responds that in such cases, the permit would not be terminated, and that the specific plant-trait-MOA combination for which the RSR was completed (resulting in a determination that the plant-trait-MOA GE plant combination is not subject to part 340) would no longer be regulated under that permit. APHIS would continue to provide oversight for plant-trait-MOAs that are still under permit. One commenter requested clarification on permit amendment provisions, particularly as they applied to APHIS-initiated amendments in § 340.5(l)(2). The commenter expressed a concern that APHIS may arbitrarily initiate modifications to an existing permit and stated that APHIS should have no authority to initiate such amendments without scientific evidence. APHIS will not initiate a permit amendment process without sufficient scientific justification. Under § 340.5(l)(2), APHIS will initiate a permit amendment process upon determining that such an amendment is needed to address the plant pest risk posed by the GE organism or the activities allowed under the permit. In such cases, APHIS will provide notice to the responsible person of the amendment(s) and the reasons for it. Another commenter questioned whether we should include provisions for amending permits in the regulations at all. It was stated that we were reducing our flexibility by including such provisions. Contrary to the commenter’s assertion, we believe that the provisions for permit amendments allow for greater regulatory flexibility by enabling a rapid response to changing circumstances. We have included these provisions to provide an opportunity for a responsible person to request an amendment to permit conditions when circumstances have changed, as opposed to our having to withdraw the permit, which would necessitate that the responsible person then reapply. Under the permit amendment provisions, APHIS would also have the flexibility to amend a permit rather than revoking it if needed to address new or previously unknown plant pest risks presented by the organism. Another commenter recommended that APHIS specify a timeframe for review of permit amendments requested by a responsible person. The commenter stated that furthermore, APHIS should notify the requestor if the amendment PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 request is deemed to be within or outside the scope of the existing permit. The timeframe for the review for the permit amendment will be the same as for new permit applications and depends on the complexity of the requested change. Consistent with past practice, APHIS will continue to let requestors know if an amendment is outside the scope of an existing permit. Finally, we are making an editorial change to paragraph (l)(1) in § 340.5 to clarify the circumstances under which (1) APHIS will approve an amendment request from a permit holder and (2) APHIS will instead require a new permit application. Specifically, we are providing examples of situations where each would apply. APHIS will allow a permit to be amended if relatively minor changes are necessary. Requests for more substantive changes will result in a denial of the amendment request and necessitate a new permit application. Paragraph (m) of § 340.5 contains requirements for shipping under permit. Paragraph (m)(1) contains a performance standard, stating that all shipments of organisms under permit must be secure shipments. Paragraphs (m)(2) and (3) contain, respectively, documentation and labeling requirements, and paragraph (m)(4) contains provisions related to treatment and disposal of shipping containers and packing materials. One commenter stated that if APHIS’ intent in paragraph (m)(1) is to allow developers to make determinations regarding the types of containers used during transport so long as they fit the above stipulations, that represents an improvement. If this change, however, is meant to be more restrictive, especially with the removal of a variance option, then the responsible person or agent should be able to make changes to shipping container options, if needed. Paragraph (m)(1) is performancebased. It does not prescribe specific container requirements. The change to the regulations is meant to make the performance standard more explicit while at the same time making the requirements less prescriptive. Based on the definition of secure shipment (‘‘Shipment in a container or a means of conveyance of sufficient strength and integrity to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation’’), APHIS does not anticipate that shipping variances will be needed. One commenter requested that we revise the language in § 340.5(m)(4) to take into account reusable shipping containers. The commenter E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations recommended that we replace the word ‘‘treated’’ with ‘‘cleaned to remove the organism before reuse.’’ In response to this comment, we are revising the paragraph to read as follows: ‘‘Following the completion of the shipment, all packaging material, shipping containers, and any other material accompanying the organism will be devitalized consistent with supplemental permit conditions, or disposed of to prevent unauthorized release.’’ Other issues raised by commenters in relation to permits included concerns about the rigor and integrity of the process, safety of environmental releases under permit, field testing, implementation of the permitting requirements, and the formatting of permits. One commenter, noting that the definition of movement in § 340.3 includes release into the environment, stated that there can be no assurances beforehand of a safe outcome of such a release. The commenter stated that all GE organisms that are to be released into the environment should be subject to strict testing requirements. APHIS acknowledges the commenter’s concerns about safely releasing GE organisms into the environment. For reasons discussed earlier in this document, it is our view that categories of organisms that fall under the exempted categories in § 340.1(b) and (c), as well as GE plants that have been subject to an RSR in accordance with § 340.4 and for which APHIS has not identified a plausible pathway by which the GE plant or its sexually compatible relatives could pose an increased plant pest risk relative to the comparator(s), can be safely released into the environment without the need for a permit. The movement, including release into the environment, of all other GE organisms will be allowed only under permit and subject to strict standards and, if appropriate, supplementary permitting conditions to effectively mitigate any risks that may be associated with such movement or release. A commenter stated that granting developers the option to move GE plants under permit in lieu of an RSR raises concerns regarding the integrity and robustness of the regulatory process. Providing a developer the option to move a GE plant under permit rather than requesting an RSR affords that developer the benefit of maximum flexibility in the research and development of novel GE plants. The provision does not, however, provide the developer a means of evading regulatory scrutiny of new GE plants, as VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 the commenter appears to believe. Permits are a form of regulation, and movement of GE plants under permit regularly occurs under our current regulations. An RSR results in a determination, based on our evaluation of plant pest risk, that a GE plant either is not subject to the regulations, and can be moved with no further restriction under part 340, or is subject to the regulations and may be moved only under permit. Whether a product requires movement under permit as a result of an RSR, or because the developer has chosen the permitting option in lieu of the RSR, the GE plant will still be subject to a rigorous screening process. The developer will have to submit a permit application, along with all supporting information required under the regulations. APHIS will carefully review the application and, if warranted, approve it. Prior to issuance, the developer/responsible person will be required to agree in writing that he or she understands and will comply with all the standard and supplementary conditions listed on the permit. Compliance is monitored after a permit has been issued. Our permitting process is a longstanding and rigorous one that ensures that GE plants are moved only under conditions that provide safeguards against the risk of dissemination of plant pests. Temporary Transition Provisions One commenter recommended that the implementation of the new permitting provisions and elimination of notifications should be phased in so as not to disrupt seasonal field activities. Other commenters stated that given the magnitude of the changes in regulatory requirements that we proposed, we should phase in implementation so as to allow regulated parties to adjust their operations to comply with the new requirements. Some commenters recommended that we develop timelines for compliance with each component of the proposed regulation. Recommendations ranged from 30 days (30 days each for the confirmation and RSR processes) to two years (for compliance with all of the new processes). Commenters also requested that we provide guidance on the new regulatory framework to aid them in making the transition. APHIS appreciates the commenters’ concerns and supports a phased approach to implementation. This final rule identifies a date when each of the rule’s sections becomes applicable. Implementation of this rule will occur as follows. Thirty days following the publication of this rule, APHIS will discontinue PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 29815 receiving new AIR requests. This will allow developers sufficient time to make such requests following publication, while also ensuring that, to the best of the Agency’s ability, all such requests have been acted on by the time the rule becomes effective. The exemptions identified in § 340.1, and the confirmation letter process described in that section, will become effective and will be implemented 90 days after the publication date of this rule. (Please note, however, that some of the exemptions in paragraph (c) of § 340.1 are contingent on implementation of RSR, which will not occur until April 5, 2021.) In the intervening 60-day period, developers can self-determine regulated status according to the legacy definition of regulated article; APHIS is available to respond to requests for assistance in such determinations. Alternatively, developers may seek permits or use the legacy notification process during that time period in order to import regulated articles, move them interstate, or release them into the environment. The remaining provisions in this rule also will become effective (that is, will appear in the CFR) 90 days after the publication of the rule. However, they are applicable as follows: Beginning April 5, 2021, APHIS will implement the permitting provisions in § 340.5; beginning April 5, 2021, APHIS will undertake a phased implementation of the RSR process described in § 340.4 by accepting requests for reviews involving corn, soybean, cotton, potato, tomato, and alfalfa; and beginning October 1, 2021, APHIS will accept requests for RSR involving any genetically engineered plant. We have revised proposed §§ 340.4 and 340.5 to include these specific applicable dates. Until RSR is available for a particular crop based on the schedule set forth in the previous paragraph, APHIS will continue to receive petitions for determination of nonregulated status for the crop in accordance with the current regulations in § 340.6. Accordingly, developers may submit petitions for deregulation for any GE plants through April 4, 2021; beginning April 5, 2021, APHIS will discontinue receiving petitions for corn, soybean, cotton, potato, tomato, and alfalfa, but will continue to receive petitions for all other GE plants and organisms. As is currently the case, a developer may seek a permit or use the notification process instead of, or in addition to, submitting a petition. On October 1, 2021, APHIS will discontinue receiving petitions altogether. Similarly, all currently issued notifications and permits will remain valid until the expiration dates specified in such authorizations, and E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29816 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations APHIS will continue to receive notifications and permit applications pursuant to the processes in the current regulations in §§ 340.3 and 340.4, as well as the operational practices associated with those regulations, through April 4, 2021. Beginning April 5, 2021, the notification process will be discontinued, and all applications for permits must be submitted in accordance with the regulations identified in this final rule. This phased implementation mitigates potential disruption to seasonal field activities and will provide developers with the opportunity to review and adjust to the provisions in this final rule. Commenters stated that APHIS must maintain oversight over field trials, and that such trials should be allowed only under permits that mandate stringent gene containment protocols with a management goal of full containment. According to the commenters, safeguards and monitoring must be required for the organism during field trials, and monitoring should include tracking changes associated with ecosystem harm, such as degradation of water quality, air pollution, climate impacts, or loss of biological resources. It was also stated that APHIS should publish the results of APHIS supervised field trials where they will be publicly accessible, and that permit requirements should include buffer zones for GE crop fields that adjoin organic and non-GE crop fields to reduce GE trait and chemical drift. APHIS has established and will continue to establish appropriate oversight requirements for crops grown under permit, including isolation requirements based on the reproductive ecology of the plant species to prevent gene flow to plants not under the permit. APHIS does not believe that ecosystem impacts, such as degradation of water quality, air pollution, climate impacts, or loss of biological resources unrelated to plant pest risk, require tracking or monitoring under the part 340 regulations, and notes that growing non-GE plants may give rise to similar impacts. Under this rulemaking, there is no requirement that developers submit field-trial data to APHIS, although they may do so if they choose to support an RSR or confirmation letter request. As we noted in the preamble to the proposed rule, APHIS’ experience in preparing risk assessments in accordance with the petition process indicates that field trial data are generally not necessary unless they address an identifiable plausible pathway to plant pest risk. The introduced trait and MOA provide the VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 most reliable indicators of the organism’s potential for plant pest risk. If field data are needed to address a plausible plant pest risk hypothesis, those data bearing on whether an organism posed a plant pest risk would be published in support of APHIS’ decision making on the regulatory status of that plant. A commenter stated that APHIS should further clarify the length of time after a permit expires during which access to materials and premises must be allowed. The commenter was concerned that such access could be misinterpreted to be in perpetuity, which is unnecessary. We would require the responsible person to allow access to where the organisms regulated under part 340 are located, including field test sites after trials are harvested or terminated, throughout the volunteer monitoring period described in the permit, which may continue after permit expiration. Access to premises where regulated organisms are maintained must be allowed throughout the volunteer monitoring period even if the permit has expired, unless the product has been devitalized or APHIS has conducted an RSR and determined it to be not subject to part 340. Two other recommendations by commenters were that we develop a publicly available database listing all permits issued by APHIS and their requirements, and that we provide for pre-approvals of containment facilities for high-risk organisms, with permits tiered to the approved facility number. We thank the commenters for these suggestions. APHIS may explore these ideas in the future as we develop more experience with permits under the new regulations, though we do not believe that it is necessary to implement (or to decide whether to implement) these ideas immediately. For example, our ongoing experience with permits involving containment facilities may lead us at some point to consider a specific pre-approval process for certain facilities as suitable for higher-risk organisms. Finally, one commenter stated that each permit should contain introductory text describing the unreasonable risk to U.S. agriculture that the permit is designed to prevent. The commenter further stated that if no such plausible description can be proffered, then APHIS would have no reason for exercising oversight over, or requiring a permit for, the movement of the GE organism for which APHIS intends to issue the permit. Under the new regulations, GE organisms will be required to move PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 under permit for one of three reasons: (1) Because APHIS has conducted an RSR and has found a likely or indeterminate plant pest risk; (2) because the developer has opted to go directly to seeking a permit rather than requesting an RSR; or (3) because the GE plant or non-plant organism fits under one of the regulated categories in § 340.2. We do not see the need for the introductory text that the commenter recommends, which is likely to be duplicative or unnecessary in many if not all cases. In addition to the substantive changes discussed above, we are making a couple of corrections to § 340.5(b)(1) and (b)(2)(ii). In the former paragraph, which contains general information requirements for permit applications, we are adding ‘‘the organism’s genus, species and any relevant subspecies and common name information.’’ Under the latter, which contains information requirements for permits for interstate movement and listed, among other things, in the June 2019 proposed rule, ‘‘a description of the method of shipment, and means of ensuring the security of the shipment against unauthorized release of the organism,’’ we are including a requirement that the quantity of the GE organism also be listed. In both cases, the requirements were in the current regulations but were inadvertently omitted from the June 2019 proposed rule. Record Retention, Compliance, and Enforcement Numerous commenters identified concerns about the record retention requirements described in proposed § 340.6. Issues discussed included overall clarity and scope, timeframes, and reporting requirements. Some commenters suggested that we needed to clarify our recordkeeping and reporting requirements by adding more specific detail about what information APHIS will require and when. The reporting and recordkeeping requirements in § 340.6 of the June 2019 proposed rule did provide specific details regarding the types of records that need to be kept and the timeframes for retention, in paragraphs (a) and (b), respectively. At the same time, the requirements that we proposed align with our historical approach, which has provided flexibility based on variations in operations performed by different entities and different subparts of a single entity. As reflected in § 340.6(a)(1), which refers the reader back to the permit-related reporting and recordkeeping requirements in § 340.5, many of the recordkeeping and reporting requirements of this E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations rulemaking will depend on the nature of the GE organism and the intended activity and will be included in the permit conditions. It was suggested that some of the proposed information requirements were duplicative. One commenter stated that APHIS requires information about the location of a field release site to be included in the permit application and then requests the same information again after planting, resulting in duplicate or nearly duplicate records requests. The commenter stated that APHIS also requests the identity of the material being planted (the construct ID) on the application and then requests the same information again on the planting report. According to the commenter, during inspections this information is often requested a third time. The commenter stated that this duplication could be eliminated with no detrimental effects on compliance by having applicants provide it on the permit application and then having APHIS verify it during inspection. These requirements are not duplicative, and it is not particularly onerous to comply with them. Information submitted in a permit application is used for specific release site analysis. Post-planting reports provide APHIS with critical information related to the activity that has been conducted under an APHIS-issued authorization. The information submitted post-planting facilitates effective compliance oversight. Planting does not occur for every genetic construct and location that is approved in an authorization. APHIS needs documentation (post-planting report) of which constructs are planted at each specific field release site in order to perform effective compliance oversight. Additionally, this requirement addresses recommendations issued by USDA’s OIG following audits performed in 2015. A commenter recommended eliminating the requirement in § 340.6(a)(2) that records be kept to identify all locations where organisms under permit were stored. The commenter noted that while APHIS regulates interstate movement, the proposed definition of move does not include ‘‘store.’’ We do not agree with this comment. Under § 340.5(b)(2)(i), all permit applications must include, among other things, information on the origin and destination of a GE organism moved under permit, including information on addresses of all intermediate and final destinations. Additionally, § 340.5(b) states that within the permit application, locations and destination(s) VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 of regulated organisms shall be included. A storage facility is considered by APHIS to be a destination (premises). APHIS needs to know where the regulated GE organism has been maintained in order to perform effective compliance oversight. We received comments that supported our proposed timeframes for record maintenance and other comments that expressed concerns about the timeframes. One commenter raised concerns about APHIS’s ability to respond to incidents effectively if APHIS retained records associated with regulatory activities for only 2 years. The commenter may have misunderstood the recordkeeping requirement in § 340.6(b). The requirement that all records indicating that an organism that was imported or moved interstate under permit reached its intended destination be retained for 2 years applies to the responsible person(s) rather than APHIS. APHIS did not propose any changes to the duration or type of records that APHIS will retain. The proposed 2-year retention requirement did represent an increase from the one in the existing regulations, which was 1 year. APHIS believes that this 2-year record retention requirement provides sufficient time to ensure that regulated material has safely and securely reached the intended destination, without imposing an undue burden on regulated parties. One commenter viewed the requirement to retain records of permitted activities for 5 years as burdensome for small entities and urged us to ameliorate that burden by offering small entities an option to deposit such records electronically with APHIS for retention. We do not agree with this comment. APHIS does retain the records of permitted activities that are submitted to APHIS, such as required reports and other information needed to determine compliance. Large and small regulated entities also generate and retain records that they may not be required to submit to APHIS but are kept to demonstrate compliance with permit conditions and for the entities’ own stewardship purposes. Should those types of records be submitted to APHIS for retention, they would then be considered Federal records subject to the Freedom of Information Act (FOIA), which, among other things, would give rise to considerable administrative burdens for APHIS, which would be obliged (for instance) to protect submitters’ confidential business information in maintaining such records and responding to FOIA requests. PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 29817 Furthermore, adopting the commenter’s recommendation could raise concerns about disparate treatment. The comment did not include size criteria or definitions or a description of a process that would enable APHIS to make a fair determination of who could or could not submit documents for APHIS to retain. Finally, one commenter recommended that APHIS utilize the APHIS-initiated amendment procedure for site-specific enforcement in instances of noncompliance and amend § 340.6(c)(i) to explicitly allow the Administrator to deny an application or withdraw a permit ‘‘in whole or part.’’ The commenter contended that this would provide APHIS the flexibility to apply site-specific, measured enforcement. APHIS agrees with the intent of the comment but disagrees with the suggestion that a regulatory text change is necessary, because the permitamendment provisions in § 340.5(j)(2) already allow us sufficient flexibility to respond to compliance issues in the manner recommended by the commenter. Confidential Business Information (CBI) Commenters took divergent views on the issue of the proposed Confidential Business Information (CBI) exemptions in the proposed rule. Some thought the exemptions, as explained in the preamble to the proposed rule, did not provide enough protection for submitters, while others thought that the exemptions were too broad. Several commenters stated that CBI protections should extend to information pertaining to MOA and other information required to be submitted for an RSR or needed by APHIS to confirm a determination by a developer that its product is exempt from these regulations. Some commenters also suggested that submitters may forgo seeking confirmation or an RSR, and may opt to go under permits, if the MOA will be made public after a product has come through the confirmation or RSR process, because submitters want to protect that information. As noted in the preamble to the proposed rule, APHIS intends to release a general description of the plant, the trait, and the MOA of GE plants that go through an RSR, but APHIS would do so without revealing CBI. APHIS would similarly release a general description of the plant, trait, and, as applicable, the MOA associated with confirmation requests, again without revealing CBI. APHIS wants to clarify that we are not requiring submitters to waive their E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29818 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations applicable CBI claims. Further, as we noted in the preamble, certain technical information, such as data that could be used to re-create an organism and that were not otherwise made publicly available by the submitters, may be eligible for CBI designation. To the extent that CBI claims exist, APHIS will review them, consistent with applicable laws and statutory authorities, on a case-by-case basis. Submitters will be given the opportunity to review and comment on a proposed general description prior to public disclosure. Regardless of CBI determination, developers will have the flexibility to select the regulatory options, whether RSR or permit, that they deem best for their business needs. Other commenters expressed concern that extensive granting of CBI designations could impede the ability of developers to determine whether their products are eligible for exemption, and could impede peer-reviewable risk assessment. These commenters favored posting confirmation requests and responses and RSR determinations online. It was suggested that if such data are not available, developers will lack the necessary information to make reliable determinations for their GE plants and may choose permitting instead. According to these commenters, this would attenuate the regulatory relief that is one of the objectives of this rulemaking. APHIS will post confirmation requests and responses, as well as determinations of nonregulated status pursuant to the outcomes of initial RSRs, on the APHIS website, with CBI redacted. When additional review is requested, as discussed earlier in this document, the analysis, outcome, and supporting documents will be published in the Federal Register and on the website, also with CBI redacted. We recognize that, in some cases, information necessary for researchers and developers to make determinations pursuant to § 340.1(c) may not be made public, due to CBI claims. Commenters also expressed the view that mandatory field trial data should not be eligible for CBI exemption. Under this rulemaking, there is no requirement that developers submit field-trial data to APHIS, though they may do so if they choose to support an RSR or confirmation letter request. As noted above, APHIS would allow only CBI exemptions that are consistent with applicable case law and statutory authorities. A commenter requested that we clarify how the process for submitting CBI exemption requests and justifications for exemptions differs VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 from the process that occurs under the current regulations. The process for submitting and justifying CBI claims will not change under this rulemaking. Persons submitting any document to APHIS in accordance with the regulations must identify those portions of the document deemed to be CBI. Each page containing such information must be marked ‘‘CBI Copy.’’ A second copy of the document must be submitted with all such CBI deleted, and each page where the CBI was deleted must be marked ‘‘CBI Deleted.’’ In addition, any person submitting a CBI exemption request must justify the request by demonstrating how each piece of information to which the request applies is a trade secret or is commercial or financial information and is thereby privileged or confidential. Economic Analysis Some comments directly addressed the economic analysis that accompanied the June 2019 proposed rule. It was claimed that the analysis was light on data characterizing the potential economic and social impacts of the proposal. It was also stated that we did not offer sufficient analysis of the challenges of assuring other countries that imports of GE products from the United States are safe and meet the importers’ requirements. In the analysis accompanying the June 2019 proposed rule, we did request comments from the public on the potential economic impacts of the rule on affected entities. Most of the commenters who addressed potential economic impacts did so as part of a broader discussion of other issues, such as the potential economic effects of commingling, rather than addressing the economic analysis directly. Commenters did not supply actual data that would have aided us in characterizing potential social and economic impacts of the proposed rule. We do discuss potential international trade issues at some length later in this document. Regulation of Plants That Produce PlantMade Pharmaceuticals and Industrials (PMPIs) We stated in the June 2019 proposed rule that the likelihood existed that most, if not all, GE PMPI-producing plants that are currently under APHIS permits could be determined to be not regulated if an RSR found them to be unlikely to pose a plant pest risk. We also noted that our proposed rule envisioned that were this to occur, such plants could be grown outdoors without the need for APHIS permits and without APHIS oversight. PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 We received many comments on this issue. Some commenters expressed concern that the proposed change to our regulatory approach to PMPI-producing plants would weaken or eliminate APHIS’ oversight of them. Others favored less regulatory oversight of PMPI-producing plants than that provided in the existing regulations. Still others requested that we provide greater clarification of our regulatory approach to PMPI-producing plants under this rulemaking and emphasized the need for cooperation among regulatory agencies. These varying viewpoints are discussed in greater detail below. Some commenters stated that as a result of this rulemaking, APHIS would abdicate its oversight role, leaving the planting of PMPI-producing plants essentially unregulated. As a result, according to these commenters, our agricultural food systems could be made vulnerable to introduction of experimental GE crops, and environmental quality and human health could be negatively affected based on the end use of those crops for pharmaceutical or industrial purposes. One commenter expressed concern that PMPI-producing plant developers would be able to determine for themselves whether their products are eligible for exemption. All of these commenters urged us to maintain our existing level of regulatory oversight of PMPI-producing plants. Some commenters favored still more stringent requirements. They argued in favor of more restrictive oversight of PMPI-producing plants than was provided for in either the proposed rule or the existing regulations. They asserted that allowing PMPI-producing plants to be grown outdoors without APHIS oversight does not comport with the OIG’s recommendations on regulating PMPI-producing plants to prevent inadvertent release. Finally, a few commenters stated that they did not consider PMPI-producing plants to present inherent risks and argued that developers of PMPIproducing plants should be able to sufficiently self-regulate the planting of such plants. Some of these commenters took the view that APHIS’ regulatory oversight over PMPI-producing plants was, if anything, already excessive and would remain excessive or become still more so under the proposed rule. One commenter stated that developers should be given the option to be regulated by the agency most relevant to their GE products. Other commenters stressed the need for APHIS and FDA to have a memorandum of understanding E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations (MOU) for the regulation of PMPIproducing plants. After considering the comments received, we have decided to continue to maintain regulatory oversight of PMPI-producing plants by continuing to require permits for their movement. We are adding this requirement to § 340.2 of this final rule as paragraph (e), which states that a permit is required for the movement of a plant that encodes a product intended for pharmaceutical or industrial use. Accordingly, PMPIproducing plants will not be eligible for the RSR process. We also have determined that APHIS can continue to exercise oversight of PMPIs pursuant to our existing statutory authority under the PPA. We discuss how we arrived at this determination below. The commenters who favored more stringent oversight of PMPI-producing plants than under the current regulations often considered them to present a significant inherent risk by virtue of being PMPI-producing plants and/or considered our existing regulations in part 340 to contain inadequate safeguards. We do not agree that more regulatory oversight of PMPI-producing plants than under the current regulations is warranted, and we do not consider our current regulatory framework to provide inadequate safeguards. Since 1994 (58 FR 17047), we have required permits for the movement of plants that produce pharmaceutical compounds. In 2003, APHIS published an interim rule in the Federal Register (68 FR 46434–46436, Docket No. 03–038–1) that extended this permitting requirement to plants that produce industrial compounds; that same year, we implemented additional safeguards for PMPI-producing plant field trials that exceeded those previously in effect. These added safeguards, which were implemented as permitting conditions, included requiring location coordinates, authorizing release only in lowproduction geographies for the particular crop at issue, requiring dedicated equipment, and providing for frequent inspections of each trial site. Since 2003, permits for field trials of PMPI-producing plants have made up a small percentage of the overall permits that APHIS has issued pursuant to the regulations in part 340. In the intervening 17 years, we have not encountered any issues with field trials of PMPI-producing plants that call into question the overall adequacy of our permitting conditions for PMPIproducing plants. Furthermore, over time, APHIS has regulated a large number of field trials of non-PMPI producing plants under permit VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 conditions for diverse plants, traits, MOAs, geographic locations, and agroecological conditions. Regardless of whether the plant is a PMPI-producing plant or not, these permit conditions have been successful in ensuring that genetically engineered plants are confined to the field trial location. Based on our experience in permitting field trials of genetically engineered plants, we are confident in our ability to devise appropriate permit conditions to ensure confinement of all regulated plants, including PMPI-producing plants as we have done for the past 17 years. For this same reason, we do not consider it necessary to regulate PMPIproducing plants as Federal noxious weeds in accordance with our regulations in 7 CFR part 360, one of the options which we mentioned in the proposed rule. We believe that doing so could suggest that APHIS has identified unique risks associated with PMPIproducing plants based on our data since 2003; this is not the case. Instead, we agree with those commenters who have asked us to maintain our current level of regulatory oversight based on the framework first elucidated in 2003. The commenters who urged us to continue to exercise a similar or greater level of regulatory oversight of PMPIproducing plants do raise a salient point: PMPI-producing plants are not developed for food or feed use and can encode compounds that are intended to have a physiological effect in humans or animals. This is important for several reasons. First, in the 2003 interim rule that required permits for plants that encode for industrials, we stated that APHIS’ regulatory experience and scientific familiarity lay primarily at the time with GE plants produced for food or feed. This remains the case; while the Agency certainly has more familiarity with PMPI-producing plants than we possessed in 2003, PMPI-producing plants account for less than one percent of the total number of GE plants for which we have issued permits, and none have been designated nonregulated. Accordingly, the Agency still has significantly more experience with GE plants that produce food or feed than with those that produce PMPIs. Second, as we set forth in the proposed rule, the intended use of PMPIs makes them differently situated than other GE plants regulated by APHIS, such that additional evaluation beyond RSR may be needed. We therefore consider it appropriate to maintain the status quo and continue to PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 29819 require permits for PMPI-producing plants. In such instances when the risks associated with a plant or organism are not fully understood, APHIS has interpreted its authority under sections 7711 and 7712 of the Plant Protection Act and its predecessor statutes to provide a basis for regulating the plant or organism based on our best understanding of the risks presented (see 58 FR 17047; 68 FR 46434–46436). Accordingly, APHIS will continue to exercise its authority under the Plant Protection Act to maintain regulatory oversight of PMPI-producing plants. FDA has authority under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.) to take action to have foods withdrawn from the market if they contain PMPIs not approved for use in food. FDA also regulates drugs and human biological products under the FFDCA and therefore would have oversight over such products from PMPI-producing plants. FDA has not traditionally overseen field trials of PMPI-producing plants. APHIS will maintain the status quo by continuing to require permits for movement and environmental release of all PMPIproducing plants. It is not clear to us how an MOU between FDA and APHIS would be beneficial in providing oversight. One commenter recommended that we list categories of the types of PMPIproducing plants that could generate food adulteration, should they find their way into the food supply, and regulate only those types of PMPI-producing plants. Another commenter stated that we needed to clarify and possibly refine our overall regulatory approach to PMPIproducing plants. The commenter expressed a concern that a lack of clarity may result in unnecessary costs and time delays in bringing new products to market, thereby disproportionately impacting smaller developers and limiting the availability of new opportunities for farmers. As an example of a possible refinement to our regulatory approach, the same commenter suggested that in regulating PMPI-producing plants, APHIS should consider the likelihood that PMPIproducing plants will be produced in niche crops, which can be readily segregated from commodity crops, thus reducing the potential for their entering the food chain. APHIS does not plan to develop a list of food adulterants or of categories of the types of PMPI-producing plants that could generate food adulteration. As noted above, the primary oversight authority in matters concerning food E:\FR\FM\18MYR2.SGM 18MYR2 29820 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 safety involving plants, such as whether the presence of a particular substance in a food would make it adulterated, rests with FDA rather than APHIS. With regard to the latter comment, in establishing permitting requirements for PMPI-producing plant field trials, APHIS does take into consideration the specific crop in which the PMPI is produced. Regulation of Plant-Incorporated Protectants (PIPs) As noted in the preamble to the June 2019 proposed rule, certain plants are genetically engineered to produce PIPs, meaning that they produce pesticides. PIPs fall under the regulatory oversight of EPA. However, because EPA generally only requires Experimental Use Permits for field tests on 10 acres or more of land, only APHIS has historically exercised regulatory oversight over plantings of PIPproducing plants on 10 acres or less of land. Under the provisions of the June 2019 proposed rule, there would be a likelihood that many PIP-producing plants that are currently regulated under APHIS permits or notifications could be determined not to be covered by the regulations after RSRs, because such plants are unlikely to pose greater plant pest risks by comparison with their comparators. Such plants could therefore be grown outdoors without the need for an APHIS permit and without undergoing APHIS oversight. Thus, Federal oversight over small-scale (10 acres or less) outdoor field test plantings of some PIPs would rest solely with EPA. Commenters expressed a broad range of views regarding the scope of our regulatory oversight over PIP-producing plants. Some commenters expressed the view that APHIS should leave the regulation of PIPs entirely to EPA. Others stated that APHIS should continue its oversight over PIPproducing plants in coordination with EPA to ensure that PIPs are regulated at all scales. Concerns were expressed by some commenters about what they perceived as potentially a broadened regulatory scope. It was stated that small releases of PIP-producing plants that are not currently subject to APHIS regulations could be regulated under the proposed rule. After reviewing these comments, we have decided that the approach presented in our June 2019 proposed rule remains appropriate. All PIPs, as noted in that rule, are properly under the regulatory oversight of EPA; to date, EPA has not seen a need to exercise oversight over PIP-producing plants VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 planted on 10 acres or less because APHIS has exercised such oversight. Accordingly, APHIS will continue to conduct oversight over PIP-producing plants at all scales unless the PIPproducing plant were to meet the conditions for an exemption from regulation in our revised regulations, or were determined following RSR not to be covered by the regulations. If APHIS determines that a PIP-producing plant is not regulated under these regulations; EPA would still retain regulatory authority and may decide to require an Experimental Use Permit and provide oversight of field trials under 10 acres. APHIS has avenues for cooperation with EPA, such as an agreement to provide oversight assistance to EPA under the Economy Act, should EPA decide that oversight of small PIP field trials is appropriate. We have, however, decided to modify this final rule slightly to clarify the nature of this interaction between APHIS and EPA regarding PIPs. As noted above, we are adding a new § 340.5(g) stating that a permit is not required for the movement of any GE plant modified solely to contain a PIP that is currently registered with EPA as a pesticide product pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.), or that is currently exempted from FIFRA pursuant to 40 CFR 174.21. Under FIFRA, EPA is authorized to regulate pesticides. Pursuant to FIFRA, EPA regulates certain PIPs as ‘‘substances,’’ and has established a registration process for their use as pesticides. In determining whether to grant a registration for a PIP with pesticidal properties, EPA conducts ecological risk assessments to determine what risks are posed by the PIP and whether changes to the use or proposed use are necessary to protect the environment. The product is registered under FIFRA and thereby eligible for sale on the market if the results of the risk assessment indicate that the pesticide will not pose any unreasonable risks to wildlife and the environment. Environmental effects considered include effects on nontarget organisms. A PIP that is currently registered will have undergone such a risk assessment and will therefore have been determined not to pose unreasonable risks to other plants. For that reason, we can exempt, and have decided to exempt, such PIP-producing plants from our regulations. We can also exempt, and have decided to exempt, modified PIPproducing plants that EPA has exempted from FIFRA pursuant to 40 CFR part 174.21. Section 25(b) of FIFRA PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 allows EPA to promulgate regulations to exempt from the requirements of FIFRA any pesticide which the Administrator determines is ‘‘of a character which is unnecessary to be subject to [FIFRA] in order to carry out the purposes of [FIFRA].’’ Pursuant to this statutory authority, EPA’s regulations in 40 CFR part 174.21 set forth criteria used by EPA for exempting PIPs from FIFRA requirements, including that the genetic material encoding the PIP or leading to the production of the PIP is from a plant that is sexually compatible with the recipient plant. These criteria currently do not pertain to GE plants containing PIPs. However, if EPA were to establish criteria for exemption from FIFRA for certain additional plants containing PIPs, plants meeting those criteria would, by statute, have been determined by EPA to be of a character unnecessary to be subject to FIFRA in order to carry out the purposes of FIFRA. Because EPA could not make such a broad determination without consideration of the effects of such plants on the environment, including risks to other plants, we are exempting such plants from APHIS permitting requirements, as well. Other commenters expressed concern that small releases of PIP-producing plants that are not currently subject to APHIS regulations could be regulated under this rule. It is true that a GE PIP-producing plant that is not created using a plant pest as a donor organism, recipient organism, or vector or vector agent, was previously exempt from APHIS regulations under part 340 but could fall within the scope of these revised regulations if it does not qualify for an exemption under § 340.1 or under new § 340.5(g). This is, in fact, true of all GE plants that are created without the use of a plant pest donor organism, recipient organism, or vector or vector agent. However, as we discuss at greater length in the economic analysis that accompanies this final rule, we believe the number of producers and products that may be newly regulated as a result of this rule is extremely small. Moreover, we are not aware of any GE PIP-producing plant that has been produced to date without the use of a plant pest as the donor organism, recipient organism, or vector or vector agent. Finally, one commenter stated that regulating PIPs more strictly than regulating chemicals is not scientifically justifiable. The commenter noted that EPA considers biological pesticides, including PIPs, to ‘‘generally pose less risk than most conventional pesticides.’’ E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 This comment pertains to EPA’s regulatory structure for PIPs. As such, it is outside the scope of the current rulemaking. International Trade Implications A number of commenters expressed the concern that the regulatory approach that underpins this rulemaking is out of step with that of key international markets and governments. It was suggested that the rule could result in greater asymmetry in regulatory approach between APHIS and U.S. trading partners, thereby endangering U.S. export markets, and that obtaining international acceptance of our new regulatory approach should be a precondition for finalization. A commenter further stated that we need to balance our regulation of GE organisms with the need for industry to comply with international markets that are sensitive to the unintended presence of GE organisms in non-GE products. The fundamental APHIS protection goal under our regulations in part 340, which stem from and are delimited by our statutory authority to regulate plant pests under the PPA, is to protect agriculture against increased plant pest risks resulting from GE organisms. This regulatory approach has always been different from that of other national systems, which may not necessarily focus on plant pest risk and instead may be technique-based. Nevertheless, our trading partners have historically judged our approach to be acceptable, as it is transparent and science- and risk-based. Trading partners that have understood and accepted our regulatory system will not find our updated approach to meeting the same objectives confusing. Thus, we do not see this revised system as less compatible with those of our trading partners than in the past. As we have in the past, we will continue to provide technical expertise, information, and explanation to our trading partners regarding our regulatory system and determinations of regulatory status. It was further stated by commenters that a possible consequence of the unwillingness of trading partners to accept our new regulatory approach could be the undermining of the progress being made in the Global LowLevel Presence Initiative (GLI), in which countries (including the United States) are striving to achieve a science-based and risk-based approach that would allow for a commercially achievable tolerance for the presence of a biotechnology-enhanced trait that (1) has been approved as safe by an exporting country based upon scientific analysis and CODEX-adopted risk VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 assessment principles, but (2) has not yet been approved by an importing country. Additionally, the commenter interpreted the U.S.-Mexico-Canada Agreement (USMCA) to expressly commit all three countries to develop a low-level presence policy for imports. To maintain global acceptance for its regulatory approach, APHIS needs to continue to maintain and enhance its credibility and its leadership role in the field of biotechnology regulation. It was with that goal in mind that we proposed these new regulations, which reflect both the knowledge we have gained, over the more than 30 years since we first promulgated our biotechnology regulations, and new developments in the field. While it is gratifying that the APHIS system of regulation is perceived to provide protection against commingling or low level presence of plant products that are unwanted or are unauthorized in foreign (or even domestic) markets, the PPA, under which these regulations are promulgated, does not authorize APHIS to use the potential for low level presence as a basis for determining regulatory status or for monitoring what has been commercialized. USDA recognizes the focus of the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants (2003) and the associated annex addressing low level presence, an international standard. However, we note that the subject of this guidance and its agreedupon annex is for food safety alone. USDA–APHIS reviews GE plants for the potential for plant pest risk, not food safety. Finally, we disagree with the commenter’s interpretation of the USMCA. We note that it instead stipulates that each Party shall adopt or maintain policies or approaches designed to facilitate the management of any LLP Occurrence. It does not mandate development of an overarching policy. Elaborating on the concerns discussed above, some commenters emphasized the need for APHIS to develop and execute an international engagement strategy with our trading partners that explains the rationale for APHIS’ premarket regulatory approaches. For 30 years, APHIS has consistently engaged and led in many international contexts to provide knowledge of its regulatory policy, science, and systems to encourage the safe development and trade of the products of agricultural biotechnology. Most recently, APHIS has worked to implement the Presidential Executive Order Modernizing the Regulatory Framework PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 29821 for Agricultural Biotechnology Products (June 11, 2019, E.O. 13874) to ‘‘provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products.’’ 11 For the past several years, APHIS has shared rationales, experience, and information on potential regulatory changes with U.S. trade agencies (e.g., the United States Trade Representative, the Department of State, the USDA Foreign Agricultural Service), U.S. trading partners, likeminded countries, and other countries in order to garner understanding and support for this updated regulatory approach. APHIS intends to continue such engagement. Statutory Authority, Jurisdiction, and Interagency Coordination We received many comments regarding our statutory authority, or lack thereof, to implement our proposed regulations. Some commenters claimed that we did not have such authority, while others expressed the view that we were abdicating the authority we do possess and, in some cases, failing to meet our statutory obligations. Some of these issues have already been discussed elsewhere in this document in relation to topics such as allowing developers to determine whether their products are eligible for exemption. As noted above, we base our determinations of regulatory status on whether a GE plant or its sexually compatible relatives could pose an increased plant pest risk relative to the comparator(s). One commenter asserted that the PPA gives the Secretary the authority to develop regulations for the movement of plant pests only, and not the authority to develop regulations for the movement of organisms that pose a plant pest risk. We do not agree with this comment. In addition to the authority to regulate the movement of plant pests under § 7711 of the PPA, including ‘‘[a]ny article similar to or allied with any of the’’ specific plant pests listed in § 7702(14), as cited by the commenter, we note that § 7712 of the PPA specifically provides the Secretary with broad authority to protect plants by regulating the movement of, among other items, plants and articles in order to prevent the introduction or dissemination of a plant pest within the United States. 11 National Strategy for Modernizing the Regulatory System for Biotechnology Products. September, 2016. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29822 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations As noted many times in this document, for GE organisms that fall under the regulations, permits are required for three activities: Importation, interstate movement, and environmental release. One commenter asserted that regulation of environmental releases done within a State or territory is unconstitutional. We do not agree with this comment. The impact of an unauthorized environmental release may extend beyond the borders of the State in which the GE organism was released. See Atay v. County of Maui, 842 F.3d at 701–02 (‘‘Under the PPA, ‘movement’ is defined broadly and expressly includes a plant’s ‘release into the environment,’ [7 U.S.C.] § 7702(9)(E), such as open-air field testing of GE plants. Experimental GE plants grown on test fields in Maui are without doubt involved in interstate commerce. Setting aside the global market for GE seed crops, seeds and other organisms carried afield by wind or other vectors ‘‘do not acknowledge State lines.’’ 52 FR 22892, 22894 (June 16, 1987).’’) (citation omitted); id. at 702 (‘‘While the phrase ‘movement in interstate commerce’ within the meaning of the PPA’s preemption clause may be narrower than the full scope of Congress’s Commerce Clause power, we find that the phrase encompasses federally regulated GE crops grown in Hawaii. [The plaintiff’s] narrower interpretation, which would limit the scope of the preemption clause to local laws addressing plants that are in the act of traveling to or through at least one other State, is less consistent with the statute’s larger context and purpose, which clearly envisions the dissemination of plants and seeds from fields as implicating movement in interstate commerce. See, e.g., 7 U.S.C. 7711(a). Indeed, Congress expressly recognized in the PPA that ‘all plant pests, noxious weeds, plants, plant products, articles capable of harboring plant pests or noxious weeds regulated under this chapter are in or affect interstate commerce.’ Id. § 7701(9).’’) (citation omitted). In contrast to the comments discussed above, which questioned the reach of our authority to regulate, other comments faulted us for not using our authority to regulate noxious weeds under the PPA. It was stated that by not considering noxious weed potential as a criterion for determining regulatory status of GE organisms, we restrict our authority under the PPA. One commenter argued that APHIS is statutorily obligated to integrate and apply the noxious weed authority to GE crops. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 APHIS recognizes that genetic engineering may be used to introduce a trait that increases the distribution, density, or development of a plant or the weedy impacts of the plant, factors that are considered aspects of a plant’s weediness. Accordingly, we would continue our current practice of considering the weediness of the unmodified plant and whether the new trait could in any way change the weediness. We would also consider potential effects on the weediness of other plants with which the engineered plant can interbreed, because it is relevant to the assessment of the plant’s plant pest risk. Plants and their sexually compatible relatives could have increased importance as reservoirs for plant pests if they are distributed differently, are more prevalent, or are altered with respect to the time period during which they serve as a host for plant pests due to the introduced trait. As part of the RSR, APHIS would continue to consider whether the trait might change plant pest interactions, establishment, and persistence for both the plant engineered and any other plants with which it can interbreed. If the plant had the potential to be a truly troublesome and impactful weed, we would need to consider whether the plant with the specific trait being evaluated should be considered for regulation pursuant to our separate statutory authority to regulate noxious weeds and the regulations issued under that authority. The proposed regulation does not change this analysis. APHIS disagrees with the proposition that APHIS is statutorily obligated to integrate noxious weed authority into a revised part 340. In the PPA, Congress identified plant pests and noxious weeds as separate concerns, and delegated authority to the Secretary to determine how to best use this authority. See, e.g., 7 U.S.C. 7711, 7712, 7754, 7758(c); see also Center for Food Safety v. Vilsack, 718 F.3d 829, 843 (9th Cir. 2013) (‘‘Plant pests and noxious weeds are regulated under separate regulatory frameworks. Regulations for plant pests are contained in 7 CFR parts 330 and 340 while the regulations governing noxious weeds are contained in 7 CFR part 360. The separate regulatory frameworks for plant pests and noxious weeds are consistent with standards of the statute treating plant pests and noxious weeds separately. Indeed, the PPA kept in place the separate regulatory frameworks for plant pests and noxious weeds that were originally promulgated under the Federal Plant Pest Act and the Federal Noxious Weed Act.’’) (Citing 7 U.S.C. PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 7758(c)). We also do not perceive a basis at this time for overhauling part 360 noxious weed regulations, which we believe have functioned well over the years, or establishing alternate regulations in title 7 governing noxious weeds. Other commenters expressed the concern that by asserting our statutory authority narrowly and emphasizing deregulation in this rulemaking, we could be creating a regulatory vacuum. It was suggested that States or localities may take advantage of that vacuum and assert their own authorities, possibly intervening to disrupt necessary field trials. With regard to overall scope, the regulations proposed under part 340 are functionally equivalent to the rules under which APHIS has been operating for essentially three decades. Under the existing regulations, APHIS communicates with and cooperates with State and local governments as appropriate and as circumstances warrant, including for coordination of enforcement and permitting activities. APHIS does not anticipate that the working relationship with State and local governments will be changed in any significant way based upon issuance of this rule. Federal courts have already considered the applicability of preemption principles in this area, including by applying the Plant Protection Act’s express preemption provision, 7 U.S.C. 7756. See generally Atay v. County of Maui, 842 F.3d at 698–705. Some commenters addressed issues of interagency and intra-agency coordination in the regulation of GE products. A commenter suggested that we needed to coordinate with EPA to improve the commercial availability of herbicide resistant crops, concomitant with the registration of herbicides for use on those crops. The commenter stated that the asynchronous timing of USDA’s deregulation of an herbicideresistant crop cultivar and of EPA’s associated herbicide registration has led to some scenarios in which growers are tempted to illegally apply unregistered herbicide formulations. Another commenter stated that duplicative regulations from oversight agencies, including FDA, EPA, and APHIS, should be streamlined into a common regulatory oversight regime depending on the product and its intended use. The interagency working group which drafted the Coordinated Framework sought to ensure regulation adequate to ensure health and environmental safety while maintaining sufficient regulatory flexibility to avoid impeding beneficial innovation. The former commenter E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations believes that a delay in USDA regulatory decisions to better coordinate with EPA registration decisions will curtail growers and applicators from illegally applying unregistered herbicide formulations. However, USDA needs to consider whether additional regulatory burden is warranted or legally appropriate, given that the pesticide activity noted is already considered to be illegal by existing regulation. We note that one of the purposes of the Coordinated Framework is to ensure that there is a standard mechanism for communication and, to the extent possible, coordination among FDA, EPA, and APHIS as they perform their respective regulatory functions. USDA and EPA are in communication over the overarching purpose of coordination as it pertains to the pesticide regulatory issues identified by the commenter. At the same time, this rule does not impose delays on USDA decision making based on factors within the regulatory jurisdiction of other agencies, nor do we think that such delays would be appropriate. With regard to the latter commenter, while FDA, EPA, and APHIS have distinct areas of regulatory oversight relative to GE organisms, the Agencies are committed to implementing Executive Order 13874, including its requirements that EPA and USDA streamline regulations and guidance documents within their purview and that these agencies ‘‘use existing statutory authority, as appropriate, to exempt low-risk products of agricultural biotechnology from undue regulation.’’ Where areas of overlapping jurisdiction exist, the Agencies are seeking to avoid redundant regulation. For example, FDA has jurisdiction over animals, including insects, but does not regulate when another agency is regulating, as APHIS is with GE moths and bollworm. With this rule, APHIS is avoiding redundant regulation with regard to microbial pesticides and plant incorporated protectants. As noted above, new § 340.5(f) states that a permit is not required for any GE microorganism product that is currently registered with the EPA as a microbial pesticide, so long as the microorganism is not a plant pest as defined in § 340.3. Similarly, § 340.5(g) states that a permit is not required for the movement of any plant modified solely to contain a plant incorporated protectant that is currently registered with the EPA or exempt from EPA regulations. Finally, multiple commenters recommended that we provide greater clarity regarding the regulatory jurisdiction of two agencies within APHIS—Biotechnology Research VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 Services (BRS) and Plant Protection and Quarantine (PPQ)—that regulate, among other things, GE and non-GE plants, respectively. The commenters expressed concern that some of the revisions we proposed, in particular those in § 340.2, may create opportunities for duplicative regulation of products under part 340 by BRS and under 7 CFR part 330 by PPQ. The regulations in part 330 govern the movement of plant pests, biological control organisms, and associated articles, such as soil. Prior to a final rule 12 published in the Federal Register on June 25, 2019 (84 FR 29938–29967, Docket No. APHIS–2008–0076), the regulations in part 330 had specifically exempted from regulation under that part any plant pests that had been genetically engineered, as that term was defined in § 340.1. In the June 25, 2019 final rule, that specific exemption was removed from part 330. In its place, a requirement, currently found in § 330.200(a), was added. This new requirement provided that plant pests, biological control organisms, and associated articles that are not authorized for importation, interstate movement, or environmental release in accordance with part 330, and are not explicitly exempted from regulation under part 330, must be authorized for importation, interstate movement, or environmental release under other regulations in title 7 of the Code of Federal Regulations in order for that movement to be lawful. The intent of this revision was to signal that there are multiple parts in title 7 of the Code of Federal Regulations, not just part 330, that contain requirements regarding the importation, interstate movement, or environmental release of plant pests, biological control organisms, or associated articles. However, we agree with the commenter that one of the unintended effects was to cause confusion within this rulemaking concerning the clear delineation between the requirements for the movement of GE plant pests, which are found in part 340, and the requirements for plant pests that had not been genetically engineered, which are found in part 330. Accordingly, we are revising § 330.200 to indicate that GE plant pests and biological organisms are exempted from regulation under part 330, and are regulated under part 340. A commenter expressed the concern that this rulemaking does not further the Coordinated Framework established in 12 To view the rule, its supporting documents, or the comments that we received, go to https:// www.regulations.gov/docket?D=APHIS-2008-0076. PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 29823 the 1980s among USDA, FDA, and EPA regarding federal biotechnology regulation. The commenter states that the proposed rule amended part of this Coordinated Framework without fully engaging EPA and FDA and did not reflect a truly holistic approach, in the spirit of the Framework, to updating the regulatory landscape for certain GE plants. The commenter strongly believes that APHIS should follow the intent of the Coordinated Framework. APHIS has continued to coordinate with our Coordinated Framework partners at FDA and EPA on an ongoing basis, and we are committed to continuing this coordination with the implementation and operationalization of this rule. In 2017, the three agencies collaborated on an update to the Coordinated Framework. This update was intended to: • Clarify which biotechnology product areas are within the authority and responsibility of each agency; • Clarify the roles each agency plays in regulating different product areas, particularly for those products that fall within the scope of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment; • Provide a standard mechanism for communication and, as appropriate, coordination among agencies while they perform their respective regulatory functions, and identify agency designees responsible for this coordination function; and • Specify the mechanisms and timelines for regularly reviewing, and updating as appropriate, the Coordinated Framework to minimize delays, support innovation, protect health and the environment and promote public trust in the regulatory systems for biotechnology products. The updated Coordinated Framework is available at: https:// obamawhitehouse.archives.gov/sites/ default/files/microsites/ostp/2017_ coordinated_framework_update.pdf. Additionally, as part of the rulemaking process, EPA and FDA have had the opportunity to comment on this proposal and to provide meaningful insight that informed this process. Another commenter stated that language in the section of the proposed rule describing regulation of PMPIproducing plants suggests that the Coordinated Framework for regulating GE crops in the United States is not nearly as ‘‘coordinated’’ as is necessary to ensure the safety of our food supply. According to this commenter, a statute should be enacted to create a new Federal agency that would have explicit authority to provide oversight over all GE organisms (plants, animals, and GE E:\FR\FM\18MYR2.SGM 18MYR2 29824 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 microorganisms) for all possible risks, including plant pest and noxious weed risks, environmental risks to beneficial organisms as well as to ‘‘neutral’’ organisms like monarch butterflies, and human health risks such as those associated with animal carcinogens and probable human carcinogens like glyphosate. Regulation of PMPI-producing GE plants is discussed above. The remainder of this comment is outside the scope of the current rulemaking and of APHIS’ regulatory authority. We note, moreover, that scientific evidence does not support the conclusion that GE organisms, as a class, present risks that are different in degree or kind from the risks that are presented by comparable non-GE organisms (NRC, 2010; NAS, 2016b) NEPA Implementing Regulations As noted earlier, the June 2019 proposed rule proposed that the notification and petition processes be removed from the regulations. Concurrently, we proposed to remove language pertaining to notifications and petitions from the NEPA implementing regulations in 7 CFR part 372. Specifically, we proposed to remove language pertaining to notifications from § 372.5(c)(3)(iii), and to remove language pertaining to petitions from paragraphs (b)(7) and (c)(4) of § 372.5. These changes were proposed to make the NEPA regulations consistent with the proposed revised part 340. Several commenters recommended that APHIS revise its NEPA implementing regulations to ensure that individual actions taken under the proposed rule are appropriately addressed and to describe the type of environmental analysis and documentation that will generally be developed. One commenter stated that APHIS should revise § 372.5(b) to include the proposed RSR as a type of action that normally requires an environmental assessment but not necessarily an Environmental Impact Statement. Another commenter recommended that APHIS clarify that certain actions are not expected to have an impact on the environment and therefore qualify for a categorical exclusion from the requirements of NEPA. APHIS disagrees with the suggestion that part 372 needs to be further revised to more specifically describe the type of environmental analysis that is necessary for individual actions under the final rule. Actions will be accompanied by appropriate environmental analysis based on the degree of environmental impact, consistent with the final VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 programmatic environmental impact statement (PEIS). In regard to the new proposed RSR, APHIS stated in the final PEIS that RSRs will be accompanied by an appropriate environmental analysis depending on the degree of environmental impact. APHIS seeks to further clarify APHIS’ NEPA obligations under various circumstances. When a modified plant qualifies for one of the exemptions in § 340.1(b), (c), or (d), the plant is not subject to part 340 at all and APHIS renders no determination regarding its plant pest risk. Therefore, APHIS will not complete a NEPA analysis for the plant. In the case of RSRs, whether conducted before or after a person requests a permit, only some outcomes will require analysis pursuant to NEPA. If, after initial review, APHIS finds a plausible pathway to increased plant pest risk, APHIS will conduct a Plant Pest Risk Assessment (PPRA) to evaluate the factor(s) of concern. In this situation, APHIS will complete a NEPA analysis, as appropriate, for an unconfined environmental release. Finally, when permits are issued for confined environmental release, NEPA will apply as appropriate. Under most circumstances, confined environmental releases are categorically excluded in part 372 from the need to prepare an Environmental Assessment or an Environmental Impact Statement. List of Taxa In the preamble to the June 2019 proposed rule, we noted that we were proposing to remove the list of taxa containing plant pests from the regulations. Instead, APHIS proposed to maintain a list of taxa that contain plant pests on its website. We explained that the list on the website would be more useful and reliable than a static list of taxa, which becomes outdated. We solicited public comment on the proposed change. Commenters supported this change. One commenter, however, suggested that it would be useful to maintain a version history on the website, so that developers can be aware of the latest updates. The commenter also recommended that whenever the website is updated, APHIS should send an email notification to stakeholders. Another commenter requested clarification on how the list would be maintained and modified. APHIS agrees with the comment. Since taxonomic designations sometimes change and new plant pests are continually being discovered, APHIS will maintain a version history for the list of taxa that contain plant pests and PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 will provide an email notification to stakeholders when the list is changed. Oversight and Transparency Some commenters expressed the concern that the regulatory framework set forth in the June 2019 proposed rule would result in an overall weakening of APHIS’ regulatory oversight over GE products. Commenters discussed a number of potential consequences of what they regarded as diminishing APHIS’ oversight role. As noted earlier in the discussion pertaining to allowing developers to determine whether their products are eligible for exemption, commenters were concerned that there could be an increased risk of commingling of non-GE crops with GE crops. It was also stated that because GE crops are already associated with greater herbicide and pesticide use than non-GE crops, the rule could result in the development of more herbicide- and pesticide-resistant pests and weeds, leading to increased environmental and human health risks. Some commenters stated that we needed to strengthen, rather than loosen, our regulatory oversight. We have addressed many of these issues earlier in this document and the PEIS (§§ 4.3.5 Agricultural Weeds and HR management; 4.6.2 Domestic Socioeconomic Environment; and 4.6.3 International Trade). Additional discussion is presented below, under the heading ‘‘General Opposition to GE Products.’’ As we have noted, however, these issues are mostly outside the scope of the current regulations and of our statutory authority under the PPA. It was also suggested that the proposed new regulatory framework could lead to a loss of transparency. Growers of non-GE crops, as noted above, could lose access to information about neighboring GE crops. According to some commenters, the public would also lose access to important data. In particular, field-test data would no longer be available to the public because the submission and publication of such data would not always be required under the proposed rule. One commenter recommended that in addition to providing the information currently set forth in the proposed rule, APHIS should establish on its website a single list of all GE organisms that are being released into the environment. According to the commenter, that list should include all plant-trait-MOA combinations, all RSRs, all permitting, and all confirmations of developers’ determinations of an exemption. The commenter believes that with a complete and accurate list of all GE organisms that have been released into E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 the environment, food industry stakeholders and the public will be able to determine which GE plants have entered the food supply. Further, according to the commenter, a transparent and comprehensive list will provide helpful information if any food safety and environmental threats materialize. In the commenter’s view, this information will also be important for international trade because it may prevent unnecessary trade barriers from being constructed based on inaccurate information about which GE plants may be entering a country without the proper regulatory approval. Also, according to the commenter, it will improve consumer confidence about GE plants because consumers will realize that their existence is not being hidden from them. The commenter recommended that to be as useful and as transparent as possible, the list should include information about the plant, the type of modifications or edits performed, the changed traits, a summary of data about the benefits of the traits, and any testing for safety concerns. We do not agree with these comments. Under this rule, APHIS will continue to make information available that is related to permits issued under § 340.5. APHIS will also make information available concerning responses to confirmation requests under § 340.1 and RSR requests and results under § 340.4. The information will be available at https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology. As to organisms that are not regulated by APHIS, APHIS is not in the best position to provide accurate and up-to-date information about such organisms. In this regard, APHIS notes that pursuant to Executive Order 13874, USDA, EPA, and FDA recently released a unified website that provides a onestop-shop for information about the actions that the Federal Government is taking to oversee the development of agricultural biotechnology products. See https://usbiotechnology regulation.mrp.usda.gov/ biotechnologygov/home. The website provides links to relevant USDA, EPA, and FDA websites. See https:// usbiotechnology regulation.mrp.usda.gov/biotech nologygov/resources. General Opposition to GE Products Many individuals who commented opposed the rule because of their concerns about GE products generally. An issue of particular concern, raised by a large number of commenters, was the possibility of unsafe GE products’ getting into the food supply without consumers’ knowledge. Many of the VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 commenters favored labeling of foods derived from GE products. Commenters expressed the view that genetic engineering techniques are not as safe as conventional breeding methods and that all products developed using genetic engineering should be regulated, with no exemptions allowed. Others stated that we should require long-term testing of GE products prior to allowing commercialization. It was further stated that in light of these considerations, our proposed regulatory approach, with its focus on unfamiliar products developed using genetic engineering, does not adequately evaluate products of genetic engineering for potential long-term risk. Many commenters argued that all GE organisms should be subject to assessments of their long-term effects on the environment and human health and also evaluated for indirect economic effects. Commenters also claimed that the proposed rule, with its deregulatory emphasis, favored certain economic interests at the expense of public health and safety and the environment. One commenter further stated that APHIS or a new GE organism-specific agency should provide oversight over all GE organisms for all possible risks, including any associated with the MOA used for gene insertion, e.g. extra antibiotic-resistance genes, insertional mutations, and unintended changes in the inserted genetic material. According to this commenter, APHIS should require developers of GE organisms to utilize the precision of the technology available to identify the off-target effects of genetic engineering and to ensure that associated risks are minimal. The comments discussed above appear to be based on the premise that the genetic engineering process itself is inherently risky. As we noted in the preamble to the June 2019 proposed rule, and in this document, available evidence, including reports from the National Academies of Sciences, Engineering, and Medicine cited earlier in this document, does not support this view. Moreover, the comments discussed above do not reflect an accurate understanding of the limits of APHIS’ statutory authority, as explained elsewhere in this preamble. In the reports we cited, issued in 1987 and 1989, respectively, by the NRC,13 14 it was stated that there was no evidence for unique hazards inherent in the use of recombinant DNA techniques and 13 Introduction of Recombinant DNA-Engineered Organisms Into the Environment: Key Issues. 1987. NRC. Washington, DC. National Academies Press (US). 14 Field Testing Genetically Modified Organisms: Framework for Decisions. 1989. NRC (US) Washington (DC). National Academies Press (US). PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 29825 that with respect to plants, crops modified by molecular and cellular methods should pose risks no different from those modified by conventional breeding methods for similar traits. A key conclusion from these reports, taken together, is that it is not the process of genetic engineering per se that imparts the risk, but the trait or traits that it is used to introduce. A more recent NAS report, issued in 2016, reaffirmed this conclusion.15 Several commenters took a position diametrically opposed to the comments discussed above. The commenters stated that there is no scientific rationale for the continued regulation of plant products developed using genetic engineering techniques and legacy methods. We do not agree with this comment. As discussed above, responsibility for regulating GE and non-GE plants for plant pest risk is divided between APHIS BRS and APHIS PPQ. In both cases, plants and plant products are regulated or not regulated based on the risk of introducing or disseminating plant pests that may be posed by their movement or release into the environment. Because some (but not all) GE and non-GE plants are associated with increased risk, it is necessary for APHIS to regulate such plants in order to carry out its mission of protecting U.S. agriculture. Concerns were expressed by the organic farm industry regarding the economic impact that the regulatory relief offered to developers in this rulemaking would have on organic farmers, particularly as it relates to the issue of GE crops commingling with organic crops. The commenters stated that APHIS must consider how it will address the needs of USDA-certified organic operations to prevent commingling with GE organisms. Such considerations, it was stated, were not addressed in the proposed rule. The commenters asserted that the USDA National Organic Program regulations prohibit the use of genetic engineering in the production of agricultural products marketed as organic in the United States. According to these commenters, even inadvertent presence of GE organisms can jeopardize the organic status of an otherwise compliant organic product, and can lead to loss of markets and significant industry disruption. Organic farms that reported crop loss from the presence of GE organisms between 2011 and 2014 15 NAS. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29826 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations reported an average loss of $70,000 per farm (2014 USDA Organic Survey). APHIS has fully considered these factors from an economic perspective and would refer the commenter to the economic analysis accompanying this final rule. APHIS in that analysis expanded the discussion of the various costs, including the costs associated with buffer strips, spatial and temporal isolation, and the loss of premiums associated with the risk to organic and non-GE growers from cross-pollination or commingling. We note that organic crops and non-GE products that are kept separate from their GE equivalents are treated as value-added crops commanding premiums that vary according to prevailing supply and demand conditions. Organic and other identity-preserved crops generally receive a price premium, a premium adversely impacted by the unintended presence of GE traits. The premiums compensate farmers and traders for incremental costs they incur, including those borne to maintain the segregation of non-GE and other IP production from GE crops throughout the supply chain (through buffer zones, spatial and temporal isolation, etc.). In the United States, the coexistence of GE and nonGE production systems has been left to market forces. Non-GE growers bear costs of coexistence and, in turn, pass those costs on to purchasers of non-GE crops (Kalaitzandonakes and Magnier, 2016). One commenter stated that in addition to the threat of economic harm from unintended presence of GE plant material, farmers who unintentionally grow patented GE seeds or who harvest crops that are cross-pollinated with GE traits could face costly lawsuits by biotechnology companies for ‘‘seed piracy.’’ The issue raised by the commenter is outside the scope of the plant pest authority delegated to APHIS under the PPA. Some commenters argued that APHIS should conduct ongoing monitoring and assessment of GE product impacts both in pre-market field trials and following commercialization in order to protect the integrity of conventional and organic seed and crops from prohibited substances and excluded methods, including the methods of genetic engineering. According to these commenters, safeguards and monitoring must be required for the organism postcommercialization, and the FDA GRAS (Generally Recognized as Safe) notification process is not enough for such safeguards. In these commenters’ view, monitoring should include tracking changes associated with VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 ecosystem harm, such as degradation of water quality, air pollution, climate impacts, or loss of biological resources. The commenters believe that this process must be rigorous, transparent, and inclusive of APHIS’s plant pest and noxious weed authority under the PPA. APHIS does not agree with these comments. Once APHIS determines that a plant product does not pose a plant pest risk, APHIS has no further authority to regulate it as such and to mandate requirements for the submission of data unless there are new facts, such as a compliance incident, that warrant such action. The FDA regulates human and animal food from GE plants as FDA regulates all food within its regulatory jurisdiction. The existing FDA safety requirements impose a clear legal duty on everyone in the farm to table continuum to market safe foods to consumers, regardless of the process by which such foods are created. It is unlawful to produce, process, store, ship or sell to consumers unsafe foods. Comments concerning FDA’s process and requirements should be directed to FDA. One commenter discussed the need for compensating organic and other growers of non-GE crops who could suffer harm as a result of this rulemaking. It was argued that we need to establish a compensation mechanism for those harmed by commingling, and that liability in cases of commingling caused by GE crops should rest with the developers or patent holders. One commenter also recommended that we establish a fair compensation mechanism for losses caused by herbicides drifting from fields planted with herbicide-resistant GE plants. We thank the commenters for these recommendations; however, they fall outside the scope of the regulations in part 340, which establish the oversight and regulation of certain GE organisms. Regarding the final comment, application protocols/practices for pesticides are established and enumerated through EPA’s labeling requirements. Once APHIS determines that a plant product does not pose a plant pest risk, it is not subject to our regulations in part 340 unless there are new facts, such as a compliance incident, that warrant such action. Additional Comments Commenters offered a number of additional recommendations that are beyond the scope of the current rulemaking. Some commenters recommended that we invest in research to develop lower-cost rapid testing technology. It was further suggested that we commit resources to researching, PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 tracking and analyzing incidences of unintended GE presence and associated economic losses at all levels of the supply chain. One commenter recommended that we coordinate with the USDA Agricultural Marketing Service to establish contract protections for organic and identity preservation grain growers to ensure that they have fair access to testing data and recourse. We thank the commenters for these recommendations. As noted above, however, all of these recommended activities would fall outside the scope of the regulations in part 340, which establish the oversight and regulation of certain GE organisms. One commenter stated that APHIS should consider protection goals that align with making U.S. agriculture more sustainable, more environmentally friendly, and less in need of future ‘‘solutions’’ to genetic-engineeringproduced noxious weed problems that involve developing additional GE crops engineered to be tolerant of different, more noxious herbicides. This comment is outside the scope of these regulations. The PPA provides for detection, control, eradication, suppression, prevention or retardation of plant pests or noxious weeds. Another commenter expressed concern over biodiversity and food security in the context of accelerating climate change. The commenter stated that genetic uniformity leads to disease susceptibility and that biodiversity management systems need to be improved in terms of equity. According to the commenter, we need systems that support keeping diverse seeds in use, but genetic engineering has gone hand in hand with large monoculture production. This comment is outside the scope of these regulations. We note, however, that the concerns identified by the commenter do not seem specific to genetic engineering. Other commenters expressed concerns about corporate concentration and what they viewed as related feedback loops of seeds and chemical use. Particular concern was expressed over the possible consolidation of the seed industry that commenters thought could result from this rulemaking. It was stated that legal and government systems favor the largest companies, and that efforts to check the power of the largest seed companies have been overridden or have fizzled out. APHIS acknowledges the concern that the commenters have raised on this topic. The regulations proposed under part 340 are intended to streamline and offer additional regulatory relief to developers of all sizes. We anticipate E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations that since smaller-scale business and academics have limited resources and capacity to navigate regulatory systems, this rule will provide especially acute benefits to smaller researchers and businesses. APHIS has outlined and provided detailed descriptions of this dynamic in the economic analysis accompanying this regulation. Some commenters opposed the elimination of the notification and petition procedures contained in the existing regulations. It was stated that APHIS should not eliminate the petition process without more clearly defining a streamlined, predictable path through which responsible individuals can establish that their innovation no longer needs to be reviewed by APHIS prior to release and commercialization. Commenters opposed eliminating the notification procedure because they were concerned that doing so would require many developers to go to permitting, potentially disrupting business practices. Alternatives suggested by these commenters included adding provisions for streamlined permitting with standardized conditions for low-risk organisms and returning to requiring individuals to provide information on how they intend to meet performance standards. In many ways, the APHIS evaluations for notifications under current regulations are very similar to those done for permit applications, but the notification procedure relies on applicants’ agreeing to meet the performance-based standards described in the regulations rather than submitting an application for APHIS review describing the specific measures that they will employ for the activity (as is the case for permits). With permits, but not with notifications, APHIS can accept the proposed measures or add to them, and the result is a set of binding customized permit conditions. We will not be making any changes in response to these comments. As we noted in the preamble to the June 2019 proposed rule, the notification procedure in the current regulations relies upon performance-based standards. Since the specific measures that constitute compliance with the regulations are not enumerated in the performance standards, it can be difficult for APHIS inspectors to determine whether a notification holder is in compliance. This uncertainty can make enforcing the regulations, and thereby protecting U.S. agriculture from plant pest risks, more difficult than it would be if compliance measures were clearly enumerated as they are in specific conditions under a permit. For VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 this reason and to comply with OIG recommendations with which we agreed, we proposed to eliminate the notification procedure. We do not agree with the recommendation to provide streamlined permit conditions for lowrisk organisms. The standard permitting conditions in § 340.5(i) are needed to ensure that activities conducted under permit for all GE organisms can be performed with adequate mitigations for plant pest risk. Differences in the level of risk associated with different organisms will be reflected in the supplemental permitting conditions. The current petition process for GE plants stems from the manner in which regulated article is defined. As noted above, the current regulations consider a GE organism to pose a plant pest risk and therefore be a regulated article if the donor organism, recipient organism, vector, or vector agent is a plant pest. Under the proposed regulations, however, we would evaluate whether an organism would require a permit for movement based on the characteristics of the organism itself rather than on the method by which the organism is genetically engineered. Based on the proposed change in approach, APHIS believes that the petition process is no longer necessary and is removing the petition process from the regulations. (As discussed previously in this document, however, until RSR is available for a particular crop, we will continue to receive petitions under the process for that crop.) Some commenters advocated that we retain the existing regulatory framework rather than adopting the one we proposed. In the view of one commenter, the proposed rule constituted a shift from a streamlined, performance-based regulatory approach to a more prescriptive one. The commenter saw that shift as a step backwards. Another commenter expressed a preference for the processbased approach of the existing regulations rather than the productbased one that we proposed. The commenter stated that APHIS should regulate biotechnology products based on the process by which they are created, using genetic engineering as the trigger for regulatory review, to ensure that none evade oversight entirely. For reasons discussed at length in this document and in the June 2019 proposed rule, we do not agree with these comments. One commenter viewed our overall regulatory approach as not sufficiently flexible to take into account the relative risk levels associated with different crops. The commenter recommended that we consider such differences when PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 29827 making determinations about the appropriate levels of regulation for different crops. We do not agree with this comment. Our assessment of the risks associated with specific GE crops will be reflected in our RSR determinations and in the permit conditions we assign. One commenter stated that our policy on low-level presence of Regulated Genetically Engineered Plant Materials, discussed in the 2008 proposal, is absent from this one. APHIS intends to continue its support of U.S. trade agencies to address low level presence issues, as is further discussed above. This approach is consistent with APHIS’ statutory authority to regulate plant pests, as further explained above. One commenter stated that the June 2019 proposed rule lacked the summary of commenters that is common to proposed rules from other agencies. The commenter stated that APHIS should publish such a summary in the final rule and should hold at least one public consultation with stakeholders that do not have a direct or indirect financial interest in the proposed regulations. We do not agree with this comment. As we noted in the preamble to the June 2019 proposed rule: ‘‘Following the withdrawal of the January 2017 proposed rule, APHIS conducted extensive outreach to Land Grant and public university researchers, as well as small-scale biotechnology developers, agriculture innovators, and other interested stakeholders. In total, APHIS met with more than 80 organizations, including 17 universities, State Departments of Agriculture, and farmer organizations.’’ In this final rule, we have further delineated the nature of these discussions. National Environmental Policy Act To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the processes in this final rule, we have prepared a final environmental impact statement (EIS). The final EIS is based on a draft EIS, which we drafted after soliciting public comment through a notice in the Federal Register to help us delineate the scope of the issues and alternatives to be analyzed. The final EIS responds to public comments, analyzes each alternative and its environmental consequences, if any, and provides APHIS’ preferred alternative. The EIS was prepared in accordance with: (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions E:\FR\FM\18MYR2.SGM 18MYR2 29828 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372). Copies of the final EIS are available on the Regulations.gov website (see footnote 3 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. Executive Orders 12866, 13563, 13771 and Regulatory Flexibility Act This final rule is an Executive Order 13771 deregulatory action. Details on the estimated costs of this final rule can be found in the rule’s economic analysis. This final rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget. We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, and equity considerations). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides a final regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. The revisions to part 340 in this final rule create the framework for more focused, risk-based regulation of the GE organisms that pose plant pest risk. Under this rule, certain categories of plants are exempted from the regulations in part 340. Developers are able to determine, when appropriate, whether their products fit into one of the exempted categories and are therefore not subject to APHIS’ regulations. The rule also provides for a process to determine the regulatory status of a plant under part 340. GE plants having the same plant-trait-MOA combination VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 as those previously found by APHIS to be not subject to the regulations will not be regulated, nor will they be required to undergo an RSR. GE plants found likely to pose a plant pest risk and GE plants that are not eligible for an RSR will be allowed to move only under permit. For plants that do not fall into any of the exempted categories and are eligible for an RSR, developers have the option of either requesting a review or requesting a permit for the movement (including importation, interstate movement, or environmental release) of their organism in lieu of an RSR. Developers of GE organisms that are plant pests will continue to need permits to import, move interstate, or environmentally release those organisms. Shipping standards under this rule are less prescriptive and more generally applicable, and the rule provides for the issuance of multi-year permits. The provisions for record retention, compliance, and enforcement have been altered to ensure that APHIS has sufficient information to monitor compliance with its regulations and maintain effective oversight of regulated GE organisms, in accordance with provisions of the 2008 Farm Bill and recommendations of the 2015 USDA OIG report on GE organisms. These changes improve the efficiency and clarity of the regulations. The amendments in this rule will benefit developers, producers, and consumers of certain GE organisms; public and private research entities; and APHIS. There will be no decrease in the level of protection provided against plant pest risks. The regulatory framework, including the RSR process used to determine regulatory status established under this rule, will provide cost savings to some plant developers and will allow for reallocation of APHIS resources to Biotechnology Regulatory Services (BRS) priorities. Under this rule, APHIS regulatory oversight (through permitting) will not be required for plants that fall into one of the exempted categories or have been assessed by means of an RSR and have been found unlikely to pose an increased plant pest risk relative to its comparator. Direct regulatory costs to some plant developers will be reduced for the development of GE plants for which APHIS permits are no longer necessary. Savings to the regulated community will result from a reduced need to collect field data, fewer reporting requirements, and lower management costs. Costs now associated with petitions for non-regulated status will be reduced or eliminated where APHIS permits are no longer necessary. PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 Cost savings for these entities are expected to more than offset the new costs. APHIS estimated the cost savings for two regulatory oversight scenarios where USDA either has sole regulatory authority or shares oversight with EPA and/or FDA, based on a study of the costs encountered by private biotechnology developers as they pursue regulatory authorization of their innovations. When only APHIS has regulatory oversight, compliance cost savings under the rule could range from $1.6 million to $5.6 million ($3.6 million on average) for the development of a given GE plant. If EPA and/or FDA also have an oversight role in the development of a given GE plant, compliance cost savings could range from $551,000 to $937,000 ($744,000 on average; see Table A below and Table 5 of the RIA). From 1992 through September 2019, an average of just under 5 petitions were processed (granted non-regulated status or the petition withdrawn) in a given year, with a high of 14 in 1995. As the rule is expected to spur innovation, we expect the number of new GE plants developed annually to increase over time. In particular, the rule may provide impetus to the development of new horticultural varieties, where the costs of acquiring non-regulated status in the past may have been prohibitively high relative to the potential market. In the following estimate of impacts, we use the average cost savings reported above per GE plant developed and assume the annual number of new GE plants developed under the rule without APHIS permits ranges from 5 (the current annual average number of processed petitions) to 10 (twice this average). We further assume that about 20 percent of those new GE plants are solely within the purview of APHIS oversight, and that the remaining 80 percent will also be under the purview of FDA and/or EPA oversight. If five new GE plants are developed annually without APHIS permits (all with no APHIS permit, but four still with EPA and/or FDA evaluation), the annual savings would be $6.5 million.16 If 10 new GE plants are developed annually without APHIS permits (all with no APHIS permit, but 8 still with EPA and/or FDA evaluation), the annual savings will be $13.1 million.17 New costs borne by regulated entities under the rule will include rule familiarization and recordkeeping. Annual recordkeeping costs are based 16 1 × $3,573,500 = $3,573,500. 4 × $744,000 = $2,976,000. $3,573,000 + $2,976,000 = $6,549,500. 17 2 × $3,573,500 = $7,147,000. 8 × $744,000 = $5,952,000. $7,147,000 + $5,952,000 = $13,099,000. E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 on information collection categories that were described in the Paperwork Reduction Act section of the proposed rule, and are estimated to total about $1,070,000. New maintenance and record retention requirements in this rule should not significantly affect permit holders. While some of the specific records required under this rule were not explicitly included in the current regulations, they have been required as part of the supplemental permit conditions that accompany an issued permit. These records are integral to the activities under the permit and should already be maintained by the permit holder as a normal part of business operations and therefore readily be accessible. About 1,250 distinct entities have applied for permits or notifications under part 340. APHIS estimates that each of those entities will spend a total of about 24 hours becoming familiar with the provisions of this rule, at a total onetime cost of about $1.5 million. Some plants that would not have been regulated under previous regulations in part 340, because a plant pest was not used in their development, would now be under the purview of APHIS oversight. APHIS expects the number of plants in this category will be very small, likely less than 1 per year based on historical activity. For those few instances where an APHIS permit is required, developers could incur new costs associated with permitting ranging from about $13,000 to $671,000, depending on recordkeeping, reporting, stewardship, and testing requirements.18 In accordance with guidance on complying with Executive Order 13771, the primary estimate of the annual net private sector cost savings for this rule is $8.3 million. This value is the midpoint estimate of the net private cost savings annualized in perpetuity using a 7 percent discount rate. Current annual APHIS personnel costs for conducting genetic engineering related activities that will be affected by this rule total about $3.4 million. These 18 Additional recordkeeping and reporting costs could be about $13,000 annually for a field trial that requires 25 reports per year. Because few plants tested in the field are likely to demonstrate commercial viability, we expect they would be tested on a limited number of sites. Additional stewardship costs could range from about $20,000 to $120,000. In the rare case in which a plant demonstrates commercial viability and warrants further data collection under the RSR process, the developer could incur additional testing costs, which under current regulations are estimated to range between about $152,000 and $538,000. Because the data required under the RSR process will be more targeted than under the current process, testing costs would likely be closer to the lower bound. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 include compliance activities, inspection activities, ‘Am I Regulated’ (AIR) process activities, notification activities, permit activities, and petition activities. Under this rule, APHIS’ overall annual personnel costs of regulating GE plants are not expected to change. While the volume of specific activities will change, the overall volume of regulatory activities, the general nature of those activities, and the level of skills necessary to perform those activities will not change. Costs to APHIS of implementing this rule include outreach activities, developing guidance documents, training, and adjusting the permit system. APHIS estimates that public outreach, guidance and training will cost about $77,000. Requests for RSRs and response letters under the rule will be handled in a manner similar to the current AIR process, outside the electronic permitting system and without incurring new costs. Certain plants are genetically engineered in order to produce PMPIs. To date, PMPI-producing GE plants regulated by APHIS have been genetically engineered using a plant pest as the donor, vector, or vector agent, and thus fall under the scope of regulated article in the current regulations in part 340. In this rule, APHIS will maintain its oversight of PMPI-producing plants. In this final rule, we are adding this requirement to § 340.2, as paragraph (e), which states that a permit is required for the movement of a plant that encodes a product intended for pharmaceutical or industrial use. Certain plants are genetically engineered to produce PIPs, meaning that they produce pesticides. APHIS has regulated those PIP-producing plants that are captured by current regulations, i.e., when plant pests or plant pest sequences are used. The PIPs also fall under the regulatory oversight of EPA. However, because EPA generally requires Experimental Use Permits (EUP) only for field tests on 10 acres or more of land, APHIS has exercised regulatory oversight of PIP plantings on fewer than 10 acres. Under this rule, GE PIP-producing plants that are unlikely to pose an increased plant pest risk relative to their comparators will not be regulated by APHIS following an RSR. Therefore, under this rule Federal oversight of GE PIPs will rest solely with EPA. EPA may decide to require EUPs for all, some, or none of the PIPs for test plantings on fewer than 10 acres of land, and may conduct inspections of all, some, or none of the PIPs that are under permit. EPA may also exempt certain PIPs from requirements under PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 29829 the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). Current inspection costs incurred by APHIS average roughly $800 per inspection. A quicker APHIS evaluation process will mean a shorter period of regulatory uncertainty that may facilitate developers’ ability to raise venture capital. Reduced regulatory requirements may also lead to greater participation by public and private academic institutions in genetic engineering research and product development. These indirect benefits of the rule may spur genetic engineering innovations, particularly in small acreage crops where genetic engineering has not been widely utilized due to the expense of regulation. In general, new plant varieties, including GE crop varieties, are not required to be reviewed or approved for food safety by the FDA before going to market. However, the developer is responsible for ensuring product safety and developers of GE plant varieties have routinely consulted with FDA prior to marketing new varieties to resolve food safety or other questions about food within FDA’s jurisdiction. APHIS expects that stewardship practices currently used to conduct field trials of GE plant varieties will be maintained under the new rule. It will be in a plant developer’s best interest to supervise and control the development process as at present, to prevent undesired cross-pollination or commingling with non-GE crops. Developers have various legal, quality control, and marketing motivations to maintain rigorous voluntary stewardship measures. APHIS therefore believes that developers will continue to utilize strict control measures for field testing even in cases where APHIS does not require a permit. Farmers who adopt GE crops may benefit from the rule. GE crop adoption varies by crop and technology and can affect yields, net returns, and pesticide use. Fernandez-Cornejo, et al. (2014) showed that planting insect-resistant cotton and corn seed is associated with higher net returns when pest pressure is high. The extent to which adoption of herbicide tolerant (HT) traits affects net returns is mixed and depends primarily on how much weed control costs are reduced and seed costs are increased. HT soybean adoption is associated with an increase in total household income because HT soybeans require less management and enable farmers to generate income via off-farm activities or by expanding their operations. Farmers may benefit by having access to a wider variety of traits as well as a greater number of new GE crop species, E:\FR\FM\18MYR2.SGM 18MYR2 29830 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations affording them a broader selection of crops to suit their particular management objectives. Among the types of innovations expected are crops with greater resistance to disease and insect pests; greater tolerance of stress conditions such as drought, high temperature, low temperature, and salt; and more efficient use of fertilizer. These types of traits can lower farmer input costs (water, fertilizer, pesticide) and increase yields during times of adverse growing conditions. As mentioned, regulatory costs are expected to be lower under this rule, thereby potentially spurring developer innovation, especially among small companies and universities. Consumers will benefit from a wider variety of available products, including ones with improved taste, storage longevity, or nutritional content. In terms of the potential benefits of GE crop plants, an emerging area of interest is the nutritional modification of crop plants through the use of biotechnology to provide human health benefits. Some of these types of modifications are discussed in the EIS in section 4.4.1.4. They include rice varieties developed to provide vitamin A and to address iron and folate deficiency; wheat varieties with reduced levels of celiac-diseasetriggering gliadins and with increased levels of lysine and zinc; and cyanidefree cassava. Innovations may also benefit consumers through lower prices for existing products. In addition to the compliance costs associated with regulation, there are opportunity costs of delayed innovation if the approval process for a plant is longer than necessary to ensure safety with reasonable scientific certainty. Regulatory delays mean that the benefits of innovation occur later than they would otherwise and most likely at lower levels. The forgone benefits due to delayed innovation can be substantial and developers, producers and consumers all lose from regulatory delays. The forgone benefits stemming from even a relatively brief delay in product release can overshadow both research and regulatory costs. It should be noted that while the rule will alter APHIS’ evaluation process for GE plants, it is not expected to affect the evaluation of such plants by FDA or EPA or foreign regulatory agencies, the actions of whom may affect the opportunity costs of regulatory delay. When FDA and/or EPA also have a regulatory role, substantial time savings due to the rule are most likely to be realized in those instances in which the APHIS process takes the longest time. When APHIS is the only agency with oversight (as with many new horticultural varieties such as petunias or carnations modified to produce different flower color, morphology, or longevity), there could be significant time savings over the current petition process. Some farmers (e.g., growers of identity-preserved crops, including organic, other non-GE and other agricultural commodities segregated for specific purity and quality tolerances) could be indirectly negatively impacted by increased GE innovations. Identity preservation (IP) refers to a process or system of maintaining the segregation and documenting the identity of a product. Crops with unique product quality traits such as low linolenic canola require IP to capture the added value. Similarly, organic commodities must be produced according to specific criteria and segregated in the marketplace in order to receive premium prices. Some consumers choose not to purchase products derived from GE crops and instead purchase commodities such as those labeled ‘‘non-GMO.’’ In addition, the USDA organic standard does not allow for the intentional use of GE seeds. In cases where crops intended for the non-GE or other identity-preserved marketplaces contain unintended GE products, their profitability may be diminished. Unintended GE presence and diminished profitability may also occur for identity-preserved GE crops with special attributes. Such crops are more likely to be developed under the new rule. Effects of this rule on the variety of GE crop species grown in the United States and their wider adoption may increase the possibility of crosspollination or commingling. As commercial acreage of any given GE crop increases and as a greater variety of crops are modified using genetic engineering, the potential for more instances of unintended presence of a GE organism increases. Costs incurred by growers of organic and other identity-preserved varieties who seek to prevent such unintended presence may increase. Entities potentially affected by the rule fall under various categories of the North American Industry Classification System. Economic data are not available on business size for some entities. Nonetheless, based on industry data obtained from the Economic Census and the Census of Agriculture, we can assume that the majority of the businesses affected by the rule will be small. Table A provides a summary statement of the expected direct costs and cost savings of the rule: TABLE A—EXPECTED COSTS AND COSTS SAVINGS OF THE RULE FOR THE BIOTECHNOLOGY INDUSTRY AND FOR APHIS [2016 dollars] Biotechnology Industry One-time industry-wide costs of rule familiarization ............................... $1,468,000. Annual industry-wide recordkeeping costs ............................................. $1,070,000. Annual cost of permits for plants not previously regulated 1 .................. $13,000 to $671,000. Developer Savings per Trait 2 ................................................................. APHIS sole regulatory oversight ............................................................. APHIS oversight together with FDA and/or EPA oversight .................... Lower Bound Estimate .................. $1,559,000 ..................................... $551,000 ........................................ jbell on DSKJLSW7X2PROD with RULES2 APHIS Biotechnology Regulatory Services Annual costs for public outreach, training, and e-permitting 3 ................ Upper Bound Estimate. $5,588,000. $937,000. $77,000. 1 The number of plants in this category is expected to be very small, likely less than 1 per year based on historical activity. The range in cost shown is for one permit. The actual cost will depend on additional recordkeeping, reporting, stewardship, and testing requirements. 2 These savings are shown on a per trait basis. On average, if five new GE plants are developed annually without APHIS permits (all with no APHIS permit, but four still with EPA and/or FDA evaluation), the annual savings will be $6.5 million. If 10 new GE plants are developed annually without APHIS permits (all with no APHIS permit, but 8 still with EPA and/or FDA evaluation), the annual savings will be $13.1 million. 3 Requests for regulatory status and response letters under the rule will be handled in a manner similar to the current ‘Am I Regulated’ process, outside the electronic permitting system and without incurring new costs. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.) Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. Executive Order 13175 The USDA’s Office of Tribal Relations (OTR) has assessed the impact of this rule on Indian Tribes and determined that this rule has Tribal implications; however, OTR has determined that Tribal consultation under Executive Order 13175 is not required at this time. If a Tribe requests consultation, APHIS will work with the OTR to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), some of the information collection requirements included in this final rule have been approved under Office of Management and Budget (OMB) control number 0579–0085 and some of the information collection requirements were filed under OMB comment-filed number 0579–0471, which has been submitted to OMB for approval. When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take. jbell on DSKJLSW7X2PROD with RULES2 E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mr. Joseph Moxey, APHIS’ Information Collection Coordinator, at (301) 851–2483. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs has designated this action as a rule that is not a major rule, as defined by 5 U.S.C. 804(2). References Ahloowalia, B and M. Maluszynski (2001). Induced mutations—a new paradigm in plant breeding. Euphytica 118(2):167– 173. https://link.springer.com/article/ 10.1023/A:1004162323428. Arabidopsis Genome Initiative 2000. Nature 408: 796–815. Bravo, J.E.E. and D.E. Evans (2011). Protoplast Fusion for Crop Improvement. Plant Breeding Reviews. 3:193–218. DOI: 10.1002/9781118061008.ch4). Chen K., Y. Wang, R. Zhang, H. Zhang, and C. Gao (2019). CRISPR/Cas Genome Editing and Precision Plant Breeding in Agriculture. Annual Review of Plant Biology 70: 667–697. https://doi.org/ 10.1146/annurev-arplant-050718100049. Christin, P.A., E.J. Edwards, G. Besnard, S.F. Boxall, R. Gregory, E.A. Kellogg, J. Hartwell, and C.P. Osborne (2012). Adaptive evolution of C(4) photosynthesis through recurrent lateral gene transfer. Current biology: CB 22, pp. 445–449. Retrieved from http:// www.ncbi.nlm.nih.gov/pubmed/ 22342748. Custers R., J.M. Casacuberta, D. Eriksson, L. Sa´gi, and J. Schiemann (2019). Genetic alterations that do or do not occur naturally; Consequences for genome edited organisms in the context of regulatory oversight. Frontiers in Bioengineering and Biotechnology 6: DOI: 10.3389/fbioe.2018.00213. De Filippis, L.F. (2014). Crop Improvement Through Tissue Culture. In: Ahmad P., M. Wani, M. Azooz, L.S. Tran L.S. (Eds) Improvement of Crops in the Era of Climatic Changes. Springer, New York, NY. Feng C., H. Su, H. Bai, et al. (2018) Highefficiency genome editing using a dmc1 promoter-controlled CRISPR/Cas9 system in maize. Plant Biotechnol J. https://doi.org/10.1111/pbi.12920. Fernandez-Cornejo, J., Wechsler, S. Livingston, M. and Mitchell, L (2014). Genetically Engineered Crops in the United States. United States Department of Agriculture, Economic Research Service, Bulletin Number 162. Feng Z., Y. Mao, N. Xu, et al. (2014) Multigeneration analysis reveals the inheritance, specificity, and patterns of CRISPR/Cas-induced gene modifications in Arabidopsis. Proc Natl Acad Sci USA 111:4632–4637. https://www.pnas.org/ content/111/12/4632. Goulet, B.E., F. Roda, and R. Hopkins (2017). Hybridization in Plants: Old Ideas, New Techniques. Plant Physiol. 173(1): 65– 78. http://www.plantphysiol.org/content/ 173/1/65. Hahn, F. and V. Nekrasov (2019). CRISPR/ Cas precision: do we need to worry about PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 29831 off-targeting in plants? Plant Cell Reports (2019) 38:437–441). Kazama, Y., K. Ishii, T. Hirano, T. Wakana, M. Yamada, S. Ohbu, and T. Abe (2017). Different mutational function of low- and high-linear energy transfer heavy-ion irradiation demonstrated by wholegenome resequencing of Arabidopsis mutants. Plant J. 92, 1020–1030. Kharkwal, M., R. Pandey, and S. Pawar (2004). Mutation breeding for crop improvement. In Plant Breeding. Springer, pp. 601–645. Kharkwal, M.C. (2012). A brief history of plant mutagenesis. In Plant Mutation Breeding and Biotechnology. Ed Shu, Q.Y., B.P. Forster, and H. Nakagawa. CAB ebook. DOI 10.1079/ 9781780640853.0000 pp. 21–20. Krishna, H., M. Alizadeh, D. Singh, U. Singh, N. Chauhan, M. Eftekhari, and R.K. Sadh (2016). Somaclonal variations and their applications in horticultural crops improvement. 3 Biotech 6: 54 https:// link.springer.com/chapter/10.1007/9781-4614-8830-9_12. Kyndt, T., D. Quispe, H. Zhai, R. Jarret, M. Ghislain, Q. Liu, G. Gheysen, and J.F. Kreuze (2015). The genome of cultivated sweet potato contains Agrobacterium T– DNAs with expressed genes: An example of a naturally transgenic food crop. Proceedings of the National Academy of Sciences of the United States of America 112, pp. 5844–5849. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/ 25902487. Lee, K., Y. Zhang, B.P. Kleinstiver, et al. (2018). Activities and specificities of CRISPR/Cas9 and Cas12a nucleases for targeted mutagenesis in maize. Plant Biotechnol J. https:// onlinelibrary.wiley.com/doi/10.1111/ pbi.12982. Louwaars, N. (2019). Food Safety and Plant Breeding—why are there no problems in practice. European Institute for Food Law series? 11:89–101. https://doi.org/ 10.3920/978-90-8686-885-8. Manova, V. and D. Gruszka (2015). DNA Damage and Repair in Plants—From Models to Crops. Frontiers in Plant Science 6(e88872):187. Men, A.E., T.S. Laniya, I.R. Searle, I. IturbeOrmaetxe, I. Gresshoff, Q. Jiang, B.J. Carroll, and P.M. Gresshoff (2002). Fast Neutron Mutagenesis of Soybean (Glycine soja L.) Produces a Supernodulating Mutant Containing a Large Deletion in Linkage Group H. Genome Letters 3: 147–155. Naito, K., M. Kusaba, N. Shikazono, T. Takano, A. Tanaka, T. Tanisaka, and M. Nishimura (2005). Transmissible and nontransmissible mutations induced by irradiating Arabidopsis thaliana pollen with gamma-rays and carbon ions. Genetics, 169, 881–889. National Academies of Sciences, Engineering, and Medicine (2016). Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. https://www.nap.edu/catalog/23395/ genetically-engineered-cropsexperiences-and-prospects. E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29832 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations Neelakandan, A.K. and K. Wang (2012). Recent progress in the understanding of tissue culture-induced genome level changes in plants and potential applications. Plant Cell Reports 31: 597– 620. Nekrasov, V., C. Wang, J. Win, et al. (2017) Rapid generation of a transgene-free powdery mildew resistant tomato by genome deletion. Scientific Reports 7:482. https://www.nature.com/articles/ s41598-017-00578-x. NRC (1989). Field Testing Genetically Modified Organisms: Framework for Decisions. NAP. http://www.nap.edu/ catalog/1431.html. NRC (2002). Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington DC.: The National Academies Press. https://www.nap.edu/catalog/10258/ environmental-effects-of-transgenicplants-the-scope-and-adequacy-of. NRC (2004). Safety of Genetically Engineered Foods. http://www.nap.edu/catalog/ 10977.html. Oladosu Y., M.Y. Rafii, N. Abdullah, G. Hussin, A. Ramli, H.A. Rahim, G. Miah, and M. Usman (2016). Principle and application of plant mutagenesis in crop improvement: A review. Biotechnology & Biotechnological Equipment, 30:1, 1–16, DOI: 10.1080/13102818.2015.1087333. https://www.tandfonline.com/doi/full/ 10.1080/13102818.2015.1087333. NRC (2010). The Impact of Genetically Engineered Crops on Farm Sustainability in the United States. National Research Council (NRC), Washington, DC: National Academies Press. http:// www.nap.edu/catalog/12804/impact-ofgenetically-engineered-crops-on-farmsustainability-in-the-united-states. NAS (2016b). Genetically Engineered Crops: Experiences and Prospects. Washington, DC: National Academies Press. http:// www.nap.edu/catalog/23395/geneticallyengineered-crops-experiences-andprospects. Peterson, B.A., DC Haak, M.T. Nishimura, et al. (2016). Genome-wide assessment of efficiency and specificity in CRISPR/ Cas9 mediated multiple site targeting in Arabidopsis. PLoS One 11:e0162169. Sears, E. A. (1977). An induced mutant with homoeologous pairing in common wheat. Canadian J of Genetics and Cytology 19: 585–593. Singh, B.D. (1990). Plant Breeding Principles and Methods, 4th ed. Kalyani Publishers, New Delhi, pp.475–509. Tang, X, G. Liu, J. Zhou, et al. (2018) A largescale whole-genome sequencing analysis reveals highly specific genome editing by both Cas9 and Cpf1 (Cas12a) nucleases in rice. Genome Biol 19:84. https:// genomebiology.biomedcentral.com/ articles/10.1186/s13059-018-1458-5. Wang, H., M. La Russa, and L.S. Qi (2016). Crispr/Cas9 in genome editing and beyond. Annu Rev Biochem. 85:227–64. Wolter, F., P. Schindele, and H. Puchta (2019). Plant breeding at the speed of light: the power of CRISPR/Cas to generate directed genetic diversity at multiple sites. BMC Plant Biol. 19: 176. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 List of Subjects 7 CFR Part 330 Customs duties and inspection, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. 7 CFR Part 340 Administrative practice and procedure, Packaging and containers, Plant diseases and pests, Reporting and recordkeeping requirements, Transportation. 7 CFR Part 372 Environmental impact statements. Accordingly, we are amending 7 CFR parts 330, 340, and 372 as follows: PART 330—FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS, BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE 1. The authority citation for part 330 continues to read as follows: ■ Authority: 7 U.S.C. 1633, 7701–7772, 7781–7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. 2. In § 330.200, paragraphs (b) and (d) are revised to read as follows: ■ § 330.200 Scope and general restrictions. * * * * * (b) Plant pests regulated by this subpart. For the purposes of this subpart, and except for an organism that has undergone genetic engineering as defined in § 340.3 of this chapter, APHIS will consider an organism to be a plant pest if the organism directly or indirectly injures, causes damage to, or causes disease in a plant or plant product, or if the organism is an unknown risk to plants or plant products, but is similar to an organism known to directly or indirectly injure, cause damage to, or cause disease in a plant or plant product. Plant pests that have undergone genetic engineering, as defined in § 340.3 of this chapter, are subject to the regulations of part 340 of this chapter. * * * * * (d) Biological control organisms not regulated by this subpart. Paragraph (c) of this section notwithstanding, biological control organisms that have undergone genetic engineering, as defined in § 340.3 of this chapter, as well as products that are currently under an EPA experimental use permit, a Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 18 emergency exemption, or products that are currently registered with EPA as a PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 microbial pesticide product, are not regulated under this subpart. Additionally, biological control organisms that are pesticides that are not registered with EPA, but are being transferred, sold, or distributed in accordance with EPA’s regulations in 40 CFR 152.30, are not regulated under this subpart for their interstate movement or importation. However, an importer desiring to import a shipment of biological control organisms subject to FIFRA must submit to the EPA Administrator a Notice of Arrival of Pesticides and Devices as required by CBP regulations at 19 CFR 12.112. The Administrator will provide notification to the importer indicating the disposition to be made of shipment upon its entry into the customs territory of the United States. ■ 3. Part 340 is revised to read as follows: PART 340—MOVEMENT OF ORGANISMS MODIFIED OR PRODUCED THROUGH GENETIC ENGINEERING Sec. 340.1 Applicability of this part. 340.2 Scope of this part. 340.3 Definitions. 340.4 Regulatory status review. 340.5 Permits. 340.6 Record retention, compliance, and enforcement. 340.7 Confidential business information. 340.8 Costs and charges. Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. § 340.1 Applicability of this part. (a) The regulations in this part apply to those organisms described in § 340.2, but not to any organism that is exempt from this part under paragraph (b), (c), or (d) of this section. (b) The regulations in this part do not apply to plants that have been modified such that they contain either a single modification of a type listed in paragraphs (b)(1) through (3) of this section, or additional modifications as determined by the Administrator, and described in paragraph (b)(4) of this section. (1) The genetic modification is a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or (2) The genetic modification is a targeted single base pair substitution; or (3) The genetic modification introduces a gene known to occur in the plant’s gene pool, or makes changes in a targeted sequence to correspond to a known allele of such a gene or to a E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations known structural variation present in the gene pool. (4) The Administrator may propose to exempt plants with additional modifications, based on what could be achieved through conventional breeding. Such proposals may be Agency-initiated, and follow the process in paragraph (b)(4)(i) of this section, or in response to a request made in accordance with paragraph (b)(4)(ii) of this section. (i) APHIS-initiated proposals for exemptions. APHIS will publish a notice in the Federal Register of the proposal by the Administrator to exempt plants with additional modifications. The notice will make available any supporting documentation, and will request public comment. After reviewing the comments, APHIS will publish a subsequent notice in the Federal Register announcing its final determination. (ii) Other parties’ requests for exemptions. Any person may request that the Administrator exempt plants developed with additional modifications that could be achieved through conventional breeding. To submit a request, the person must provide, in writing, information supporting the modification(s). Supporting information must include the following: (A) A description of the modification(s); (B) The factual grounds demonstrating that the proposed modification(s) could be achieved through conventional plant breeding; (C) Copies of scientific literature, unpublished studies, or other data that support the request; and (D) Any information known to the requestor that would be unfavorable to the request. (iii) Timeframe for Agency review of requests for additional exemptions. After APHIS receives all information required under paragraph (b)(4)(ii) of this section, APHIS will complete its review of the request and render a determination within 12 months, except in circumstances that could not reasonably have been anticipated. (iv) Denial of requests. If APHIS disagrees with the conclusions of the request or determines that there is insufficient evidence that the modification could be achieved through conventional breeding methods, APHIS will deny the request and notify the requestor in writing regarding this denial. (v) Agreement with requests. If APHIS initially determines that the modification could be achieved through VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 conventional breeding methods, APHIS will publish a notice in the Federal Register and request public comments in accordance with the process set forth in paragraph (b)(4)(i) of this section. After reviewing the comments, APHIS will publish a subsequent notice in the Federal Register announcing its final determination. (vi) website posting. A list specifying the additional modifications will be posted on the APHIS website at https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology. (c) The regulations in this part do not apply to a plant with: (1) A plant-trait-mechanism of action combination that has previously undergone an analysis by APHIS in accordance with § 340.4 and has been determined by APHIS not to be regulated under this part, or (2) A plant-trait-mechanism of action combination found in a plant that APHIS determined to be deregulated in response to a petition submitted prior to October 1, 2021, pursuant to § 340.6 as that section was set forth prior to August 17, 2020. All plants determined by APHIS to be deregulated pursuant to § 340.6 as that section was set forth prior to August 17, 2020 will retain their nonregulated status under these regulations. (d) The regulations in this part do not apply to plants determined by APHIS not to require regulation under this part pursuant to the ‘‘Am I Regulated’’ process. All plants determined by APHIS not to require regulation under this part pursuant to the ‘‘Am I Regulated’’ process will retain their nonregulated status under these regulations. (e) Developers may request confirmation from APHIS that a plant is not within the scope of this part. APHIS will provide a written response (confirmation letter) within 120 days of receiving a sufficiently detailed confirmation request, except in circumstances that could not reasonably have been anticipated. (Approved by the Office of Management and Budget under control number 0579– 0471) § 340.2 Scope of this part. Except under a permit issued by the Administrator in accordance with § 340.5, no person shall move any GE organism that: (a) Is a plant that has a plant-traitmechanism of action combination that has not been evaluated by APHIS in accordance with § 340.4 or that, as a result of such evaluation, is subject to the regulations; or PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 29833 (b) Meets the definition of a plant pest in § 340.3; or (c) Is not a plant but has received deoxyribonucleic acid (DNA) from a plant pest, as defined in § 340.3, and the DNA from the donor organism either is capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or (d) Is a microorganism used to control plant pests, or an invertebrate predator or parasite (parasitoid) used to control invertebrate plant pests, and could pose a plant pest risk; or (e) Is a plant that encodes a product intended for pharmaceutical or industrial use. § 340.3 Definitions. Terms used in the singular form in this part shall be construed as the plural, and vice versa, as the case may demand. The following terms, when used in this part, shall be construed, respectively, to mean: Access. The ability during regular business hours to enter, or pass to and from, a location, inspect, and/or obtain or make use or copies of any records, data, or samples necessary to evaluate compliance with this part and all conditions of a permit issued in accordance with § 340.5. Administrator. The Administrator of the Animal and Plant Health Inspection Service (APHIS) or any other employee of APHIS to whom authority has been or may be delegated to act in the Administrator’s stead. Agent. A person who is designated by the responsible person to act in whole or in part on behalf of the permittee to maintain control over an organism under permit during its movement and to ensure compliance with all applicable permit conditions and the requirements in this part. Multiple agents may be associated with a single responsible person or permit. Agents may be, but are not limited to, brokers, farmers, researchers, or site cooperators. An agent must be at least 18 years of age and be a legal resident of the United States. Animal and Plant Health Inspection Service (APHIS). An agency of the United States Department of Agriculture (USDA). Article. Any material or tangible object that could harbor plant pests. Contained facility. A structure for the storage and/or propagation of living organisms designed with physical barriers capable of preventing the escape of the organisms. Examples include but are not limited to laboratories, growth chambers, E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29834 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations fermenters, and containment greenhouses. Donor organism. The organism from which genetic material is obtained for transfer to the recipient organism. Environment. All the land, air, and water; and all living organisms in association with land, air, and water. Gene pool. Germplasm within which sexual recombination is possible as a result of hybridization, including via methods such as embryo culture or bridging crosses. Genetic engineering. Techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome. Import (importation). To move into, or the act of movement into, the territorial limits of the United States. Inspector. Any individual authorized by the Administrator or by the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part. Interstate. From one State into or through any other State or within the District of Columbia, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Mechanism of action (MOA). The biochemical process(es) through which genetic material determines a trait. Move (moving, movement). To carry, enter, import, mail, ship, or transport; aid, abet, cause, or induce the carrying, entering, importing, mailing, shipping, or transporting; to offer to carry, enter, import, mail, ship, or transport; to receive to carry, enter, import, mail, ship, or transport; to release into the environment; or to allow any of the above activities to occur. Organism. Any active, infective, or dormant stage of life form of an entity characterized as living, including vertebrate and invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-like organisms, as well as entities such as viroids, viruses, or any entity characterized as living, related to the foregoing. Permit. A written authorization, including by electronic methods, by the Administrator to move organisms regulated under this part and associated articles under conditions prescribed by the Administrator. Person. Any individual, partnership, corporation, company, society, association, or other organized group. Plant. Any plant (including any plant part) for or capable of propagation, including a tree, a tissue culture, a plantlet culture, pollen, a shrub, a vine, VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 a cutting, a graft, a scion, a bud, a bulb, a root, or a seed. Plant pest. Any living stage of a protozoan, nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the foregoing, that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product. Plant pest risk. The potential for direct or indirect injury to, damage to, or disease in any plant or plant product resulting from introducing or disseminating a plant pest, or the potential for exacerbating the impact of a plant pest. Plant product. (1) Any flower, fruit, vegetable, root, bulb, seed, or other plant part that is not included in the definition of plant; or (2) Any manufactured or processed plant or plant part. Recipient organism. The organism whose nucleic acid sequence will be modified through the use of genetic engineering. Release into the environment (environmental release). The use of an organism outside the physical constraints of a contained facility. Responsible person. The individual responsible for maintaining control over a GE organism under permit during its movement and for ensuring compliance with all conditions contained in any applicable permit as well as with other requirements in this part and in the Plant Protection Act (7 U.S.C. 7701 et seq.). This individual must sign the permit application, and must be at least 18 years of age, and must be a legal resident of the United States. Secure shipment. Shipment in a container or a means of conveyance of sufficient strength and integrity to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation. State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territories or possessions of the United States. State or Tribal regulatory official. State or Tribal official with responsibilities for plant health, or any other duly designated State or Tribal official, in the State or on the Tribal lands where the movement is to take place. Trait. An observable (able to be seen or otherwise identified) characteristic of an organism. PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 Unauthorized release. The intentional or accidental movement of an organism under a permit issued pursuant to this part in a manner not authorized by the permit; or the intentional or accidental movement without a permit of an organism that is subject to the regulations in this part. § 340.4 Regulatory status review. (a)(1) Any person may submit a request to APHIS for a regulatory status review, pursuant to paragraph (b)(3) of this section. (2) Any person may request re-review of a GE plant previously found to be subject to this part after an initial review was conducted, provided that the request is supported by new, scientifically valid evidence bearing on the plant pest risk associated with movement of the plant. (3) APHIS may also initiate a regulatory status review or re-review of a GE plant to identify whether it is subject to regulation under this part. (4) Information submitted in support of a request for a regulatory status review or re-review must meet the requirements listed in paragraphs (a)(4)(i) through (iii) of this section. (i) A description of the comparator plant(s), to include genus, species, and any relevant subspecies information; (ii) The genotype of the modified plant, including a detailed description of the differences in genotype between the modified and unmodified plant; and (iii) A detailed description of the new trait(s) of the modified plant. (iv) Detailed information on how to meet the above-listed requirements can be found on the APHIS website at https://www.aphis.usda.gov/aphis/ ourfocus/biotechnology. If APHIS proposes revisions to the detailed information on the APHIS website, APHIS will make the proposed revisions available for notice and public comment prior to implementation. (b)(1) When APHIS receives a request for a regulatory status review of a GE plant, APHIS will conduct an initial review to determine whether there is a plausible pathway by which the GE plant, or any sexually compatible relatives that can acquire the engineered trait from the GE plant, would pose an increased plant pest risk relative to the plant pest risk posed by the respective non-GE or other appropriate comparator(s), based on the following factors: (i) The biology of the comparator plant(s) and its sexually compatible relatives; (ii) The trait and mechanism-of-action of the modification(s); and E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations (iii) The effect of the trait and mechanism-of-action on: (A) The distribution, density, or development of the plant and its sexually compatible relatives; (B) The production, creation, or enhancement of a plant pest or a reservoir for a plant pest; (C) Harm to non-target organisms beneficial to agriculture; and (D) The weedy impacts of the plant and its sexually compatible relatives. (2) APHIS will complete the initial review within 180 days of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section, except in circumstances that could not reasonably have been anticipated. If APHIS does not identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the GE plant is not subject to the regulations in this part. APHIS will post the plant, trait, and general description of the MOA on its website. (b)(3)(i) If APHIS does identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the requestor may apply for a permit and/or request that APHIS conduct an evaluation of the factor(s) of concern identified in the initial review to determine the likelihood and consequence of the plausible increased plant pest risk. APHIS may request additional information as needed to evaluate the factor(s) of concern. (ii) For those GE plants for which such an evaluation is conducted, APHIS will publish the results of the evaluation in the Federal Register and will solicit and review comments from the public. Except in circumstances that could not reasonably have been anticipated, APHIS will complete these steps within 15 months of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section. (iii) If APHIS finds that the GE plant and its sexually compatible relatives are unlikely to pose an increased plant pest risk relative to their comparator(s), the GE plant is not subject to this part. APHIS will publish its evaluation of the plant-trait-MOA combination in a subsequent Federal Register document and will also post it on the APHIS website. If APHIS does not make such a finding, the GE plant will remain regulated under this part, and its movement will be allowed only under permit in accordance with § 340.5. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 (c) This section is applicable beginning April 5, 2021 for GE corn, soybean, cotton, potato, tomato, and alfalfa, and on October 1, 2021 for all GE plants. (Approved by the Office of Management and Budget under control number 0579– 0471) § 340.5 Permits. (a) Permit requirement. A permit from APHIS is required for the movement of all GE organisms subject to the regulations under this part. (b) Permit application requirements. All applications for permits must be submitted in accordance with the requirements of this section. The responsible person must apply for and obtain a permit through APHIS’ website. The application must also include the following information: (1) General information requirements for all permit applications. All permit applications must include the name, title, and contact information of the responsible person and agent (if any); the country (or countries) and locality (or localities) where the organism was collected, developed, manufactured, reared, cultivated, and cultured (as applicable); the organism’s genus, species and any relevant subspecies and common name information; the intended activity (i.e., importation, interstate movement, or release into the environment of the GE organism); and information on the intended trait and the genotype of the intended trait. All permit applications must be signed by the responsible person. (2) Information requirements for permit applications for interstate movement or importation. Applications for permits for interstate movement or importation of GE organisms must include the following additional information: (i) The origin and destination of the GE organism, including information on the addresses and contact details of the sender and recipient, if different from the responsible person; (ii) The quantity of the GE organism, the method of shipment, and means of ensuring the security of the shipment against unauthorized release of the organism; and (iii) The manner in which packaging material, shipping containers, and any other material accompanying the organism will be disposed of to prevent unauthorized release. (3) Information requirements for permit applications for release into the environment. Applications for permits for release of GE organisms into the environment must include information PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 29835 on all proposed environmental release sites, including land area (size), Global Positioning System coordinates, addresses, and land use history of the site and adjacent areas; and the name and contact information of a person at each environmental release site, if different from the responsible person. In the event that additional release sites are requested after the issuance of a permit, APHIS will evaluate and amend permits as appropriate, in accordance with paragraph (l) of this section. (c) Exemption for GE Arabidopsis thaliana. A permit for interstate movement is not required for GE Arabidopsis thaliana, provided that it is moved as a secure shipment, the modified genetic material is stably integrated into the plant genome, and the modified material does not include the complete infectious genome of a plant pest. (d) Exemption for GE disarmed Agrobacterium species. A permit for importation or interstate movement is not required for any GE disarmed Agrobacterium species, provided that it is moved as a secure shipment, the modified genetic material is stably integrated into the genome, and the modified material does not include the complete infectious genome of a plant pest. (e) Exemption for Drosophila melanogaster. A permit for importation or interstate movement is not required for GE Drosophila melanogaster, provided that it is moved as a secure shipment and that any introduced genetic material is not designed to propagate through a population by biasing the inheritance rate. (f) Exemption for certain microbial pesticides. A permit is not required for the movement of any GE microorganism product that is currently registered with the Environmental Protection Agency (EPA) as a microbial pesticide, so long as the microorganism is not a plant pest as defined in § 340.3. (g) Exemption of certain plantincorporated protectants. A permit is not required for the movement of any GE plant modified solely to contain a plant-incorporated protectant that is currently registered with EPA as a pesticide product pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq., FIFRA) or that is currently exempted from FIFRA pursuant to 40 CFR 174.21. (h) Administrative actions—(1) Review of permit applications. APHIS will review the permit application to determine whether it is complete. APHIS will notify the applicant orally or in writing if the application is incomplete, and the applicant will be E:\FR\FM\18MYR2.SGM 18MYR2 jbell on DSKJLSW7X2PROD with RULES2 29836 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations provided the opportunity to revise the application. Once an application is complete, APHIS will review it to determine whether to approve or deny the application. (2) APHIS assignment of permit conditions. If a permit application is approved, the Administrator will issue a permit with conditions as described in paragraph (i) of this section. Prior to issuance of a permit, the responsible person must agree in writing, in a manner prescribed by the Administrator, that the responsible person and all agents of the responsible person are aware of, understand, and will comply with the permit conditions. Failure to comply with this provision will be grounds for the denial of a permit. (3) Inspections. All premises associated with the permit are subject to inspection before and after permit issuance, and all materials associated with the movement are subject to sampling after permit issuance. The responsible person and agents must provide inspectors access to premises, facilities, release locations, storage areas, waypoints, materials, equipment, means of conveyance, documents, and records related to the movement of organisms permitted under this part. Failure to provide access for inspection prior to the issuance of a permit will be grounds for the denial of a permit. Failure to provide access for inspection following permit issuance will be grounds for withdrawal of the permit. (4) State or Tribal review and comment. The Administrator will submit for notification and review a copy of the permit application, without confidential business information (CBI), and any permit conditions to the appropriate State or Tribal regulatory official. Timely comments received from the State or Tribal regulatory official will be considered by the Administrator prior to permit issuance. (5) Approval or denial of a permit. Except in circumstances that could not reasonably have been anticipated, APHIS will approve or deny the permit within: (i) 45 days of receipt of a complete application for a permit for interstate movement or for importation; or (ii) 120 days of receipt of a complete application for a permit for release into the environment. (iii) The 120-day period may be extended if preparation of an environmental assessment or environmental impact statement is necessary. (i) Permit conditions. The standard conditions listed in this paragraph (i) will be assigned to all permits issued VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 under this section. The Administrator may assign supplemental permit conditions as deemed necessary to ensure confinement of the GE organism. Prior to issuance of a permit or an amended permit, the responsible person will be required to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the permit, as described in this paragraph (i). If the responsible person does not agree to the conditions, the amendment will be denied. (1) The organism under permit must be maintained and disposed of in a manner so as to prevent its unauthorized release, spread, dispersal, and/or persistence in the environment. (2) The organism under permit must be kept separate from other organisms, except as specifically allowed in the permit. (3) The organism under permit must be maintained only in areas and premises specified in the permit. (4) The identity of the organism under permit must be maintained and verifiable at all times. (5) Authorized activities may be engaged in only while the permit is valid; the duration for which the permit is valid will be listed on the permit itself. (6) Records related to activities carried out under the permit must be maintained by the responsible person and must be of sufficient accuracy, quality, and completeness to demonstrate compliance with all permit conditions and requirements under this part. APHIS must be allowed access to all records, to include visual inspection and reproduction (e.g., photocopying, digital reproduction). The responsible person must submit reports and notices to APHIS, containing the information specified within the permit, at the times specified in the permit. At a minimum: (i) Following an environmental release, environmental release reports must be submitted for all authorized release locations where the release occurred. Environmental release reports must contain details of sufficient accuracy, quality, and completeness to identify the location, shape, and size of the release and the organism(s) released into the environment. In the event no release occurs at an authorized location, an environmental release report of no environmental release must be submitted for all authorized locations where an environmental release did not occur. Unauthorized releases must be reported in accordance with paragraph (i)(9) of this section. (ii) When the environmental release is of a plant, reports of volunteer monitoring activities and findings must PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 be submitted for all authorized release locations where an environmental release occurred. If no monitoring activities are conducted, a volunteer monitoring report of no monitoring must be submitted indicating why no volunteer monitoring was done. (7) Inspectors must be allowed access, during regular business hours, to all locations related to the permitted activities. (8) The organism under permit must undergo the application of measures determined by the Administrator to be necessary to prevent its unauthorized release, spread, dispersal, and/or persistence in the environment. (9) In the event of a possible or actual unauthorized release, the responsible person must contact APHIS as described in the permit within 24 hours of discovery and must subsequently supply a statement of facts in writing no later than 5 business days after discovery. (10) The responsible person for a permit remains the responsible person for the permit unless a transfer of responsibility is approved by APHIS. The responsible person must contact APHIS to initiate any transfer. The new responsible person assumes all responsibilities for ensuring compliance with the existing permit and permit conditions and for meeting the requirements of this part. (j) Denial or withdrawal of a permit. Permit applications may be denied, or permits withdrawn, in accordance with this paragraph. (1) Denial of permits. The Administrator may deny, either orally or in writing, any application for a permit. If the denial is oral, the Administrator will then communicate, as promptly as circumstances allow, the denial, and the reasons for it, in writing. The Administrator may deny a permit application if: (i) The Administrator concludes that the proposed actions, e.g., movements under permit, may not prevent the unauthorized release, spread, dispersal, and/or persistence in the environment of the organism; or (ii) The Administrator determines that the responsible person or any agent of the responsible person has failed to comply with any material provision of this part, any other regulations issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.) or the Plant Protection Act itself; (iii) In addition, no permit will be issued if the responsible person and his or her agents do not agree in writing, in accordance with paragraph (h)(2) of this section, to comply with the permit conditions or, in accordance with E:\FR\FM\18MYR2.SGM 18MYR2 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES2 paragraph (h)(3) of this section, to allow inspection by APHIS. (2) Withdrawal of permits. The Administrator may withdraw, either orally or in writing, any permit that has been issued. If the withdrawal is oral, the Administrator will communicate, as promptly as circumstances allow, the withdrawal, and the reasons for it, in writing. The Administrator may withdraw a permit if: (i) Following issuance of the permit, the Administrator receives information that would have provided grounds for APHIS to deny the original permit application; (ii) The Administrator determines that actions taken under the permit have resulted in the unauthorized release, spread, dispersal, and/or persistence in the environment of the organism under permit; or (iii) The Administrator determines that the responsible person or any agent of the responsible person has failed to comply at any time with any material provision of this part or with any other regulations issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.). This includes failure to comply with the conditions of any permit issued. (k) Appeal of denial or withdrawal of permit. Any person whose permit application has been denied or whose permit has been withdrawn may appeal the decision in writing to the Administrator.1 The applicant must submit in writing an acknowledgment of the denial or withdrawal, and a statement of intent to appeal, within 10 days after receiving written notification of the denial or withdrawal. The applicant may request additional time to prepare the appeal. The appeal must state all of the facts and reasons upon which the person relies to assert that the permit was wrongfully denied or withdrawn. The Administrator will grant or deny the appeal in writing, stating the reasons for the decision as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. (l) Amendment of permits—(1) Amendment at responsible person’s request. If the responsible person determines that circumstances have changed since the permit was initially issued and wishes the permit to be amended accordingly, the responsible person must request the amendment by 1 The Office of the Administrator, as established in § 371.2 of this chapter, will review appeals involving the denial or withdrawal of a permit. Appeals may be sent to Office of the Administrator, United States Department of Agriculture, Jamie L. Whitten Building, Room 312–E, 1400 Independence Ave. SW, Washington, DC 20250. VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 contacting APHIS directly. The responsible person will have to provide supporting information justifying the amendment. APHIS will review the amendment request, and will amend the permit if APHIS determines that relatively minor changes are necessary. Requests for more substantive changes will require a new permit application. Prior to issuance of an amended permit, the responsible person will be required to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the amended permit. If the responsible person does not agree to the conditions, the amendment will be denied. (2) Amendment initiated by APHIS. APHIS may amend any permit and its conditions at any time, upon determining that the amendment is needed to address plant pest risks presented by the organism or the activities allowed under the permit. APHIS will notify the responsible person of the amendment to the permit and, as soon as circumstances allow, the reason(s) for it. The responsible person may have to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the amended permit before APHIS will issue it. If APHIS requests such an agreement, and the responsible person does not accept it, the existing permit will be withdrawn. (m) Shipping under a permit. (1) All shipments of organisms under permit must be secure shipments. Organisms under permit must be shipped in accordance with the regulations in 49 CFR part 178. (2) The container must be accompanied by a document that includes the names and contact details for the sender and recipient. (3) For any organism to be imported into the United States, the outmost container must bear information regarding the nature and quantity of the contents; the country (or countries) and locality (localities) where collected, developed, manufactured, reared, cultivated, and cultured (as applicable); the name and address of the shipper, owner, or person shipping or forwarding the organism; the name, address, and telephone number of the consignee; the identifying shipper’s mark and number; and the permit number authorizing the importation. For organisms imported under permits by mail, the container must also be addressed to a plant inspection station listed in the USDA Plants for Planting Manual, which can be accessed at: https:// www.aphis.usda.gov/import_export/ plants/manuals/ports/downloads/ plants_for_planting.pdf. All imported PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 29837 containers of organisms under permits must be accompanied by an invoice or packing list indicating the contents of the shipment. (4) Following the completion of the shipment, all packaging material, shipping containers, and any other material accompanying the organism will be devitalized consistent with supplemental permit conditions, or disposed of to prevent unauthorized release. (n) Applicability date: This section is applicable beginning April 5, 2021. (Approved by the Office of Management and Budget under control number 0579– 0471) § 340.6 Record retention, compliance, and enforcement. (a) Recordkeeping. Responsible persons and their agents are required to establish, keep, and make available to APHIS the following records: (1) Records and reports required under § 340.5(i); (2) Addresses and any other information (e.g., GPS coordinates, maps) needed to identify all locations where the organism under permit was stored or used, including all contained facilities and environmental release locations; (3) A copy of the APHIS permit authorizing the permitted activity; and (4) Legible copies of contracts (including amendments to contracts) between the responsible person and agents that conduct activities subject to this part for the responsible person, and copies of documents relating to agreements made without a written contract. (b) Record retention. Records indicating that an organism under permit that was imported or moved interstate reached its intended destination must be retained for at least 2 years. All other records related to a permit must be retained for 5 years following the expiration of the permit, unless a longer retention period is determined to be needed by the Administrator and is documented in the supplemental permit conditions. (c) Compliance and enforcement. (1) Responsible persons and their agents must comply with all of the requirements of this part. Failure to comply with any of the requirements of this part may result in any or all of the following: (i) Denial of a permit application or withdrawal of a permit in accordance with § 340.5(j); (ii) Application of remedial measures in accordance with the Plant Protection Act (7 U.S.C. 7701 et seq.); and E:\FR\FM\18MYR2.SGM 18MYR2 29838 Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations (iii) Criminal and/or civil penalties in accordance with the Plant Protection Act (7 U.S.C. 7701 et seq.). (2) Prior to the issuance of a complaint seeking a civil penalty, the Administrator may enter into a stipulation, in accordance with § 380.10 of this chapter. (d) Liability for acts of an agent. For purposes of enforcing this part, the act, omission, or failure of any agent for a responsible person may be deemed also to be the act, omission, or failure of the responsible person. (Approved by the Office of Management and Budget under control number 0579– 0471) § 340.7 Confidential business information. jbell on DSKJLSW7X2PROD with RULES2 Persons including confidential business information (CBI) in any document submitted to APHIS under this part should do so in the following manner. If there are portions of a document deemed to contain confidential business information, those portions must be identified, and each page containing such information must VerDate Sep<11>2014 18:47 May 15, 2020 Jkt 250001 be marked ‘‘CBI Copy.’’ A second copy of the document must be submitted with all such CBI deleted, and each page where the CBI was deleted must be marked ‘‘CBI Deleted.’’ In addition, any person submitting CBI must justify how each piece of information requested to be treated as CBI is a trade secret or, if not a trade secret, is either commercial or financial information that is privileged or confidential. § 340.8 1 The Department’s provisions relating to overtime charges for an inspector’s services are set forth in part 354 of this chapter. Frm 00050 Fmt 4701 Sfmt 9990 4. The authority citation for part 372 continues to read as follows: ■ Authority: 42 U.S.C. 4321 et seq.; 40 CFR parts 1500–1508; 7 CFR parts 1b, 2.22, 2.80, and 371.9. § 372.5 [Amended] 5. Section 372.5 is amended as follows: ■ a. By removing paragraph (b)(7); ■ b. In paragraph (c)(3)(iii), by removing the words ‘‘, or acknowledgment of notifications for,’’ and adding the word ‘‘for’’ in their place; and ■ c. By removing and reserving paragraph (c)(4). ■ Costs and charges. The services of the inspector related to carrying out this part and provided during regularly assigned hours of duty and at the usual places of duty will be furnished by APHIS without cost to the responsible person.1 The U.S. Department of Agriculture will not be responsible for any costs or charges incidental to inspections or compliance with the provisions of this part, other than for the services of the inspector. PO 00000 PART 372—NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES Done in Washington, DC, this 13th day of May 2020. Lorren Walker, Acting Under Secretary for Marketing and Regulatory Programs. [FR Doc. 2020–10638 Filed 5–15–20; 8:45 am] BILLING CODE 3410–34–P E:\FR\FM\18MYR2.SGM 18MYR2

Agencies

[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29790-29838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10638]



[[Page 29789]]

Vol. 85

Monday,

No. 96

May 18, 2020

Part II





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 330, 340 and 372





Movement of Certain Genetically Engineered Organisms; Final Rule

Federal Register / Vol. 85 , No. 96 / Monday, May 18, 2020 / Rules 
and Regulations

[[Page 29790]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 330, 340, and 372

[Docket No. APHIS-2018-0034]
RIN 0579-AE47


Movement of Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the movement 
(importation, interstate movement, and environmental release) of 
certain genetically engineered organisms in response to advances in 
genetic engineering and our understanding of the plant pest risk posed 
by genetically engineered organisms, thereby reducing the regulatory 
burden for developers of organisms that are unlikely to pose plant pest 
risks. This final rule, which marks the first comprehensive revision of 
the regulations since they were established in 1987, provides a clear, 
predictable, and efficient regulatory pathway for innovators, 
facilitating the development of genetically engineered organisms that 
are unlikely to pose plant pest risks.

DATES: Effective August 17, 2020. Sections 340.4 and 340.5 are 
applicable beginning April 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Assistant Deputy 
Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road, Unit 98, Riverdale, MD 20737-1238; (301) 851-3944.

SUPPLEMENTARY INFORMATION: 

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA) administers the 
regulations in 7 CFR part 340, ``Introduction of Organisms and Products 
Altered or Produced Through Genetic Engineering Which are Plant Pests 
or Which There is Reason to Believe are Plant Pests'' (referred to 
below as ``the regulations'').
    These regulations govern the introduction (importation, interstate 
movement, or release into the environment) of certain genetically 
engineered (GE) organisms.
    Along with the Environmental Protection Agency (EPA), and the Food 
and Drug Administration (FDA), APHIS is responsible for the oversight 
and review of GE organisms. In 1986, the Coordinated Framework for 
Regulation of Biotechnology (Coordinated Framework) \1\ was published 
by the Office of Science and Technology Policy. It describes the 
comprehensive Federal regulatory policy for ensuring the safety of 
biotechnology research and products and explains how Federal agencies 
use existing Federal statutes to ensure public health and environmental 
safety while maintaining regulatory flexibility to avoid impeding the 
growth of the biotechnology industry. The Coordinated Framework 
explains the regulatory roles and authorities for APHIS, EPA, and the 
FDA. The Coordinated Framework was updated in 2017 in light of advances 
that had occurred since 1986 in the field of biotechnology.
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    \1\ To view the 1986 framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf. To 
view the 2017 revision to the framework, go to https://www.aphis.usda.gov/biotechnology/downloads/2017_coordinated_framework_update.pdf.
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    APHIS first issued these regulations in 1987 under the authority of 
the Federal Plant Pest Act of 1957 and the Plant Quarantine Act of 
1912, two acts that were subsumed into the Plant Protection Act (PPA, 7 
U.S.C. 7701 et seq.) in 2000, along with other provisions. Since 1987, 
APHIS has amended the regulations six times, in 1988, 1990, 1993, 1994, 
1997, and 2005, to institute exemptions from the requirement for 
permits to conduct activities for certain microorganisms and 
Arabidopsis, to institute the current notification process and petition 
procedure, and to exclude plants engineered to produce industrial 
compounds from the notification process.
    While the regulations have been effective in ensuring the safe 
introduction of GE organisms during the past 30 years, they do not 
reflect the findings from APHIS' three decades of experience in 
evaluating GE organisms for plant pest risk or account for developments 
in genetic engineering over that period. APHIS' evaluations to date 
have provided evidence that genetically engineering a plant with a 
plant pest as a vector, vector agent, or donor does not result in a GE 
plant that presents a plant pest risk. Further, genetic engineering 
techniques have been developed that do not employ plant pests as donor 
organisms, recipient organisms, vectors, or vector agents, yet may 
result in organisms that do pose a plant pest risk. Given these 
developments, as well as legal and policy issues discussed below, it 
has become necessary, in our view, to update our regulations 
accordingly.
    On January 19, 2017, we published in the Federal Register (82 FR 
7008-7039, Docket No. APHIS-2015-0057) a proposed rule \2\ intended to 
revise our regulatory approach from ``regulate first before analyzing 
risks'' to ``analyze plant pest and noxious weed risks of GE organisms 
prior to imposing regulatory restrictions.''
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    \2\ To view the 2017 proposed rule, the subsequent withdrawal, 
all supporting documents, and comments APHIS received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.
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    Under the January 2017 proposed rule, a stakeholder could request 
that we conduct a risk assessment to determine whether a GE organism 
would pose plant pest or noxious weed risks and thus need to be 
regulated. Regulated GE organisms could be imported, moved interstate, 
or released into the environment under a flexible, risk-based 
permitting procedure.
    APHIS received 203 comments on the proposal during the comment 
period. Commenters expressed concerns about many provisions of the 
proposed rule. Many stated that the proposed requirements would be too 
burdensome and had the potential to stifle innovation.
    After reviewing the comments, APHIS subsequently withdrew the 
proposed rule. Following the withdrawal, APHIS conducted extensive 
outreach. Our outreach efforts took place in all regions of the United 
States and encompassed all sectors of the agriculture supply chain, as 
well as academic researchers, growers of various crops, and advocacy 
groups. Organizations ranged in size from small laboratories to larger 
scale businesses. APHIS also took proactive steps to meet with 
organizations both supportive and skeptical of agricultural 
biotechnology. In total, APHIS met with more than 80 organizations, 
including 17 universities, State departments of agriculture, and farmer 
organizations.
    Much of the feedback received during this process centered on the 
need to focus regulatory efforts and oversight upon risk, rather than 
the method used to develop GE organisms. Stakeholders also expressed a 
desire for flexible and adaptable regulations so that future 
innovations do not invalidate the regulations. We also received 
feedback urging us to keep international trade objectives in mind when 
proposing new regulations and ensuring that new regulatory requirements 
are transparent and clearly articulated.
    The feedback we received led us to update APHIS' regulatory 
framework, in a manner that further focuses our regulatory efforts on 
the properties of the GE organism itself rather than on the

[[Page 29791]]

method used to produce it. We believed that this regulatory approach 
would better reflect our current knowledge of the field of 
biotechnology and would therefore enable us to evaluate GE organisms 
for plant pest risk with greater precision than the existing framework 
allowed. The regulatory framework was also intended to enable APHIS to 
avoid conducting repetitive analyses, to utilize its staff time more 
efficiently than before, and to provide better stewardship of taxpayer 
dollars.
    On June 6, 2019, we published in the Federal Register (84 FR 26514-
26541, Docket No. APHIS-2018-0034) a proposal \3\ to amend the 
regulations in accordance with the Secretary of Agriculture's March 28, 
2018, statement on plant breeding innovations. The Secretary's 
statement and the accompanying explanatory details provided 
clarification on the USDA's oversight over plants produced through 
innovative, new breeding techniques, including genome editing 
techniques. (The statement and further details are available at: 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-and-information/2018_brs_news/plant_breeding.)
---------------------------------------------------------------------------

    \3\ To view the proposed rule, the comments we received, and 
supporting documents, go to http://www.regulations.gov/#!docketDetail;vD=APHIS-2018-0034. Additionally, please note that 
within the body of this document, that rule and this final rule are 
referred to at times as the Sustainable, Ecological, Consistent, 
Uniform, Responsible, Efficient (SECURE) rule. The SECURE rule is 
the nomenclature used by USDA to discuss the rule with stakeholders.
---------------------------------------------------------------------------

    We would note also that the June 2019 proposed rule and this final 
rule are consistent with the President's ``Executive Order on 
Modernizing the Regulatory Framework for Agricultural Biotechnology 
Products'' (June 11, 2019, Executive Order 13874). Executive Order 
13874 directs the Federal Government to adopt regulatory approaches for 
the products of agricultural biotechnology that are proportionate to 
the risks such products pose, and that avoid arbitrary or unjustifiable 
distinctions across like products developed through different 
technologies. Among other things, Executive Order 13874 states that 
regulatory decisions should be science- and evidence-based, taking 
economic factors into account as appropriate and consistent with 
applicable law; that regulatory reviews should be conducted in a timely 
and efficient manner; and that biotechnology regulations should be 
transparent, predictable, and consistent.
    We solicited comments on our proposed rule and its supporting 
analyses until August 6, 2019. We received 6,150 comments by that date. 
They were from developers of GE organisms; growers of GE plants for 
food crops and other uses; trade associations representing both of 
those groups and sellers of such commodities as corn, soybeans, and 
grain; scientists representing academic institutions; organic farmers 
and trade associations representing their interests; consumer and 
public interest groups; and individuals. Most of the comments, while 
not form letters, expressed a generalized, similarly themed opposition 
to GE products. Of the comments that specifically addressed the 
provisions of the rule, approximately 25 expressed some support for the 
rule. The comments are discussed below by topic.

Applicability of the Regulations

Exemptions
    The June 2019 proposed rule exempted from the regulations certain 
categories of plants that have been modified. Specifically, Sec.  
340.1(b)(1) through (4) proposed to exempt such plants if:
     The genetic modification is solely a deletion of any size; 
or
     The genetic modification is a single base pair 
substitution; or
     The genetic modification is solely introducing nucleic 
acid sequences from within the plant's natural gene pool or from 
editing nucleic acid sequences in a plant to correspond to a sequence 
known to occur in that plant's natural gene pool; or
     The plant is an offspring of a GE plant and does not 
retain the genetic modification in the GE plant parent.
    In addition to above-listed categories, proposed Sec.  340.1(c) 
stated that modified plants would not be subject to the regulations if 
they have plant-trait-mechanism of action (MOA) combinations that are 
the same as those of modified plants for which APHIS has conducted a 
regulatory status review (RSR) and found not to be subject to the 
regulations under part 340.
    The above-listed exemptions elicited a broad spectrum of comments. 
Some commenters welcomed the regulatory relief offered by the 
exemptions as written, while others viewed them as too broad and still 
others as excessively restrictive.
    Among the commenters who viewed the exemptions as excessively 
broad, several commenters stated that APHIS did not provide the 
``necessary scientific justifications'' for the exemptions from 
regulation listed in proposed Sec.  340.1(b)(1) through (3).
    The exemptions in Sec.  340.1(b)(1) through (3) are based on the 
principles listed below. (For reasons discussed later in this document, 
we are removing from this final rule the exemption contained in Sec.  
340.1(b)(4) of the proposed rule, which would have pertained to ``null 
segregants,'' or the offspring of a GE plant that does not retain the 
genetic modification in the GE plant parent; while there is still a 
paragraph (b)(4) in this final rule, it serves a different purpose 
which we discuss later in this document.)
    1. Plants created through conventional breeding have a history of 
safe use related to plant pest risk;
    2. The types of plants that qualify for these exemptions can also 
be created through conventional breeding; and
    3. There is no evidence that use of recombinant deoxyribonucleic 
acid (DNA) or genome editing techniques necessarily and in and of 
itself introduces plant pest risk, irrespective of the technique 
employed.
    When a plant meets one of the above-listed exemptions, therefore, 
it is not expected to pose plant pest risks greater than the plant pest 
risks posed by plants modified by conventional breeding methods and 
thus should rightly not be subjected to regulation under part 340. (The 
term ``conventional breeding'' may generally be used interchangeably 
with ``traditional breeding.'' In the June 2019 proposed rule, APHIS 
used both terms, with ``traditional breeding'' appearing more 
frequently in the text. Based in part on dialogue with other agencies 
involved in regulating biotechnology, we have elected to use the term 
``conventional breeding'' throughout this final rule and its supporting 
documents, except when the need to quote directly indicates otherwise. 
For purposes of this rule and its supporting documents, ``conventional 
breeding'' has the meaning it is understood to have within the context 
of part 340, based on the examples provided immediately below. Other 
Federal or State regulations may use the term ``conventional breeding'' 
in the context of their regulations and attribute slightly different 
meanings.)
    We noted in the preamble to the June 2019 proposed rule that 
conventionally bred crops have a long history of safe use with respect 
to plant pest risk and that the long history of conventional plant 
breeding gives us extensive experience in safely managing any 
associated plant pest risks. Conventional breeding techniques generally 
involve the deliberate selection of plants with desirable traits from 
existing population genetic variation or from new genetic variation

[[Page 29792]]

created through artificial hybridization or induced mutagenesis. As we 
noted in the June 2019 proposed rule, such techniques include marker-
assisted breeding, tissue culture, protoplast, cell, or embryo fusion, 
and chemical or radiation-based mutagenesis. Products generated solely 
using such techniques have never been regulated under the part 340 
regulations. Although conventional breeding is not risk free, the risks 
associated with it are, according to a 1989 National Research Council 
(NRC) report,\4\ ``manageable by accepted standards.'' In other words, 
the types of traits that can be introduced through conventional 
breeding have not led to plant pest risk concerns.
---------------------------------------------------------------------------

    \4\ National Research Council (NRC) 1989. Field Testing 
Genetically Modified Organisms: Framework for Decisions. Washington 
DC. National Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
---------------------------------------------------------------------------

    The types of DNA modifications that occur through conventional 
breeding by mutagenesis are well characterized (Oladosu, et al., 2016; 
Kharkwal, et al., 2012). Among the common outcomes that result from 
mutagenesis are deletions, insertions, inversions, or translocations of 
DNA and base pair substitutions (Oladosu, et al., 2016) which often 
result from double strand breaks in the DNA followed by natural DNA 
repair. Base-pair substitution also results from chemical modification 
of a base followed by natural DNA repair. These types of modifications 
occur at a low rate from naturally occurring environmental exposure to 
ionizing radiation, radical oxygen, chemical compounds, or biological 
agents such as viruses, or at an elevated rate in response to radiation 
and chemical-induced mutagenesis. In conventional breeding, these types 
of DNA modifications are introduced randomly. Individual plants 
possessing a mutation conferring a useful phenotype are isolated by 
screening, and random mutations that are introduced and do not convey a 
useful phenotype are addressed during backcrossing. New plant breeding 
technologies, such as those used in genome editing, can be used to 
create targeted double strand breaks in specific parts of the genome 
that when repaired result in deletions and small insertions, just as 
from natural environmental exposure or radiation mutagenesis (Chen, et 
al., 2019). Likewise, new plant breeding technologies can also be used, 
in a specific, targeted manner, to create base pair substitutions that 
are similar to the modifications that can be created by random chemical 
mutagenesis. In other words, the same types of DNA modifications that 
occur in conventional breeding can also be constructed precisely using 
new plant breeding technologies (Custers, et al., 2019). We are 
exempting plants generated using plant breeding technologies that have 
non-templated insertions and deletions and that have a single base pair 
substitution, because they could otherwise be created by conventional 
breeding and pose no increased plant pest risk relative to their 
conventionally bred counterparts.
    The exemption in proposed Sec.  340.1(b)(3) applies to the use of 
new plant breeding technologies to recreate the introduction of a gene, 
allele of a gene, or structural variation that could otherwise be 
introduced by crosses. APHIS notes that conventional methods of plant 
breeding and new plant breeding technologies often share the same goals 
with similar results. Human selection of plants has been used for 
thousands of years; and crossing has been used to introduce alleles 
into breeding populations since at least the early 18th century 
(Goulet, et al., 2017). More recently, plant breeders have expanded the 
source of genetic material that can be used to introduce genetic 
changes into breeding populations through wide crosses, embryo rescue, 
and protoplast fusion (Bravo, et al., 2011; De Filippis, 2014; Singh, 
1990), as well as the rate of introduction of genetic material through 
marker-assisted and genomic selection; all of these approaches are 
considered conventional breeding methods and are used to expand and 
guide changes in the gene pool available within a population. Genetic 
engineering can be used to introduce a genetic sequence from any donor 
source into plants, which cannot be accomplished through conventional 
breeding. To limit the exemption in paragraph (b)(3) to what is 
possible in conventional breeding, the third exemption applies only to 
the introduction of a gene, allele, or structural variant known to 
occur from a donor source (1) in the same species as the recipient, or 
(2) in a species compatible via wide crosses, embryo rescue, or 
protoplast fusion with the recipient species.
    The NRC has concluded in multiple studies \5\ that there was no 
evidence of unique hazards inherent in the use of recombinant DNA 
techniques with respect to plants, and that crops modified by molecular 
and cellular methods should pose risks no different from those modified 
by conventional breeding methods for similar traits. Moreover, new 
molecular methods for editing genomes have been developed since the NRC 
studies that can be more specific and precise than those evaluated by 
the NRC studies, and plants modified by these new methods should also 
pose plant pest risks that are no different from plants that are 
modified for similar traits by conventional breeding methods. For all 
of the foregoing reasons, we consider the exemptions to be based on the 
best available science.
---------------------------------------------------------------------------

    \5\ National Academies of Sciences, Engineering, and Medicine 
(NAS) 1987. Introduction of Recombinant DNA-engineered Organisms 
into the Environment: Key Issues. Washington, DC National Academy 
Press. 24 pp. Retrieved from https://www.nap.edu/read/18907/chapter/1.
    National Research Council (NRC) 1989. Field Testing Genetically 
Modified Organisms: Framework for Decisions. Washington DC. National 
Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
    National Academies of Sciences, Engineering, and Medicine (NAS) 
2016. Genetically Engineered Crops: Experiences and Prospects. 
Washington, DC National Academy Press. 420 pp. doi:10.17226/23395. 
Retrieved from http://www.nap.edu/23395.
---------------------------------------------------------------------------

    Some commenters stated that APHIS did not adequately consider risk 
when developing the exemptions. It was stated that the proposed 
exemptions do not consider potential pest risks or human, 
environmental, or agricultural impacts on nontarget organisms. A 
commenter claimed that APHIS regulates risks other than plant pest 
risks, such as inadvertent introduction to the food supply and economic 
impacts from gene flow, so there should be scientific evidence that 
plants exempted from regulations do not pose any of the full range of 
risks.
    We do not agree with these comments. With regard to the commenters 
who stated that the exemptions failed to consider impacts on non-target 
organisms, APHIS considers impacts on non-target organisms that are 
beneficial to plants to be indirect plant pest impacts. It is not 
accurate to say that APHIS has previously regulated risks other than 
plant pest risks. Under the current regulations prior to the effective 
date of this final rule (referred to below as ``the current 
regulations''), APHIS has imposed measures to limit gene flow from GE 
plants that already met the definition of a regulated article. (Please 
see the ``Implementation Table'' on Regulations.gov regarding the dates 
when various provisions of this rule become applicable.) In these 
cases, APHIS considered the GE plants to be regulated articles because 
they had used a plant pest as the donor organism, recipient organism, 
or vector or vector agent, and therefore could pose a plant pest risk. 
As noted in the proposed rule, APHIS' evaluations to date have provided 
evidence that genetically

[[Page 29793]]

engineering a plant with a plant pest does not in and of itself result 
in a plant that presents a plant pest risk, however. In cases where GE 
crops were not subject to regulation, no ``other risks'' such as 
inadvertent introduction to the food supply or economic impacts from 
gene flow have been regulated by APHIS insofar as they were outside the 
scope of the regulations.
    A commenter opposed the exemptions listed in proposed Sec.  
340.1(b)(1) through (3) on the basis that plants produced through most 
methods that would be used for genome editing are regenerated from 
single cells in tissue culture, resulting in somaclonal variation with 
unpredictable consequences, and that off-target mutations caused by 
genome editing are more likely than chemical and radiation mutagenesis 
to be non-random. A second commenter asked that the exemptions be 
limited so that they apply only to plants produced using techniques 
that minimize off-target mutations. A third commenter asked whether 
off-target mutations are considered when determining eligibility for an 
exemption.
    Somaclonal variation has been utilized extensively for breeding 
purposes, and the resultant new plant variety is not subject to the 
APHIS regulations in part 340 that we are replacing with this final 
rule (Krishna, et al., 2016; Neelakandan and Wang, 2012). APHIS is not 
aware of a reason to mandate government oversight over new plant 
varieties resulting from somaclonal variation.
    Background mutation occurs naturally in plants and does not raise 
plant pest risk concerns in conventional breeding programs. APHIS does 
not believe it is necessary to regulate off-target effects of genome 
editing in plants because (1) the off-target mutation rate from genome 
editing is low relative to the background mutation rate that occurs in 
conventional breeding, and (2) whatever changes do occur are likely to 
be segregated away from the target mutation during the breeding 
process. Comprehensive CRISPR/Cas off-target analysis on a genome-wide 
scale has been performed in rice, maize, tomato, and Arabidopsis (Feng, 
et al., 2014; Feng, et al., 2018; Peterson, et al., 2016; Nekrasov, et 
al., 2017; Lee, et al., 2018; Tang, et al., 2018). In these cases where 
the frequency of off-target mutation was measured in CRISPR/Cas 
expressing lines and their progeny, the authors concluded that the rate 
of off-target mutation was below the level of background mutation 
induced during seed amplification or tissue culture (Hahn and Nekrasov, 
2019). Although there can be variation in off-target mutation rates due 
to the nature of the technique used and the biological system to which 
it is applied, the mutation rates in such conventional breeding 
techniques as chemical and irradiation-based mutagenesis dwarf the rate 
associated with such methods.
    Due to the nature of plant breeding--in which populations are 
created and evaluated, and individual plants are selected for the 
intended modifications--off-target changes are likely to be lost unless 
they are genetically linked to the targeted modification that is 
introduced. APHIS wishes to clarify that, for these reasons, off-target 
mutations are not considered when determining eligibility for an 
exemption. This is also consistent with APHIS' approach regarding 
conventional breeding techniques. As noted above, these techniques 
often have a high mutation rate, but have a history of safe use with 
respect to plant pest risk. APHIS has modified the regulatory text in 
Sec.  340.1(b) to indicate that we are considering only targeted 
modifications when determining eligibility for an exemption.
    Some commenters stated that the scope of the exemptions listed in 
proposed Sec.  340.1(b)(1) through (3) should be broadened to encompass 
the range of genetic modifications that are accessible to plant 
breeders through conventional breeding methods, and proposed 
alternative language that would allow an unlimited number of genetic 
modifications to be made and exempt from the regulations.
    The commenters appear to have interpreted our references in the 
June 2019 proposed rule and its preamble to plants that could otherwise 
have been developed through ``traditional breeding methods'' to mean 
any type and extent of genetic change that is theoretically possible 
through conventional breeding methods. There are many biological and 
practical factors that affect a plant breeder's ability to develop a 
new crop variety by introducing genetic variation and intentionally 
selecting for desired traits. These include the number of targeted loci 
and type of desired genetic changes, the genetic distance between the 
desired changes, generation time, breeding system (sexual or asexual, 
self-compatibility), ploidy level and genomic complexity, resource 
availability (time, money, labor, and genomic resources), and other 
factors. These factors, and thus the extent of intentionally selected 
genetic variation that can be introduced, vary widely among plant 
species. Moreover, new plant breeding techniques can make possible more 
complex combinations of genetic modifications than can practically be 
achieved through conventional breeding methods (Custers, et al., 2019; 
Wolter, et al., 2019; Najera, et al., 2019). Currently, APHIS lacks 
sufficient familiarity to develop a risk-based exemption for products 
containing complex combinations that might be produced in the future. 
APHIS is clarifying that the exemptions listed in Sec.  340.1(b)(1) 
through (3) are based on types of modifications that are easily 
recognizable to the developers of the organism and on genetic changes 
that could be practically achieved by conventional breeding methods in 
any plant species. However, over time, APHIS expects to gain more 
familiarity with the products of these new plant breeding innovations. 
Accordingly, we are revising Sec.  340.1(b) to establish a process for 
listing additional modifications that plants can contain while still 
being exempted from the regulations. This process is specified in 
paragraph (b)(4) of Sec.  340.1 in this final rule.
    Some commenters inquired how the exemptions in proposed Sec.  
340.1(b)(1) through (3) pertain to combinations of genetic 
modifications or to sequential edits. For example, would a deletion and 
a single base substitution made at the same time in a plant qualify for 
exemption? If a single change is made to a plant, when could another 
change be made that qualified for an exemption? Some commenters argued 
that there is no valid scientific reason that the exemptions should not 
allow multiple simultaneous genomic changes to be made. Other 
commenters asked us to reaffirm that the exemptions are limited to only 
a single genome editing change, and that a plant containing multiple 
changes made at the same or different times would not be exempt, or 
that we delete the exemptions altogether, since genome edits could be 
made sequentially such that each intermediate organisms would be 
exempt, cumulatively resulting in a final organism with many targeted 
changes that would also be exempt. Several commenters requested that 
APHIS include a process for adding new categories of exemptions and 
revising exemptions in order to ensure that the regulatory system stays 
up to date and keeps pace with advances in scientific knowledge, 
evidence, and experience.
    APHIS seeks to clarify that exemptions listed in Sec.  340.1(b)(1) 
through (3) apply to plants containing single targeted modifications. 
The exemptions were formulated to apply to what could otherwise be 
achieved through conventional plant breeding

[[Page 29794]]

techniques in any species. As discussed above, the plants that are 
eligible for exemption would have no increased plant pest risk than 
conventionally bred plants. APHIS realizes that in some species, a 
single targeted modification is often less than what could otherwise be 
developed through conventional breeding. However, as noted above, the 
extent of intentionally selected variation that could otherwise be 
introduced through conventional breeding varies depending on the plant 
species. To establish clear and unambiguous exemptions that could apply 
to any plant species while enabling for variation in what can be 
achieved through conventional breeding, APHIS has revised the 
regulatory text in Sec.  340.1(b).
    Initially, the exemptions will apply only to plants containing a 
single targeted modification in one of the categories listed. APHIS 
anticipates scientific information and/or experience may, over time, 
allow APHIS to list additional modifications that plants can contain 
and still be exempted from the regulations so that the regulatory 
system stays up to date and keeps pace with advances in scientific 
knowledge, evidence, and experience. This may include multiple 
simultaneous genomic changes. If the Administrator determines that it 
is appropriate to list additional modifications, APHIS will notify the 
public in the Federal Register and will take public comment. After 
reviewing the comments, APHIS will issue a subsequent notice announcing 
its determination. This process is provided in new paragraph (b)(4) in 
Sec.  340.1.
    One commenter requested that APHIS document examples of deletions 
of any size that could be made by conventional breeding.
    The first exemption allows a single deletion of any size because 
radiation can create any size deletion. As mutations are typically 
detrimental to the organism, what is achievable in practice is limited 
by the viability and fertility of the organism. Large mutations can be 
maintained in a heterozygous state but do not tend to undergo 
homozygous inheritance (Naito, 2005). For example, in Arabidopsis, 
which has a genome size of 135 Mb (Arabidopsis Genome Initiative, 
2000), a radiation-induced deletion of 3.1 Mb was obtained that 
disrupted 852 genes and was maintainable only as a heterozygote 
presumably because genes essential for survival are present in the 
deleted region (Kazama, et al., 2017). Polyploid plants and those with 
large genomes are better able to accommodate even larger deletions (Men 
et al., 2002). For example, in hexaploid wheat, X-ray mutagenesis was 
used to create a mutant, Ph1-, widely used in breeding programs, that 
has a 70 Mb deletion (Sears, 1977). To put the size of this deletion in 
perspective, it is larger than half of the entire genome of 
Arabidopsis.
    Some commenters recommended that the exemption in Sec.  340.1(b)(1) 
be broadened to allow for insertions that occur during the natural DNA 
repair mechanism after double-strand break of the DNA. In the proposed 
rule, the exemption in paragraph (b)(1) mentions only deletions.
    APHIS agrees with the comment. Deletions, small insertions, and 
combinations of deletions and insertions are all possible outcomes 
resulting from the cellular mechanisms used to repair DNA breaks that 
occur naturally or that are induced during conventional plant breeding, 
and all have been used in conventional plant breeding (Manova and 
Gruszka, 2015; Wang, et al., 2016). The exemption in Sec.  340.1(b)(1) 
has been revised to reflect all of the possible outcomes of natural DNA 
repair mechanisms that occur in the absence of a deliberately provided 
repair template.
    A commenter asked that APHIS eliminate the exemptions for deletions 
and single base pair substitutions, arguing that any type of change in 
a gene sequence can potentially cause phenotypic changes that have 
significant consequences.
    APHIS disagrees with this argument. Naturally occurring single base 
pair substitutions and deletions are commonly induced and are widely 
used to generate new crop varieties in conventional mutation breeding, 
which includes both chemically induced and irradiation-based 
mutagenesis (Oladosu, et al., 2016; Kharkwal, 2012; Ahloowalia and 
Maluszynski, 2001). The targeted single base pair substitutions or 
deletions covered by these exemptions are the same in kind as, and do 
not pose any increased plant pest risks than, the substitutions or 
deletions introduced through conventional breeding. Thus, they should 
not be subject to the regulations.
    Many commenters argued that limiting the exemption in proposed 
Sec.  340.1(b)(1) to a single deletion and the exemption in Sec.  
340.1(b)(2) to a single base pair substitution does not take into 
account that multiple base pair substitutions and/or deletions are 
routinely and safely introduced into plants using conventional breeding 
methods, including mutagenesis.
    The argument that multiple substitutions or deletions can occur 
through conventional breeding methods, including mutagenesis, seems to 
be conflating the specific targeted changes that can be made via genome 
editing techniques with the multiple random changes that occur during 
conventional breeding, only one or few of which might contribute to the 
desired phenotype. In the case of random chemical or radiation 
mutagenesis, thousands of mutations are introduced into the plant but 
most are detrimental, or neutral at best. The fact that multiple 
mutations exist in the plant is a negative feature that needs to be 
overcome by laboriously self-fertilizing or backcrossing the mutated 
plant for multiple generations. Even then, a developer may not find an 
agronomically suitable phenotype. By applying selection, it is 
possible, though at a very low frequency, to get two desirable 
mutations in a single mutated line if the mutations are unlinked. It is 
improbable to get two linked mutations in a single line, particularly 
if the mutations are sought within the same gene. In contrast, genome 
editing can easily introduce multiple beneficial changes in one 
generation, leading to phenotypes that we have not seen by conventional 
breeding.
    The exemptions listed in Sec.  340.1(b) are based on measures that 
are easily defined, are based on familiarity, and thus are meant to be 
limited to genetic changes that could practically be achieved by 
conventional breeding methods in any plant. It is not possible to 
define a number of such changes greater than one which could 
practically be achieved by conventional breeding methods in all plant 
species. The number of changes that can practically be achieved through 
conventional breeding methods can vary widely from one species to 
another. For this reason, APHIS is retaining the limitation of a single 
modification, as this approach ensures that we can identify those 
plants that pose a plant pest risk. We anticipate that most plants that 
are not eligible for the exemption and do not pose a plant pest risk 
will pass through the RSR process quickly.
    In addition, as noted above, we are revising Sec.  340.1(b) by 
adding a new paragraph (b)(4) that establishes a process for listing 
additional modifications that plants can contain while being exempted 
from the regulations, based on what could be achieved through 
conventional plant breeding. Thus, while the exemptions in Sec.  
340.1(b)(1) through (3) will initially apply only to plants containing 
a single modification in one of the categories listed, APHIS 
anticipates that scientific information and/or experience will,

[[Page 29795]]

over time, allow multiple and sequential changes in some species after 
public notice and comment.
    The introductory text of Sec.  340.1(b)(4) provides that the 
Administrator may propose to exempt plants with additional 
modifications, based on what could be achieved through conventional 
breeding. Such proposals may be APHIS-initiated, or in response to a 
request.
    Paragraph (b)(4)(i) sets forth the process for APHIS-initiated 
proposals. APHIS will publish a notice in the Federal Register of the 
proposal by the Administrator to exempt plants with additional 
modifications. The notice will make available any supporting 
documentation, and will request public comment. After reviewing the 
comments, APHIS will publish a subsequent notice in the Federal 
Register announcing its final determination and responding to the 
comments received.
    Under paragraph (b)(4)(ii), any person may request that APHIS 
exempt plants developed with additional modifications that could be 
achieved through conventional breeding. The request will have to 
include the following supporting information, in writing:
     A description of the modification(s);
     The factual grounds demonstrating that the proposed 
modification(s) could be achieved through conventional plant breeding;
     Copies of scientific literature, unpublished studies, or 
other data that support the request; and
     Any information known to the requestor that would be 
unfavorable to the request.
    Paragraph (b)(4)(iii) provides the timeframe for Agency review of 
such requests. It provides that, after APHIS receives all the 
information required for a request, APHIS will complete its review of 
the request and render a final determination within 12 months, except 
in circumstances that could not reasonably have been anticipated.
    Under paragraph (b)(4)(iv) if, after review of the request, APHIS 
disagrees with the conclusions of the request or determines that there 
is insufficient evidence that the modification could be achieved 
through conventional breeding methods, APHIS will deny the request and 
notify the requestor in writing regarding this denial.
    Paragraph (b)(4)(v) provides for Agency actions when we agree with 
a request. It states that, if APHIS initially determines that the 
modification could be achieved through conventional breeding methods, 
APHIS will publish a notice in the Federal Register in accordance with 
the process set forth in Sec.  340.1(b)(4)(i).
    Under paragraph (b)(4)(vi), a list specifying the additional 
modifications allowed will be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. This list would 
include both those additional modifications originally proposed by the 
Administrator and those that originate with a request.
    Some commenters suggested a change to the exemption in proposed 
Sec.  340.1(b)(2) so that it would allow a limitless number of 
synonymous base pair changes. Synonymous base pair changes, it was 
stated, do not alter the amino acid composition of the encoded protein. 
One commenter suggested changing the exemption to allow however many 
specific and known base pair changes are needed to achieve the intended 
MOA.
    APHIS rejects the first suggestion because synonymous changes can 
lead, and indeed have been made, to generate significant phenotypic 
changes, e.g., by altering mRNA splice sites, promoters, and regulatory 
RNAs. APHIS acknowledges that these types of phenotypic changes could, 
in principle, also occur through a single deletion, insertion, or base 
pair change in conventional breeding. However, these types of 
phenotypic changes are unlikely to be possible in all or perhaps even 
most genes through deletion or single base pair changes. Moreover, 
multiple targeted changes within a single gene are generally not likely 
to be achieved in conventional breeding. Therefore, the exemption will 
not be broadened to include multiple synonymous base pair changes. 
However, as discussed below under this same subheading of comment 
responses, we have revised the exemption in Sec.  340.1(b)(3) to 
clarify that if multiple sequence changes are needed to generate an 
allele that will result in the intended phenotype and if those changes 
are known to occur in the plant's gene pool, the GE plant would qualify 
for the exemption.
    One commenter stated that APHIS should eliminate the exemption in 
paragraph (b)(3), regarding introducing variation known to occur in the 
gene pool, because sequences found naturally in closely related, 
sexually compatible organisms do not necessarily have acceptable risks 
when introduced into other species. The commenter offered an example, 
stating that ``the introduced nucleic acids can direct the synthesis of 
toxins, change metabolism in harmful ways, turn on or off genes and 
metabolic pathways in the genetically engineered host, and make the 
genetically engineered organism more susceptible to pests and 
pathogens, or more fit in the wild and more weedy.''
    APHIS disagrees with the comment. The commenter is pointing out 
harms that potentially could occur, and are no less likely to occur, in 
conventional breeding programs. However, such harms have not 
materialized in conventional breeding programs because they rarely 
occur and are intentionally eliminated during the evaluation and 
selection process (NRC, 1989).
    One commenter wished to know whether the exemption in proposed 
Sec.  340.1(b)(3) supersedes the exemption in Sec.  340.1(b)(1) and 
(b)(2). Another commenter felt that the exemptions in paragraphs (b)(1) 
and (b)(2) were too narrow because polymorphisms, insertions, 
inversions, and multiple megabase deletions and translocations are 
abundant in nature and frequently induced in breeding programs through 
mutagenesis.
    APHIS seeks to clarify that Sec.  340.1(b)(3) does supersede Sec.  
340.1(b)(1) and (b)(2) in the number of changes that can be made under 
the exemption. APHIS also seeks to clarify that paragraphs (b)(1) and 
(b)(2) pertain to products of mutagenesis which have not been observed 
in the gene pool, whereas paragraph (b)(3) applies only to variation 
already known to occur in the gene pool. Therefore, the exemption in 
paragraph (b)(3) allows the introduction of a gene, i.e., a functional 
unit of DNA that encodes an RNA or protein, or of an allele (a variant 
form of a gene or, for the purposes of this regulation, a genetic 
sequence) containing multiple sequence changes as long as the allele is 
known to occur in the gene pool of the plant. With regard to the 
comment that the exemptions in paragraphs (b)(1) and (b)(2) are 
unnecessarily restrictive because there are changes abundant in nature 
not covered by these exemptions, APHIS wishes to clarify that the 
duplications, inversions, translocations, and transpositions already 
known to occur in the gene pool would qualify under the exemption in 
paragraph (b)(3).
    Some commenters suggested deleting ``natural'' from Sec.  
340.1(b)(3) because the gene pool of a plant may include variation that 
has been previously induced through chemical or radiation mutagenesis 
or that could be introduced via human-assisted wide crosses. Further 
comments on the exemption in paragraph (b)(3) recommended substituting 
the phrase ``known to occur'' with some variation of

[[Page 29796]]

``otherwise accessible through traditional plant breeding methods.''
    APHIS agrees with the first comment and disagrees with the second. 
APHIS considers the known and accessible gene pool of a plant to 
include not only genetic sequences that can be introduced to a plant 
via crosses that can take place without human assistance, but also 
genetic sequences that can be introduced to a plant via human-assisted 
wide crosses between distantly related species. In systems for which 
breeding techniques such as bridging and embryo rescue have been 
developed to enable wide crosses, distantly related plants are also 
considered part of the gene pool. However, these categories may not be 
considered ``natural,'' so APHIS is in favor of deleting this term. 
APHIS is retaining the phrase ``known to occur,'' however. As discussed 
above, when we refer to GE plants that could otherwise have been 
developed through conventional breeding methods, we do not mean any 
genetic changes that are theoretically possible. Almost any genetic 
change is theoretically possible, given enough time. APHIS' intention 
in Sec.  340.1(b)(3) is to exempt from regulation a product that could 
be practically expected to be pursued and achieved in a conventional 
breeding program. To qualify for an exemption based on occurrence in 
the gene pool, the genetic change must be known to occur. We do not 
intend the exemption to apply to limitless possibilities that are 
theoretically possible but not currently known to occur in the gene 
pool. Consequently, the exemption in paragraph (b)(3) has been slightly 
modified for accuracy and clarity.
    Some commenters asked that the exemption in paragraph (b)(3) be 
expanded to include plants in which an allele has been modified to 
align with a similar known allele found in a close relative, or in a 
more distant relative beyond the family level of taxonomy, or that we 
exempt plants containing any sequence from a plant that is known not to 
be a plant pest and is routinely used for food.
    APHIS considers the known and accessible gene pool of a plant to 
include not only genetic sequences that can be introduced to a plant 
via crosses that can take place without human assistance, but also 
human-assisted wide crosses between more distantly related species. In 
systems for which breeding techniques such as bridging and embryo 
rescue have been developed to enable wide crosses, more distantly 
related plants are also considered part of the known gene pool. APHIS 
agrees in principle that exchange of genetic information between 
unrelated species is likely to be safe in most cases. However, APHIS 
does not have the experience to definitively state that exempting all 
exchange of DNA between plants will not lead to increased plant pest 
risk. In cases where genetic material from a more distantly related 
plant species is introduced into the plant, developers can request an 
RSR.
    A commenter stated that their understanding is that the exemption 
in Sec.  340.1(b)(3) would include any insertion or other sequence 
modification of less than 20 base pairs. APHIS disagrees and seeks to 
clarify that even an insertion or sequence modification smaller than 20 
base pairs that does not otherwise qualify for exemptions Sec.  
340.1(b)(1) or (b)(2) still has to meet the criteria of paragraph 
(b)(3) to qualify for exemption under paragraph (b)(3). The exemption 
does not apply to what is theoretically possible. The genetic variation 
must be known to occur in the plant's gene pool in order to qualify for 
the exemption.
    A commenter stated that the regulation could clarify that exemption 
under paragraph (b)(3) covers the introduction of natural or chemically 
synthesized copies of nucleic acid sequences from one plant species 
into the same or a crossable plant species, including (a) the targeted 
insertion or replacement of sequences exceeding 20 base pairs in length 
(e.g., the insertion or replacement or a promoter, terminator, exon, 
intron, or small open reading frame, excluding complete genes), (b) the 
targeted replacement of a cisgenic allele (i.e., perfect allelic 
replacement), (c) the targeted insertion of a cisgenic sequence at the 
same or a different location in the genome of the recipient species, 
and (d) the targeted insertion of a cisgene with a new combination of 
genetic elements, as plants containing such changes could have occurred 
naturally or could result from conventional breeding since they fall 
under exemption under paragraph (b)(3). A second commenter stated that 
some genetic engineering experiments will replace promoters, altering 
gene expression patterns in ways that are not attainable by today's 
breeders.
    APHIS does not intend to modify the regulation text per the 
commenter's suggestion. Exemption under paragraph (b)(3) will exempt 
from regulation plants that have been modified to introduce a gene 
known to occur in the plant's gene pool, or that make changes in a 
targeted sequence to correspond to a known allele of such a gene or to 
a known structural variation present in the gene pool. Some of the 
examples provided by the first commenter may thus not be eligible for 
exemption under paragraph (b)(3). For instance, (b)(3) will not exempt 
from regulation a plant containing an insertion of a gene that is known 
to occur in the gene pool if the insertion results in the creation of a 
gene not known to occur in the gene pool, e.g., a gene that results in 
the production of a protein or RNA, or a loss or gain of function, that 
is not known to be produced by plants within the gene pool. However, if 
a specific modification can be demonstrated to be present in the 
plant's gene pool, then it can be exempted under paragraph (b)(3). If a 
developer has a question about whether its plant is exempt from the 
regulation, the developer can contact APHIS for a consultation.
    Some commenters asked how the deletion exemption in Sec.  
340.1(b)(1) pertains to diploid and polyploid plants. For example, if a 
deletion is made to both alleles of a diploid or all four or six 
alleles in tetraploid and hexaploid plants, respectively, would those 
plants qualify for the exemption?
    APHIS seeks to clarify that exemptions in Sec.  340.1(b)(1) through 
(3) apply to modifications made to one pair of homologous chromosomes. 
It is very straightforward in conventional breeding to identify a 
single allele in a diploid line and then convert the heterozygote to a 
homozygote in the next generation. However, it is very difficult 
through conventional breeding to create the same allele in all 
homoeologous genomes in polyploid plants. Therefore, for polyploid 
plants, the exemptions would initially apply only to modifications made 
to one pair of homologous chromosomes. As an example, consider a change 
to a gene in common wheat (bread wheat). Common wheat has three sets 
(AA BB DD) of homoeologous chromosomes. A developer can qualify for the 
exemption if modifying the A genome through a change that qualifies for 
exemption (b)(1), (b)(2), or (b)(3). If the developer wanted to make 
the same corresponding changes to the B and D genomes, the developer 
would go through the RSR process (as described below). Once APHIS 
determines that this A/B/D plant is unlikely to pose an increased plant 
pest risk, it will go on the list of plant-trait-MOAs that do not 
require regulation (i.e., the Sec.  340.1(c) exemption list). At that 
point, this developer, and any others, would be able to make the same 
plant-trait-MOA combination and be exempt from regulation under part 
340.
    Some commenters noted that the exemption in proposed Sec.  
340.1(b)(4), i.e., the exemption of null segregants derived from GE 
plants, is superfluous

[[Page 29797]]

because the definition of genetic engineering applies only to organisms 
whose DNA sequence has been modified.
    APHIS agrees with these commenters. According to our definition of 
genetic engineering, the genome of null segregants has not been created 
or modified. Therefore, null segregants do not need an exemption from 
regulation, and APHIS is removing this exemption from the final rule.
    Some commenters stated that the exemption in proposed Sec.  
340.1(c) for a GE plant with a plant-trait-MOA combination that has 
previously undergone an analysis in accordance with Sec.  340.4 and has 
been found by the Administrator to be unlikely to pose a plant pest 
risk should be eliminated. One commenter stated that the impact of 
releasing new GE plants into the environment cannot be accurately 
predicted or assessed without case-by-case analysis and controlled 
field experiments. Another commenter stated that every transformation 
event is unique, and thus potentially has a novel phenotype that must 
be assessed to determine appropriate regulation. The commenter further 
stated that the National Academy of Sciences (NAS) has also advocated 
the use of genetic engineering [i.e., transformation] as ``both a 
useful and scientifically justifiable regulatory trigger'' because 
``there is no scientific basis'' on which to exclude GE organisms from 
regulatory review prior to evaluation of data on the interactions 
between ``trait, organism and environment.''
    APHIS disagrees with these points. Based on the risk assessments we 
have performed in accordance with the petition process over 30 years, 
we have determined that, in many cases, we would have been able to 
evaluate the plant pest risks associated with a GE organism without 
field-test data. Rather, APHIS has discovered that the introduced trait 
of the GE organism provides the most reliable indicator of the 
organism's potential for deleterious effects on plants and plant 
products. These observations are expected and are consistent with the 
findings of reports of NAS (NRC, 1989; NAS, 2016). APHIS will seek 
additional information, potentially including data from controlled 
field experiments, in cases where APHIS identifies a plausible pathway 
to increased plant pest risk.
    The same NAS study (NRC, 2002) cited by the commenter stated the 
following: ``Transgenic organisms have potential environmental risks, 
but the committee expects that most of them will not produce 
significant actual environmental risks. Consequently, the committee 
also suggests that for environmental risk regulatory oversight should 
be designed to winnow the potentially riskier transgenic crops from the 
less risky ones before a substantial regulatory burden is imposed on 
the less risky ones.'' APHIS has designed a system where organisms that 
pose a plausible plant pest risk are rapidly distinguished from those 
that do not, based on the RSR process described below under the 
subheading ``Regulatory Status Review,'' focusing regulation on the 
former. The exemption that we proposed in Sec.  340.1(c) will apply 
only to those GE plants that have undergone a risk assessment in the 
RSR process. The revised regulations are proportionate to risk and are 
therefore consistent with the recommendation of NAS's study.
    Several comments were received on the definition and application of 
the term MOA as it relates to the exemption in Sec.  340.1(c). The 
issues raised by the commenters are discussed in detail below.
    Two commenters stated that the categories of trait (defined in the 
June 2019 proposed rule as ``an observable (able to be seen or 
otherwise identified) characteristic of an organism'') and MOA (defined 
as ``the biochemical process(es) through which genetic material 
determines a trait'') could be interpreted so broadly that new GE 
plants that have a plant-trait-MOA combination similar to that of a 
nonregulated plant, yet contain unique features with unknown impacts on 
non-target organisms and the surrounding ecosystem, would not require 
review by APHIS. They stated that, for example, the ``Cry \6\ protein 
MOA'' could include dozens of possibilities with unknown effects, and 
that it could even be the case that APHIS review would not be required 
when any gene encoding a Cry protein that targets broad orders of 
insect pests is inserted into a plant that had previously been 
engineered with any other trait and had been found by APHIS not to pose 
a plant pest risk.
---------------------------------------------------------------------------

    \6\ A Cry protein is a crystalline protein toxic to certain 
species of insects primarily produced by the bacterium Bacillus 
thuringiensis (Bt). Genes for Cry proteins have been widely used to 
confer resistance to insect pests in several types of crop plants.
---------------------------------------------------------------------------

    APHIS disagrees with the suggestion that the proposed definition of 
MOA is too broad. The suggestion is based on a misreading of the 
definitions and the preamble of the June 2019 proposed rule. As 
described in the preamble, the MOA refers to the specific manner by 
which the genetic modification confers the intended trait on the plant. 
We noted that the same trait can be obtained by different MOAs that 
would thus be subject to distinct RSRs. In the example cited, the 
preamble was clear that non-target impacts related to Cry proteins 
depend on whether the non-target insect has the correct receptor in its 
gut to bind the Cry protein; thus, for each new Cry protein it will be 
important to evaluate the potential for non-target impacts. Similarly, 
the preamble provided an example of RNA interference-based resistance, 
where it would be important to consider the specific target RNA and its 
corresponding protein in order to determine whether there could be non-
target effects. Moreover, the regulatory text and preamble were clear 
that it is the specific plant-trait-MOA combination that is the subject 
of the RSR and decision. Developers could not qualify for exemption 
under Sec.  340.1(c) by inserting any cry gene that encodes a protein 
targeting a broad order or orders of insects into a plant with any 
other trait and MOA that was previously reviewed by APHIS.
    Another commenter stated that reasonably broad MOA categories 
should be established that would cover broad protein functional 
classes, account for all normal polymorphisms found in nature at the 
DNA and protein levels at the genus level, and account for the normal 
wide variation in expression seen among transgenic events and 
backgrounds. An additional commenter recommended that the definition of 
MOA refer to the biochemical process(es) through which the gene, rather 
than the genetic material, determines a trait, stating that it is a 
gene product and not the genetic material that determines the resulting 
biochemical process. Finally, a commenter requested that the final rule 
clarify which products would qualify for the exemption in Sec.  
340.1(c), noting that APHIS alternately used the terms ``same'' and 
``similar'' to describe products that could qualify based on their use 
of a crop-trait-MOA combination that has already been assessed by APHIS 
and determined unlikely to pose a plant pest risk than the appropriate 
comparator(s).
    APHIS agrees that in most cases, the MOA could cover all normal 
polymorphisms of a gene found in nature, even at levels broader than 
the genus. For example, the outcome of an RSR would apply to genetic 
material encoding an enzyme that catalyzes a specific biochemical 
reaction regardless of whether the genetic material is sourced from a 
plant or a microbe, as long as the enzyme catalyzes the same 
biochemical reaction regardless of the organism from which the genetic 
material encoding the enzyme is obtained, and does not catalyze any

[[Page 29798]]

additional biochemical reactions that differ among the source 
organisms. APHIS does not agree that the MOA would be so broad as to 
cover broad functional classes, since broad functional classes could 
encompass many different proteins that have multiple differences in the 
biochemical processes in which they participate. Typically, an RSR 
would be conducted at the level of the MOA of individual genes. If 
those genes when stacked produce a new phenotype, such as a new 
biochemical pathway, APHIS will consider the interaction of the gene 
products in the RSR. Regarding variation in expression, in most cases 
APHIS anticipates that variation in expression should not affect the 
outcome of an RSR. However, as we noted in the preamble to the June 
2019 proposed rule, there may be cases where it is important to 
consider where, when, or at what level the genetic material is 
expressed in the plant. In those cases, APHIS will specify whether and 
in what way variation in expression limits the outcome of the review.
    APHIS will not revise the definition of MOA in response to these 
additional comments, because some MOAs may not involve changes in gene 
products but rather changes in genetic material that affect the 
expression of gene products. As this discussion makes clear, a plant-
trait-MOA combination may qualify for the exemption only if the 
combination is the same as a previously reviewed plant-trait-MOA 
combination that has been found to be unlikely to pose a plant pest 
risk. To be clear, a merely ``similar'' combination does not qualify as 
a ``same'' combination, but a ``similar'' product may qualify for the 
exemption if it has the same combination as a previously reviewed 
combination.
    One commenter urged that in addition to mutated products of genome 
editing, the concept of exemptions due to familiarity should be 
broadened to include plants with transgenic traits that are familiar in 
type and inherently unlikely to give a significant advantage to wild 
plants. Examples would be sterility traits, stature reduction traits, 
and quality traits relevant to industrial processing (e.g., modified 
lignin in alfalfa and trees). According to the commenter, another class 
of strong candidates for plant kingdom-wide exemption are the widely 
used marker genes, such as nptII for kanamycin resistance, T-DNA 
borders, and widely used promoters such as 35S and NOS.
    APHIS appreciates these comments. The commenter did not provide any 
scientific evidence or explanation that would make the comments 
actionable at this time, however.
    Several commenters asked that APHIS clarify the regulation of 
plants containing stacked traits. One commenter requested that APHIS 
codify in the regulations that plants developed through conventional 
breeding that are derived from products determined to not be regulated 
(either because of an exemption or as a result of an RSR) would 
themselves be unlikely to pose increased plant pest risk and therefore 
would not be subject to regulation. Other commenters argued that APHIS 
should assess the risks of stacked traits, particularly plants 
containing multiple herbicide resistance traits, using the noxious weed 
authority.
    A discussion of our noxious weed authority in the context of these 
regulations is presented later in this document.
    APHIS notes that in accordance with Sec.  340.1(c), the regulations 
under part 340 do not apply to a GE plant with a plant-trait-MOA 
combination that has previously undergone an analysis in accordance 
with Sec.  340.4 and is not subject to the regulations. APHIS notes 
that the word ``combination'' used in the regulation text is 
deliberately enumerated as singular and not plural in order to denote 
that the exemption applies to a single plant-trait-MOA combination and 
not a molecular stack of multiple plant-trait-MOA combinations. Plant-
trait-MOA combinations that have undergone an analysis in accordance 
with Sec.  340.4 and are not subject to the regulations may be stacked 
by conventional breeding methods and would still qualify for the 
exemption. However, this is not the case for plant-trait-MOAs stacked 
molecularly; today stacked traits typically have independent MOAs. In 
the future, we anticipate seeing more interactions between or among the 
products of genes in molecular stacks, potentially including new MOAs 
that were not evident in the review of individual traits. For this 
reason, APHIS anticipates that plants that are the genetically 
engineered product of more than one previously evaluated combination 
will be subject to evaluation under Sec.  340.4. In cases where there 
is no interaction between trait-MOA combinations, we expect to be able 
to use the results of previous reviews to quickly reach a regulatory 
status determination.
    Finally, several commenters requested clarity on the regulatory 
status of plant-trait-MOA combinations that were previously deregulated 
under part 340 or deemed to be not regulated under the ``Am I 
Regulated'' (AIR) process.
    To provide the clarity the commenters requested, we are amending 
paragraph (c) to exempt from these regulations a GE plant that has a 
plant-trait-MOA combination contained in a GE plant determined by APHIS 
to be deregulated under a petition submitted prior to October 1, 2021 
pursuant to Sec.  340.6 of the current regulations in part 340. We are 
also adding a new paragraph (d) to Sec.  340.1, stating that all GE 
plants determined not to require regulation pursuant to the AIR process 
will retain their nonregulated status under these regulations.
    As we have noted, APHIS will publish a list (referred to earlier in 
this document as the Sec.  340.1(c) exemption list) of plant-trait-MOA 
combinations that have been evaluated under our new RSR process and 
found not to require regulation under part 340. That list may be used 
by a developer to determine whether its novel GE plant would qualify 
for exemption under Sec.  340.1(c). GE plants previously evaluated 
under the petition process will be included on the Sec.  340.1(c) 
exemption list because such plants will have effectively been evaluated 
at the MOA level and determined not to pose a plant pest risk.
    Plants that have been determined not to require regulation pursuant 
to the previous AIR process will not be included on the Sec.  340.1(c) 
exemption list because they will not have been evaluated at the MOA 
level or by analogous criteria. Such plants will be identified at a 
separate list, at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. Because the plants to be identified on this separate AIR 
list were not evaluated under the petition process or under the RSR 
process, developers will not be able to use the AIR list in determining 
whether new GE plants they develop should be subject to or exempt from 
the regulations. At the same time, we have multiple reasons for 
concluding that the specific plants on the AIR list should retain their 
nonregulated status under these regulations. Not only do we lack a 
basis for overturning our prior individualized determinations reached 
pursuant to the AIR process, we also believe that it is appropriate for 
us to take into account the importance of preventing potential market 
disruptions, including potential trade disruptions, and providing 
regulatory certainty for developers, third parties, and the general 
public.
Self Determination
    Under the June 2019 proposed rule, developers would have the option 
to determine whether their plants belong to one of the categories 
listed under Sec.  340.1(b) or (c) and are therefore

[[Page 29799]]

exempt from the regulations. As stated in the preamble to that proposed 
rule, allowing for such ``self-determinations'' would provide 
developers with regulatory relief and would open more efficient and 
predictable pathways for innovators to get new modified plants that do 
not require regulation to market, in turn supporting further 
innovation. Eliminating the need for redundant evaluations of products 
would allow APHIS to devote more attention to assessing and regulating 
GE organisms that are likely to be associated with potential plant pest 
risks.
    While many commenters agreed with the rationale discussed above and 
welcomed the regulatory relief that allowing for developer ``self-
determination'' would provide, others either opposed the concept 
entirely or expressed reservations. Many in the latter category cited 
what they believed to be potential risks that could result from 
allowing developers to determine whether their products are eligible 
for exemption from the regulations. Some industry commenters questioned 
whether allowing developers to make such determinations would actually 
relieve regulatory burden and incentivize innovation to the extent that 
we anticipated. The comments are discussed in detail in the paragraphs 
that follow.
    Many commenters opposed ``self-determination'' on the ground that 
allowing developers to regulate themselves could result in conflicts of 
interest. It was stated that developers of GE products with a financial 
stake in the outcome should not be allowed to determine which products 
should be subject to regulatory review. According to these commenters, 
such an approach would fatally undermine the integrity, rigor, and 
credibility of what must be an independent regulatory process, 
weakening Agency ability to protect the public interest, and furthering 
mistrust in the U.S. Federal regulatory system in the public's eye and 
among key trading partners. By avoiding the RSR or permitting process, 
these commenters believed, the developer could get its new product to 
market without its ever having undergone an objective, third-party 
review. In allowing developers to determine whether their products are 
eligible for exemption, according to these commenters, we are 
effectively abdicating our regulatory authority and not carrying out 
our mission to protect U.S. agriculture.
    We do not agree with these comments. The revised regulations in 
part 340 recognize that plant products that are the result of 
modifications that coincide with conventional plant breeding do not 
pose additional plant pest risk and should not be regulated under these 
regulations. Products that do not fall within the regulatory scope of 
part 340 have not been subject to compulsory regulation in the past, 
and developers have always been able to act accordingly to determine 
whether their products are subject to the regulations.
    It was further argued that allowing developers to determine the 
regulatory status of their products will result in less transparency 
and greater risk of commingling with organic and other non-GE crops and 
will damage consumer confidence. Allowing developers to determine the 
regulatory status of their products, it was claimed, will result in an 
overall loss of transparency in that the public would not have access 
to the data used by developers to make their determinations. Organic 
farmers would have less information about modified crops grown near 
their fields than they do now, because the information that informed 
developers' determinations would remain proprietary, and their ability 
to take preventive measures would be hindered. Some commenters cited 
the recent finding in Washington of unapproved GE glyphosate-resistant 
wheat \7\ as an example of risks posed by allowing developers to 
determine whether their products are eligible for exemption and by 
reducing our regulatory oversight over GE products more broadly.
---------------------------------------------------------------------------

    \7\ On June 7, 2019, APHIS confirmed the discovery of GE wheat 
plants growing in an unplanted agricultural field in Washington 
State. The GE wheat in question was resistant to glyphosate, 
commonly referred to as Round Up. On July 12, 2019, APHIS announced 
that the GE wheat plants in question were developed by Monsanto (now 
owned by Bayer CropScience (BCS)) and referred to as MON 71300 and 
MON 71800. APHIS also announced that there is no evidence that any 
GE wheat entered commerce or is in the food supply. https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-andinformation/2019_brs_news/wheat_update_jul2019.
---------------------------------------------------------------------------

    We do not agree with these comments. With regard to transparency, 
we anticipate that many developers whose products fall within an 
exemption will request confirmation letters because the letters will 
help them market their products domestically and overseas. Those 
letters will be posted on the APHIS website and will be available to 
the general public, including organic and other growers of non-GE 
crops. Information from previous RSRs will also be available to the 
public. We do not agree that self-determinations will limit organic 
growers from learning whether their neighbors are growing GE crops. 
This information principally comes from conversation with neighbors and 
from other voluntary interactions and arrangements, and is not based on 
USDA decisions on regulatory status. We also do not agree that the 
finding of GE wheat in Washington fields is relevant to the regulatory 
changes made in this final rule. Under the new regulations set forth in 
this final rule, the GE wheat involved in the incident would not be 
eligible for an exemption and would need to go through the RSR process. 
The commenters are generally confusing a fact-specific compliance 
issue, which could arise under any number of regulatory schemes, with 
broader questions about the appropriate regulatory approach. If APHIS 
were to find that a plant was unlikely to pose an increased plant pest 
risk, APHIS would make information publicly available regarding the 
plant, trait, and a general description of the MOA. In cases where GE 
crops are not subject to regulation because they are unlikely to pose a 
plant pest risk, no other risks are regulated by APHIS insofar as they 
are outside the scope of the regulations.
    In the preamble to the June 2019 proposed rule, we stated that a 
developer who made a determination of regulatory status that APHIS 
found not to be valid would be subject to remedial measures or 
penalties in accordance with the compliance and enforcement provisions 
contained in Sec.  340.6 of the June 2019 proposed rule.
    Some commenters stated that there is a need for a plan for 
detection and enforcement in cases where developers incorrectly 
determine their products to be non-regulated, or where changes in 
evidence may call a developer's determination into question. Without a 
record of what plants are being released, according to these 
commenters, it will be impossible to conduct any kind of periodic 
surveillance or audit to ensure compliance. These commenters believe 
that this difficulty may be partly addressed by having a compulsory 
reporting mechanism whereby a responsible party fills out a form to 
declare its modification and assert its exempt status. This would 
create a searchable record. According to such commenters, a database 
compiled from self-reported data would not offer complete protection 
against bad actors, but when combined with penalties that are 
proportional to the degree of harm done by a developer incorrectly 
making a determination, such a database may aid in correcting incorrect 
determinations by developers.
    APHIS disagrees with the proposal for a mandatory process and the 
data base proposals associated with it and has instead included 
provisions in part 340 for a voluntary confirmation process for

[[Page 29800]]

products exempted from the regulation. Voluntary confirmation will be 
public information, however, and interested parties could search for it 
of their own volition.
    Under APHIS's long-standing regulations, APHIS regulates articles 
based only upon a narrow and limited plant pest mechanism. The products 
that commenters are concerned will be ``missed'' or ``overlooked'' in 
the ``future'' have no current regulatory trigger. Under this rule, 
APHIS' focus will be on plant pest risk associated with the product, 
consistent with our legal authority. Consistent with long-standing 
practices, we will continue to offer voluntary confirmation of 
regulatory status to those who seek it. APHIS agrees with comments 
expressing concern that a mandatory process may trigger confusion among 
both consumers and the international trading partners, by unnecessarily 
hindering global acceptance of products of biotechnology. That said, if 
the market demands confirmation of regulatory status, APHIS has created 
a mechanism for developers to request such confirmation, and for us to 
provide it.
    APHIS also notes that a large number of commenters supported the 
kind of voluntary confirmation process contained in this final rule for 
regulatory exemptions, noting public access to the confirmation 
letters. Those comments noted that a voluntary process would provide 
domestic and international transparency, be beneficial for marketing of 
new products, support deregulation processes in other countries, 
facilitate exports, facilitate the development of new genome edited 
plant varieties, encourage the continued domestic and global adoption 
of new traits, and enhance harmonization of global trait approvals.
    If a plant pest issue arises from a plant that is exempt from these 
regulations, APHIS has mechanisms to address such risks subsequently 
and has a wealth of experience in dealing with such instances. As under 
the current regulations, a developer could knowingly or unknowingly 
violate APHIS regulations by transporting, importing, or releasing into 
the environment a regulated plant without APHIS authorization. The PPA 
contains authority for the Administrator of APHIS at any point to place 
such articles under regulation. If a determination made by a developer 
should be found to be invalid, however, APHIS does have the authority 
to enforce sanctions. As noted in the preamble to the June 2019 
proposed rule, pursuant to sections 7714 and 7731 of the PPA, APHIS may 
seize, quarantine, treat, destroy, or apply other remedial measures to 
an organism covered under the regulations that is new to or not widely 
prevalent or distributed in the United States to prevent dissemination 
of the organism. Enforcement provisions are also included in Sec.  
340.6 of this rule. APHIS has many years of experience in initiating 
and coordinating enforcement action as appropriate, in cases where 
compliance issues exist.
    Even in cases where we would impose penalties for invalid 
determinations by developers, some commenters expressed skepticism that 
those penalties would be efficacious in remediating harm or preventing 
further harm. In the view of these commenters, if the movement or 
release of a GE product that had already reached the market based on a 
faulty determination by a developer resulted in commingling with other 
crops or the dissemination of plant pests, whatever penalties or 
remedial actions APHIS would impose would likely neither prove adequate 
to address injuries to innocent parties nor provide sufficient 
disincentives to discourage bad actors from making invalid 
determinations. Elaborating on the latter point, one commenter stated 
that penalties imposed by APHIS after the fact may not even be legally 
defensible if we have allowed a developer to determine whether its 
product is eligible for exemption. Another commenter stated that APHIS, 
lacking a post-commercialization monitoring program, has little 
capacity to recall the products of invalid determinations by 
developers.
    We do not agree with these comments. In the event that APHIS 
discovers that a developer makes an invalid determination, the specific 
penalties and/or remedial action will be applied case by case, as 
appropriate. Similarly, whether the discovery of an invalid 
determination is too late will also be decided on a case-by-case basis. 
In regard to legal defensibility, the PPA provides ample flexibility 
and broad civil penalty authority to deter violations of the PPA. For 
example, the PPA provides statutory maximum penalties of $1,000,000 per 
violation for any person who willfully violates the PPA.
    Other commenters feared that the penalties could be excessive. It 
was stated that any such penalty applied to a developer must be based 
on a demonstration of significant economic harm to another entity from 
the error, and not on technical or minor errors in interpretation. The 
commenters further stated that in such situations, the penalties must 
be proportional to that harm.
    We agree that penalties must be proportional to the severity of 
violations and the harms that may result from them, and we will enforce 
the regulations accordingly. Furthermore, the harms must fall within 
the harms considered under the PPA. Congress has outlined the factors 
for consideration in assessing penalties under the PPA. These factors 
include ``the nature, circumstance, extent, and gravity of the 
violation or violations,'' as well as the violator's ability to pay, 
the effect of the penalties on the violator's ability to continue to do 
business, and any history of prior violations. (See 7 U.S.C. 7734.)
    In the preamble to the June 2019 proposed rule, we stated that one 
of the benefits of ``self-determination'' is that it would enable APHIS 
to focus its regulatory resources and risk analyses on unfamiliar 
products and thereby to avoid conducting repetitive analyses on GE 
products that are very similar to those that we have already evaluated 
for regulatory status. APHIS would thus be able to utilize its staff 
time more efficiently, and provide better stewardship of taxpayer 
dollars than it could under the existing regulations.
    One commenter viewed allowing developer-made determinations as 
evading APHIS' regulatory responsibilities rather than enabling APHIS 
to use its resources more efficiently. The commenter stated that if GE 
developers are concerned about delays in getting their products to 
market because, in their view, APHIS does not have sufficient resources 
to conduct all reviews in a timely manner, then those developers should 
lobby Congress to provide more funding to enable APHIS to perform its 
duties in a more timely manner, as opposed to having APHIS reduce its 
oversight role.
    APHIS disagrees with this comment. The plants that qualify for 
exemption under part 340 fall into three categories: (1) Those that 
could otherwise have been developed through conventional breeding 
methods and have a history of safe use related to plant pest risk that 
does not require regulation (Sec.  340.1(b)(1) through (3)); (2) those 
that have the same plant-trait-MOA combination as other plants that 
have already been evaluated by APHIS and have been found to be not 
subject to the regulations (Sec.  340.1(c)); or (3) those determined to 
be not subject to the regulations under the AIR process. It should be 
noted that plants that qualify for exemption under Sec.  340.1(c) are 
very similar to plants that have been evaluated previously by APHIS. 
APHIS can utilize its resources most efficiently

[[Page 29801]]

by evaluating GE plants that do not fall into these categories and 
therefore may pose a level of plant pest risk that requires regulation.
    Many other commenters expressed skepticism from an opposing 
perspective about the efficacy of allowing developers to determine 
whether their products are eligible for exemption. These commenters 
doubted that such ``self-determination'' would provide the regulatory 
relief that we claimed in the preamble to the June 2019 proposed rule. 
One reason given was that most developers would seek certification or 
confirmation from APHIS that their determinations were valid, given the 
possible liabilities associated with making incorrect determinations. 
Such certification would therefore become a de facto requirement. One 
commenter expressed the concern that in order to receive such 
confirmation, developers would need to provide the information 
described in proposed Sec.  340.4, which contains information 
requirements for RSRs. It was further suggested that while academics, 
startups, and small developers could see some benefit from ``self-
determination,'' companies with existing portfolios of GE crops will be 
in a better position to benefit.
    We do not agree with these comments. If innovators choose to forgo 
the regulatory relief provisions offered by our revision of the 
regulations in part 340 for any reason, they are welcome to do so. In 
this final rule, APHIS focuses on plant protection, while also easing 
regulatory burdens. Accordingly, we also aim to be responsive to 
repeated concerns raised by small businesses, academic-based 
researchers, and other innovators who have reported past difficulty 
successfully seeing products through to commercialization. The approach 
APHIS has taken is fully consistent with the priorities and direction 
provided by Executive Order 13874, which we have discussed earlier.
    In Sec.  340.1(d) \8\ of the June 2019 proposed rule, we indicated 
that developers may request confirmation from APHIS that the plant is 
not within the scope of the regulations in part 340. A developer may 
find a confirmation letter useful in marketing its products 
domestically or overseas because the letter would serve as verification 
to an importing country or other party that APHIS concurs with the 
developer's determination. Confirmation is not required, however, and 
for developers not seeking confirmation letters, no submission of 
information to APHIS is required, nor is any response from APHIS. 
Guidelines for the information that would need to be submitted to 
enable APHIS to respond to a request for confirmation are discussed 
below under this same subheading of comment responses.
---------------------------------------------------------------------------

    \8\ Due to the addition of a new paragraph (d) in Sec.  340.1, 
as described earlier, provisions related to confirmation letters are 
contained in Sec.  340.1(e) of this final rule.
---------------------------------------------------------------------------

    Some commenters expressed doubt that developers would even be able 
to employ the ``self-determination'' option due to what they perceived 
as a lack of clarity surrounding it. It was stated that decisions on a 
product's regulatory status would be based on APHIS' assessment of 
plant pest risk, but that because APHIS would define plant pest risk 
and because APHIS did not provide a list of traits for identification 
of a plant pest in the proposed rule, a developer would lack the 
guidance to make a determination safely.
    APHIS disagrees with this comment. This rule clearly outlines the 
kinds of information needed to successfully navigate the APHIS 
regulatory system, as well as the protection goals and criteria that 
APHIS will consider as part of this process. Plants that meet the 
exemptions listed under Sec.  340.1 will not require regulatory 
oversight under the regulations in part 340. The exemptions in Sec.  
340.1(b) are based not on the trait, but on whether the plant could 
have otherwise been produced through conventional plant breeding 
techniques. The exemption in Sec.  340.1(c) is based on whether the 
plant-trait-MOA combination is the same as one that APHIS has 
previously determined to be nonregulated. APHIS will publish a list of 
such combinations, which developers may use in determining whether 
their GE plants qualify for exemption under Sec.  340.1(c). As more GE 
plants undergo RSRs to determine their regulatory status, that list 
will grow. A list of traits for identification of a plant pest is not 
needed in order for developers to determine whether their products meet 
one of these exemptions in Sec.  340.1(b) or (c).
    Several commenters recommended that we provide more certainty about 
the process by issuing guidance documents to aid developers in making 
their determinations. Such documents, it was stated, could include, 
among other things, information requirements and timelines, including 
timelines for APHIS responses to requests for confirmation. Many 
commenters stated that, in general, defined timeframes for APHIS 
regulatory actions are important to improve predictability and to 
support the planning needed to conduct seasonally based field research, 
and therefore should be included in the regulations. Most commenters 
who provided specific timeframes for confirmation requests suggested 
that APHIS should respond to such requests within 60 days. It was 
further suggested that to provide developers with additional guidance 
for making determinations, APHIS should maintain a database of products 
that have undergone RSRs and been found not to be subject to the 
regulations.
    APHIS has had a longstanding practice of providing guidance to aid 
the regulated community in complying with the regulations. APHIS will 
provide guidance to developers regarding the confirmation process. We 
will also maintain on our website requests for and results of RSRs. 
That information will aid developers in making their determinations.
    Regarding timeframes, in the preamble to the proposed rule, APHIS 
noted that we anticipate a timely turnaround time in providing 
confirmation letters. APHIS agrees that providing a more specific 
timeframe for responses to confirmation requests would improve 
predictability. Based on our experience with the current AIR process, 
which is functionally similar to the confirmation process, APHIS has 
amended Sec.  340.1(e) by adding a sentence indicating that, except in 
unforeseen circumstances, written responses will be provided within 120 
days of receiving a confirmation request containing sufficient detail 
to determine whether the plant meets one of the exemptions in Sec.  
340.1.
    One commenter stated that the type of information provided to APHIS 
by developers should be a description of the crop and the justification 
for meeting the exclusion, which would be similar to the information 
submitted for the ``Am I Regulated'' Process.
    APHIS agrees with the sentiment expressed in this comment and is 
therefore setting out guidelines for parties requesting confirmations 
to submit to APHIS in support of their requests. The guidelines are 
listed below and will also be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. In addition, 
developers who have specific concerns may consult with APHIS.
    In communications with APHIS requesting confirmation of exemption 
from the regulations, requestors will be expected to submit the 
following:
    1. A description of the plant, trait(s), and modification(s).
    2. A clear statement of which regulatory exemption the 
biotechnology developer is claiming for the plant and

[[Page 29802]]

why the plant qualifies for that exemption.
    3. Details about the scientific method used to validate that the 
plant met the exemption criterion.
    APHIS expects that the description of the plant will include both 
the scientific and common names. The trait information should include a 
description of the intended and any observed phenotype(s) of the plant. 
Details about the modification(s) must provide APHIS with a clear 
understanding of the genetic change in the plant. In the case of Sec.  
340.1(c) exemptions, requestors must submit the MOA.
    Many commenters advocated that we establish a mandatory process for 
developers to notify APHIS of their determinations and for APHIS to 
issue confirmations. (We would note here, however, that there was 
considerable divergence of opinion on this issue, with 25 commenters 
expressing support for maintaining a voluntary confirmation process.) 
Some commenters requested that confirmation be mandatory for all 
determinations made by developers, while others stated that 
confirmation should be mandatory only for developer-made determinations 
of products that will be commercialized. Many requested that the 
process be streamlined and include information and self-reporting 
requirements and timelines. It was recommended by some commenters that 
developers be required to provide notice to APHIS 90 days before 
putting a product on the market.
    We will not be making any changes to this final rule in response to 
these comments. The confirmation process laid out in the June 2019 
proposed rule was voluntary, and switching over to a ``mandatory'' 
confirmation and/or notification process in this final rule would run 
counter to the spirit of regulatory relief underlying our new 
regulatory framework. A voluntary confirmation process allows the 
market to drive the demand for new plants, avoids codifying a process 
that may grow antiquated as technology develops, provides developers 
with a method to obtain confirmation that their products are in fact 
exempt from the regulations, and avoids differential treatment for 
genome-edited products that are otherwise equivalent to conventionally 
bred and/or developed products.
    Commenters did not persuasively explain how developers of products 
that are not subject to the regulations could be compelled to comply 
with a requirement for mandatory participation in a confirmation 
process. APHIS notes that even if the commenters had provided a 
sufficient regulatory mechanism to impose such a requirement, a 
mandatory process would likely trigger the emergence of trade concerns, 
as products that are scientifically justified to be exempt would also 
appear on lists of GE organisms-essentially creating a third category 
of products that are required to be listed but are otherwise exempt 
from regulation (in addition to two other categories: (1) Organisms 
that were subject to RSR and determined not to be regulated by APHIS, 
and (2) regulated organisms). APHIS further notes that a mandatory 
process would likely disadvantage the very small-scale, mid-size, and 
university researchers and innovators that the rule was intended to 
aid. Lastly, APHIS notes that the proposal for a mandatory confirmation 
provides no added benefit in plant protection.
    Some of the commenters who favored a formal or mandatory 
confirmation process did so because they questioned the utility of a 
voluntary process. It was stated that an APHIS confirmation that a 
determination made by a developer is valid, as provided for in the June 
2019 proposed rule, will be a formulaic letter without an accompanying 
risk assessment. Some trading partners may not view such confirmation 
letters as sufficient to meet their own requirements for admission of 
U.S. GE products. It was stated that to keep export markets running 
smoothly, industry needs an official U.S. attestation that the new 
traits do not pose a plant pest risk.
    We do not agree with these comments. The confirmation letters will 
state that the product in question meets a regulatory exemption or has 
a plant-trait-MOA combination that has already been reviewed by APHIS. 
APHIS currently works with, and is committed to continuing to work 
with, international trading partners and exporters to resolve trade 
concerns. International trade issues are discussed in greater detail 
later in this document.
    Some commenters addressed the issue of whether, or how much, 
information pertaining to determinations made by developers and APHIS 
confirmations should be made public. Some commenters, citing the need 
for transparency and certainty, recommended that we post confirmation 
inquiries and confirmation letters on our website. Others, however, 
thought that such information should be treated as confidential 
business information (CBI) and therefore not be made publicly 
available. One commenter suggested that we use a process similar to 
that of the existing ``Am I Regulated'' process, under which CBI 
exemptions could be claimed in the request for confirmation submitted 
to APHIS, and a non-CBI version of the submission could be made 
publicly available.
    In the interest of transparency, APHIS will post the confirmation 
letters online. APHIS notes, however, that confirmation letters are 
subject to claims of CBI and will proceed in implementation of such 
posting in accordance with all applicable laws and procedures. In 
accordance with USDA regulations, 7 CFR 1.8(a) through (c), a submitter 
of confidential commercial information must use good-faith efforts to 
designate, at the time of submission, any portion of its submission 
that it considers to be protected from disclosure under Exemption 4 of 
the Freedom of Information Act (FOIA) (5 U.S.C. 552). When making 
discretionary releases of records, as is the case with the posting of 
the confirmation letters online, APHIS follows the FOIA, USDA, and 
APHIS implementing regulations (7 CFR subpart A and 7 CFR 370.5, 
respectively), and guidance from the U.S. Department of Justice's 
Office of Information Policy relating to the handling of confidential 
business information.
    Finally, there were a few comments on proposed Sec.  340.1 that did 
not fall into any of the categories discussed above.
    One commenter suggested that the exemptions should focus on plant 
species, not variety, as well as the purpose and type of application of 
genome editing. The commenter stated that genome editing can be used 
both to produce or improve on a specific characteristic or phenotype, 
such as by silencing a disease sensitive gene, and to improve existing 
breeding processes themselves, such as by using gene editing to more 
efficiently induce double haploids.
    The ``purpose and type of application of genome editing'' is just 
another way of describing the plant-trait-MOA combination. In the 
example given above where genome editing is used to improve an existing 
breeding process by more efficiently inducing double haploids, genomic 
modifications will be made to a specific plant, with a specific trait, 
having a specific MOA. Recently a widely used haploid inducer in corn 
was identified to be a defective allele (matL) of the gene named 
Matrilineal (Kelleher, 2017). A haploid induction trait was shown to 
work in rice by genome editing the matL allele (Yao, 2018). APHIS 
considers this new process to be an example of a plant (rice), trait 
(haploid induction), MOA (defective pollen specific phospholipase) 
combination. Upon

[[Page 29803]]

completion of an RSR for this plant trait MOA combination, the Sec.  
340.1(c) exemption would apply to all varieties of rice, not just the 
variety it was introduced into.
    Another commenter thought that there was a possible conflict 
between Sec. Sec.  340.1(c) and 340.2(a). The latter paragraph of the 
proposed rule stated that a plant with a plant-trait-MOA combination 
that has not been evaluated by APHIS for regulatory status in 
accordance with Sec.  340.4 would have to move under permit. According 
to the commenter, the conflict arises because products we would allow 
to move without permits based on developers' determinations would not 
have been evaluated by APHIS.
    We do not see such a conflict. When a developer determines that a 
GE plant falls under Sec.  340.1(c), it is not subject to the 
regulations in part 340 and therefore does not require a permit for 
movement. We are making an editorial change to Sec.  340.2(a), however, 
to clarify that a GE plant will be subject to the regulations: (1) If 
it has not undergone an RSR in accordance with Sec.  340.4; or (2) if 
it has undergone an RSR and, as a result of the evaluation, is subject 
to the regulations. Such GE plants will require permits for movement.
    One commenter stated that by allowing developers to determine 
whether their products are eligible for exemption, we would not be in 
compliance with the requirement of the Cartagena Protocol on Biosafety 
that countries list all GE organisms released into the environment in 
the Biosafety Clearing House.
    APHIS notes this comment, and wishes to clarify that the United 
States is not a signatory to the Cartagena Protocol on Biosafety. APHIS 
also notes that Article 3 of the Cartagena Protocol on Biosafety does 
not reference ``GE organisms.'' Instead, Article 3 (g) states that 
``living modified organism means any living organism that possesses a 
novel combination of genetic material obtained through the use of 
modern biotechnology.'' Many international efforts are underway to 
align regulatory approaches and to seek compatibility for emerging 
technologies that were not in existence when existing policies were 
developed.
    Two commenters requested that APHIS develop and issue guidance for 
developers of non-plant GE organisms to give them an opportunity to 
determine for themselves whether their products are subject to the 
regulations and to apply to APHIS for confirmation of regulatory 
status.
    APHIS does not agree that such a new process needs to be developed. 
Currently, the Agency responds to the developers' questions about 
whether a specific GE organism, including a non-plant organism, is 
subject to the regulations. APHIS will continue that practice after 
this final rule becomes effective.

Scope of the Regulations

    Section 340.2 of the June 2019 proposed rule delineated the scope 
of the regulations. We proposed to regulate, i.e., require a permit for 
the movement of, any GE organism that:
    1. Is a plant that has a plant-trait-MOA combination that has not 
been subject to RSR; or
    2. Meets our proposed definition of a plant pest; or
    3. Is not a plant but has received deoxyribonucleic acid (DNA) from 
a plant pest, and the DNA from the donor organism either is capable of 
producing an infectious agent that causes plant disease or encodes a 
compound that is capable of causing plant disease; or
    4. Is a microorganism used to control plant pests or an 
invertebrate predator or parasite (parasitoid) used to control 
invertebrate plant pests and could pose a plant pest risk.
    As was the case with the proposed exemptions, commenters expressed 
a wide range of views regarding the scope of the proposed regulations. 
While some supported our overall approach, others expressed the view 
that the proposed rule would either narrow or broaden our regulatory 
oversight excessively.
    Some commenters who favored a broader scope stated that a 
regulatory approach that provides for regulations of only those GE 
organisms that are plant pests or pose a plant pest risk is too narrow. 
Such an approach, it was stated, isolates the GE organism from the 
environment in which it is used and the process by which it is 
developed, thereby impeding science-based risk assessment. According to 
these commenters, other hazards potentially associated with GE 
organisms and not accounted for in the June 2019 proposed rule need to 
be addressed. Some concepts discussed in these submissions included the 
increased potential for commingling with non-GE crops; the potential 
for contributing to the creation of herbicide-resistant weeds; 
pesticide overuse; habitat destruction; reductions in insect 
populations; and increased herbicide use, which, according to the 
commenters, has been associated with GE crops and may have additional 
deleterious effects on the environment and on human health.
    While we recognize commenters' interests in addressing these 
concerns, many of these comments are outside the scope of this 
rulemaking and APHIS's statutory authority under the PPA. Commingling 
between GE and non-GE crops is generally a market issue unrelated to 
plant pest risk. Herbicide use is regulated by EPA, not USDA, so is not 
within the scope of this regulation. The basis for the commenter's 
claim that GE crops result in habitat destruction is not clear; 
however, we note that APHIS does not regulate farming practices. USDA's 
National Resources Conservation Service does have incentive programs to 
promote more sustainable farming. The current rule includes an RSR 
process that considers, as appropriate, impacts (if any) of a GE crop 
on populations of beneficial insects and other non-target organisms 
beneficial to agriculture.
    Some commenters questioned the scientific justifications for the 
above listed categories of GE organisms that would fall under the 
regulations. It was stated that APHIS needs to re-cast its entire 
proposal and frame it around the identification of the characteristics 
of the organism or phenotypes of concern for which a plausible case can 
be made, based not on speculation but data and experience, that they 
present an unreasonable risk to American agriculture. It was further 
argued that there is no scientific justification for regulating by 
plant-trait-MOA instead of phenotype associated with the trait.
    In order for the regulations under part 340 to enable future 
innovation while simultaneously protecting American agriculture from 
potential risks to plant health, it is vital that the regulations be 
prospective rather than retrospective, while being appropriately 
tailored to risk. A regulation that enumerated specific phenotypes that 
APHIS is concerned with would not only be impractical, since a 
phenotype may be of concern in one plant species but not in another 
(including depending on whether the plant has sexually compatible 
relatives, an attribute important for considering the distribution of a 
phenotype introduced into a plant), but would become immediately 
obsolete upon issuance. As articulated clearly in numerous studies, 
including those by the National Academy of Sciences, no entity has the 
foresight to identify only those phenotypes that present concerns 
decades into the future. Moreover, the MOA utilized by the developer 
matters when determining if there is a plant pest risk. The same 
intended phenotype can result from multiple different MOAs, but each 
MOA may differ in other phenotypes and thus may differ in their ability 
to present a plant pest risk and

[[Page 29804]]

in the types of plant pest risk they may present.
    APHIS thus does not consider the approach of regulating solely by 
phenotype to be feasible. Instead, APHIS has articulated a regulatory 
approach that is adaptable to future innovation and continues to 
protect against risk, even in cases where it is not possible to 
envision the kinds of products being developed in the future. In 
particular, we have developed the RSR process in order to determine, 
based on scientific knowledge and information, if a GE plant contains a 
plant-trait-MOA combination that could plausibly present an increased 
plant pest risk than the appropriate comparator plant(s). We will 
regulate a GE plant only when we identify and are unable to rule out a 
plausible pathway to increased plant pest risk. In this way, when 
sufficient data and experience are lacking to rule out a plausible risk 
identified by APHIS, we have a mechanism to acquire more information to 
test the specific plausible risk hypothesis before decision making.
    The risk-based system APHIS has developed in part 340 appropriately 
provides entrance for genetically engineered organisms into the 
regulatory framework and provides appropriate off-ramps from regulation 
for those products that do not pose plant pest risks. Conversely, a 
narrowly focused characterization of an intended phenotype, regardless 
of the plant species or MOA by which the phenotype is conferred, would 
not provide a sound scientific basis for an entire regulatory program. 
Many commenters expressed support for our scientific and risk-based 
regulatory process that evaluates plants based on their plant-trait-MOA 
combination.
    A commenter stated that the restriction in Sec.  340.2(c) covering 
a non-plant GE organism that has received DNA from a plant pest is 
unclear and lacking in scientific justification. The commenter 
questioned whether receiving DNA from a plant pest would likely make 
the recipient into a plant pest.
    The commenter misconstrues Sec.  340.2(c), which states that non-
plant GE organisms that receive DNA from a plant pest will be regulated 
if that DNA is capable of producing an infectious agent that causes 
plant disease or if the DNA encodes a compound that is capable of 
causing plant disease. Such non-plant GE organisms could pose a plant 
pest risk, justifying their regulation under part 340.
    Some commenters stated that organisms and microorganisms used to 
control plant pests should not require regulation if they are not plant 
pests themselves or do not pose a plant pest risk. One commenter stated 
that there appears to be a conflict between Sec.  340.2(d) and EPA's 
regulatory authority under the Federal Insecticide, Fungicide, and 
Rodenticide Act for microbial pesticides. The commenter further stated 
that the intent of the PPA for biological control organisms is to 
facilitate their development, but that APHIS is proposing to require 
additional regulatory requirements without indicating a need for these 
extra requirements in terms of protecting against plant pests.
    We agree with the first comment (i.e., that organisms and 
microorganisms used to control plant pests should not require 
regulation if they are not plant pests themselves or do not pose a 
plant pest risk), and this rulemaking does not provide for the 
regulation of biological control organisms if they are not plant pests 
themselves or do not pose a plant pest risk. As we noted in the 
preamble to the June 2019 proposed rule, ``GE non-plant organisms that 
do not pose a plant pest risk would not fall under the scope of the 
regulations and therefore would not require permits for movement.'' We 
disagree with the remaining comments. As we noted in the preamble to 
the proposed rule, while biological control organisms are generally not 
plant pests, some biological control organisms could be plant pests 
because their potential effects on organisms beneficial to agriculture 
could indirectly affect plant health. The PPA provides the authority to 
regulate such biological control organisms used to control plant pests 
to ensure that they do not pose a plant pest risk. As with non-GE 
biological control organisms, the types of GE biological control 
organisms that APHIS would regulate include organisms that could pose a 
plant pest risk by lacking sufficient specificity for the target pest 
and thereby harming beneficial non-target organisms, such as other 
invertebrate predators or parasites (parasitoids), pollinators, or 
microbes that promote plant health. Because biological control 
organisms are almost always intended for eventual release into the 
environment, it is not sufficient for us to consider only their use in 
controlling their target plant pest. We must also take into 
consideration the indirect plant pest risks that the organism may pose 
due to harmful impacts on non-target organisms that are beneficial to 
agriculture (e.g., harm to natural enemies of plant pests). If the GE 
organism is known to have harmful impacts on beneficial non-target 
organisms, it is consistent with APHIS' authority under the PPA to 
prohibit or restrict its release. To the extent that we do not know 
whether a GE biological control organism is sufficiently specific to 
avoid harming beneficial non-target organisms, it is also prudent for 
us to place regulatory controls on the movement and release of the GE 
biological control organism until the impacts on beneficial non-target 
organisms and any resulting direct or indirect plant pest effects are 
better understood. In addition, we will exempt biological control 
organism-containing microbial pesticide products that are currently 
registered with EPA as microbial pesticide products that are not plant 
pests.

Definitions

    In this final rule, we have revised the definition of article to 
provide greater clarity. The definition in the June 2019 proposed rule 
was drawn from that provided in the PPA. However, while the PPA 
indicates that an article may be an object that could harbor noxious 
weeds, upon review of the provisions of the proposed rule, we have 
determined that it is not appropriate to consider such an object an 
article under these revised part 340 regulations. The proposed 
definition could have been interpreted to suggest that APHIS intends to 
regulate GE organisms, and require permits for their movement, under 
the revised regulations based solely on their noxious weed potential. 
As discussed elsewhere in this document, however, this is inconsistent 
with APHIS' intent. The revised definition reads as follows: ``[a]ny 
material or tangible object that could harbor plant pests.''
    A commenter stated that we need to define environment, because 
movement under permit includes release into the environment. 
Environment was defined in the proposed rule, however, and we are 
retaining that definition in this final rule.
    In the June 2019 proposed rule, we defined environment as ``[a]ll 
the land, air, and water; and all living organisms in association with 
land, air, and water.'' We are retaining that proposed definition 
without modification in this final rule.
    Numerous commenters stated that the proposed definition of genetic 
engineering requires greater clarity. Several commenters asked APHIS to 
clarify that ``synthetic'' nucleic acids, for the purposes of this 
regulation, are those that are non-naturally occurring. Some commenters 
requested that APHIS clarify what is meant by both ``recombinant'' and 
``synthetic'' nucleic

[[Page 29805]]

acids and cited the definitions and exemptions in the National 
Institutes of Health (NIH) Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules'' (https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf). One commenter 
stated that they understood the term ``synthetic nucleic acid'' to 
refer to a sequence that was created ``new from scratch,'' and not to a 
plant's nucleic acid sequence that was modified.
    APHIS does not agree that the term ``recombinant'' requires further 
definition in these regulations. After nearly half a century of 
research and development involving recombinant nucleic acids, the term 
``recombinant nucleic acids'' is well understood. The definition that 
APHIS proposed was based on the definition of ``recombinant and 
synthetic nucleic acids'' contained in Section I-B of the NIH 
Guidelines. Accordingly, by ``synthetic'' nucleic acids we mean nucleic 
acids that are chemically or by other means synthesized or amplified, 
including those that are chemically or otherwise modified but can base 
pair with naturally occurring nucleic acid molecules. Such nucleic 
acids are not limited to those that are non-naturally occurring. They 
could also include nucleic acids with sequences identical to those that 
are naturally occurring, but which have been synthesized or amplified, 
rather than constructed by joining nucleic acid molecules (nucleic 
acids that have been so constructed are recombinant nucleic acids). 
APHIS agrees that greater clarity regarding the term ``synthetic'' 
would provide developers and other stakeholders with a clearer picture 
of the products that are included within the scope of the regulations. 
Therefore, we are changing the definition of ``genetic engineering'' to 
``techniques that use recombinant, synthesized, or amplified nucleic 
acids to modify or create a genome.'' This change is consistent with 
the objectives of the Coordinated Framework, in that it aligns our 
usage of the term ``synthetic'' with that of the NIH.
    One commenter believes that the definition for genetic engineering 
should include changes to the epigenome.
    APHIS does not agree. Epigenetic changes are caused by endogenous 
regulatory processes, such as DNA methylation and histone modifications 
through naturally occurring enzymes. Epigenetic changes are also caused 
by small naturally occurring RNA molecules. Epigenetic changes reflect 
an interaction of the genome with the environment that leads to changes 
in gene expression without changing the sequence of DNA. Epigenetic 
engineering differs from genetic engineering in that the former merely 
adjusts the innate potential of the genome of an existing organism, 
whereas genetic engineering has the potential to create organisms that 
could not exist but for the technology.
    Some commenters recommended that we add a definition of genetically 
engineered organism to provide greater clarity relating to which 
organisms would be regulated. The following language was a suggested 
definition: ``An organism developed using genetic engineering, 
excluding those offspring that do not retain the genetic modification 
of the parent. For the purposes of this part, a plant will not be 
considered a genetically engineered organism if it meets any of the 
criteria outlined in Sec.  340.1(b)(1)(3).''
    We do not agree with this comment. At the forefront, the SECURE 
rule establishes clear exemptions for products that are not subject to 
regulatory oversight under part 340, and, thereafter, sets forth 
definitions for genetic engineering and for organism. Although we are 
able to offer regulatory relief in part 340 by excluding those products 
of biotechnology that mimic what can be achieved though plant breeding, 
APHIS has not, in this rulemaking or prior rulemakings involving part 
340, taken the position that genome editing does not constitute genetic 
engineering. Taking such a position would be inconsistent with the 
generally accepted scientific characterization of genome editing 
technology (Knott and Doudna, 2018). While some commenters have asked 
APHIS to revisit its proposed definition of ``genetically engineered 
organism'' from the 2017 proposed rule involving part 340, even in that 
rulemaking APHIS did not take the position that genome editing was 
outside the scope of genetic engineering. Instead, APHIS explained it 
was defining ``genetically engineered organism'' for the purpose of 
establishing regulatory exemptions from part 340, including exemptions 
for certain organisms created using techniques that fall within the 
scope of genetic engineering, as follows: APHIS ``would also exclude, 
from its definition of GE organism, certain organisms that are created 
using techniques that fall within the scope of genetic engineering, but 
that could otherwise have been produced using traditional breeding 
techniques . . . .'' (82 FR pp.7008 and 7015, January 19, 2017). As 
discussed above, the SECURE rule establishes regulatory exemptions at 
the forefront, which promotes clarity regarding the scope of part 340, 
and avoids adopting a confusing characterization of techniques of 
biotechnology.
    A couple of commenters stated that the proposed rule lacked a 
definition of natural gene pool and a discussion of its relevance in 
terms of safety.
    The term was used in the regulatory text in Sec.  340.1(b)(3). As 
discussed above, we have removed ``natural'' from that paragraph. We 
discussed the relevance of exemption under paragraph (b)(3) to plant 
pest risk above. We are, however, adding a definition of the term gene 
pool to the regulations in this final rule in response to these 
comments. Gene pool is defined as germplasm within which sexual 
recombination is possible as a result of hybridization, including via 
methods such as embryo culture or bridging crosses.
    One commenter viewed our proposed definition of person as 
potentially problematic in that it could open APHIS to legal 
challenges. The commenter expressed concern that because the definition 
includes not only individuals, business entities, and associations but 
also any other ``organized group,'' the argument could be made that 
APHIS falls under the definition. If so, according to the commenter, 
there might be the possibility of a conflict if decisions under these 
regulations are taken by the Administrator of APHIS. The commenter 
requested clarification on this issue.
    The definition of person would apply to individuals or entities 
regulated by APHIS, including APHIS. Under the law, a company is an 
entity that is recognized as a legal person that exists independently, 
with rights and liabilities. APHIS has, in the past, issued itself 
permits in conjunction with enforcement of the regulations so that 
plant products could move legally across state lines. This practice is 
not inconsistent with the PPA or with the prior or new regulations. 
Therefore, regulation by APHIS under part 340 will not create conflict 
or otherwise be adversely impacted.
    A commenter stated that the proposed definition of plant pest is 
too broad and could be construed to cover model organisms, such as 
Drosophila melanogaster, that do not have significant negative effects 
on agriculture. The commenter stated that an overly broad definition is 
of concern to biomedical researchers because some invertebrates they 
use could be classified as plant pests. Noting the lack of a mechanism 
to acknowledge that an organism that consumes plant material is not 
detrimental to agriculture, the commenter recommended that APHIS 
establish a mechanism for classifying an

[[Page 29806]]

organism as ``agriculturally unimportant within the plant pest 
category'' and that such a classification have influence on APHIS' 
regulatory processes.
    APHIS appreciates the comment, but does not believe that it is 
necessary for APHIS to establish such a mechanism. The definition of 
plant pest is based directly on, and does not exceed, the definition of 
the term in the PPA. The proposed regulations contained an exemption 
from the requirement for permit for interstate movement for Arabidopsis 
thaliana. In this final rule, we are adding an exemption from some 
permitting requirements for GE Drosophila melanogaster, which we will 
discuss in more detail below, under the subheading ``Permits.''
    Another commenter stated that by adopting a definition of plant 
pest that aligns with the definition provided in the PPA, APHIS would 
regulate a broad range of GE animals, including those used in medical 
research, thereby imposing large, new, and unwarranted regulatory 
burdens on researchers in medical research and other fields.
    APHIS disagrees with the comment. As we stated in the preamble to 
the proposed rule, while the PPA gives APHIS authority to regulate any 
nonhuman animal as a plant pest, it is longstanding APHIS policy not to 
regulate vertebrate animals as plant pests. In the absence of such a 
policy, all herbivores and omnivores could be considered plant pests, 
and thus subject to regulation, an untenable position since this would 
require APHIS to consider livestock, such as cows, sheep, and horses, 
as well as many laboratory research animals, to be plant pests.
    In the June 2019 proposed rule, we defined plant pest risk as 
``[t]he possibility of harm to plants resulting from introducing or 
disseminating a plant pest or exacerbating the impact of a plant 
pest.'' Many commenters viewed the proposed definition as vague and 
potentially problematic due to the terminology we used.
    Commenters expressed concern that the words ``possibility of'' in 
the proposed definition are vague and uncharacteristic of standard risk 
assessment terminology and methodology, which characterizes risk as 
either a likely or probable adverse outcome. Some commenters requested 
that the definition of plant pest risk be defined in terms of the 
likelihood and magnitude of harm. Commenters also expressed concern 
that the word ``harm'' in the proposed definition is inconsistent with 
the PPA, and that the regulatory end-point should be risk of causing 
injury to, damage to, or disease in any plant or plant product. It was 
stated that the inconsistency and lack of precision in the terminology 
used in the proposed definition could leave risk-based decisions made 
by APHIS open to criticism or challenge for not addressing all 
possibilities for harm, no matter how unlikely.
    APHIS agrees with the commenters that greater clarity and 
consistency in the definition of plant pest risk would be useful. APHIS 
is revising the definition accordingly. We agree that the words 
``possibility of'' could be construed in a manner that is 
inappropriate. Numerous scenarios could be put forward as the basis for 
events that represent the ``possibility'' of harm without any plausible 
basis for concluding that such scenarios have any likelihood of 
occurring. The glossary of the Society for Risk Analysis (SRA), which 
is available at https://www.sra.org/sites/default/files/pdf/SRA_glossary_20150622.pdf, defines risk as, among other things, ``the 
potential for realization of unwanted, negative consequences of an 
event.'' The SRA glossary makes clear the distinction between the 
qualitative definition of risk and the metrics that are used to measure 
or characterize risk, which are framed in terms of likelihood and 
magnitude of an adverse outcome. We view a qualitative definition as 
more appropriate for defining risk, and use likelihood and consequence 
to evaluate scientifically plausible risks identified in the RSR 
process discussed below under the subheading ``Regulatory Status 
Review.'' We also find the SRA terminology to be more useful than 
``possibility of'' and are revising our definition of plant pest risk 
accordingly. We are also revising the definition to refer to injury to, 
damage to, or disease in any plant or plant product. Accordingly, this 
final rule defines plant pest risk as ``[t]he potential for direct or 
indirect injury to, damage to, or disease in any plant or plant product 
resulting from introducing or disseminating a plant pest, or the 
potential for exacerbating the impact of a plant pest.''
    Importantly, while APHIS defines plant pest risk in this rule in 
reference to the potential for direct or indirect injury, damage, or 
disease, the RSR process itself is based on standard risk assessment 
practices and uses a methodology that focuses on a likelihood and 
magnitude assessment of plausible risks. Since the RSR process will 
require that a plausible risk be identified in order to proceed with 
further risk assessment, it will not be an open-ended evaluation of any 
conceivably ``possible'' scenario that could be imagined.
    One commenter stated that the term plant-trait-MOA is not defined 
as a combination, though the individual terms are defined in the 
proposed rule, and that if the combination has its own meaning, APHIS 
should clarify that.
    The term plant-trait-MOA refers to three individual terms/factors 
for analyzing whether certain GE organisms may present a plausible 
pathway to plant pest risk and by which we determine whether a product 
actually poses a plant pest risk.
    Under the definition of responsible person in the June 2019 
proposed rule, responsibility for maintaining control over a GE 
organism under permit during its movement and assuring compliance with 
all permitting conditions could be given to an individual or an 
institution. A commenter stated that individuals should not be included 
under the definition. According to the commenter, responsibility should 
reside only with the institution with which the signatory or any other 
individual bearing such responsibility is affiliated. The commenter 
pointed out that staff often move among jobs well before permit 
conditions are fulfilled.
    As discussed in the preamble to the June 2019 proposed rule, 
attributing responsibility for a GE organism moved under permit to only 
an institution may be problematic for enforcement of the regulations, 
because such responsibility can be diffused, resulting in no 
individual's being held responsible for compliance with the permit 
conditions, the regulations in part 340, and the PPA. Our definition 
ensures that for each permit, there is a single individual who is 
responsible for ensuring an institution's compliance with permit 
conditions, regulatory requirements, and the PPA. If this individual 
moves to a different job or otherwise leaves an institution, 
responsibility for any permits can be officially transferred, subject 
to APHIS' approval, to another qualified individual, as described in 
Sec.  340.5(i)(10) of this final rule (``permit conditions'').
    A commenter stated that there is no justification for the 
requirement, contained in the proposed definitions of both agent and 
responsible person, that they be legal U.S. residents, and that there 
is no means of verifying such a requirement.
    We are retaining the requirement, as it would be a stronger 
mechanism for ensuring accountability in the regulatory program than 
the existing definition. We have learned through administration of the 
program that the existing definition is not adequate, and has not 
provided the necessary framework to hold noncompliant

[[Page 29807]]

developers responsible (e.g., academic researchers who returned to 
their native countries without taking steps to destroy their GE-test 
material prior to departure).
    Finally, we have revised the definition of State to read as 
follows: ``[a]ny of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the 
United States, or any other territories or possessions of the United 
States.'' This definition aligns with that contained in the PPA.
Regulatory Status Review
    Section 340.4 of the June 2019 proposed rule set out the RSR 
process, under which developers may request that APHIS evaluate their 
novel plants and determine whether or not they fall within the scope of 
the regulations, i.e., under one or more of the categories in Sec.  
340.2. The section contained requirements for submitting requests for 
reviews and re-reviews, including supporting information; listed the 
factors that APHIS would consider in the course of its reviews; 
described the review process; and provided for public notice of RSR 
determinations. Commenters addressed all these topics.
    As noted in the preamble to the June 2019 proposed rule, the RSR 
process applies only to GE plants. APHIS specifically solicited 
comments on whether the scope of the RSR should be expanded to include 
non-plant GE organisms as well as GE plants, whether some equivalent 
process for evaluating such organisms for regulatory status should be 
developed instead, and, if so, what factors APHIS should consider in 
its analyses.
    Several commenters did request that APHIS develop a process to 
evaluate the regulatory status of non-plant GE organisms, based on the 
subject organism's potential plant pest risk; however, the commenters 
did not provide specifics on what factors APHIS should consider in its 
analyses. APHIS believes that further discussion and outreach with 
impacted developers and other stakeholders on this issue is required 
before pursuing rulemaking.
    We received several comments pertaining to the re-review process. 
Some commenters stressed the need to consider whether our requirements 
adequately address the risk of requests for spurious reviews. Noting 
that we proposed to require that any request for a re-review be 
supported by ``new, scientifically valid evidence bearing on plant pest 
risk,'' commenters urged us to clarify what we mean by ``scientifically 
valid evidence'' in order to ensure that trivial evidence or 
conjecture, or publications in non-credible online ``scientific'' 
journals, cannot form the basis of a request. Clarification was also 
requested as to whether re-reviews can be initiated for all products 
for which RSRs have been completed or only for those found after an 
initial RSR to be subject to the part 340 regulations. One commenter 
stated that in cases of re-reviews initiated by APHIS, APHIS needed to 
provide for due process by allowing developers adequate time to 
respond.
    APHIS agrees that requests for re-review must be based on 
``scientifically valid evidence'' that relates to plant pest risk. 
APHIS has experience dealing with such requests and will conduct an 
objective analysis of re-review requests to determine whether re-
reviews are warranted. A valid re-review request would apply only to 
those GE plants or plant products that were previously found to be 
subject to the regulations after an initial RSR was conducted.
    In the June 2019 proposed rule, Sec.  340.4(a)(4) specified 
information requirements for persons submitting a request for APHIS to 
conduct an RSR of a GE plant and stated that additional guidance on how 
to meet the requirements would be found on the APHIS website. A few 
commenters requested that APHIS either (1) incorporate the additional 
guidance into the regulations; (2) commit not to change the guidance 
without public notice and comment procedures; or (3) make clear that 
the additional guidance is non-binding because any changes made to it 
would not otherwise be subject to formal notice and comment.
    After reviewing these comments, APHIS has decided to pursue the 
second of the three recommended options. When APHIS seeks to make a 
substantive change to the information provided on our website, we will 
indicate the proposed change, provide an explanation for it, and take 
public comment on it. We will then review the comments and make a 
determination as to whether to implement the change. In this final 
rule, we are revising Sec.  340.4 to incorporate the notice-and-comment 
process. The revised Sec.  340.4 also uses the term ``detailed 
information'' rather than ``guidance,'' which was used in the proposed 
rule. We are making this change, which we have placed in a new 
paragraph (a)(4)(iv), to clarify that in order to satisfy the broad 
requirements contained in the regulations for information on the 
comparator plant(s), the genotype of the modified plant, and the new 
trait(s) of the modified plant, the developer must provide the detailed 
information indicated on the website. We anticipate that this change 
will provide more consistency and predictability regarding information 
requirements than would have been afforded by the June 2019 proposed 
rule. Such predictability is important for ensuring that developers can 
adequately comply with the regulations and can plan their product 
development activities accordingly.
    A number of commenters expressed concerns about specific details of 
how to meet the detailed information requirements for the RSR process 
that will be maintained on APHIS website. Some commenters were 
concerned that the requirement for information on the genotype of the 
modified plant was unclear and could be interpreted as requiring 
sequence information comparing the entire genome of the modified plant 
with that of the unmodified plant. Commenters stated that sequence 
information should be limited to sequence information for the specific 
genetic modification(s) in the plant. One commenter noted that some 
gene-edited products could have had genetic material inserted during 
development that was subsequently segregated away, and that we could 
clarify that the whole genome sequence information is not required by 
specifying that the required sequence information pertains to the 
targeted modified sequence.
    APHIS agrees with these comments. It was not our intent to request 
whole genome sequence information. Rather, we are requesting sequence 
information on the specific targeted genetic modification(s) in the 
plant. We have revised the information that will be published on the 
APHIS website to clarify the sequence information that must be 
provided.
    Some commenters stated that sequence information is not needed to 
determine whether a GE plant poses a plant pest risk, as long as 
developers provide the type of modification and describe the genotype 
by providing information on the insertion, deletion, and/or expressed 
gene product, and that if sequence information is required, it should 
be limited only to sequences that confer the trait(s) and should 
exclude vector sequences that are not in the final plant.
    APHIS largely disagrees with these comments. The specified sequence 
information is needed by APHIS in order to confirm the intended 
trait(s) at the molecular/genetic level; to understand the MOA for 
purposes of assessing the plant pest impact(s), if any, of the 
modification(s); and to assess similarity with previously reviewed GE

[[Page 29808]]

plants. For inserted genetic material, APHIS requires the sequence of 
the entire insert for molecular characterization. All genetic elements 
integrated into the plant genome need to be described; therefore, 
vector sequence information is not required if vector sequences are not 
inserted. For genome editing, the sequence of the entire edited gene or 
functional motif of a regulatory region (e.g., a transcription factor 
binding site in a promoter region) is required to understand the 
targeted sequence modification(s). The characteristics imparted by 
inserted or edited regulatory sequences (such as expression levels, 
patterns, and timing) are necessary to verify the full extent of the 
engineered genetic changes as part of understanding the plant pest risk 
associated with the modification(s).
    Commenters raised concerns about how to meet the information 
requirements concerning the MOA. One commenter stated that while there 
may be information on a specific gene product, the precise mechanism of 
action may not be elucidated.
    APHIS recognizes that the MOA may not always be well characterized. 
As we indicated in the preamble to the June 2019 proposed rule, we are 
requiring information on the MOA to the extent that it is known. We 
have revised the detailed information provided on the APHIS website to 
clarify this point.
    Other commenters stated that certain information categories appear 
to exceed what APHIS has historically asked for when reviewing 
petitions for nonregulated status under the current regulations, and 
that RSR information requirements should align with the information 
APHIS has required previously, should not increase a developer's data 
submission burden, and should be sufficiently flexible to accommodate 
the nature of the particular product being evaluated. A commenter 
stated that gene expression data are unnecessary in many cases and that 
APHIS should clarify when such data would be required, such as when the 
intent is to change the expression pattern of a gene. Another commenter 
stated that information on the production, creation, or enhancement of 
a reservoir for a plant pest goes beyond the type of information 
currently submitted by developers in support of petitions for 
nonregulated status.
    APHIS largely disagrees with these comments but recognizes that the 
preamble to the June 2019 proposed rule lacked sufficient clarity 
regarding information requirements that apply at various stages of the 
RSR process. The information developers must submit, as specified in 
Sec.  340.4(a) of this final rule and on the APHIS website, generally 
aligns with information APHIS has been seeking previously, will reduce 
rather than increase a developer's data submission burden, and is 
intended to be sufficiently flexible to accommodate the nature of the 
plant being evaluated. Under the petition process, developers have had 
to submit data and information regarding a broad range of possible 
harms for evaluation by APHIS, regardless of whether the plant could 
plausibly pose a plant pest risk. The RSR process differs from the 
petition process in that APHIS is requesting much less information for 
the initial review, with no requirement for laboratory or field-test 
data. If APHIS is unable to identify a plausible pathway by which the 
GE plant could pose an increased plant pest risk in the initial review, 
developers will not be required to submit any additional information to 
APHIS. When there is a plausible pathway to plant pest risk identified, 
developers will receive feedback about the type(s) of information that 
APHIS would need to assess the identified plausible pathway and 
complete a plant pest risk assessment. This information could include 
field-test data, gene expression data, or other data relevant to 
assessing whether the GE plant could have increased importance as a 
host for plant pests. The preamble to the proposed rule discussed some 
of the types of information that might be required in this situation, 
but incorrectly made it appear as if this information would be required 
for all initial reviews. We now clarify that such information could be 
submitted during the initial review stage, but that any such submission 
would be optional. To clarify that additional data would be requested 
on the basis of identified plausible pathways to plant pest risk, APHIS 
has added the following language to the existing text in Sec.  
340.4(b)(3)(i): ``APHIS may request additional information as needed to 
evaluate the factor(s) of concern.'' We are revising the detailed 
information that will be published on the APHIS website to make this 
distinction clear.
    One commenter found it difficult to understand how plant-trait-MOA 
could be adequately evaluated without field trials.
    Data from field trials do not provide information about the plant-
trait-MOA. As we noted in the preamble to the proposed rule, APHIS' 
experience in preparing risk assessments in accordance with the 
petition process indicates that field trial data are generally not 
necessary unless they address an identifiable plausible pathway to 
plant pest risk. The introduced trait and MOA provide the most reliable 
indicators of the organism's potential for plant pest risk. As we also 
noted in the June 2019 preamble, our conclusions are consistent with 
findings of reports of NAS.7 8
---------------------------------------------------------------------------

    \7\ National Research Council (NRC) 1989. Field Testing 
Genetically Modified Organisms: Framework for Decisions. Washington, 
DC. National Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
    \8\ National Academies of Sciences, Engineering, and Medicine 
(NAS) 2016. Genetically Engineered Crops: Experiences and Prospects. 
Washington, DC: National Academy Press. 420 pp. doi: 10.17226/23395. 
Retrieved from http://www.nap.edu/23395.
---------------------------------------------------------------------------

    By having an understanding of the biology and any existing impacts 
of the plant, the genetic trait to be inserted into the plant, and the 
MOA, APHIS is able to conduct a review based upon a large body of 
scientific publications, as well as APHIS' knowledge and experience. 
Information from field tests would be unnecessary, in most cases, for a 
determination of regulatory status under these regulations. 
Accordingly, field test information would not be a generally applicable 
requirement for the initial RSR and would be requested only as needed 
when further analysis is required. This approach would not preclude 
developers from providing information from field tests that they 
consider pertinent to our analysis. For example, if a developer 
requested a reevaluation of a GE plant that APHIS had previously 
considered to be subject to regulation, field test information 
demonstrating a lack of plant pest risk could be provided in support of 
that request. Nor would the provisions preclude APHIS from asking for 
field test information if APHIS considers it necessary in order to 
conclude review of a particular request.
    The revised detailed information requirements that will appear on 
the APHIS website are listed below.
    1. A description of the comparator plant(s), to include common 
name(s), genus, species, and any relevant subspecies information that 
would distinguish the plant.
    2. The genotype of the modified plant, including a detailed 
description of the differences in genotype between the modified and 
unmodified plant, specifically:
    a. If genetic material is inserted into the genome, provide 
information on all inserted genetic material, including:
    i. For genetic sequences, the name of the sequence, the donor 
organism(s) or source, the function of the sequence, the nucleotide 
sequence, and if applicable, the publicly available sequence 
identification, protein accession

[[Page 29809]]

number, and enzyme commission number. If inserted genetic sequences 
have been modified (e.g., codon usage efficiency, gene shuffling), a 
statement regarding the nature and purpose of the modification, and 
identification of the modifications by submitting an alignment of the 
modified sequence with the unmodified sequence.
    ii. For regulatory sequences, the function of each regulatory 
sequence as it relates to the gene sequence and the donor organism(s) 
or source of each regulatory sequence. Identify promoters as 
constitutive, inducible, developmental, or tissue specific. If 
developmental/tissue specific, describe the stage(s)/tissue(s) at/in 
which the promotor is intended to be active.
    b. If genetic material is not inserted into, or was inserted and is 
no longer present in, the genome, and the genome is modified in a way 
that does not fall under the exemptions in Sec.  340.1(b), provide:
    i. The nature of the modification(s) and the gene(s) and 
function(s) being modified;
    ii. For substituted based pairs, the number of substitutions;
    iii. The original unmodified sequence aligned to the targeted 
modified sequence.
    3. A detailed description of the new trait(s) of the modified 
plant, including:
    a. The purpose and intended phenotype of the new trait and 
available information on the MOA by which the intended trait is 
conferred;
    b. Any expected changes in metabolism, physiology, and development 
due to the trait/genetic modification, to the extent known;
    c. Optional: Any additional experimental data, publications, and 
other science-based assessments that may be helpful for APHIS' 
evaluation of the potential of the plant to pose plant pest risks. Such 
information could include, to the extent that it is known, information 
about any new enzymes or other gene products produced; where, when, and 
at what level the introduced or modified genetic material is expressed 
in the plant; the biochemical action of the genetic material or its 
product; and how the genetic material or its product participates in or 
interacts with metabolic, physiological, or developmental processes in 
the engineered plant or in other organisms. (APHIS does not intend to 
require submitters to generate experimental data specifically for an 
RSR. However, if a submitter is aware of information or experimental 
data in the public domain that may support our assessment, the 
submitter may include the data.)
    The June 2019 proposed rule specified, in Sec.  340.4(b)(1)(i) 
through (iii), the factors that APHIS would consider when conducting an 
initial review of the plant pest risk posed by the GE plant and any 
sexually compatible relatives that could acquire the engineered trait, 
relative to that posed by their respective non-GE or other appropriate 
comparator(s). To provide context for the discussion that follows, we 
are listing those factors below, as they appeared in the proposed rule.
    1. The biology of the comparator plant(s) and its sexually 
compatible relatives;
    2. The trait and mechanism-of-action of the modification(s); and
    3. The effect of the trait and mechanism-of-action on:
    a. The distribution, density, or development of the plant and its 
sexually compatible relatives;
    b. The production, creation, or enhancement of a plant pest or a 
reservoir for a plant pest;
    c. Harm to non-target organisms beneficial to agriculture; and
    d. The weedy impacts of the plant and its sexually compatible 
relatives.
    Commenters had concerns and questions about some of the factors. 
One commenter stated that APHIS should clarify that a comparator could 
be a GE plant, even though Codex Food Safety Guidelines do not allow a 
GE crop to be a comparator, because the majority of certain crops, such 
as corn and soybean, are already GE.
    APHIS agrees that in some circumstances a GE plant could be an 
appropriate comparator for the purpose of evaluating plant pest risk, 
and notes that the Codex Guidelines address food safety and do not 
address plant pest risk. Typically, a comparator plant is the non-GE 
plant from which the GE plant is derived. In some cases it may be 
appropriate to use another GE variety of the plant as a comparator. 
This could occur if, for example, a developer is using genetic 
engineering to add a new trait to an existing GE plant. To date, APHIS 
has not generally seen the use of a GE plant as a comparator, but this 
could change in the future as products of genetic engineering become 
more complex.
    One commenter requested that APHIS define how it intends to 
determine ``distribution, density, or development of the plant and its 
sexually compatible relatives and weediness across plant types.'' 
Another suggested that we add a definition of weediness because it is 
mentioned in the context of the RSR.
    APHIS is making no changes to the rule in response to these 
comments. The plant pest risk assessment framework document that 
accompanied the proposed rule described how the distribution (including 
density) of the GE plant and its sexually compatible relatives can be 
predicted by the biological properties of the plant compared with the 
known distribution and properties of the comparator(s), in the context 
of the receiving environment. The development of the GE plant and its 
sexually compatible relatives can similarly be predicted. Assessment of 
these factors is important for determining whether the GE trait(s) 
could increase the prevalence or alter the distribution of the plant or 
its sexually compatible relative(s) in such a way that they could have 
increased importance as hosts for plant pests. It is also important to 
point out that consideration of weediness in this manner has long been 
a part of the plant pest risk assessments conducted in response to 
petitions for nonregulated status since the 1990s, under the 
regulations that we are replacing in this final rule. This final rule 
does not change this analysis, and does not expand the scope of APHIS' 
consideration of weediness in evaluating plant pest risks as compared 
with the scope of consideration that was present in APHIS' exercise of 
its authority under the regulations that we are replacing.
    Some commenters had concerns about the factor ``harm to non-target 
organisms beneficial to agriculture,'' and asked us to shift our focus 
to adverse effect on trophic functional groups beneficial to 
agriculture and to articulate a scientific rationale as to how a plant, 
whether GE or not, could pose a plant pest risk on the basis of its 
potentially harming an insect predator or pollinator.
    Beneficial organisms such as predators and pollinators fall 
squarely under APHIS' authority because predators and pollinators are 
essential to plant health, and harm to these organisms may result in 
greater injury or damage to plants. APHIS analyses are based on whether 
a GE trait introduced into a plant will had adverse impacts on non-
target organisms beneficial to agriculture. Non-target organisms 
beneficial to agriculture encompass a broad range of organisms that 
provide ecosystem services. Focusing on certain trophic guilds is not 
adequate to address all aspects of plant pest risk to non-target 
organisms beneficial to agriculture. For example, some GE traits may 
have greater effects on closely related groups of insects, regardless 
of the trophic guild of members of that group. Focusing on trophic 
levels may also expand the scope to impacts

[[Page 29810]]

outside of agriculture. When there is a scientifically plausible link 
to harm to non-target organisms beneficial to agriculture, the 
information needed for a plant pest risk analysis would be determined 
on a case-by-case basis, accounting for the particular biology of the 
GE plant, the MOA of the GE trait, and the environment.
    In addition to listing the factors discussed above, proposed Sec.  
340.4(b) set out the components of the RSR process, including making 
determinations and providing public notice of such determinations. 
Proposed paragraph (b)(1) stated that when APHIS receives a request for 
an RSR, APHIS will conduct an initial review of the potential plant 
pest risk posed by the GE plant and any sexually compatible relatives 
that could acquire the engineered trait, relative to the plant pest 
risk posed by their respective non-GE or other appropriate 
comparator(s), based on the factors discussed above. Proposed paragraph 
(b)(2) stated that if APHIS is unable to identify potential plant pest 
risks in the initial review, the GE plant will not be subject to the 
regulations. Proposed paragraph (b)(3)(i) stated that if APHIS does 
identify potential plant pest risks in the initial review, APHIS will 
conduct an evaluation of the factor(s) of concern to determine the 
likelihood and consequence of the potential plant pest risk posed by 
the GE plant. Proposed paragraph (b)(3)(iii) stated that if the GE 
plant is found unlikely to pose a plant pest risk and, therefore, not 
to require regulation under part 340, then APHIS will post the finding 
on its website. Proposed paragraph (b)(3)(iv) stated that if APHIS is 
unable to find the GE plant unlikely to pose a pest risk, then the 
plant will require regulation, and its movement will be allowed only 
under permit in accordance with Sec.  340.5.
    Commenters expressed numerous concerns about this process as we 
described it in the proposed rule. Some thought that we provided 
insufficient detail, especially concerning the distinction between the 
initial review and the additional evaluation that some GE plants would 
need to undergo. Others took issue with some of the terminology that we 
used, stating that it lacked clarity and could lead to confusion about 
our regulatory focus and decision making process. Numerous commenters 
proposed alternative language, in some cases arguing that their 
proposed alternatives were more consistent with standard risk 
assessment terminology and the PPA than what we had proposed. 
Commenters also stated that in order for regulation to be appropriately 
calibrated with actual risk, our decision-making criteria should 
incorporate the concept that the plant pest risk posed by the GE plant 
should be greater than that posed by the plant from which it was 
derived.
    APHIS agrees with many of these comments. In this final rule, we 
have amended Sec.  340.4(b) to provide additional detail and clarity 
and to incorporate the concept that in order for regulation to be 
appropriate, the plant pest risk posed by the GE plant or its sexually 
compatible relatives must pose an increased plant pest risk relative to 
the comparator(s).
    Regarding terminology, we have revised Sec.  340.4(b) to indicate 
that in the initial reviews, we will make determinations concerning 
whether further review is necessary based on a finding of 
``plausible,'' rather than ``potential,'' plant pest risks. We view the 
former term as more precise and more in keeping with standard risk 
assessment terminology. Further, since the RSR process will require 
that a scientifically plausible risk be identified in order to proceed 
with further risk assessment, the revision will ensure that the initial 
review will not be an open-ended evaluation of any conceivably possible 
scenario that could be imagined.
    As noted earlier in this document, in connection with the 
discussion on confirmation letters, some commenters saw a need for 
timeframes for APHIS regulatory processes for purposes of 
predictability and business planning. Commenters raised the issue in 
connection with the RSR as well. We agree with the commenters on the 
need for timeframes and are adding them to paragraphs (b)(2) and (3), 
as discussed below.
    Revised Sec.  340.4(b)(1) contains provisions related to the 
initial review. The introductory text states that when APHIS receives a 
request for an RSR of a GE plant, APHIS will conduct an initial review 
to determine whether there is any plausible pathway by which the GE 
plant, or any sexually compatible relatives that can acquire the 
engineered trait from the GE plant, would pose an increased plant pest 
risk relative to the plant pest risk posed by the respective non-GE or 
other appropriate comparator(s), based on the factors listed in 
paragraphs (b)(1)(i) through (iii) (also listed above), which remain 
the same as those in the proposed rule.
    Revised Sec.  340.4(b)(2) provides that except in unforeseen 
circumstances, APHIS will complete the initial review within 180 days 
of receiving a request that meets the requirements specified in this 
section. If APHIS does not identify a plausible pathway by which the GE 
plant or its sexually compatible relatives would pose an increased 
plant pest risk relative to the comparator(s) in the initial review, 
the GE plant will not be subject to the regulations. APHIS will post 
information on the plant and trait and a general description of the MOA 
on its website.
    Regarding the timeframe, while the RSR process is new to APHIS, we 
anticipate that in many cases the initial review may be completed 
rapidly (that is, within 60 to 90 days). However, for plants that APHIS 
has infrequently authorized in the past, we anticipate that additional 
time may be required to compile information on the appropriate 
comparator(s) needed to conduct the initial review. In addition, we 
anticipate that additional time may be required to compile the 
information on less familiar or more complex MOAs needed to conduct 
initial reviews. Based on our experience, we anticipate that we will 
generally be able to complete reviews of less familiar plants and MOAs 
within 180 days, barring unforeseen circumstances.
    Revised Sec.  340.4(b)(3)(i) states that if APHIS does identify a 
plausible pathway by which the GE plant or its sexually compatible 
relatives would pose an increased plant pest risk relative to the 
comparator(s) in the initial review, the requestor may apply for a 
permit and/or request that APHIS conduct an evaluation of the factor(s) 
of concern to determine the likelihood and consequence of the increased 
plant pest risk.
    Revised paragraph (b)(3)(ii) states that for those GE plants for 
which such an evaluation is conducted, APHIS will publish the results 
of the evaluation in the Federal Register and will solicit and review 
comments from the public. Soliciting public comments will allow APHIS 
to collect information we might have missed and receive additional 
comment. Except in circumstances that could not reasonably have been 
anticipated, APHIS will complete these steps within 15 months of 
receiving a request for an RSR that meets our requirements. This 
evaluation will be similar to the current petition process, and will 
include, in addition to public notice and comment, preparation of any 
applicable National Environmental Policy Act (NEPA) analysis; hence, 
the longer timeline.
    Revised paragraph (b)(3)(iii) states that if APHIS finds that the 
GE plant and its sexually compatible relatives are unlikely to pose an 
increased plant pest risk relative to their comparator(s), the GE plant 
is not subject to part 340 and APHIS will announce the final 
determination in a subsequent Federal

[[Page 29811]]

Register notice and post the finding on its website. If APHIS does not 
make such a finding, the GE plant will remain regulated, and its 
movement will be allowed only under permit in accordance with Sec.  
340.5.
    Due to the changes made in Sec.  340.4(b)(2) and (b)(3)(iii), we 
are not finalizing proposed paragraph (c), as it is no longer 
necessary. (There is a paragraph (c) in Sec.  340.4 of this final rule, 
but it discusses when the section becomes applicable, and is discussed 
later in this document.) APHIS does not agree with other changes to the 
regulatory text suggested by some commenters. Specifically, the 
commenters recommended that we predicate our decisionmaking on whether 
the GE plant poses an ``unacceptable plant pest risk'' or an 
``unacceptable'' or ``unreasonable'' ``increase in plant pest risk.''
    APHIS appreciates these comments and has given them full 
consideration. APHIS does not find these terms to be necessary for 
purposes of our decisionmaking, nor have we concluded that such terms 
would provide the necessary precision to become the foundation for 
regulatory analysis and decisionmaking. For example, these terms could 
be interpreted to take into account considerations unrelated to plant 
pest risk and, if used as a regulatory benchmark, could be used to 
attempt to place APHIS risk assessors in the position of deemphasizing 
scientific considerations. As such, APHIS does not make changes to the 
regulatory text under in part 340 as suggested by the commenters.
    A commenter stated that just as the MOA for achieving a phenotypic 
trait in a GE organism should be taken into account, the MOA for 
achieving the genotype changes used to achieve those phenotypic traits 
should be taken into account as well. According to the commenter, the 
reason why APHIS regulations have historically been ``event-specific'' 
\9\ is that genetic material is inserted into recipient plants in an 
essentially random manner during the genetic engineering process which 
can create mutations in recipients at rates of ~30-60 percent, and that 
uncharacterized genetic material/DNA can unintentionally become 
incorporated into recipients about 20 percent of the time.
---------------------------------------------------------------------------

    \9\ Event-specific is used to distinguish the genome position of 
the same DNA insertions after transformation. As noted by the 
commenter, the same DNA introduced into a plant by transformation 
will insert randomly in the genome. To distinguish the fact that the 
position of the same inserted DNA varies between transformations, 
each transformation is referred to as an event.
---------------------------------------------------------------------------

    We do not agree with this comment. As noted above, we have not seen 
evidence in the scientific literature that there are unique hazards 
that arise solely from the use of recombinant DNA techniques, as 
compared with more conventional plant breeding techniques.
    One commenter stated that putting RSR results on the web would 
encourage copycats rather than innovators.
    We do not agree with this comment. As discussed later in this 
document, certain sensitive RSR information will be eligible for CBI 
exemptions and, therefore, protected.
Permits
    Paragraphs (a) and (b) of proposed Sec.  340.5 contained, 
respectively, permit issuing and application requirements. Proposed 
Sec.  340.5(f) contained requirements for APHIS review of permit 
applications.
    In the June 2019 proposed rule, APHIS proposed to remove timeframes 
for review of permit applications so as to ensure that APHIS has the 
appropriate time to evaluate each permit application based upon the 
plant pest risk posed by the GE organism and the complexity of the 
application. Some commenters opposed the change and requested that we 
retain those requirements in the regulations or otherwise incorporate 
into this final rule ``reasonable'' timeframes to provide greater 
certainty for developers about the length of the process. Commenters 
had various suggestions as to the length of the timeframe(s). One 
commenter, for example, recommended that APHIS be allowed 10 days to 
review applications for permits for interstate movement and 30 days for 
release permit applications. It was also recommended that we establish 
timeframes for making determinations on permit amendments and for 
review and comment by State and Tribal officials on permit 
applications.
    Although we recognize the need for certainty about the length of 
the process, our experience has been that some permit and notification 
applications take a minimal amount of time and others take longer, and 
we anticipate this to continue. A review of our experience over the 
last 2 years demonstrates that 45 days is currently sufficient to 
authorize import and interstate movement permits, while up to 120 days 
are often needed to authorize release permits. Therefore, APHIS is 
adding a new Sec.  340.5(h)(5) \10\ containing timeframes for review of 
permit applications. New paragraph (h)(5)(i) states that except in 
circumstances that could not reasonably have been anticipated, 
interstate movement and import permits will be approved or denied 
within 45 days of receipt of a complete permit application. New 
paragraph (h)(5)(ii) states that except in circumstances that could not 
reasonably have been anticipated, release permits will be approved or 
denied within 120 days of receipt of a complete permit application. New 
paragraph (h)(5)(iii) states that in cases where an environmental 
assessment or environmental impact statement is necessary to issue the 
permit, the 120-day period will be extended.
---------------------------------------------------------------------------

    \10\ As explained below, we are adding new paragraphs (e), (f) 
and (g) to Sec.  340.5. As a result, except where otherwise 
indicated by a specific reference to the proposed rule, for purposes 
of this discussion, paragraphs will be referred to by their 
designation in the regulatory text of this final rule.
---------------------------------------------------------------------------

    Paragraph (h)(3) of Sec.  340.5 contains requirements for 
inspections related to permitted activities. The paragraph states that 
all premises associated with the permit are subject to inspection 
before and after permit issuance, and that all materials associated 
with the movement are subject to sampling after permit issuance. In 
addition, the responsible person and agents must provide inspectors 
access to premises, facilities, release locations, storage areas, 
waypoints, materials, equipment, means of conveyance, documents, and 
records related to the movement of organisms permitted under part 340.
    A commenter stated that APHIS should define waypoint in a manner 
that accounts for the fact that applicants for permits may not be able 
to legally guarantee access to all waypoints, such as those that may be 
the sole property of a third-party shipping company.
    APHIS will work cooperatively with the permit holder if there is 
need to gain access to a waypoint not under the permit holder's 
control. A permit holder will not be held responsible for providing 
access that is outside the permit holder's power to grant or deny.
    In Sec.  340.5(h)(3), APHIS mandates that all materials associated 
with activities conducted under permit would be subject to sampling. 
One commenter questioned the need to include this requirement in the 
regulations. According to the commenter, the PPA gives APHIS authority 
to conduct investigations, including sampling, when required. The 
commenter stated that sampling has never been done outside the scope of 
an investigation,

[[Page 29812]]

and that practice should remain. The commenter said that if APHIS 
decides to move forward with inclusion of a sampling requirement, it 
should clearly describe how those samples will be handled, the level of 
confidentiality that they will be subject to, and the specific uses for 
which samples may be taken in order to protect confidential business 
information. The commenter further stated that such samples are of 
proprietary research materials and valuable enough to be targets of 
misappropriation if not handled appropriately.
    APHIS appreciates the comment and wants to reassure the regulated 
community that sampling will be done only when necessary. APHIS accepts 
that regulated material is proprietary property of the regulated entity 
and will ensure the taking only of quantities of samples required for 
diagnostic evaluation. The language in Sec.  340.5(h)(3) is consistent 
with APHIS' authority under the PPA to conduct inspections. When 
sampling is done, APHIS follows strict chain of custody protocols. 
APHIS will protect all proprietary information and CBI associated with 
sampling, and APHIS will share results only within USDA (marking 
documents containing CBI to ensure protection of such information) and 
with the regulated entity.
    Paragraphs (c) and (d) of proposed Sec.  340.5 contained, 
respectively, exemptions from permitting requirements for interstate 
movement for GE Arabidopsis thaliana and Agrobacterium tumefaciens, 
subject to certain conditions. Some commenters suggested that we 
consider additional exemptions. One such commenter requested that in 
addition to A. thaliana, APHIS should exempt specialty crops, in which 
an allele has been edited to align with a similar, known allele in a 
close relative. Another commenter pointed out that disarmed versions of 
Agrobacterium rhizogenes have a record for transformation that is 
equally useful and safe as the record for disarmed versions of A. 
tumefaciens. The commenter requested that the exemption for ``disarmed 
Agrobacterium tumefaciens'' be broadened to ``disarmed Agrobacterium 
strains'' or ``disarmed members of the Rhizobiales'', such as 
Ochrobactrum haywardense. Using the same reasons and arguments, the 
commenter stated that APHIS should consider exempting Nicotiana 
benthamiana. It was also suggested that because disarmed viruses are 
commonly used in plant molecular biology studies, any pathogen with the 
pathogenicity demonstrably removed could be exempted. Some commenters 
favored even broader exemptions, stating that most types of transgenic 
plants should also be exempted when shipments are small or in a form in 
which persistence in the environment is very unlikely. The lack of such 
exemptions, according to these commenters, impedes collaborative 
research and breeding substantially.
    We agree with these comments in part. Historically, A. thaliana and 
A. tumefaciens have been exempted from permitting requirements for 
interstate movement because interstate movement of the organisms has 
not resulted in the dissemination of plant pests within the United 
States. A. thaliana has been a research model plant species, and the 
research community is very familiar with the biological and ecological 
characteristics of the species. We have had extensive experience 
assessing the plant pest risks associated with the interstate movement 
of both organisms. In both cases, the plant pest risks are very low, 
and safeguards exist that can adequately mitigate those risks. APHIS 
agrees that other disarmed Agrobacterium species can be exempted from 
the requirement of permits for importation or interstate movement and 
has revised 340.5(d) accordingly. While some strains of disarmed 
Agrobacterium species may cause mild plant disease symptoms in some 
cases, importing them or moving them interstate presents very low plant 
pest risk given their specific usage in transforming plants, their lack 
of persistence in the newly transformed plants, and existing practices 
for shipping Agrobacterium strains. We do not have sufficient 
experience with the order Rhizobiales to further broaden this exemption 
at this time. Other GE organisms, such as specialty crops, have not 
been exempted before, and APHIS does not have extensive experience 
assessing their plant pest risks. Therefore, APHIS does not think it is 
appropriate to exempt such GE plants at this time in the same way as A. 
thaliana and A. tumefaciens.
    As noted earlier in the discussion of the definition of plant pest, 
we are adding to this final rule an exemption from the requirement for 
permits for import and interstate movement for GE Drosophila 
melanogaster in response to public comments that this organism does not 
have significant negative impacts on agriculture. This exemption is 
contained in a new paragraph (e) of Sec.  340.5. This exemption 
excludes strains that have been engineered to propagate through a 
population by biasing the inheritance rate (e.g., gene drives), because 
such strains could be designed to persist in the environment and we do 
not have sufficient experience to conclude that such strains would not 
pose a significant plant pest risk. We have also revised the exemption 
text for Arabidopsis thaliana and Agrobacterium strains in Sec.  
340.5(c) and (d), respectively, to conform with the revised definition 
of genetic engineering, which is not limited to the insertion of 
``cloned'' genetic material into an organism.
    In response to comments about interagency coordination, which are 
discussed in detail below under the subheading ``Statutory Authority, 
Jurisdiction, and Interagency Coordination,'' we are adding a new 
paragraph (f) to Sec.  340.5, which contains an exemption from 
permitting requirements for any microbial pesticide that is currently 
registered with the EPA as a microbial pesticide, so long as the 
microorganism is not a plant pest as defined in Sec.  340.3. The 
addition of this exemption ensures that these organisms will not be 
subject to duplicative regulation.
    Also in the interest of interagency coordination, as well as other 
considerations discussed in detail later in this document in the 
section pertaining to plant incorporated protectants (PIPs), we are 
also adding a new paragraph (g) to Sec.  340.5 that exempts from the 
permitting requirement for movement of any GE plant modified solely to 
contain a PIP that is currently registered with EPA as a pesticide 
product pursuant to the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA, 7 U.S.C. 136 et seq.) or that is currently exempted from 
FIFRA pursuant to 40 CFR 174.21.
    Numerous commenters expressed concerns about our proposed permit 
conditions. Those issues are discussed individually in the paragraphs 
that follow.
    One commenter viewed the permit conditions in general as 
excessively strict. The commenter stated that the conditions strive 
toward zero risk, as opposed to the Coordinated Framework criterion of 
unreasonable risk. It is important to maintain measures commensurate to 
risk, according to the commenter.
    We do not agree with this commenter's suggestion that our permit 
conditions are too strict or are striving toward zero risk. Our permit 
conditions are set to ensure containment and confinement of the 
organism under permit. They are designed to be commensurate with the 
risk posed by the GE organism. The commenter did not offer specific 
guidance on how we should apply the ``unreasonable risk'' standard.

[[Page 29813]]

    Some commenters requested that we clarify the distinction between 
standard permit conditions that apply to all GE organisms and those 
that apply only to GE plants or to GE microorganisms or insects.
    We believe that the standard permit requirements, as listed in 
Sec.  340.5(i)(1) through (10) of this final rule, make this 
distinction clear. As written, all the standard conditions listed in 
Sec.  340.5(i) of this final rule, except for paragraph (i)(6)(ii) 
(which pertains specifically to GE plant volunteer monitoring), are 
applicable to all GE organisms. Therefore, we are not making any 
changes in response to these comments.
    One commenter recommended that we adopt a hybrid permit system 
under which performance standards are primarily used as the enforcement 
mechanism. According to the commenter, specific permit conditions 
should be added only when scientifically justified.
    We will not be making any changes to the final rule as a result of 
this comment. Some of the standard permit conditions in Sec.  340.5(i) 
are, in fact, performance standards, consistent with the commenter's 
recommendation. For example, paragraph (i)(1) states that ``[t]he 
organism under permit must be maintained and disposed of in a manner so 
as to prevent its unauthorized release, spread, dispersal, and/or 
persistence in the environment.'' Under paragraph (i)(6), records 
related to permit activity by the responsible person must ``be of 
sufficient accuracy, quality, and completeness to demonstrate 
compliance with all permit conditions and requirements under this 
part.''
    Nonetheless, we do not believe that a sole or primary regulatory 
focus on performance standards would be desirable for the regulations 
in part 340. As noted in the preamble to the June 2019 proposed rule, 
Office of Inspector General (OIG) audits conducted in 2008 and 2015 
recommended, among other things, that APHIS generally reduce its 
reliance on performance-based standards in the regulations in part 340. 
APHIS agrees with the OIG recommendations. While performance standards 
offer the advantages of administrative streamlining for APHIS and 
flexibility for regulated parties, there are also significant 
disadvantages to a performance-standard-based regulatory approach. The 
absence of specific measures that constitute compliance with the 
regulations in performance-based standards introduces an element of 
uncertainty into the process of determining whether a regulated party 
is in compliance with the regulations. Enforcing the regulations, and 
thereby protecting U.S. agriculture from plant pest risks, would thus 
be made more difficult than it is when compliance measures are clearly 
enumerated in specific permit conditions, as they always have been 
under the regulations in part 340 and will continue to be as a result 
of this rulemaking. Because permit conditions specify which actions 
need to be taken by the responsible person to be in compliance with the 
regulations and do not rely as much on subjective determinations (by 
both the responsible person and APHIS personnel) as do performance 
standards, the permitting system can provide more risk-appropriate 
oversight, better regulatory enforcement, and transparency.
    A commenter questioned the necessity of the requirement in Sec.  
340.5(i)(6) for the submission of a report of no environmental release 
for all authorized locations in which an environmental release of a GE 
organism did not occur. It was stated that this provision is 
inconsistent with the policy approach of the Coordinated Framework and 
represents regulatory overreach that should be set aside. The commenter 
saw no risk mitigation value in this requirement.
    APHIS appreciates the commenter's concern but disagrees with the 
commenter's arguments. A permit authorization often covers many sites, 
and planting may never occur at some sites. Similar to the need for a 
post-planting report (PPR) to indicate which sites are planted and 
when, APHIS needs to know which sites were not planted, so as to 
provide efficient and appropriately focused oversight. APHIS thinks 
that the submission of a report of no release can help APHIS track the 
status of all authorized test field locations in order to account for 
and sufficiently monitor all such locations, thereby preventing the 
accidental release of GE organisms into the environment. Additionally, 
this requirement addresses recommendations issued by USDA's OIG, 
following audits performed in 2015.
    One commenter stated that developers may operate under multiple 
permits for multiple plant-trait-MOA combinations at one time. The 
commenter stated that plant lines within these multiple permits are 
planted in proximity to one another to facilitate comparative science 
and to utilize resources in the most efficient way possible, and that 
if APHIS were to issue each permit with different conditions, of which 
the developer may learn only weeks before planting, these materials may 
have to be physically separated from each other or research would need 
to be abandoned, inhibiting innovation and increasing the cost to 
develop new products.
    APHIS does not consider such scenarios to be likely. The permit 
conditions for non-plant-made pharmaceutical and industrial (PMPI)-
producing plants are based on the reproductive ecology of each species 
and the receiving environment. APHIS anticipates that such permit 
conditions will generally be consistent across multiple permits for the 
same species. The timeframes for the issuance of permits that have been 
added to the regulations will enable developers to plan adequately to 
meet the specified permit conditions.
    One commenter stated that APHIS should specify in the regulations 
timeframes for the submission by the responsible person of reports of 
activities under permit that are required under Sec.  340.5(i)(6).
    We do not agree with this comment. The types of reports to be 
submitted and the timing of their submission will vary by species and, 
therefore, will be included in each permit in the supplemental permit 
conditions, rather than in the regulations.
    One commenter recommended that we allow for changes in the 
designation of a responsible person via a notification process.
    We do not agree with this comment. In Sec.  340.3, we define 
responsible person as the person responsible for maintaining control 
over a GE organism under permit during its movement and for ensuring 
compliance with all conditions contained in any applicable permit as 
well as other requirements in part 340. In Sec.  340.5(i)(10), we state 
that the responsible person for a permit remains responsible unless a 
transfer of responsibility is approved by APHIS. The requirement for 
APHIS approval is necessary to ensure that, in the event a transfer 
becomes necessary, the new responsible person is aware, prepared, and 
equipped to work with APHIS. That provision does not apply, however, to 
an agent, a term defined in the June 2019 proposed rule as someone 
designated by the responsible person to act on behalf of the permittee 
to maintain control over an organism under permit during its movement 
and to ensure compliance with permit conditions. A change in agent may 
be effected through a notification.
    One commenter requested that we not require Global Positioning 
Satellite (GPS) coordinates in permit-related records, a requirement 
that, according to the commenter, is effectively a permit condition, 
though it is actually

[[Page 29814]]

contained in Sec.  340.6, the section covering recordkeeping. The 
commenter stated that information on actual acreage shortly after 
planting would suffice.
    APHIS disagrees with this comment. GPS coordinates allow APHIS to 
fully utilize Geographic Information System capabilities to oversee 
what will be released within the defined authorized area. For example, 
APHIS uses GPS coordinates information to determine whether a proposed 
release site happens to be on Federal land or critical habitat.
    Paragraph (j) of Sec.  340.5 addresses permit denials and 
withdrawals. One commenter stated that APHIS must make it clear that 
denial should occur only to prevent an unreasonable risk to U.S. 
agriculture. The commenter further suggested that APHIS should include 
assurances that a permit will be presumptively issued unless APHIS can 
present a plausible argument that failure to comply with the permitting 
conditions would result in such an unreasonable risk. Another commenter 
suggested that the rule should be clarified to indicate that a permit 
application may be withdrawn by the applicant as well as the 
Administrator.
    We will not be making any changes to the final rule as a result of 
these comments. Under Sec.  340.5(j)(1), the Administrator may deny a 
permit application if he or she concludes that the proposed actions 
under permit may not prevent the unauthorized release, spread, 
dispersal, and/or persistence in the environment of the GE organism; if 
the responsible person or agent has materially failed to comply with 
any provision of these regulations; or if the responsible person or 
agent has failed to comply with any other regulations issued pursuant 
to the PPA or the PPA itself. Permits will also be denied if the 
responsible person or agent does not agree in writing to comply with 
permit conditions or to allow inspection by APHIS. These conditions are 
necessary to protect U.S. agriculture. Regarding withdrawal, the 
existing regulations do not specify that a permit application may be 
withdrawn by the applicant. Nonetheless, under current regulations, 
applicants may request withdrawal of permit applications prior to the 
issuance of the permit. This will continue to be the case when the 
revised regulations become effective.
    One commenter stated that developers may operate by covering 
multiple plant-trait-MOA combinations under a single permit. According 
to the commenter, permits may be requested by location, with many 
experiments, containing multiple plant-trait-MOA combinations, planted 
in the same location. The commenter submits that if a permit is 
terminated due to a completed RSR, the termination should not apply to 
the entire permit, but only to the individual plant-trait-MOA which was 
reviewed.
    APHIS responds that in such cases, the permit would not be 
terminated, and that the specific plant-trait-MOA combination for which 
the RSR was completed (resulting in a determination that the plant-
trait-MOA GE plant combination is not subject to part 340) would no 
longer be regulated under that permit. APHIS would continue to provide 
oversight for plant-trait-MOAs that are still under permit.
    One commenter requested clarification on permit amendment 
provisions, particularly as they applied to APHIS-initiated amendments 
in Sec.  340.5(l)(2). The commenter expressed a concern that APHIS may 
arbitrarily initiate modifications to an existing permit and stated 
that APHIS should have no authority to initiate such amendments without 
scientific evidence.
    APHIS will not initiate a permit amendment process without 
sufficient scientific justification. Under Sec.  340.5(l)(2), APHIS 
will initiate a permit amendment process upon determining that such an 
amendment is needed to address the plant pest risk posed by the GE 
organism or the activities allowed under the permit. In such cases, 
APHIS will provide notice to the responsible person of the amendment(s) 
and the reasons for it.
    Another commenter questioned whether we should include provisions 
for amending permits in the regulations at all. It was stated that we 
were reducing our flexibility by including such provisions.
    Contrary to the commenter's assertion, we believe that the 
provisions for permit amendments allow for greater regulatory 
flexibility by enabling a rapid response to changing circumstances. We 
have included these provisions to provide an opportunity for a 
responsible person to request an amendment to permit conditions when 
circumstances have changed, as opposed to our having to withdraw the 
permit, which would necessitate that the responsible person then 
reapply. Under the permit amendment provisions, APHIS would also have 
the flexibility to amend a permit rather than revoking it if needed to 
address new or previously unknown plant pest risks presented by the 
organism.
    Another commenter recommended that APHIS specify a timeframe for 
review of permit amendments requested by a responsible person. The 
commenter stated that furthermore, APHIS should notify the requestor if 
the amendment request is deemed to be within or outside the scope of 
the existing permit.
    The timeframe for the review for the permit amendment will be the 
same as for new permit applications and depends on the complexity of 
the requested change. Consistent with past practice, APHIS will 
continue to let requestors know if an amendment is outside the scope of 
an existing permit.
    Finally, we are making an editorial change to paragraph (l)(1) in 
Sec.  340.5 to clarify the circumstances under which (1) APHIS will 
approve an amendment request from a permit holder and (2) APHIS will 
instead require a new permit application. Specifically, we are 
providing examples of situations where each would apply. APHIS will 
allow a permit to be amended if relatively minor changes are necessary. 
Requests for more substantive changes will result in a denial of the 
amendment request and necessitate a new permit application.
    Paragraph (m) of Sec.  340.5 contains requirements for shipping 
under permit. Paragraph (m)(1) contains a performance standard, stating 
that all shipments of organisms under permit must be secure shipments. 
Paragraphs (m)(2) and (3) contain, respectively, documentation and 
labeling requirements, and paragraph (m)(4) contains provisions related 
to treatment and disposal of shipping containers and packing materials.
    One commenter stated that if APHIS' intent in paragraph (m)(1) is 
to allow developers to make determinations regarding the types of 
containers used during transport so long as they fit the above 
stipulations, that represents an improvement. If this change, however, 
is meant to be more restrictive, especially with the removal of a 
variance option, then the responsible person or agent should be able to 
make changes to shipping container options, if needed.
    Paragraph (m)(1) is performance-based. It does not prescribe 
specific container requirements. The change to the regulations is meant 
to make the performance standard more explicit while at the same time 
making the requirements less prescriptive. Based on the definition of 
secure shipment (``Shipment in a container or a means of conveyance of 
sufficient strength and integrity to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation''), APHIS does not anticipate that shipping 
variances will be needed.
    One commenter requested that we revise the language in Sec.  
340.5(m)(4) to take into account reusable shipping containers. The 
commenter

[[Page 29815]]

recommended that we replace the word ``treated'' with ``cleaned to 
remove the organism before reuse.''
    In response to this comment, we are revising the paragraph to read 
as follows: ``Following the completion of the shipment, all packaging 
material, shipping containers, and any other material accompanying the 
organism will be devitalized consistent with supplemental permit 
conditions, or disposed of to prevent unauthorized release.''
    Other issues raised by commenters in relation to permits included 
concerns about the rigor and integrity of the process, safety of 
environmental releases under permit, field testing, implementation of 
the permitting requirements, and the formatting of permits.
    One commenter, noting that the definition of movement in Sec.  
340.3 includes release into the environment, stated that there can be 
no assurances beforehand of a safe outcome of such a release. The 
commenter stated that all GE organisms that are to be released into the 
environment should be subject to strict testing requirements.
    APHIS acknowledges the commenter's concerns about safely releasing 
GE organisms into the environment. For reasons discussed earlier in 
this document, it is our view that categories of organisms that fall 
under the exempted categories in Sec.  340.1(b) and (c), as well as GE 
plants that have been subject to an RSR in accordance with Sec.  340.4 
and for which APHIS has not identified a plausible pathway by which the 
GE plant or its sexually compatible relatives could pose an increased 
plant pest risk relative to the comparator(s), can be safely released 
into the environment without the need for a permit. The movement, 
including release into the environment, of all other GE organisms will 
be allowed only under permit and subject to strict standards and, if 
appropriate, supplementary permitting conditions to effectively 
mitigate any risks that may be associated with such movement or 
release.
    A commenter stated that granting developers the option to move GE 
plants under permit in lieu of an RSR raises concerns regarding the 
integrity and robustness of the regulatory process.
    Providing a developer the option to move a GE plant under permit 
rather than requesting an RSR affords that developer the benefit of 
maximum flexibility in the research and development of novel GE plants. 
The provision does not, however, provide the developer a means of 
evading regulatory scrutiny of new GE plants, as the commenter appears 
to believe. Permits are a form of regulation, and movement of GE plants 
under permit regularly occurs under our current regulations. An RSR 
results in a determination, based on our evaluation of plant pest risk, 
that a GE plant either is not subject to the regulations, and can be 
moved with no further restriction under part 340, or is subject to the 
regulations and may be moved only under permit. Whether a product 
requires movement under permit as a result of an RSR, or because the 
developer has chosen the permitting option in lieu of the RSR, the GE 
plant will still be subject to a rigorous screening process. The 
developer will have to submit a permit application, along with all 
supporting information required under the regulations. APHIS will 
carefully review the application and, if warranted, approve it. Prior 
to issuance, the developer/responsible person will be required to agree 
in writing that he or she understands and will comply with all the 
standard and supplementary conditions listed on the permit. Compliance 
is monitored after a permit has been issued. Our permitting process is 
a longstanding and rigorous one that ensures that GE plants are moved 
only under conditions that provide safeguards against the risk of 
dissemination of plant pests.
Temporary Transition Provisions
    One commenter recommended that the implementation of the new 
permitting provisions and elimination of notifications should be phased 
in so as not to disrupt seasonal field activities. Other commenters 
stated that given the magnitude of the changes in regulatory 
requirements that we proposed, we should phase in implementation so as 
to allow regulated parties to adjust their operations to comply with 
the new requirements. Some commenters recommended that we develop 
timelines for compliance with each component of the proposed 
regulation. Recommendations ranged from 30 days (30 days each for the 
confirmation and RSR processes) to two years (for compliance with all 
of the new processes). Commenters also requested that we provide 
guidance on the new regulatory framework to aid them in making the 
transition.
    APHIS appreciates the commenters' concerns and supports a phased 
approach to implementation. This final rule identifies a date when each 
of the rule's sections becomes applicable. Implementation of this rule 
will occur as follows.
    Thirty days following the publication of this rule, APHIS will 
discontinue receiving new AIR requests. This will allow developers 
sufficient time to make such requests following publication, while also 
ensuring that, to the best of the Agency's ability, all such requests 
have been acted on by the time the rule becomes effective. The 
exemptions identified in Sec.  340.1, and the confirmation letter 
process described in that section, will become effective and will be 
implemented 90 days after the publication date of this rule. (Please 
note, however, that some of the exemptions in paragraph (c) of Sec.  
340.1 are contingent on implementation of RSR, which will not occur 
until April 5, 2021.) In the intervening 60-day period, developers can 
self-determine regulated status according to the legacy definition of 
regulated article; APHIS is available to respond to requests for 
assistance in such determinations. Alternatively, developers may seek 
permits or use the legacy notification process during that time period 
in order to import regulated articles, move them interstate, or release 
them into the environment.
    The remaining provisions in this rule also will become effective 
(that is, will appear in the CFR) 90 days after the publication of the 
rule. However, they are applicable as follows: Beginning April 5, 2021, 
APHIS will implement the permitting provisions in Sec.  340.5; 
beginning April 5, 2021, APHIS will undertake a phased implementation 
of the RSR process described in Sec.  340.4 by accepting requests for 
reviews involving corn, soybean, cotton, potato, tomato, and alfalfa; 
and beginning October 1, 2021, APHIS will accept requests for RSR 
involving any genetically engineered plant. We have revised proposed 
Sec. Sec.  340.4 and 340.5 to include these specific applicable dates.
    Until RSR is available for a particular crop based on the schedule 
set forth in the previous paragraph, APHIS will continue to receive 
petitions for determination of nonregulated status for the crop in 
accordance with the current regulations in Sec.  340.6. Accordingly, 
developers may submit petitions for deregulation for any GE plants 
through April 4, 2021; beginning April 5, 2021, APHIS will discontinue 
receiving petitions for corn, soybean, cotton, potato, tomato, and 
alfalfa, but will continue to receive petitions for all other GE plants 
and organisms. As is currently the case, a developer may seek a permit 
or use the notification process instead of, or in addition to, 
submitting a petition. On October 1, 2021, APHIS will discontinue 
receiving petitions altogether. Similarly, all currently issued 
notifications and permits will remain valid until the expiration dates 
specified in such authorizations, and

[[Page 29816]]

APHIS will continue to receive notifications and permit applications 
pursuant to the processes in the current regulations in Sec. Sec.  
340.3 and 340.4, as well as the operational practices associated with 
those regulations, through April 4, 2021. Beginning April 5, 2021, the 
notification process will be discontinued, and all applications for 
permits must be submitted in accordance with the regulations identified 
in this final rule.
    This phased implementation mitigates potential disruption to 
seasonal field activities and will provide developers with the 
opportunity to review and adjust to the provisions in this final rule.
    Commenters stated that APHIS must maintain oversight over field 
trials, and that such trials should be allowed only under permits that 
mandate stringent gene containment protocols with a management goal of 
full containment. According to the commenters, safeguards and 
monitoring must be required for the organism during field trials, and 
monitoring should include tracking changes associated with ecosystem 
harm, such as degradation of water quality, air pollution, climate 
impacts, or loss of biological resources. It was also stated that APHIS 
should publish the results of APHIS supervised field trials where they 
will be publicly accessible, and that permit requirements should 
include buffer zones for GE crop fields that adjoin organic and non-GE 
crop fields to reduce GE trait and chemical drift.
    APHIS has established and will continue to establish appropriate 
oversight requirements for crops grown under permit, including 
isolation requirements based on the reproductive ecology of the plant 
species to prevent gene flow to plants not under the permit. APHIS does 
not believe that ecosystem impacts, such as degradation of water 
quality, air pollution, climate impacts, or loss of biological 
resources unrelated to plant pest risk, require tracking or monitoring 
under the part 340 regulations, and notes that growing non-GE plants 
may give rise to similar impacts. Under this rulemaking, there is no 
requirement that developers submit field-trial data to APHIS, although 
they may do so if they choose to support an RSR or confirmation letter 
request. As we noted in the preamble to the proposed rule, APHIS' 
experience in preparing risk assessments in accordance with the 
petition process indicates that field trial data are generally not 
necessary unless they address an identifiable plausible pathway to 
plant pest risk. The introduced trait and MOA provide the most reliable 
indicators of the organism's potential for plant pest risk. If field 
data are needed to address a plausible plant pest risk hypothesis, 
those data bearing on whether an organism posed a plant pest risk would 
be published in support of APHIS' decision making on the regulatory 
status of that plant.
    A commenter stated that APHIS should further clarify the length of 
time after a permit expires during which access to materials and 
premises must be allowed. The commenter was concerned that such access 
could be misinterpreted to be in perpetuity, which is unnecessary.
    We would require the responsible person to allow access to where 
the organisms regulated under part 340 are located, including field 
test sites after trials are harvested or terminated, throughout the 
volunteer monitoring period described in the permit, which may continue 
after permit expiration. Access to premises where regulated organisms 
are maintained must be allowed throughout the volunteer monitoring 
period even if the permit has expired, unless the product has been 
devitalized or APHIS has conducted an RSR and determined it to be not 
subject to part 340.
    Two other recommendations by commenters were that we develop a 
publicly available database listing all permits issued by APHIS and 
their requirements, and that we provide for pre-approvals of 
containment facilities for high-risk organisms, with permits tiered to 
the approved facility number.
    We thank the commenters for these suggestions. APHIS may explore 
these ideas in the future as we develop more experience with permits 
under the new regulations, though we do not believe that it is 
necessary to implement (or to decide whether to implement) these ideas 
immediately. For example, our ongoing experience with permits involving 
containment facilities may lead us at some point to consider a specific 
pre-approval process for certain facilities as suitable for higher-risk 
organisms.
    Finally, one commenter stated that each permit should contain 
introductory text describing the unreasonable risk to U.S. agriculture 
that the permit is designed to prevent. The commenter further stated 
that if no such plausible description can be proffered, then APHIS 
would have no reason for exercising oversight over, or requiring a 
permit for, the movement of the GE organism for which APHIS intends to 
issue the permit.
    Under the new regulations, GE organisms will be required to move 
under permit for one of three reasons: (1) Because APHIS has conducted 
an RSR and has found a likely or indeterminate plant pest risk; (2) 
because the developer has opted to go directly to seeking a permit 
rather than requesting an RSR; or (3) because the GE plant or non-plant 
organism fits under one of the regulated categories in Sec.  340.2. We 
do not see the need for the introductory text that the commenter 
recommends, which is likely to be duplicative or unnecessary in many if 
not all cases.
    In addition to the substantive changes discussed above, we are 
making a couple of corrections to Sec.  340.5(b)(1) and (b)(2)(ii). In 
the former paragraph, which contains general information requirements 
for permit applications, we are adding ``the organism's genus, species 
and any relevant subspecies and common name information.'' Under the 
latter, which contains information requirements for permits for 
interstate movement and listed, among other things, in the June 2019 
proposed rule, ``a description of the method of shipment, and means of 
ensuring the security of the shipment against unauthorized release of 
the organism,'' we are including a requirement that the quantity of the 
GE organism also be listed. In both cases, the requirements were in the 
current regulations but were inadvertently omitted from the June 2019 
proposed rule.
Record Retention, Compliance, and Enforcement
    Numerous commenters identified concerns about the record retention 
requirements described in proposed Sec.  340.6. Issues discussed 
included overall clarity and scope, timeframes, and reporting 
requirements.
    Some commenters suggested that we needed to clarify our 
recordkeeping and reporting requirements by adding more specific detail 
about what information APHIS will require and when.
    The reporting and recordkeeping requirements in Sec.  340.6 of the 
June 2019 proposed rule did provide specific details regarding the 
types of records that need to be kept and the timeframes for retention, 
in paragraphs (a) and (b), respectively. At the same time, the 
requirements that we proposed align with our historical approach, which 
has provided flexibility based on variations in operations performed by 
different entities and different subparts of a single entity. As 
reflected in Sec.  340.6(a)(1), which refers the reader back to the 
permit-related reporting and recordkeeping requirements in Sec.  340.5, 
many of the recordkeeping and reporting requirements of this

[[Page 29817]]

rulemaking will depend on the nature of the GE organism and the 
intended activity and will be included in the permit conditions.
    It was suggested that some of the proposed information requirements 
were duplicative. One commenter stated that APHIS requires information 
about the location of a field release site to be included in the permit 
application and then requests the same information again after 
planting, resulting in duplicate or nearly duplicate records requests. 
The commenter stated that APHIS also requests the identity of the 
material being planted (the construct ID) on the application and then 
requests the same information again on the planting report. According 
to the commenter, during inspections this information is often 
requested a third time. The commenter stated that this duplication 
could be eliminated with no detrimental effects on compliance by having 
applicants provide it on the permit application and then having APHIS 
verify it during inspection.
    These requirements are not duplicative, and it is not particularly 
onerous to comply with them. Information submitted in a permit 
application is used for specific release site analysis. Post-planting 
reports provide APHIS with critical information related to the activity 
that has been conducted under an APHIS-issued authorization. The 
information submitted post-planting facilitates effective compliance 
oversight. Planting does not occur for every genetic construct and 
location that is approved in an authorization. APHIS needs 
documentation (post-planting report) of which constructs are planted at 
each specific field release site in order to perform effective 
compliance oversight. Additionally, this requirement addresses 
recommendations issued by USDA's OIG following audits performed in 
2015.
    A commenter recommended eliminating the requirement in Sec.  
340.6(a)(2) that records be kept to identify all locations where 
organisms under permit were stored. The commenter noted that while 
APHIS regulates interstate movement, the proposed definition of move 
does not include ``store.''
    We do not agree with this comment. Under Sec.  340.5(b)(2)(i), all 
permit applications must include, among other things, information on 
the origin and destination of a GE organism moved under permit, 
including information on addresses of all intermediate and final 
destinations. Additionally, Sec.  340.5(b) states that within the 
permit application, locations and destination(s) of regulated organisms 
shall be included. A storage facility is considered by APHIS to be a 
destination (premises). APHIS needs to know where the regulated GE 
organism has been maintained in order to perform effective compliance 
oversight.
    We received comments that supported our proposed timeframes for 
record maintenance and other comments that expressed concerns about the 
timeframes.
    One commenter raised concerns about APHIS's ability to respond to 
incidents effectively if APHIS retained records associated with 
regulatory activities for only 2 years.
    The commenter may have misunderstood the recordkeeping requirement 
in Sec.  340.6(b). The requirement that all records indicating that an 
organism that was imported or moved interstate under permit reached its 
intended destination be retained for 2 years applies to the responsible 
person(s) rather than APHIS. APHIS did not propose any changes to the 
duration or type of records that APHIS will retain. The proposed 2-year 
retention requirement did represent an increase from the one in the 
existing regulations, which was 1 year. APHIS believes that this 2-year 
record retention requirement provides sufficient time to ensure that 
regulated material has safely and securely reached the intended 
destination, without imposing an undue burden on regulated parties.
    One commenter viewed the requirement to retain records of permitted 
activities for 5 years as burdensome for small entities and urged us to 
ameliorate that burden by offering small entities an option to deposit 
such records electronically with APHIS for retention.
    We do not agree with this comment. APHIS does retain the records of 
permitted activities that are submitted to APHIS, such as required 
reports and other information needed to determine compliance. Large and 
small regulated entities also generate and retain records that they may 
not be required to submit to APHIS but are kept to demonstrate 
compliance with permit conditions and for the entities' own stewardship 
purposes. Should those types of records be submitted to APHIS for 
retention, they would then be considered Federal records subject to the 
Freedom of Information Act (FOIA), which, among other things, would 
give rise to considerable administrative burdens for APHIS, which would 
be obliged (for instance) to protect submitters' confidential business 
information in maintaining such records and responding to FOIA 
requests. Furthermore, adopting the commenter's recommendation could 
raise concerns about disparate treatment. The comment did not include 
size criteria or definitions or a description of a process that would 
enable APHIS to make a fair determination of who could or could not 
submit documents for APHIS to retain.
    Finally, one commenter recommended that APHIS utilize the APHIS-
initiated amendment procedure for site-specific enforcement in 
instances of noncompliance and amend Sec.  340.6(c)(i) to explicitly 
allow the Administrator to deny an application or withdraw a permit 
``in whole or part.'' The commenter contended that this would provide 
APHIS the flexibility to apply site-specific, measured enforcement.
    APHIS agrees with the intent of the comment but disagrees with the 
suggestion that a regulatory text change is necessary, because the 
permit-amendment provisions in Sec.  340.5(j)(2) already allow us 
sufficient flexibility to respond to compliance issues in the manner 
recommended by the commenter.
Confidential Business Information (CBI)
    Commenters took divergent views on the issue of the proposed 
Confidential Business Information (CBI) exemptions in the proposed 
rule. Some thought the exemptions, as explained in the preamble to the 
proposed rule, did not provide enough protection for submitters, while 
others thought that the exemptions were too broad.
    Several commenters stated that CBI protections should extend to 
information pertaining to MOA and other information required to be 
submitted for an RSR or needed by APHIS to confirm a determination by a 
developer that its product is exempt from these regulations. Some 
commenters also suggested that submitters may forgo seeking 
confirmation or an RSR, and may opt to go under permits, if the MOA 
will be made public after a product has come through the confirmation 
or RSR process, because submitters want to protect that information.
    As noted in the preamble to the proposed rule, APHIS intends to 
release a general description of the plant, the trait, and the MOA of 
GE plants that go through an RSR, but APHIS would do so without 
revealing CBI. APHIS would similarly release a general description of 
the plant, trait, and, as applicable, the MOA associated with 
confirmation requests, again without revealing CBI. APHIS wants to 
clarify that we are not requiring submitters to waive their

[[Page 29818]]

applicable CBI claims. Further, as we noted in the preamble, certain 
technical information, such as data that could be used to re-create an 
organism and that were not otherwise made publicly available by the 
submitters, may be eligible for CBI designation. To the extent that CBI 
claims exist, APHIS will review them, consistent with applicable laws 
and statutory authorities, on a case-by-case basis. Submitters will be 
given the opportunity to review and comment on a proposed general 
description prior to public disclosure. Regardless of CBI 
determination, developers will have the flexibility to select the 
regulatory options, whether RSR or permit, that they deem best for 
their business needs.
    Other commenters expressed concern that extensive granting of CBI 
designations could impede the ability of developers to determine 
whether their products are eligible for exemption, and could impede 
peer-reviewable risk assessment. These commenters favored posting 
confirmation requests and responses and RSR determinations online. It 
was suggested that if such data are not available, developers will lack 
the necessary information to make reliable determinations for their GE 
plants and may choose permitting instead. According to these 
commenters, this would attenuate the regulatory relief that is one of 
the objectives of this rulemaking.
    APHIS will post confirmation requests and responses, as well as 
determinations of nonregulated status pursuant to the outcomes of 
initial RSRs, on the APHIS website, with CBI redacted. When additional 
review is requested, as discussed earlier in this document, the 
analysis, outcome, and supporting documents will be published in the 
Federal Register and on the website, also with CBI redacted. We 
recognize that, in some cases, information necessary for researchers 
and developers to make determinations pursuant to Sec.  340.1(c) may 
not be made public, due to CBI claims.
    Commenters also expressed the view that mandatory field trial data 
should not be eligible for CBI exemption.
    Under this rulemaking, there is no requirement that developers 
submit field-trial data to APHIS, though they may do so if they choose 
to support an RSR or confirmation letter request. As noted above, APHIS 
would allow only CBI exemptions that are consistent with applicable 
case law and statutory authorities.
    A commenter requested that we clarify how the process for 
submitting CBI exemption requests and justifications for exemptions 
differs from the process that occurs under the current regulations.
    The process for submitting and justifying CBI claims will not 
change under this rulemaking. Persons submitting any document to APHIS 
in accordance with the regulations must identify those portions of the 
document deemed to be CBI. Each page containing such information must 
be marked ``CBI Copy.'' A second copy of the document must be submitted 
with all such CBI deleted, and each page where the CBI was deleted must 
be marked ``CBI Deleted.'' In addition, any person submitting a CBI 
exemption request must justify the request by demonstrating how each 
piece of information to which the request applies is a trade secret or 
is commercial or financial information and is thereby privileged or 
confidential.
Economic Analysis
    Some comments directly addressed the economic analysis that 
accompanied the June 2019 proposed rule. It was claimed that the 
analysis was light on data characterizing the potential economic and 
social impacts of the proposal. It was also stated that we did not 
offer sufficient analysis of the challenges of assuring other countries 
that imports of GE products from the United States are safe and meet 
the importers' requirements.
    In the analysis accompanying the June 2019 proposed rule, we did 
request comments from the public on the potential economic impacts of 
the rule on affected entities. Most of the commenters who addressed 
potential economic impacts did so as part of a broader discussion of 
other issues, such as the potential economic effects of commingling, 
rather than addressing the economic analysis directly. Commenters did 
not supply actual data that would have aided us in characterizing 
potential social and economic impacts of the proposed rule. We do 
discuss potential international trade issues at some length later in 
this document.
Regulation of Plants That Produce Plant-Made Pharmaceuticals and 
Industrials (PMPIs)
    We stated in the June 2019 proposed rule that the likelihood 
existed that most, if not all, GE PMPI-producing plants that are 
currently under APHIS permits could be determined to be not regulated 
if an RSR found them to be unlikely to pose a plant pest risk. We also 
noted that our proposed rule envisioned that were this to occur, such 
plants could be grown outdoors without the need for APHIS permits and 
without APHIS oversight.
    We received many comments on this issue. Some commenters expressed 
concern that the proposed change to our regulatory approach to PMPI-
producing plants would weaken or eliminate APHIS' oversight of them. 
Others favored less regulatory oversight of PMPI-producing plants than 
that provided in the existing regulations. Still others requested that 
we provide greater clarification of our regulatory approach to PMPI-
producing plants under this rulemaking and emphasized the need for 
cooperation among regulatory agencies. These varying viewpoints are 
discussed in greater detail below.
    Some commenters stated that as a result of this rulemaking, APHIS 
would abdicate its oversight role, leaving the planting of PMPI-
producing plants essentially unregulated. As a result, according to 
these commenters, our agricultural food systems could be made 
vulnerable to introduction of experimental GE crops, and environmental 
quality and human health could be negatively affected based on the end 
use of those crops for pharmaceutical or industrial purposes. One 
commenter expressed concern that PMPI-producing plant developers would 
be able to determine for themselves whether their products are eligible 
for exemption. All of these commenters urged us to maintain our 
existing level of regulatory oversight of PMPI-producing plants.
    Some commenters favored still more stringent requirements. They 
argued in favor of more restrictive oversight of PMPI-producing plants 
than was provided for in either the proposed rule or the existing 
regulations. They asserted that allowing PMPI-producing plants to be 
grown outdoors without APHIS oversight does not comport with the OIG's 
recommendations on regulating PMPI-producing plants to prevent 
inadvertent release.
    Finally, a few commenters stated that they did not consider PMPI-
producing plants to present inherent risks and argued that developers 
of PMPI-producing plants should be able to sufficiently self-regulate 
the planting of such plants. Some of these commenters took the view 
that APHIS' regulatory oversight over PMPI-producing plants was, if 
anything, already excessive and would remain excessive or become still 
more so under the proposed rule. One commenter stated that developers 
should be given the option to be regulated by the agency most relevant 
to their GE products. Other commenters stressed the need for APHIS and 
FDA to have a memorandum of understanding

[[Page 29819]]

(MOU) for the regulation of PMPI-producing plants.
    After considering the comments received, we have decided to 
continue to maintain regulatory oversight of PMPI-producing plants by 
continuing to require permits for their movement. We are adding this 
requirement to Sec.  340.2 of this final rule as paragraph (e), which 
states that a permit is required for the movement of a plant that 
encodes a product intended for pharmaceutical or industrial use. 
Accordingly, PMPI-producing plants will not be eligible for the RSR 
process. We also have determined that APHIS can continue to exercise 
oversight of PMPIs pursuant to our existing statutory authority under 
the PPA. We discuss how we arrived at this determination below.
    The commenters who favored more stringent oversight of PMPI-
producing plants than under the current regulations often considered 
them to present a significant inherent risk by virtue of being PMPI-
producing plants and/or considered our existing regulations in part 340 
to contain inadequate safeguards.
    We do not agree that more regulatory oversight of PMPI-producing 
plants than under the current regulations is warranted, and we do not 
consider our current regulatory framework to provide inadequate 
safeguards. Since 1994 (58 FR 17047), we have required permits for the 
movement of plants that produce pharmaceutical compounds. In 2003, 
APHIS published an interim rule in the Federal Register (68 FR 46434-
46436, Docket No. 03-038-1) that extended this permitting requirement 
to plants that produce industrial compounds; that same year, we 
implemented additional safeguards for PMPI-producing plant field trials 
that exceeded those previously in effect. These added safeguards, which 
were implemented as permitting conditions, included requiring location 
coordinates, authorizing release only in low-production geographies for 
the particular crop at issue, requiring dedicated equipment, and 
providing for frequent inspections of each trial site.
    Since 2003, permits for field trials of PMPI-producing plants have 
made up a small percentage of the overall permits that APHIS has issued 
pursuant to the regulations in part 340. In the intervening 17 years, 
we have not encountered any issues with field trials of PMPI-producing 
plants that call into question the overall adequacy of our permitting 
conditions for PMPI-producing plants. Furthermore, over time, APHIS has 
regulated a large number of field trials of non-PMPI producing plants 
under permit conditions for diverse plants, traits, MOAs, geographic 
locations, and agroecological conditions. Regardless of whether the 
plant is a PMPI-producing plant or not, these permit conditions have 
been successful in ensuring that genetically engineered plants are 
confined to the field trial location. Based on our experience in 
permitting field trials of genetically engineered plants, we are 
confident in our ability to devise appropriate permit conditions to 
ensure confinement of all regulated plants, including PMPI-producing 
plants as we have done for the past 17 years.
    For this same reason, we do not consider it necessary to regulate 
PMPI-producing plants as Federal noxious weeds in accordance with our 
regulations in 7 CFR part 360, one of the options which we mentioned in 
the proposed rule. We believe that doing so could suggest that APHIS 
has identified unique risks associated with PMPI-producing plants based 
on our data since 2003; this is not the case. Instead, we agree with 
those commenters who have asked us to maintain our current level of 
regulatory oversight based on the framework first elucidated in 2003.
    The commenters who urged us to continue to exercise a similar or 
greater level of regulatory oversight of PMPI-producing plants do raise 
a salient point: PMPI-producing plants are not developed for food or 
feed use and can encode compounds that are intended to have a 
physiological effect in humans or animals. This is important for 
several reasons.
    First, in the 2003 interim rule that required permits for plants 
that encode for industrials, we stated that APHIS' regulatory 
experience and scientific familiarity lay primarily at the time with GE 
plants produced for food or feed. This remains the case; while the 
Agency certainly has more familiarity with PMPI-producing plants than 
we possessed in 2003, PMPI-producing plants account for less than one 
percent of the total number of GE plants for which we have issued 
permits, and none have been designated nonregulated. Accordingly, the 
Agency still has significantly more experience with GE plants that 
produce food or feed than with those that produce PMPIs.
    Second, as we set forth in the proposed rule, the intended use of 
PMPIs makes them differently situated than other GE plants regulated by 
APHIS, such that additional evaluation beyond RSR may be needed. We 
therefore consider it appropriate to maintain the status quo and 
continue to require permits for PMPI-producing plants.
    In such instances when the risks associated with a plant or 
organism are not fully understood, APHIS has interpreted its authority 
under sections 7711 and 7712 of the Plant Protection Act and its 
predecessor statutes to provide a basis for regulating the plant or 
organism based on our best understanding of the risks presented (see 58 
FR 17047; 68 FR 46434-46436).
    Accordingly, APHIS will continue to exercise its authority under 
the Plant Protection Act to maintain regulatory oversight of PMPI-
producing plants. FDA has authority under the Federal Food, Drug, and 
Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.) to take action to have 
foods withdrawn from the market if they contain PMPIs not approved for 
use in food. FDA also regulates drugs and human biological products 
under the FFDCA and therefore would have oversight over such products 
from PMPI-producing plants. FDA has not traditionally overseen field 
trials of PMPI-producing plants. APHIS will maintain the status quo by 
continuing to require permits for movement and environmental release of 
all PMPI-producing plants. It is not clear to us how an MOU between FDA 
and APHIS would be beneficial in providing oversight.
    One commenter recommended that we list categories of the types of 
PMPI-producing plants that could generate food adulteration, should 
they find their way into the food supply, and regulate only those types 
of PMPI-producing plants.
    Another commenter stated that we needed to clarify and possibly 
refine our overall regulatory approach to PMPI-producing plants. The 
commenter expressed a concern that a lack of clarity may result in 
unnecessary costs and time delays in bringing new products to market, 
thereby disproportionately impacting smaller developers and limiting 
the availability of new opportunities for farmers. As an example of a 
possible refinement to our regulatory approach, the same commenter 
suggested that in regulating PMPI-producing plants, APHIS should 
consider the likelihood that PMPI-producing plants will be produced in 
niche crops, which can be readily segregated from commodity crops, thus 
reducing the potential for their entering the food chain.
    APHIS does not plan to develop a list of food adulterants or of 
categories of the types of PMPI-producing plants that could generate 
food adulteration. As noted above, the primary oversight authority in 
matters concerning food

[[Page 29820]]

safety involving plants, such as whether the presence of a particular 
substance in a food would make it adulterated, rests with FDA rather 
than APHIS. With regard to the latter comment, in establishing 
permitting requirements for PMPI-producing plant field trials, APHIS 
does take into consideration the specific crop in which the PMPI is 
produced.
Regulation of Plant-Incorporated Protectants (PIPs)
    As noted in the preamble to the June 2019 proposed rule, certain 
plants are genetically engineered to produce PIPs, meaning that they 
produce pesticides. PIPs fall under the regulatory oversight of EPA. 
However, because EPA generally only requires Experimental Use Permits 
for field tests on 10 acres or more of land, only APHIS has 
historically exercised regulatory oversight over plantings of PIP-
producing plants on 10 acres or less of land.
    Under the provisions of the June 2019 proposed rule, there would be 
a likelihood that many PIP-producing plants that are currently 
regulated under APHIS permits or notifications could be determined not 
to be covered by the regulations after RSRs, because such plants are 
unlikely to pose greater plant pest risks by comparison with their 
comparators. Such plants could therefore be grown outdoors without the 
need for an APHIS permit and without undergoing APHIS oversight. Thus, 
Federal oversight over small-scale (10 acres or less) outdoor field 
test plantings of some PIPs would rest solely with EPA.
    Commenters expressed a broad range of views regarding the scope of 
our regulatory oversight over PIP-producing plants. Some commenters 
expressed the view that APHIS should leave the regulation of PIPs 
entirely to EPA. Others stated that APHIS should continue its oversight 
over PIP-producing plants in coordination with EPA to ensure that PIPs 
are regulated at all scales. Concerns were expressed by some commenters 
about what they perceived as potentially a broadened regulatory scope. 
It was stated that small releases of PIP-producing plants that are not 
currently subject to APHIS regulations could be regulated under the 
proposed rule.
    After reviewing these comments, we have decided that the approach 
presented in our June 2019 proposed rule remains appropriate. All PIPs, 
as noted in that rule, are properly under the regulatory oversight of 
EPA; to date, EPA has not seen a need to exercise oversight over PIP-
producing plants planted on 10 acres or less because APHIS has 
exercised such oversight.
    Accordingly, APHIS will continue to conduct oversight over PIP-
producing plants at all scales unless the PIP-producing plant were to 
meet the conditions for an exemption from regulation in our revised 
regulations, or were determined following RSR not to be covered by the 
regulations. If APHIS determines that a PIP-producing plant is not 
regulated under these regulations; EPA would still retain regulatory 
authority and may decide to require an Experimental Use Permit and 
provide oversight of field trials under 10 acres. APHIS has avenues for 
cooperation with EPA, such as an agreement to provide oversight 
assistance to EPA under the Economy Act, should EPA decide that 
oversight of small PIP field trials is appropriate.
    We have, however, decided to modify this final rule slightly to 
clarify the nature of this interaction between APHIS and EPA regarding 
PIPs. As noted above, we are adding a new Sec.  340.5(g) stating that a 
permit is not required for the movement of any GE plant modified solely 
to contain a PIP that is currently registered with EPA as a pesticide 
product pursuant to the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA, 7 U.S.C. 136 et seq.), or that is currently exempted from 
FIFRA pursuant to 40 CFR 174.21.
    Under FIFRA, EPA is authorized to regulate pesticides. Pursuant to 
FIFRA, EPA regulates certain PIPs as ``substances,'' and has 
established a registration process for their use as pesticides. In 
determining whether to grant a registration for a PIP with pesticidal 
properties, EPA conducts ecological risk assessments to determine what 
risks are posed by the PIP and whether changes to the use or proposed 
use are necessary to protect the environment. The product is registered 
under FIFRA and thereby eligible for sale on the market if the results 
of the risk assessment indicate that the pesticide will not pose any 
unreasonable risks to wildlife and the environment. Environmental 
effects considered include effects on nontarget organisms. A PIP that 
is currently registered will have undergone such a risk assessment and 
will therefore have been determined not to pose unreasonable risks to 
other plants. For that reason, we can exempt, and have decided to 
exempt, such PIP-producing plants from our regulations.
    We can also exempt, and have decided to exempt, modified PIP-
producing plants that EPA has exempted from FIFRA pursuant to 40 CFR 
part 174.21. Section 25(b) of FIFRA allows EPA to promulgate 
regulations to exempt from the requirements of FIFRA any pesticide 
which the Administrator determines is ``of a character which is 
unnecessary to be subject to [FIFRA] in order to carry out the purposes 
of [FIFRA].'' Pursuant to this statutory authority, EPA's regulations 
in 40 CFR part 174.21 set forth criteria used by EPA for exempting PIPs 
from FIFRA requirements, including that the genetic material encoding 
the PIP or leading to the production of the PIP is from a plant that is 
sexually compatible with the recipient plant. These criteria currently 
do not pertain to GE plants containing PIPs.
    However, if EPA were to establish criteria for exemption from FIFRA 
for certain additional plants containing PIPs, plants meeting those 
criteria would, by statute, have been determined by EPA to be of a 
character unnecessary to be subject to FIFRA in order to carry out the 
purposes of FIFRA. Because EPA could not make such a broad 
determination without consideration of the effects of such plants on 
the environment, including risks to other plants, we are exempting such 
plants from APHIS permitting requirements, as well.
    Other commenters expressed concern that small releases of PIP-
producing plants that are not currently subject to APHIS regulations 
could be regulated under this rule.
    It is true that a GE PIP-producing plant that is not created using 
a plant pest as a donor organism, recipient organism, or vector or 
vector agent, was previously exempt from APHIS regulations under part 
340 but could fall within the scope of these revised regulations if it 
does not qualify for an exemption under Sec.  340.1 or under new Sec.  
340.5(g). This is, in fact, true of all GE plants that are created 
without the use of a plant pest donor organism, recipient organism, or 
vector or vector agent. However, as we discuss at greater length in the 
economic analysis that accompanies this final rule, we believe the 
number of producers and products that may be newly regulated as a 
result of this rule is extremely small. Moreover, we are not aware of 
any GE
    PIP-producing plant that has been produced to date without the use 
of a plant pest as the donor organism, recipient organism, or vector or 
vector agent.
    Finally, one commenter stated that regulating PIPs more strictly 
than regulating chemicals is not scientifically justifiable. The 
commenter noted that EPA considers biological pesticides, including 
PIPs, to ``generally pose less risk than most conventional 
pesticides.''

[[Page 29821]]

    This comment pertains to EPA's regulatory structure for PIPs. As 
such, it is outside the scope of the current rulemaking.
International Trade Implications
    A number of commenters expressed the concern that the regulatory 
approach that underpins this rulemaking is out of step with that of key 
international markets and governments. It was suggested that the rule 
could result in greater asymmetry in regulatory approach between APHIS 
and U.S. trading partners, thereby endangering U.S. export markets, and 
that obtaining international acceptance of our new regulatory approach 
should be a precondition for finalization. A commenter further stated 
that we need to balance our regulation of GE organisms with the need 
for industry to comply with international markets that are sensitive to 
the unintended presence of GE organisms in non-GE products.
    The fundamental APHIS protection goal under our regulations in part 
340, which stem from and are delimited by our statutory authority to 
regulate plant pests under the PPA, is to protect agriculture against 
increased plant pest risks resulting from GE organisms. This regulatory 
approach has always been different from that of other national systems, 
which may not necessarily focus on plant pest risk and instead may be 
technique-based. Nevertheless, our trading partners have historically 
judged our approach to be acceptable, as it is transparent and science- 
and risk-based. Trading partners that have understood and accepted our 
regulatory system will not find our updated approach to meeting the 
same objectives confusing. Thus, we do not see this revised system as 
less compatible with those of our trading partners than in the past. As 
we have in the past, we will continue to provide technical expertise, 
information, and explanation to our trading partners regarding our 
regulatory system and determinations of regulatory status.
    It was further stated by commenters that a possible consequence of 
the unwillingness of trading partners to accept our new regulatory 
approach could be the undermining of the progress being made in the 
Global Low-Level Presence Initiative (GLI), in which countries 
(including the United States) are striving to achieve a science-based 
and risk-based approach that would allow for a commercially achievable 
tolerance for the presence of a biotechnology-enhanced trait that (1) 
has been approved as safe by an exporting country based upon scientific 
analysis and CODEX-adopted risk assessment principles, but (2) has not 
yet been approved by an importing country. Additionally, the commenter 
interpreted the U.S.-Mexico-Canada Agreement (USMCA) to expressly 
commit all three countries to develop a low-level presence policy for 
imports.
    To maintain global acceptance for its regulatory approach, APHIS 
needs to continue to maintain and enhance its credibility and its 
leadership role in the field of biotechnology regulation. It was with 
that goal in mind that we proposed these new regulations, which reflect 
both the knowledge we have gained, over the more than 30 years since we 
first promulgated our biotechnology regulations, and new developments 
in the field.
    While it is gratifying that the APHIS system of regulation is 
perceived to provide protection against commingling or low level 
presence of plant products that are unwanted or are unauthorized in 
foreign (or even domestic) markets, the PPA, under which these 
regulations are promulgated, does not authorize APHIS to use the 
potential for low level presence as a basis for determining regulatory 
status or for monitoring what has been commercialized. USDA recognizes 
the focus of the Codex Guideline for the Conduct of Food Safety 
Assessment of Foods Derived from Recombinant DNA Plants (2003) and the 
associated annex addressing low level presence, an international 
standard. However, we note that the subject of this guidance and its 
agreed-upon annex is for food safety alone. USDA-APHIS reviews GE 
plants for the potential for plant pest risk, not food safety.
    Finally, we disagree with the commenter's interpretation of the 
USMCA. We note that it instead stipulates that each Party shall adopt 
or maintain policies or approaches designed to facilitate the 
management of any LLP Occurrence. It does not mandate development of an 
overarching policy.
    Elaborating on the concerns discussed above, some commenters 
emphasized the need for APHIS to develop and execute an international 
engagement strategy with our trading partners that explains the 
rationale for APHIS' pre-market regulatory approaches.
    For 30 years, APHIS has consistently engaged and led in many 
international contexts to provide knowledge of its regulatory policy, 
science, and systems to encourage the safe development and trade of the 
products of agricultural biotechnology. Most recently, APHIS has worked 
to implement the Presidential Executive Order Modernizing the 
Regulatory Framework for Agricultural Biotechnology Products (June 11, 
2019, E.O. 13874) to ``provide leadership in international fora to 
promote scientific competency, understanding of the U.S. regulatory 
approach, and regulatory compatibility worldwide for biotechnology 
products.'' \11\ For the past several years, APHIS has shared 
rationales, experience, and information on potential regulatory changes 
with U.S. trade agencies (e.g., the United States Trade Representative, 
the Department of State, the USDA Foreign Agricultural Service), U.S. 
trading partners, like-minded countries, and other countries in order 
to garner understanding and support for this updated regulatory 
approach. APHIS intends to continue such engagement.
---------------------------------------------------------------------------

    \11\ National Strategy for Modernizing the Regulatory System for 
Biotechnology Products. September, 2016.
---------------------------------------------------------------------------

Statutory Authority, Jurisdiction, and Interagency Coordination
    We received many comments regarding our statutory authority, or 
lack thereof, to implement our proposed regulations. Some commenters 
claimed that we did not have such authority, while others expressed the 
view that we were abdicating the authority we do possess and, in some 
cases, failing to meet our statutory obligations. Some of these issues 
have already been discussed elsewhere in this document in relation to 
topics such as allowing developers to determine whether their products 
are eligible for exemption.
    As noted above, we base our determinations of regulatory status on 
whether a GE plant or its sexually compatible relatives could pose an 
increased plant pest risk relative to the comparator(s). One commenter 
asserted that the PPA gives the Secretary the authority to develop 
regulations for the movement of plant pests only, and not the authority 
to develop regulations for the movement of organisms that pose a plant 
pest risk.
    We do not agree with this comment. In addition to the authority to 
regulate the movement of plant pests under Sec.  7711 of the PPA, 
including ``[a]ny article similar to or allied with any of the'' 
specific plant pests listed in Sec.  7702(14), as cited by the 
commenter, we note that Sec.  7712 of the PPA specifically provides the 
Secretary with broad authority to protect plants by regulating the 
movement of, among other items, plants and articles in order to prevent 
the introduction or dissemination of a plant pest within the United 
States.

[[Page 29822]]

    As noted many times in this document, for GE organisms that fall 
under the regulations, permits are required for three activities: 
Importation, interstate movement, and environmental release. One 
commenter asserted that regulation of environmental releases done 
within a State or territory is unconstitutional.
    We do not agree with this comment. The impact of an unauthorized 
environmental release may extend beyond the borders of the State in 
which the GE organism was released. See Atay v. County of Maui, 842 
F.3d at 701-02 (``Under the PPA, `movement' is defined broadly and 
expressly includes a plant's `release into the environment,' [7 U.S.C.] 
Sec.  7702(9)(E), such as open-air field testing of GE plants. 
Experimental GE plants grown on test fields in Maui are without doubt 
involved in interstate commerce. Setting aside the global market for GE 
seed crops, seeds and other organisms carried afield by wind or other 
vectors ``do not acknowledge State lines.'' 52 FR 22892, 22894 (June 
16, 1987).'') (citation omitted); id. at 702 (``While the phrase 
`movement in interstate commerce' within the meaning of the PPA's 
preemption clause may be narrower than the full scope of Congress's 
Commerce Clause power, we find that the phrase encompasses federally 
regulated GE crops grown in Hawaii. [The plaintiff's] narrower 
interpretation, which would limit the scope of the preemption clause to 
local laws addressing plants that are in the act of traveling to or 
through at least one other State, is less consistent with the statute's 
larger context and purpose, which clearly envisions the dissemination 
of plants and seeds from fields as implicating movement in interstate 
commerce. See, e.g., 7 U.S.C. 7711(a). Indeed, Congress expressly 
recognized in the PPA that `all plant pests, noxious weeds, plants, 
plant products, articles capable of harboring plant pests or noxious 
weeds regulated under this chapter are in or affect interstate 
commerce.' Id. Sec.  7701(9).'') (citation omitted).
    In contrast to the comments discussed above, which questioned the 
reach of our authority to regulate, other comments faulted us for not 
using our authority to regulate noxious weeds under the PPA. It was 
stated that by not considering noxious weed potential as a criterion 
for determining regulatory status of GE organisms, we restrict our 
authority under the PPA. One commenter argued that APHIS is statutorily 
obligated to integrate and apply the noxious weed authority to GE 
crops.
    APHIS recognizes that genetic engineering may be used to introduce 
a trait that increases the distribution, density, or development of a 
plant or the weedy impacts of the plant, factors that are considered 
aspects of a plant's weediness. Accordingly, we would continue our 
current practice of considering the weediness of the unmodified plant 
and whether the new trait could in any way change the weediness. We 
would also consider potential effects on the weediness of other plants 
with which the engineered plant can interbreed, because it is relevant 
to the assessment of the plant's plant pest risk. Plants and their 
sexually compatible relatives could have increased importance as 
reservoirs for plant pests if they are distributed differently, are 
more prevalent, or are altered with respect to the time period during 
which they serve as a host for plant pests due to the introduced trait. 
As part of the RSR, APHIS would continue to consider whether the trait 
might change plant pest interactions, establishment, and persistence 
for both the plant engineered and any other plants with which it can 
interbreed. If the plant had the potential to be a truly troublesome 
and impactful weed, we would need to consider whether the plant with 
the specific trait being evaluated should be considered for regulation 
pursuant to our separate statutory authority to regulate noxious weeds 
and the regulations issued under that authority. The proposed 
regulation does not change this analysis.
    APHIS disagrees with the proposition that APHIS is statutorily 
obligated to integrate noxious weed authority into a revised part 340. 
In the PPA, Congress identified plant pests and noxious weeds as 
separate concerns, and delegated authority to the Secretary to 
determine how to best use this authority. See, e.g., 7 U.S.C. 7711, 
7712, 7754, 7758(c); see also Center for Food Safety v. Vilsack, 718 
F.3d 829, 843 (9th Cir. 2013) (``Plant pests and noxious weeds are 
regulated under separate regulatory frameworks. Regulations for plant 
pests are contained in 7 CFR parts 330 and 340 while the regulations 
governing noxious weeds are contained in 7 CFR part 360. The separate 
regulatory frameworks for plant pests and noxious weeds are consistent 
with standards of the statute treating plant pests and noxious weeds 
separately. Indeed, the PPA kept in place the separate regulatory 
frameworks for plant pests and noxious weeds that were originally 
promulgated under the Federal Plant Pest Act and the Federal Noxious 
Weed Act.'') (Citing 7 U.S.C. 7758(c)). We also do not perceive a basis 
at this time for overhauling part 360 noxious weed regulations, which 
we believe have functioned well over the years, or establishing 
alternate regulations in title 7 governing noxious weeds.
    Other commenters expressed the concern that by asserting our 
statutory authority narrowly and emphasizing deregulation in this 
rulemaking, we could be creating a regulatory vacuum. It was suggested 
that States or localities may take advantage of that vacuum and assert 
their own authorities, possibly intervening to disrupt necessary field 
trials.
    With regard to overall scope, the regulations proposed under part 
340 are functionally equivalent to the rules under which APHIS has been 
operating for essentially three decades. Under the existing 
regulations, APHIS communicates with and cooperates with State and 
local governments as appropriate and as circumstances warrant, 
including for coordination of enforcement and permitting activities. 
APHIS does not anticipate that the working relationship with State and 
local governments will be changed in any significant way based upon 
issuance of this rule. Federal courts have already considered the 
applicability of preemption principles in this area, including by 
applying the Plant Protection Act's express preemption provision, 7 
U.S.C. 7756. See generally Atay v. County of Maui, 842 F.3d at 698-705.
    Some commenters addressed issues of interagency and intra-agency 
coordination in the regulation of GE products. A commenter suggested 
that we needed to coordinate with EPA to improve the commercial 
availability of herbicide resistant crops, concomitant with the 
registration of herbicides for use on those crops. The commenter stated 
that the asynchronous timing of USDA's deregulation of an herbicide-
resistant crop cultivar and of EPA's associated herbicide registration 
has led to some scenarios in which growers are tempted to illegally 
apply unregistered herbicide formulations. Another commenter stated 
that duplicative regulations from oversight agencies, including FDA, 
EPA, and APHIS, should be streamlined into a common regulatory 
oversight regime depending on the product and its intended use.
    The interagency working group which drafted the Coordinated 
Framework sought to ensure regulation adequate to ensure health and 
environmental safety while maintaining sufficient regulatory 
flexibility to avoid impeding beneficial innovation. The former 
commenter

[[Page 29823]]

believes that a delay in USDA regulatory decisions to better coordinate 
with EPA registration decisions will curtail growers and applicators 
from illegally applying unregistered herbicide formulations. However, 
USDA needs to consider whether additional regulatory burden is 
warranted or legally appropriate, given that the pesticide activity 
noted is already considered to be illegal by existing regulation. We 
note that one of the purposes of the Coordinated Framework is to ensure 
that there is a standard mechanism for communication and, to the extent 
possible, coordination among FDA, EPA, and APHIS as they perform their 
respective regulatory functions. USDA and EPA are in communication over 
the overarching purpose of coordination as it pertains to the pesticide 
regulatory issues identified by the commenter. At the same time, this 
rule does not impose delays on USDA decision making based on factors 
within the regulatory jurisdiction of other agencies, nor do we think 
that such delays would be appropriate.
    With regard to the latter commenter, while FDA, EPA, and APHIS have 
distinct areas of regulatory oversight relative to GE organisms, the 
Agencies are committed to implementing Executive Order 13874, including 
its requirements that EPA and USDA streamline regulations and guidance 
documents within their purview and that these agencies ``use existing 
statutory authority, as appropriate, to exempt low-risk products of 
agricultural biotechnology from undue regulation.'' Where areas of 
overlapping jurisdiction exist, the Agencies are seeking to avoid 
redundant regulation. For example, FDA has jurisdiction over animals, 
including insects, but does not regulate when another agency is 
regulating, as APHIS is with GE moths and bollworm. With this rule, 
APHIS is avoiding redundant regulation with regard to microbial 
pesticides and plant incorporated protectants. As noted above, new 
Sec.  340.5(f) states that a permit is not required for any GE 
microorganism product that is currently registered with the EPA as a 
microbial pesticide, so long as the microorganism is not a plant pest 
as defined in Sec.  340.3. Similarly, Sec.  340.5(g) states that a 
permit is not required for the movement of any plant modified solely to 
contain a plant incorporated protectant that is currently registered 
with the EPA or exempt from EPA regulations.
    Finally, multiple commenters recommended that we provide greater 
clarity regarding the regulatory jurisdiction of two agencies within 
APHIS--Biotechnology Research Services (BRS) and Plant Protection and 
Quarantine (PPQ)--that regulate, among other things, GE and non-GE 
plants, respectively. The commenters expressed concern that some of the 
revisions we proposed, in particular those in Sec.  340.2, may create 
opportunities for duplicative regulation of products under part 340 by 
BRS and under 7 CFR part 330 by PPQ.
    The regulations in part 330 govern the movement of plant pests, 
biological control organisms, and associated articles, such as soil. 
Prior to a final rule \12\ published in the Federal Register on June 
25, 2019 (84 FR 29938-29967, Docket No. APHIS-2008-0076), the 
regulations in part 330 had specifically exempted from regulation under 
that part any plant pests that had been genetically engineered, as that 
term was defined in Sec.  340.1. In the June 25, 2019 final rule, that 
specific exemption was removed from part 330. In its place, a 
requirement, currently found in Sec.  330.200(a), was added. This new 
requirement provided that plant pests, biological control organisms, 
and associated articles that are not authorized for importation, 
interstate movement, or environmental release in accordance with part 
330, and are not explicitly exempted from regulation under part 330, 
must be authorized for importation, interstate movement, or 
environmental release under other regulations in title 7 of the Code of 
Federal Regulations in order for that movement to be lawful.
---------------------------------------------------------------------------

    \12\ To view the rule, its supporting documents, or the comments 
that we received, go to https://www.regulations.gov/docket?D=APHIS-2008-0076.
---------------------------------------------------------------------------

    The intent of this revision was to signal that there are multiple 
parts in title 7 of the Code of Federal Regulations, not just part 330, 
that contain requirements regarding the importation, interstate 
movement, or environmental release of plant pests, biological control 
organisms, or associated articles. However, we agree with the commenter 
that one of the unintended effects was to cause confusion within this 
rulemaking concerning the clear delineation between the requirements 
for the movement of GE plant pests, which are found in part 340, and 
the requirements for plant pests that had not been genetically 
engineered, which are found in part 330.
    Accordingly, we are revising Sec.  330.200 to indicate that GE 
plant pests and biological organisms are exempted from regulation under 
part 330, and are regulated under part 340.
    A commenter expressed the concern that this rulemaking does not 
further the Coordinated Framework established in the 1980s among USDA, 
FDA, and EPA regarding federal biotechnology regulation. The commenter 
states that the proposed rule amended part of this Coordinated 
Framework without fully engaging EPA and FDA and did not reflect a 
truly holistic approach, in the spirit of the Framework, to updating 
the regulatory landscape for certain GE plants. The commenter strongly 
believes that APHIS should follow the intent of the Coordinated 
Framework.
    APHIS has continued to coordinate with our Coordinated Framework 
partners at FDA and EPA on an ongoing basis, and we are committed to 
continuing this coordination with the implementation and 
operationalization of this rule. In 2017, the three agencies 
collaborated on an update to the Coordinated Framework. This update was 
intended to:
     Clarify which biotechnology product areas are within the 
authority and responsibility of each agency;
     Clarify the roles each agency plays in regulating 
different product areas, particularly for those products that fall 
within the scope of multiple agencies, and how those roles relate to 
each other in the course of a regulatory assessment;
     Provide a standard mechanism for communication and, as 
appropriate, coordination among agencies while they perform their 
respective regulatory functions, and identify agency designees 
responsible for this coordination function; and
     Specify the mechanisms and timelines for regularly 
reviewing, and updating as appropriate, the Coordinated Framework to 
minimize delays, support innovation, protect health and the environment 
and promote public trust in the regulatory systems for biotechnology 
products.
    The updated Coordinated Framework is available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf.
    Additionally, as part of the rulemaking process, EPA and FDA have 
had the opportunity to comment on this proposal and to provide 
meaningful insight that informed this process.
    Another commenter stated that language in the section of the 
proposed rule describing regulation of PMPI-producing plants suggests 
that the Coordinated Framework for regulating GE crops in the United 
States is not nearly as ``coordinated'' as is necessary to ensure the 
safety of our food supply. According to this commenter, a statute 
should be enacted to create a new Federal agency that would have 
explicit authority to provide oversight over all GE organisms (plants, 
animals, and GE

[[Page 29824]]

microorganisms) for all possible risks, including plant pest and 
noxious weed risks, environmental risks to beneficial organisms as well 
as to ``neutral'' organisms like monarch butterflies, and human health 
risks such as those associated with animal carcinogens and probable 
human carcinogens like glyphosate.
    Regulation of PMPI-producing GE plants is discussed above. The 
remainder of this comment is outside the scope of the current 
rulemaking and of APHIS' regulatory authority. We note, moreover, that 
scientific evidence does not support the conclusion that GE organisms, 
as a class, present risks that are different in degree or kind from the 
risks that are presented by comparable non-GE organisms (NRC, 2010; 
NAS, 2016b)
NEPA Implementing Regulations
    As noted earlier, the June 2019 proposed rule proposed that the 
notification and petition processes be removed from the regulations. 
Concurrently, we proposed to remove language pertaining to 
notifications and petitions from the NEPA implementing regulations in 7 
CFR part 372. Specifically, we proposed to remove language pertaining 
to notifications from Sec.  372.5(c)(3)(iii), and to remove language 
pertaining to petitions from paragraphs (b)(7) and (c)(4) of Sec.  
372.5. These changes were proposed to make the NEPA regulations 
consistent with the proposed revised part 340.
    Several commenters recommended that APHIS revise its NEPA 
implementing regulations to ensure that individual actions taken under 
the proposed rule are appropriately addressed and to describe the type 
of environmental analysis and documentation that will generally be 
developed. One commenter stated that APHIS should revise Sec.  372.5(b) 
to include the proposed RSR as a type of action that normally requires 
an environmental assessment but not necessarily an Environmental Impact 
Statement. Another commenter recommended that APHIS clarify that 
certain actions are not expected to have an impact on the environment 
and therefore qualify for a categorical exclusion from the requirements 
of NEPA.
    APHIS disagrees with the suggestion that part 372 needs to be 
further revised to more specifically describe the type of environmental 
analysis that is necessary for individual actions under the final rule. 
Actions will be accompanied by appropriate environmental analysis based 
on the degree of environmental impact, consistent with the final 
programmatic environmental impact statement (PEIS). In regard to the 
new proposed RSR, APHIS stated in the final PEIS that RSRs will be 
accompanied by an appropriate environmental analysis depending on the 
degree of environmental impact.
    APHIS seeks to further clarify APHIS' NEPA obligations under 
various circumstances. When a modified plant qualifies for one of the 
exemptions in Sec.  340.1(b), (c), or (d), the plant is not subject to 
part 340 at all and APHIS renders no determination regarding its plant 
pest risk. Therefore, APHIS will not complete a NEPA analysis for the 
plant.
    In the case of RSRs, whether conducted before or after a person 
requests a permit, only some outcomes will require analysis pursuant to 
NEPA. If, after initial review, APHIS finds a plausible pathway to 
increased plant pest risk, APHIS will conduct a Plant Pest Risk 
Assessment (PPRA) to evaluate the factor(s) of concern. In this 
situation, APHIS will complete a NEPA analysis, as appropriate, for an 
unconfined environmental release. Finally, when permits are issued for 
confined environmental release, NEPA will apply as appropriate. Under 
most circumstances, confined environmental releases are categorically 
excluded in part 372 from the need to prepare an Environmental 
Assessment or an Environmental Impact Statement.
List of Taxa
    In the preamble to the June 2019 proposed rule, we noted that we 
were proposing to remove the list of taxa containing plant pests from 
the regulations. Instead, APHIS proposed to maintain a list of taxa 
that contain plant pests on its website. We explained that the list on 
the website would be more useful and reliable than a static list of 
taxa, which becomes outdated. We solicited public comment on the 
proposed change.
    Commenters supported this change. One commenter, however, suggested 
that it would be useful to maintain a version history on the website, 
so that developers can be aware of the latest updates. The commenter 
also recommended that whenever the website is updated, APHIS should 
send an email notification to stakeholders. Another commenter requested 
clarification on how the list would be maintained and modified.
    APHIS agrees with the comment. Since taxonomic designations 
sometimes change and new plant pests are continually being discovered, 
APHIS will maintain a version history for the list of taxa that contain 
plant pests and will provide an email notification to stakeholders when 
the list is changed.
Oversight and Transparency
    Some commenters expressed the concern that the regulatory framework 
set forth in the June 2019 proposed rule would result in an overall 
weakening of APHIS' regulatory oversight over GE products. Commenters 
discussed a number of potential consequences of what they regarded as 
diminishing APHIS' oversight role. As noted earlier in the discussion 
pertaining to allowing developers to determine whether their products 
are eligible for exemption, commenters were concerned that there could 
be an increased risk of commingling of non-GE crops with GE crops. It 
was also stated that because GE crops are already associated with 
greater herbicide and pesticide use than non-GE crops, the rule could 
result in the development of more herbicide- and pesticide-resistant 
pests and weeds, leading to increased environmental and human health 
risks. Some commenters stated that we needed to strengthen, rather than 
loosen, our regulatory oversight.
    We have addressed many of these issues earlier in this document and 
the PEIS (Sec. Sec.  4.3.5 Agricultural Weeds and HR management; 4.6.2 
Domestic Socioeconomic Environment; and 4.6.3 International Trade). 
Additional discussion is presented below, under the heading ``General 
Opposition to GE Products.'' As we have noted, however, these issues 
are mostly outside the scope of the current regulations and of our 
statutory authority under the PPA.
    It was also suggested that the proposed new regulatory framework 
could lead to a loss of transparency. Growers of non-GE crops, as noted 
above, could lose access to information about neighboring GE crops. 
According to some commenters, the public would also lose access to 
important data. In particular, field-test data would no longer be 
available to the public because the submission and publication of such 
data would not always be required under the proposed rule.
    One commenter recommended that in addition to providing the 
information currently set forth in the proposed rule, APHIS should 
establish on its website a single list of all GE organisms that are 
being released into the environment. According to the commenter, that 
list should include all plant-trait-MOA combinations, all RSRs, all 
permitting, and all confirmations of developers' determinations of an 
exemption. The commenter believes that with a complete and accurate 
list of all GE organisms that have been released into

[[Page 29825]]

the environment, food industry stakeholders and the public will be able 
to determine which GE plants have entered the food supply. Further, 
according to the commenter, a transparent and comprehensive list will 
provide helpful information if any food safety and environmental 
threats materialize. In the commenter's view, this information will 
also be important for international trade because it may prevent 
unnecessary trade barriers from being constructed based on inaccurate 
information about which GE plants may be entering a country without the 
proper regulatory approval. Also, according to the commenter, it will 
improve consumer confidence about GE plants because consumers will 
realize that their existence is not being hidden from them. The 
commenter recommended that to be as useful and as transparent as 
possible, the list should include information about the plant, the type 
of modifications or edits performed, the changed traits, a summary of 
data about the benefits of the traits, and any testing for safety 
concerns.
    We do not agree with these comments. Under this rule, APHIS will 
continue to make information available that is related to permits 
issued under Sec.  340.5. APHIS will also make information available 
concerning responses to confirmation requests under Sec.  340.1 and RSR 
requests and results under Sec.  340.4. The information will be 
available at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. 
As to organisms that are not regulated by APHIS, APHIS is not in the 
best position to provide accurate and up-to-date information about such 
organisms. In this regard, APHIS notes that pursuant to Executive Order 
13874, USDA, EPA, and FDA recently released a unified website that 
provides a one-stop-shop for information about the actions that the 
Federal Government is taking to oversee the development of agricultural 
biotechnology products. See https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home. The 
website provides links to relevant USDA, EPA, and FDA websites. See 
https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/resources.
General Opposition to GE Products
    Many individuals who commented opposed the rule because of their 
concerns about GE products generally. An issue of particular concern, 
raised by a large number of commenters, was the possibility of unsafe 
GE products' getting into the food supply without consumers' knowledge. 
Many of the commenters favored labeling of foods derived from GE 
products. Commenters expressed the view that genetic engineering 
techniques are not as safe as conventional breeding methods and that 
all products developed using genetic engineering should be regulated, 
with no exemptions allowed. Others stated that we should require long-
term testing of GE products prior to allowing commercialization. It was 
further stated that in light of these considerations, our proposed 
regulatory approach, with its focus on unfamiliar products developed 
using genetic engineering, does not adequately evaluate products of 
genetic engineering for potential long-term risk. Many commenters 
argued that all GE organisms should be subject to assessments of their 
long-term effects on the environment and human health and also 
evaluated for indirect economic effects. Commenters also claimed that 
the proposed rule, with its deregulatory emphasis, favored certain 
economic interests at the expense of public health and safety and the 
environment.
    One commenter further stated that APHIS or a new GE organism-
specific agency should provide oversight over all GE organisms for all 
possible risks, including any associated with the MOA used for gene 
insertion, e.g. extra antibiotic-resistance genes, insertional 
mutations, and unintended changes in the inserted genetic material. 
According to this commenter, APHIS should require developers of GE 
organisms to utilize the precision of the technology available to 
identify the off-target effects of genetic engineering and to ensure 
that associated risks are minimal.
    The comments discussed above appear to be based on the premise that 
the genetic engineering process itself is inherently risky. As we noted 
in the preamble to the June 2019 proposed rule, and in this document, 
available evidence, including reports from the National Academies of 
Sciences, Engineering, and Medicine cited earlier in this document, 
does not support this view. Moreover, the comments discussed above do 
not reflect an accurate understanding of the limits of APHIS' statutory 
authority, as explained elsewhere in this preamble.
    In the reports we cited, issued in 1987 and 1989, respectively, by 
the NRC,13 14 it was stated that there was no evidence for 
unique hazards inherent in the use of recombinant DNA techniques and 
that with respect to plants, crops modified by molecular and cellular 
methods should pose risks no different from those modified by 
conventional breeding methods for similar traits. A key conclusion from 
these reports, taken together, is that it is not the process of genetic 
engineering per se that imparts the risk, but the trait or traits that 
it is used to introduce. A more recent NAS report, issued in 2016, 
reaffirmed this conclusion.\15\
---------------------------------------------------------------------------

    \13\ Introduction of Recombinant DNA-Engineered Organisms Into 
the Environment: Key Issues. 1987. NRC. Washington, DC. National 
Academies Press (US).
    \14\ Field Testing Genetically Modified Organisms: Framework for 
Decisions. 1989. NRC (US) Washington (DC). National Academies Press 
(US).
    \15\ NAS. 2016. Genetically Engineered Crops: Experiences and 
Prospects. Washington, DC: The National Academies Press. doi: 
10.17226/23395.
---------------------------------------------------------------------------

    Several commenters took a position diametrically opposed to the 
comments discussed above. The commenters stated that there is no 
scientific rationale for the continued regulation of plant products 
developed using genetic engineering techniques and legacy methods.
    We do not agree with this comment. As discussed above, 
responsibility for regulating GE and non-GE plants for plant pest risk 
is divided between APHIS BRS and APHIS PPQ. In both cases, plants and 
plant products are regulated or not regulated based on the risk of 
introducing or disseminating plant pests that may be posed by their 
movement or release into the environment. Because some (but not all) GE 
and non-GE plants are associated with increased risk, it is necessary 
for APHIS to regulate such plants in order to carry out its mission of 
protecting U.S. agriculture.
    Concerns were expressed by the organic farm industry regarding the 
economic impact that the regulatory relief offered to developers in 
this rulemaking would have on organic farmers, particularly as it 
relates to the issue of GE crops commingling with organic crops. The 
commenters stated that APHIS must consider how it will address the 
needs of USDA-certified organic operations to prevent commingling with 
GE organisms. Such considerations, it was stated, were not addressed in 
the proposed rule. The commenters asserted that the USDA National 
Organic Program regulations prohibit the use of genetic engineering in 
the production of agricultural products marketed as organic in the 
United States. According to these commenters, even inadvertent presence 
of GE organisms can jeopardize the organic status of an otherwise 
compliant organic product, and can lead to loss of markets and 
significant industry disruption. Organic farms that reported crop loss 
from the presence of GE organisms between 2011 and 2014

[[Page 29826]]

reported an average loss of $70,000 per farm (2014 USDA Organic 
Survey).
    APHIS has fully considered these factors from an economic 
perspective and would refer the commenter to the economic analysis 
accompanying this final rule. APHIS in that analysis expanded the 
discussion of the various costs, including the costs associated with 
buffer strips, spatial and temporal isolation, and the loss of premiums 
associated with the risk to organic and non-GE growers from cross-
pollination or commingling. We note that organic crops and non-GE 
products that are kept separate from their GE equivalents are treated 
as value-added crops commanding premiums that vary according to 
prevailing supply and demand conditions. Organic and other identity-
preserved crops generally receive a price premium, a premium adversely 
impacted by the unintended presence of GE traits. The premiums 
compensate farmers and traders for incremental costs they incur, 
including those borne to maintain the segregation of non-GE and other 
IP production from GE crops throughout the supply chain (through buffer 
zones, spatial and temporal isolation, etc.). In the United States, the 
coexistence of GE and non-GE production systems has been left to market 
forces. Non-GE growers bear costs of coexistence and, in turn, pass 
those costs on to purchasers of non-GE crops (Kalaitzandonakes and 
Magnier, 2016).
    One commenter stated that in addition to the threat of economic 
harm from unintended presence of GE plant material, farmers who 
unintentionally grow patented GE seeds or who harvest crops that are 
cross-pollinated with GE traits could face costly lawsuits by 
biotechnology companies for ``seed piracy.''
    The issue raised by the commenter is outside the scope of the plant 
pest authority delegated to APHIS under the PPA.
    Some commenters argued that APHIS should conduct ongoing monitoring 
and assessment of GE product impacts both in pre-market field trials 
and following commercialization in order to protect the integrity of 
conventional and organic seed and crops from prohibited substances and 
excluded methods, including the methods of genetic engineering. 
According to these commenters, safeguards and monitoring must be 
required for the organism post-commercialization, and the FDA GRAS 
(Generally Recognized as Safe) notification process is not enough for 
such safeguards. In these commenters' view, monitoring should include 
tracking changes associated with ecosystem harm, such as degradation of 
water quality, air pollution, climate impacts, or loss of biological 
resources. The commenters believe that this process must be rigorous, 
transparent, and inclusive of APHIS's plant pest and noxious weed 
authority under the PPA.
    APHIS does not agree with these comments. Once APHIS determines 
that a plant product does not pose a plant pest risk, APHIS has no 
further authority to regulate it as such and to mandate requirements 
for the submission of data unless there are new facts, such as a 
compliance incident, that warrant such action. The FDA regulates human 
and animal food from GE plants as FDA regulates all food within its 
regulatory jurisdiction. The existing FDA safety requirements impose a 
clear legal duty on everyone in the farm to table continuum to market 
safe foods to consumers, regardless of the process by which such foods 
are created. It is unlawful to produce, process, store, ship or sell to 
consumers unsafe foods. Comments concerning FDA's process and 
requirements should be directed to FDA.
    One commenter discussed the need for compensating organic and other 
growers of non-GE crops who could suffer harm as a result of this 
rulemaking. It was argued that we need to establish a compensation 
mechanism for those harmed by commingling, and that liability in cases 
of commingling caused by GE crops should rest with the developers or 
patent holders. One commenter also recommended that we establish a fair 
compensation mechanism for losses caused by herbicides drifting from 
fields planted with herbicide-resistant GE plants.
    We thank the commenters for these recommendations; however, they 
fall outside the scope of the regulations in part 340, which establish 
the oversight and regulation of certain GE organisms. Regarding the 
final comment, application protocols/practices for pesticides are 
established and enumerated through EPA's labeling requirements. Once 
APHIS determines that a plant product does not pose a plant pest risk, 
it is not subject to our regulations in part 340 unless there are new 
facts, such as a compliance incident, that warrant such action.
Additional Comments
    Commenters offered a number of additional recommendations that are 
beyond the scope of the current rulemaking. Some commenters recommended 
that we invest in research to develop lower-cost rapid testing 
technology. It was further suggested that we commit resources to 
researching, tracking and analyzing incidences of unintended GE 
presence and associated economic losses at all levels of the supply 
chain. One commenter recommended that we coordinate with the USDA 
Agricultural Marketing Service to establish contract protections for 
organic and identity preservation grain growers to ensure that they 
have fair access to testing data and recourse.
    We thank the commenters for these recommendations. As noted above, 
however, all of these recommended activities would fall outside the 
scope of the regulations in part 340, which establish the oversight and 
regulation of certain GE organisms.
    One commenter stated that APHIS should consider protection goals 
that align with making U.S. agriculture more sustainable, more 
environmentally friendly, and less in need of future ``solutions'' to 
genetic-engineering-produced noxious weed problems that involve 
developing additional GE crops engineered to be tolerant of different, 
more noxious herbicides.
    This comment is outside the scope of these regulations. The PPA 
provides for detection, control, eradication, suppression, prevention 
or retardation of plant pests or noxious weeds.
    Another commenter expressed concern over biodiversity and food 
security in the context of accelerating climate change. The commenter 
stated that genetic uniformity leads to disease susceptibility and that 
biodiversity management systems need to be improved in terms of equity. 
According to the commenter, we need systems that support keeping 
diverse seeds in use, but genetic engineering has gone hand in hand 
with large monoculture production.
    This comment is outside the scope of these regulations. We note, 
however, that the concerns identified by the commenter do not seem 
specific to genetic engineering.
    Other commenters expressed concerns about corporate concentration 
and what they viewed as related feedback loops of seeds and chemical 
use. Particular concern was expressed over the possible consolidation 
of the seed industry that commenters thought could result from this 
rulemaking. It was stated that legal and government systems favor the 
largest companies, and that efforts to check the power of the largest 
seed companies have been overridden or have fizzled out.
    APHIS acknowledges the concern that the commenters have raised on 
this topic. The regulations proposed under part 340 are intended to 
streamline and offer additional regulatory relief to developers of all 
sizes. We anticipate

[[Page 29827]]

that since smaller-scale business and academics have limited resources 
and capacity to navigate regulatory systems, this rule will provide 
especially acute benefits to smaller researchers and businesses. APHIS 
has outlined and provided detailed descriptions of this dynamic in the 
economic analysis accompanying this regulation.
    Some commenters opposed the elimination of the notification and 
petition procedures contained in the existing regulations. It was 
stated that APHIS should not eliminate the petition process without 
more clearly defining a streamlined, predictable path through which 
responsible individuals can establish that their innovation no longer 
needs to be reviewed by APHIS prior to release and commercialization. 
Commenters opposed eliminating the notification procedure because they 
were concerned that doing so would require many developers to go to 
permitting, potentially disrupting business practices. Alternatives 
suggested by these commenters included adding provisions for 
streamlined permitting with standardized conditions for low-risk 
organisms and returning to requiring individuals to provide information 
on how they intend to meet performance standards.
    In many ways, the APHIS evaluations for notifications under current 
regulations are very similar to those done for permit applications, but 
the notification procedure relies on applicants' agreeing to meet the 
performance-based standards described in the regulations rather than 
submitting an application for APHIS review describing the specific 
measures that they will employ for the activity (as is the case for 
permits). With permits, but not with notifications, APHIS can accept 
the proposed measures or add to them, and the result is a set of 
binding customized permit conditions.
    We will not be making any changes in response to these comments. As 
we noted in the preamble to the June 2019 proposed rule, the 
notification procedure in the current regulations relies upon 
performance-based standards. Since the specific measures that 
constitute compliance with the regulations are not enumerated in the 
performance standards, it can be difficult for APHIS inspectors to 
determine whether a notification holder is in compliance. This 
uncertainty can make enforcing the regulations, and thereby protecting 
U.S. agriculture from plant pest risks, more difficult than it would be 
if compliance measures were clearly enumerated as they are in specific 
conditions under a permit. For this reason and to comply with OIG 
recommendations with which we agreed, we proposed to eliminate the 
notification procedure. We do not agree with the recommendation to 
provide streamlined permit conditions for low-risk organisms. The 
standard permitting conditions in Sec.  340.5(i) are needed to ensure 
that activities conducted under permit for all GE organisms can be 
performed with adequate mitigations for plant pest risk. Differences in 
the level of risk associated with different organisms will be reflected 
in the supplemental permitting conditions.
    The current petition process for GE plants stems from the manner in 
which regulated article is defined. As noted above, the current 
regulations consider a GE organism to pose a plant pest risk and 
therefore be a regulated article if the donor organism, recipient 
organism, vector, or vector agent is a plant pest. Under the proposed 
regulations, however, we would evaluate whether an organism would 
require a permit for movement based on the characteristics of the 
organism itself rather than on the method by which the organism is 
genetically engineered. Based on the proposed change in approach, APHIS 
believes that the petition process is no longer necessary and is 
removing the petition process from the regulations. (As discussed 
previously in this document, however, until RSR is available for a 
particular crop, we will continue to receive petitions under the 
process for that crop.)
    Some commenters advocated that we retain the existing regulatory 
framework rather than adopting the one we proposed. In the view of one 
commenter, the proposed rule constituted a shift from a streamlined, 
performance-based regulatory approach to a more prescriptive one. The 
commenter saw that shift as a step backwards. Another commenter 
expressed a preference for the process-based approach of the existing 
regulations rather than the product-based one that we proposed. The 
commenter stated that APHIS should regulate biotechnology products 
based on the process by which they are created, using genetic 
engineering as the trigger for regulatory review, to ensure that none 
evade oversight entirely.
    For reasons discussed at length in this document and in the June 
2019 proposed rule, we do not agree with these comments.
    One commenter viewed our overall regulatory approach as not 
sufficiently flexible to take into account the relative risk levels 
associated with different crops. The commenter recommended that we 
consider such differences when making determinations about the 
appropriate levels of regulation for different crops. We do not agree 
with this comment. Our assessment of the risks associated with specific 
GE crops will be reflected in our RSR determinations and in the permit 
conditions we assign.
    One commenter stated that our policy on low-level presence of 
Regulated Genetically Engineered Plant Materials, discussed in the 2008 
proposal, is absent from this one.
    APHIS intends to continue its support of U.S. trade agencies to 
address low level presence issues, as is further discussed above. This 
approach is consistent with APHIS' statutory authority to regulate 
plant pests, as further explained above.
    One commenter stated that the June 2019 proposed rule lacked the 
summary of commenters that is common to proposed rules from other 
agencies. The commenter stated that APHIS should publish such a summary 
in the final rule and should hold at least one public consultation with 
stakeholders that do not have a direct or indirect financial interest 
in the proposed regulations.
    We do not agree with this comment. As we noted in the preamble to 
the June 2019 proposed rule: ``Following the withdrawal of the January 
2017 proposed rule, APHIS conducted extensive outreach to Land Grant 
and public university researchers, as well as small-scale biotechnology 
developers, agriculture innovators, and other interested stakeholders. 
In total, APHIS met with more than 80 organizations, including 17 
universities, State Departments of Agriculture, and farmer 
organizations.'' In this final rule, we have further delineated the 
nature of these discussions.
National Environmental Policy Act
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
processes in this final rule, we have prepared a final environmental 
impact statement (EIS). The final EIS is based on a draft EIS, which we 
drafted after soliciting public comment through a notice in the Federal 
Register to help us delineate the scope of the issues and alternatives 
to be analyzed. The final EIS responds to public comments, analyzes 
each alternative and its environmental consequences, if any, and 
provides APHIS' preferred alternative. The EIS was prepared in 
accordance with: (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions

[[Page 29828]]

of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing 
NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 
CFR part 372).
    Copies of the final EIS are available on the Regulations.gov 
website (see footnote 3 in this document for a link to Regulations.gov) 
or by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT.
Executive Orders 12866, 13563, 13771 and Regulatory Flexibility Act
    This final rule is an Executive Order 13771 deregulatory action. 
Details on the estimated costs of this final rule can be found in the 
rule's economic analysis.
    This final rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health, and safety 
effects, and equity considerations). Executive Order 13563 emphasizes 
the importance of quantifying both costs and benefits, of reducing 
costs, of harmonizing rules, and of promoting flexibility. The economic 
analysis also provides a final regulatory flexibility analysis that 
examines the potential economic effects of this rule on small entities, 
as required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis are available on the 
Regulations.gov website (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    The revisions to part 340 in this final rule create the framework 
for more focused, risk-based regulation of the GE organisms that pose 
plant pest risk. Under this rule, certain categories of plants are 
exempted from the regulations in part 340. Developers are able to 
determine, when appropriate, whether their products fit into one of the 
exempted categories and are therefore not subject to APHIS' 
regulations.
    The rule also provides for a process to determine the regulatory 
status of a plant under part 340. GE plants having the same plant-
trait-MOA combination as those previously found by APHIS to be not 
subject to the regulations will not be regulated, nor will they be 
required to undergo an RSR. GE plants found likely to pose a plant pest 
risk and GE plants that are not eligible for an RSR will be allowed to 
move only under permit. For plants that do not fall into any of the 
exempted categories and are eligible for an RSR, developers have the 
option of either requesting a review or requesting a permit for the 
movement (including importation, interstate movement, or environmental 
release) of their organism in lieu of an RSR. Developers of GE 
organisms that are plant pests will continue to need permits to import, 
move interstate, or environmentally release those organisms.
    Shipping standards under this rule are less prescriptive and more 
generally applicable, and the rule provides for the issuance of multi-
year permits. The provisions for record retention, compliance, and 
enforcement have been altered to ensure that APHIS has sufficient 
information to monitor compliance with its regulations and maintain 
effective oversight of regulated GE organisms, in accordance with 
provisions of the 2008 Farm Bill and recommendations of the 2015 USDA 
OIG report on GE organisms. These changes improve the efficiency and 
clarity of the regulations.
    The amendments in this rule will benefit developers, producers, and 
consumers of certain GE organisms; public and private research 
entities; and APHIS. There will be no decrease in the level of 
protection provided against plant pest risks. The regulatory framework, 
including the RSR process used to determine regulatory status 
established under this rule, will provide cost savings to some plant 
developers and will allow for reallocation of APHIS resources to 
Biotechnology Regulatory Services (BRS) priorities.
    Under this rule, APHIS regulatory oversight (through permitting) 
will not be required for plants that fall into one of the exempted 
categories or have been assessed by means of an RSR and have been found 
unlikely to pose an increased plant pest risk relative to its 
comparator. Direct regulatory costs to some plant developers will be 
reduced for the development of GE plants for which APHIS permits are no 
longer necessary. Savings to the regulated community will result from a 
reduced need to collect field data, fewer reporting requirements, and 
lower management costs. Costs now associated with petitions for non-
regulated status will be reduced or eliminated where APHIS permits are 
no longer necessary.
    Cost savings for these entities are expected to more than offset 
the new costs. APHIS estimated the cost savings for two regulatory 
oversight scenarios where USDA either has sole regulatory authority or 
shares oversight with EPA and/or FDA, based on a study of the costs 
encountered by private biotechnology developers as they pursue 
regulatory authorization of their innovations. When only APHIS has 
regulatory oversight, compliance cost savings under the rule could 
range from $1.6 million to $5.6 million ($3.6 million on average) for 
the development of a given GE plant. If EPA and/or FDA also have an 
oversight role in the development of a given GE plant, compliance cost 
savings could range from $551,000 to $937,000 ($744,000 on average; see 
Table A below and Table 5 of the RIA). From 1992 through September 
2019, an average of just under 5 petitions were processed (granted non-
regulated status or the petition withdrawn) in a given year, with a 
high of 14 in 1995. As the rule is expected to spur innovation, we 
expect the number of new GE plants developed annually to increase over 
time. In particular, the rule may provide impetus to the development of 
new horticultural varieties, where the costs of acquiring non-regulated 
status in the past may have been prohibitively high relative to the 
potential market.
    In the following estimate of impacts, we use the average cost 
savings reported above per GE plant developed and assume the annual 
number of new GE plants developed under the rule without APHIS permits 
ranges from 5 (the current annual average number of processed 
petitions) to 10 (twice this average). We further assume that about 20 
percent of those new GE plants are solely within the purview of APHIS 
oversight, and that the remaining 80 percent will also be under the 
purview of FDA and/or EPA oversight. If five new GE plants are 
developed annually without APHIS permits (all with no APHIS permit, but 
four still with EPA and/or FDA evaluation), the annual savings would be 
$6.5 million.\16\ If 10 new GE plants are developed annually without 
APHIS permits (all with no APHIS permit, but 8 still with EPA and/or 
FDA evaluation), the annual savings will be $13.1 million.\17\
---------------------------------------------------------------------------

    \16\ 1 x $3,573,500 = $3,573,500. 4 x $744,000 = $2,976,000. 
$3,573,000 + $2,976,000 = $6,549,500.
    \17\ 2 x $3,573,500 = $7,147,000. 8 x $744,000 = $5,952,000. 
$7,147,000 + $5,952,000 = $13,099,000.
---------------------------------------------------------------------------

    New costs borne by regulated entities under the rule will include 
rule familiarization and recordkeeping. Annual recordkeeping costs are 
based

[[Page 29829]]

on information collection categories that were described in the 
Paperwork Reduction Act section of the proposed rule, and are estimated 
to total about $1,070,000. New maintenance and record retention 
requirements in this rule should not significantly affect permit 
holders. While some of the specific records required under this rule 
were not explicitly included in the current regulations, they have been 
required as part of the supplemental permit conditions that accompany 
an issued permit. These records are integral to the activities under 
the permit and should already be maintained by the permit holder as a 
normal part of business operations and therefore readily be accessible. 
About 1,250 distinct entities have applied for permits or notifications 
under part 340. APHIS estimates that each of those entities will spend 
a total of about 24 hours becoming familiar with the provisions of this 
rule, at a total one-time cost of about $1.5 million.
    Some plants that would not have been regulated under previous 
regulations in part 340, because a plant pest was not used in their 
development, would now be under the purview of APHIS oversight. APHIS 
expects the number of plants in this category will be very small, 
likely less than 1 per year based on historical activity. For those few 
instances where an APHIS permit is required, developers could incur new 
costs associated with permitting ranging from about $13,000 to 
$671,000, depending on recordkeeping, reporting, stewardship, and 
testing requirements.\18\
---------------------------------------------------------------------------

    \18\ Additional recordkeeping and reporting costs could be about 
$13,000 annually for a field trial that requires 25 reports per 
year. Because few plants tested in the field are likely to 
demonstrate commercial viability, we expect they would be tested on 
a limited number of sites. Additional stewardship costs could range 
from about $20,000 to $120,000. In the rare case in which a plant 
demonstrates commercial viability and warrants further data 
collection under the RSR process, the developer could incur 
additional testing costs, which under current regulations are 
estimated to range between about $152,000 and $538,000. Because the 
data required under the RSR process will be more targeted than under 
the current process, testing costs would likely be closer to the 
lower bound.
---------------------------------------------------------------------------

    In accordance with guidance on complying with Executive Order 
13771, the primary estimate of the annual net private sector cost 
savings for this rule is $8.3 million. This value is the mid-point 
estimate of the net private cost savings annualized in perpetuity using 
a 7 percent discount rate.
    Current annual APHIS personnel costs for conducting genetic 
engineering related activities that will be affected by this rule total 
about $3.4 million. These include compliance activities, inspection 
activities, `Am I Regulated' (AIR) process activities, notification 
activities, permit activities, and petition activities. Under this 
rule, APHIS' overall annual personnel costs of regulating GE plants are 
not expected to change. While the volume of specific activities will 
change, the overall volume of regulatory activities, the general nature 
of those activities, and the level of skills necessary to perform those 
activities will not change.
    Costs to APHIS of implementing this rule include outreach 
activities, developing guidance documents, training, and adjusting the 
permit system. APHIS estimates that public outreach, guidance and 
training will cost about $77,000. Requests for RSRs and response 
letters under the rule will be handled in a manner similar to the 
current AIR process, outside the electronic permitting system and 
without incurring new costs.
    Certain plants are genetically engineered in order to produce 
PMPIs. To date, PMPI-producing GE plants regulated by APHIS have been 
genetically engineered using a plant pest as the donor, vector, or 
vector agent, and thus fall under the scope of regulated article in the 
current regulations in part 340. In this rule, APHIS will maintain its 
oversight of PMPI-producing plants. In this final rule, we are adding 
this requirement to Sec.  340.2, as paragraph (e), which states that a 
permit is required for the movement of a plant that encodes a product 
intended for pharmaceutical or industrial use.
    Certain plants are genetically engineered to produce PIPs, meaning 
that they produce pesticides. APHIS has regulated those PIP-producing 
plants that are captured by current regulations, i.e., when plant pests 
or plant pest sequences are used. The PIPs also fall under the 
regulatory oversight of EPA. However, because EPA generally requires 
Experimental Use Permits (EUP) only for field tests on 10 acres or more 
of land, APHIS has exercised regulatory oversight of PIP plantings on 
fewer than 10 acres. Under this rule, GE PIP-producing plants that are 
unlikely to pose an increased plant pest risk relative to their 
comparators will not be regulated by APHIS following an RSR. Therefore, 
under this rule Federal oversight of GE PIPs will rest solely with EPA. 
EPA may decide to require EUPs for all, some, or none of the PIPs for 
test plantings on fewer than 10 acres of land, and may conduct 
inspections of all, some, or none of the PIPs that are under permit. 
EPA may also exempt certain PIPs from requirements under the Federal 
Insecticide Fungicide and Rodenticide Act (FIFRA). Current inspection 
costs incurred by APHIS average roughly $800 per inspection.
    A quicker APHIS evaluation process will mean a shorter period of 
regulatory uncertainty that may facilitate developers' ability to raise 
venture capital. Reduced regulatory requirements may also lead to 
greater participation by public and private academic institutions in 
genetic engineering research and product development. These indirect 
benefits of the rule may spur genetic engineering innovations, 
particularly in small acreage crops where genetic engineering has not 
been widely utilized due to the expense of regulation.
    In general, new plant varieties, including GE crop varieties, are 
not required to be reviewed or approved for food safety by the FDA 
before going to market. However, the developer is responsible for 
ensuring product safety and developers of GE plant varieties have 
routinely consulted with FDA prior to marketing new varieties to 
resolve food safety or other questions about food within FDA's 
jurisdiction.
    APHIS expects that stewardship practices currently used to conduct 
field trials of GE plant varieties will be maintained under the new 
rule. It will be in a plant developer's best interest to supervise and 
control the development process as at present, to prevent undesired 
cross-pollination or commingling with non-GE crops. Developers have 
various legal, quality control, and marketing motivations to maintain 
rigorous voluntary stewardship measures. APHIS therefore believes that 
developers will continue to utilize strict control measures for field 
testing even in cases where APHIS does not require a permit.
    Farmers who adopt GE crops may benefit from the rule. GE crop 
adoption varies by crop and technology and can affect yields, net 
returns, and pesticide use. Fernandez-Cornejo, et al. (2014) showed 
that planting insect-resistant cotton and corn seed is associated with 
higher net returns when pest pressure is high. The extent to which 
adoption of herbicide tolerant (HT) traits affects net returns is mixed 
and depends primarily on how much weed control costs are reduced and 
seed costs are increased. HT soybean adoption is associated with an 
increase in total household income because HT soybeans require less 
management and enable farmers to generate income via off-farm 
activities or by expanding their operations. Farmers may benefit by 
having access to a wider variety of traits as well as a greater number 
of new GE crop species,

[[Page 29830]]

affording them a broader selection of crops to suit their particular 
management objectives. Among the types of innovations expected are 
crops with greater resistance to disease and insect pests; greater 
tolerance of stress conditions such as drought, high temperature, low 
temperature, and salt; and more efficient use of fertilizer. These 
types of traits can lower farmer input costs (water, fertilizer, 
pesticide) and increase yields during times of adverse growing 
conditions.
    As mentioned, regulatory costs are expected to be lower under this 
rule, thereby potentially spurring developer innovation, especially 
among small companies and universities. Consumers will benefit from a 
wider variety of available products, including ones with improved 
taste, storage longevity, or nutritional content. In terms of the 
potential benefits of GE crop plants, an emerging area of interest is 
the nutritional modification of crop plants through the use of 
biotechnology to provide human health benefits. Some of these types of 
modifications are discussed in the EIS in section 4.4.1.4. They include 
rice varieties developed to provide vitamin A and to address iron and 
folate deficiency; wheat varieties with reduced levels of celiac-
disease-triggering gliadins and with increased levels of lysine and 
zinc; and cyanide-free cassava. Innovations may also benefit consumers 
through lower prices for existing products.
    In addition to the compliance costs associated with regulation, 
there are opportunity costs of delayed innovation if the approval 
process for a plant is longer than necessary to ensure safety with 
reasonable scientific certainty. Regulatory delays mean that the 
benefits of innovation occur later than they would otherwise and most 
likely at lower levels. The forgone benefits due to delayed innovation 
can be substantial and developers, producers and consumers all lose 
from regulatory delays. The forgone benefits stemming from even a 
relatively brief delay in product release can overshadow both research 
and regulatory costs.
    It should be noted that while the rule will alter APHIS' evaluation 
process for GE plants, it is not expected to affect the evaluation of 
such plants by FDA or EPA or foreign regulatory agencies, the actions 
of whom may affect the opportunity costs of regulatory delay. When FDA 
and/or EPA also have a regulatory role, substantial time savings due to 
the rule are most likely to be realized in those instances in which the 
APHIS process takes the longest time. When APHIS is the only agency 
with oversight (as with many new horticultural varieties such as 
petunias or carnations modified to produce different flower color, 
morphology, or longevity), there could be significant time savings over 
the current petition process.
    Some farmers (e.g., growers of identity-preserved crops, including 
organic, other non-GE and other agricultural commodities segregated for 
specific purity and quality tolerances) could be indirectly negatively 
impacted by increased GE innovations. Identity preservation (IP) refers 
to a process or system of maintaining the segregation and documenting 
the identity of a product. Crops with unique product quality traits 
such as low linolenic canola require IP to capture the added value. 
Similarly, organic commodities must be produced according to specific 
criteria and segregated in the marketplace in order to receive premium 
prices. Some consumers choose not to purchase products derived from GE 
crops and instead purchase commodities such as those labeled ``non-
GMO.'' In addition, the USDA organic standard does not allow for the 
intentional use of GE seeds. In cases where crops intended for the non-
GE or other identity-preserved marketplaces contain unintended GE 
products, their profitability may be diminished. Unintended GE presence 
and diminished profitability may also occur for identity-preserved GE 
crops with special attributes. Such crops are more likely to be 
developed under the new rule.
    Effects of this rule on the variety of GE crop species grown in the 
United States and their wider adoption may increase the possibility of 
cross-pollination or commingling. As commercial acreage of any given GE 
crop increases and as a greater variety of crops are modified using 
genetic engineering, the potential for more instances of unintended 
presence of a GE organism increases. Costs incurred by growers of 
organic and other identity-preserved varieties who seek to prevent such 
unintended presence may increase.
    Entities potentially affected by the rule fall under various 
categories of the North American Industry Classification System. 
Economic data are not available on business size for some entities. 
Nonetheless, based on industry data obtained from the Economic Census 
and the Census of Agriculture, we can assume that the majority of the 
businesses affected by the rule will be small.
    Table A provides a summary statement of the expected direct costs 
and cost savings of the rule:

      Table A--Expected Costs and Costs Savings of the Rule for the
                  Biotechnology Industry and for APHIS
                             [2016 dollars]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Biotechnology Industry
One-time industry-wide costs of                 $1,468,000.
 rule familiarization.
------------------------------------------------------------------------
Annual industry-wide                            $1,070,000.
 recordkeeping costs.
------------------------------------------------------------------------
Annual cost of permits for                 $13,000 to $671,000.
 plants not previously regulated
 \1\.
------------------------------------------------------------------------
Developer Savings per Trait \2\.  Lower Bound         Upper Bound
                                   Estimate.           Estimate.
APHIS sole regulatory oversight.  $1,559,000........  $5,588,000.
APHIS oversight together with     $551,000..........  $937,000.
 FDA and/or EPA oversight.
------------------------------------------------------------------------
APHIS Biotechnology Regulatory
 Services
Annual costs for public                          $77,000.
 outreach, training, and e-
 permitting \3\.
------------------------------------------------------------------------
\1\ The number of plants in this category is expected to be very small,
  likely less than 1 per year based on historical activity. The range in
  cost shown is for one permit. The actual cost will depend on
  additional recordkeeping, reporting, stewardship, and testing
  requirements.
\2\ These savings are shown on a per trait basis. On average, if five
  new GE plants are developed annually without APHIS permits (all with
  no APHIS permit, but four still with EPA and/or FDA evaluation), the
  annual savings will be $6.5 million. If 10 new GE plants are developed
  annually without APHIS permits (all with no APHIS permit, but 8 still
  with EPA and/or FDA evaluation), the annual savings will be $13.1
  million.
\3\ Requests for regulatory status and response letters under the rule
  will be handled in a manner similar to the current `Am I Regulated'
  process, outside the electronic permitting system and without
  incurring new costs.


[[Page 29831]]

Executive Order 12372
    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)
Executive Order 12988
    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.
Executive Order 13175
    The USDA's Office of Tribal Relations (OTR) has assessed the impact 
of this rule on Indian Tribes and determined that this rule has Tribal 
implications; however, OTR has determined that Tribal consultation 
under Executive Order 13175 is not required at this time.
    If a Tribe requests consultation, APHIS will work with the OTR to 
ensure meaningful consultation is provided where changes, additions, 
and modifications identified herein are not expressly mandated by 
Congress.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), some of the information collection 
requirements included in this final rule have been approved under 
Office of Management and Budget (OMB) control number 0579-0085 and some 
of the information collection requirements were filed under OMB 
comment-filed number 0579-0471, which has been submitted to OMB for 
approval. When OMB notifies us of its decision, if approval is denied, 
we will publish a document in the Federal Register providing notice of 
what action we plan to take.
E-Government Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mr. Joseph Moxey, 
APHIS' Information Collection Coordinator, at (301) 851-2483.
Congressional Review Act
    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs has designated this 
action as a rule that is not a major rule, as defined by 5 U.S.C. 
804(2).

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List of Subjects

7 CFR Part 330

    Customs duties and inspection, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

7 CFR Part 340

    Administrative practice and procedure, Packaging and containers, 
Plant diseases and pests, Reporting and recordkeeping requirements, 
Transportation.

7 CFR Part 372

    Environmental impact statements.

    Accordingly, we are amending 7 CFR parts 330, 340, and 372 as 
follows:

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS, 
BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE

0
1. The authority citation for part 330 continues to read as follows:

    Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.


0
2. In Sec.  330.200, paragraphs (b) and (d) are revised to read as 
follows:


Sec.  330.200  Scope and general restrictions.

* * * * *
    (b) Plant pests regulated by this subpart. For the purposes of this 
subpart, and except for an organism that has undergone genetic 
engineering as defined in Sec.  340.3 of this chapter, APHIS will 
consider an organism to be a plant pest if the organism directly or 
indirectly injures, causes damage to, or causes disease in a plant or 
plant product, or if the organism is an unknown risk to plants or plant 
products, but is similar to an organism known to directly or indirectly 
injure, cause damage to, or cause disease in a plant or plant product. 
Plant pests that have undergone genetic engineering, as defined in 
Sec.  340.3 of this chapter, are subject to the regulations of part 340 
of this chapter.
* * * * *
    (d) Biological control organisms not regulated by this subpart. 
Paragraph (c) of this section notwithstanding, biological control 
organisms that have undergone genetic engineering, as defined in Sec.  
340.3 of this chapter, as well as products that are currently under an 
EPA experimental use permit, a Federal Insecticide Fungicide and 
Rodenticide Act (FIFRA) section 18 emergency exemption, or products 
that are currently registered with EPA as a microbial pesticide 
product, are not regulated under this subpart. Additionally, biological 
control organisms that are pesticides that are not registered with EPA, 
but are being transferred, sold, or distributed in accordance with 
EPA's regulations in 40 CFR 152.30, are not regulated under this 
subpart for their interstate movement or importation. However, an 
importer desiring to import a shipment of biological control organisms 
subject to FIFRA must submit to the EPA Administrator a Notice of 
Arrival of Pesticides and Devices as required by CBP regulations at 19 
CFR 12.112. The Administrator will provide notification to the importer 
indicating the disposition to be made of shipment upon its entry into 
the customs territory of the United States.

0
3. Part 340 is revised to read as follows:

PART 340--MOVEMENT OF ORGANISMS MODIFIED OR PRODUCED THROUGH 
GENETIC ENGINEERING

Sec.
340.1 Applicability of this part.
340.2 Scope of this part.
340.3 Definitions.
340.4 Regulatory status review.
340.5 Permits.
340.6 Record retention, compliance, and enforcement.
340.7 Confidential business information.
340.8 Costs and charges.

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.


Sec.  340.1  Applicability of this part.

    (a) The regulations in this part apply to those organisms described 
in Sec.  340.2, but not to any organism that is exempt from this part 
under paragraph (b), (c), or (d) of this section.
    (b) The regulations in this part do not apply to plants that have 
been modified such that they contain either a single modification of a 
type listed in paragraphs (b)(1) through (3) of this section, or 
additional modifications as determined by the Administrator, and 
described in paragraph (b)(4) of this section.
    (1) The genetic modification is a change resulting from cellular 
repair of a targeted DNA break in the absence of an externally provided 
repair template; or
    (2) The genetic modification is a targeted single base pair 
substitution; or
    (3) The genetic modification introduces a gene known to occur in 
the plant's gene pool, or makes changes in a targeted sequence to 
correspond to a known allele of such a gene or to a

[[Page 29833]]

known structural variation present in the gene pool.
    (4) The Administrator may propose to exempt plants with additional 
modifications, based on what could be achieved through conventional 
breeding. Such proposals may be Agency-initiated, and follow the 
process in paragraph (b)(4)(i) of this section, or in response to a 
request made in accordance with paragraph (b)(4)(ii) of this section.
    (i) APHIS-initiated proposals for exemptions. APHIS will publish a 
notice in the Federal Register of the proposal by the Administrator to 
exempt plants with additional modifications. The notice will make 
available any supporting documentation, and will request public 
comment. After reviewing the comments, APHIS will publish a subsequent 
notice in the Federal Register announcing its final determination.
    (ii) Other parties' requests for exemptions. Any person may request 
that the Administrator exempt plants developed with additional 
modifications that could be achieved through conventional breeding. To 
submit a request, the person must provide, in writing, information 
supporting the modification(s). Supporting information must include the 
following:
    (A) A description of the modification(s);
    (B) The factual grounds demonstrating that the proposed 
modification(s) could be achieved through conventional plant breeding;
    (C) Copies of scientific literature, unpublished studies, or other 
data that support the request; and
    (D) Any information known to the requestor that would be 
unfavorable to the request.
    (iii) Timeframe for Agency review of requests for additional 
exemptions. After APHIS receives all information required under 
paragraph (b)(4)(ii) of this section, APHIS will complete its review of 
the request and render a determination within 12 months, except in 
circumstances that could not reasonably have been anticipated.
    (iv) Denial of requests. If APHIS disagrees with the conclusions of 
the request or determines that there is insufficient evidence that the 
modification could be achieved through conventional breeding methods, 
APHIS will deny the request and notify the requestor in writing 
regarding this denial.
    (v) Agreement with requests. If APHIS initially determines that the 
modification could be achieved through conventional breeding methods, 
APHIS will publish a notice in the Federal Register and request public 
comments in accordance with the process set forth in paragraph 
(b)(4)(i) of this section. After reviewing the comments, APHIS will 
publish a subsequent notice in the Federal Register announcing its 
final determination.
    (vi) website posting. A list specifying the additional 
modifications will be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology.
    (c) The regulations in this part do not apply to a plant with:
    (1) A plant-trait-mechanism of action combination that has 
previously undergone an analysis by APHIS in accordance with Sec.  
340.4 and has been determined by APHIS not to be regulated under this 
part, or
    (2) A plant-trait-mechanism of action combination found in a plant 
that APHIS determined to be deregulated in response to a petition 
submitted prior to October 1, 2021, pursuant to Sec.  340.6 as that 
section was set forth prior to August 17, 2020. All plants determined 
by APHIS to be deregulated pursuant to Sec.  340.6 as that section was 
set forth prior to August 17, 2020 will retain their nonregulated 
status under these regulations.
    (d) The regulations in this part do not apply to plants determined 
by APHIS not to require regulation under this part pursuant to the ``Am 
I Regulated'' process. All plants determined by APHIS not to require 
regulation under this part pursuant to the ``Am I Regulated'' process 
will retain their nonregulated status under these regulations.
    (e) Developers may request confirmation from APHIS that a plant is 
not within the scope of this part. APHIS will provide a written 
response (confirmation letter) within 120 days of receiving a 
sufficiently detailed confirmation request, except in circumstances 
that could not reasonably have been anticipated.


(Approved by the Office of Management and Budget under control number 
0579-0471)


Sec.  340.2  Scope of this part.

    Except under a permit issued by the Administrator in accordance 
with Sec.  340.5, no person shall move any GE organism that:
    (a) Is a plant that has a plant-trait-mechanism of action 
combination that has not been evaluated by APHIS in accordance with 
Sec.  340.4 or that, as a result of such evaluation, is subject to the 
regulations; or
    (b) Meets the definition of a plant pest in Sec.  340.3; or
    (c) Is not a plant but has received deoxyribonucleic acid (DNA) 
from a plant pest, as defined in Sec.  340.3, and the DNA from the 
donor organism either is capable of producing an infectious agent that 
causes plant disease or encodes a compound that is capable of causing 
plant disease; or
    (d) Is a microorganism used to control plant pests, or an 
invertebrate predator or parasite (parasitoid) used to control 
invertebrate plant pests, and could pose a plant pest risk; or
    (e) Is a plant that encodes a product intended for pharmaceutical 
or industrial use.


Sec.  340.3   Definitions.

    Terms used in the singular form in this part shall be construed as 
the plural, and vice versa, as the case may demand. The following 
terms, when used in this part, shall be construed, respectively, to 
mean:
    Access. The ability during regular business hours to enter, or pass 
to and from, a location, inspect, and/or obtain or make use or copies 
of any records, data, or samples necessary to evaluate compliance with 
this part and all conditions of a permit issued in accordance with 
Sec.  340.5.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS) or any other employee of APHIS to whom 
authority has been or may be delegated to act in the Administrator's 
stead.
    Agent. A person who is designated by the responsible person to act 
in whole or in part on behalf of the permittee to maintain control over 
an organism under permit during its movement and to ensure compliance 
with all applicable permit conditions and the requirements in this 
part. Multiple agents may be associated with a single responsible 
person or permit. Agents may be, but are not limited to, brokers, 
farmers, researchers, or site cooperators. An agent must be at least 18 
years of age and be a legal resident of the United States.
    Animal and Plant Health Inspection Service (APHIS). An agency of 
the United States Department of Agriculture (USDA).
    Article. Any material or tangible object that could harbor plant 
pests.
    Contained facility. A structure for the storage and/or propagation 
of living organisms designed with physical barriers capable of 
preventing the escape of the organisms. Examples include but are not 
limited to laboratories, growth chambers,

[[Page 29834]]

fermenters, and containment greenhouses.
    Donor organism. The organism from which genetic material is 
obtained for transfer to the recipient organism.
    Environment. All the land, air, and water; and all living organisms 
in association with land, air, and water.
    Gene pool. Germplasm within which sexual recombination is possible 
as a result of hybridization, including via methods such as embryo 
culture or bridging crosses.
    Genetic engineering. Techniques that use recombinant, synthesized, 
or amplified nucleic acids to modify or create a genome.
    Import (importation). To move into, or the act of movement into, 
the territorial limits of the United States.
    Inspector. Any individual authorized by the Administrator or by the 
Commissioner of Customs and Border Protection, Department of Homeland 
Security, to enforce the regulations in this part.
    Interstate. From one State into or through any other State or 
within the District of Columbia, the Commonwealth of the Northern 
Mariana Islands, the Commonwealth of Puerto Rico, Guam, the Virgin 
Islands of the United States, or any other territory or possession of 
the United States.
    Mechanism of action (MOA). The biochemical process(es) through 
which genetic material determines a trait.
    Move (moving, movement). To carry, enter, import, mail, ship, or 
transport; aid, abet, cause, or induce the carrying, entering, 
importing, mailing, shipping, or transporting; to offer to carry, 
enter, import, mail, ship, or transport; to receive to carry, enter, 
import, mail, ship, or transport; to release into the environment; or 
to allow any of the above activities to occur.
    Organism. Any active, infective, or dormant stage of life form of 
an entity characterized as living, including vertebrate and 
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any 
entity characterized as living, related to the foregoing.
    Permit. A written authorization, including by electronic methods, 
by the Administrator to move organisms regulated under this part and 
associated articles under conditions prescribed by the Administrator.
    Person. Any individual, partnership, corporation, company, society, 
association, or other organized group.
    Plant. Any plant (including any plant part) for or capable of 
propagation, including a tree, a tissue culture, a plantlet culture, 
pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a 
root, or a seed.
    Plant pest. Any living stage of a protozoan, nonhuman animal, 
parasitic plant, bacterium, fungus, virus or viroid, infectious agent 
or other pathogen, or any article similar to or allied with any of the 
foregoing, that can directly or indirectly injure, cause damage to, or 
cause disease in any plant or plant product.
    Plant pest risk. The potential for direct or indirect injury to, 
damage to, or disease in any plant or plant product resulting from 
introducing or disseminating a plant pest, or the potential for 
exacerbating the impact of a plant pest.
    Plant product. (1) Any flower, fruit, vegetable, root, bulb, seed, 
or other plant part that is not included in the definition of plant; or
    (2) Any manufactured or processed plant or plant part.
    Recipient organism. The organism whose nucleic acid sequence will 
be modified through the use of genetic engineering.
    Release into the environment (environmental release). The use of an 
organism outside the physical constraints of a contained facility.
    Responsible person. The individual responsible for maintaining 
control over a GE organism under permit during its movement and for 
ensuring compliance with all conditions contained in any applicable 
permit as well as with other requirements in this part and in the Plant 
Protection Act (7 U.S.C. 7701 et seq.). This individual must sign the 
permit application, and must be at least 18 years of age, and must be a 
legal resident of the United States.
    Secure shipment. Shipment in a container or a means of conveyance 
of sufficient strength and integrity to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the 
United States, or any other territories or possessions of the United 
States.
    State or Tribal regulatory official. State or Tribal official with 
responsibilities for plant health, or any other duly designated State 
or Tribal official, in the State or on the Tribal lands where the 
movement is to take place.
    Trait. An observable (able to be seen or otherwise identified) 
characteristic of an organism.
    Unauthorized release. The intentional or accidental movement of an 
organism under a permit issued pursuant to this part in a manner not 
authorized by the permit; or the intentional or accidental movement 
without a permit of an organism that is subject to the regulations in 
this part.


Sec.  340.4  Regulatory status review.

    (a)(1) Any person may submit a request to APHIS for a regulatory 
status review, pursuant to paragraph (b)(3) of this section.
    (2) Any person may request re-review of a GE plant previously found 
to be subject to this part after an initial review was conducted, 
provided that the request is supported by new, scientifically valid 
evidence bearing on the plant pest risk associated with movement of the 
plant.
    (3) APHIS may also initiate a regulatory status review or re-review 
of a GE plant to identify whether it is subject to regulation under 
this part.
    (4) Information submitted in support of a request for a regulatory 
status review or re-review must meet the requirements listed in 
paragraphs (a)(4)(i) through (iii) of this section.
    (i) A description of the comparator plant(s), to include genus, 
species, and any relevant subspecies information;
    (ii) The genotype of the modified plant, including a detailed 
description of the differences in genotype between the modified and 
unmodified plant; and
    (iii) A detailed description of the new trait(s) of the modified 
plant.
    (iv) Detailed information on how to meet the above-listed 
requirements can be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. If APHIS proposes 
revisions to the detailed information on the APHIS website, APHIS will 
make the proposed revisions available for notice and public comment 
prior to implementation.
    (b)(1) When APHIS receives a request for a regulatory status review 
of a GE plant, APHIS will conduct an initial review to determine 
whether there is a plausible pathway by which the GE plant, or any 
sexually compatible relatives that can acquire the engineered trait 
from the GE plant, would pose an increased plant pest risk relative to 
the plant pest risk posed by the respective non-GE or other appropriate 
comparator(s), based on the following factors:
    (i) The biology of the comparator plant(s) and its sexually 
compatible relatives;
    (ii) The trait and mechanism-of-action of the modification(s); and

[[Page 29835]]

    (iii) The effect of the trait and mechanism-of-action on:
    (A) The distribution, density, or development of the plant and its 
sexually compatible relatives;
    (B) The production, creation, or enhancement of a plant pest or a 
reservoir for a plant pest;
    (C) Harm to non-target organisms beneficial to agriculture; and
    (D) The weedy impacts of the plant and its sexually compatible 
relatives.
    (2) APHIS will complete the initial review within 180 days of 
receiving a request for a regulatory status review that meets the 
requirements specified in paragraph (a)(4) of this section, except in 
circumstances that could not reasonably have been anticipated. If APHIS 
does not identify a plausible pathway by which the GE plant or its 
sexually compatible relatives would pose an increased plant pest risk 
relative to the comparator(s) in the initial review, the GE plant is 
not subject to the regulations in this part. APHIS will post the plant, 
trait, and general description of the MOA on its website.
    (b)(3)(i) If APHIS does identify a plausible pathway by which the 
GE plant or its sexually compatible relatives would pose an increased 
plant pest risk relative to the comparator(s) in the initial review, 
the requestor may apply for a permit and/or request that APHIS conduct 
an evaluation of the factor(s) of concern identified in the initial 
review to determine the likelihood and consequence of the plausible 
increased plant pest risk. APHIS may request additional information as 
needed to evaluate the factor(s) of concern.
    (ii) For those GE plants for which such an evaluation is conducted, 
APHIS will publish the results of the evaluation in the Federal 
Register and will solicit and review comments from the public. Except 
in circumstances that could not reasonably have been anticipated, APHIS 
will complete these steps within 15 months of receiving a request for a 
regulatory status review that meets the requirements specified in 
paragraph (a)(4) of this section.
    (iii) If APHIS finds that the GE plant and its sexually compatible 
relatives are unlikely to pose an increased plant pest risk relative to 
their comparator(s), the GE plant is not subject to this part. APHIS 
will publish its evaluation of the plant-trait-MOA combination in a 
subsequent Federal Register document and will also post it on the APHIS 
website. If APHIS does not make such a finding, the GE plant will 
remain regulated under this part, and its movement will be allowed only 
under permit in accordance with Sec.  340.5.
    (c) This section is applicable beginning April 5, 2021 for GE corn, 
soybean, cotton, potato, tomato, and alfalfa, and on October 1, 2021 
for all GE plants.


(Approved by the Office of Management and Budget under control number 
0579-0471)


Sec.  340.5  Permits.

    (a) Permit requirement. A permit from APHIS is required for the 
movement of all GE organisms subject to the regulations under this 
part.
    (b) Permit application requirements. All applications for permits 
must be submitted in accordance with the requirements of this section. 
The responsible person must apply for and obtain a permit through 
APHIS' website. The application must also include the following 
information:
    (1) General information requirements for all permit applications. 
All permit applications must include the name, title, and contact 
information of the responsible person and agent (if any); the country 
(or countries) and locality (or localities) where the organism was 
collected, developed, manufactured, reared, cultivated, and cultured 
(as applicable); the organism's genus, species and any relevant 
subspecies and common name information; the intended activity (i.e., 
importation, interstate movement, or release into the environment of 
the GE organism); and information on the intended trait and the 
genotype of the intended trait. All permit applications must be signed 
by the responsible person.
    (2) Information requirements for permit applications for interstate 
movement or importation. Applications for permits for interstate 
movement or importation of GE organisms must include the following 
additional information:
    (i) The origin and destination of the GE organism, including 
information on the addresses and contact details of the sender and 
recipient, if different from the responsible person;
    (ii) The quantity of the GE organism, the method of shipment, and 
means of ensuring the security of the shipment against unauthorized 
release of the organism; and
    (iii) The manner in which packaging material, shipping containers, 
and any other material accompanying the organism will be disposed of to 
prevent unauthorized release.
    (3) Information requirements for permit applications for release 
into the environment. Applications for permits for release of GE 
organisms into the environment must include information on all proposed 
environmental release sites, including land area (size), Global 
Positioning System coordinates, addresses, and land use history of the 
site and adjacent areas; and the name and contact information of a 
person at each environmental release site, if different from the 
responsible person. In the event that additional release sites are 
requested after the issuance of a permit, APHIS will evaluate and amend 
permits as appropriate, in accordance with paragraph (l) of this 
section.
    (c) Exemption for GE Arabidopsis thaliana. A permit for interstate 
movement is not required for GE Arabidopsis thaliana, provided that it 
is moved as a secure shipment, the modified genetic material is stably 
integrated into the plant genome, and the modified material does not 
include the complete infectious genome of a plant pest.
    (d) Exemption for GE disarmed Agrobacterium species. A permit for 
importation or interstate movement is not required for any GE disarmed 
Agrobacterium species, provided that it is moved as a secure shipment, 
the modified genetic material is stably integrated into the genome, and 
the modified material does not include the complete infectious genome 
of a plant pest.
    (e) Exemption for Drosophila melanogaster. A permit for importation 
or interstate movement is not required for GE Drosophila melanogaster, 
provided that it is moved as a secure shipment and that any introduced 
genetic material is not designed to propagate through a population by 
biasing the inheritance rate.
    (f) Exemption for certain microbial pesticides. A permit is not 
required for the movement of any GE microorganism product that is 
currently registered with the Environmental Protection Agency (EPA) as 
a microbial pesticide, so long as the microorganism is not a plant pest 
as defined in Sec.  340.3.
    (g) Exemption of certain plant-incorporated protectants. A permit 
is not required for the movement of any GE plant modified solely to 
contain a plant-incorporated protectant that is currently registered 
with EPA as a pesticide product pursuant to the Federal Insecticide, 
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq., FIFRA) or that is 
currently exempted from FIFRA pursuant to 40 CFR 174.21.
    (h) Administrative actions--(1) Review of permit applications. 
APHIS will review the permit application to determine whether it is 
complete. APHIS will notify the applicant orally or in writing if the 
application is incomplete, and the applicant will be

[[Page 29836]]

provided the opportunity to revise the application. Once an application 
is complete, APHIS will review it to determine whether to approve or 
deny the application.
    (2) APHIS assignment of permit conditions. If a permit application 
is approved, the Administrator will issue a permit with conditions as 
described in paragraph (i) of this section. Prior to issuance of a 
permit, the responsible person must agree in writing, in a manner 
prescribed by the Administrator, that the responsible person and all 
agents of the responsible person are aware of, understand, and will 
comply with the permit conditions. Failure to comply with this 
provision will be grounds for the denial of a permit.
    (3) Inspections. All premises associated with the permit are 
subject to inspection before and after permit issuance, and all 
materials associated with the movement are subject to sampling after 
permit issuance. The responsible person and agents must provide 
inspectors access to premises, facilities, release locations, storage 
areas, waypoints, materials, equipment, means of conveyance, documents, 
and records related to the movement of organisms permitted under this 
part. Failure to provide access for inspection prior to the issuance of 
a permit will be grounds for the denial of a permit. Failure to provide 
access for inspection following permit issuance will be grounds for 
withdrawal of the permit.
    (4) State or Tribal review and comment. The Administrator will 
submit for notification and review a copy of the permit application, 
without confidential business information (CBI), and any permit 
conditions to the appropriate State or Tribal regulatory official. 
Timely comments received from the State or Tribal regulatory official 
will be considered by the Administrator prior to permit issuance.
    (5) Approval or denial of a permit. Except in circumstances that 
could not reasonably have been anticipated, APHIS will approve or deny 
the permit within:
    (i) 45 days of receipt of a complete application for a permit for 
interstate movement or for importation; or
    (ii) 120 days of receipt of a complete application for a permit for 
release into the environment.
    (iii) The 120-day period may be extended if preparation of an 
environmental assessment or environmental impact statement is 
necessary.
    (i) Permit conditions. The standard conditions listed in this 
paragraph (i) will be assigned to all permits issued under this 
section. The Administrator may assign supplemental permit conditions as 
deemed necessary to ensure confinement of the GE organism. Prior to 
issuance of a permit or an amended permit, the responsible person will 
be required to agree in writing or electronically that he or she and 
his or her agents will comply with the conditions of the permit, as 
described in this paragraph (i). If the responsible person does not 
agree to the conditions, the amendment will be denied.
    (1) The organism under permit must be maintained and disposed of in 
a manner so as to prevent its unauthorized release, spread, dispersal, 
and/or persistence in the environment.
    (2) The organism under permit must be kept separate from other 
organisms, except as specifically allowed in the permit.
    (3) The organism under permit must be maintained only in areas and 
premises specified in the permit.
    (4) The identity of the organism under permit must be maintained 
and verifiable at all times.
    (5) Authorized activities may be engaged in only while the permit 
is valid; the duration for which the permit is valid will be listed on 
the permit itself.
    (6) Records related to activities carried out under the permit must 
be maintained by the responsible person and must be of sufficient 
accuracy, quality, and completeness to demonstrate compliance with all 
permit conditions and requirements under this part. APHIS must be 
allowed access to all records, to include visual inspection and 
reproduction (e.g., photocopying, digital reproduction). The 
responsible person must submit reports and notices to APHIS, containing 
the information specified within the permit, at the times specified in 
the permit. At a minimum:
    (i) Following an environmental release, environmental release 
reports must be submitted for all authorized release locations where 
the release occurred. Environmental release reports must contain 
details of sufficient accuracy, quality, and completeness to identify 
the location, shape, and size of the release and the organism(s) 
released into the environment. In the event no release occurs at an 
authorized location, an environmental release report of no 
environmental release must be submitted for all authorized locations 
where an environmental release did not occur. Unauthorized releases 
must be reported in accordance with paragraph (i)(9) of this section.
    (ii) When the environmental release is of a plant, reports of 
volunteer monitoring activities and findings must be submitted for all 
authorized release locations where an environmental release occurred. 
If no monitoring activities are conducted, a volunteer monitoring 
report of no monitoring must be submitted indicating why no volunteer 
monitoring was done.
    (7) Inspectors must be allowed access, during regular business 
hours, to all locations related to the permitted activities.
    (8) The organism under permit must undergo the application of 
measures determined by the Administrator to be necessary to prevent its 
unauthorized release, spread, dispersal, and/or persistence in the 
environment.
    (9) In the event of a possible or actual unauthorized release, the 
responsible person must contact APHIS as described in the permit within 
24 hours of discovery and must subsequently supply a statement of facts 
in writing no later than 5 business days after discovery.
    (10) The responsible person for a permit remains the responsible 
person for the permit unless a transfer of responsibility is approved 
by APHIS. The responsible person must contact APHIS to initiate any 
transfer. The new responsible person assumes all responsibilities for 
ensuring compliance with the existing permit and permit conditions and 
for meeting the requirements of this part.
    (j) Denial or withdrawal of a permit. Permit applications may be 
denied, or permits withdrawn, in accordance with this paragraph.
    (1) Denial of permits. The Administrator may deny, either orally or 
in writing, any application for a permit. If the denial is oral, the 
Administrator will then communicate, as promptly as circumstances 
allow, the denial, and the reasons for it, in writing. The 
Administrator may deny a permit application if:
    (i) The Administrator concludes that the proposed actions, e.g., 
movements under permit, may not prevent the unauthorized release, 
spread, dispersal, and/or persistence in the environment of the 
organism; or
    (ii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply with any 
material provision of this part, any other regulations issued pursuant 
to the Plant Protection Act (7 U.S.C. 7701 et seq.) or the Plant 
Protection Act itself;
    (iii) In addition, no permit will be issued if the responsible 
person and his or her agents do not agree in writing, in accordance 
with paragraph (h)(2) of this section, to comply with the permit 
conditions or, in accordance with

[[Page 29837]]

paragraph (h)(3) of this section, to allow inspection by APHIS.
    (2) Withdrawal of permits. The Administrator may withdraw, either 
orally or in writing, any permit that has been issued. If the 
withdrawal is oral, the Administrator will communicate, as promptly as 
circumstances allow, the withdrawal, and the reasons for it, in 
writing. The Administrator may withdraw a permit if:
    (i) Following issuance of the permit, the Administrator receives 
information that would have provided grounds for APHIS to deny the 
original permit application;
    (ii) The Administrator determines that actions taken under the 
permit have resulted in the unauthorized release, spread, dispersal, 
and/or persistence in the environment of the organism under permit; or
    (iii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply at any time 
with any material provision of this part or with any other regulations 
issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.). 
This includes failure to comply with the conditions of any permit 
issued.
    (k) Appeal of denial or withdrawal of permit. Any person whose 
permit application has been denied or whose permit has been withdrawn 
may appeal the decision in writing to the Administrator.\1\ The 
applicant must submit in writing an acknowledgment of the denial or 
withdrawal, and a statement of intent to appeal, within 10 days after 
receiving written notification of the denial or withdrawal. The 
applicant may request additional time to prepare the appeal. The appeal 
must state all of the facts and reasons upon which the person relies to 
assert that the permit was wrongfully denied or withdrawn. The 
Administrator will grant or deny the appeal in writing, stating the 
reasons for the decision as promptly as circumstances allow. If there 
is a conflict as to any material fact, a hearing shall be held to 
resolve such conflict.
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    \1\ The Office of the Administrator, as established in Sec.  
371.2 of this chapter, will review appeals involving the denial or 
withdrawal of a permit. Appeals may be sent to Office of the 
Administrator, United States Department of Agriculture, Jamie L. 
Whitten Building, Room 312-E, 1400 Independence Ave. SW, Washington, 
DC 20250.
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    (l) Amendment of permits--(1) Amendment at responsible person's 
request. If the responsible person determines that circumstances have 
changed since the permit was initially issued and wishes the permit to 
be amended accordingly, the responsible person must request the 
amendment by contacting APHIS directly. The responsible person will 
have to provide supporting information justifying the amendment. APHIS 
will review the amendment request, and will amend the permit if APHIS 
determines that relatively minor changes are necessary. Requests for 
more substantive changes will require a new permit application. Prior 
to issuance of an amended permit, the responsible person will be 
required to agree in writing or electronically that he or she and his 
or her agents will comply with the conditions of the amended permit. If 
the responsible person does not agree to the conditions, the amendment 
will be denied.
    (2) Amendment initiated by APHIS. APHIS may amend any permit and 
its conditions at any time, upon determining that the amendment is 
needed to address plant pest risks presented by the organism or the 
activities allowed under the permit. APHIS will notify the responsible 
person of the amendment to the permit and, as soon as circumstances 
allow, the reason(s) for it. The responsible person may have to agree 
in writing or electronically that he or she and his or her agents will 
comply with the conditions of the amended permit before APHIS will 
issue it. If APHIS requests such an agreement, and the responsible 
person does not accept it, the existing permit will be withdrawn.
    (m) Shipping under a permit. (1) All shipments of organisms under 
permit must be secure shipments. Organisms under permit must be shipped 
in accordance with the regulations in 49 CFR part 178.
    (2) The container must be accompanied by a document that includes 
the names and contact details for the sender and recipient.
    (3) For any organism to be imported into the United States, the 
outmost container must bear information regarding the nature and 
quantity of the contents; the country (or countries) and locality 
(localities) where collected, developed, manufactured, reared, 
cultivated, and cultured (as applicable); the name and address of the 
shipper, owner, or person shipping or forwarding the organism; the 
name, address, and telephone number of the consignee; the identifying 
shipper's mark and number; and the permit number authorizing the 
importation. For organisms imported under permits by mail, the 
container must also be addressed to a plant inspection station listed 
in the USDA Plants for Planting Manual, which can be accessed at: 
https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/plants_for_planting.pdf. All imported containers of organisms 
under permits must be accompanied by an invoice or packing list 
indicating the contents of the shipment.
    (4) Following the completion of the shipment, all packaging 
material, shipping containers, and any other material accompanying the 
organism will be devitalized consistent with supplemental permit 
conditions, or disposed of to prevent unauthorized release.
    (n) Applicability date: This section is applicable beginning April 
5, 2021.


(Approved by the Office of Management and Budget under control number 
0579-0471)


Sec.  340.6  Record retention, compliance, and enforcement.

    (a) Recordkeeping. Responsible persons and their agents are 
required to establish, keep, and make available to APHIS the following 
records:
    (1) Records and reports required under Sec.  340.5(i);
    (2) Addresses and any other information (e.g., GPS coordinates, 
maps) needed to identify all locations where the organism under permit 
was stored or used, including all contained facilities and 
environmental release locations;
    (3) A copy of the APHIS permit authorizing the permitted activity; 
and
    (4) Legible copies of contracts (including amendments to contracts) 
between the responsible person and agents that conduct activities 
subject to this part for the responsible person, and copies of 
documents relating to agreements made without a written contract.
    (b) Record retention. Records indicating that an organism under 
permit that was imported or moved interstate reached its intended 
destination must be retained for at least 2 years. All other records 
related to a permit must be retained for 5 years following the 
expiration of the permit, unless a longer retention period is 
determined to be needed by the Administrator and is documented in the 
supplemental permit conditions.
    (c) Compliance and enforcement. (1) Responsible persons and their 
agents must comply with all of the requirements of this part. Failure 
to comply with any of the requirements of this part may result in any 
or all of the following:
    (i) Denial of a permit application or withdrawal of a permit in 
accordance with Sec.  340.5(j);
    (ii) Application of remedial measures in accordance with the Plant 
Protection Act (7 U.S.C. 7701 et seq.); and

[[Page 29838]]

    (iii) Criminal and/or civil penalties in accordance with the Plant 
Protection Act (7 U.S.C. 7701 et seq.).
    (2) Prior to the issuance of a complaint seeking a civil penalty, 
the Administrator may enter into a stipulation, in accordance with 
Sec.  380.10 of this chapter.
    (d) Liability for acts of an agent. For purposes of enforcing this 
part, the act, omission, or failure of any agent for a responsible 
person may be deemed also to be the act, omission, or failure of the 
responsible person.


(Approved by the Office of Management and Budget under control number 
0579-0471)


Sec.  340.7  Confidential business information.

    Persons including confidential business information (CBI) in any 
document submitted to APHIS under this part should do so in the 
following manner. If there are portions of a document deemed to contain 
confidential business information, those portions must be identified, 
and each page containing such information must be marked ``CBI Copy.'' 
A second copy of the document must be submitted with all such CBI 
deleted, and each page where the CBI was deleted must be marked ``CBI 
Deleted.'' In addition, any person submitting CBI must justify how each 
piece of information requested to be treated as CBI is a trade secret 
or, if not a trade secret, is either commercial or financial 
information that is privileged or confidential.


Sec.  340.8  Costs and charges.

    The services of the inspector related to carrying out this part and 
provided during regularly assigned hours of duty and at the usual 
places of duty will be furnished by APHIS without cost to the 
responsible person.\1\ The U.S. Department of Agriculture will not be 
responsible for any costs or charges incidental to inspections or 
compliance with the provisions of this part, other than for the 
services of the inspector.
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    \1\ The Department's provisions relating to overtime charges for 
an inspector's services are set forth in part 354 of this chapter.
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PART 372--NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES

0
4. The authority citation for part 372 continues to read as follows:

    Authority: 42 U.S.C. 4321 et seq.; 40 CFR parts 1500-1508; 7 CFR 
parts 1b, 2.22, 2.80, and 371.9.


Sec.  372.5  [Amended]

0
5. Section 372.5 is amended as follows:
0
a. By removing paragraph (b)(7);
0
b. In paragraph (c)(3)(iii), by removing the words ``, or 
acknowledgment of notifications for,'' and adding the word ``for'' in 
their place; and
0
c. By removing and reserving paragraph (c)(4).

    Done in Washington, DC, this 13th day of May 2020.
Lorren Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2020-10638 Filed 5-15-20; 8:45 am]
 BILLING CODE 3410-34-P