Plant Pest Regulations, 29938-29967 [2019-13246]

Download as PDF 29938 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Parts 318, 319, 330, and 352 [Docket No. APHIS–2008–0076] RIN 0579–AC98 Plant Pest Regulations Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. AGENCY: We are revising our regulations regarding the movement of plant pests. We are also adding criteria to the regulations for the importation, interstate movement, and release of biological control organisms. This final rule also establishes regulations to allow the interstate movement of certain plant pests and biological control organisms without restriction by granting exceptions from permit requirements for those pests and organisms. Finally, we are revising our regulations regarding the importation and interstate movement of soil. This rule clarifies the points that we will consider when assessing the risks associated with the movement and release of certain organisms and facilitates the movement of regulated organisms and articles in a manner that protects U.S. agriculture. DATES: Effective August 9, 2019. FOR FURTHER INFORMATION CONTACT: Dr. Colin D. Stewart, Assistant Director, Pests, Pathogens, and Biocontrol Permits Branch, Plant Health Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737–1236; colin.stewart@usda.gov; (301) 851–2237. SUPPLEMENTARY INFORMATION: SUMMARY: Background khammond on DSKBBV9HB2PROD with RULES2 Under the Plant Protection Act (7 U.S.C. 7701 et seq., referred to below as the PPA or the Act), the Secretary of Agriculture has authority to carry out operations or measures to detect, control, eradicate, suppress, prevent, or retard the spread of plant pests.1 Section 7711(a) of the Act provides that no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized 1 The Act defines a plant pest as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: (A) A protozoan; (B) A nonhuman animal; (C) A parasitic plant; (D) A bacterium; (E) A fungus; (F) A virus or viroid; (G) An infectious agent or other pathogen; (H) Any article similar to or allied with any of the articles specified in the preceding subparagraphs. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 under general or specific permit and in accordance with such regulations as the Secretary may issue to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States. In addition, section 7712(a) of the Act provides that the Secretary may prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of, among other things, any biological control organism if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination of a plant pest or noxious weed within the United States. The Act defines a biological control organism as ‘‘any enemy, antagonist, or competitor used to control a plant pest or noxious weed.’’ The purpose of the regulations in ‘‘Subpart B—Movement of Plant Pests’’ (7 CFR 330.200 through 330.212) and ‘‘Subpart C—Movement of Soil, Stone, and Quarry Products’’ (7 CFR 330.300 through 330.302) is to prevent the dissemination of plant pests into the United States, or interstate, by regulating the importation and movement in interstate commerce of plant pests, soil, stone, and quarry products. On January 19, 2017, we published in the Federal Register (82 FR 6980–7005, Docket No. APHIS–2008–0076) a proposal 2 to revise our regulations regarding the movement of plant pests to include criteria for the importation, movement in interstate commerce, and environmental release of biological control organisms, and to establish regulations to allow the importation and movement in interstate commerce of certain types of plant pests without restriction by granting exceptions from permitting requirements for those pests. We also proposed to revise our regulations regarding the importation and interstate movement of soil. We solicited comments concerning our proposal for 60 days ending March 20, 2017. We extended the deadline for comments until April 19, 2017, in a document published in the Federal Register on February 13, 2017 (82 FR 10444, Docket No. APHIS–2008–0076). We received 62 comments by that date. The comments were from State departments of agriculture, nature centers, research laboratories, professional associations, universities, industry groups, manufacturers, law 2 To view the proposed rule, supporting documents, the comment extension notice, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2008-0076. PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 firms, and private citizens. The comments are discussed below by topic. Definitions (§ 330.100) We received comments regarding our proposed changes to § 330.100, ‘‘Definitions,’’ including requests to include additional terms to the section. Two commenters asked about the purposes for which continued curation permits are issued. In proposed § 330.200(a)(3), we included requirements for such permits but did not provide a definition that explains their use. To address these commenters, we are adding a definition for continued curation permit to read as set out in the regulatory text below. We proposed to add the term import (importation) to the list of definitions in § 330.100. A commenter asked if our proposed definition of import (importation) means that the organism or article in question arrives in and originates from outside the United States. The commenter is correct. We define importation to mean ‘‘to move into, or the act of movement into, the territorial limits of the United States.’’ A commenter asked that we add the term ‘‘plant health’’ to § 330.100 and allow industry stakeholders to provide a definition for it. We are making no changes in response to the commenter’s request. ‘‘Plant health’’ is not used in any specific or technical context in the proposed or current part 330 regulations and we consider the generally understood meaning of the term to be sufficient. We proposed to add the term responsible individual to § 330.100 to mean the individual designated by the permittee to oversee and control the actions taken under a permit. We are requiring the assignment of a responsible individual to serve as the primary point of contact in order to improve communication between the Animal and Plant Health Inspection Service (APHIS) and the permittee. If the permittee is an individual, that individual can assign him or herself to the role should they so choose. We included as a condition that ‘‘for the duration of the permit, the individual must be physically present during normal business hours at or near the location specified on the permit.’’ Several commenters raised questions about our proposed definition of responsible individual. One commenter stated that our proposed definition of responsible individual does not allow for a designee to substitute for the responsible individual when that individual cannot be at or near the E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations specified location for the duration of the permit due to illness or vacation. The commenter added that, if taken literally, the definition would likely result in nearly every permitted entity being in violation of permit requirements at some point. Similarly, another commenter stated that designating a responsible individual in a field release application is complicated by the fact that the applicant is often not the same person in charge of a field experiment station. The commenter added that a company may test microbial formulations at dozens of sites, making it impossible for one person to enforce permit compliance and be physically present during business hours at each location. The commenter requested that corporate permittees be allowed to designate more than one responsible individual on a permit. As the commenters noted, many permit applications for regulated articles do involve multiple field sites under the shared responsibility of several persons. Under current policy, we allow application requests to include more than one responsible individual, and more than one site within a single State may be designated as the permit location. This approach has ensured that permit actions are undertaken safely while accommodating stakeholder needs for flexibility. Our intention in proposing the definition was to emphasize responsible oversight of actions taken under the permit without literally requiring an individual’s presence during business hours at all locations specified on the permit. Accordingly, we are removing the requirement that the responsible individual be physically present during normal business hours at or near the location specified on the permit as the ultimate destination of the plant pest, biological control organism, or associated article. We continue to require that the responsible individual or individuals ensure compliance with permit conditions during all phases of the activities being performed. We proposed to define taxon (taxa) to mean any recognized grouping or rank within the biological nomenclature of organisms, such as class, order, family, genus, species, subspecies, pathovar, biotype, race, forma specialis, or cultivar. Two commenters asked for clarification of our proposed definition of taxon (taxa), with one commenter suggesting that taxon (taxa) be defined by the biopesticide and biostimulant industries. We defined taxon as any recognized grouping or rank within the biological nomenclature of organisms. This VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 definition is consistent with the term as it is used in the International Plant Protection Convention (IPPC’s) Glossary of Phytosanitary Terms.3 Aligning our definition of taxon in this way makes it easier to communicate and trade with other IPPC signatory countries. We disagree with the commenter that industry stakeholders should develop a separate definition of taxon, as doing so could result in a less flexible definition and potential conflicts with the internationally recognized IPPC definition. A commenter asked APHIS to add the term ‘‘yield enhancement’’ to § 330.100 and to define it as ‘‘the use of microorganisms whose function when applied to plants or the rhizosphere is to stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and crop quality.’’ While some organisms we propose to regulate may stimulate natural processes in plants, we have no plans to define ‘‘yield enhancement’’ as we make no reference in the regulations to the term or the processes listed by the commenter. The ability of organisms or products to enhance plant yields is not a criterion that APHIS uses when determining whether to regulate an organism as a plant pest or a biological control organism. Scope and General Restrictions (§ 330.200) We proposed revising the subpart ‘‘Movement of Plant Pests’’ to regulate not only plant pests but biological control organisms and associated articles such as soil and packaging material. In proposed § 330.200, we specified the types of plant pests and biological control organisms that APHIS would regulate. We also established restrictions on the importation and movement of biological control organisms and plant pests. General Permit In § 330.200(a), we proposed to include a general permit as one means by which we may authorize the movement of plant pests, biological control organisms, and associated articles that we regard to be of low risk in certain areas of the United States. We indicated that we have only issued specific permits, that is, permits issued to individual persons, for each movement of plant pests interstate. We noted, however, that section 7711 of the 3 International Standards for Phytosanitary Measures, ISPM 5, ‘‘Glossary of Phytosanitary Terms (2015): https://www.ippc.int/static/media/ files/publication/en/2015/05/ISPM_05_En_2015-0529_CPM-10.pdf. PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 29939 PPA gives APHIS the authority to issue general permits for the importation or interstate movement of plant pests. Such a permit would authorize organizations that frequently move certain low-risk plant pests and organisms interstate to do so without having to obtain an individual permit for each movement. The general permit for the plant pest or organism would be posted on the APHIS website with a list of permit requirements. Persons would not be required to sign a permit or record movements of the plant pest or organism. Some commenters endorsed the issuance of general permits for the importation and interstate movement of low-risk pests, while others expressed concern about whether a general permit will ensure adequate accountability, enforceability, and risk management. One commenter asked how a corporation or university would be able to apply the conditions of a general permit to every situation and added that assigning responsibility for a permit at an organizational rather than an individual level will dilute that responsibility. We acknowledge the concerns raised by commenters regarding general permits and questions about accountability and will therefore continue issuing only specific permits in which one or more responsible individuals are identified in the permit and agree to abide by its requirements. However, for future needs we are retaining in the regulations the language we proposed for issuing general permits and reaffirming our authority under the PPA to issue such permits. We will continue to evaluate the uses and purposes of general permits, and whenever we begin issuing them we will announce in a Federal Register notice the existence, location, and content of each such permit we issue. Types of Plant Pests Regulated In proposed § 330.200(b), we specified the types of plant pests that we would regulate under the revised subpart. For the purposes of the subpart, we stated that we consider an organism to be a plant pest if the organism directly or indirectly injures, damages, or causes disease in a plant or plant product, or if the organism is not known to be a 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. Several commenters commented on the criteria by which APHIS considers an organism to be a plant pest. E:\FR\FM\25JNR2.SGM 25JNR2 29940 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES2 One commenter stated that it would be helpful if the criteria for plant pests could be limited to identifying only pests that cause direct, actual damage to beneficial plants rather than indirect damage. As an example of indirect damage, the commenter cited an organism that has a negative impact on another organism that in turn has a beneficial impact on a desired crop or plant. We identify those organisms that indirectly harm or cause disease to plants and plant products as plant pests because the consequences of indirect harm can be as disruptive and costly as direct harm, particularly if such organisms establish themselves in the environment or harm organisms having a beneficial impact on crops, to cite the commenter’s example. Moreover, the PPA specifically states that causing ‘‘direct or indirect injury to plants or plant products’’ is one attribute of a plant pest. Another commenter stated that a plant pest’s effect on plants or plant products is either known or unknown and asked for clarification of proposed § 330.200(b). If an organism poses an unknown risk to plants or plant products but is similar to a plant pest or pathogen known to directly or indirectly injure, cause damage to, or cause disease in a plant or plant product, we will regulate that organism pending positive identification and an evaluation of the organism’s actual risk to plants and plant products. One commenter recommended that, for organisms that are not known to be plant pests, APHIS should notify the applicant of the reason a permit was required and explain how the organism is similar to one that meets the definition of a plant pest, thereby giving the applicant information needed to address the agency’s concern for future regulatory actions for the organism. We do not consider the commenter’s suggestion to be practicable for every permit application involving an organism not known to be a plant pest. However, if a permit applicant has specific questions regarding why a permit is required for a particular organism, we recommend that the applicant contact APHIS.4 Types of Biological Control Organisms Regulated In proposed § 330.200(c), we listed the biological control organisms we would regulate under the subpart. We 4 For questions about organism and soil permits, please call (301) 851–2357 or (866) 524–5421 (toll free), or email Pest.Permits@usda.gov. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 stated that these organisms consist of invertebrate predators, competitors, herbivores, microbial parasites, and microbial pathogens used to control invertebrate plant pests, plant pathogens, and noxious weeds. A commenter stated that there are approved weed biological control organisms that attack exotic invasive plants not currently listed as ‘‘noxious weeds’’ by a regulatory authority. For this reason, the commenter recommended that in proposed § 330.200(c) we use the term ‘‘exotic invasive plants’’ instead of ‘‘noxious weeds’’ when referring to exotic invasive plants not officially identified as ‘‘noxious.’’ An exotic invasive plant can be considered a noxious weed and regulated as such without being listed as a Federal noxious weed as long as it meets the PPA’s definition of a noxious weed. Meeting this definition are new incursions of plants that, like listed noxious weeds, can directly or indirectly injure or cause damage to crops, livestock, poultry, other interests of agriculture, or the environment. While federally-recognized noxious weeds are covered under 7 CFR part 360, the use of invertebrate herbivores and microbial pathogens to control such weeds is covered under part 330. A commenter stated that, for any imported biological control organism, host-specificity testing documentation and identification verification are essential for protecting the resources of the United States. We agree with the commenter. We exercise considerable care to ensure host specificity before approving an organism for release into the environment. As necessary, we conduct host-specificity testing documentation and identification verification as part of evaluating a permit application. Persons with questions about applications and uses of organisms and host-specificity testing can contact the person listed above under the heading FOR FURTHER INFORMATION CONTACT. EPA Oversight In proposed § 330.200(d), we exempted from this subpart biological control organism products regulated by the Environmental Protection Agency (EPA). This oversight exemption applies only to EPA registered products, experimental use permits, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 18 emergency exemptions, the importation of pesticides being imported under a EPA Pesticide Notice of arrival, as well as the interstate movement of pesticides being moved in accordance with EPA’s PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 regulations in 40 CFR 152.30, If EPA does not regulate an organism under APHIS jurisdiction, APHIS would regulate it regardless of whether it is commercial (applied to more than 10 acres) or experimental. A commenter stated that while the regulatory status of microbial pathogens regulated by EPA is clear, the proposed rule was ambiguous regarding organisms that have been formulated into plant growth-promoting products, also known as biostimulants. The commenter asked what the framework is for regulating plant growth-promoting microbial pathogens and organisms as commercial products excluded from registration under FIFRA. Although APHIS is not authorized under the PPA to regulate products based on their biostimulant properties, the Act does allow APHIS to regulate and impose restrictions on a product in order to prevent the introduction or dissemination of plant pests within the United States. APHIS will evaluate each product and its uses to assess their potential plant pest risks and determine whether restrictions are warranted based on plant pest risk. Manufacturers or producers of products that EPA determines not to require registration should not assume that they would not be subject to regulation by APHIS under part 330. A commenter stated that the proposal to establish criteria for the movement and release of unregistered microbial pesticides needs to be clarified in the regulations, suggesting that the expanded ability to import biological control organisms should also include the following: Research samples containing organisms that were part of a fermentation process destined to become an EPA registered bio-pesticide, material no longer meeting EPAestablished specifications (expired lots), partially formulated bio-pesticides, experimental formulations, culture strains, and quality control samples. We will continue to observe EPA’s jurisdiction over organisms subject to their regulations as described in § 330.200(d). Other organisms falling outside EPA’s jurisdiction but within the scope of APHIS’ authority under the PPA will be subject to the regulations under part 330 as appropriate. A commenter stated that having EPAregistered microbial pesticides be exempt from current APHIS regulations is a positive benefit, but that there needs to be clear, documented guidance to allow for successful clearances at U.S. border facilities. We noted in the proposed rule that biological control organisms that are pesticides and not registered with EPA, E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations but that are transferred, sold, or distributed in accordance with EPA’s regulations in 40 CFR 152.30, would not be regulated under this subpart for their importation or interstate movement. However, persons desiring to import shipments of biological control organisms that are subject to FIFRA will need to submit to EPA a Notice of Arrival by Pesticides and Devices as required by U.S. Customs and Border Protection (CBP) regulations. APHIS is working closely with CBP and EPA to ensure that such guidance is available and sufficient for clearances at U.S. border facilities. One commenter asked if APHIS would issue general permits through the process outlined in a Memorandum of Understanding (MOU) with EPA or provide details of the process through APHIS guidance documents. APHIS has no plans to continue issuing permits for the importation of EPA-registered materials. These items will be imported under EPA’s regulatory oversight. In addition to the MOU between EPA and APHIS, a commenter asked if there would be ongoing coordination between the agencies for regulating new products. We intend to continue coordinating with EPA with respect to coordinating regulation of new products not yet registered by EPA. APHIS typically confirms EPA product registrations containing specific strains and maintains its own permitting database to include these strains. A commenter asked if the APHIS regulatory oversight exemption for EPAregulated materials applies to registered Technical Grade Active Ingredient, End Product, Active Ingredients, and Experimental Use permit materials, as well as Section 18 requests.5 The commenter added that according to the guidance available, no APHIS permit would be required for any of these products. The commenter is incorrect. The exemption applies only to EPA registered products and experimental use permits or pesticides being imported under a EPA Pesticide Notice of Arrival. A commenter stated that in order to prevent ‘‘double regulating,’’ APHIS should enter into an MOU with the U.S. Fish and Wildlife Service (USFWS) as it has done with EPA. The commenter stated that USFWS exempts arthropods from their oversight that are ‘‘farm 5 Permits issued under section 18 of FIFRA that allow State and Federal agencies to permit the unregistered use of a pesticide in a specific geographic area for a limited time if emergency pest conditions exist. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 raised’’ per the definition in 50 CFR 14.4. The commenter added that many commercially produced biological control arthropods have been farm raised for decades and fall under the definition, nevertheless USFWS requires permits at several ports of entry for organisms already regulated by APHIS. We acknowledge the commenter’s concern to prevent double regulating by APHIS and USFWS and will continue to work with affected entities and the USFWS to identify and address instances of this occurring. The same commenter recommended that APHIS establish a policy concerning symbionts 6 of pests, noting that while symbionts can promote pest fitness, they can also exist in non-pest contexts, as when a symbiont has multiple hosts. The commenter suggested that we define ‘‘symbiont’’ accordingly, as microbial taxa will inevitably occur on a pest host as environmental contaminants. The commenter stated that if detection on a pest host defines a symbiont organism, all environmental taxa might fit the definition of ‘‘symbiont’’ because of ephemeral encounters by pest hosts moving within their normal environments. We acknowledge the commenter’s concern but have no plans to provide a definition for ‘‘symbiont.’’ We do not use the term in the regulations, and establishing a regulatory policy for all invertebrate plant pests and biological control organisms under a single definition of the term would by necessity be overly broad. Symbiont relationships may be beneficial or detrimental to the organisms involved in combinations and environmental contexts too varied to document. Moreover, the available information regarding symbionts of any particular organism is typically incomplete, with a knowledge base frequently needing to be updated and revised. For these reasons, APHIS will retain the authority under the regulations to regulate symbionts as necessary on a case-bycase basis. A few commenters stated that we did not define what we mean by ‘‘similar’’ in proposed § 330.200(b), ‘‘Plant pests regulated by this Subpart,’’ with respect to similarities existing between plant pests having an unknown risk potential and those having a known risk potential. One such commenter suggested that a definition of ‘‘similar’’ be defined through guidance instead of including it in the regulations so that 6 Generally defined as organisms that live in symbiosis with one another. PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 29941 APHIS will have sufficient flexibility to define the term based on evolving science. Another commenter noted that regulating organisms based on similarities to other regulated organisms could result in unintended consequences and suggested that such issues may be mitigated in part by using tools such as molecular evaluation of organisms. We did not include a definition of ‘‘similar’’ in the proposed regulations as it is an inherently relative term, and as a commenter noted, scientific methods and genetic comparison techniques are evolving rapidly and requiring APHIS to maintain a degree of regulatory flexibility. A broad definition of ‘‘similar’’ that attempts to cover every possible situation would require potentially arbitrary restrictions on the characteristics used to compare organisms. If an initial comparison of an organism reveals similarities with a known plant pest or pathogen, we will undertake a closer evaluation of the pest risk potential for that organism. Permit Requirements (§ 330.201) Under the proposed section ‘‘Permit requirements,’’ we listed the types of permits that would be required for the importation, movement in interstate commerce, and particular uses of plant pests, biological control organisms, and associated articles. We also proposed requirements for permit applicants as well as procedures for evaluating and taking action on permit applications. In proposed § 330.201(a), we listed the types of permits that APHIS would issue for plant pests, biological control organisms, and associated articles. We also listed permit application requirements and conditions under which APHIS would assess applications and issue, deny, suspend, revoke, and amend permits. One commenter stated that instead of requiring persons to apply separately for permits for different plant pathogens, APHIS should develop a list of conditions under which qualified persons can transport pathogen cultures, infected plant material, and infected soil under a blanket permit for organisms that will not be released or organisms that are native to a State. The commenter added that having to obtain new permits for every sample can be restrictive with respect to sharing isolates. The commenter appears to be describing the general permit that we included in the proposal under § 330.200(a). In the above discussion of § 330.200, we decided to defer issuing general permits but are retaining the provision for issuing such permits for E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29942 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations future needs. However, we acknowledge the commenter’s suggestion and note that other options are available. Applicants meeting the requirements in proposed § 330.201 may include more than one type of organism and its intended use in a permit application, especially within a discipline such as plant pathology, but we often ask that arthropods and plant pathogens appear on separate applications. This lessens confusion for permit reviewers, permittees, and State and Federal regulators. APHIS also maintains lists of plant pathogenic fungi, bacteria, and viruses recognized as widely prevalent within various States. Finally, we note that we are establishing a petition-based process for listing certain biological control organisms and plant pests (in §§ 330.202 and 330.204, respectively) that may be moved interstate within the continental United States without restriction. A commenter stated that the availability of a comprehensive list of pathogens that APHIS considers to be high-risk plant pests would alleviate the permit application process and reduce follow-up questions. The commenter added that such a list would help to ensure that sufficient evidence is provided to APHIS for scientific review. We acknowledge the commenter’s suggestion for improving the permit application process. However, we do not consider it practical to compile a comprehensive list of high-risk plant pests, as any criteria we might develop to identify such pests is subject to many situational variables that require caseby-case evaluation. We note that in 7 CFR 331.3 we maintain a list of highrisk biological agents and toxins that have the potential to pose a severe threat to plant health or plant products. Persons applying for a permit for what they believe may be a high-risk organism are encouraged to contact APHIS with any questions they have about preparing and submitting an application. We proposed in § 330.201(a)(1) that when import permits are issued to a corporate entity, that entity will need to maintain an address or business office in the United States with a designated individual for service of process. A commenter stated that APHIS should consider whether ‘‘designated individual for service of process’’ should use the term in the plural as a way to create more flexibility for the permittee. ‘‘Service of process’’ is the act of serving notice of legal action against another party. The ‘‘designated individual’’ in proposed § 330.201(a)(1) is a person located in the United States VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 who receives notice of legal action on behalf of the corporate entity. As a corporate entity can designate more than one individual to act in this role, we will change the wording to read ‘‘one or more individuals.’’ One commenter noted that many biological products companies conduct research activities in U.S. territories and requested that corporate permits be allowed to cover such activities in those areas. U.S. territories, as well as the District of Columbia, fall within the definition of State under the PPA and part 330, so interstate movement permits for activities regulated under part 330 may be issued for movement from those areas. Curation Permits In proposed § 330.201(a)(3), we set forth provisions regarding continued curation permits, which are issued in conjunction with either an import permit or interstate movement permit prior to the expiration date of the permit. A commenter asked whether continued curation permits as proposed in § 330.201(a)(3) are also intended to cover research and diagnostic activities. Continued curation permits are issued prior to the expiration date for an import or interstate movement permit in order for a permittee to continue research or other actions listed on the import or interstate movement permit. Before a continued curation permit can be issued, the required laboratory conditions for safeguarding organisms received or isolated for research under an import or interstate movement permit must be reevaluated. Two other commenters asked that we clarify the difference between a continued curation permit and the renewal of an existing movement permit authorizing diagnostic or research activities. Continued curation permits do not allow acquisition of additional organisms for research and other authorized activities and only address retention of existing organisms for authorized uses. Continued curation permits are intended for situations in which the permit applicant wishes to retain live regulated organisms but does not request permission for their continued or additional movement, which would require a separate permit. The renewal of a permit would allow for such movement, although it is not required that movement occur. Thus it is usually more desirable to renew a permit authorizing movement in case organisms need to be restored or PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 additional organisms might need to be received. Application Process and Permit Issuance In proposed § 330.201(b), we provided that permit applications would have to be submitted by the applicant in writing or electronically via the internet. A commenter requested that APHIS continue to modernize its information technology systems to enable multistate listings on a single permit application as allowed by APHIS for permits under its biotechnology regulations in 7 CFR part 340. We acknowledge the commenter’s request. APHIS is modernizing its information technology systems and is currently making only critical technical improvements. However, we will consider including this feature in future updates to the permit application page on the Plant Protection and Quarantine (PPQ) website. Another commenter stated that it would be useful for applicants to track the progress of permit applications. We note that a tracking feature exists in the current online electronic permitting system.7 One commenter suggested that it might be helpful to have affected scientific societies and their members involved in designing the APHIS permitting process. APHIS typically solicits comments and feedback from scientific societies and other stakeholders to continuously improve our permitting process. In addition, APHIS received considerable input from other Federal agencies, State regulatory officials, and industry prior to developing the proposed rule. In the preamble discussion of proposed § 330.201(c), we noted that in order to facilitate timely issuance of a permit, an application should be submitted at least 90 days before the actions proposed on the permit application are scheduled to take place, with additional time allotted for complex or novel applications, or applications for high-risk plant pests. We intended this number of days to be a suggestion to help ensure that permit decisions are made prior to the applicant’s proposed permit activity. One commenter asked that we define ‘‘novel’’ within the scope of APHIS’ legal authority under the PPA as it relates to plant pests, noxious weeds, and biocontrol organisms. The commenter stated that ‘‘novel’’ should 7 To access an existing account or register for a new APHIS ePermits account, visit ePermits at https://www.aphis.usda.gov/aphis/resources/ permits. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations be defined solely within the scope of APHIS’ legal authority under the PPA and not in a general sense. We disagree with the commenter that our use of the word ‘‘novel’’ is outside the scope of our authority under the PPA. The commenter is referring to our use of the word ‘‘novel’’ in the proposed rule when referring to permit applications, in which we state that additional time should be allotted for submitting ‘‘complex or novel applications, or applications for highrisk plant pests.’’ Such applications typically include new or unusual processes, safeguards, designs, and methods of organism destruction. As APHIS’ primary purpose under the PPA is to safeguard the United States against the introduction or infestation of plant pests, noxious weeds, and biological control organisms, novel applications require additional evaluation to ensure that the intended activities do not harbor a new or unforeseen plant pest risk. Another commenter stated that the proposed rule does not indicate whether the targeted 90 days for submission of a permit application pertains to permits for imports, interstate movements, field releases, or all of these, and asked for clarification. The guidance regarding 90 days to allow for sufficient processing was suggested for all permit applications. Two other commenters asked that we provide timelines for permit-related actions and decisions. One suggested that a consultation timeline of 30 days and a permitting timeline of 60 days is reasonable. As we indicate on the PPQ Plant Health website,8 permit applications can be processed in as little as 30 days after they are received, but the specific circumstances of many applications make it difficult to publish accurate timelines for evaluating and making decisions on them. These circumstances can include the need for a facility inspection, the need to obtain additional equipment or equipment certifications, or the need for additional information from the applicant. Persons inquiring about the status of a permit application can contact APHIS.9 As part of APHIS’ action on permit applications, we noted in proposed § 330.201(d)(1) that we will share a copy of the application and the proposed permit conditions with the appropriate State or Tribal regulatory officials. A commenter stated that APHIS should ensure that proper procedures 8 The website address is: https:// www.aphis.usda.gov/planthealth/organism-soilpermits. 9 See footnote 4 for contact information. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 are in place whenever sensitive permit application information is shared with States or Tribes. The commenter stated that many States and other entities do not have procedures in place to protect sensitive information to the extent that Federal agencies such as APHIS do, adding that many of them are legally required to provide information in their possession through ‘‘Sunshine Acts’’ and similar public disclosure laws. We acknowledge the commenter’s concern regarding the protection of sensitive and confidential information. Although APHIS may sometimes request confidential business information as part of the permit application process, as a matter of policy we do not share the sensitive or confidential business information included in applications with States or Tribes. Another commenter asked if APHIS informs the permit applicant when an application is shared with other persons or groups for analysis, and if so, whether the applicant is informed of who those persons or groups are. The commenter also asked how APHIS handles any objections arising from sharing permit information with third parties. APHIS typically does not inform permit applicants about details of the evaluation process, of which deliberations with outside experts is sometimes a part. However, if an applicant has questions or concerns about the status of an application and how it is evaluated, he or she can contact APHIS.10 We indicated in proposed § 330.201(d)(3)(ii) that permits would be valid for no more than 3 years. One commenter stated that a timeframe of 5 years for a permit to be valid would be more desirable. We acknowledge the commenter’s view but are making no changes to the proposal. Evolving developments in science, technology, and policy necessitate a re-evaluation of permits every few years. Under a longer timeframe, the original conditions of permitted activity could become obsolete or be subject to new policy or regulatory changes. One commenter said that the requirements for biocontrol agents as currently administered are burdensome. The commenter noted that the APHIS Level 2 user requirement is a significant hurdle to working with many organizations because they are required to obtain this level before they can apply for permits. 10 See PO 00000 Fmt 4701 The commenter is referring to the requirement for obtaining a Level 2 user account from APHIS, which allows users to apply for permits electronically through the APHIS ePermits system. The ePermits system currently supports Level 2 users for all permit application types and Level 1 users for selected permit application types. Level 2 access differs from Level 1 in that it requires identity authentication either through correctly answering online identity verification questions or by presenting a Government-issued photo ID at a local U.S. Department of Agriculture (USDA) office.11 APHIS considers the procedures for obtaining a Level 2 user account to be necessary to maintaining adequate security and we do not believe its requirements to be unduly burdensome. In proposed § 330.201(d)(3), we indicated that APHIS may issue a permit to an applicant if APHIS concludes that the actions indicated in the permit application are not likely to introduce or disseminate a plant pest, biological control organism, or noxious weed within the United States in a manner that exposes plants and plant products to unacceptable risk. A commenter stated that a purely riskbased approach on deciding whether to issue permits does not consider benefits to U.S. agriculture. The commenter said that the presence of a ‘‘balancing condition’’ that considers both risks and benefits is most appropriate for agriculture, and that the absence of such biological control alternatives has resulted in the current standard of chemical control with its associated risks. Another commenter similarly expressed support for researchers who consider both the risks and the benefits of imported biocontrol agents. The commenter noted that Australia has long been a leader in the regulation of biocontrol agents and has included in its analyses both the risks and benefits of importing biological control organisms. The primary mission of APHIS is to safeguard American agriculture and the environment by applying and enforcing adequate protections to prevent the introduction and spread of harmful organisms. Although we are aware that both risks and benefits can be inherent in any permitting decision, the PPA provides us with no directive to consider benefits when issuing import or movement permits. While the PPA indicates that APHIS should facilitate 11 See the website address in footnote 7 for more information about obtaining an ePermits account. footnote 4. Frm 00007 29943 Sfmt 4700 E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29944 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations the use of biological controls,12 no part of the Act directs us to consider benefits other than safeguards to reduce risk. On a practical level, the environmental risk or benefit occurring from release of an organism is circumstantial and difficult to predict. Conducting a risk/benefit analysis requires making assumptions and analyzing hypothetical situations that may or may not occur. Moreover, once a released organism establishes itself in the environment, there may be no way to reverse the action if unexpected risks arise or expected benefits never materialize. A commenter asked if APHIS evaluates risk differently for different activities when considering issuing a permit for the release of biological control organisms, such as greenhouse releases versus field releases, or for agricultural purposes versus recreational or celebratory events such as weddings. The commenter suggested that APHIS should consider relative risk when making release determinations. We agree with the commenter. APHIS always evaluates movement or release risk of organisms relative to the individual species and its intended use. A commenter noted that in proposed paragraphs (d)(3) and (4) of § 330.201, we explain the processes for permit application issuance and denial but provide no details of the initial consultation. The commenter referred to an initial consultation process presented by APHIS–PPQ in September 2016 in which potential applicants consulted with APHIS to determine whether an organism required a permit and, if it did, to gain initial feedback on what data would need to be provided in an application. The commenter asked that we include the consultation process in the regulations to provide transparency and consistency for the entire permitting process. We do not plan to establish a formal consultation process in the regulations, as the consultation process is specific to the circumstances of each application. However, we will continue to use an informal process of initial consultation for complex situations on a case-by-case basis. Two commenters raised concerns about the Letters of No Jurisdiction (LONJ) that APHIS issues in response to permit applications for organisms or products that do not fall under APHIS regulatory authority. One commenter acknowledged that although LONJs are important for clearing imported samples through customs, the letters sometimes contain extraneous information that can 12 See PPA, section 7701(2), Findings. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 be confusing to CBP agents. The commenter cited as an example a LONJ stating that a sample can only move from a certain country to a certain State even though APHIS has no jurisdiction over the sample. The commenter asked that we not include country, State, and address information in the LONJ and simply state that the organism is not regulated by APHIS and can be imported and moved without restriction. Another commenter similarly asked that APHIS revise the LONJ to state specifically that all actions taken with the organism or product, such as movement and release, are not under APHIS jurisdiction. We acknowledge the commenters’ concerns and will consider revising our LONJ templates accordingly. If APHIS issues a LONJ for an organism or product, it means that APHIS has no jurisdiction over its movement or release. However, we encourage persons to determine whether other Federal or State agencies have jurisdiction over actions relating to the organism or product. A commenter requested that APHIS develop guidance to help permit applicants provide the appropriate information to show that an organism is not a plant pest. The commenter stated that if the applicant can provide such information, APHIS should issue a LONJ to the previous permit holder. We are making no changes in response to the comment’s request. Guidance regarding the determination of jurisdiction is intended to be specific to the taxonomic identity and biological properties of the organism listed in the permit application and is not retroactive to previous permit holders. APHIS will continue to work with applicants on a case-by-case basis. A commenter asked that we not issue Letters of No Permit Required with an expiration date, as doing so results in additional administrative activities for APHIS and the applicant to obtain the same letter again following its expiration. The commenter acknowledged that APHIS has the authority to rescind this letter if circumstances change and the activities instead need to be conducted under a permit. APHIS issues Letters of No Permit Required for organisms and products over which APHIS has legal authority but has determined that movement of the organism or product presents no appreciable risk. However, as a condition of granting an exception from permit requirements, the letter may base the exception narrowly on how the organisms are used, their geographical location, or other circumstances. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 Although most such letters issued by APHIS do not include expiration dates, we reserve the right to include them when warranted to maintain the flexibility needed to minimize risks to plants and plant products. One commenter stated that the proposed permitting requirements for movement or importation of organisms are not consistent with how APHIS administers the permitting process. According to the commenter, the APHIS website states that a PPQ 526 permit typically is not required for the interstate movement or release into the environment of domestically isolated microorganisms that are not plant pests and that are widely distributed in the continental United States. The commenter stated that, despite what the website says, APHIS currently requires permits for microorganisms that are not plant pests that are found and collected in multiple locations in the continental United States. We regulate microorganisms if they are known plant pests, act as direct biological control organisms, or if their mode of action is unknown. We are therefore obligated to require permits for their interstate movement and importation regardless of how common they are in the environment. We will review our website content and clarify any requirements that may be unclear to readers. In proposed § 330.201(d)(5), we included provisions for the withdrawal of a permit application. Applicants who wish to withdraw a permit application are required to provide this request in writing to APHIS, which in turn notifies the applicant regarding reception of the request and withdrawal of the application. A commenter representing a State government wanted to know if withdrawals of applications by permit applicants could be posted on the APHIS ePermit website, or if States could otherwise be notified of the withdrawal. The commenter stated that knowledge of application withdrawals helps the State maintain a better awareness of pest and biocontrol-related activities of familiar and new applicants. Permit applications withdrawn by APHIS at the request of the applicant are recorded internally within the ePermit system. APHIS does not plan to modify the system to share additional information with States or stakeholders about applications that are not processed to a permit decision. If we consider a permit withdrawal to materially affect a State’s agricultural or environmental welfare, we will share E:\FR\FM\25JNR2.SGM 25JNR2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations this information with the State accordingly. Biological Control Organisms (§ 330.202) In proposed § 330.202, we presented criteria for the importation, interstate movement, and release of biological control organisms. We noted that we regulate biological control organisms under authority of the PPA insofar as they have the potential to pose a plant pest or noxious weed risk. In § 330.202(a), we proposed general conditions for the importation, interstate movement, and release of biological control organisms. We proposed that, except as provided in proposed § 330.202(b), no biological control organism regulated under the subpart may be imported, moved in interstate commerce, or released into the environment unless a permit has been issued in accordance with § 330.201 authorizing such importation, interstate movement, or release. A commenter asked how APHIS will determine the pest risk to plants and plant products when considering issuing a permit for a biological control organism. If APHIS determines the requested biological control organism is not established in the continental United States and will be a first-time release into the environment, we will undertake a more comprehensive evaluation of the permit application. APHIS will conduct a scientific risk review of the proposed release of the particular organism. khammond on DSKBBV9HB2PROD with RULES2 Biological Control Organisms: Exceptions From Permitting In the proposed rule, we established a notice-based process 13 by which persons could submit petitions for excepting certain biological control organisms from permitting requirements for importation, interstate movement, or environmental release. As part of this informal adjudication process, we will evaluate each petition we receive to determine whether the biological control organism is of a sufficiently low risk. If we determine there is sufficient evidence that the organism exists throughout its geographical or ecological range in the continental United States and that subsequent releases of the organism into the environment will present no additional plant pest risk, we will announce the availability of the petition in a notice 13 We also proposed establishing in § 330.204 a parallel process for excepting certain plant pests from permitting requirements. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 published in the Federal Register and solicit public comment. After we consider the comments we receive, we will announce our final decision on whether to except the organism from permitting requirements in a subsequent notice published in the Federal Register. The final notice constitutes final agency action, which is subject to being challenged in court under the Administrative Procedure Act. We proposed the petition process for permit exceptions because we determined that certain low-risk biological control organisms have become established throughout their geographical or ecological range in the continental United States. The additional release of pure cultures derived from field populations of taxa of these organisms into the environment presents no additional plant pest risk (direct or indirect) to plants or plant products. We posted draft lists of these organisms for comment online.14 Referring to the list of organisms excepted from permitting requirements, a commenter asked APHIS to provide examples of items that would be in the list. We posted examples of invertebrate organisms excepted from permit requirements for review and comment in an online list.15 Products consisting of mixtures of biological control organisms may also be eligible for exceptions from permitting provided that all organisms included in the formulation appear on the list of exceptions. With respect to a taxon’s establishment throughout its geographical or ecological range, a commenter asked what the taxon is and does it have one strain or multiple strains. As we noted in our proposed definition of the term, a taxon can be any recognized grouping or rank within the biological nomenclature of organisms, such as class, order, family, genus, species, subspecies, pathovar, biotype, race, forma specialis, or cultivar. A taxon can contain one strain or multiple strains. A commenter asked if taxon identification will be based on whole genome sequencing. APHIS will require identification using techniques appropriate for the 14 See footnote 2 for the draft lists, which include ‘‘Invertebrate Organisms for the Biological Control of Weeds’’ and ‘‘Invertebrate Organisms for the Biological Control of Invertebrate Plant Pests.’’ These lists will be published and maintained on the PPQ Permits and Certifications website: https:// www.aphis.usda.gov/aphis/resources/permits. 15 See footnote 2. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 29945 taxon and the particular circumstances of the permit request. The same commenter also asked whether a permit will be required to move an organism to a State outside its range if an organism is established throughout its geographic or ecological range within the United States. If an organism is on the list of biological control organisms excepted from permit requirements, that organism will not require a permit for interstate movement within the continental United States. Inclusion on the list indicates sufficient evidence that the species on the list cannot persist outside of its recorded range and that the species has already had ample opportunity to do so naturally. The commenter also asked if APHIS will provide public access to the information that we use to determine a taxon’s geographical or ecological distribution. APHIS will provide access to the information referenced by the commenter. If a person petitions for a species to be added to the list of biological control organisms excepted from permit requirements, they do so with the understanding that we will make publicly available any information submitted by the petitioner with respect to determining the distribution of that species. A commenter representing a State expressed concern that allowing certain biological control organisms to be moved interstate within the continental United States without further restriction does not take into account the organism’s status in individual States and that any such list would need to be subject to review by individual States where agents will be used. As we noted in proposed § 330.201(d)(1), APHIS will share a copy of the petition with the appropriate State or Tribal regulatory officials. APHIS does not approve the use or distribution of biological control organisms within the continental United States without first considering the organism’s status in individual States. We also note that § 330.202(e) indicates that any organism may be removed from the list of organisms excepted from permitting requirements if information emerges that would have otherwise led APHIS to deny the petition to add an organism to the list. In paragraph (b)(1) of § 330.202, we proposed that pure cultures of organisms excepted from permitting requirements may be imported into or moved interstate within the continental United States without further restriction under subpart B of part 330. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29946 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations Citing pest risk concerns, several commenters recommended that all imported biological control organisms be excluded from the draft list of organisms excepted from permitting and that such imported organisms not be eligible for the proposed permit exception process. One commenter stated that biological control organisms could be imported from unverified sources and result in the inadvertent introduction of exotic parasitoids. The commenter added that the risk is high for weed biocontrol agents and plant pests because herbivores from a different geographic source than the originally introduced population often have different host ranges or are discovered to be a different species. Another stated that the proposed rule does not account for different or new foreign sources that would be added to the list of pests and organisms excepted from permit requirements, which may present varying levels of risk in terms of the reliability of sources to ensure correct identification, safe release practices, and freedom from contamination by harmful species. While we have confidence in our proposed petition-based process for excepting organisms from permit requirements that pose a low risk to plants or plant products, we acknowledge that the importation of organisms from new sources and geographic locations could be a potential source of new unapproved exotic species or parasites and diseases of those species. An imported plant pest poses a potentially higher risk level than the same domestic species moved interstate because the former may be carrying unknown diseases or microbial pathogens from the foreign source. Therefore, we will continue at present to require permits for the importation of biological control organisms and plant pests in order to continue the appropriate safeguards with respect to foreign sources. As we envision that stakeholders may wish in the future to import low risk species such as Drosophila melanogaster, we will retain the petition process for excepting biological control organisms and plant pests from permitting requirements in §§ 330.202 and 330.204, respectively. If we receive petitions for importing certain organisms or pests without a permit, we will review and consider making the petitions available for public comment. Any organisms and pests that APHIS lists as being able to be moved interstate without a permit will not be eligible to be imported without a permit unless APHIS expressly indicates otherwise. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 One commenter objected to any regulation of the interstate movement of beneficial insects and mites because they are not plant pests. The commenter stated that the proposed regulatory changes would place beneficial insects and mites under the same movement restrictions applied to plant pests unless they are included in the list ‘‘Organisms for the Biological Control of Invertebrate Plant Pests.’’ The commenter stated that this list should be used to determine whether organisms can cross international boundaries unhindered but that no interstate movement of beneficial insects and mites should be regulated. The commenter also suggested that entire taxa containing no plant pests should be included in the proposed list of excepted organisms, as parasites and predators of plant pests except weed biocontrol agents should be ‘‘innocent until proven guilty.’’ The commenter cited as an example of such taxa the predatory mite family Phytoseiidae, which according to the commenter contains no species known to cause harm to plants. We are making no changes with respect to our proposal to regulate beneficial invertebrates as biological control organisms. In response to previous documents published in the Federal Register in which we discussed codifying requirements for biological control organisms, some commenters stated that APHIS should regulate biological control organisms only when their efficacy at controlling a target plant pest or noxious weed is in question. However, the risk exists that nonspecific and indiscriminant invertebrate parasites and predators intended for beneficial purposes can also attack non-target invertebrates that are themselves beneficial as pollinators or biocontrol organisms. The draft list we posted for public review and comment contains only those organisms for which there exists an established record of observed information and that meet the criteria for exception from permitting set forth in the regulations. We took this approach to the list to minimize the potential direct or indirect plant risk that adding entire taxa could pose absent an evaluation of the risk potential of these taxa. As authorized under the PPA, APHIS is required to evaluate the plant pest effects that organisms may pose to non-target plants and plant targets and regulate them until we are certain that such organisms can be safely released into the environment without further restriction. Pure Culture A number of commenters asked us to define ‘‘pure culture.’’ One commenter PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 noted that many products containing biological control organisms are typically formulated with carrier or host material, such as insects as a food source for entomophagous mites, and asked if such formulations can be considered as pure cultures. Another commenter stated that the requirements for pure cultures need to be clearly defined to ensure they consist of only specified biological control organisms free of predators, parasites, and pathogens, and contain no host material such as exotic invasive plant propagules. Another commenter expressed concern about how identification or purity of organisms could be assured prior to release into the environment, particularly as the term ‘‘pure culture’’ does not appear to be defined in law or policy. We acknowledge that defining the term ‘‘pure culture’’ will provide stakeholders with a clearer understanding of requirements under the regulations and what constitutes a ‘‘clean’’ package of organisms excepted from permitting requirements, especially for field collected sources for weed biocontrol. Accordingly, we will define the term pure culture as a single species of invertebrate originating only from an identified/described population and free of disease and parasites, cryptic species, soil and other biological material, except host material and substrate as APHIS deems appropriate. Examples of ‘‘identified/described population’’ are those originating from a specific laboratory colony or field collection from a specified geographic area, such as an entire country, or States or provinces of a country. For the excepted biological control organisms listed on the PPQ Permits and Certifications website (referenced in § 330.202(b)), we will also include the sources for each species excepted from permit. For example, species of commercial entomophagous biological control organisms will require verification that they are from domestic laboratory colonies. Likewise, weed biological control organisms will need to be field collected from within the continental United States or derived from domestic colonies from those field sources. Another commenter asked how ‘‘pure culture’’ will be defined if organisms are harvested from the established geographical or ecological range in the continental United States. As we noted above, a pure culture consists of a single species of invertebrate originating only from an identified/described population and free of disease and parasites, cryptic species, soil and other biological material except E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations host material and substrate. The source of the organism may originate from the species’ established geographical or ecological range within the continental United States. Another commenter asked whether the term ‘‘pure culture’’ also includes ‘‘pure populations’’ in reference to invertebrates. We cannot answer the commenter’s question as we do not know what is meant by ‘‘pure populations’’ and how it differs from ‘‘pure culture.’’ A commenter stated that ‘‘pure culture’’ can mean a single species derived from a population in a defined geographical area, but added that the biological control industry also considers the term to mean the absence of contamination in commercial inbound shipments and compliance with ‘‘truth in labeling’’ laws that require a package’s label to be identical to its content. The commenter stated that packages are randomly checked by USDA inspectors for permitted organisms and that clarification is needed on how to resolve purity issues in organisms excepted from permitting requirements. As we noted above, we will continue at present to require permits for the importation of biological control organisms and plant pests but will retain the petition process we proposed for excepting biological control organisms and plant pests from permitting in §§ 330.202 and 330.204, respectively. If we receive petitions to allow the importation of certain organisms or pests without a permit, we will review them and submit them for public comment. A commenter asked what additional documentation or certificates may be required to move organisms and products defined as pure cultures, and what provisions will be implemented to ensure clarity with inspectors when importing listed organisms. Documents and certificates required to move organisms and products are typically listed on the permit. APHIS provides guidance to CBP so that inspectors are clear about importation requirements for biological control organisms and products. A commenter recommended that to ensure all redistribution efforts for weed classical biological control organisms, APHIS should consider the Code of Best Practices for Classical Biological Control of Weeds.16 16 Proceedings of the X International Symposium on Biological Control of Weeds 435 4–14 July 1999, Montana State University, Bozeman, Montana, USA; Neal R. Spencer [ed.]. p. 435 (2000). (https:// bugwoodcloud.org/ibiocontrol/proceedings/pdf/10_ 435.pdf.) VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 APHIS is familiar with the document cited by the commenter and agrees in principle with its best practices. One commenter expressed concern that if all bacteria belonging to the same genus as a plant pathogen are regulated, students isolating antibiotic-producing Streptomyces bacteria in an introductory-level microbiology lab exercise could inadvertently fall under APHIS purview. The commenter stated that this could occur because students would not typically move beyond morphologically classifying their isolates as Streptomyces and this genus contains plant pathogens such as Streptomyces scabies. If persons have questions about lab or other specific activities that may fall under APHIS’ regulation of plant pathogens, they are encouraged to contact APHIS for clarification.17 The commenter also stated that it would be helpful to have access to a comprehensive list of microbial pathogens of concern to APHIS so that stakeholders can identify and deal with problematic taxa appropriately. APHIS has regulatory authority over all plant pests and biological control organisms moved in interstate commerce and imported into the United States. While we do not keep such a comprehensive list, an extensive table of U.S. regulated plant pests is available on the APHIS–PPQ website.18 Proposed § 330.202(c) lists the steps by which APHIS accepts and evaluates petitions for adding biological control organisms to the lists of those organisms granted exceptions from permit requirements for their importation or interstate movement. We noted that we drafted two lists of biological control organisms (one list for control of invertebrate plant pests, one for control of weeds) for which we would grant exceptions from the permit requirements, and made the lists available for comment.19 Persons could request that an organism be added to a list by submitting a petition to APHIS. A notice of the petition would be published in the Federal Register for public comment. We stated in proposed § 330.202(c) that such petitions must provide evidence that the organism is indigenous to the continental United States throughout its range, or selfreplicating for a period of time sufficient to consider the organism to be established in its range in the continental United States. The petition would also have to provide results from 17 See footnote 4 for contact information. 18 https://www.aphis.usda.gov/aphis/ourfocus/ planthealth/import-information/rppl/rppl-table. 19 See footnote 2. PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 29947 a field study during which data was collected from representative habitats occupied by the organism and provide any data indicating that subsequent releases of the organism into the continental United States will present no additional plant pest risk. A commenter stated that, because the proposed rule addresses the process for requesting that biological control organisms be added to the lists of organisms excepted from permit requirements, APHIS needs to make the current list readily available. Another commenter stated that a clear description of how to access the lists is needed, and two other commenters stated that a mechanism for updating the lists also needs to be added to the regulations. We made draft lists of biological control organisms excepted from permitting available for review at the website address listed in footnote 2.20 We noted in the proposed rule that while we will consider comments received on the draft lists to be distinct from those received on the proposed rule, the comments received on the draft lists will inform our evaluation of the suitability of the exceptions from permitting requirements contained in proposed § 330.202(b). Once the rule is finalized and a list of excepted organisms is established on the APHIS website, persons can submit petitions according to the provisions included in § 330.202(c). One commenter supported a process for excepting certain biological control organisms from permit requirements, but expressed concern that publishing petition notices in the Federal Register and soliciting public comment may make the process sufficiently onerous as to effectively limit its use. Instead, the commenter suggested that we establish a Technical Advisory Group (TAG) to expedite the listing process for excepted biological control organisms. APHIS is committed to ensuring transparency and public participation with respect to reviewing petitions for permit exceptions. For this reason, we intend to publish notices of petitions we receive in the Federal Register and request public comment on them. We may also use our Stakeholder Registry as another means of notifying the public of proposed actions and requesting comment. Although we maintain an active TAG, we disagree with the commenter and do not consider it to be 20 Invertebrate Organisms for the Biological Control of Weeds; Invertebrate Organisms for the Biological Control of Invertebrate Plant Pests; and Native and Naturalized Plant Pests Permitted by Regulation (Individual Permits not Required) for Their Interstate Movement within the United States. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29948 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations as efficient or as transparent as the petition comment process. Under § 330.201(d)(1), APHIS will have the option of consulting with technical experts on petitions as the need arises. The same commenter opposed a blanket permit for interstate movement of select organisms that appears to include fieldto-field collections and releases without screening such organisms for unwanted contaminants, but acknowledged that field-to-field movement can include beneficial predators such as coccinellids (lady beetles). The commenter stated that a blanket permit system may result in intentional or unintentional mislabeling of shipments leading to accidental introduction of a potentially serious pest. The commenter seems to be referring to the general permit we discuss above, which authorizes organizations that frequently move certain low-risk plant pests and organisms interstate to do so without having to obtain a separate permit for each movement. As we noted, we have decided to defer issuing general permits until a later time. We also note that APHIS does not approve the interstate movement and release of any biological control organism without consideration of the organism’s status in individual States, and to that end solicits State review. Moreover, the issue of contaminants is mitigated in two ways. The majority of biocontrol releases are at present coordinated by government-related programs or personnel, who have training and experience in moving clean shipments. Likewise, commercial entities are economically motivated to provide clean, quality shipments. State and local plant regulatory personnel also have the opportunity and authority to observe, report, and enforce regulations regarding the movement and release of non-exempt, contaminant organisms in any shipment. One commenter stated that movement permits need to be specific to each State, noting that transporting biological control organisms that are effective in California may have consequences if the same agents are used in another State. The commenter cited the potential danger of walnut twig bark beetles on the West Coast spreading Thousand Cankers disease to the Eastern United States. The commenter added that while allowing permits for the transport of biological control organisms may help problems such as this one, it should be the decision of States to allow movement of certain agents across their borders. The species listed by APHIS for exception from permitting requirements VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 are species that exist throughout their full ecological range in the United States and therefore, from a State-by-State view, are either already present in a given State or have been shown to be unable to live in that State as a selfreproducing population. All other petitions for biological control organisms would be subject to APHIS permits for interstate movement and made available for review and input from Tribal and State representatives as provided for in proposed § 330.201(d)(1). One commenter observed that the regulatory status of entomopathogenic nematodes is not addressed specifically in the proposed rule. Entomopathogenic nematodes meet the definition of biological control organism we proposed in § 330.100 and therefore we regulate them accordingly. However, we have included seven such species on the draft list of biological control organisms proposed to be excepted from permit, which we posted for public comment. One commenter stated that in classical biological control, individual populations of a species have been identified as possible importation sources into the United States, but even these need to be quarantined for screening for contaminants. The commenter stated that the list of excepted organisms maintained online should be reviewed in light of the International Code of Best Practices for Biological Control. We note above that in this final rule we are not at present allowing importation of biological control organisms without a permit but will consider the commenter’s suggestion should we begin to do so. One commenter noted that the need for export certification on biological control organisms is not addressed, and suggested that APHIS should issue permits certifying the condition of organisms and associated articles that are destined for export from the United States. Another commenter stated that the need for export certification on biological control organisms has been addressed in the North American Plant Protection Organization (NAPPO) Regional Standards for Phytosanitary Measures (RSPM) 26 and that the approved RSPM has been waiting for the current proposed rule for appropriate action. APHIS acknowledges that the proposed regulations do not include provisions for certifying the export of regulated biological control organisms. The IPPC has, however, published a set PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 of guidelines 21 that addresses the export of biological control organisms, and the NAPPO standard 22 addresses foreign export certification requirements for biological control organisms being moved from the United States to Canada or Mexico. As a signatory and participating member of these organizations, APHIS observes internationally agreed upon standards for the export of biological control organisms and products. Another commenter stated that a generic permit or other indication of status is needed for organisms listed as being excepted from permit requirements and recommended that we explain how the list relates to the biological control species approved in RSPM 26 Appendix II.23 The proposed list of biocontrol organisms to be excepted from PPQ permit requirements includes all the species on the list of biological control organisms approved in RSPM 26, Appendix II. One commenter stated that RSPM 12, ‘‘Guidelines for Petition for First Release of Non-indigenous Entomophagous Biological Control Agents,’’ 24 should be added to the rule with respect to the petitioning process for excepted organisms. The commenter added that the RSPM already outlines many of the proposed requirements. We considered RSPM 12 guidelines when developing the proposed rule. However, RSPM 12 is a tri-national agreement, is intended only as a guideline, and is periodically revised. For these reasons, it would not be practical or necessary to add RSPM 12 guidelines to the regulations. One commenter proposed that a tiered, science-based approach be adopted to determine permit requirements for microorganisms isolated within the continental United States. The commenter suggested using the following three categories: ‘‘No permit required,’’ if the microbe is identified by its complete genome sequence and contains no proven plant pathogenic sequences; ‘‘fast track,’’ if the microbe is a member of a taxon not known to be a crop pathogen; and ‘‘all other microorganisms.’’ The commenter added that guidelines to the identity of these sequences should be developed by 21 ISPM 3, ‘‘Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms,’’ published 2016. 22 RSPM–26 ‘‘Certification of commercial arthropod biological control agents moving into NAPPO member countries,’’ published 2015. 23 See footnote 22. 24 https://www.nappo.org/files/1814/4065/2949/ RSPM12_30-07-2015-e.pdf. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations the biopesticide industry and the research community. We are making no changes in response to the commenter’s proposal. Our approach to determining the permit status and requirements for microorganisms is done on a case-bycase basis. Our requirements for a ‘‘no permit required’’ determination include origin and distribution information and intended use that we evaluate for each application. Due to the evolving science, we do not identify specific microbial identification techniques but we do use the best and most appropriate methodology available to identify organisms. A commenter stated that plant growth and plant health enhancing consortia and biostimulants should be treated the same as biological products making pesticidal claims, since the potential safety hazards are the same for all these groups of novel microorganisms. Under the PPA, APHIS has no authority to regulate products on the basis of their plant health or growth enhancing attributes, but only on the basis of pest risk potential. One commenter suggested that a specific organism used to manufacture an EPA-registered biopesticide should not require a plant pest permit to move interstate as a pure culture or as part of a formulation. The commenter added that if a beneficial organism can be applied to crops as a registered biopesticide, a small-scale release from an experimental formulation in a field trial should not pose a risk to U.S. agriculture. Typically, APHIS does not require a permit for the interstate movement of a product that is regulated by EPA. However, other isolates or nonregistered uses may require a permit. Two commenters addressed the topic of States regulating the movement of plant pests and biological control organisms. One commenter opposed allowing States to establish regulations for interstate movement of organisms that are more restrictive than those established by the Federal Government, while another stated that States have the option of independently establishing more restrictive regulations. Under the PPA, a State may not regulate the movement in interstate commerce of any biological control organism, plant pest, or noxious weed if the Secretary has issued a regulation or order to prevent its dissemination within the United States. There are two exceptions listed in the Act: A State may impose movement restrictions as long as they are consistent with and do not exceed the regulations or orders issued by the Secretary, and a State may VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 impose movement restrictions that are in addition to Federal restrictions as long as the State demonstrates a clear need to do so based on science and pest risk. As we noted in the proposed rule, States and localities may have laws and regulations that restrict the movement or release of plant pests, biological control organisms, and associated articles for various reasons (for example, impact on the environment of the State or locality), and we encourage applicants to consult with these authorities when applying for a permit. One commenter stated that if the proposed regulations supersede permits that were specifically issued for national defense projects, means of conveyance, and organisms that are not subject to APHIS regulation (i.e., courtesy permits), then this information needs to be conveyed to regulatory personnel so that packages containing organisms can be transported without inspection delays during the period of transition to the new regulations. The proposed regulations do not supersede or nullify the status of current, valid permits. A few commenters questioned whether notice of the petition and public comment are necessary for excepting certain organisms from permit requirements, with one commenter adding that APHIS could simply respond to the petition by conducting the risk assessment and notifying the petitioner of the decision, and that organisms either added or removed from the list could be noted on the website. APHIS embraces a transparent process and is committed to public involvement during the petition process. In § 330.202, paragraph (c)(1) states that petitioners proposing additions to the lists of organisms excepted from permitting requirements must provide evidence indicating that the organism is indigenous to the continental United States. A commenter requested that APHIS provide guidance and examples that would demonstrate that an organism is indigenous. Guidance and examples for permit applicants are posted on the APHIS Regulated Organism and Soil Permits website.25 Applicants may also contact APHIS using the information in footnote 4. A commenter asked if the development of a new biocontrol product involving previously unreleased organisms requires completion of a PPQ 526 Form (Application for Permit to Move Live 25 https://www.aphis.usda.gov/planthealth/ organism-soil-permits. PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 29949 Plant Pests or Noxious Weeds) and an assessment of potential environmental effects. Any new biological control organism or product that has not been released into the environment requires completion of a PPQ 526 permit application form and an environmental assessment. Soil (§ 330.203) As we noted in the proposed rule, we are integrating the soil regulations into the revised ‘‘Subpart B—Plant Pests, Biological Control Organisms, Soil, and Associated Articles.’’ We moved the regulation of soil into the revised subpart B in order to highlight the fact that soil, as an associated article, may harbor plant pests and noxious weeds that can be spread within the United States through importation or interstate movement. In proposed § 330.203(a), we established that, as an associated article, the importation or interstate movement of soil is subject to the permitting requirements in § 330.201 unless otherwise indicated in the regulations. Soil and Associated Articles From Canada We proposed to amend the regulations in § 330.203(b)(1) so that soil from any area of Canada regulated by the Canadian Food Inspection Agency (CFIA, the national plant protection organization of Canada) for a soil-borne plant pest would require a permit. We noted that this change is in response to recent detections of soil-borne plant pests of quarantine significance in new areas of Canada. Previously, permits were required for soil imports from a few small areas of Canada. These areas, and areas with new detections of soilborne plant pests, are now regulated by the CFIA, and the risk of inadvertently introducing plant pests into the United States is higher in soil imported from these areas. Two commenters disagreed with this proposed change. One of these commenters asked us to identify the specific quarantined areas in Canada from which importation of soil into the United States is not allowed and requested that we define what information is required with shipments of soil from Canada. The commenter stated that doing so would provide a consistent process for applicants to demonstrate to inspection officials at ports of entry that the soil is not from an area regulated by the CFIA for soilborne plant pests. Similarly, another commenter asked us to indicate the procedure for proving to U.S. inspectors that imported soil is not from a quarantined area in Canada. The E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29950 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations commenter stated that there is nothing specified in the proposal on how to prove the soil from Canada is not from a quarantined area. Persons wishing to import soil into the United States from any area of Canada not regulated by the CFIA for soil-borne plant pests are responsible for verifying to inspectors that the soil is from such a non-regulated area. CBP inspectors at U.S. ports of entry typically require documentation provided by the CFIA to verify soil origin. Inspectors can corroborate this documentation with other shipment documentation, such as a bill of lading, to verify the origin of each shipment. One option for persons for whom providing such documentation is not practicable is to apply for a permit to move such soil. APHIS will evaluate the request and, if no permit is necessary, issue a Letter of No Permit Required on the basis that the soil originates from an area not regulated by CFIA for a soilborne plant pest. In paragraphs (b)(2) through (4) of § 330.203, we proposed additional conditions for the importation of soil into the United States. A commenter asked if each of the purposes listed in those paragraphs requires an import permit along with the other conditions described. An import permit with specific conditions is required for importation of soil via hand-carry, importation of soil intended for the extraction of plant pests, and importation of soil contaminated with plant pests and intended for disposal. Section 330.203(b)(3) provides additional conditions for the importation of soil intended for the extraction of plant pests. To mitigate the risk of introducing plant pests through the movement of such soil, we will require the soil to be imported directly to an approved biocontainment facility. One commenter agreed with the conditions proposed in § 330.203(b)(3) but wanted to know if the biocontainment facility will be at the permittee’s destination or at a central inspection center prior to transport to the permittee’s final destination. The commenter asked that we specify in the regulations that the facility must be an APHIS-approved biocontainment facility. We would require such soil to be imported directly to the permittee’s APHIS-approved biocontainment facility. Maintaining a biocontainment facility and having APHIS approve it for the extraction of plant pests are prerequisites for this type of permit. In § 330.203(b)(5), we proposed to establish import permit exemptions for VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 a list of articles, including rocks, silt, clay, and other quarry products, that are not soil. If the article being imported is free of organic material, it will not require an import permit unless the Administrator has issued an order stating that a particular article is an associated article. A commenter asked us to clarify how § 330.203(b)(5) would apply to the following materials: Products of nonsoil stone or quarry products combined with plant nutritive or soil conditioning materials such as composts and manures; bone meal, feather meal, or blood meal; fish, shellfish, or kelp materials; peat, coconut coir, humates, spores or live mycorrhizae, as often used with potting mixes; animal and insect repellent compounds like biological oils or neem oils, or geranium extracts; animal derived or extract materials such as insect pheromones; synthetic chemicals such as pesticides or fertilizers, and recovered nutrients from sewage. The commenter added that many beneficial plant growth products that include these materials are being developed and marketed, and that preventing their interstate movement could significantly inhibit the benefits they provide to agriculture. To the extent that any of the articles listed by the commenter contain organic material and are thus associated articles having the potential to contain pests or plants and plant parts that pose a risk to American agriculture and the environment, a permit would be required to import such products or to move them interstate. Permit applicants with questions about specific articles can contact APHIS using the information in footnote 4. The commenter also asked about interstate movement of plant growth enhancers in relation to the permit exemptions in § 330.203(b)(5), which addresses the import of certain articles but makes no reference to interstate movement. APHIS considers permit requests for importation or interstate movement of the materials listed on a case-by-case basis. To facilitate our evaluation and permit decision process, we typically ask prospective permittees wishing to import or move plant growth enhancers to answer questions located on the APHIS plant growth enhancer website.26 We note that some animal material, including bone, blood, and feathers, are regulated under the jurisdiction of APHIS Veterinary Services or other Federal agencies. 26 https://www.aphis.usda.gov/planthealth/ organism-soil-permits. PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 The same commenter asked whether zeolite minerals, lignitic and humate minerals, various cation-exchange capacity-enhancing clay minerals, phosphate rock, limestone, dolomite, and green sands would be exempt and considered non-soils under this proposed rule. Articles eligible for exemption in proposed § 330.203(b)(5) must be free of all organic materials and considered to be non-soil. The examples of exempted materials listed in paragraphs (b)(5)(i) through (iv) are not intended to be exhaustive. If the materials cited by the commenter are free of organic material and thus considered to be non-soil, such material will be exempted from permitting requirements. The commenter also asked if sterilization, heat treating, or other methods of killing possible pathogens or organisms applied to the products cited would allow for them to be exempt from regulation for interstate movement. If we determine that any of the materials indicated contain soil, then restrictions for the interstate movement of soil will apply. Even if the customer claims that sterilization, heat treatment, or other methods of killing possible pathogens or organisms has been performed on the material and its intended use is for release into the environment, APHIS must first evaluate the material to determine a regulatory action. Finally, the commenter asked whether meeting the USDA organic standards for composts, minimum heating times, and temperature regimes allow for interstate movement without special permitting or regulation under the proposed regulations. The National Organic Program is administered by the USDA Agricultural Marketing Service and develops national standards for organically produced agricultural products. Those standards do not address plant pest risks. As we noted above, we proposed placing revised regulations for the importation and interstate movement of soil under new ‘‘Subpart B—Movement of Plant Pests, Biological Control Organisms, and Associated Articles,’’ and removing and reserving current ‘‘Subpart C—Movement of Soil, Stone, and Quarry Products.’’ As part of this change, we removed current § 330.301, which contains restrictions for the movement of stone and quarry products from areas in Canada infested with gypsy moth. We explained in the proposed rule that we would retain these conditions but move them to 7 CFR 319.77–4 of ‘‘Subpart R—Gypsy Moth Host Material from Canada,’’ as E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations we consider that subpart to be a more appropriate location for regulating gypsy moth. One commenter stated that open gravel pits and other disturbed areas can harbor noxious weeds due to ground disturbances. The commenter expressed concern that importation of stone and quarry products from Canada without proper decontamination for noxious weeds may increase the genetic diversity of the weed population in the United States. Under the soil regulations in § 330.203(b)(5), we proposed to exempt from regulation the importation and interstate movement of stones, rocks, and other quarry products that are free of organic material. If a shipment of gravel or other stone is found to contain organic material, it will be considered to be an associated article and be subject to the regulations under § 330.203. Another commenter asked us to revise proposed § 330.203(b)(5)(ii), which includes a permit exemption for sediment, mud, rock, and similar articles from saltwater bodies of water, to include an exemption for similar articles taken from freshwater bodies of water. We already consider peat, cosmetic mud, and other mud products from freshwater estuaries or the earth’s upper surface, if processed to a uniform consistency and free of plant parts and seeds, to be exempt from our regulations. Rocks and other non-soil articles are already exempt under § 330.203(b)(5). However, plant pests can thrive in freshwater bodies of water and therefore articles containing organic material from freshwater bodies of water must be evaluated by APHIS to determine their regulatory status. In proposed § 330.203(c), we established regulations governing the interstate movement of soil, which includes general conditions for moving soil interstate within the United States and conditions for moving soil interstate for specific purposes. Except for soil moved in accordance with § 330.203(c)(2) through (5), soil may be moved interstate within the United States without a permit or a compliance agreement. We require, however, that all soil moved interstate is subject to any restrictions and remedial measures specified for such movement in our domestic quarantine regulations referenced in 7 CFR part 301. We proposed in § 330.203(c)(2) that soil may be moved in interstate commerce within the continental United States with the intent of extracting plant pests only if an interstate movement permit has been issued in accordance with § 330.201 and VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 the soil will be moved directly to a biocontainment facility approved by APHIS. A commenter asked if proposed § 330.203(c)(2) would provide additional conditions for the importation of soil intended for the extraction of plant pests. To mitigate the risk that such soil could present a pathway for the introduction or dissemination of plant pests within the United States, the commenter stated that APHIS would need to require all such soil to be imported directly to an approved biocontainment facility. As indicated in § 330.203(b)(3), importation of soil into the United States intended for the extraction of plant pests requires a permit and the soil must be moved directly to a biocontainment facility approved by APHIS. The shipment is subject to all conditions for movement specified on the permit, including safeguarding requirements. Proposed § 330.203(c)(4) allows for the movement of soil samples from an area quarantined in accordance with part 301 without prior issuance of an interstate movement permit, provided that the soil is moved to a laboratory that has entered into and is operating under a compliance agreement with APHIS and is approved by APHIS to conduct chemical/physical tests and analyses of such samples. One commenter asked if no permit is required for movement of soil under § 330.203(c)(4) will there be another document required to accompany the soil. The commenter also wanted to know if a permit application needs to be submitted for such movement. Proposed § 330.203(c)(4) requires that the laboratory to which the sample is destined to be moved enter into a compliance agreement with APHIS. The movement can be made without prior issuance of an interstate movement permit. One commenter stated that the regulations for interstate movement of restricted soil between approved laboratories should be expanded to include foreign soil samples that are otherwise subject to the same handling and disposal requirements. The commenter noted that currently it is necessary to get USDA approval on a case-by-case basis to move foreign samples between laboratories. Imports of soil, unless otherwise exempted in the regulations, must be accompanied by an import permit and sent directly to an APHIS-approved biocontainment facility. If we authorize additional movements of imported soil, the movements must also be to an APHIS-approved biocontainment PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 29951 facility with the same safeguarding and containment capacity as the original facility and must be moved under a permit as well. As we consider imported soil to present a higher risk to U.S. agriculture and the environment, we consider it necessary to track and approve all foreign soil movements and disposition on a case-by-case basis as part of our standard permit conditions. Exceptions To Permitting Requirements for the Importation or Interstate Movement of Certain Plant Pests (§ 330.204) In accordance with the PPA, we proposed in § 330.204 to establish regulations allowing the importation and movement in interstate commerce of plant pests without further restriction if we determine that no permit is required. Specifically, we proposed a notice-based petition process by which the public could petition to have pests either added to or removed from the list of plant pests excepted from permitting requirements for importation or interstate movement. As part of this informal adjudication process, we will evaluate the petition to determine whether the plant pest is of a sufficiently low risk. If, after review of the petition, we determine that the plant pest belongs to one of the categories in § 330.204(a) that make it eligible for listing, we will publish a notice in the Federal Register announcing the availability of the petition and our intention to add it to the list of plant pests that may be imported into or moved interstate within the continental United States without restriction. We will also solicit public comment on the notice and petition. If after we consider the comments we determine that our conclusions regarding the petition have not been affected, we will publish in the Federal Register a subsequent notice stating that the plant pest has been listed and excepted from permitting requirements. This subsequent notice constitutes final agency action, which is subject to being challenged in court under the Administrative Procedure Act. Several commenters expressed concern that importation of plant pests excepted from permitting could result in new diseases and damage to beneficial plants and plant products within the United States, particularly plant pests imported from new sources and locations. These comments raise concerns similar to those we received for § 330.202(b), in which we proposed allowing the exception from permitting for the importation and interstate movement of certain biological control E:\FR\FM\25JNR2.SGM 25JNR2 29952 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES2 organisms. We acknowledge that the importation of plant pests from new sources and locations could carry a risk for introducing new, unapproved plant pest species or parasites and diseases of those species. An imported plant pest poses a potentially higher risk level than the same domestic species of that pest moved interstate because the former may be carrying unknown diseases or microbial pathogens from the foreign source. Therefore, we will continue at present to require permits for the importation of plant pests. However, we will retain the petition process for excepting plant pests from permit requirements in § 330.204. If APHIS receives a petition for allowing the importation of low risk plant pests without a permit, we will review it. Based on our review, we will either deny the petition or submit it for public comment. Plant pests that APHIS lists as being able to be moved interstate without a permit will not be eligible to be imported without a permit unless APHIS expressly indicates otherwise. Categories of Plant Pests Eligible for Exception From Permit Requirements In § 330.204(a), we proposed three categories of plant pests that would be eligible for exception from permitting requirements: Pests from field populations or lab cultures derived from field populations of a taxon established throughout its entire geographical or ecological range within the continental United States; pests that are sufficiently attenuated so that they no longer pose a risk to plants or plant products; and pests that are commercially available and raised under the regulatory purview of other Federal agencies. We are making a change to § 330.204 with respect to excepting from permit requirements certain plant pests imported or moved interstate. In § 330.204(a)(2), we proposed excepting from permit requirements the category of plant pests that are sufficiently attenuated so that they no longer pose a risk to plants or plant products. We noted in the proposed rule that when a pest becomes attenuated, it loses its defining pest or biocontrol properties. For this reason, there is no longer a sufficient basis to presume that the pest presents a risk of injuring, damaging, or causing disease in plants or plant products; in other words, an attenuated pest de facto no longer falls within the scope of the definition of plant pest under the PPA. Accordingly, we will remove this category from the proposed regulations. In the case of an attenuated pest, we will issue a LONJ to a petitioner rather than a Letter of No Permit Required as the organism is no VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 longer considered to be a plant pest and therefore is not under APHIS’ jurisdiction. A commenter stated that APHIS’ guidance about permitting is inconsistent with how we administer the permitting process. The commenter noted that the APHIS website says a permit is typically not required for the interstate movement or release into the environment of domestically isolated microorganisms that are not plant pests and are widely prevalent in the continental United States. The commenter noted that, despite what the guidance says, APHIS currently requires permits for microorganisms that are not plant pests that are found and collected throughout the continental United States. To address this inconsistency, the commenter requested that we define several terms, including ‘‘common,’’ ‘‘prevalent,’’ and ‘‘widespread,’’ so that persons can determine whether they need a permit for activities involving plant pests and biological control organisms. We are making no changes in response to the commenter’s request as we do not believe that defining these terms is necessary to determining whether a permit is needed for interstate movement or release of a given organism. Persons with questions about whether an activity requires a permit under the regulations are encouraged to contact APHIS.27 A commenter representing the State of California noted that the State is opposed to and does not participate in the Widely Prevalent List program. The commenter noted that California is a large State with many microclimates that could support new invasive pests, that potential pathways for invasive species are numerous, and that the introduction of unwanted parasites and pathogens that can accompany such species would increase with a webbased permit system. APHIS carefully evaluates the pest risk potential of organisms before considering them to be widely prevalent and will not allow any organisms posing a pest risk to be candidates for an exception to the permit requirements. The same commenter stated his opposition to having the Federal Register be the only forum for contributing input regarding the list of plant pests excepted from permit requirements. In addition to accepting public comments on notices, petitions, and proposed rules published in the Federal Register, we typically conduct 27 See PO 00000 footnote 4 for contact information. Frm 00016 Fmt 4701 Sfmt 4700 stakeholder outreach and invite stakeholders to contact APHIS if they have questions or concerns. A commenter asked whether the application process would exclude those species already on the approved species list for no permit. The commenter is correct. Species on the list have been determined by APHIS to not require a permit. A commenter recommended that APHIS clarify that the exempted activities include release into the environment because the definition of move includes that action. We agree with the commenter. Movement without restriction implies all uses, including release. A commenter asked whether documentation supporting a petition to add or remove organisms from the list of those excepted from permitting requirements will also be made available for comment when the petition is published in the Federal Register. When APHIS issues a notice of petition in the Federal Register, we will also make available for comment any documentation available that supports the petition. A commenter asked whether the omission of ‘‘environmental release’’ from the heading of § 330.204(a) is intentional or accidental. We did not consider it necessary to include the term ‘‘environmental release’’ in the heading ‘‘Exceptions to permitting requirements for the importation or interstate movement of certain plant pests’’ because the definition of move (moved and movement) we proposed in § 330.100 specifically includes releases into the environment. The commenter also asked if the term ‘‘without restriction’’ in § 330.204(a) means that no permit of any kind is needed, and whether States are notified in such cases. States will be notified of APHIS’ decision to not require permits for the importation or interstate movement of a given plant pest or organism. States, however, have the authority to require permits for the movement of these organisms into their boundaries. For example, while no Federal permit is required for the interstate movement of the Madagascar hissing cockroach, the State of Florida requires a permit to move the cockroaches to Florida from another State. One commenter noted that APHIS maintains a list of plant pests in § 340.2 and stated that, because the authority for APHIS–PPQ and APHISBiotechnology Regulatory Services (BRS) to regulate plant pests comes from the PPA, PPQ and BRS should work E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations together to ensure that the list in § 340.2 and the proposed list referenced in § 330.204 are consistent. The list cited by the commenter in § 340.2(a) lists groups of organisms which are or contain plant pests for the purpose of determining what genetically produced or altered plant pests and products are regulated under the regulations in part 340. The list proposed for § 330.204 will include plant pests that may be moved interstate without a permit under the plant pest regulations in part 330. APHIS–PPQ and APHIS–BRS collaborate regularly to ensure that there are no inconsistencies between their respective lists. Referring to native and naturalized plant pests, a commenter asked APHIS to clarify the meaning of ‘‘permitted by regulation.’’ The commenter is referring to the proposed list we made available for review, titled ‘‘USDA–APHIS–PPQ Native and Naturalized Plant Pests Permitted by Regulation (Individual Permits Not Required) For Their Interstate Movement within the United States.’’ 28 This refers to the organisms proposed to be excepted from permit requirements under these regulations. One commenter wanted to know the source of the proposed list we provided for review and what its intended use would be. Draft lists were developed by APHIS and reviewed by the National Plant Board as well as by professional societies and Tribes. Many of the individual species are of a lower risk and commonly requested in applications processed by APHIS. The same commenter, citing the categories in paragraphs (a)(2) and (3) of § 330.200, asked which of these categories applies to the list of native and naturalized plant pests permitted by regulation. Section 330.200(a)(3) refers to organisms under APHIS jurisdiction explicitly granted an exception from permitting requirements in this subpart. The term ‘‘permit by regulation’’ used by the commenter was not used in the proposed rule. However, we have used the term in the past in some APHIS documents and communications regarding these proposed regulations to denote the organisms that would be excepted from permitting requirements. A commenter stated that APHIS should exempt dried herbarium specimens from permitting because they are dried by heating and then frozen. The commenter stated that no disease, pest, or invasive species has escaped from a herbarium specimen. 28 See footnote 2 for the location of the draft list. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 This rulemaking only covers articles that fall under the plant pest regulations, which includes herbarium specimens of parasitic plants not classified as Federal noxious weeds and specimens collected as plant disease samples. APHIS currently requires pest permits for the movement of these plants because of the potential for the presence of viable seeds in the case of parasitic plants, or of persistent resting stages (e.g., sclerotia, chlamydospores) in the case of plant pathogens. As there is some risk associated with the importation and interstate movement of dried herbarium specimens, we acknowledge that the risk to U.S. agriculture and the environment from these specimens is low as long as risk protocols are observed. A commenter noted that that tobacco mosaic virus (TMV) is on the proposed list of plant pests excepted from permitting requirements and suggested that tomato mosaic virus (ToMV) be added as well. The commenter stated that while differentiated by serological reaction and the amino acid sequences of the coat protein, these two Tobamoviruses are nearly identical in their control by the tomato and pepper resistance genes, mechanical and seed transmission, and host range. We disagree with the commenter. Although we acknowledge that TMV and ToMV are similar in morphology and serologically closely related, the sequence information of the genome is distinct enough to differentiate these viruses at a molecular level as different viral species according to the International Committee of Taxonomy of Viruses.29 Another commenter stated that the list of plant pests excepted from permitting requirements should contain all plant pests that are widely prevalent and thus present little additional plant pest risk due to movement. Under the amended regulations, persons will be able to petition APHIS to add such plant pests to the list of plant pests excepted from permitting requirements. The commenter also recommended that Pantoea stewartii (Stewart’s wilt) be removed from the list of plant pests excepted from permitting requirements for interstate movement, as it has not been observed in the field for 8 years and testing for this pest costs the seed industry millions of dollars to allow import of seed to other countries. We agree with the commenter and will remove this species from the list. 29 See https://talk.ictvonline.org/ictv-reports/ictv_ online_report/positive-sense-rna-viruses/w/ virgaviridae/672/genus-tobamovirus. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 29953 We are also changing the name Agrobacterium tumefaciens (crown gall) to Rhizobium radiobacter on the list of plant pests excepted from permitting requirements for interstate movement. We did this in order to update the name of the organism. Finally, during Tribal consultation, a Tribe raised concerns about specific biological control organisms included on the draft list of organisms excepted from permitting requirements for interstate movement. Their concern was that the control organisms, which target species of St. John’s wort, could be released without a permit on Tribal lands. As a result, we decided to continue to require permits for biological control organisms that target these species. Invertebrate Plant Pests We received several comments requesting that certain animals be excepted from the permit requirements as plant pests. Arthropods Several commenters requested exceptions from permitting requirements for the importation and interstate movement of insects that cannot establish themselves in parts of the continental United States due to seasonal climate differences. One commenter requested that we except certain ants from regulation as they are already established throughout the United States. The commenter added that several ant species cannot survive outside of heated buildings and are only found living with humans. Similarly, another commenter asked that we allow tropical species to move into the continental United States for use as pets because they cannot become established due to the cold seasonal climate in most of the country and are not threats to agriculture as many do not eat living plants. A few commenters asked that we relax restrictions on species that have been wiped out of an area or tropical species that cannot survive in our climate and that therefore pose no biological threat. Another commenter stated that foreign rhinoceros and stag beetles should be allowed to be imported without a permit because they cannot survive severe winters, acknowledging that warm States such as Florida should require continued monitoring. Another commenter asked that APHIS review, if not eliminate, restrictions upon certain beetle species that are common in zoos and the pet trade. As examples, the commenter cited Dynastes, Megasoma, and Goliathus species. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29954 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations We do not intend to relax restrictions on the importation and interstate movement of arthropods with respect to seasonal climate differences. The biological threat of arthropod plant pests can be unseen, as unknown diseases and parasitoids may be transported significant distances through the movement and distribution of live specimens. We can, however, consider permit exceptions for arthropod stock that has been isolated and evaluated for disease and parasites. We note that this rulemaking establishes a petition process for persons wishing to add organisms to the list of plant pests that are excepted from permit requirements. A commenter stated that the U.S. cricket pet food industry has been devastated by epizootic Acheta domesticus densovirus outbreaks, and that efforts to find an alternative, virusresistant field cricket species have led to the widespread U.S. distribution of a previously unnamed Gryllus species despite Federal regulations to prevent such movement. The commenter expressed concern that this taxon is likely to become widely distributed throughout the United States and become an established agricultural pest, and claimed that the USDA has taken no action to prevent the movement and sales of Gryllus. The commenter asked that all cultures of G. assimilis and G. locorojo be eliminated from retail outlets in the United States. We are evaluating our policies for the regulation of crickets and other arthropods used both as feeder insects and fish bait. We intend to address issues relating to the species noted by the commenter through policy statements and the permitting process rather than through rulemaking. A commenter requested that APHIS use its authority under the PPA to regulate the interstate movement of bumble bee adults, nests, and used nest materials. The commenter also asked APHIS to promulgate rules prohibiting movement of bumble bee adults, nests, and used nest materials outside of their native ranges and to allow such articles to be moved within their ranges only if the permit applicant shows that all such articles are certified to be free of disease. APHIS has initiated a scientific review and is collecting data regarding the interstate movement of certain species of bumble bee adults, nests, and related articles outside of their native ranges. If we develop such regulations on the movement of bumble bees and related materials, we will promulgate those regulations in 7 CFR part 322, ‘‘Bees, Beekeeping Byproducts, and Beekeeping Equipment.’’ VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 A commenter stated that the permit process is onerous for acquiring zebra swallowtail butterflies and other native species that do not harm crops, and suggested that there are many species that are regulated for no good reason. Zebra swallowtail butterflies are regulated for several reasons. The caterpillars feed on plants (in the genus Asimina) which makes them plant pests, placing them under the authority of the PPA. Butterflies are also important pollinators. Distributing zebra swallowtail butterflies significant distances could result in the dissemination of diseases or parasitoids to other lepidopteran species A commenter stated that it should not be so difficult to obtain a permit to import dead insects because they cause no harm to the environment. The commenter added that just because Ornithoptera alexandrae is in need of protection does not mean that all members of the genus Ornithoptera, including dead specimens, should require permits for importation. APHIS does not require import permits for dead insects unless they carry live plant pests or diseases in or on them. As indicated in part 322, we do have separate requirements for the importation of dead bees in the superfamily Apoidea. Dead insects and those overseen by the Convention on International Trade in Endangered Species, in particular, are regulated by the USFWS. Two commenters stated that some species of particular importance to the research community should be included on the proposed list of plant pests excepted from permitting requirements that we provided for review. The species cited by the commenters are: Corn earworm, Helicoverpa zea; tobacco budworm, Heliothis virescens; European corn borer, Ostrinia nubilalis, and codling moth, Cydia pomonella. Two commenters supported the inclusion of Helicoverpa zea, Heliothis virescens, Ostrinia nubilalis, and Cydia pomonella to the proposed list of insect species excepted from permit requirements. APHIS will consider adding these species to the proposed list of organisms for which no permit is required if we receive the supporting information required as part of the petition process. Many more insect species were initially considered for the list and have been removed at the request of the National Association of State Departments of Agriculture and other groups. Snails We also received a number of comments requesting that we exempt PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 certain snails from regulation as plant pests. One commenter stated that the Federal government overregulates the snail industry. The commenter acknowledged that certain States may need to regulate and monitor movement of Helix aspersa movement but disagreed that Federal regulation of the species is necessary. The commenter noted that the need to regulate H. aspersa in Minnesota or New York is not as great as it is in Florida, which has already banned the species. We are making no changes in response to the commenter. The brown garden snail, Cornu aspersum (formerly H. aspersa, Cantareus aspersus, and Cryptomphalus aspersus) is a serious plant pest causing significant damage in areas where it has escaped cultivation. It feeds on a wide range of plant hosts and can be readily transported in contaminated nursery stock. More than 13 States have imposed quarantines against the brown garden snail and several States have spent considerable time and resources to eradicate infestations. We consider it necessary to continue regulating this snail species to prevent new introductions and limit its further spread. Another commenter stated that certain snail species should be allowed to be transported, raised, and processed for food because they are not a threat to people or the environment. The commenter asked APHIS to create rules allowing easier transport of captive gastropods for pets and to remove the ban on giant African land snails, while another commenter asked that non-plant pest snail species (detritophages and epiphytic growth feeders) be exempted from regulation. Snail species that are not plant pests are not regulated by APHIS under the regulations in part 330. We will consider adding species to our list of plant pests excepted from permitting if we receive the supporting information required as part of the petition process. However, APHIS will continue to regulate species of snails that are plant pests and cause significant damage in areas where they have escaped cultivation. Hand-Carry of Plant Pests, Biological Control Organisms, and Soil (§ 330.205) In proposed § 330.205, we included provisions that allow for plant pests, biological control organisms, and soil to be hand-carried into the United States under permit. A few commenters specifically voiced support for the continued issuance of permits for hand-carrying plant pests, organisms, and soil into the United E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations States. One commenter disagreed with the 2003 Office of the Inspector General audit referenced in the proposed rule recommending that hand-carry of samples be prohibited and noted that APHIS currently authorizes the importation of plant pests in personal baggage under § 330.212 of the regulations. The commenter agreed with APHIS that individual hand-carry is important from a safeguarding perspective, as this option allows a responsible individual to exercise direct and continuous oversight of an article’s importation. APHIS recognizes the importance of hand-carry and will continue to authorize hand-carry events. In § 330.205(b), we proposed that hand-carry permittees be required to provide APHIS with a copy of the first page of the passport and other identifying information. In paragraph (c) of § 330.205, we requested that permittees notify APHIS about the dates and itinerary of the permitted movement. A commenter noted that APHIS makes no mention as to whether the passport page copy is attached to their permit file, or how long APHIS keeps this passport information. The commenter recommended that there be more specific language to address how securely personal information from permit applications will be stored and disseminated. We have reevaluated the application requirements we proposed for handcarry permits and determined that making them available on the APHIS website would allow more flexibility to adjust the requirements as conditions warrant. As a result, we are revising § 330.205(b) to state that after the permittee has obtained an import permit but no less than 20 days prior to movement, the permittee must provide APHIS, through its online portal for permit applications or by fax, with the names of the designated hand carrier, or carriers, assigned to that movement. We will also note in paragraph (b) that additional conditions for hand-carry are available on the APHIS website. Other conditions for hand-carry that were contained in proposed paragraph (c) will also be moved to the APHIS website. The commenter also asked what the expected expiration date of the import permit would be, adding that it is not clearly defined whether the permittee must apply each time they travel but continue with the same permit, or whether the permittee must apply online each time. We consider each hand-carry trip to be a unique event. For this reason, we VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 require that the person wishing to handcarry regulated materials or organisms under a current permit to notify APHIS through our online portal of the intention for a hand-carry event. Packaging Requirements (§ 330.206) We proposed in § 330.206 to include general and specific packaging requirements for the importation, interstate movement, or transit of plant pests, biological control organisms, and associated articles into or through the United States. Regarding shipping of commercial biological control organisms, a commenter stated that APHIS should cooperate with industry to establish a process for shippers to expedite importation and movement of commercial biological control organisms, and to develop an efficient system for clearing shipments of commercial biological control organisms with potentially affected governmental agencies and State departments of agriculture. The commenter also stated that APHIS should identify points of contact for resolving problems that often occur when importing and transshipping commercial biological control organisms. APHIS regularly works with industry to improve the efficiency and timeliness for clearance of imported commercial biological control organisms, including designating certain ports where clearance is a priority and delays are minimal. We recognize, however, that these specific designated ports (which is not the same as ‘‘port of entry’’) may not be convenient for all importers and situations. APHIS will continue to work with industry to seek additional solutions while maintaining the safeguards needed for importation of live organisms. A commenter wanted to know why we did not refer to RSPM 39 30 as it relates to packaging. We did not refer to the guidelines mentioned by the commenter because we consider the proposed requirements for packaging to be adequate. RSPM 39 provides packaging guidelines to facilitate the movement of invertebrate biological control organisms into NAPPO member countries. The provisions and recommendations of RSPM 39, as currently written, exceed the packaging requirements of § 330.206. Moreover, RSPM guidelines are subject to change independent of the status of the plant protection regulations of any member country. 30 https://www.nappo.org/files/5714/3889/7020/ RSPM39Rev-08-12-2014-e.pdf. PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 29955 The commenter also asked whether organisms attenuated and excepted from permitting are also exempt from packaging requirements, as they do not require a permit. As we noted in the above discussion of § 330.204, attenuated organisms will no longer be considered as plant pests and therefore not included on the exception list. In proposed § 330.206(a), we include packaging requirements for the outer shipping container and inner packages. These include the requirements that the outer shipping container must be rigid, impenetrable, and durable enough to remain closed and structurally intact, and that inner packages must be sealed. A few commenters expressed concerns about the lack of flexibility in the proposed packaging requirements, particularly as they relate to the environmental needs of live organisms. One commenter stated that some packaged cultures consume oxygen quickly and generate carbon dioxide, creating conditions that kill beneficial organisms if there are no air holes for oxygen exchange. As an example, the commenter cited the current use of strong cardboard boxes with 1 to 1.5inch holes drilled in the sides for transporting commercial packages of beneficial organisms, including predatory mites and lady beetles. The commenter emphasized that the packaging described in the proposed regulation would block all airflow vital for the survival of beneficial organisms. For interstate travel of organisms that are not plant pests, the commenter stated that containment in one layer of packaging plus an outer breathable layer that keeps the inner packages from impact should be sufficient. Another commenter recommended establishing a performance-based standard for packaging that would require the permittee to ship the organism or soil in a secure manner and suggested that APHIS provide guidance and examples on its website for meeting this standard. We acknowledge the commenters’ concerns about the packing regulations and organism viability during shipment. We note that the regulations allow for modifications as long as they are in keeping with the proposed requirement that the packaging should not be capable of harboring or being a means of dissemination of the organism or article. For example, the requirement in § 330.206(a) that inner packages must be ‘‘securely sealed’’ does not equate to ‘‘airtight’’ unless it is appropriate to the organisms being shipped. We agree that additional guidance can be helpful, and accordingly APHIS will continue to E:\FR\FM\25JNR2.SGM 25JNR2 29956 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES2 work with industry and other stakeholders to address their concerns. In proposed paragraphs (b) and (c) of § 330.206, we required that packing material and shipping containers be new, sterilized, or disinfected prior to reuse, or otherwise destroyed or disposed of at the point of destination. A commenter suggested that the provision prohibiting the reuse of shipping containers, except for those sterilized or disinfected prior to reuse, should not apply to most insect shipments. The commenter stated that it is costly and time consuming to disinfect cardboard clad foam shippers, and that using only new containers will generate additional waste. Another commenter agreed that not all shipping containers warrant sterilization and suggested revising proposed § 330.206(c). As an illustration, the commenter cited the content of a shipment containing all life stages of live insects within multiple packages. The commenter stated that the removal of only the inner containment packaging, which holds the insects, should suffice as decontamination. We agree with the commenters that shipping containers do not warrant sterilization or disinfection for reuse as long as the inner packaging sufficiently contains the organisms to prevent contamination of the outer shipping container. We are revising § 330.206(c) accordingly. Costs and Charges (§ 330.207) In proposed § 330.207, we stated that we would furnish inspection services without cost during regularly assigned hours of duty and usual places of duty. We also stated that APHIS would not be responsible for any costs or charges incidental to inspections or compliance with the provisions of this subpart other than the services of the inspector. A commenter asked if APHIS imposes charges for inspections and compliance checks. Another commenter recommended that APHIS include guidelines for charges associated with conducting inspections and verifying compliance with the regulations. As we note in § 330.207, APHIS does not impose charges for inspections and compliance checks carried out during regularly assigned hours and usual places of duty. As we furnish inspection services under these conditions without cost, we see no reason to include guidelines for charging for such services. Other Comments Several persons submitted general comments that did not address specific provisions included in the proposal. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 One commenter noted that in a separate proposal to revise the regulations to 7 CFR part 340, APHIS noted that a genetically engineered plant pest organism meeting a proposed exemption from the part 340 definition of genetic engineering would still be subject to part 330 because an exemption, by its nature, is not considered an ‘‘explicit authorization.’’ The commenter asked that we wait to promulgate any final rule under part 330 until we fully consider comments received under the separate part 340 proposed rulemaking. On November 7, 2017, APHIS published a document 31 in the Federal Register announcing withdrawal of the proposal referred to by the commenter. Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule with the changes discussed in this document. Executive Orders 12866, 13563, 13771, and Regulatory Flexibility Act. 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. This final rule is considered an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this proposed rule can be found in the rule’s economic analysis. 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). 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 2 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. 31 https://www.federalregister.gov/documents/ 2017/11/07/2017-24202/importation-interstatemovement-and-environmental-release-of-certaingenetically-engineered. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 This rule will amend regulations regarding the importation, interstate movement, and environmental release of plant pests to incorporate provisions regarding biological control organisms and the movement of soils from which plant pests and biological control organisms are extracted. The rule adds definitions, streamlines the permitting and compliance processes, and provides APHIS with increased flexibility in the regulation of plant pests. The regulations in 7 CFR parts 318, 319, and 352 will be updated to reflect the changes in part 330. The rule will codify an existing process for electronically requesting permits. Using the online permit process yields time and cost savings as compared to mailing paper applications. The rule will also reduce the number of permits issued under part 330, which numbered 6,538 in fiscal year (FY) 2015. About one-third of these permits (2,158) were for the movement or environmental release of plant pests or biological control organisms for which this rule will authorize exemption from permitting requirements, based on plant health risks. Their exemption from permitting requirements will reduce the permitting burden for applicants. Because one permit may list multiple biological control organisms or plant pests, we expect, overall, a 10 to 30 percent reduction in the time spent acquiring permits under part 330. Based on the 6,538 permits issued in FY 2015, and assuming the time required to submit an application is one hour, the annual time savings attributable to the rule will total between 654 and 1,961 hours. Given an average hourly wage of $44.50 per hour, the annual total cost savings will be between about $29,100 and $87,300. In accordance with guidance on complying with Executive Order 13771, the primary estimate of annualized cost savings attributable to this rule is $54,950 (including consideration of the cost of unscheduled assessments by APHIS of sites, facilities, and means of conveyance). This value is the midpoint estimate of cost savings annualized in perpetuity using a 7 percent discount rate. Listing of exempted organisms on an APHIS–PPQ website, transparent procedures for petitioning for exceptions or exemptions to permitting, and provision for a notice-based process for adding and removing listed organisms will also combine to make an efficient, transparent, and userresponsive system that will facilitate the movement and environmental release of plant pests and biological control organisms. E:\FR\FM\25JNR2.SGM 25JNR2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES2 Certain regulated entities will continue to incur time costs associated with providing information during the permitting application process as was experienced before this rule was proposed. The time required overall for permitting will be reduced, however, because of the exempted organisms and the online, streamlined permitting system. These revisions to part 330 will benefit entities, large and small, by increasing the efficiency of the permitting and compliance processes and by improving the clarity and transparency of these regulations. The majority of entities that will benefit from this rule are small, based on information obtained from the U.S. Economic Census. These entities include: Academic, government, and commercial researchers; diagnostic enterprises such as plant pathogen diagnostic laboratories; biological supply enterprises that include suppliers of biology teaching kits and suppliers of butterflies for release at special occasions; biological control organism producers; educational display enterprises such as butterfly houses, zoos, and museums; discovery companies that evaluate living organisms for novel pharmaceuticals and pesticides; taxonomists and systematists; educators; and hobbyists (see full economic analysis). The rule will also facilitate the Agency’s coordination with other Federal and State agencies in regulating the movement and environmental release of plant pests and biological control organisms. In our final regulatory flexibility analysis, we have used the best data available to examine potential impacts of the rule to achieve desired policy goals. We have determined that the rule will result in net cost savings for affected entities, nearly all of which are small. We cannot certify that this rule will have no significant impacts on small entities, but have found no evidence that it would have such impacts. We did not receive information during the public comment period on the proposed rule that would alter this assessment. Given the expected net cost savings, we have not identified steps that would minimize these impacts. 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.) VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 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 In accordance with Executive Order 13175, APHIS has consulted with Tribal Government officials. A Tribal summary impact statement has been prepared that includes a summary of Tribal officials’ concerns and of how APHIS has attempted to address them. The Tribal summary impact statement may be viewed on the Regulations.gov website.32 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) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions 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 2 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579–0187, have been submitted for approval to the Office of Management and Budget 32 See PO 00000 footnote 2. Frm 00021 Fmt 4701 Sfmt 4700 29957 (OMB). 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 EGovernment 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 Ms. Kimberly Hardy, APHIS’ Information Collection Coordinator, at (301) 851–2483. List of Subjects 7 CFR Part 318 Cotton, Cottonseeds, Fruits, Guam, Plant diseases and pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin Islands. 7 CFR Part 319 Coffee, Cotton, Fruits, Honey, Imports, Plants for planting, Plant diseases and pests, Plants, Quarantine, Reporting and recordkeeping requirements, Rice, Sugar, Vegetables. 7 CFR Part 330 Customs duties and inspection, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. 7 CFR Part 352 Customs duties and inspection, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, we are amending 7 CFR parts 318, 319, 330, and 352 as follows: PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES 1. The authority citation for part 318 continues to read as follows: ■ Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 7 CFR 2.22, 2.80, and 371.3. 2. In § 318.60, paragraph (c) introductory text is revised to read as follows: ■ § 318.60 Notice of quarantine. * * * * * (c) Sand (other than clean ocean sand), soil, or earth around the roots of plants must not be shipped, offered for shipment to a common carrier, received for transportation or transported by a common carrier, or carried, transported, moved, or allowed to be moved by any E:\FR\FM\25JNR2.SGM 25JNR2 29958 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations person from Hawaii, Puerto Rico, or the Virgin Islands of the United States into or through any other State, Territory, or District of the United States: Provided, That the prohibitions in this paragraph (c) do not apply to the movement of soil from Hawaii, Puerto Rico, and the Virgin Islands other than that soil around the roots of plants; movement of soil that is not around the roots of plants is regulated under part 330 of this chapter: Provided further, That the prohibitions of this section shall not apply to the movement of such products in either direction between Puerto Rico and the Virgin Islands of the United States: Provided further, That such prohibitions shall not prohibit the movement of such products by the United States Department of Agriculture for scientific or experimental purposes, nor prohibit the movement of sand, soil, or earth around the roots of plants which are carried, for ornamental purposes, on vessels into mainland ports of the United States and which are not intended to be landed thereat, when evidence is presented satisfactory to the inspector of the Plant Protection and Quarantine Programs of the Department of Agriculture that such sand, soil, or earth has been so processed or is of such nature that no pest risk is involved, or that the plants with sand, soil, or earth around them are maintained on board under such safeguards as will preclude pest escape: And provided further, That such prohibitions shall not prohibit the movement of plant cuttings or plants that have been— * * * * * medium if the phytosanitary certificate accompanying it contains an additional declaration that the plant was grown in a manner to prevent infestation by that soil-borne plant pest. * * * * * ■ 5. Section 319.69 is amended as follows: ■ a. By revising paragraph (a) introductory text; ■ b. By revising paragraph (a)(8); ■ c. By removing the undesignated paragraph after paragraph (a)(8); and ■ d. By removing paragraph (b)(4). The revisions read as follows: PART 319—FOREIGN QUARANTINE NOTICES § 319.69–1 Notice of quarantine. (a) The following plants and plant products, when used as packing materials, are prohibited entry into the United States from the countries and localities named in this paragraph (a), exceptions to the prohibitions may be authorized in the case of specific materials which have been so prepared, manufactured, or processed that in the judgment of the inspector no pest risk is involved in their entry: * * * * * (8) Organic decaying vegetative matter from all countries, unless the matter is expressly authorized to be used as a packing material in this part. Exceptions to the prohibitions in paragraphs (a)(1) through (7) of this section may be authorized in the case of specific materials which has been so prepared, manufactured, or processed that in the judgment of the inspector no pest risk is involved in their entry. * * * * * [Amended] Authority: 7 U.S.C. 1633, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. 6. Section 319.69–1 is amended by removing paragraph (b) and redesignating paragraph (c) as paragraph (b). ■ 7. Section 319.69–5 is revised to read as follows: 4. In § 319.37–10, paragraph (b) is revised to read as follows: § 319.69–5 Types of organic decaying vegetative matter authorized for packing. ■ 3. The authority citation for part 319 continues to read as follows: ■ ■ § 319.37–10 Growing media. * khammond on DSKBBV9HB2PROD with RULES2 § 319.69 * * * * (b)(1) Plants for planting from Canada may be imported in any growing medium, except as restricted in the Plants for Planting Manual. Restrictions on growing media for specific types of plants for planting imported from Canada will be added, changed, or removed in accordance with § 319.37– 20. (2) Plants for planting from an area of Canada regulated by the national plant protection organization of Canada for a soil-borne plant pest may only be imported in an approved growing VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 The following types of organic decaying vegetative matter are authorized as safe for packing: (a) Peat; (b) Peat moss; and (c) Osmunda fiber. ■ 8. Section 319.77–2 is amended as follows: ■ a. In paragraph (e), by removing the word ‘‘and’’; ■ b. By revising paragraph (f); and ■ c. By adding paragraph (g). The revision and addition read as follows: § 319.77–2 Regulated articles. * * PO 00000 * Frm 00022 * Fmt 4701 * Sfmt 4700 (f) Mobile homes and their associated equipment; and (g) Stone and quarry products. ■ 9. Section 319.77–4 is amended by adding paragraph (d) to read as follows: § 319.77–4 Conditions for the importation of regulated articles. * * * * * (d) Stone and quarry products. Stone and quarry products originating in a Canadian infested area may be imported into the United States only if they are destined for an infested area of the United States and will not be moved through any noninfested areas of the United States, and may be moved through the United States if they are moved only through infested areas. * * * * * PART 330—FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS, BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE 10. 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. 11. The heading of part 330 is revised to read as set forth above. ■ 12. Section 330.100 is revised to read as follows: ■ § 330.100 Definitions. The following terms, when used in this part, shall be construed, respectively, to mean: Administrative instructions. Published documents relating to the enforcement of this part, and issued under authority thereof by the Administrator. Administrator. The Administrator of the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture, or any employee of APHIS to whom authority has been delegated to act in the Administrator’s stead. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture. Article. Any material or tangible object, including a living organism, that could harbor living plant pests or noxious weeds. The term includes associated articles such as soil and packaging. Biocontainment facility. A physical structure or portion thereof, constructed and maintained in order to contain plant pests, biological control organisms, or associated articles. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations Biological control organism. Any enemy, antagonist, or competitor used to control a plant pest or noxious weed. Continental United States. The contiguous 48 States, Alaska, and the District of Columbia. Continued curation permit. A permit issued prior to the expiration date for an import permit or interstate movement permit in order for a permittee to continue research or other actions listed on the import or interstate movement permit. Continued curation permits do not allow acquisition of additional organisms for research and other authorized activities and only address retention of existing organisms for authorized uses. Department. The United States Department of Agriculture. Deputy Administrator. The Deputy Administrator of the Plant Protection and Quarantine Programs or any employee of the Plant Protection and Quarantine Programs delegated to act in his or her stead. Enter (entry). To move into, or the act of movement into, the commerce of the United States. EPA. The Environmental Protection Agency of the United States. Export (exportation). To move from, or the act of movement from, the United States to any place outside the United States. Garbage. That material designated as ‘‘garbage’’ in § 330.400(b). Hand-carry. Importation of an organism that remains in one’s personal possession and in close proximity to one’s person. 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 of APHIS or the Commissioner of U.S. Customs and Border Protection to enforce the regulations in this part. Interstate movement. Movement from one State into or through any other State; or movement within the District of Columbia, Guam, the U.S. Virgin Islands, or any other territory or possession of the United States. Living. Viable or potentially viable. Means of conveyance. Any personal or public property used for or intended for use for the movement of any other property. This specifically includes, but is not limited to, automobiles, trucks, railway cars, aircraft, boats, freight containers, and other means of transportation. Move (moved and movement). To carry, enter, import, mail, ship, or transport; to aid, abet, cause, or induce the carrying, entering, importing, mailing, shipping, or transporting; to VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 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 those activities. Noxious weed. Any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. Owner. The owner, or his or her agent, having possession of a plant pest, biological control organism, associated article, or any other means of conveyance, products, or article subject to the regulations in this part. Permit. A written authorization, including by electronic methods, by the Administrator to move plant pests, biological control organisms, or associated articles under conditions prescribed by the Administrator. Permittee. The person to whom APHIS has issued a permit in accordance with this part and who must comply with the provisions of the permit and the regulations in this part. Person. Any individual, partnership, corporation, association, joint venture, or other legal entity. Plant. Any plant (including any plant part) for or capable of propagation including trees, tissue cultures, plantlet cultures, pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots, and seeds. Plant pest. Any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: 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. Plant product. Any flower, fruit, vegetable, root, bulb, seed, or other plant part that is not included in the definition of plant; or any manufactured or processed plant or plant part. Plant Protection and Quarantine Programs. The Plant Protection and Quarantine Programs of the Animal and Plant Inspection Health Service. Pure culture. A single species of invertebrate originating only from an identified/described population and free of disease and parasites, cryptic species, soil and other biological material except host material and substrate as APHIS deems appropriate. Examples of identified/described population are those originating from a specific laboratory colony or field collection from a specified geographic area, such PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 29959 as an entire country or States or provinces of a country. Regulated garbage. That material designated as regulated garbage in § 330.400(c) and (d). Responsible individual. One or more individuals who a permittee designates to appropriately oversee and control the staff, facilities, and/or site(s) at the location(s) specified on the permit as the ultimate destination of the plant pest, biological control organism, or associated article, to ensure compliance with the permit conditions during all phases of the activities being performed with the regulated articles authorized under a permit issued in accordance with this part for the movement or curation of a plant pest, biological control organism, or associated article. For the duration of the permit, the individual(s) must serve as a primary contact for communication with APHIS. The permittee may designate him or herself as the responsible individual. The responsible individual(s) must be at least 18 years of age and to be able meet with and provide information to an APHIS representative within a reasonable time frame. In accordance with section 7734 of the Plant Protection Act (7 U.S.C. 7701 et seq.), the act, omission, or failure of any responsible individual will also be deemed the act, omission, or failure of a permittee. Secure shipment. Shipment of a regulated plant pest, biological control organism, or associated article in a container or a means of conveyance of sufficient strength and integrity to prevent leakage of contents and to withstand shocks, pressure changes, and other conditions incident to ordinary handling in transportation. Shelf-stable. The condition achieved in a product, by application of heat, alone or in combination with other ingredients and/or other treatments, of being rendered free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50 °F or 10 °C). Soil. The unconsolidated material from the earth’s surface that consists of rock and mineral particles and that supports or is capable of supporting biotic communities. State. Any of the States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the U.S. Virgin Islands, and all other territories or possessions of the United States. Sterilization (sterile, sterilized). A chemical or physical process that results in the death of all living organisms on or within the article subject to the E:\FR\FM\25JNR2.SGM 25JNR2 29960 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations process. Examples include, but are not limited to, autoclaving and incineration. Taxon (taxa). Any recognized grouping or rank within the biological nomenclature of organisms, such as class, order, family, genus, species, subspecies, pathovar, biotype, race, forma specialis, or cultivar. Transit. Movement from and to a foreign destination through the United States. United States. All of the States and territories. U.S. Customs and Border Protection (CBP). U.S. Customs and Border Protection within the Department of Homeland Security. § 330.105 [Amended] 13. In § 330.105, paragraph (a) is amended by removing the citation ‘‘§ 330.300’’ both times it appears and adding the words ‘‘this part’’ in its place. ■ 14. Subpart B is revised to read as follows: ■ Subpart B—Movement of Plant Pests, Biological Control Organisms, and Associated Articles Sec. 330.200 Scope and general restrictions. 330.201 Permit requirements. 330.202 Biological control organisms. 330.203 Soil. 330.204 Exceptions to permitting requirements for the importation or interstate movement of certain plant pests. 330.205 Hand-carry of plant pests, biological control organisms, and soil. 330.206 Packaging requirements. 330.207 Costs and charges. Subpart B—Movement of Plant Pests, Biological Control Organisms, and Associated Articles khammond on DSKBBV9HB2PROD with RULES2 § 330.200 Scope and general restrictions. (a) Restrictions. No person shall import, move interstate, transit, or release into the environment plant pests, biological control organisms, or associated articles, unless the importation, interstate movement, transit, or release into the environment of the plant pests, biological control organisms, or associated articles is: (1) Authorized under an import, interstate movement, or continued curation permit issued in accordance with § 330.201; or (2) Authorized in accordance with other APHIS regulations in this chapter; or (3) Explicitly granted an exception from permitting requirements in this subpart; or (4) Authorized under a general permit issued by the Administrator. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 (b) Plant pests regulated by this subpart. For the purposes of this subpart, 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. (c) Biological control organisms regulated by this subpart. For the purposes of this subpart, biological control organisms include: (1) Invertebrate predators and parasites (parasitoids) used to control invertebrate plant pests; (2) Invertebrate competitors used to control invertebrate plant pests; (3) Invertebrate herbivores used to control noxious weeds; (4) Microbial pathogens used to control invertebrate plant pests; (5) Microbial pathogens used to control noxious weeds; (6) Microbial parasites used to control plant pathogens; and (7) Any other types of biological control organisms, as determined by APHIS. (d) Biological control organisms not regulated by this subpart. Paragraph (c) of this section notwithstanding, biological control organism-containing products that are currently under an EPA experimental use permit, a Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 18 emergency exemption, or 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. § 330.201 Permit requirements. (a) Types of permits. APHIS issues import permits, interstate movement permits, continued curation permits, and transit permits for plant pests, PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 biological control organisms, and associated articles.1 (1) Import permit. Import permits are issued to persons for secure shipment from outside the United States into the territorial limits of the United States. When import permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When import permits are issued to corporate persons, these persons must maintain an address or business office in the United States with one or more designated individuals for service of process. (2) Interstate movement permit. Interstate movement permits are issued to persons for secure shipment from any State into or through any other State. When interstate movement permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When interstate movement permits are issued to corporate persons, these persons must maintain an address or business office in the United States with a designated individual for service of process. (3) Continued curation permits. Continued curation permits are issued in conjunction with and prior to the expiration date for an import permit or interstate movement permit, in order for the permittee to continue the actions listed on the import permit or interstate movement permit. When continued curation permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When continued curation permits are issued to corporate persons, these persons must maintain an address or business office in the United States with one or more designated individuals for service of process. (4) Transit permits. Transit permits are issued for secure shipments through the United States. Transit permits are issued in accordance with part 352 of this chapter. (b) Applying for a permit. Permit applications must be submitted by the applicant in writing or electronically through one of the means listed at https://www.aphis.usda.gov/plant_ health/permits/index.shtml in advance of the action(s) proposed on the permit application. 1 Persons contemplating the shipment of plant pests, biological control organisms, or associated articles to places outside the United States should make arrangements directly, or through the recipient, with the country of destination for the export of the plant pests, biological control organisms, or associated articles into that country. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations (c) Completing a permit application. A permit application must be complete before APHIS will evaluate it in order to determine whether to issue the permit requested. To facilitate timely processing, applications should be submitted as far in advance as possible of the date of the proposed permit activity. Guidance regarding how to complete a permit application, including guidance specific to the various information blocks on the application, is available at https:// www.aphis.usda.gov/plant_health/ permits/index.shtml. (d) APHIS action on permit applications. APHIS will review the information on the application to determine whether it is complete. In order to consider an application complete, APHIS may request additional information that it determines to be necessary in order to assess the risk to plants and plant products that may be posed by the actions proposed on the application. When it is determined that an application is complete, APHIS will commence review of the information provided. (1) State or Tribal consultation and comment; consultation with other individuals. APHIS will share a copy of the permit application, and the proposed permit conditions, with the appropriate State or Tribal regulatory officials, and may share the application and the proposed conditions with other persons or groups to provide comment. (2) Initial assessment of sites and facilities. Prior to issuance of a permit, APHIS will assess all sites and facilities that are listed on the permit application, including private residences, biocontainment facilities, and field locations where the organism 2 or associated article will be held or released. As part of this assessment, all sites and facilities are subject to inspection. All facilities must be determined by APHIS to be constructed and maintained in a manner that prevents the dissemination or dispersal of plant pests, biological control organisms, or associated articles from the facility. The applicant must provide all information requested by APHIS regarding this assessment, and must allow all inspections requested by APHIS during normal business hours (8 a.m. to 4:30 p.m., Monday through Friday, excluding holidays). Failure to do so constitutes grounds for denial of the permit application. (3) Issuance of a permit. APHIS may issue a permit to an applicant if APHIS 2 Includes biological control organisms and plant pests. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 concludes that the actions indicated in the permit application are not likely to introduce or disseminate a plant pest, biological control organism, or noxious weed within the United States in a manner that exposes plants and plant products to unacceptable risk. Issuance will occur as follows: (i) Prior to issuing the permit, APHIS will notify the applicant in writing or electronically of all proposed permit conditions. The applicant must agree in writing or electronically that he or she, and all his or her employees, agents, and/or officers, will comply with all permit conditions and all provisions of this subpart. If the organism or associated article will be contained in a private residence, the applicant must state in this agreement that he or she authorizes APHIS to conduct unscheduled assessments of the residence during normal business hours if a permit is issued. (ii) APHIS will issue the permit after it receives and reviews the applicant’s agreement. The permit will be valid for no more than 3 years. During that period, the permittee must abide by all permitting conditions, and the use of the organism or associated article must conform to the intended use on the permit. Moreover, the use of organisms derived from a regulated parent organism during that period must conform to the intended use specified on the permit for the parent organism. (iii) All activities carried out under the permit must cease on or before the expiration date for the permit, unless, prior to that expiration date, the permittee has submitted a new permit application and a new permit has been issued to authorize continuation of those actions. (iv) At any point following issuance of a permit but prior to its expiration date, an inspector may conduct unscheduled assessments of the site or facility in which the organisms or associated articles are held, to determine whether they are constructed and are being maintained in a manner that prevents the dissemination of organisms or associated articles from the site or facility. The permittee must allow all such assessments requested by APHIS during normal business hours. Failure to allow such assessments constitutes grounds for revocation of the permit. (4) Denial of a permit application. APHIS may deny an application for a permit if: (i) APHIS concludes that the actions proposed in the permit application would present an unacceptable risk to plants and plant products because of the introduction or dissemination of a plant pest, biological control organism, or PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 29961 noxious weed within the United States; or (ii) The actions proposed in the permit application would be adverse to the conduct of an APHIS eradication, suppression, control, or regulatory program; or (iii) A State or Tribal executive official, or a State or Tribal plant protection official authorized to do so, objects to the movement in writing and provides specific, detailed information that there is a risk the movement will result in the dissemination of a plant pest or noxious weed into the State, APHIS evaluates the information and agrees, and APHIS determines that such plant pest or noxious weed risk cannot be adequately addressed or mitigated; or (iv) The applicant does not agree to observe all of the proposed permit conditions that APHIS has determined are necessary to mitigate identified risks; or (v) The applicant does not provide information requested by APHIS as part of an assessment of sites or facilities, or does not allow APHIS to inspect sites or facilities associated with the actions listed on the permit application; or (vi) APHIS determines that the applicant has not followed prior permit conditions, or has not adequately demonstrated that they can meet the requirements for the current application. Factors that may contribute to such a determination include, but are not limited to: (A) The applicant, or a partnership, firm, corporation, or other legal entity in which the applicant has a substantial interest, financial or otherwise, has not complied with any permit that was previously issued by APHIS. (B) Issuing the permit would circumvent any order denying or revoking a previous permit issued by APHIS. (C) The applicant has previously failed to comply with any APHIS regulation. (D) The applicant has previously failed to comply with any other Federal, State, or local laws, regulations, or instructions pertaining to plant health. (E) The applicant has previously failed to comply with the laws or regulations of a national plant protection organization or equivalent body, as these pertain to plant health. (F) APHIS has determined that the applicant has made false or fraudulent statements or provided false or fraudulent records to APHIS. (G) The applicant has been convicted or has pled nolo contendere to any crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity. E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29962 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations (5) Withdrawal of a permit application. Any permit application may be withdrawn at the request of the applicant. If the applicant wishes to withdraw a permit application, he or she must provide the request in writing to APHIS. APHIS will provide written notification to the applicant as promptly as circumstances allow regarding reception of the request and withdrawal of the application. (6) Cancellation of a permit. Any permit that has been issued may be canceled at the request of the permittee. If a permittee wishes a permit to be canceled, he or she must provide the request in writing to APHIS–PPQ. Whenever a permit is canceled, APHIS will notify the permittee in writing regarding such cancellation. (7) Revocation of a permit. APHIS may revoke a permit for any of the following reasons: (i) After issuing the permit, APHIS obtains information that would have otherwise provided grounds for it to deny the permit application; or (ii) APHIS determines that the actions undertaken under the permit have resulted in or are likely to result in the introduction into or dissemination within the United States of a plant pest or noxious weed in a manner that presents an unacceptable risk to plants or plant products; or (iii) APHIS determines that the permittee, or any employee, agent, or officer of the permittee, has failed to comply with a provision of the permit or the regulations under which the permit was issued. (8) Amendment of permits—(i) Amendment at permittee’s request. If a permittee determines that circumstances have changed since the permit was initially issued and wishes the permit to be amended accordingly, he or she must request the amendment, either through APHIS’ online portal for permit applications, or by contacting APHIS directly via phone or email. The permittee may have to provide supporting information justifying the amendment. APHIS will review the amendment request, and may amend the permit if only minor changes are necessary. Requests for more substantive changes may require a new permit application. Prior to issuance of an amended permit, the permittee may be required to agree in writing that he or she, and his or her employees, agents, and/or officers will comply with the amended permit and conditions. (ii) Amendment initiated by APHIS. APHIS may amend any permit and its conditions at any time, upon determining that the amendment is needed to address newly identified VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 considerations concerning the risks presented by the organism or the activities being conducted under the permit. APHIS may also amend a permit at any time to ensure that the permit conditions are consistent with all of the requirements of this part. As soon as circumstances allow, APHIS will notify the permittee of the amendment to the permit and the reason(s) for it. Depending on the nature of the amendment, the permittee may have to agree in writing or electronically that he or she, and his or her employees, agents, and/or officers, will comply with the permit and conditions as amended before APHIS will issue the amended permit. If APHIS requests such an agreement, and the permittee does not agree in writing that he or she, and his or her employees, agents, and/or officers, will comply with the amended permit and conditions, the existing permit will be revoked. (9) Suspension of permitted actions. APHIS may suspend authorization of actions authorized under a permit if it identifies new factors that cause it to reevaluate the risk associated with those actions. APHIS will notify the permittee in writing of this suspension explaining the reasons for it and stating the actions for which APHIS is suspending authorization. Depending on the results of APHIS’ evaluation, APHIS will subsequently contact the permittee to remove the suspension, amend the permit, or revoke the permit. (10) Appeals. Any person whose application has been denied, whose permit has been revoked or amended, or whose authorization for actions authorized under a permit has been suspended, may appeal the decision in writing to the Administrator within 10 business days after receiving the written notification of the denial, revocation, amendment, or suspension. The appeal shall state all of the facts and reasons upon which the person relies to show that the application was wrongfully denied, permit revoked or amended, or authorization for actions under a permit suspended. The Administrator shall grant or deny the appeal, stating the reasons for the decision as promptly as circumstances allow. (Approved by the Office of Management and Budget Under Control Number 0579–0054) § 330.202 Biological control organisms. (a) General conditions for importation, interstate movement, and release of biological control organisms. Except as provided in paragraph (b) of this section, no biological control organism regulated under this subpart may be imported, moved in interstate commerce, or released into the PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 environment unless a permit has been issued in accordance with § 330.201 authorizing such importation, interstate movement, or release, and the organism is moved or released in accordance with this permit and the regulations in this subpart. The regulations in 40 CFR parts 1500 through 1508, part 1b of this title, and part 372 of this chapter may require APHIS to request additional information from an applicant regarding the proposed release of a biological control organism as part of its evaluation of a permit application. Further information regarding the types of information that may be requested, and the manner in which this information will be evaluated, is found at https:// www.aphis.usda.gov/plant_health/ permits/index.shtml. (b) Exceptions from permitting requirements for certain biological control organisms. APHIS has determined that certain biological control organisms have become established throughout their geographical or ecological range in the continental United States, such that the additional release of pure cultures derived from field populations of taxa of such organisms into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products. Lists of biological control organisms for invertebrate plant pests and for weeds are maintained on the PPQ Permits and Certifications website at https://www.aphis.usda.gov/aphis/ resources/permits. (1) Importation and interstate movement of listed organisms. Pure cultures of organisms excepted from permit requirements, unless otherwise indicated, may be imported or moved interstate within the continental United States without further restriction under this subpart. (2) Release of listed organisms. Pure cultures of organisms on the list may be released into the environment of the continental United States without further restriction under this subpart. (c) Additions to the list of organisms granted exceptions from permitting requirements for their importation, interstate movement, or release. Any person may request that APHIS add a biological control organism to the list referred to in paragraph (b) of this section by submitting a petition to APHIS via email to pest.permits@ usda.gov or through any means listed at https://www.aphis.usda.gov/plant_ health/permits/index.shtml. The petition must include the following information: (1) Evidence indicating that the organism is indigenous to the E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations continental United States throughout its geographical or ecological range, or evidence indicating that the organism has produced self-replicating populations within the continental United States for an amount of time sufficient, based on the organism’s taxon, to consider that taxon established throughout its geographical or ecological range in the continental United States; or (2) Evidence that the organism’s geographical or ecological range includes an extremely limited area of or none of the continental United States based on its inability to maintain year to year self-replicating populations despite repeated introductions over a sufficient range of time; or (3) The petition would include evidence that the organism cannot establish anywhere in the continental United States; or (4) Results from a field study where data were collected from representative habitats occupied by the biological control organism. Studies must include sampling for any direct or indirect impacts on target and non-target hosts of the biological control organism in these habitats. Supporting scientific literature must be cited; or (5) Any other data, including published scientific reports, that suggest that subsequent releases of the organism into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products. (d) APHIS review of petitions—(1) Evaluation. APHIS will review the petition to determine whether it is complete. If APHIS determines that the petition is complete, it will conduct an evaluation of the petition to determine whether there is sufficient evidence that the organism exists throughout its geographical or ecological range in the continental United States and that subsequent releases of pure cultures of field populations of the organism into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products. (2) Notice of availability of the petition. If APHIS determines that there is sufficient evidence that the organism exists throughout its geographical or ecological range in the continental United States and that subsequent releases of pure cultures of the organism into the environment of the continental United States will present no additional plant pest risk to plants or plant products, APHIS will publish a notice in the Federal Register announcing the availability of the petition and VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 requesting public comment on that document. (3) Notice of determination. (i) If no comments are received, or if the comments received do not lead APHIS to reconsider its determination, APHIS will publish in the Federal Register a subsequent notice describing the comments received and stating that the organism has been added to the list referred to in paragraph (b) of this section. (ii) If the comments received lead APHIS to reconsider its determination, APHIS will publish in the Federal Register a subsequent notice describing the comments received and stating its reasons for determining not to add the organism to the list referred to in paragraph (b) of this section. (e) Removal of organisms from the list of exempt organisms. Any biological control organism may be removed from the list referred to in paragraph (b) of this section if information emerges that would have otherwise led APHIS to deny the petition to add the organism to the list. Whenever an organism is removed from the list, APHIS will publish a notice in the Federal Register announcing that action and the basis for it. (Approved by the Office of Management and Budget under control number 0579–0187) § 330.203 Soil. (a) Requirements. The Administrator has determined that, unless it has been sterilized, soil is an associated article, and is thus subject to the permitting requirements of § 330.201, unless its movement: (1) Is regulated pursuant to other APHIS regulations in this chapter; or (2) Does not require such a permit under the provisions of paragraph (b)(1) or (c)(1) of this section. (b) Conditions governing the importation of soil—(1) Permit. Except as provided in § 319.37–10 of this chapter and except for soil imported from areas of Canada not regulated by the national plant protection organization of Canada for a soil-borne plant pest, soil may be imported into the United States if an import permit has been issued in accordance with § 330.201 and if the soil is imported under the conditions specified on the permit. (2) Additional conditions for the importation of soil via hand-carry. In addition to the condition of paragraph (b)(1) of this section, soil may be handcarried into the United States only if the importation meets the conditions of § 330.205. (3) Additional conditions for the importation of soil intended for the PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 29963 extraction of plant pests. In addition to the condition of paragraph (b)(1) of this section, soil may be imported into the United States for the extraction of plant pests if the soil will be imported directly to an APHIS-approved biocontainment facility. (4) Additional conditions for the importation of soil contaminated with plant pests and intended for disposal. In addition to the condition of paragraph (b)(1) of this section, soil may be imported into the United States for the disposal of plant pests if the soil will be imported directly to an APHIS-approved disposal facility. (5) Exemptions. The articles listed in this paragraph (b) are not soil, provided that they are free of organic material. Therefore, they may be imported into the United States without an import permit issued in accordance with § 330.201, unless the Administrator has issued an order stating otherwise. All such articles are, however, subject to inspection at the port of first arrival, subsequent reinspection at other locations, other remedial measures deemed necessary by an inspector to remove any risk the items pose of disseminating plant pests or noxious weeds, and any other restrictions of this chapter: (i) Consolidated material derived from any strata or substrata of the earth. Examples include clay (laterites, bentonite, china clay, attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel. (ii) Sediment, mud, or rock from saltwater bodies of water. (iii) Cosmetic mud and other commercial mud products. (iv) Stones, rocks, and quarry products. (c) Conditions governing the interstate movement of soil—(1) General conditions. Except for soil moved in accordance with paragraphs (c)(2) through (5) of this section, soil may be moved interstate within the United States without prior issuance of an interstate movement permit in accordance with § 330.201 or further restriction under this subpart. However, all soil moved interstate is subject to any movement restrictions and remedial measures specified for such movement referenced in part 301 of this chapter. (2) Conditions for the interstate movement within the continental United States of soil intended for the extraction of plant pests. Soil may be moved in interstate commerce within the continental United States with the intent of extracting plant pests, only if an interstate movement permit has been issued for its movement in accordance with § 330.201, and if the soil will be E:\FR\FM\25JNR2.SGM 25JNR2 khammond on DSKBBV9HB2PROD with RULES2 29964 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations moved directly to an APHIS-approved biocontainment facility in a secure manner that prevents its dissemination into the outside environment. (3) Conditions for the interstate movement within the continental United States of soil infested with plant pests and intended for disposal. Soil may be moved in interstate commerce within the continental United States with the intent of disposing of plant pests, only if an interstate movement permit has been issued for its movement in accordance with § 330.201, and the soil will be moved directly to an APHISapproved disposal facility in a secure manner that prevents its dissemination into the outside environment. (4) Conditions for the interstate movement of soil samples from an area quarantined in accordance with part 301 of this chapter for chemical or compositional testing or analysis. Soil samples may be moved for chemical or compositional testing or analysis from an area that is quarantined in accordance with part 301 of this chapter without prior issuance of an interstate movement permit in accordance with § 330.201 or further restriction under this chapter, provided that the soil is moved to a laboratory that has entered into and is operating under a compliance agreement with APHIS, is abiding by all terms and conditions of the compliance agreement, and is approved by APHIS to test and/or analyze such samples. (5) Additional conditions for interstate movement of soil to, from, or between Hawaii, the territories, and the continental United States. In addition to all general conditions for interstate movement of soil, soil may be moved in interstate commerce to, from, or between Hawaii, the territories, and the continental United States only if an interstate movement permit has been issued for its movement in accordance with § 330.201. In addition, soil moved to, from, or between Hawaii, the territories, and the continental United States with the intent of extracting plant pests is subject to the conditions of paragraph (c)(2) of this section, while soil infested with plant pests and intended for disposal is subject to the conditions of paragraph (c)(3) of this section. (d) Conditions governing the transit of soil through the United States. Soil may transit through the United States only if a transit permit has been issued for its movement in accordance with part 352 of this chapter. (Approved by the Office of Management and Budget Under Control Number 0579–0054) VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 § 330.204 Exceptions to permitting requirements for the importation or interstate movement of certain plant pests. Pursuant to section 7711 of the Plant Protection Act (7 U.S.C. 7701 et seq.), the Administrator has determined that certain plant pests may be moved interstate within the continental United States without restriction. The list of all such plant pests is on the PPQ Permits and Certifications website at https:// www.aphis.usda.gov/aphis/resources/ permits. Plant pests listed as being excepted from permitting requirements, unless otherwise indicated, may be moved interstate within the continental United States without further restriction under this subpart. (a) Categories. In order to be included on the list, a plant pest must: (1) Be from field populations or lab cultures derived from field populations of a taxon that is established throughout its entire geographical or ecological range within the continental United States; or (2) Be commercially available and raised under the regulatory purview of other Federal agencies. (b) Petition process to add plant pests to the list—(1) Petition. Any person may petition APHIS to have an additional plant pest added to the list of plant pests that may be imported into or moved in interstate commerce within the continental United States without restriction. To submit a petition, the person must provide, in writing, information supporting the placement of a particular pest in one of the categories listed in paragraph (a) of this section. (i) Information that the plant pest belongs to a taxon that is established throughout its entire geographical or ecological range within the United States must include scientific literature, unpublished studies, or data regarding: (A) The biology of the plant pest, including characteristics that allow it to be identified, known hosts, and virulence; (B) The geographical or ecological range of the plant pest within the continental United States; and (C) The areas of the continental United States within which the plant pest is established. (ii) Information that the plant pest is commercially available and raised under the regulatory purview of another Federal agency must include a citation to the relevant law, regulation, or order under which the agency exercises such oversight. (2) APHIS review. APHIS will review the information contained in the petition to determine whether it is complete. In order to consider the petition complete, APHIS may require PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 additional information to determine whether the plant pest belongs to one of the categories listed in paragraph (a) of this section. When it is determined that the information is complete, APHIS will commence review of the petition. (3) Action on petitions to add pests. (i) If, after review of the petition, APHIS determines there is insufficient evidence that the plant pest belongs to one of the categories listed in paragraph (a) of this section, APHIS will deny the petition, and notify the petitioner in writing regarding this denial. (ii) If, after review of the petition, APHIS determines that the plant pest belongs to one of the categories in paragraph (a) of this section, APHIS will publish a notice in the Federal Register that announces the availability of the petition and any supporting documentation to the public, that states that APHIS intends to add the plant pest to the list of plant pests that may be imported into or moved in interstate commerce within the continental United States without restriction, and that requests public comment. If no comments are received on the notice, or if, based on the comments received, APHIS determines that its conclusions regarding the petition have not been affected, APHIS will publish in the Federal Register a subsequent notice stating that the plant pest has been added to the list. (c) Petition process to have plant pests removed from the list—(1) Petition. Any person may petition to have a plant pest removed from the list of plant pests that may be imported into or moved interstate within the continental United States without restriction by writing to APHIS. The petition must contain independently verifiable information demonstrating that APHIS’ initial determination that the plant pest belongs to one of the categories in paragraph (a) of the section should be changed, or that additional information is now available that would have caused us to change the initial decision. (2) APHIS review. APHIS will review the information contained in the petition to determine whether it is complete. In order to consider the petition complete, APHIS may require additional information supporting the petitioner’s claim. When it is determined that the information is complete, APHIS will commence review of the petition. (3) APHIS action on petitions to remove pests. (i) If, after review of the petition, APHIS determines that there is insufficient evidence to suggest that its initial determination should be changed, APHIS will deny the petition, E:\FR\FM\25JNR2.SGM 25JNR2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations and notify the petitioner in writing regarding this denial. (ii) If, after review of the petition, APHIS determines that there is a sufficient basis to suggest that its initial determination should be changed, APHIS will publish a notice in the Federal Register that announces the availability of the petition, and that requests public comment regarding removing the plant pest from the list of plant pests that may be imported into or move in interstate commerce within the continental United States without restriction. If no comments are received on the notice, or if the comments received do not affect APHIS’ conclusions regarding the petition, APHIS will publish a subsequent notice in the Federal Register stating that the plant pest has been removed from the list. (d) APHIS-initiated changes to the list. (1) APHIS may propose to add a plant pest to or remove a pest from the list of plant pests that may be imported into or move in interstate commerce within the continental United States without restriction, if it determines that there is sufficient evidence that the plant pest belongs to one of the categories listed in paragraph (a) of the section, or if evidence emerges that leads APHIS to reconsider its initial determination that the plant pest was or was not in one of the categories listed in paragraph (a) of this section. APHIS will publish a notice in the Federal Register announcing this proposed addition or removal, making available any supporting documentation that it prepares, and requesting public comment. (2) If no comments are received on the notice or if the comments received do not affect the conclusions of the notice, APHIS will publish a subsequent notice in the Federal Register stating that the plant pest has been added to or removed from the list. (Approved by the Office of Management and Budget Under Control Number 0579–0187) khammond on DSKBBV9HB2PROD with RULES2 § 330.205 Hand-carry of plant pests, biological control organisms, and soil. Plant pests, biological control organisms, and soil may be hand-carried into the United States only in accordance with the provisions of this section. (a) Authorization to hand-carry—(1) Application for a permit; specification of ‘‘hand-carry’’ as proposed method of movement. A person must apply for an import permit for the plant pest, biological control organism, or soil, in accordance with § 330.201, and specify hand-carry of the organism or article as the method of proposed movement. VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 (2) Specification of individual who will hand-carry. The application must also specify the individual or individuals who will hand-carry the plant pest, biological control organism, or soil into the United States. If APHIS authorizes this individual or these individuals to hand-carry, the authorization may not be transferred to nor actions under it performed by individuals other than those identified on the permit application. (b) Notification of intent to handcarry. After the permittee has obtained an import permit but no less than 20 days prior to movement, the permittee must provide APHIS through APHIS’ online portal for permit applications or by fax with the names of the designated hand carrier, or carriers, assigned to that movement. Additional conditions for hand-carry are available on the APHIS website.3 (c) Denial, amendment, or cancellation of authorization to handcarry. APHIS may deny a request to hand-carry, or amend or cancel any hand-carry authorization at any time, if it deems such action necessary to prevent the introduction or dissemination of plant pests or noxious weeds within the United States. (d) Appeal of denial, amendment, or cancellation. Any person whose request to hand-carry has been denied, or whose authorization to hand-carry has been amended or canceled, may appeal the decision in writing to APHIS. § 330.206 Packaging requirements. Shipments in which plant pests, biological control organisms, and associated articles are imported into, moved in interstate commerce, or transited through the United States must meet the general packaging requirements of this section, as well as all specific packaging requirements on the permit itself. (a) Packaging requirements. All shipments must consist of an outer shipping container and at least two packages within the container. Both the container and inner packages must be securely sealed to prevent the dissemination of the enclosed plant pests, biological control organisms, or associated articles. (1) Outer shipping container. The outer shipping container must be rigid, impenetrable and durable enough to remain closed and structurally intact in the event of dropping, lateral impact with other objects, and other shocks incidental to handling. 3 https://www.aphis.usda.gov/plant_health/ permits/organism/downloads/HandCarryPolicy.pdf. PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 29965 (2) Inner packages. The innermost package or packages within the shipping container must contain all of the organisms or articles that will be moved. As a safeguard, the innermost package must be placed within another, larger package. All packages within the shipping container must be constructed or safeguarded so that they will remain sealed and structurally intact throughout transit. The packages must be able to withstand changes in pressure, temperature, and other climatic conditions incidental to shipment. (b) Packing material. Packing materials may be placed in the inner packages or shipping container for such purposes as cushioning, stabilizing, water absorption or retention, nourishment or substrate for regulated articles, etc. Packing material for importation must be free of plant pests, noxious weeds, biological control organisms not listed on the permit or associated articles, and, as such, must be new, or must have been sterilized or disinfected prior to reuse. Packing material must be suited for the enclosed organism or article, as well as any medium in which the organism or article will be maintained. (c) Requirements following receipt of the shipment at the point of destination. (1) Packing material, including media and substrates, must be destroyed by incineration, be decontaminated using autoclaving or another approved method, or otherwise be disposed of in a manner specified in the permit itself. (2) Shipping containers may be reused, provided that the container has not been contaminated with plant pests, noxious weeds, biological control organisms, or associated articles. Shipping containers that have been in contact with or otherwise contaminated with any of these items must be sufficiently sterilized or disinfected prior to reuse, or otherwise disposed of. (d) Costs. Permittees who fail to meet the requirements of this section may be held responsible for all costs incident to inspection, rerouting, repackaging, subsequent movement, and any treatments. § 330.207 Cost and charges. The inspection services of APHIS inspectors during regularly assigned hours of duty and at the usual places of duty will be furnished without cost. APHIS will not be responsible for any costs or charges incidental to inspections or compliance with the provisions of this subpart, other than for the inspection services of the inspector. E:\FR\FM\25JNR2.SGM 25JNR2 29966 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations Subpart C—[Removed and Reserved] 15. Subpart C, consisting of §§ 330.300 through 330.302, is removed and reserved. ■ PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS 16. The authority citation for part 352 continues to read as follows: ■ Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. 17. In § 352.1, paragraph (b) is amended as follows: ■ a. By adding, in alphabetical order, a definition for Biological control organism; ■ b. By revising the definition for Deputy Administrator; ■ c. By adding, in alphabetical order, a definition for Noxious weed; and ■ d. By revising the definitions for Person, Plant pest, and Soil. The additions and revisions read as follows: ■ § 352.1 Definitions. khammond on DSKBBV9HB2PROD with RULES2 * * * * * (b) * * * Biological control organism. Any enemy, antagonist, or competitor used to control a plant pest or noxious weed. * * * * * Deputy Administrator. The Deputy Administrator of the Plant Protection and Quarantine Programs or any employee of the Plant Protection and Quarantine Programs delegated to act in his or her stead. * * * * * Noxious weed. Any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. * * * * * Person. Any individual, partnership, corporation, association, joint venture, society, or other legal entity. Plant pest. Any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, nonhuman animal, parasitic plant, bacterium, VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the plant pests listed in this definition. * * * * * Soil. The unconsolidated material from the earth’s surface that consists of rock and mineral particles and that supports or is capable of supporting biotic communities. * * * * * § 352.2 [Amended] 18. In § 352.2, paragraph (a) introductory text, the first sentence is amended by removing the words ‘‘plant pests, noxious weeds, soil,’’ and adding the words ‘‘plant pests, biological control organisms, noxious weeds, soil,’’ in their place and removing the words ‘‘contain plant pests or noxious weeds’’ and adding the words ‘‘contain plant pests, biological control organisms, or noxious weeds’’ in their place. ■ § 352.3 [Amended] 19. Section 352.3 is amended as follows: ■ a. In paragraphs (a) and (b), by adding the words ‘‘biological control organisms,’’ after the words ‘‘plant pests,’’ each time they appear; and ■ b. In paragraph (d), by removing the words ‘‘plant pest or noxious weed dissemination’’ and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place. ■ § 352.5 [Amended] 20. Section 352.5 is amended by adding the words ‘‘biological control organisms,’’ after the words ‘‘plant pests,’’ each time they appear. ■ § 352.6 [Amended] 21. Section 352.6 is amended as follows: ■ a. In paragraph (b), by removing footnote 2 and removing the words ‘‘as specified by’’ and adding the words ‘‘in accordance with’’ in their place; and ■ b. In paragraph (c), by removing the reference to footnote 2 and removing the citation ‘‘§ 330.300(b)’’ and adding the citation ‘‘§ 330.203’’ in its place. ■ c. In paragraph (e), by removing the words ‘‘plant pest or noxious weed dissemination’’ both times they appear and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place. ■ PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 § 352.9 [Amended] 22. Section 352.9 is amended by adding the words ‘‘biological control organisms,’’ after the words ‘‘plant pests,’’. ■ § 352.10 [Amended] 23. Section 352.10 is amended as follows: ■ a. By redesignating footnote 3 as footnote 2; ■ b. In paragraph (b)(1), by removing the words ‘‘plant pest or noxious weed dissemination’’ each time they appear and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place and adding the words ‘‘biological control organisms,’’ after the words ‘‘Prohibited or restricted plants, plant products, plant pests,’’; ■ c. In paragraph (b)(2) introductory text, by removing the words ‘‘plant pest or noxious weed dissemination’’ both times they appear and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place; ■ d. In paragraph (b)(2)(i), by adding the words ‘‘or biological control organisms’’ after the words ‘‘plant pests’’; ■ e. In paragraph (b)(2)(ii), by adding the words ‘‘biological control organisms,’’ after the words ‘‘plant pests,’’; ■ f. In paragraph (b)(2)(iii), by removing the words ‘‘plant pest or noxious weed dissemination’’ and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place; ■ g. In paragraph (b)(2)(iv), by removing the words ‘‘plant pest dispersal’’ and adding the words ‘‘plant pest or biological control organism dispersal’’ in their place; and ■ h. In paragraph (c)(1), by removing the words ‘‘plant pest or noxious weed dissemination’’ and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place. ■ § 352.11 [Amended] 24. In § 352.11, paragraph (a)(1) is amended by removing the words ‘‘plant pests, noxious weeds, and soil’’ and adding the words ‘‘plant pests, biological control organisms, noxious weeds, soil, or other products or articles’’ in their place. ■ E:\FR\FM\25JNR2.SGM 25JNR2 Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Rules and Regulations § 352.13 [Amended] § 352.15 25. Section 352.13 is amended by removing the words ‘‘plant pests, noxious weeds, and soil’’ and adding the words ‘‘plant pests, biological control organisms, noxious weeds, soil, or other products or articles’’ in their place and removing the word ‘‘parts’’ and adding the word ‘‘part’’ in its place. ■ [Amended] § 352.30 26. Section 352.15 is amended by removing the words ‘‘plant pest or noxious weed dissemination’’ and adding the words ‘‘plant pest, noxious weed, or biological control organism dissemination’’ in their place. ■ 29967 [Amended] 27. Section 352.30 is amended by redesignating footnotes 4 and 5 as footnotes 3 and 4, respectively. ■ Done in Washington, DC, this 17th day of June 2019. Lorren E.S. Walker, Acting Under Secretary for Marketing and Regulatory Programs. [FR Doc. 2019–13246 Filed 6–21–19; 8:45 am] khammond on DSKBBV9HB2PROD with RULES2 BILLING CODE 3410–34–P VerDate Sep<11>2014 20:37 Jun 24, 2019 Jkt 247001 PO 00000 Frm 00031 Fmt 4701 Sfmt 9990 E:\FR\FM\25JNR2.SGM 25JNR2

Agencies

[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Rules and Regulations]
[Pages 29938-29967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13246]



[[Page 29937]]

Vol. 84

Tuesday,

No. 122

June 25, 2019

Part II





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 318, 319, 330, et al.





Plant Pest Regulations; Final Rule

Federal Register / Vol. 84 , No. 122 / Tuesday, June 25, 2019 / Rules 
and Regulations

[[Page 29938]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 318, 319, 330, and 352

[Docket No. APHIS-2008-0076]
RIN 0579-AC98


Plant Pest Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are revising our regulations regarding the movement of 
plant pests. We are also adding criteria to the regulations for the 
importation, interstate movement, and release of biological control 
organisms. This final rule also establishes regulations to allow the 
interstate movement of certain plant pests and biological control 
organisms without restriction by granting exceptions from permit 
requirements for those pests and organisms. Finally, we are revising 
our regulations regarding the importation and interstate movement of 
soil. This rule clarifies the points that we will consider when 
assessing the risks associated with the movement and release of certain 
organisms and facilitates the movement of regulated organisms and 
articles in a manner that protects U.S. agriculture.

DATES: Effective August 9, 2019.

FOR FURTHER INFORMATION CONTACT: Dr. Colin D. Stewart, Assistant 
Director, Pests, Pathogens, and Biocontrol Permits Branch, Plant Health 
Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-
1236; [email protected]; (301) 851-2237.

SUPPLEMENTARY INFORMATION: 

Background

    Under the Plant Protection Act (7 U.S.C. 7701 et seq., referred to 
below as the PPA or the Act), the Secretary of Agriculture has 
authority to carry out operations or measures to detect, control, 
eradicate, suppress, prevent, or retard the spread of plant pests.\1\ 
Section 7711(a) of the Act provides that no person shall import, enter, 
export, or move in interstate commerce any plant pest, unless the 
importation, entry, exportation, or movement is authorized under 
general or specific permit and in accordance with such regulations as 
the Secretary may issue to prevent the introduction of plant pests into 
the United States or the dissemination of plant pests within the United 
States.
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    \1\ The Act defines a plant pest as any living stage of any of 
the following that can directly or indirectly injure, cause damage 
to, or cause disease in any plant or plant product: (A) A protozoan; 
(B) A nonhuman animal; (C) A parasitic plant; (D) A bacterium; (E) A 
fungus; (F) A virus or viroid; (G) An infectious agent or other 
pathogen; (H) Any article similar to or allied with any of the 
articles specified in the preceding subparagraphs.
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    In addition, section 7712(a) of the Act provides that the Secretary 
may prohibit or restrict the importation, entry, exportation, or 
movement in interstate commerce of, among other things, any biological 
control organism if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into the United 
States or the dissemination of a plant pest or noxious weed within the 
United States. The Act defines a biological control organism as ``any 
enemy, antagonist, or competitor used to control a plant pest or 
noxious weed.''
    The purpose of the regulations in ``Subpart B--Movement of Plant 
Pests'' (7 CFR 330.200 through 330.212) and ``Subpart C--Movement of 
Soil, Stone, and Quarry Products'' (7 CFR 330.300 through 330.302) is 
to prevent the dissemination of plant pests into the United States, or 
interstate, by regulating the importation and movement in interstate 
commerce of plant pests, soil, stone, and quarry products.
    On January 19, 2017, we published in the Federal Register (82 FR 
6980-7005, Docket No. APHIS-2008-0076) a proposal \2\ to revise our 
regulations regarding the movement of plant pests to include criteria 
for the importation, movement in interstate commerce, and environmental 
release of biological control organisms, and to establish regulations 
to allow the importation and movement in interstate commerce of certain 
types of plant pests without restriction by granting exceptions from 
permitting requirements for those pests. We also proposed to revise our 
regulations regarding the importation and interstate movement of soil. 
We solicited comments concerning our proposal for 60 days ending March 
20, 2017.
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    \2\ To view the proposed rule, supporting documents, the comment 
extension notice, and the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2008-0076.
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    We extended the deadline for comments until April 19, 2017, in a 
document published in the Federal Register on February 13, 2017 (82 FR 
10444, Docket No. APHIS-2008-0076). We received 62 comments by that 
date. The comments were from State departments of agriculture, nature 
centers, research laboratories, professional associations, 
universities, industry groups, manufacturers, law firms, and private 
citizens. The comments are discussed below by topic.

Definitions (Sec.  330.100)

    We received comments regarding our proposed changes to Sec.  
330.100, ``Definitions,'' including requests to include additional 
terms to the section.
    Two commenters asked about the purposes for which continued 
curation permits are issued.
    In proposed Sec.  330.200(a)(3), we included requirements for such 
permits but did not provide a definition that explains their use. To 
address these commenters, we are adding a definition for continued 
curation permit to read as set out in the regulatory text below.
    We proposed to add the term import (importation) to the list of 
definitions in Sec.  330.100.
    A commenter asked if our proposed definition of import 
(importation) means that the organism or article in question arrives in 
and originates from outside the United States.
    The commenter is correct. We define importation to mean ``to move 
into, or the act of movement into, the territorial limits of the United 
States.''
    A commenter asked that we add the term ``plant health'' to Sec.  
330.100 and allow industry stakeholders to provide a definition for it.
    We are making no changes in response to the commenter's request. 
``Plant health'' is not used in any specific or technical context in 
the proposed or current part 330 regulations and we consider the 
generally understood meaning of the term to be sufficient.
    We proposed to add the term responsible individual to Sec.  330.100 
to mean the individual designated by the permittee to oversee and 
control the actions taken under a permit. We are requiring the 
assignment of a responsible individual to serve as the primary point of 
contact in order to improve communication between the Animal and Plant 
Health Inspection Service (APHIS) and the permittee. If the permittee 
is an individual, that individual can assign him or herself to the role 
should they so choose. We included as a condition that ``for the 
duration of the permit, the individual must be physically present 
during normal business hours at or near the location specified on the 
permit.''
    Several commenters raised questions about our proposed definition 
of responsible individual. One commenter stated that our proposed 
definition of responsible individual does not allow for a designee to 
substitute for the responsible individual when that individual cannot 
be at or near the

[[Page 29939]]

specified location for the duration of the permit due to illness or 
vacation. The commenter added that, if taken literally, the definition 
would likely result in nearly every permitted entity being in violation 
of permit requirements at some point. Similarly, another commenter 
stated that designating a responsible individual in a field release 
application is complicated by the fact that the applicant is often not 
the same person in charge of a field experiment station. The commenter 
added that a company may test microbial formulations at dozens of 
sites, making it impossible for one person to enforce permit compliance 
and be physically present during business hours at each location. The 
commenter requested that corporate permittees be allowed to designate 
more than one responsible individual on a permit.
    As the commenters noted, many permit applications for regulated 
articles do involve multiple field sites under the shared 
responsibility of several persons. Under current policy, we allow 
application requests to include more than one responsible individual, 
and more than one site within a single State may be designated as the 
permit location. This approach has ensured that permit actions are 
undertaken safely while accommodating stakeholder needs for 
flexibility. Our intention in proposing the definition was to emphasize 
responsible oversight of actions taken under the permit without 
literally requiring an individual's presence during business hours at 
all locations specified on the permit. Accordingly, we are removing the 
requirement that the responsible individual be physically present 
during normal business hours at or near the location specified on the 
permit as the ultimate destination of the plant pest, biological 
control organism, or associated article. We continue to require that 
the responsible individual or individuals ensure compliance with permit 
conditions during all phases of the activities being performed.
    We proposed to define taxon (taxa) to mean any recognized grouping 
or rank within the biological nomenclature of organisms, such as class, 
order, family, genus, species, subspecies, pathovar, biotype, race, 
forma specialis, or cultivar.
    Two commenters asked for clarification of our proposed definition 
of taxon (taxa), with one commenter suggesting that taxon (taxa) be 
defined by the biopesticide and biostimulant industries.
    We defined taxon as any recognized grouping or rank within the 
biological nomenclature of organisms. This definition is consistent 
with the term as it is used in the International Plant Protection 
Convention (IPPC's) Glossary of Phytosanitary Terms.\3\ Aligning our 
definition of taxon in this way makes it easier to communicate and 
trade with other IPPC signatory countries. We disagree with the 
commenter that industry stakeholders should develop a separate 
definition of taxon, as doing so could result in a less flexible 
definition and potential conflicts with the internationally recognized 
IPPC definition.
---------------------------------------------------------------------------

    \3\ International Standards for Phytosanitary Measures, ISPM 5, 
``Glossary of Phytosanitary Terms (2015): https://www.ippc.int/static/media/files/publication/en/2015/05/ISPM_05_En_2015-05-29_CPM-10.pdf.
---------------------------------------------------------------------------

    A commenter asked APHIS to add the term ``yield enhancement'' to 
Sec.  330.100 and to define it as ``the use of microorganisms whose 
function when applied to plants or the rhizosphere is to stimulate 
natural processes to benefit nutrient uptake, nutrient efficiency, 
tolerance to abiotic stress, and crop quality.''
    While some organisms we propose to regulate may stimulate natural 
processes in plants, we have no plans to define ``yield enhancement'' 
as we make no reference in the regulations to the term or the processes 
listed by the commenter. The ability of organisms or products to 
enhance plant yields is not a criterion that APHIS uses when 
determining whether to regulate an organism as a plant pest or a 
biological control organism.

Scope and General Restrictions (Sec.  330.200)

    We proposed revising the subpart ``Movement of Plant Pests'' to 
regulate not only plant pests but biological control organisms and 
associated articles such as soil and packaging material. In proposed 
Sec.  330.200, we specified the types of plant pests and biological 
control organisms that APHIS would regulate. We also established 
restrictions on the importation and movement of biological control 
organisms and plant pests.

General Permit

    In Sec.  330.200(a), we proposed to include a general permit as one 
means by which we may authorize the movement of plant pests, biological 
control organisms, and associated articles that we regard to be of low 
risk in certain areas of the United States. We indicated that we have 
only issued specific permits, that is, permits issued to individual 
persons, for each movement of plant pests interstate. We noted, 
however, that section 7711 of the PPA gives APHIS the authority to 
issue general permits for the importation or interstate movement of 
plant pests. Such a permit would authorize organizations that 
frequently move certain low-risk plant pests and organisms interstate 
to do so without having to obtain an individual permit for each 
movement. The general permit for the plant pest or organism would be 
posted on the APHIS website with a list of permit requirements. Persons 
would not be required to sign a permit or record movements of the plant 
pest or organism.
    Some commenters endorsed the issuance of general permits for the 
importation and interstate movement of low-risk pests, while others 
expressed concern about whether a general permit will ensure adequate 
accountability, enforceability, and risk management. One commenter 
asked how a corporation or university would be able to apply the 
conditions of a general permit to every situation and added that 
assigning responsibility for a permit at an organizational rather than 
an individual level will dilute that responsibility.
    We acknowledge the concerns raised by commenters regarding general 
permits and questions about accountability and will therefore continue 
issuing only specific permits in which one or more responsible 
individuals are identified in the permit and agree to abide by its 
requirements. However, for future needs we are retaining in the 
regulations the language we proposed for issuing general permits and 
reaffirming our authority under the PPA to issue such permits. We will 
continue to evaluate the uses and purposes of general permits, and 
whenever we begin issuing them we will announce in a Federal Register 
notice the existence, location, and content of each such permit we 
issue.

Types of Plant Pests Regulated

    In proposed Sec.  330.200(b), we specified the types of plant pests 
that we would regulate under the revised subpart. For the purposes of 
the subpart, we stated that we consider an organism to be a plant pest 
if the organism directly or indirectly injures, damages, or causes 
disease in a plant or plant product, or if the organism is not known to 
be a 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.
    Several commenters commented on the criteria by which APHIS 
considers an organism to be a plant pest.

[[Page 29940]]

    One commenter stated that it would be helpful if the criteria for 
plant pests could be limited to identifying only pests that cause 
direct, actual damage to beneficial plants rather than indirect damage. 
As an example of indirect damage, the commenter cited an organism that 
has a negative impact on another organism that in turn has a beneficial 
impact on a desired crop or plant.
    We identify those organisms that indirectly harm or cause disease 
to plants and plant products as plant pests because the consequences of 
indirect harm can be as disruptive and costly as direct harm, 
particularly if such organisms establish themselves in the environment 
or harm organisms having a beneficial impact on crops, to cite the 
commenter's example. Moreover, the PPA specifically states that causing 
``direct or indirect injury to plants or plant products'' is one 
attribute of a plant pest.
    Another commenter stated that a plant pest's effect on plants or 
plant products is either known or unknown and asked for clarification 
of proposed Sec.  330.200(b).
    If an organism poses an unknown risk to plants or plant products 
but is similar to a plant pest or pathogen known to directly or 
indirectly injure, cause damage to, or cause disease in a plant or 
plant product, we will regulate that organism pending positive 
identification and an evaluation of the organism's actual risk to 
plants and plant products.
    One commenter recommended that, for organisms that are not known to 
be plant pests, APHIS should notify the applicant of the reason a 
permit was required and explain how the organism is similar to one that 
meets the definition of a plant pest, thereby giving the applicant 
information needed to address the agency's concern for future 
regulatory actions for the organism.
    We do not consider the commenter's suggestion to be practicable for 
every permit application involving an organism not known to be a plant 
pest. However, if a permit applicant has specific questions regarding 
why a permit is required for a particular organism, we recommend that 
the applicant contact APHIS.\4\
---------------------------------------------------------------------------

    \4\ For questions about organism and soil permits, please call 
(301) 851-2357 or (866) 524-5421 (toll free), or email 
[email protected].
---------------------------------------------------------------------------

Types of Biological Control Organisms Regulated

    In proposed Sec.  330.200(c), we listed the biological control 
organisms we would regulate under the subpart. We stated that these 
organisms consist of invertebrate predators, competitors, herbivores, 
microbial parasites, and microbial pathogens used to control 
invertebrate plant pests, plant pathogens, and noxious weeds.
    A commenter stated that there are approved weed biological control 
organisms that attack exotic invasive plants not currently listed as 
``noxious weeds'' by a regulatory authority. For this reason, the 
commenter recommended that in proposed Sec.  330.200(c) we use the term 
``exotic invasive plants'' instead of ``noxious weeds'' when referring 
to exotic invasive plants not officially identified as ``noxious.''
    An exotic invasive plant can be considered a noxious weed and 
regulated as such without being listed as a Federal noxious weed as 
long as it meets the PPA's definition of a noxious weed. Meeting this 
definition are new incursions of plants that, like listed noxious 
weeds, can directly or indirectly injure or cause damage to crops, 
livestock, poultry, other interests of agriculture, or the environment. 
While federally-recognized noxious weeds are covered under 7 CFR part 
360, the use of invertebrate herbivores and microbial pathogens to 
control such weeds is covered under part 330.
    A commenter stated that, for any imported biological control 
organism, host-specificity testing documentation and identification 
verification are essential for protecting the resources of the United 
States.
    We agree with the commenter. We exercise considerable care to 
ensure host specificity before approving an organism for release into 
the environment. As necessary, we conduct host-specificity testing 
documentation and identification verification as part of evaluating a 
permit application. Persons with questions about applications and uses 
of organisms and host-specificity testing can contact the person listed 
above under the heading FOR FURTHER INFORMATION CONTACT.

EPA Oversight

    In proposed Sec.  330.200(d), we exempted from this subpart 
biological control organism products regulated by the Environmental 
Protection Agency (EPA). This oversight exemption applies only to EPA 
registered products, experimental use permits, Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) section 18 emergency exemptions, 
the importation of pesticides being imported under a EPA Pesticide 
Notice of arrival, as well as the interstate movement of pesticides 
being moved in accordance with EPA's regulations in 40 CFR 152.30, If 
EPA does not regulate an organism under APHIS jurisdiction, APHIS would 
regulate it regardless of whether it is commercial (applied to more 
than 10 acres) or experimental.
    A commenter stated that while the regulatory status of microbial 
pathogens regulated by EPA is clear, the proposed rule was ambiguous 
regarding organisms that have been formulated into plant growth-
promoting products, also known as biostimulants. The commenter asked 
what the framework is for regulating plant growth-promoting microbial 
pathogens and organisms as commercial products excluded from 
registration under FIFRA.
    Although APHIS is not authorized under the PPA to regulate products 
based on their biostimulant properties, the Act does allow APHIS to 
regulate and impose restrictions on a product in order to prevent the 
introduction or dissemination of plant pests within the United States. 
APHIS will evaluate each product and its uses to assess their potential 
plant pest risks and determine whether restrictions are warranted based 
on plant pest risk. Manufacturers or producers of products that EPA 
determines not to require registration should not assume that they 
would not be subject to regulation by APHIS under part 330.
    A commenter stated that the proposal to establish criteria for the 
movement and release of unregistered microbial pesticides needs to be 
clarified in the regulations, suggesting that the expanded ability to 
import biological control organisms should also include the following: 
Research samples containing organisms that were part of a fermentation 
process destined to become an EPA registered bio-pesticide, material no 
longer meeting EPA-established specifications (expired lots), partially 
formulated bio-pesticides, experimental formulations, culture strains, 
and quality control samples.
    We will continue to observe EPA's jurisdiction over organisms 
subject to their regulations as described in Sec.  330.200(d). Other 
organisms falling outside EPA's jurisdiction but within the scope of 
APHIS' authority under the PPA will be subject to the regulations under 
part 330 as appropriate.
    A commenter stated that having EPA-registered microbial pesticides 
be exempt from current APHIS regulations is a positive benefit, but 
that there needs to be clear, documented guidance to allow for 
successful clearances at U.S. border facilities.
    We noted in the proposed rule that biological control organisms 
that are pesticides and not registered with EPA,

[[Page 29941]]

but that are transferred, sold, or distributed in accordance with EPA's 
regulations in 40 CFR 152.30, would not be regulated under this subpart 
for their importation or interstate movement. However, persons desiring 
to import shipments of biological control organisms that are subject to 
FIFRA will need to submit to EPA a Notice of Arrival by Pesticides and 
Devices as required by U.S. Customs and Border Protection (CBP) 
regulations. APHIS is working closely with CBP and EPA to ensure that 
such guidance is available and sufficient for clearances at U.S. border 
facilities.
    One commenter asked if APHIS would issue general permits through 
the process outlined in a Memorandum of Understanding (MOU) with EPA or 
provide details of the process through APHIS guidance documents.
    APHIS has no plans to continue issuing permits for the importation 
of EPA-registered materials. These items will be imported under EPA's 
regulatory oversight.
    In addition to the MOU between EPA and APHIS, a commenter asked if 
there would be ongoing coordination between the agencies for regulating 
new products.
    We intend to continue coordinating with EPA with respect to 
coordinating regulation of new products not yet registered by EPA. 
APHIS typically confirms EPA product registrations containing specific 
strains and maintains its own permitting database to include these 
strains.
    A commenter asked if the APHIS regulatory oversight exemption for 
EPA-regulated materials applies to registered Technical Grade Active 
Ingredient, End Product, Active Ingredients, and Experimental Use 
permit materials, as well as Section 18 requests.\5\ The commenter 
added that according to the guidance available, no APHIS permit would 
be required for any of these products.
---------------------------------------------------------------------------

    \5\ Permits issued under section 18 of FIFRA that allow State 
and Federal agencies to permit the unregistered use of a pesticide 
in a specific geographic area for a limited time if emergency pest 
conditions exist.
---------------------------------------------------------------------------

    The commenter is incorrect. The exemption applies only to EPA 
registered products and experimental use permits or pesticides being 
imported under a EPA Pesticide Notice of Arrival.
    A commenter stated that in order to prevent ``double regulating,'' 
APHIS should enter into an MOU with the U.S. Fish and Wildlife Service 
(USFWS) as it has done with EPA. The commenter stated that USFWS 
exempts arthropods from their oversight that are ``farm raised'' per 
the definition in 50 CFR 14.4. The commenter added that many 
commercially produced biological control arthropods have been farm 
raised for decades and fall under the definition, nevertheless USFWS 
requires permits at several ports of entry for organisms already 
regulated by APHIS.
    We acknowledge the commenter's concern to prevent double regulating 
by APHIS and USFWS and will continue to work with affected entities and 
the USFWS to identify and address instances of this occurring.
    The same commenter recommended that APHIS establish a policy 
concerning symbionts \6\ of pests, noting that while symbionts can 
promote pest fitness, they can also exist in non-pest contexts, as when 
a symbiont has multiple hosts. The commenter suggested that we define 
``symbiont'' accordingly, as microbial taxa will inevitably occur on a 
pest host as environmental contaminants. The commenter stated that if 
detection on a pest host defines a symbiont organism, all environmental 
taxa might fit the definition of ``symbiont'' because of ephemeral 
encounters by pest hosts moving within their normal environments.
---------------------------------------------------------------------------

    \6\ Generally defined as organisms that live in symbiosis with 
one another.
---------------------------------------------------------------------------

    We acknowledge the commenter's concern but have no plans to provide 
a definition for ``symbiont.'' We do not use the term in the 
regulations, and establishing a regulatory policy for all invertebrate 
plant pests and biological control organisms under a single definition 
of the term would by necessity be overly broad. Symbiont relationships 
may be beneficial or detrimental to the organisms involved in 
combinations and environmental contexts too varied to document. 
Moreover, the available information regarding symbionts of any 
particular organism is typically incomplete, with a knowledge base 
frequently needing to be updated and revised. For these reasons, APHIS 
will retain the authority under the regulations to regulate symbionts 
as necessary on a case-by-case basis.
    A few commenters stated that we did not define what we mean by 
``similar'' in proposed Sec.  330.200(b), ``Plant pests regulated by 
this Subpart,'' with respect to similarities existing between plant 
pests having an unknown risk potential and those having a known risk 
potential. One such commenter suggested that a definition of 
``similar'' be defined through guidance instead of including it in the 
regulations so that APHIS will have sufficient flexibility to define 
the term based on evolving science. Another commenter noted that 
regulating organisms based on similarities to other regulated organisms 
could result in unintended consequences and suggested that such issues 
may be mitigated in part by using tools such as molecular evaluation of 
organisms.
    We did not include a definition of ``similar'' in the proposed 
regulations as it is an inherently relative term, and as a commenter 
noted, scientific methods and genetic comparison techniques are 
evolving rapidly and requiring APHIS to maintain a degree of regulatory 
flexibility. A broad definition of ``similar'' that attempts to cover 
every possible situation would require potentially arbitrary 
restrictions on the characteristics used to compare organisms. If an 
initial comparison of an organism reveals similarities with a known 
plant pest or pathogen, we will undertake a closer evaluation of the 
pest risk potential for that organism.

Permit Requirements (Sec.  330.201)

    Under the proposed section ``Permit requirements,'' we listed the 
types of permits that would be required for the importation, movement 
in interstate commerce, and particular uses of plant pests, biological 
control organisms, and associated articles. We also proposed 
requirements for permit applicants as well as procedures for evaluating 
and taking action on permit applications.
    In proposed Sec.  330.201(a), we listed the types of permits that 
APHIS would issue for plant pests, biological control organisms, and 
associated articles. We also listed permit application requirements and 
conditions under which APHIS would assess applications and issue, deny, 
suspend, revoke, and amend permits.
    One commenter stated that instead of requiring persons to apply 
separately for permits for different plant pathogens, APHIS should 
develop a list of conditions under which qualified persons can 
transport pathogen cultures, infected plant material, and infected soil 
under a blanket permit for organisms that will not be released or 
organisms that are native to a State. The commenter added that having 
to obtain new permits for every sample can be restrictive with respect 
to sharing isolates.
    The commenter appears to be describing the general permit that we 
included in the proposal under Sec.  330.200(a). In the above 
discussion of Sec.  330.200, we decided to defer issuing general 
permits but are retaining the provision for issuing such permits for

[[Page 29942]]

future needs. However, we acknowledge the commenter's suggestion and 
note that other options are available. Applicants meeting the 
requirements in proposed Sec.  330.201 may include more than one type 
of organism and its intended use in a permit application, especially 
within a discipline such as plant pathology, but we often ask that 
arthropods and plant pathogens appear on separate applications. This 
lessens confusion for permit reviewers, permittees, and State and 
Federal regulators. APHIS also maintains lists of plant pathogenic 
fungi, bacteria, and viruses recognized as widely prevalent within 
various States. Finally, we note that we are establishing a petition-
based process for listing certain biological control organisms and 
plant pests (in Sec. Sec.  330.202 and 330.204, respectively) that may 
be moved interstate within the continental United States without 
restriction.
    A commenter stated that the availability of a comprehensive list of 
pathogens that APHIS considers to be high-risk plant pests would 
alleviate the permit application process and reduce follow-up 
questions. The commenter added that such a list would help to ensure 
that sufficient evidence is provided to APHIS for scientific review.
    We acknowledge the commenter's suggestion for improving the permit 
application process. However, we do not consider it practical to 
compile a comprehensive list of high-risk plant pests, as any criteria 
we might develop to identify such pests is subject to many situational 
variables that require case-by-case evaluation. We note that in 7 CFR 
331.3 we maintain a list of high-risk biological agents and toxins that 
have the potential to pose a severe threat to plant health or plant 
products. Persons applying for a permit for what they believe may be a 
high-risk organism are encouraged to contact APHIS with any questions 
they have about preparing and submitting an application.
    We proposed in Sec.  330.201(a)(1) that when import permits are 
issued to a corporate entity, that entity will need to maintain an 
address or business office in the United States with a designated 
individual for service of process.
    A commenter stated that APHIS should consider whether ``designated 
individual for service of process'' should use the term in the plural 
as a way to create more flexibility for the permittee.
    ``Service of process'' is the act of serving notice of legal action 
against another party. The ``designated individual'' in proposed Sec.  
330.201(a)(1) is a person located in the United States who receives 
notice of legal action on behalf of the corporate entity. As a 
corporate entity can designate more than one individual to act in this 
role, we will change the wording to read ``one or more individuals.''
    One commenter noted that many biological products companies conduct 
research activities in U.S. territories and requested that corporate 
permits be allowed to cover such activities in those areas.
    U.S. territories, as well as the District of Columbia, fall within 
the definition of State under the PPA and part 330, so interstate 
movement permits for activities regulated under part 330 may be issued 
for movement from those areas.

Curation Permits

    In proposed Sec.  330.201(a)(3), we set forth provisions regarding 
continued curation permits, which are issued in conjunction with either 
an import permit or interstate movement permit prior to the expiration 
date of the permit.
    A commenter asked whether continued curation permits as proposed in 
Sec.  330.201(a)(3) are also intended to cover research and diagnostic 
activities.
    Continued curation permits are issued prior to the expiration date 
for an import or interstate movement permit in order for a permittee to 
continue research or other actions listed on the import or interstate 
movement permit. Before a continued curation permit can be issued, the 
required laboratory conditions for safeguarding organisms received or 
isolated for research under an import or interstate movement permit 
must be reevaluated.
    Two other commenters asked that we clarify the difference between a 
continued curation permit and the renewal of an existing movement 
permit authorizing diagnostic or research activities.
    Continued curation permits do not allow acquisition of additional 
organisms for research and other authorized activities and only address 
retention of existing organisms for authorized uses. Continued curation 
permits are intended for situations in which the permit applicant 
wishes to retain live regulated organisms but does not request 
permission for their continued or additional movement, which would 
require a separate permit. The renewal of a permit would allow for such 
movement, although it is not required that movement occur. Thus it is 
usually more desirable to renew a permit authorizing movement in case 
organisms need to be restored or additional organisms might need to be 
received.

Application Process and Permit Issuance

    In proposed Sec.  330.201(b), we provided that permit applications 
would have to be submitted by the applicant in writing or 
electronically via the internet.
    A commenter requested that APHIS continue to modernize its 
information technology systems to enable multistate listings on a 
single permit application as allowed by APHIS for permits under its 
biotechnology regulations in 7 CFR part 340.
    We acknowledge the commenter's request. APHIS is modernizing its 
information technology systems and is currently making only critical 
technical improvements. However, we will consider including this 
feature in future updates to the permit application page on the Plant 
Protection and Quarantine (PPQ) website.
    Another commenter stated that it would be useful for applicants to 
track the progress of permit applications.
    We note that a tracking feature exists in the current online 
electronic permitting system.\7\
---------------------------------------------------------------------------

    \7\ To access an existing account or register for a new APHIS 
ePermits account, visit ePermits at https://www.aphis.usda.gov/aphis/resources/permits.
---------------------------------------------------------------------------

    One commenter suggested that it might be helpful to have affected 
scientific societies and their members involved in designing the APHIS 
permitting process.
    APHIS typically solicits comments and feedback from scientific 
societies and other stakeholders to continuously improve our permitting 
process. In addition, APHIS received considerable input from other 
Federal agencies, State regulatory officials, and industry prior to 
developing the proposed rule.
    In the preamble discussion of proposed Sec.  330.201(c), we noted 
that in order to facilitate timely issuance of a permit, an application 
should be submitted at least 90 days before the actions proposed on the 
permit application are scheduled to take place, with additional time 
allotted for complex or novel applications, or applications for high-
risk plant pests. We intended this number of days to be a suggestion to 
help ensure that permit decisions are made prior to the applicant's 
proposed permit activity.
    One commenter asked that we define ``novel'' within the scope of 
APHIS' legal authority under the PPA as it relates to plant pests, 
noxious weeds, and biocontrol organisms. The commenter stated that 
``novel'' should

[[Page 29943]]

be defined solely within the scope of APHIS' legal authority under the 
PPA and not in a general sense.
    We disagree with the commenter that our use of the word ``novel'' 
is outside the scope of our authority under the PPA. The commenter is 
referring to our use of the word ``novel'' in the proposed rule when 
referring to permit applications, in which we state that additional 
time should be allotted for submitting ``complex or novel applications, 
or applications for high-risk plant pests.'' Such applications 
typically include new or unusual processes, safeguards, designs, and 
methods of organism destruction. As APHIS' primary purpose under the 
PPA is to safeguard the United States against the introduction or 
infestation of plant pests, noxious weeds, and biological control 
organisms, novel applications require additional evaluation to ensure 
that the intended activities do not harbor a new or unforeseen plant 
pest risk.
    Another commenter stated that the proposed rule does not indicate 
whether the targeted 90 days for submission of a permit application 
pertains to permits for imports, interstate movements, field releases, 
or all of these, and asked for clarification.
    The guidance regarding 90 days to allow for sufficient processing 
was suggested for all permit applications.
    Two other commenters asked that we provide timelines for permit-
related actions and decisions. One suggested that a consultation 
timeline of 30 days and a permitting timeline of 60 days is reasonable.
    As we indicate on the PPQ Plant Health website,\8\ permit 
applications can be processed in as little as 30 days after they are 
received, but the specific circumstances of many applications make it 
difficult to publish accurate timelines for evaluating and making 
decisions on them. These circumstances can include the need for a 
facility inspection, the need to obtain additional equipment or 
equipment certifications, or the need for additional information from 
the applicant. Persons inquiring about the status of a permit 
application can contact APHIS.\9\
---------------------------------------------------------------------------

    \8\ The website address is: https://www.aphis.usda.gov/planthealth/organism-soil-permits.
    \9\ See footnote 4 for contact information.
---------------------------------------------------------------------------

    As part of APHIS' action on permit applications, we noted in 
proposed Sec.  330.201(d)(1) that we will share a copy of the 
application and the proposed permit conditions with the appropriate 
State or Tribal regulatory officials.
    A commenter stated that APHIS should ensure that proper procedures 
are in place whenever sensitive permit application information is 
shared with States or Tribes. The commenter stated that many States and 
other entities do not have procedures in place to protect sensitive 
information to the extent that Federal agencies such as APHIS do, 
adding that many of them are legally required to provide information in 
their possession through ``Sunshine Acts'' and similar public 
disclosure laws.
    We acknowledge the commenter's concern regarding the protection of 
sensitive and confidential information. Although APHIS may sometimes 
request confidential business information as part of the permit 
application process, as a matter of policy we do not share the 
sensitive or confidential business information included in applications 
with States or Tribes.
    Another commenter asked if APHIS informs the permit applicant when 
an application is shared with other persons or groups for analysis, and 
if so, whether the applicant is informed of who those persons or groups 
are. The commenter also asked how APHIS handles any objections arising 
from sharing permit information with third parties.
    APHIS typically does not inform permit applicants about details of 
the evaluation process, of which deliberations with outside experts is 
sometimes a part. However, if an applicant has questions or concerns 
about the status of an application and how it is evaluated, he or she 
can contact APHIS.\10\
---------------------------------------------------------------------------

    \10\ See footnote 4.
---------------------------------------------------------------------------

    We indicated in proposed Sec.  330.201(d)(3)(ii) that permits would 
be valid for no more than 3 years. One commenter stated that a 
timeframe of 5 years for a permit to be valid would be more desirable.
    We acknowledge the commenter's view but are making no changes to 
the proposal. Evolving developments in science, technology, and policy 
necessitate a re-evaluation of permits every few years. Under a longer 
timeframe, the original conditions of permitted activity could become 
obsolete or be subject to new policy or regulatory changes.
    One commenter said that the requirements for biocontrol agents as 
currently administered are burdensome. The commenter noted that the 
APHIS Level 2 user requirement is a significant hurdle to working with 
many organizations because they are required to obtain this level 
before they can apply for permits.
    The commenter is referring to the requirement for obtaining a Level 
2 user account from APHIS, which allows users to apply for permits 
electronically through the APHIS ePermits system. The ePermits system 
currently supports Level 2 users for all permit application types and 
Level 1 users for selected permit application types. Level 2 access 
differs from Level 1 in that it requires identity authentication either 
through correctly answering online identity verification questions or 
by presenting a Government-issued photo ID at a local U.S. Department 
of Agriculture (USDA) office.\11\ APHIS considers the procedures for 
obtaining a Level 2 user account to be necessary to maintaining 
adequate security and we do not believe its requirements to be unduly 
burdensome.
---------------------------------------------------------------------------

    \11\ See the website address in footnote 7 for more information 
about obtaining an ePermits account.
---------------------------------------------------------------------------

    In proposed Sec.  330.201(d)(3), we indicated that APHIS may issue 
a permit to an applicant if APHIS concludes that the actions indicated 
in the permit application are not likely to introduce or disseminate a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that exposes plants and plant products to 
unacceptable risk.
    A commenter stated that a purely risk-based approach on deciding 
whether to issue permits does not consider benefits to U.S. 
agriculture. The commenter said that the presence of a ``balancing 
condition'' that considers both risks and benefits is most appropriate 
for agriculture, and that the absence of such biological control 
alternatives has resulted in the current standard of chemical control 
with its associated risks. Another commenter similarly expressed 
support for researchers who consider both the risks and the benefits of 
imported biocontrol agents. The commenter noted that Australia has long 
been a leader in the regulation of biocontrol agents and has included 
in its analyses both the risks and benefits of importing biological 
control organisms.
    The primary mission of APHIS is to safeguard American agriculture 
and the environment by applying and enforcing adequate protections to 
prevent the introduction and spread of harmful organisms. Although we 
are aware that both risks and benefits can be inherent in any 
permitting decision, the PPA provides us with no directive to consider 
benefits when issuing import or movement permits. While the PPA 
indicates that APHIS should facilitate

[[Page 29944]]

the use of biological controls,\12\ no part of the Act directs us to 
consider benefits other than safeguards to reduce risk.
---------------------------------------------------------------------------

    \12\ See PPA, section 7701(2), Findings.
---------------------------------------------------------------------------

    On a practical level, the environmental risk or benefit occurring 
from release of an organism is circumstantial and difficult to predict. 
Conducting a risk/benefit analysis requires making assumptions and 
analyzing hypothetical situations that may or may not occur. Moreover, 
once a released organism establishes itself in the environment, there 
may be no way to reverse the action if unexpected risks arise or 
expected benefits never materialize.
    A commenter asked if APHIS evaluates risk differently for different 
activities when considering issuing a permit for the release of 
biological control organisms, such as greenhouse releases versus field 
releases, or for agricultural purposes versus recreational or 
celebratory events such as weddings. The commenter suggested that APHIS 
should consider relative risk when making release determinations.
    We agree with the commenter. APHIS always evaluates movement or 
release risk of organisms relative to the individual species and its 
intended use.
    A commenter noted that in proposed paragraphs (d)(3) and (4) of 
Sec.  330.201, we explain the processes for permit application issuance 
and denial but provide no details of the initial consultation. The 
commenter referred to an initial consultation process presented by 
APHIS-PPQ in September 2016 in which potential applicants consulted 
with APHIS to determine whether an organism required a permit and, if 
it did, to gain initial feedback on what data would need to be provided 
in an application. The commenter asked that we include the consultation 
process in the regulations to provide transparency and consistency for 
the entire permitting process.
    We do not plan to establish a formal consultation process in the 
regulations, as the consultation process is specific to the 
circumstances of each application. However, we will continue to use an 
informal process of initial consultation for complex situations on a 
case-by-case basis.
    Two commenters raised concerns about the Letters of No Jurisdiction 
(LONJ) that APHIS issues in response to permit applications for 
organisms or products that do not fall under APHIS regulatory 
authority. One commenter acknowledged that although LONJs are important 
for clearing imported samples through customs, the letters sometimes 
contain extraneous information that can be confusing to CBP agents. The 
commenter cited as an example a LONJ stating that a sample can only 
move from a certain country to a certain State even though APHIS has no 
jurisdiction over the sample. The commenter asked that we not include 
country, State, and address information in the LONJ and simply state 
that the organism is not regulated by APHIS and can be imported and 
moved without restriction. Another commenter similarly asked that APHIS 
revise the LONJ to state specifically that all actions taken with the 
organism or product, such as movement and release, are not under APHIS 
jurisdiction.
    We acknowledge the commenters' concerns and will consider revising 
our LONJ templates accordingly. If APHIS issues a LONJ for an organism 
or product, it means that APHIS has no jurisdiction over its movement 
or release. However, we encourage persons to determine whether other 
Federal or State agencies have jurisdiction over actions relating to 
the organism or product.
    A commenter requested that APHIS develop guidance to help permit 
applicants provide the appropriate information to show that an organism 
is not a plant pest. The commenter stated that if the applicant can 
provide such information, APHIS should issue a LONJ to the previous 
permit holder.
    We are making no changes in response to the comment's request. 
Guidance regarding the determination of jurisdiction is intended to be 
specific to the taxonomic identity and biological properties of the 
organism listed in the permit application and is not retroactive to 
previous permit holders. APHIS will continue to work with applicants on 
a case-by-case basis.
    A commenter asked that we not issue Letters of No Permit Required 
with an expiration date, as doing so results in additional 
administrative activities for APHIS and the applicant to obtain the 
same letter again following its expiration. The commenter acknowledged 
that APHIS has the authority to rescind this letter if circumstances 
change and the activities instead need to be conducted under a permit.
    APHIS issues Letters of No Permit Required for organisms and 
products over which APHIS has legal authority but has determined that 
movement of the organism or product presents no appreciable risk. 
However, as a condition of granting an exception from permit 
requirements, the letter may base the exception narrowly on how the 
organisms are used, their geographical location, or other 
circumstances. Although most such letters issued by APHIS do not 
include expiration dates, we reserve the right to include them when 
warranted to maintain the flexibility needed to minimize risks to 
plants and plant products.
    One commenter stated that the proposed permitting requirements for 
movement or importation of organisms are not consistent with how APHIS 
administers the permitting process. According to the commenter, the 
APHIS website states that a PPQ 526 permit typically is not required 
for the interstate movement or release into the environment of 
domestically isolated microorganisms that are not plant pests and that 
are widely distributed in the continental United States. The commenter 
stated that, despite what the website says, APHIS currently requires 
permits for microorganisms that are not plant pests that are found and 
collected in multiple locations in the continental United States.
    We regulate microorganisms if they are known plant pests, act as 
direct biological control organisms, or if their mode of action is 
unknown. We are therefore obligated to require permits for their 
interstate movement and importation regardless of how common they are 
in the environment. We will review our website content and clarify any 
requirements that may be unclear to readers.
    In proposed Sec.  330.201(d)(5), we included provisions for the 
withdrawal of a permit application. Applicants who wish to withdraw a 
permit application are required to provide this request in writing to 
APHIS, which in turn notifies the applicant regarding reception of the 
request and withdrawal of the application.
    A commenter representing a State government wanted to know if 
withdrawals of applications by permit applicants could be posted on the 
APHIS ePermit website, or if States could otherwise be notified of the 
withdrawal. The commenter stated that knowledge of application 
withdrawals helps the State maintain a better awareness of pest and 
biocontrol-related activities of familiar and new applicants.
    Permit applications withdrawn by APHIS at the request of the 
applicant are recorded internally within the ePermit system. APHIS does 
not plan to modify the system to share additional information with 
States or stakeholders about applications that are not processed to a 
permit decision. If we consider a permit withdrawal to materially 
affect a State's agricultural or environmental welfare, we will share

[[Page 29945]]

this information with the State accordingly.

Biological Control Organisms (Sec.  330.202)

    In proposed Sec.  330.202, we presented criteria for the 
importation, interstate movement, and release of biological control 
organisms. We noted that we regulate biological control organisms under 
authority of the PPA insofar as they have the potential to pose a plant 
pest or noxious weed risk.
    In Sec.  330.202(a), we proposed general conditions for the 
importation, interstate movement, and release of biological control 
organisms. We proposed that, except as provided in proposed Sec.  
330.202(b), no biological control organism regulated under the subpart 
may be imported, moved in interstate commerce, or released into the 
environment unless a permit has been issued in accordance with Sec.  
[thinsp]330.201 authorizing such importation, interstate movement, or 
release.
    A commenter asked how APHIS will determine the pest risk to plants 
and plant products when considering issuing a permit for a biological 
control organism.
    If APHIS determines the requested biological control organism is 
not established in the continental United States and will be a first-
time release into the environment, we will undertake a more 
comprehensive evaluation of the permit application. APHIS will conduct 
a scientific risk review of the proposed release of the particular 
organism.

Biological Control Organisms: Exceptions From Permitting

    In the proposed rule, we established a notice-based process \13\ by 
which persons could submit petitions for excepting certain biological 
control organisms from permitting requirements for importation, 
interstate movement, or environmental release. As part of this informal 
adjudication process, we will evaluate each petition we receive to 
determine whether the biological control organism is of a sufficiently 
low risk. If we determine there is sufficient evidence that the 
organism exists throughout its geographical or ecological range in the 
continental United States and that subsequent releases of the organism 
into the environment will present no additional plant pest risk, we 
will announce the availability of the petition in a notice published in 
the Federal Register and solicit public comment.
---------------------------------------------------------------------------

    \13\ We also proposed establishing in Sec.  330.204 a parallel 
process for excepting certain plant pests from permitting 
requirements.
---------------------------------------------------------------------------

    After we consider the comments we receive, we will announce our 
final decision on whether to except the organism from permitting 
requirements in a subsequent notice published in the Federal Register. 
The final notice constitutes final agency action, which is subject to 
being challenged in court under the Administrative Procedure Act.
    We proposed the petition process for permit exceptions because we 
determined that certain low-risk biological control organisms have 
become established throughout their geographical or ecological range in 
the continental United States. The additional release of pure cultures 
derived from field populations of taxa of these organisms into the 
environment presents no additional plant pest risk (direct or indirect) 
to plants or plant products. We posted draft lists of these organisms 
for comment online.\14\
---------------------------------------------------------------------------

    \14\ See footnote 2 for the draft lists, which include 
``Invertebrate Organisms for the Biological Control of Weeds'' and 
``Invertebrate Organisms for the Biological Control of Invertebrate 
Plant Pests.'' These lists will be published and maintained on the 
PPQ Permits and Certifications website: https://www.aphis.usda.gov/aphis/resources/permits.
---------------------------------------------------------------------------

    Referring to the list of organisms excepted from permitting 
requirements, a commenter asked APHIS to provide examples of items that 
would be in the list.
    We posted examples of invertebrate organisms excepted from permit 
requirements for review and comment in an online list.\15\ Products 
consisting of mixtures of biological control organisms may also be 
eligible for exceptions from permitting provided that all organisms 
included in the formulation appear on the list of exceptions.
---------------------------------------------------------------------------

    \15\ See footnote 2.
---------------------------------------------------------------------------

    With respect to a taxon's establishment throughout its geographical 
or ecological range, a commenter asked what the taxon is and does it 
have one strain or multiple strains.
    As we noted in our proposed definition of the term, a taxon can be 
any recognized grouping or rank within the biological nomenclature of 
organisms, such as class, order, family, genus, species, subspecies, 
pathovar, biotype, race, forma specialis, or cultivar. A taxon can 
contain one strain or multiple strains.
    A commenter asked if taxon identification will be based on whole 
genome sequencing.
    APHIS will require identification using techniques appropriate for 
the taxon and the particular circumstances of the permit request.
    The same commenter also asked whether a permit will be required to 
move an organism to a State outside its range if an organism is 
established throughout its geographic or ecological range within the 
United States.
    If an organism is on the list of biological control organisms 
excepted from permit requirements, that organism will not require a 
permit for interstate movement within the continental United States. 
Inclusion on the list indicates sufficient evidence that the species on 
the list cannot persist outside of its recorded range and that the 
species has already had ample opportunity to do so naturally.
    The commenter also asked if APHIS will provide public access to the 
information that we use to determine a taxon's geographical or 
ecological distribution.
    APHIS will provide access to the information referenced by the 
commenter. If a person petitions for a species to be added to the list 
of biological control organisms excepted from permit requirements, they 
do so with the understanding that we will make publicly available any 
information submitted by the petitioner with respect to determining the 
distribution of that species.
    A commenter representing a State expressed concern that allowing 
certain biological control organisms to be moved interstate within the 
continental United States without further restriction does not take 
into account the organism's status in individual States and that any 
such list would need to be subject to review by individual States where 
agents will be used.
    As we noted in proposed Sec.  330.201(d)(1), APHIS will share a 
copy of the petition with the appropriate State or Tribal regulatory 
officials. APHIS does not approve the use or distribution of biological 
control organisms within the continental United States without first 
considering the organism's status in individual States. We also note 
that Sec.  330.202(e) indicates that any organism may be removed from 
the list of organisms excepted from permitting requirements if 
information emerges that would have otherwise led APHIS to deny the 
petition to add an organism to the list.
    In paragraph (b)(1) of Sec.  330.202, we proposed that pure 
cultures of organisms excepted from permitting requirements may be 
imported into or moved interstate within the continental United States 
without further restriction under subpart B of part 330.

[[Page 29946]]

    Citing pest risk concerns, several commenters recommended that all 
imported biological control organisms be excluded from the draft list 
of organisms excepted from permitting and that such imported organisms 
not be eligible for the proposed permit exception process. One 
commenter stated that biological control organisms could be imported 
from unverified sources and result in the inadvertent introduction of 
exotic parasitoids. The commenter added that the risk is high for weed 
biocontrol agents and plant pests because herbivores from a different 
geographic source than the originally introduced population often have 
different host ranges or are discovered to be a different species. 
Another stated that the proposed rule does not account for different or 
new foreign sources that would be added to the list of pests and 
organisms excepted from permit requirements, which may present varying 
levels of risk in terms of the reliability of sources to ensure correct 
identification, safe release practices, and freedom from contamination 
by harmful species.
    While we have confidence in our proposed petition-based process for 
excepting organisms from permit requirements that pose a low risk to 
plants or plant products, we acknowledge that the importation of 
organisms from new sources and geographic locations could be a 
potential source of new unapproved exotic species or parasites and 
diseases of those species. An imported plant pest poses a potentially 
higher risk level than the same domestic species moved interstate 
because the former may be carrying unknown diseases or microbial 
pathogens from the foreign source. Therefore, we will continue at 
present to require permits for the importation of biological control 
organisms and plant pests in order to continue the appropriate 
safeguards with respect to foreign sources. As we envision that 
stakeholders may wish in the future to import low risk species such as 
Drosophila melanogaster, we will retain the petition process for 
excepting biological control organisms and plant pests from permitting 
requirements in Sec. Sec.  330.202 and 330.204, respectively. If we 
receive petitions for importing certain organisms or pests without a 
permit, we will review and consider making the petitions available for 
public comment. Any organisms and pests that APHIS lists as being able 
to be moved interstate without a permit will not be eligible to be 
imported without a permit unless APHIS expressly indicates otherwise.
    One commenter objected to any regulation of the interstate movement 
of beneficial insects and mites because they are not plant pests. The 
commenter stated that the proposed regulatory changes would place 
beneficial insects and mites under the same movement restrictions 
applied to plant pests unless they are included in the list ``Organisms 
for the Biological Control of Invertebrate Plant Pests.'' The commenter 
stated that this list should be used to determine whether organisms can 
cross international boundaries unhindered but that no interstate 
movement of beneficial insects and mites should be regulated. The 
commenter also suggested that entire taxa containing no plant pests 
should be included in the proposed list of excepted organisms, as 
parasites and predators of plant pests except weed biocontrol agents 
should be ``innocent until proven guilty.'' The commenter cited as an 
example of such taxa the predatory mite family Phytoseiidae, which 
according to the commenter contains no species known to cause harm to 
plants.
    We are making no changes with respect to our proposal to regulate 
beneficial invertebrates as biological control organisms. In response 
to previous documents published in the Federal Register in which we 
discussed codifying requirements for biological control organisms, some 
commenters stated that APHIS should regulate biological control 
organisms only when their efficacy at controlling a target plant pest 
or noxious weed is in question. However, the risk exists that 
nonspecific and indiscriminant invertebrate parasites and predators 
intended for beneficial purposes can also attack non-target 
invertebrates that are themselves beneficial as pollinators or 
biocontrol organisms. The draft list we posted for public review and 
comment contains only those organisms for which there exists an 
established record of observed information and that meet the criteria 
for exception from permitting set forth in the regulations. We took 
this approach to the list to minimize the potential direct or indirect 
plant risk that adding entire taxa could pose absent an evaluation of 
the risk potential of these taxa. As authorized under the PPA, APHIS is 
required to evaluate the plant pest effects that organisms may pose to 
non-target plants and plant targets and regulate them until we are 
certain that such organisms can be safely released into the environment 
without further restriction.

Pure Culture

    A number of commenters asked us to define ``pure culture.'' One 
commenter noted that many products containing biological control 
organisms are typically formulated with carrier or host material, such 
as insects as a food source for entomophagous mites, and asked if such 
formulations can be considered as pure cultures. Another commenter 
stated that the requirements for pure cultures need to be clearly 
defined to ensure they consist of only specified biological control 
organisms free of predators, parasites, and pathogens, and contain no 
host material such as exotic invasive plant propagules. Another 
commenter expressed concern about how identification or purity of 
organisms could be assured prior to release into the environment, 
particularly as the term ``pure culture'' does not appear to be defined 
in law or policy.
    We acknowledge that defining the term ``pure culture'' will provide 
stakeholders with a clearer understanding of requirements under the 
regulations and what constitutes a ``clean'' package of organisms 
excepted from permitting requirements, especially for field collected 
sources for weed biocontrol. Accordingly, we will define the term pure 
culture as a single species of invertebrate originating only from an 
identified/described population and free of disease and parasites, 
cryptic species, soil and other biological material, except host 
material and substrate as APHIS deems appropriate. Examples of 
``identified/described population'' are those originating from a 
specific laboratory colony or field collection from a specified 
geographic area, such as an entire country, or States or provinces of a 
country.
    For the excepted biological control organisms listed on the PPQ 
Permits and Certifications website (referenced in Sec.  330.202(b)), we 
will also include the sources for each species excepted from permit. 
For example, species of commercial entomophagous biological control 
organisms will require verification that they are from domestic 
laboratory colonies. Likewise, weed biological control organisms will 
need to be field collected from within the continental United States or 
derived from domestic colonies from those field sources.
    Another commenter asked how ``pure culture'' will be defined if 
organisms are harvested from the established geographical or ecological 
range in the continental United States.
    As we noted above, a pure culture consists of a single species of 
invertebrate originating only from an identified/described population 
and free of disease and parasites, cryptic species, soil and other 
biological material except

[[Page 29947]]

host material and substrate. The source of the organism may originate 
from the species' established geographical or ecological range within 
the continental United States.
    Another commenter asked whether the term ``pure culture'' also 
includes ``pure populations'' in reference to invertebrates.
    We cannot answer the commenter's question as we do not know what is 
meant by ``pure populations'' and how it differs from ``pure culture.''
    A commenter stated that ``pure culture'' can mean a single species 
derived from a population in a defined geographical area, but added 
that the biological control industry also considers the term to mean 
the absence of contamination in commercial inbound shipments and 
compliance with ``truth in labeling'' laws that require a package's 
label to be identical to its content. The commenter stated that 
packages are randomly checked by USDA inspectors for permitted 
organisms and that clarification is needed on how to resolve purity 
issues in organisms excepted from permitting requirements.
    As we noted above, we will continue at present to require permits 
for the importation of biological control organisms and plant pests but 
will retain the petition process we proposed for excepting biological 
control organisms and plant pests from permitting in Sec. Sec.  330.202 
and 330.204, respectively. If we receive petitions to allow the 
importation of certain organisms or pests without a permit, we will 
review them and submit them for public comment.
    A commenter asked what additional documentation or certificates may 
be required to move organisms and products defined as pure cultures, 
and what provisions will be implemented to ensure clarity with 
inspectors when importing listed organisms.
    Documents and certificates required to move organisms and products 
are typically listed on the permit. APHIS provides guidance to CBP so 
that inspectors are clear about importation requirements for biological 
control organisms and products.
    A commenter recommended that to ensure all redistribution efforts 
for weed classical biological control organisms, APHIS should consider 
the Code of Best Practices for Classical Biological Control of 
Weeds.\16\
---------------------------------------------------------------------------

    \16\ Proceedings of the X International Symposium on Biological 
Control of Weeds 435 4-14 July 1999, Montana State University, 
Bozeman, Montana, USA; Neal R. Spencer [ed.]. p. 435 (2000). (https://bugwoodcloud.org/ibiocontrol/proceedings/pdf/10_435.pdf.)
---------------------------------------------------------------------------

    APHIS is familiar with the document cited by the commenter and 
agrees in principle with its best practices.
    One commenter expressed concern that if all bacteria belonging to 
the same genus as a plant pathogen are regulated, students isolating 
antibiotic-producing Streptomyces bacteria in an introductory-level 
microbiology lab exercise could inadvertently fall under APHIS purview. 
The commenter stated that this could occur because students would not 
typically move beyond morphologically classifying their isolates as 
Streptomyces and this genus contains plant pathogens such as 
Streptomyces scabies.
    If persons have questions about lab or other specific activities 
that may fall under APHIS' regulation of plant pathogens, they are 
encouraged to contact APHIS for clarification.\17\
---------------------------------------------------------------------------

    \17\ See footnote 4 for contact information.
---------------------------------------------------------------------------

    The commenter also stated that it would be helpful to have access 
to a comprehensive list of microbial pathogens of concern to APHIS so 
that stakeholders can identify and deal with problematic taxa 
appropriately.
    APHIS has regulatory authority over all plant pests and biological 
control organisms moved in interstate commerce and imported into the 
United States. While we do not keep such a comprehensive list, an 
extensive table of U.S. regulated plant pests is available on the 
APHIS-PPQ website.\18\
---------------------------------------------------------------------------

    \18\ https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information/rppl/rppl-table.
---------------------------------------------------------------------------

    Proposed Sec.  [thinsp]330.202(c) lists the steps by which APHIS 
accepts and evaluates petitions for adding biological control organisms 
to the lists of those organisms granted exceptions from permit 
requirements for their importation or interstate movement. We noted 
that we drafted two lists of biological control organisms (one list for 
control of invertebrate plant pests, one for control of weeds) for 
which we would grant exceptions from the permit requirements, and made 
the lists available for comment.\19\ Persons could request that an 
organism be added to a list by submitting a petition to APHIS. A notice 
of the petition would be published in the Federal Register for public 
comment. We stated in proposed Sec.  330.202(c) that such petitions 
must provide evidence that the organism is indigenous to the 
continental United States throughout its range, or self-replicating for 
a period of time sufficient to consider the organism to be established 
in its range in the continental United States. The petition would also 
have to provide results from a field study during which data was 
collected from representative habitats occupied by the organism and 
provide any data indicating that subsequent releases of the organism 
into the continental United States will present no additional plant 
pest risk.
---------------------------------------------------------------------------

    \19\ See footnote 2.
---------------------------------------------------------------------------

    A commenter stated that, because the proposed rule addresses the 
process for requesting that biological control organisms be added to 
the lists of organisms excepted from permit requirements, APHIS needs 
to make the current list readily available. Another commenter stated 
that a clear description of how to access the lists is needed, and two 
other commenters stated that a mechanism for updating the lists also 
needs to be added to the regulations.
    We made draft lists of biological control organisms excepted from 
permitting available for review at the website address listed in 
footnote 2.\20\ We noted in the proposed rule that while we will 
consider comments received on the draft lists to be distinct from those 
received on the proposed rule, the comments received on the draft lists 
will inform our evaluation of the suitability of the exceptions from 
permitting requirements contained in proposed Sec.  330.202(b). Once 
the rule is finalized and a list of excepted organisms is established 
on the APHIS website, persons can submit petitions according to the 
provisions included in Sec.  330.202(c).
---------------------------------------------------------------------------

    \20\ Invertebrate Organisms for the Biological Control of Weeds; 
Invertebrate Organisms for the Biological Control of Invertebrate 
Plant Pests; and Native and Naturalized Plant Pests Permitted by 
Regulation (Individual Permits not Required) for Their Interstate 
Movement within the United States.
---------------------------------------------------------------------------

    One commenter supported a process for excepting certain biological 
control organisms from permit requirements, but expressed concern that 
publishing petition notices in the Federal Register and soliciting 
public comment may make the process sufficiently onerous as to 
effectively limit its use. Instead, the commenter suggested that we 
establish a Technical Advisory Group (TAG) to expedite the listing 
process for excepted biological control organisms.
    APHIS is committed to ensuring transparency and public 
participation with respect to reviewing petitions for permit 
exceptions. For this reason, we intend to publish notices of petitions 
we receive in the Federal Register and request public comment on them. 
We may also use our Stakeholder Registry as another means of notifying 
the public of proposed actions and requesting comment. Although we 
maintain an active TAG, we disagree with the commenter and do not 
consider it to be

[[Page 29948]]

as efficient or as transparent as the petition comment process. Under 
Sec.  330.201(d)(1), APHIS will have the option of consulting with 
technical experts on petitions as the need arises.
    The same commenter opposed a blanket permit for interstate movement 
of select organisms that appears to include fieldto-field collections 
and releases without screening such organisms for unwanted 
contaminants, but acknowledged that field-to-field movement can include 
beneficial predators such as coccinellids (lady beetles). The commenter 
stated that a blanket permit system may result in intentional or 
unintentional mislabeling of shipments leading to accidental 
introduction of a potentially serious pest.
    The commenter seems to be referring to the general permit we 
discuss above, which authorizes organizations that frequently move 
certain low-risk plant pests and organisms interstate to do so without 
having to obtain a separate permit for each movement. As we noted, we 
have decided to defer issuing general permits until a later time. We 
also note that APHIS does not approve the interstate movement and 
release of any biological control organism without consideration of the 
organism's status in individual States, and to that end solicits State 
review. Moreover, the issue of contaminants is mitigated in two ways. 
The majority of biocontrol releases are at present coordinated by 
government-related programs or personnel, who have training and 
experience in moving clean shipments. Likewise, commercial entities are 
economically motivated to provide clean, quality shipments. State and 
local plant regulatory personnel also have the opportunity and 
authority to observe, report, and enforce regulations regarding the 
movement and release of non-exempt, contaminant organisms in any 
shipment.
    One commenter stated that movement permits need to be specific to 
each State, noting that transporting biological control organisms that 
are effective in California may have consequences if the same agents 
are used in another State. The commenter cited the potential danger of 
walnut twig bark beetles on the West Coast spreading Thousand Cankers 
disease to the Eastern United States. The commenter added that while 
allowing permits for the transport of biological control organisms may 
help problems such as this one, it should be the decision of States to 
allow movement of certain agents across their borders.
    The species listed by APHIS for exception from permitting 
requirements are species that exist throughout their full ecological 
range in the United States and therefore, from a State-by-State view, 
are either already present in a given State or have been shown to be 
unable to live in that State as a self-reproducing population. All 
other petitions for biological control organisms would be subject to 
APHIS permits for interstate movement and made available for review and 
input from Tribal and State representatives as provided for in proposed 
Sec.  330.201(d)(1).
    One commenter observed that the regulatory status of 
entomopathogenic nematodes is not addressed specifically in the 
proposed rule.
    Entomopathogenic nematodes meet the definition of biological 
control organism we proposed in Sec.  330.100 and therefore we regulate 
them accordingly. However, we have included seven such species on the 
draft list of biological control organisms proposed to be excepted from 
permit, which we posted for public comment.
    One commenter stated that in classical biological control, 
individual populations of a species have been identified as possible 
importation sources into the United States, but even these need to be 
quarantined for screening for contaminants. The commenter stated that 
the list of excepted organisms maintained online should be reviewed in 
light of the International Code of Best Practices for Biological 
Control.
    We note above that in this final rule we are not at present 
allowing importation of biological control organisms without a permit 
but will consider the commenter's suggestion should we begin to do so.
    One commenter noted that the need for export certification on 
biological control organisms is not addressed, and suggested that APHIS 
should issue permits certifying the condition of organisms and 
associated articles that are destined for export from the United 
States. Another commenter stated that the need for export certification 
on biological control organisms has been addressed in the North 
American Plant Protection Organization (NAPPO) Regional Standards for 
Phytosanitary Measures (RSPM) 26 and that the approved RSPM has been 
waiting for the current proposed rule for appropriate action.
    APHIS acknowledges that the proposed regulations do not include 
provisions for certifying the export of regulated biological control 
organisms. The IPPC has, however, published a set of guidelines \21\ 
that addresses the export of biological control organisms, and the 
NAPPO standard \22\ addresses foreign export certification requirements 
for biological control organisms being moved from the United States to 
Canada or Mexico. As a signatory and participating member of these 
organizations, APHIS observes internationally agreed upon standards for 
the export of biological control organisms and products.
---------------------------------------------------------------------------

    \21\ ISPM 3, ``Guidelines for the export, shipment, import and 
release of biological control agents and other beneficial 
organisms,'' published 2016.
    \22\ RSPM-26 ``Certification of commercial arthropod biological 
control agents moving into NAPPO member countries,'' published 2015.
---------------------------------------------------------------------------

    Another commenter stated that a generic permit or other indication 
of status is needed for organisms listed as being excepted from permit 
requirements and recommended that we explain how the list relates to 
the biological control species approved in RSPM 26 Appendix II.\23\
---------------------------------------------------------------------------

    \23\ See footnote 22.
---------------------------------------------------------------------------

    The proposed list of biocontrol organisms to be excepted from PPQ 
permit requirements includes all the species on the list of biological 
control organisms approved in RSPM 26, Appendix II.
    One commenter stated that RSPM 12, ``Guidelines for Petition for 
First Release of Non-indigenous Entomophagous Biological Control 
Agents,'' \24\ should be added to the rule with respect to the 
petitioning process for excepted organisms. The commenter added that 
the RSPM already outlines many of the proposed requirements.
---------------------------------------------------------------------------

    \24\ https://www.nappo.org/files/1814/4065/2949/RSPM12_30-07-2015-e.pdf.
---------------------------------------------------------------------------

    We considered RSPM 12 guidelines when developing the proposed rule. 
However, RSPM 12 is a tri-national agreement, is intended only as a 
guideline, and is periodically revised. For these reasons, it would not 
be practical or necessary to add RSPM 12 guidelines to the regulations.
    One commenter proposed that a tiered, science-based approach be 
adopted to determine permit requirements for microorganisms isolated 
within the continental United States. The commenter suggested using the 
following three categories: ``No permit required,'' if the microbe is 
identified by its complete genome sequence and contains no proven plant 
pathogenic sequences; ``fast track,'' if the microbe is a member of a 
taxon not known to be a crop pathogen; and ``all other 
microorganisms.'' The commenter added that guidelines to the identity 
of these sequences should be developed by

[[Page 29949]]

the biopesticide industry and the research community.
    We are making no changes in response to the commenter's proposal. 
Our approach to determining the permit status and requirements for 
microorganisms is done on a case-by-case basis. Our requirements for a 
``no permit required'' determination include origin and distribution 
information and intended use that we evaluate for each application. Due 
to the evolving science, we do not identify specific microbial 
identification techniques but we do use the best and most appropriate 
methodology available to identify organisms.
    A commenter stated that plant growth and plant health enhancing 
consortia and biostimulants should be treated the same as biological 
products making pesticidal claims, since the potential safety hazards 
are the same for all these groups of novel microorganisms.
    Under the PPA, APHIS has no authority to regulate products on the 
basis of their plant health or growth enhancing attributes, but only on 
the basis of pest risk potential.
    One commenter suggested that a specific organism used to 
manufacture an EPA-registered biopesticide should not require a plant 
pest permit to move interstate as a pure culture or as part of a 
formulation. The commenter added that if a beneficial organism can be 
applied to crops as a registered biopesticide, a small-scale release 
from an experimental formulation in a field trial should not pose a 
risk to U.S. agriculture.
    Typically, APHIS does not require a permit for the interstate 
movement of a product that is regulated by EPA. However, other isolates 
or non-registered uses may require a permit.
    Two commenters addressed the topic of States regulating the 
movement of plant pests and biological control organisms. One commenter 
opposed allowing States to establish regulations for interstate 
movement of organisms that are more restrictive than those established 
by the Federal Government, while another stated that States have the 
option of independently establishing more restrictive regulations.
    Under the PPA, a State may not regulate the movement in interstate 
commerce of any biological control organism, plant pest, or noxious 
weed if the Secretary has issued a regulation or order to prevent its 
dissemination within the United States. There are two exceptions listed 
in the Act: A State may impose movement restrictions as long as they 
are consistent with and do not exceed the regulations or orders issued 
by the Secretary, and a State may impose movement restrictions that are 
in addition to Federal restrictions as long as the State demonstrates a 
clear need to do so based on science and pest risk. As we noted in the 
proposed rule, States and localities may have laws and regulations that 
restrict the movement or release of plant pests, biological control 
organisms, and associated articles for various reasons (for example, 
impact on the environment of the State or locality), and we encourage 
applicants to consult with these authorities when applying for a 
permit.
    One commenter stated that if the proposed regulations supersede 
permits that were specifically issued for national defense projects, 
means of conveyance, and organisms that are not subject to APHIS 
regulation (i.e., courtesy permits), then this information needs to be 
conveyed to regulatory personnel so that packages containing organisms 
can be transported without inspection delays during the period of 
transition to the new regulations.
    The proposed regulations do not supersede or nullify the status of 
current, valid permits.
    A few commenters questioned whether notice of the petition and 
public comment are necessary for excepting certain organisms from 
permit requirements, with one commenter adding that APHIS could simply 
respond to the petition by conducting the risk assessment and notifying 
the petitioner of the decision, and that organisms either added or 
removed from the list could be noted on the website.
    APHIS embraces a transparent process and is committed to public 
involvement during the petition process.
    In Sec.  330.202, paragraph (c)(1) states that petitioners 
proposing additions to the lists of organisms excepted from permitting 
requirements must provide evidence indicating that the organism is 
indigenous to the continental United States.
    A commenter requested that APHIS provide guidance and examples that 
would demonstrate that an organism is indigenous.
    Guidance and examples for permit applicants are posted on the APHIS 
Regulated Organism and Soil Permits website.\25\ Applicants may also 
contact APHIS using the information in footnote 4.
---------------------------------------------------------------------------

    \25\ https://www.aphis.usda.gov/planthealth/organism-soil-permits.
---------------------------------------------------------------------------

    A commenter asked if the development of a new biocontrol product 
involving previously unreleased organisms requires completion of a PPQ 
526 Form (Application for Permit to Move Live Plant Pests or Noxious 
Weeds) and an assessment of potential environmental effects.
    Any new biological control organism or product that has not been 
released into the environment requires completion of a PPQ 526 permit 
application form and an environmental assessment.

Soil (Sec.  330.203)

    As we noted in the proposed rule, we are integrating the soil 
regulations into the revised ``Subpart B--Plant Pests, Biological 
Control Organisms, Soil, and Associated Articles.'' We moved the 
regulation of soil into the revised subpart B in order to highlight the 
fact that soil, as an associated article, may harbor plant pests and 
noxious weeds that can be spread within the United States through 
importation or interstate movement. In proposed Sec.  330.203(a), we 
established that, as an associated article, the importation or 
interstate movement of soil is subject to the permitting requirements 
in Sec.  330.201 unless otherwise indicated in the regulations.

Soil and Associated Articles From Canada

    We proposed to amend the regulations in Sec.  330.203(b)(1) so that 
soil from any area of Canada regulated by the Canadian Food Inspection 
Agency (CFIA, the national plant protection organization of Canada) for 
a soil-borne plant pest would require a permit. We noted that this 
change is in response to recent detections of soil-borne plant pests of 
quarantine significance in new areas of Canada. Previously, permits 
were required for soil imports from a few small areas of Canada. These 
areas, and areas with new detections of soil-borne plant pests, are now 
regulated by the CFIA, and the risk of inadvertently introducing plant 
pests into the United States is higher in soil imported from these 
areas.
    Two commenters disagreed with this proposed change. One of these 
commenters asked us to identify the specific quarantined areas in 
Canada from which importation of soil into the United States is not 
allowed and requested that we define what information is required with 
shipments of soil from Canada. The commenter stated that doing so would 
provide a consistent process for applicants to demonstrate to 
inspection officials at ports of entry that the soil is not from an 
area regulated by the CFIA for soil-borne plant pests. Similarly, 
another commenter asked us to indicate the procedure for proving to 
U.S. inspectors that imported soil is not from a quarantined area in 
Canada. The

[[Page 29950]]

commenter stated that there is nothing specified in the proposal on how 
to prove the soil from Canada is not from a quarantined area.
    Persons wishing to import soil into the United States from any area 
of Canada not regulated by the CFIA for soil-borne plant pests are 
responsible for verifying to inspectors that the soil is from such a 
non-regulated area. CBP inspectors at U.S. ports of entry typically 
require documentation provided by the CFIA to verify soil origin. 
Inspectors can corroborate this documentation with other shipment 
documentation, such as a bill of lading, to verify the origin of each 
shipment. One option for persons for whom providing such documentation 
is not practicable is to apply for a permit to move such soil. APHIS 
will evaluate the request and, if no permit is necessary, issue a 
Letter of No Permit Required on the basis that the soil originates from 
an area not regulated by CFIA for a soil-borne plant pest.
    In paragraphs (b)(2) through (4) of Sec.  330.203, we proposed 
additional conditions for the importation of soil into the United 
States.
    A commenter asked if each of the purposes listed in those 
paragraphs requires an import permit along with the other conditions 
described.
    An import permit with specific conditions is required for 
importation of soil via hand-carry, importation of soil intended for 
the extraction of plant pests, and importation of soil contaminated 
with plant pests and intended for disposal.
    Section 330.203(b)(3) provides additional conditions for the 
importation of soil intended for the extraction of plant pests. To 
mitigate the risk of introducing plant pests through the movement of 
such soil, we will require the soil to be imported directly to an 
approved biocontainment facility.
    One commenter agreed with the conditions proposed in Sec.  
330.203(b)(3) but wanted to know if the biocontainment facility will be 
at the permittee's destination or at a central inspection center prior 
to transport to the permittee's final destination. The commenter asked 
that we specify in the regulations that the facility must be an APHIS-
approved biocontainment facility.
    We would require such soil to be imported directly to the 
permittee's APHIS-approved biocontainment facility. Maintaining a 
biocontainment facility and having APHIS approve it for the extraction 
of plant pests are prerequisites for this type of permit.
    In Sec.  330.203(b)(5), we proposed to establish import permit 
exemptions for a list of articles, including rocks, silt, clay, and 
other quarry products, that are not soil. If the article being imported 
is free of organic material, it will not require an import permit 
unless the Administrator has issued an order stating that a particular 
article is an associated article.
    A commenter asked us to clarify how Sec.  330.203(b)(5) would apply 
to the following materials: Products of non-soil stone or quarry 
products combined with plant nutritive or soil conditioning materials 
such as composts and manures; bone meal, feather meal, or blood meal; 
fish, shellfish, or kelp materials; peat, coconut coir, humates, spores 
or live mycorrhizae, as often used with potting mixes; animal and 
insect repellent compounds like biological oils or neem oils, or 
geranium extracts; animal derived or extract materials such as insect 
pheromones; synthetic chemicals such as pesticides or fertilizers, and 
recovered nutrients from sewage. The commenter added that many 
beneficial plant growth products that include these materials are being 
developed and marketed, and that preventing their interstate movement 
could significantly inhibit the benefits they provide to agriculture.
    To the extent that any of the articles listed by the commenter 
contain organic material and are thus associated articles having the 
potential to contain pests or plants and plant parts that pose a risk 
to American agriculture and the environment, a permit would be required 
to import such products or to move them interstate. Permit applicants 
with questions about specific articles can contact APHIS using the 
information in footnote 4.
    The commenter also asked about interstate movement of plant growth 
enhancers in relation to the permit exemptions in Sec.  330.203(b)(5), 
which addresses the import of certain articles but makes no reference 
to interstate movement.
    APHIS considers permit requests for importation or interstate 
movement of the materials listed on a case-by-case basis. To facilitate 
our evaluation and permit decision process, we typically ask 
prospective permittees wishing to import or move plant growth enhancers 
to answer questions located on the APHIS plant growth enhancer 
website.\26\ We note that some animal material, including bone, blood, 
and feathers, are regulated under the jurisdiction of APHIS Veterinary 
Services or other Federal agencies.
---------------------------------------------------------------------------

    \26\ https://www.aphis.usda.gov/planthealth/organism-soil-permits.
---------------------------------------------------------------------------

    The same commenter asked whether zeolite minerals, lignitic and 
humate minerals, various cation-exchange capacity-enhancing clay 
minerals, phosphate rock, limestone, dolomite, and green sands would be 
exempt and considered non-soils under this proposed rule.
    Articles eligible for exemption in proposed Sec.  330.203(b)(5) 
must be free of all organic materials and considered to be non-soil. 
The examples of exempted materials listed in paragraphs (b)(5)(i) 
through (iv) are not intended to be exhaustive. If the materials cited 
by the commenter are free of organic material and thus considered to be 
non-soil, such material will be exempted from permitting requirements.
    The commenter also asked if sterilization, heat treating, or other 
methods of killing possible pathogens or organisms applied to the 
products cited would allow for them to be exempt from regulation for 
interstate movement.
    If we determine that any of the materials indicated contain soil, 
then restrictions for the interstate movement of soil will apply. Even 
if the customer claims that sterilization, heat treatment, or other 
methods of killing possible pathogens or organisms has been performed 
on the material and its intended use is for release into the 
environment, APHIS must first evaluate the material to determine a 
regulatory action.
    Finally, the commenter asked whether meeting the USDA organic 
standards for composts, minimum heating times, and temperature regimes 
allow for interstate movement without special permitting or regulation 
under the proposed regulations.
    The National Organic Program is administered by the USDA 
Agricultural Marketing Service and develops national standards for 
organically produced agricultural products. Those standards do not 
address plant pest risks.
    As we noted above, we proposed placing revised regulations for the 
importation and interstate movement of soil under new ``Subpart B--
Movement of Plant Pests, Biological Control Organisms, and Associated 
Articles,'' and removing and reserving current ``Subpart C--Movement of 
Soil, Stone, and Quarry Products.'' As part of this change, we removed 
current Sec.  330.301, which contains restrictions for the movement of 
stone and quarry products from areas in Canada infested with gypsy 
moth. We explained in the proposed rule that we would retain these 
conditions but move them to 7 CFR 319.77-4 of ``Subpart R--Gypsy Moth 
Host Material from Canada,'' as

[[Page 29951]]

we consider that subpart to be a more appropriate location for 
regulating gypsy moth.
    One commenter stated that open gravel pits and other disturbed 
areas can harbor noxious weeds due to ground disturbances. The 
commenter expressed concern that importation of stone and quarry 
products from Canada without proper decontamination for noxious weeds 
may increase the genetic diversity of the weed population in the United 
States.
    Under the soil regulations in Sec.  330.203(b)(5), we proposed to 
exempt from regulation the importation and interstate movement of 
stones, rocks, and other quarry products that are free of organic 
material. If a shipment of gravel or other stone is found to contain 
organic material, it will be considered to be an associated article and 
be subject to the regulations under Sec.  330.203.
    Another commenter asked us to revise proposed Sec.  
330.203(b)(5)(ii), which includes a permit exemption for sediment, mud, 
rock, and similar articles from saltwater bodies of water, to include 
an exemption for similar articles taken from freshwater bodies of 
water.
    We already consider peat, cosmetic mud, and other mud products from 
freshwater estuaries or the earth's upper surface, if processed to a 
uniform consistency and free of plant parts and seeds, to be exempt 
from our regulations. Rocks and other non-soil articles are already 
exempt under Sec.  330.203(b)(5). However, plant pests can thrive in 
freshwater bodies of water and therefore articles containing organic 
material from freshwater bodies of water must be evaluated by APHIS to 
determine their regulatory status.
    In proposed Sec.  330.203(c), we established regulations governing 
the interstate movement of soil, which includes general conditions for 
moving soil interstate within the United States and conditions for 
moving soil interstate for specific purposes. Except for soil moved in 
accordance with Sec.  330.203(c)(2) through (5), soil may be moved 
interstate within the United States without a permit or a compliance 
agreement. We require, however, that all soil moved interstate is 
subject to any restrictions and remedial measures specified for such 
movement in our domestic quarantine regulations referenced in 7 CFR 
part 301.
    We proposed in Sec.  330.203(c)(2) that soil may be moved in 
interstate commerce within the continental United States with the 
intent of extracting plant pests only if an interstate movement permit 
has been issued in accordance with Sec.  330.201 and the soil will be 
moved directly to a biocontainment facility approved by APHIS.
    A commenter asked if proposed Sec.  330.203(c)(2) would provide 
additional conditions for the importation of soil intended for the 
extraction of plant pests. To mitigate the risk that such soil could 
present a pathway for the introduction or dissemination of plant pests 
within the United States, the commenter stated that APHIS would need to 
require all such soil to be imported directly to an approved 
biocontainment facility.
    As indicated in Sec.  330.203(b)(3), importation of soil into the 
United States intended for the extraction of plant pests requires a 
permit and the soil must be moved directly to a biocontainment facility 
approved by APHIS. The shipment is subject to all conditions for 
movement specified on the permit, including safeguarding requirements.
    Proposed Sec.  330.203(c)(4) allows for the movement of soil 
samples from an area quarantined in accordance with part 301 without 
prior issuance of an interstate movement permit, provided that the soil 
is moved to a laboratory that has entered into and is operating under a 
compliance agreement with APHIS and is approved by APHIS to conduct 
chemical/physical tests and analyses of such samples.
    One commenter asked if no permit is required for movement of soil 
under Sec.  330.203(c)(4) will there be another document required to 
accompany the soil. The commenter also wanted to know if a permit 
application needs to be submitted for such movement.
    Proposed Sec.  330.203(c)(4) requires that the laboratory to which 
the sample is destined to be moved enter into a compliance agreement 
with APHIS. The movement can be made without prior issuance of an 
interstate movement permit.
    One commenter stated that the regulations for interstate movement 
of restricted soil between approved laboratories should be expanded to 
include foreign soil samples that are otherwise subject to the same 
handling and disposal requirements. The commenter noted that currently 
it is necessary to get USDA approval on a case-by-case basis to move 
foreign samples between laboratories.
    Imports of soil, unless otherwise exempted in the regulations, must 
be accompanied by an import permit and sent directly to an APHIS-
approved biocontainment facility. If we authorize additional movements 
of imported soil, the movements must also be to an APHIS-approved 
biocontainment facility with the same safeguarding and containment 
capacity as the original facility and must be moved under a permit as 
well. As we consider imported soil to present a higher risk to U.S. 
agriculture and the environment, we consider it necessary to track and 
approve all foreign soil movements and disposition on a case-by-case 
basis as part of our standard permit conditions.

Exceptions To Permitting Requirements for the Importation or Interstate 
Movement of Certain Plant Pests (Sec.  330.204)

    In accordance with the PPA, we proposed in Sec.  330.204 to 
establish regulations allowing the importation and movement in 
interstate commerce of plant pests without further restriction if we 
determine that no permit is required. Specifically, we proposed a 
notice-based petition process by which the public could petition to 
have pests either added to or removed from the list of plant pests 
excepted from permitting requirements for importation or interstate 
movement. As part of this informal adjudication process, we will 
evaluate the petition to determine whether the plant pest is of a 
sufficiently low risk. If, after review of the petition, we determine 
that the plant pest belongs to one of the categories in Sec.  
330.204(a) that make it eligible for listing, we will publish a notice 
in the Federal Register announcing the availability of the petition and 
our intention to add it to the list of plant pests that may be imported 
into or moved interstate within the continental United States without 
restriction. We will also solicit public comment on the notice and 
petition. If after we consider the comments we determine that our 
conclusions regarding the petition have not been affected, we will 
publish in the Federal Register a subsequent notice stating that the 
plant pest has been listed and excepted from permitting requirements. 
This subsequent notice constitutes final agency action, which is 
subject to being challenged in court under the Administrative Procedure 
Act.
    Several commenters expressed concern that importation of plant 
pests excepted from permitting could result in new diseases and damage 
to beneficial plants and plant products within the United States, 
particularly plant pests imported from new sources and locations.
    These comments raise concerns similar to those we received for 
Sec.  330.202(b), in which we proposed allowing the exception from 
permitting for the importation and interstate movement of certain 
biological control

[[Page 29952]]

organisms. We acknowledge that the importation of plant pests from new 
sources and locations could carry a risk for introducing new, 
unapproved plant pest species or parasites and diseases of those 
species. An imported plant pest poses a potentially higher risk level 
than the same domestic species of that pest moved interstate because 
the former may be carrying unknown diseases or microbial pathogens from 
the foreign source. Therefore, we will continue at present to require 
permits for the importation of plant pests. However, we will retain the 
petition process for excepting plant pests from permit requirements in 
Sec.  330.204. If APHIS receives a petition for allowing the 
importation of low risk plant pests without a permit, we will review 
it. Based on our review, we will either deny the petition or submit it 
for public comment. Plant pests that APHIS lists as being able to be 
moved interstate without a permit will not be eligible to be imported 
without a permit unless APHIS expressly indicates otherwise.

Categories of Plant Pests Eligible for Exception From Permit 
Requirements

    In Sec.  330.204(a), we proposed three categories of plant pests 
that would be eligible for exception from permitting requirements: 
Pests from field populations or lab cultures derived from field 
populations of a taxon established throughout its entire geographical 
or ecological range within the continental United States; pests that 
are sufficiently attenuated so that they no longer pose a risk to 
plants or plant products; and pests that are commercially available and 
raised under the regulatory purview of other Federal agencies.
    We are making a change to Sec.  330.204 with respect to excepting 
from permit requirements certain plant pests imported or moved 
interstate. In Sec.  330.204(a)(2), we proposed excepting from permit 
requirements the category of plant pests that are sufficiently 
attenuated so that they no longer pose a risk to plants or plant 
products. We noted in the proposed rule that when a pest becomes 
attenuated, it loses its defining pest or biocontrol properties. For 
this reason, there is no longer a sufficient basis to presume that the 
pest presents a risk of injuring, damaging, or causing disease in 
plants or plant products; in other words, an attenuated pest de facto 
no longer falls within the scope of the definition of plant pest under 
the PPA. Accordingly, we will remove this category from the proposed 
regulations. In the case of an attenuated pest, we will issue a LONJ to 
a petitioner rather than a Letter of No Permit Required as the organism 
is no longer considered to be a plant pest and therefore is not under 
APHIS' jurisdiction.
    A commenter stated that APHIS' guidance about permitting is 
inconsistent with how we administer the permitting process. The 
commenter noted that the APHIS website says a permit is typically not 
required for the interstate movement or release into the environment of 
domestically isolated microorganisms that are not plant pests and are 
widely prevalent in the continental United States. The commenter noted 
that, despite what the guidance says, APHIS currently requires permits 
for microorganisms that are not plant pests that are found and 
collected throughout the continental United States.
    To address this inconsistency, the commenter requested that we 
define several terms, including ``common,'' ``prevalent,'' and 
``widespread,'' so that persons can determine whether they need a 
permit for activities involving plant pests and biological control 
organisms.
    We are making no changes in response to the commenter's request as 
we do not believe that defining these terms is necessary to determining 
whether a permit is needed for interstate movement or release of a 
given organism. Persons with questions about whether an activity 
requires a permit under the regulations are encouraged to contact 
APHIS.\27\
---------------------------------------------------------------------------

    \27\ See footnote 4 for contact information.
---------------------------------------------------------------------------

    A commenter representing the State of California noted that the 
State is opposed to and does not participate in the Widely Prevalent 
List program. The commenter noted that California is a large State with 
many microclimates that could support new invasive pests, that 
potential pathways for invasive species are numerous, and that the 
introduction of unwanted parasites and pathogens that can accompany 
such species would increase with a web-based permit system.
    APHIS carefully evaluates the pest risk potential of organisms 
before considering them to be widely prevalent and will not allow any 
organisms posing a pest risk to be candidates for an exception to the 
permit requirements.
    The same commenter stated his opposition to having the Federal 
Register be the only forum for contributing input regarding the list of 
plant pests excepted from permit requirements.
    In addition to accepting public comments on notices, petitions, and 
proposed rules published in the Federal Register, we typically conduct 
stakeholder outreach and invite stakeholders to contact APHIS if they 
have questions or concerns.
    A commenter asked whether the application process would exclude 
those species already on the approved species list for no permit.
    The commenter is correct. Species on the list have been determined 
by APHIS to not require a permit.
    A commenter recommended that APHIS clarify that the exempted 
activities include release into the environment because the definition 
of move includes that action.
    We agree with the commenter. Movement without restriction implies 
all uses, including release.
    A commenter asked whether documentation supporting a petition to 
add or remove organisms from the list of those excepted from permitting 
requirements will also be made available for comment when the petition 
is published in the Federal Register.
    When APHIS issues a notice of petition in the Federal Register, we 
will also make available for comment any documentation available that 
supports the petition.
    A commenter asked whether the omission of ``environmental release'' 
from the heading of Sec.  330.204(a) is intentional or accidental.
    We did not consider it necessary to include the term 
``environmental release'' in the heading ``Exceptions to permitting 
requirements for the importation or interstate movement of certain 
plant pests'' because the definition of move (moved and movement) we 
proposed in Sec.  330.100 specifically includes releases into the 
environment.
    The commenter also asked if the term ``without restriction'' in 
Sec.  330.204(a) means that no permit of any kind is needed, and 
whether States are notified in such cases.
    States will be notified of APHIS' decision to not require permits 
for the importation or interstate movement of a given plant pest or 
organism. States, however, have the authority to require permits for 
the movement of these organisms into their boundaries. For example, 
while no Federal permit is required for the interstate movement of the 
Madagascar hissing cockroach, the State of Florida requires a permit to 
move the cockroaches to Florida from another State.
    One commenter noted that APHIS maintains a list of plant pests in 
Sec.  340.2 and stated that, because the authority for APHIS-PPQ and 
APHIS-Biotechnology Regulatory Services (BRS) to regulate plant pests 
comes from the PPA, PPQ and BRS should work

[[Page 29953]]

together to ensure that the list in Sec.  340.2 and the proposed list 
referenced in Sec.  330.204 are consistent.
    The list cited by the commenter in Sec.  340.2(a) lists groups of 
organisms which are or contain plant pests for the purpose of 
determining what genetically produced or altered plant pests and 
products are regulated under the regulations in part 340. The list 
proposed for Sec.  330.204 will include plant pests that may be moved 
interstate without a permit under the plant pest regulations in part 
330. APHIS-PPQ and APHIS-BRS collaborate regularly to ensure that there 
are no inconsistencies between their respective lists.
    Referring to native and naturalized plant pests, a commenter asked 
APHIS to clarify the meaning of ``permitted by regulation.''
    The commenter is referring to the proposed list we made available 
for review, titled ``USDA-APHIS-PPQ Native and Naturalized Plant Pests 
Permitted by Regulation (Individual Permits Not Required) For Their 
Interstate Movement within the United States.'' \28\ This refers to the 
organisms proposed to be excepted from permit requirements under these 
regulations.
---------------------------------------------------------------------------

    \28\ See footnote 2 for the location of the draft list.
---------------------------------------------------------------------------

    One commenter wanted to know the source of the proposed list we 
provided for review and what its intended use would be.
    Draft lists were developed by APHIS and reviewed by the National 
Plant Board as well as by professional societies and Tribes. Many of 
the individual species are of a lower risk and commonly requested in 
applications processed by APHIS.
    The same commenter, citing the categories in paragraphs (a)(2) and 
(3) of Sec.  330.200, asked which of these categories applies to the 
list of native and naturalized plant pests permitted by regulation.
    Section 330.200(a)(3) refers to organisms under APHIS jurisdiction 
explicitly granted an exception from permitting requirements in this 
subpart. The term ``permit by regulation'' used by the commenter was 
not used in the proposed rule. However, we have used the term in the 
past in some APHIS documents and communications regarding these 
proposed regulations to denote the organisms that would be excepted 
from permitting requirements.
    A commenter stated that APHIS should exempt dried herbarium 
specimens from permitting because they are dried by heating and then 
frozen. The commenter stated that no disease, pest, or invasive species 
has escaped from a herbarium specimen.
    This rulemaking only covers articles that fall under the plant pest 
regulations, which includes herbarium specimens of parasitic plants not 
classified as Federal noxious weeds and specimens collected as plant 
disease samples. APHIS currently requires pest permits for the movement 
of these plants because of the potential for the presence of viable 
seeds in the case of parasitic plants, or of persistent resting stages 
(e.g., sclerotia, chlamydospores) in the case of plant pathogens. As 
there is some risk associated with the importation and interstate 
movement of dried herbarium specimens, we acknowledge that the risk to 
U.S. agriculture and the environment from these specimens is low as 
long as risk protocols are observed.
    A commenter noted that that tobacco mosaic virus (TMV) is on the 
proposed list of plant pests excepted from permitting requirements and 
suggested that tomato mosaic virus (ToMV) be added as well. The 
commenter stated that while differentiated by serological reaction and 
the amino acid sequences of the coat protein, these two Tobamoviruses 
are nearly identical in their control by the tomato and pepper 
resistance genes, mechanical and seed transmission, and host range.
    We disagree with the commenter. Although we acknowledge that TMV 
and ToMV are similar in morphology and serologically closely related, 
the sequence information of the genome is distinct enough to 
differentiate these viruses at a molecular level as different viral 
species according to the International Committee of Taxonomy of 
Viruses.\29\
---------------------------------------------------------------------------

    \29\ See https://talk.ictvonline.org/ictv-reports/ictv_online_report/positive-sense-rna-viruses/w/virgaviridae/672/genus-tobamovirus.
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    Another commenter stated that the list of plant pests excepted from 
permitting requirements should contain all plant pests that are widely 
prevalent and thus present little additional plant pest risk due to 
movement.
    Under the amended regulations, persons will be able to petition 
APHIS to add such plant pests to the list of plant pests excepted from 
permitting requirements.
    The commenter also recommended that Pantoea stewartii (Stewart's 
wilt) be removed from the list of plant pests excepted from permitting 
requirements for interstate movement, as it has not been observed in 
the field for 8 years and testing for this pest costs the seed industry 
millions of dollars to allow import of seed to other countries.
    We agree with the commenter and will remove this species from the 
list.
    We are also changing the name Agrobacterium tumefaciens (crown 
gall) to Rhizobium radiobacter on the list of plant pests excepted from 
permitting requirements for interstate movement. We did this in order 
to update the name of the organism.
    Finally, during Tribal consultation, a Tribe raised concerns about 
specific biological control organisms included on the draft list of 
organisms excepted from permitting requirements for interstate 
movement. Their concern was that the control organisms, which target 
species of St. John's wort, could be released without a permit on 
Tribal lands. As a result, we decided to continue to require permits 
for biological control organisms that target these species.

Invertebrate Plant Pests

    We received several comments requesting that certain animals be 
excepted from the permit requirements as plant pests.
Arthropods
    Several commenters requested exceptions from permitting 
requirements for the importation and interstate movement of insects 
that cannot establish themselves in parts of the continental United 
States due to seasonal climate differences.
    One commenter requested that we except certain ants from regulation 
as they are already established throughout the United States. The 
commenter added that several ant species cannot survive outside of 
heated buildings and are only found living with humans. Similarly, 
another commenter asked that we allow tropical species to move into the 
continental United States for use as pets because they cannot become 
established due to the cold seasonal climate in most of the country and 
are not threats to agriculture as many do not eat living plants. A few 
commenters asked that we relax restrictions on species that have been 
wiped out of an area or tropical species that cannot survive in our 
climate and that therefore pose no biological threat. Another commenter 
stated that foreign rhinoceros and stag beetles should be allowed to be 
imported without a permit because they cannot survive severe winters, 
acknowledging that warm States such as Florida should require continued 
monitoring. Another commenter asked that APHIS review, if not 
eliminate, restrictions upon certain beetle species that are common in 
zoos and the pet trade. As examples, the commenter cited Dynastes, 
Megasoma, and Goliathus species.

[[Page 29954]]

    We do not intend to relax restrictions on the importation and 
interstate movement of arthropods with respect to seasonal climate 
differences. The biological threat of arthropod plant pests can be 
unseen, as unknown diseases and parasitoids may be transported 
significant distances through the movement and distribution of live 
specimens. We can, however, consider permit exceptions for arthropod 
stock that has been isolated and evaluated for disease and parasites. 
We note that this rulemaking establishes a petition process for persons 
wishing to add organisms to the list of plant pests that are excepted 
from permit requirements.
    A commenter stated that the U.S. cricket pet food industry has been 
devastated by epizootic Acheta domesticus densovirus outbreaks, and 
that efforts to find an alternative, virus-resistant field cricket 
species have led to the widespread U.S. distribution of a previously 
unnamed Gryllus species despite Federal regulations to prevent such 
movement. The commenter expressed concern that this taxon is likely to 
become widely distributed throughout the United States and become an 
established agricultural pest, and claimed that the USDA has taken no 
action to prevent the movement and sales of Gryllus. The commenter 
asked that all cultures of G. assimilis and G. locorojo be eliminated 
from retail outlets in the United States.
    We are evaluating our policies for the regulation of crickets and 
other arthropods used both as feeder insects and fish bait. We intend 
to address issues relating to the species noted by the commenter 
through policy statements and the permitting process rather than 
through rulemaking.
    A commenter requested that APHIS use its authority under the PPA to 
regulate the interstate movement of bumble bee adults, nests, and used 
nest materials. The commenter also asked APHIS to promulgate rules 
prohibiting movement of bumble bee adults, nests, and used nest 
materials outside of their native ranges and to allow such articles to 
be moved within their ranges only if the permit applicant shows that 
all such articles are certified to be free of disease.
    APHIS has initiated a scientific review and is collecting data 
regarding the interstate movement of certain species of bumble bee 
adults, nests, and related articles outside of their native ranges. If 
we develop such regulations on the movement of bumble bees and related 
materials, we will promulgate those regulations in 7 CFR part 322, 
``Bees, Beekeeping Byproducts, and Beekeeping Equipment.''
    A commenter stated that the permit process is onerous for acquiring 
zebra swallowtail butterflies and other native species that do not harm 
crops, and suggested that there are many species that are regulated for 
no good reason.
    Zebra swallowtail butterflies are regulated for several reasons. 
The caterpillars feed on plants (in the genus Asimina) which makes them 
plant pests, placing them under the authority of the PPA. Butterflies 
are also important pollinators. Distributing zebra swallowtail 
butterflies significant distances could result in the dissemination of 
diseases or parasitoids to other lepidopteran species
    A commenter stated that it should not be so difficult to obtain a 
permit to import dead insects because they cause no harm to the 
environment. The commenter added that just because Ornithoptera 
alexandrae is in need of protection does not mean that all members of 
the genus Ornithoptera, including dead specimens, should require 
permits for importation.
    APHIS does not require import permits for dead insects unless they 
carry live plant pests or diseases in or on them. As indicated in part 
322, we do have separate requirements for the importation of dead bees 
in the superfamily Apoidea. Dead insects and those overseen by the 
Convention on International Trade in Endangered Species, in particular, 
are regulated by the USFWS.
    Two commenters stated that some species of particular importance to 
the research community should be included on the proposed list of plant 
pests excepted from permitting requirements that we provided for 
review. The species cited by the commenters are: Corn earworm, 
Helicoverpa zea; tobacco budworm, Heliothis virescens; European corn 
borer, Ostrinia nubilalis, and codling moth, Cydia pomonella. Two 
commenters supported the inclusion of Helicoverpa zea, Heliothis 
virescens, Ostrinia nubilalis, and Cydia pomonella to the proposed list 
of insect species excepted from permit requirements.
    APHIS will consider adding these species to the proposed list of 
organisms for which no permit is required if we receive the supporting 
information required as part of the petition process. Many more insect 
species were initially considered for the list and have been removed at 
the request of the National Association of State Departments of 
Agriculture and other groups.
Snails
    We also received a number of comments requesting that we exempt 
certain snails from regulation as plant pests.
    One commenter stated that the Federal government overregulates the 
snail industry. The commenter acknowledged that certain States may need 
to regulate and monitor movement of Helix aspersa movement but 
disagreed that Federal regulation of the species is necessary. The 
commenter noted that the need to regulate H. aspersa in Minnesota or 
New York is not as great as it is in Florida, which has already banned 
the species.
    We are making no changes in response to the commenter. The brown 
garden snail, Cornu aspersum (formerly H. aspersa, Cantareus aspersus, 
and Cryptomphalus aspersus) is a serious plant pest causing significant 
damage in areas where it has escaped cultivation. It feeds on a wide 
range of plant hosts and can be readily transported in contaminated 
nursery stock. More than 13 States have imposed quarantines against the 
brown garden snail and several States have spent considerable time and 
resources to eradicate infestations. We consider it necessary to 
continue regulating this snail species to prevent new introductions and 
limit its further spread.
    Another commenter stated that certain snail species should be 
allowed to be transported, raised, and processed for food because they 
are not a threat to people or the environment. The commenter asked 
APHIS to create rules allowing easier transport of captive gastropods 
for pets and to remove the ban on giant African land snails, while 
another commenter asked that non-plant pest snail species 
(detritophages and epiphytic growth feeders) be exempted from 
regulation.
    Snail species that are not plant pests are not regulated by APHIS 
under the regulations in part 330. We will consider adding species to 
our list of plant pests excepted from permitting if we receive the 
supporting information required as part of the petition process. 
However, APHIS will continue to regulate species of snails that are 
plant pests and cause significant damage in areas where they have 
escaped cultivation.

Hand-Carry of Plant Pests, Biological Control Organisms, and Soil 
(Sec.  330.205)

    In proposed Sec.  330.205, we included provisions that allow for 
plant pests, biological control organisms, and soil to be hand-carried 
into the United States under permit.
    A few commenters specifically voiced support for the continued 
issuance of permits for hand-carrying plant pests, organisms, and soil 
into the United

[[Page 29955]]

States. One commenter disagreed with the 2003 Office of the Inspector 
General audit referenced in the proposed rule recommending that hand-
carry of samples be prohibited and noted that APHIS currently 
authorizes the importation of plant pests in personal baggage under 
Sec.  330.212 of the regulations. The commenter agreed with APHIS that 
individual hand-carry is important from a safeguarding perspective, as 
this option allows a responsible individual to exercise direct and 
continuous oversight of an article's importation.
    APHIS recognizes the importance of hand-carry and will continue to 
authorize hand-carry events.
    In Sec.  330.205(b), we proposed that hand-carry permittees be 
required to provide APHIS with a copy of the first page of the passport 
and other identifying information. In paragraph (c) of Sec.  330.205, 
we requested that permittees notify APHIS about the dates and itinerary 
of the permitted movement.
    A commenter noted that APHIS makes no mention as to whether the 
passport page copy is attached to their permit file, or how long APHIS 
keeps this passport information. The commenter recommended that there 
be more specific language to address how securely personal information 
from permit applications will be stored and disseminated.
    We have reevaluated the application requirements we proposed for 
hand-carry permits and determined that making them available on the 
APHIS website would allow more flexibility to adjust the requirements 
as conditions warrant. As a result, we are revising Sec.  330.205(b) to 
state that after the permittee has obtained an import permit but no 
less than 20 days prior to movement, the permittee must provide APHIS, 
through its online portal for permit applications or by fax, with the 
names of the designated hand carrier, or carriers, assigned to that 
movement. We will also note in paragraph (b) that additional conditions 
for hand-carry are available on the APHIS website. Other conditions for 
hand-carry that were contained in proposed paragraph (c) will also be 
moved to the APHIS website.
    The commenter also asked what the expected expiration date of the 
import permit would be, adding that it is not clearly defined whether 
the permittee must apply each time they travel but continue with the 
same permit, or whether the permittee must apply online each time.
    We consider each hand-carry trip to be a unique event. For this 
reason, we require that the person wishing to hand-carry regulated 
materials or organisms under a current permit to notify APHIS through 
our online portal of the intention for a hand-carry event.

Packaging Requirements (Sec.  330.206)

    We proposed in Sec.  330.206 to include general and specific 
packaging requirements for the importation, interstate movement, or 
transit of plant pests, biological control organisms, and associated 
articles into or through the United States.
    Regarding shipping of commercial biological control organisms, a 
commenter stated that APHIS should cooperate with industry to establish 
a process for shippers to expedite importation and movement of 
commercial biological control organisms, and to develop an efficient 
system for clearing shipments of commercial biological control 
organisms with potentially affected governmental agencies and State 
departments of agriculture. The commenter also stated that APHIS should 
identify points of contact for resolving problems that often occur when 
importing and transshipping commercial biological control organisms.
    APHIS regularly works with industry to improve the efficiency and 
timeliness for clearance of imported commercial biological control 
organisms, including designating certain ports where clearance is a 
priority and delays are minimal. We recognize, however, that these 
specific designated ports (which is not the same as ``port of entry'') 
may not be convenient for all importers and situations. APHIS will 
continue to work with industry to seek additional solutions while 
maintaining the safeguards needed for importation of live organisms.
    A commenter wanted to know why we did not refer to RSPM 39 \30\ as 
it relates to packaging.
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    \30\ https://www.nappo.org/files/5714/3889/7020/RSPM39Rev-08-12-2014-e.pdf.
---------------------------------------------------------------------------

    We did not refer to the guidelines mentioned by the commenter 
because we consider the proposed requirements for packaging to be 
adequate. RSPM 39 provides packaging guidelines to facilitate the 
movement of invertebrate biological control organisms into NAPPO member 
countries. The provisions and recommendations of RSPM 39, as currently 
written, exceed the packaging requirements of Sec.  330.206. Moreover, 
RSPM guidelines are subject to change independent of the status of the 
plant protection regulations of any member country.
    The commenter also asked whether organisms attenuated and excepted 
from permitting are also exempt from packaging requirements, as they do 
not require a permit.
    As we noted in the above discussion of Sec.  330.204, attenuated 
organisms will no longer be considered as plant pests and therefore not 
included on the exception list.
    In proposed Sec.  330.206(a), we include packaging requirements for 
the outer shipping container and inner packages. These include the 
requirements that the outer shipping container must be rigid, 
impenetrable, and durable enough to remain closed and structurally 
intact, and that inner packages must be sealed.
    A few commenters expressed concerns about the lack of flexibility 
in the proposed packaging requirements, particularly as they relate to 
the environmental needs of live organisms.
    One commenter stated that some packaged cultures consume oxygen 
quickly and generate carbon dioxide, creating conditions that kill 
beneficial organisms if there are no air holes for oxygen exchange. As 
an example, the commenter cited the current use of strong cardboard 
boxes with 1 to 1.5-inch holes drilled in the sides for transporting 
commercial packages of beneficial organisms, including predatory mites 
and lady beetles. The commenter emphasized that the packaging described 
in the proposed regulation would block all airflow vital for the 
survival of beneficial organisms. For interstate travel of organisms 
that are not plant pests, the commenter stated that containment in one 
layer of packaging plus an outer breathable layer that keeps the inner 
packages from impact should be sufficient. Another commenter 
recommended establishing a performance-based standard for packaging 
that would require the permittee to ship the organism or soil in a 
secure manner and suggested that APHIS provide guidance and examples on 
its website for meeting this standard.
    We acknowledge the commenters' concerns about the packing 
regulations and organism viability during shipment. We note that the 
regulations allow for modifications as long as they are in keeping with 
the proposed requirement that the packaging should not be capable of 
harboring or being a means of dissemination of the organism or article. 
For example, the requirement in Sec.  330.206(a) that inner packages 
must be ``securely sealed'' does not equate to ``airtight'' unless it 
is appropriate to the organisms being shipped. We agree that additional 
guidance can be helpful, and accordingly APHIS will continue to

[[Page 29956]]

work with industry and other stakeholders to address their concerns.
    In proposed paragraphs (b) and (c) of Sec.  330.206, we required 
that packing material and shipping containers be new, sterilized, or 
disinfected prior to reuse, or otherwise destroyed or disposed of at 
the point of destination.
    A commenter suggested that the provision prohibiting the reuse of 
shipping containers, except for those sterilized or disinfected prior 
to reuse, should not apply to most insect shipments. The commenter 
stated that it is costly and time consuming to disinfect cardboard clad 
foam shippers, and that using only new containers will generate 
additional waste. Another commenter agreed that not all shipping 
containers warrant sterilization and suggested revising proposed Sec.  
330.206(c). As an illustration, the commenter cited the content of a 
shipment containing all life stages of live insects within multiple 
packages. The commenter stated that the removal of only the inner 
containment packaging, which holds the insects, should suffice as 
decontamination.
    We agree with the commenters that shipping containers do not 
warrant sterilization or disinfection for reuse as long as the inner 
packaging sufficiently contains the organisms to prevent contamination 
of the outer shipping container. We are revising Sec.  330.206(c) 
accordingly.

Costs and Charges (Sec.  330.207)

    In proposed Sec.  330.207, we stated that we would furnish 
inspection services without cost during regularly assigned hours of 
duty and usual places of duty. We also stated that APHIS would not be 
responsible for any costs or charges incidental to inspections or 
compliance with the provisions of this subpart other than the services 
of the inspector.
    A commenter asked if APHIS imposes charges for inspections and 
compliance checks. Another commenter recommended that APHIS include 
guidelines for charges associated with conducting inspections and 
verifying compliance with the regulations.
    As we note in Sec.  330.207, APHIS does not impose charges for 
inspections and compliance checks carried out during regularly assigned 
hours and usual places of duty. As we furnish inspection services under 
these conditions without cost, we see no reason to include guidelines 
for charging for such services.

Other Comments

    Several persons submitted general comments that did not address 
specific provisions included in the proposal.
    One commenter noted that in a separate proposal to revise the 
regulations to 7 CFR part 340, APHIS noted that a genetically 
engineered plant pest organism meeting a proposed exemption from the 
part 340 definition of genetic engineering would still be subject to 
part 330 because an exemption, by its nature, is not considered an 
``explicit authorization.'' The commenter asked that we wait to 
promulgate any final rule under part 330 until we fully consider 
comments received under the separate part 340 proposed rulemaking.
    On November 7, 2017, APHIS published a document \31\ in the Federal 
Register announcing withdrawal of the proposal referred to by the 
commenter.
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    \31\ https://www.federalregister.gov/documents/2017/11/07/2017-24202/importation-interstate-movement-and-environmental-release-of-certain-genetically-engineered.
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    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule with the 
changes discussed in this document. Executive Orders 12866, 13563, 
13771, and Regulatory Flexibility Act.
    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.
    This final rule is considered an Executive Order 13771 deregulatory 
action. Details on the estimated cost savings of this proposed rule can 
be found in the rule's economic analysis.
    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). 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 2 in this document for a link to Regulations.gov) 
or by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT.
    This rule will amend regulations regarding the importation, 
interstate movement, and environmental release of plant pests to 
incorporate provisions regarding biological control organisms and the 
movement of soils from which plant pests and biological control 
organisms are extracted. The rule adds definitions, streamlines the 
permitting and compliance processes, and provides APHIS with increased 
flexibility in the regulation of plant pests. The regulations in 7 CFR 
parts 318, 319, and 352 will be updated to reflect the changes in part 
330. The rule will codify an existing process for electronically 
requesting permits. Using the online permit process yields time and 
cost savings as compared to mailing paper applications.
    The rule will also reduce the number of permits issued under part 
330, which numbered 6,538 in fiscal year (FY) 2015. About one-third of 
these permits (2,158) were for the movement or environmental release of 
plant pests or biological control organisms for which this rule will 
authorize exemption from permitting requirements, based on plant health 
risks. Their exemption from permitting requirements will reduce the 
permitting burden for applicants. Because one permit may list multiple 
biological control organisms or plant pests, we expect, overall, a 10 
to 30 percent reduction in the time spent acquiring permits under part 
330. Based on the 6,538 permits issued in FY 2015, and assuming the 
time required to submit an application is one hour, the annual time 
savings attributable to the rule will total between 654 and 1,961 
hours. Given an average hourly wage of $44.50 per hour, the annual 
total cost savings will be between about $29,100 and $87,300.
    In accordance with guidance on complying with Executive Order 
13771, the primary estimate of annualized cost savings attributable to 
this rule is $54,950 (including consideration of the cost of 
unscheduled assessments by APHIS of sites, facilities, and means of 
conveyance). This value is the mid-point estimate of cost savings 
annualized in perpetuity using a 7 percent discount rate.
    Listing of exempted organisms on an APHIS-PPQ website, transparent 
procedures for petitioning for exceptions or exemptions to permitting, 
and provision for a notice-based process for adding and removing listed 
organisms will also combine to make an efficient, transparent, and 
user-responsive system that will facilitate the movement and 
environmental release of plant pests and biological control organisms.

[[Page 29957]]

    Certain regulated entities will continue to incur time costs 
associated with providing information during the permitting application 
process as was experienced before this rule was proposed. The time 
required overall for permitting will be reduced, however, because of 
the exempted organisms and the online, streamlined permitting system.
    These revisions to part 330 will benefit entities, large and small, 
by increasing the efficiency of the permitting and compliance processes 
and by improving the clarity and transparency of these regulations. The 
majority of entities that will benefit from this rule are small, based 
on information obtained from the U.S. Economic Census. These entities 
include: Academic, government, and commercial researchers; diagnostic 
enterprises such as plant pathogen diagnostic laboratories; biological 
supply enterprises that include suppliers of biology teaching kits and 
suppliers of butterflies for release at special occasions; biological 
control organism producers; educational display enterprises such as 
butterfly houses, zoos, and museums; discovery companies that evaluate 
living organisms for novel pharmaceuticals and pesticides; taxonomists 
and systematists; educators; and hobbyists (see full economic 
analysis). The rule will also facilitate the Agency's coordination with 
other Federal and State agencies in regulating the movement and 
environmental release of plant pests and biological control organisms.
    In our final regulatory flexibility analysis, we have used the best 
data available to examine potential impacts of the rule to achieve 
desired policy goals. We have determined that the rule will result in 
net cost savings for affected entities, nearly all of which are small. 
We cannot certify that this rule will have no significant impacts on 
small entities, but have found no evidence that it would have such 
impacts. We did not receive information during the public comment 
period on the proposed rule that would alter this assessment. Given the 
expected net cost savings, we have not identified steps that would 
minimize these impacts.
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
    In accordance with Executive Order 13175, APHIS has consulted with 
Tribal Government officials. A Tribal summary impact statement has been 
prepared that includes a summary of Tribal officials' concerns and of 
how APHIS has attempted to address them. The Tribal summary impact 
statement may be viewed on the Regulations.gov website.\32\
---------------------------------------------------------------------------

    \32\ See footnote 2.
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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) The National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions 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 2 in this document for a link to Regulations.gov) 
or by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule, which were 
filed under 0579-0187, have been submitted for approval to the Office 
of Management and Budget (OMB). 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 EGovernment 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 Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Plant diseases and pests, Puerto 
Rico, Quarantine, Transportation, Vegetables, Virgin Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Honey, Imports, Plants for planting, Plant 
diseases and pests, Plants, Quarantine, Reporting and recordkeeping 
requirements, Rice, Sugar, Vegetables.

7 CFR Part 330

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

7 CFR Part 352

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

    Accordingly, we are amending 7 CFR parts 318, 319, 330, and 352 as 
follows:

PART 318--STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES

0
1. The authority citation for part 318 continues to read as follows:

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

0
2. In Sec.  318.60, paragraph (c) introductory text is revised to read 
as follows:


Sec.  318.60  Notice of quarantine.

* * * * *
    (c) Sand (other than clean ocean sand), soil, or earth around the 
roots of plants must not be shipped, offered for shipment to a common 
carrier, received for transportation or transported by a common 
carrier, or carried, transported, moved, or allowed to be moved by any

[[Page 29958]]

person from Hawaii, Puerto Rico, or the Virgin Islands of the United 
States into or through any other State, Territory, or District of the 
United States: Provided, That the prohibitions in this paragraph (c) do 
not apply to the movement of soil from Hawaii, Puerto Rico, and the 
Virgin Islands other than that soil around the roots of plants; 
movement of soil that is not around the roots of plants is regulated 
under part 330 of this chapter: Provided further, That the prohibitions 
of this section shall not apply to the movement of such products in 
either direction between Puerto Rico and the Virgin Islands of the 
United States: Provided further, That such prohibitions shall not 
prohibit the movement of such products by the United States Department 
of Agriculture for scientific or experimental purposes, nor prohibit 
the movement of sand, soil, or earth around the roots of plants which 
are carried, for ornamental purposes, on vessels into mainland ports of 
the United States and which are not intended to be landed thereat, when 
evidence is presented satisfactory to the inspector of the Plant 
Protection and Quarantine Programs of the Department of Agriculture 
that such sand, soil, or earth has been so processed or is of such 
nature that no pest risk is involved, or that the plants with sand, 
soil, or earth around them are maintained on board under such 
safeguards as will preclude pest escape: And provided further, That 
such prohibitions shall not prohibit the movement of plant cuttings or 
plants that have been--
* * * * *

PART 319--FOREIGN QUARANTINE NOTICES

0
3. The authority citation for part 319 continues to read as follows:

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


0
4. In Sec.  319.37-10, paragraph (b) is revised to read as follows:


Sec.  319.37-10  Growing media.

* * * * *
    (b)(1) Plants for planting from Canada may be imported in any 
growing medium, except as restricted in the Plants for Planting Manual. 
Restrictions on growing media for specific types of plants for planting 
imported from Canada will be added, changed, or removed in accordance 
with Sec.  319.37-20.
    (2) Plants for planting from an area of Canada regulated by the 
national plant protection organization of Canada for a soil-borne plant 
pest may only be imported in an approved growing medium if the 
phytosanitary certificate accompanying it contains an additional 
declaration that the plant was grown in a manner to prevent infestation 
by that soil-borne plant pest.
* * * * *

0
5. Section 319.69 is amended as follows:
0
a. By revising paragraph (a) introductory text;
0
b. By revising paragraph (a)(8);
0
c. By removing the undesignated paragraph after paragraph (a)(8); and
0
d. By removing paragraph (b)(4).
    The revisions read as follows:


Sec.  319.69  Notice of quarantine.

    (a) The following plants and plant products, when used as packing 
materials, are prohibited entry into the United States from the 
countries and localities named in this paragraph (a), exceptions to the 
prohibitions may be authorized in the case of specific materials which 
have been so prepared, manufactured, or processed that in the judgment 
of the inspector no pest risk is involved in their entry:
* * * * *
    (8) Organic decaying vegetative matter from all countries, unless 
the matter is expressly authorized to be used as a packing material in 
this part. Exceptions to the prohibitions in paragraphs (a)(1) through 
(7) of this section may be authorized in the case of specific materials 
which has been so prepared, manufactured, or processed that in the 
judgment of the inspector no pest risk is involved in their entry.
* * * * *


Sec.  319.69-1  [Amended]

0
6. Section 319.69-1 is amended by removing paragraph (b) and 
redesignating paragraph (c) as paragraph (b).

0
7. Section 319.69-5 is revised to read as follows:


Sec.  319.69-5  Types of organic decaying vegetative matter authorized 
for packing.

    The following types of organic decaying vegetative matter are 
authorized as safe for packing:
    (a) Peat;
    (b) Peat moss; and
    (c) Osmunda fiber.

0
8. Section 319.77-2 is amended as follows:
0
a. In paragraph (e), by removing the word ``and'';
0
b. By revising paragraph (f); and
0
c. By adding paragraph (g).
    The revision and addition read as follows:


Sec.  319.77-2  Regulated articles.

* * * * *
    (f) Mobile homes and their associated equipment; and
    (g) Stone and quarry products.

0
9. Section 319.77-4 is amended by adding paragraph (d) to read as 
follows:


Sec.  319.77-4  Conditions for the importation of regulated articles.

* * * * *
    (d) Stone and quarry products. Stone and quarry products 
originating in a Canadian infested area may be imported into the United 
States only if they are destined for an infested area of the United 
States and will not be moved through any noninfested areas of the 
United States, and may be moved through the United States if they are 
moved only through infested areas.
* * * * *

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

0
10. 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
11. The heading of part 330 is revised to read as set forth above.
0
12. Section 330.100 is revised to read as follows:


Sec.  330.100  Definitions.

    The following terms, when used in this part, shall be construed, 
respectively, to mean:
    Administrative instructions. Published documents relating to the 
enforcement of this part, and issued under authority thereof by the 
Administrator.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS), United States Department of Agriculture, or 
any employee of APHIS to whom authority has been delegated to act in 
the Administrator's stead.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Article. Any material or tangible object, including a living 
organism, that could harbor living plant pests or noxious weeds. The 
term includes associated articles such as soil and packaging.
    Biocontainment facility. A physical structure or portion thereof, 
constructed and maintained in order to contain plant pests, biological 
control organisms, or associated articles.

[[Page 29959]]

    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
    Continental United States. The contiguous 48 States, Alaska, and 
the District of Columbia.
    Continued curation permit. A permit issued prior to the expiration 
date for an import permit or interstate movement permit in order for a 
permittee to continue research or other actions listed on the import or 
interstate movement permit. Continued curation permits do not allow 
acquisition of additional organisms for research and other authorized 
activities and only address retention of existing organisms for 
authorized uses.
    Department. The United States Department of Agriculture.
    Deputy Administrator. The Deputy Administrator of the Plant 
Protection and Quarantine Programs or any employee of the Plant 
Protection and Quarantine Programs delegated to act in his or her 
stead.
    Enter (entry). To move into, or the act of movement into, the 
commerce of the United States.
    EPA. The Environmental Protection Agency of the United States.
    Export (exportation). To move from, or the act of movement from, 
the United States to any place outside the United States.
    Garbage. That material designated as ``garbage'' in Sec.  
330.400(b).
    Hand-carry. Importation of an organism that remains in one's 
personal possession and in close proximity to one's person.
    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 of APHIS 
or the Commissioner of U.S. Customs and Border Protection to enforce 
the regulations in this part.
    Interstate movement. Movement from one State into or through any 
other State; or movement within the District of Columbia, Guam, the 
U.S. Virgin Islands, or any other territory or possession of the United 
States.
    Living. Viable or potentially viable.
    Means of conveyance. Any personal or public property used for or 
intended for use for the movement of any other property. This 
specifically includes, but is not limited to, automobiles, trucks, 
railway cars, aircraft, boats, freight containers, and other means of 
transportation.
    Move (moved and movement). To carry, enter, import, mail, ship, or 
transport; to 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 those activities.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Owner. The owner, or his or her agent, having possession of a plant 
pest, biological control organism, associated article, or any other 
means of conveyance, products, or article subject to the regulations in 
this part.
    Permit. A written authorization, including by electronic methods, 
by the Administrator to move plant pests, biological control organisms, 
or associated articles under conditions prescribed by the 
Administrator.
    Permittee. The person to whom APHIS has issued a permit in 
accordance with this part and who must comply with the provisions of 
the permit and the regulations in this part.
    Person. Any individual, partnership, corporation, association, 
joint venture, or other legal entity.
    Plant. Any plant (including any plant part) for or capable of 
propagation including trees, tissue cultures, plantlet cultures, 
pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots, 
and seeds.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: 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.
    Plant product. Any flower, fruit, vegetable, root, bulb, seed, or 
other plant part that is not included in the definition of plant; or 
any manufactured or processed plant or plant part.
    Plant Protection and Quarantine Programs. The Plant Protection and 
Quarantine Programs of the Animal and Plant Inspection Health Service.
    Pure culture. A single species of invertebrate originating only 
from an identified/described population and free of disease and 
parasites, cryptic species, soil and other biological material except 
host material and substrate as APHIS deems appropriate. Examples of 
identified/described population are those originating from a specific 
laboratory colony or field collection from a specified geographic area, 
such as an entire country or States or provinces of a country.
    Regulated garbage. That material designated as regulated garbage in 
Sec.  330.400(c) and (d).
    Responsible individual. One or more individuals who a permittee 
designates to appropriately oversee and control the staff, facilities, 
and/or site(s) at the location(s) specified on the permit as the 
ultimate destination of the plant pest, biological control organism, or 
associated article, to ensure compliance with the permit conditions 
during all phases of the activities being performed with the regulated 
articles authorized under a permit issued in accordance with this part 
for the movement or curation of a plant pest, biological control 
organism, or associated article. For the duration of the permit, the 
individual(s) must serve as a primary contact for communication with 
APHIS. The permittee may designate him or herself as the responsible 
individual. The responsible individual(s) must be at least 18 years of 
age and to be able meet with and provide information to an APHIS 
representative within a reasonable time frame. In accordance with 
section 7734 of the Plant Protection Act (7 U.S.C. 7701 et seq.), the 
act, omission, or failure of any responsible individual will also be 
deemed the act, omission, or failure of a permittee.
    Secure shipment. Shipment of a regulated plant pest, biological 
control organism, or associated article in a container or a means of 
conveyance of sufficient strength and integrity to prevent leakage of 
contents and to withstand shocks, pressure changes, and other 
conditions incident to ordinary handling in transportation.
    Shelf-stable. The condition achieved in a product, by application 
of heat, alone or in combination with other ingredients and/or other 
treatments, of being rendered free of microorganisms capable of growing 
in the product at nonrefrigerated conditions (over 50 [deg]F or 10 
[deg]C).
    Soil. The unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
    State. Any of the States of the United States, the Commonwealth of 
the Northern Mariana Islands, the Commonwealth of Puerto Rico, the 
District of Columbia, Guam, the U.S. Virgin Islands, and all other 
territories or possessions of the United States.
    Sterilization (sterile, sterilized). A chemical or physical process 
that results in the death of all living organisms on or within the 
article subject to the

[[Page 29960]]

process. Examples include, but are not limited to, autoclaving and 
incineration.
    Taxon (taxa). Any recognized grouping or rank within the biological 
nomenclature of organisms, such as class, order, family, genus, 
species, subspecies, pathovar, biotype, race, forma specialis, or 
cultivar.
    Transit. Movement from and to a foreign destination through the 
United States.
    United States. All of the States and territories.
    U.S. Customs and Border Protection (CBP). U.S. Customs and Border 
Protection within the Department of Homeland Security.


Sec.  330.105  [Amended]

0
13. In Sec.  330.105, paragraph (a) is amended by removing the citation 
``Sec.  330.300'' both times it appears and adding the words ``this 
part'' in its place.

0
14. Subpart B is revised to read as follows:
Subpart B--Movement of Plant Pests, Biological Control Organisms, and 
Associated Articles
Sec.
330.200 Scope and general restrictions.
330.201 Permit requirements.
330.202 Biological control organisms.
330.203 Soil.
330.204 Exceptions to permitting requirements for the importation or 
interstate movement of certain plant pests.
330.205 Hand-carry of plant pests, biological control organisms, and 
soil.
330.206 Packaging requirements.
330.207 Costs and charges.

Subpart B--Movement of Plant Pests, Biological Control Organisms, 
and Associated Articles


Sec.  330.200  Scope and general restrictions.

    (a) Restrictions. No person shall import, move interstate, transit, 
or release into the environment plant pests, biological control 
organisms, or associated articles, unless the importation, interstate 
movement, transit, or release into the environment of the plant pests, 
biological control organisms, or associated articles is:
    (1) Authorized under an import, interstate movement, or continued 
curation permit issued in accordance with Sec.  330.201; or
    (2) Authorized in accordance with other APHIS regulations in this 
chapter; or
    (3) Explicitly granted an exception from permitting requirements in 
this subpart; or
    (4) Authorized under a general permit issued by the Administrator.
    (b) Plant pests regulated by this subpart. For the purposes of this 
subpart, 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.
    (c) Biological control organisms regulated by this subpart. For the 
purposes of this subpart, biological control organisms include:
    (1) Invertebrate predators and parasites (parasitoids) used to 
control invertebrate plant pests;
    (2) Invertebrate competitors used to control invertebrate plant 
pests;
    (3) Invertebrate herbivores used to control noxious weeds;
    (4) Microbial pathogens used to control invertebrate plant pests;
    (5) Microbial pathogens used to control noxious weeds;
    (6) Microbial parasites used to control plant pathogens; and
    (7) Any other types of biological control organisms, as determined 
by APHIS.
    (d) Biological control organisms not regulated by this subpart. 
Paragraph (c) of this section notwithstanding, biological control 
organism-containing products that are currently under an EPA 
experimental use permit, a Federal Insecticide Fungicide and 
Rodenticide Act (FIFRA) section 18 emergency exemption, or 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.


Sec.  330.201  Permit requirements.

    (a) Types of permits. APHIS issues import permits, interstate 
movement permits, continued curation permits, and transit permits for 
plant pests, biological control organisms, and associated articles.\1\
---------------------------------------------------------------------------

    \1\ Persons contemplating the shipment of plant pests, 
biological control organisms, or associated articles to places 
outside the United States should make arrangements directly, or 
through the recipient, with the country of destination for the 
export of the plant pests, biological control organisms, or 
associated articles into that country.
---------------------------------------------------------------------------

    (1) Import permit. Import permits are issued to persons for secure 
shipment from outside the United States into the territorial limits of 
the United States. When import permits are issued to individuals, these 
individuals must be 18 years of age or older and have a physical 
address within the United States. When import permits are issued to 
corporate persons, these persons must maintain an address or business 
office in the United States with one or more designated individuals for 
service of process.
    (2) Interstate movement permit. Interstate movement permits are 
issued to persons for secure shipment from any State into or through 
any other State. When interstate movement permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When interstate 
movement permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with a 
designated individual for service of process.
    (3) Continued curation permits. Continued curation permits are 
issued in conjunction with and prior to the expiration date for an 
import permit or interstate movement permit, in order for the permittee 
to continue the actions listed on the import permit or interstate 
movement permit. When continued curation permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When continued 
curation permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with one or 
more designated individuals for service of process.
    (4) Transit permits. Transit permits are issued for secure 
shipments through the United States. Transit permits are issued in 
accordance with part 352 of this chapter.
    (b) Applying for a permit. Permit applications must be submitted by 
the applicant in writing or electronically through one of the means 
listed at https://www.aphis.usda.gov/plant_health/permits/index.shtml in 
advance of the action(s) proposed on the permit application.

[[Page 29961]]

    (c) Completing a permit application. A permit application must be 
complete before APHIS will evaluate it in order to determine whether to 
issue the permit requested. To facilitate timely processing, 
applications should be submitted as far in advance as possible of the 
date of the proposed permit activity. Guidance regarding how to 
complete a permit application, including guidance specific to the 
various information blocks on the application, is available at https://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (d) APHIS action on permit applications. APHIS will review the 
information on the application to determine whether it is complete. In 
order to consider an application complete, APHIS may request additional 
information that it determines to be necessary in order to assess the 
risk to plants and plant products that may be posed by the actions 
proposed on the application. When it is determined that an application 
is complete, APHIS will commence review of the information provided.
    (1) State or Tribal consultation and comment; consultation with 
other individuals. APHIS will share a copy of the permit application, 
and the proposed permit conditions, with the appropriate State or 
Tribal regulatory officials, and may share the application and the 
proposed conditions with other persons or groups to provide comment.
    (2) Initial assessment of sites and facilities. Prior to issuance 
of a permit, APHIS will assess all sites and facilities that are listed 
on the permit application, including private residences, biocontainment 
facilities, and field locations where the organism \2\ or associated 
article will be held or released. As part of this assessment, all sites 
and facilities are subject to inspection. All facilities must be 
determined by APHIS to be constructed and maintained in a manner that 
prevents the dissemination or dispersal of plant pests, biological 
control organisms, or associated articles from the facility. The 
applicant must provide all information requested by APHIS regarding 
this assessment, and must allow all inspections requested by APHIS 
during normal business hours (8 a.m. to 4:30 p.m., Monday through 
Friday, excluding holidays). Failure to do so constitutes grounds for 
denial of the permit application.
---------------------------------------------------------------------------

    \2\ Includes biological control organisms and plant pests.
---------------------------------------------------------------------------

    (3) Issuance of a permit. APHIS may issue a permit to an applicant 
if APHIS concludes that the actions indicated in the permit application 
are not likely to introduce or disseminate a plant pest, biological 
control organism, or noxious weed within the United States in a manner 
that exposes plants and plant products to unacceptable risk. Issuance 
will occur as follows:
    (i) Prior to issuing the permit, APHIS will notify the applicant in 
writing or electronically of all proposed permit conditions. The 
applicant must agree in writing or electronically that he or she, and 
all his or her employees, agents, and/or officers, will comply with all 
permit conditions and all provisions of this subpart. If the organism 
or associated article will be contained in a private residence, the 
applicant must state in this agreement that he or she authorizes APHIS 
to conduct unscheduled assessments of the residence during normal 
business hours if a permit is issued.
    (ii) APHIS will issue the permit after it receives and reviews the 
applicant's agreement. The permit will be valid for no more than 3 
years. During that period, the permittee must abide by all permitting 
conditions, and the use of the organism or associated article must 
conform to the intended use on the permit. Moreover, the use of 
organisms derived from a regulated parent organism during that period 
must conform to the intended use specified on the permit for the parent 
organism.
    (iii) All activities carried out under the permit must cease on or 
before the expiration date for the permit, unless, prior to that 
expiration date, the permittee has submitted a new permit application 
and a new permit has been issued to authorize continuation of those 
actions.
    (iv) At any point following issuance of a permit but prior to its 
expiration date, an inspector may conduct unscheduled assessments of 
the site or facility in which the organisms or associated articles are 
held, to determine whether they are constructed and are being 
maintained in a manner that prevents the dissemination of organisms or 
associated articles from the site or facility. The permittee must allow 
all such assessments requested by APHIS during normal business hours. 
Failure to allow such assessments constitutes grounds for revocation of 
the permit.
    (4) Denial of a permit application. APHIS may deny an application 
for a permit if:
    (i) APHIS concludes that the actions proposed in the permit 
application would present an unacceptable risk to plants and plant 
products because of the introduction or dissemination of a plant pest, 
biological control organism, or noxious weed within the United States; 
or
    (ii) The actions proposed in the permit application would be 
adverse to the conduct of an APHIS eradication, suppression, control, 
or regulatory program; or
    (iii) A State or Tribal executive official, or a State or Tribal 
plant protection official authorized to do so, objects to the movement 
in writing and provides specific, detailed information that there is a 
risk the movement will result in the dissemination of a plant pest or 
noxious weed into the State, APHIS evaluates the information and 
agrees, and APHIS determines that such plant pest or noxious weed risk 
cannot be adequately addressed or mitigated; or
    (iv) The applicant does not agree to observe all of the proposed 
permit conditions that APHIS has determined are necessary to mitigate 
identified risks; or
    (v) The applicant does not provide information requested by APHIS 
as part of an assessment of sites or facilities, or does not allow 
APHIS to inspect sites or facilities associated with the actions listed 
on the permit application; or
    (vi) APHIS determines that the applicant has not followed prior 
permit conditions, or has not adequately demonstrated that they can 
meet the requirements for the current application. Factors that may 
contribute to such a determination include, but are not limited to:
    (A) The applicant, or a partnership, firm, corporation, or other 
legal entity in which the applicant has a substantial interest, 
financial or otherwise, has not complied with any permit that was 
previously issued by APHIS.
    (B) Issuing the permit would circumvent any order denying or 
revoking a previous permit issued by APHIS.
    (C) The applicant has previously failed to comply with any APHIS 
regulation.
    (D) The applicant has previously failed to comply with any other 
Federal, State, or local laws, regulations, or instructions pertaining 
to plant health.
    (E) The applicant has previously failed to comply with the laws or 
regulations of a national plant protection organization or equivalent 
body, as these pertain to plant health.
    (F) APHIS has determined that the applicant has made false or 
fraudulent statements or provided false or fraudulent records to APHIS.
    (G) The applicant has been convicted or has pled nolo contendere to 
any crime involving fraud, bribery, extortion, or any other crime 
involving a lack of integrity.

[[Page 29962]]

    (5) Withdrawal of a permit application. Any permit application may 
be withdrawn at the request of the applicant. If the applicant wishes 
to withdraw a permit application, he or she must provide the request in 
writing to APHIS. APHIS will provide written notification to the 
applicant as promptly as circumstances allow regarding reception of the 
request and withdrawal of the application.
    (6) Cancellation of a permit. Any permit that has been issued may 
be canceled at the request of the permittee. If a permittee wishes a 
permit to be canceled, he or she must provide the request in writing to 
APHIS-PPQ. Whenever a permit is canceled, APHIS will notify the 
permittee in writing regarding such cancellation.
    (7) Revocation of a permit. APHIS may revoke a permit for any of 
the following reasons:
    (i) After issuing the permit, APHIS obtains information that would 
have otherwise provided grounds for it to deny the permit application; 
or
    (ii) APHIS determines that the actions undertaken under the permit 
have resulted in or are likely to result in the introduction into or 
dissemination within the United States of a plant pest or noxious weed 
in a manner that presents an unacceptable risk to plants or plant 
products; or
    (iii) APHIS determines that the permittee, or any employee, agent, 
or officer of the permittee, has failed to comply with a provision of 
the permit or the regulations under which the permit was issued.
    (8) Amendment of permits--(i) Amendment at permittee's request. If 
a permittee determines that circumstances have changed since the permit 
was initially issued and wishes the permit to be amended accordingly, 
he or she must request the amendment, either through APHIS' online 
portal for permit applications, or by contacting APHIS directly via 
phone or email. The permittee may have to provide supporting 
information justifying the amendment. APHIS will review the amendment 
request, and may amend the permit if only minor changes are necessary. 
Requests for more substantive changes may require a new permit 
application. Prior to issuance of an amended permit, the permittee may 
be required to agree in writing that he or she, and his or her 
employees, agents, and/or officers will comply with the amended permit 
and conditions.
    (ii) Amendment initiated by APHIS. APHIS may amend any permit and 
its conditions at any time, upon determining that the amendment is 
needed to address newly identified considerations concerning the risks 
presented by the organism or the activities being conducted under the 
permit. APHIS may also amend a permit at any time to ensure that the 
permit conditions are consistent with all of the requirements of this 
part. As soon as circumstances allow, APHIS will notify the permittee 
of the amendment to the permit and the reason(s) for it. Depending on 
the nature of the amendment, the permittee may have to agree in writing 
or electronically that he or she, and his or her employees, agents, 
and/or officers, will comply with the permit and conditions as amended 
before APHIS will issue the amended permit. If APHIS requests such an 
agreement, and the permittee does not agree in writing that he or she, 
and his or her employees, agents, and/or officers, will comply with the 
amended permit and conditions, the existing permit will be revoked.
    (9) Suspension of permitted actions. APHIS may suspend 
authorization of actions authorized under a permit if it identifies new 
factors that cause it to reevaluate the risk associated with those 
actions. APHIS will notify the permittee in writing of this suspension 
explaining the reasons for it and stating the actions for which APHIS 
is suspending authorization. Depending on the results of APHIS' 
evaluation, APHIS will subsequently contact the permittee to remove the 
suspension, amend the permit, or revoke the permit.
    (10) Appeals. Any person whose application has been denied, whose 
permit has been revoked or amended, or whose authorization for actions 
authorized under a permit has been suspended, may appeal the decision 
in writing to the Administrator within 10 business days after receiving 
the written notification of the denial, revocation, amendment, or 
suspension. The appeal shall state all of the facts and reasons upon 
which the person relies to show that the application was wrongfully 
denied, permit revoked or amended, or authorization for actions under a 
permit suspended. The Administrator shall grant or deny the appeal, 
stating the reasons for the decision as promptly as circumstances 
allow.

(Approved by the Office of Management and Budget Under Control 
Number 0579-0054)


Sec.  330.202  Biological control organisms.

    (a) General conditions for importation, interstate movement, and 
release of biological control organisms. Except as provided in 
paragraph (b) of this section, no biological control organism regulated 
under this subpart may be imported, moved in interstate commerce, or 
released into the environment unless a permit has been issued in 
accordance with Sec.  330.201 authorizing such importation, interstate 
movement, or release, and the organism is moved or released in 
accordance with this permit and the regulations in this subpart. The 
regulations in 40 CFR parts 1500 through 1508, part 1b of this title, 
and part 372 of this chapter may require APHIS to request additional 
information from an applicant regarding the proposed release of a 
biological control organism as part of its evaluation of a permit 
application. Further information regarding the types of information 
that may be requested, and the manner in which this information will be 
evaluated, is found at https://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (b) Exceptions from permitting requirements for certain biological 
control organisms. APHIS has determined that certain biological control 
organisms have become established throughout their geographical or 
ecological range in the continental United States, such that the 
additional release of pure cultures derived from field populations of 
taxa of such organisms into the environment of the continental United 
States will present no additional plant pest risk (direct or indirect) 
to plants or plant products. Lists of biological control organisms for 
invertebrate plant pests and for weeds are maintained on the PPQ 
Permits and Certifications website at https://www.aphis.usda.gov/aphis/resources/permits.
    (1) Importation and interstate movement of listed organisms. Pure 
cultures of organisms excepted from permit requirements, unless 
otherwise indicated, may be imported or moved interstate within the 
continental United States without further restriction under this 
subpart.
    (2) Release of listed organisms. Pure cultures of organisms on the 
list may be released into the environment of the continental United 
States without further restriction under this subpart.
    (c) Additions to the list of organisms granted exceptions from 
permitting requirements for their importation, interstate movement, or 
release. Any person may request that APHIS add a biological control 
organism to the list referred to in paragraph (b) of this section by 
submitting a petition to APHIS via email to [email protected] or 
through any means listed at https://www.aphis.usda.gov/plant_health/permits/index.shtml. The petition must include the following 
information:
    (1) Evidence indicating that the organism is indigenous to the

[[Page 29963]]

continental United States throughout its geographical or ecological 
range, or evidence indicating that the organism has produced self-
replicating populations within the continental United States for an 
amount of time sufficient, based on the organism's taxon, to consider 
that taxon established throughout its geographical or ecological range 
in the continental United States; or
    (2) Evidence that the organism's geographical or ecological range 
includes an extremely limited area of or none of the continental United 
States based on its inability to maintain year to year self-replicating 
populations despite repeated introductions over a sufficient range of 
time; or
    (3) The petition would include evidence that the organism cannot 
establish anywhere in the continental United States; or
    (4) Results from a field study where data were collected from 
representative habitats occupied by the biological control organism. 
Studies must include sampling for any direct or indirect impacts on 
target and non-target hosts of the biological control organism in these 
habitats. Supporting scientific literature must be cited; or
    (5) Any other data, including published scientific reports, that 
suggest that subsequent releases of the organism into the environment 
of the continental United States will present no additional plant pest 
risk (direct or indirect) to plants or plant products.
    (d) APHIS review of petitions--(1) Evaluation. APHIS will review 
the petition to determine whether it is complete. If APHIS determines 
that the petition is complete, it will conduct an evaluation of the 
petition to determine whether there is sufficient evidence that the 
organism exists throughout its geographical or ecological range in the 
continental United States and that subsequent releases of pure cultures 
of field populations of the organism into the environment of the 
continental United States will present no additional plant pest risk 
(direct or indirect) to plants or plant products.
    (2) Notice of availability of the petition. If APHIS determines 
that there is sufficient evidence that the organism exists throughout 
its geographical or ecological range in the continental United States 
and that subsequent releases of pure cultures of the organism into the 
environment of the continental United States will present no additional 
plant pest risk to plants or plant products, APHIS will publish a 
notice in the Federal Register announcing the availability of the 
petition and requesting public comment on that document.
    (3) Notice of determination. (i) If no comments are received, or if 
the comments received do not lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating that the organism 
has been added to the list referred to in paragraph (b) of this 
section.
    (ii) If the comments received lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating its reasons for 
determining not to add the organism to the list referred to in 
paragraph (b) of this section.
    (e) Removal of organisms from the list of exempt organisms. Any 
biological control organism may be removed from the list referred to in 
paragraph (b) of this section if information emerges that would have 
otherwise led APHIS to deny the petition to add the organism to the 
list. Whenever an organism is removed from the list, APHIS will publish 
a notice in the Federal Register announcing that action and the basis 
for it.

(Approved by the Office of Management and Budget under control 
number 0579-0187)


Sec.  330.203  Soil.

    (a) Requirements. The Administrator has determined that, unless it 
has been sterilized, soil is an associated article, and is thus subject 
to the permitting requirements of Sec.  330.201, unless its movement:
    (1) Is regulated pursuant to other APHIS regulations in this 
chapter; or
    (2) Does not require such a permit under the provisions of 
paragraph (b)(1) or (c)(1) of this section.
    (b) Conditions governing the importation of soil--(1) Permit. 
Except as provided in Sec.  319.37-10 of this chapter and except for 
soil imported from areas of Canada not regulated by the national plant 
protection organization of Canada for a soil-borne plant pest, soil may 
be imported into the United States if an import permit has been issued 
in accordance with Sec.  330.201 and if the soil is imported under the 
conditions specified on the permit.
    (2) Additional conditions for the importation of soil via hand-
carry. In addition to the condition of paragraph (b)(1) of this 
section, soil may be hand-carried into the United States only if the 
importation meets the conditions of Sec.  330.205.
    (3) Additional conditions for the importation of soil intended for 
the extraction of plant pests. In addition to the condition of 
paragraph (b)(1) of this section, soil may be imported into the United 
States for the extraction of plant pests if the soil will be imported 
directly to an APHIS-approved biocontainment facility.
    (4) Additional conditions for the importation of soil contaminated 
with plant pests and intended for disposal. In addition to the 
condition of paragraph (b)(1) of this section, soil may be imported 
into the United States for the disposal of plant pests if the soil will 
be imported directly to an APHIS-approved disposal facility.
    (5) Exemptions. The articles listed in this paragraph (b) are not 
soil, provided that they are free of organic material. Therefore, they 
may be imported into the United States without an import permit issued 
in accordance with Sec.  330.201, unless the Administrator has issued 
an order stating otherwise. All such articles are, however, subject to 
inspection at the port of first arrival, subsequent reinspection at 
other locations, other remedial measures deemed necessary by an 
inspector to remove any risk the items pose of disseminating plant 
pests or noxious weeds, and any other restrictions of this chapter:
    (i) Consolidated material derived from any strata or substrata of 
the earth. Examples include clay (laterites, bentonite, china clay, 
attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.
    (ii) Sediment, mud, or rock from saltwater bodies of water.
    (iii) Cosmetic mud and other commercial mud products.
    (iv) Stones, rocks, and quarry products.
    (c) Conditions governing the interstate movement of soil--(1) 
General conditions. Except for soil moved in accordance with paragraphs 
(c)(2) through (5) of this section, soil may be moved interstate within 
the United States without prior issuance of an interstate movement 
permit in accordance with Sec.  330.201 or further restriction under 
this subpart. However, all soil moved interstate is subject to any 
movement restrictions and remedial measures specified for such movement 
referenced in part 301 of this chapter.
    (2) Conditions for the interstate movement within the continental 
United States of soil intended for the extraction of plant pests. Soil 
may be moved in interstate commerce within the continental United 
States with the intent of extracting plant pests, only if an interstate 
movement permit has been issued for its movement in accordance with 
Sec.  330.201, and if the soil will be

[[Page 29964]]

moved directly to an APHIS-approved biocontainment facility in a secure 
manner that prevents its dissemination into the outside environment.
    (3) Conditions for the interstate movement within the continental 
United States of soil infested with plant pests and intended for 
disposal. Soil may be moved in interstate commerce within the 
continental United States with the intent of disposing of plant pests, 
only if an interstate movement permit has been issued for its movement 
in accordance with Sec.  330.201, and the soil will be moved directly 
to an APHIS-approved disposal facility in a secure manner that prevents 
its dissemination into the outside environment.
    (4) Conditions for the interstate movement of soil samples from an 
area quarantined in accordance with part 301 of this chapter for 
chemical or compositional testing or analysis. Soil samples may be 
moved for chemical or compositional testing or analysis from an area 
that is quarantined in accordance with part 301 of this chapter without 
prior issuance of an interstate movement permit in accordance with 
Sec.  330.201 or further restriction under this chapter, provided that 
the soil is moved to a laboratory that has entered into and is 
operating under a compliance agreement with APHIS, is abiding by all 
terms and conditions of the compliance agreement, and is approved by 
APHIS to test and/or analyze such samples.
    (5) Additional conditions for interstate movement of soil to, from, 
or between Hawaii, the territories, and the continental United States. 
In addition to all general conditions for interstate movement of soil, 
soil may be moved in interstate commerce to, from, or between Hawaii, 
the territories, and the continental United States only if an 
interstate movement permit has been issued for its movement in 
accordance with Sec.  330.201. In addition, soil moved to, from, or 
between Hawaii, the territories, and the continental United States with 
the intent of extracting plant pests is subject to the conditions of 
paragraph (c)(2) of this section, while soil infested with plant pests 
and intended for disposal is subject to the conditions of paragraph 
(c)(3) of this section.
    (d) Conditions governing the transit of soil through the United 
States. Soil may transit through the United States only if a transit 
permit has been issued for its movement in accordance with part 352 of 
this chapter.

(Approved by the Office of Management and Budget Under Control 
Number 0579-0054)


Sec.  330.204  Exceptions to permitting requirements for the 
importation or interstate movement of certain plant pests.

    Pursuant to section 7711 of the Plant Protection Act (7 U.S.C. 7701 
et seq.), the Administrator has determined that certain plant pests may 
be moved interstate within the continental United States without 
restriction. The list of all such plant pests is on the PPQ Permits and 
Certifications website at https://www.aphis.usda.gov/aphis/resources/permits. Plant pests listed as being excepted from permitting 
requirements, unless otherwise indicated, may be moved interstate 
within the continental United States without further restriction under 
this subpart.
    (a) Categories. In order to be included on the list, a plant pest 
must:
    (1) Be from field populations or lab cultures derived from field 
populations of a taxon that is established throughout its entire 
geographical or ecological range within the continental United States; 
or
    (2) Be commercially available and raised under the regulatory 
purview of other Federal agencies.
    (b) Petition process to add plant pests to the list--(1) Petition. 
Any person may petition APHIS to have an additional plant pest added to 
the list of plant pests that may be imported into or moved in 
interstate commerce within the continental United States without 
restriction. To submit a petition, the person must provide, in writing, 
information supporting the placement of a particular pest in one of the 
categories listed in paragraph (a) of this section.
    (i) Information that the plant pest belongs to a taxon that is 
established throughout its entire geographical or ecological range 
within the United States must include scientific literature, 
unpublished studies, or data regarding:
    (A) The biology of the plant pest, including characteristics that 
allow it to be identified, known hosts, and virulence;
    (B) The geographical or ecological range of the plant pest within 
the continental United States; and
    (C) The areas of the continental United States within which the 
plant pest is established.
    (ii) Information that the plant pest is commercially available and 
raised under the regulatory purview of another Federal agency must 
include a citation to the relevant law, regulation, or order under 
which the agency exercises such oversight.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information to 
determine whether the plant pest belongs to one of the categories 
listed in paragraph (a) of this section. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) Action on petitions to add pests. (i) If, after review of the 
petition, APHIS determines there is insufficient evidence that the 
plant pest belongs to one of the categories listed in paragraph (a) of 
this section, APHIS will deny the petition, and notify the petitioner 
in writing regarding this denial.
    (ii) If, after review of the petition, APHIS determines that the 
plant pest belongs to one of the categories in paragraph (a) of this 
section, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition and any supporting 
documentation to the public, that states that APHIS intends to add the 
plant pest to the list of plant pests that may be imported into or 
moved in interstate commerce within the continental United States 
without restriction, and that requests public comment. If no comments 
are received on the notice, or if, based on the comments received, 
APHIS determines that its conclusions regarding the petition have not 
been affected, APHIS will publish in the Federal Register a subsequent 
notice stating that the plant pest has been added to the list.
    (c) Petition process to have plant pests removed from the list--(1) 
Petition. Any person may petition to have a plant pest removed from the 
list of plant pests that may be imported into or moved interstate 
within the continental United States without restriction by writing to 
APHIS. The petition must contain independently verifiable information 
demonstrating that APHIS' initial determination that the plant pest 
belongs to one of the categories in paragraph (a) of the section should 
be changed, or that additional information is now available that would 
have caused us to change the initial decision.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information 
supporting the petitioner's claim. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) APHIS action on petitions to remove pests. (i) If, after review 
of the petition, APHIS determines that there is insufficient evidence 
to suggest that its initial determination should be changed, APHIS will 
deny the petition,

[[Page 29965]]

and notify the petitioner in writing regarding this denial.
    (ii) If, after review of the petition, APHIS determines that there 
is a sufficient basis to suggest that its initial determination should 
be changed, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition, and that requests public 
comment regarding removing the plant pest from the list of plant pests 
that may be imported into or move in interstate commerce within the 
continental United States without restriction. If no comments are 
received on the notice, or if the comments received do not affect 
APHIS' conclusions regarding the petition, APHIS will publish a 
subsequent notice in the Federal Register stating that the plant pest 
has been removed from the list.
    (d) APHIS-initiated changes to the list. (1) APHIS may propose to 
add a plant pest to or remove a pest from the list of plant pests that 
may be imported into or move in interstate commerce within the 
continental United States without restriction, if it determines that 
there is sufficient evidence that the plant pest belongs to one of the 
categories listed in paragraph (a) of the section, or if evidence 
emerges that leads APHIS to reconsider its initial determination that 
the plant pest was or was not in one of the categories listed in 
paragraph (a) of this section. APHIS will publish a notice in the 
Federal Register announcing this proposed addition or removal, making 
available any supporting documentation that it prepares, and requesting 
public comment.
    (2) If no comments are received on the notice or if the comments 
received do not affect the conclusions of the notice, APHIS will 
publish a subsequent notice in the Federal Register stating that the 
plant pest has been added to or removed from the list.

(Approved by the Office of Management and Budget Under Control 
Number 0579-0187)


Sec.  330.205  Hand-carry of plant pests, biological control organisms, 
and soil.

    Plant pests, biological control organisms, and soil may be hand-
carried into the United States only in accordance with the provisions 
of this section.
    (a) Authorization to hand-carry--(1) Application for a permit; 
specification of ``hand-carry'' as proposed method of movement. A 
person must apply for an import permit for the plant pest, biological 
control organism, or soil, in accordance with Sec.  330.201, and 
specify hand-carry of the organism or article as the method of proposed 
movement.
    (2) Specification of individual who will hand-carry. The 
application must also specify the individual or individuals who will 
hand-carry the plant pest, biological control organism, or soil into 
the United States. If APHIS authorizes this individual or these 
individuals to hand-carry, the authorization may not be transferred to 
nor actions under it performed by individuals other than those 
identified on the permit application.
    (b) Notification of intent to hand-carry. After the permittee has 
obtained an import permit but no less than 20 days prior to movement, 
the permittee must provide APHIS through APHIS' online portal for 
permit applications or by fax with the names of the designated hand 
carrier, or carriers, assigned to that movement. Additional conditions 
for hand-carry are available on the APHIS website.\3\
---------------------------------------------------------------------------

    \3\ https://www.aphis.usda.gov/plant_health/permits/organism/downloads/HandCarryPolicy.pdf.
---------------------------------------------------------------------------

    (c) Denial, amendment, or cancellation of authorization to hand-
carry. APHIS may deny a request to hand-carry, or amend or cancel any 
hand-carry authorization at any time, if it deems such action necessary 
to prevent the introduction or dissemination of plant pests or noxious 
weeds within the United States.
    (d) Appeal of denial, amendment, or cancellation. Any person whose 
request to hand-carry has been denied, or whose authorization to hand-
carry has been amended or canceled, may appeal the decision in writing 
to APHIS.


Sec.  330.206  Packaging requirements.

    Shipments in which plant pests, biological control organisms, and 
associated articles are imported into, moved in interstate commerce, or 
transited through the United States must meet the general packaging 
requirements of this section, as well as all specific packaging 
requirements on the permit itself.
    (a) Packaging requirements. All shipments must consist of an outer 
shipping container and at least two packages within the container. Both 
the container and inner packages must be securely sealed to prevent the 
dissemination of the enclosed plant pests, biological control 
organisms, or associated articles.
    (1) Outer shipping container. The outer shipping container must be 
rigid, impenetrable and durable enough to remain closed and 
structurally intact in the event of dropping, lateral impact with other 
objects, and other shocks incidental to handling.
    (2) Inner packages. The innermost package or packages within the 
shipping container must contain all of the organisms or articles that 
will be moved. As a safeguard, the innermost package must be placed 
within another, larger package. All packages within the shipping 
container must be constructed or safeguarded so that they will remain 
sealed and structurally intact throughout transit. The packages must be 
able to withstand changes in pressure, temperature, and other climatic 
conditions incidental to shipment.
    (b) Packing material. Packing materials may be placed in the inner 
packages or shipping container for such purposes as cushioning, 
stabilizing, water absorption or retention, nourishment or substrate 
for regulated articles, etc. Packing material for importation must be 
free of plant pests, noxious weeds, biological control organisms not 
listed on the permit or associated articles, and, as such, must be new, 
or must have been sterilized or disinfected prior to reuse. Packing 
material must be suited for the enclosed organism or article, as well 
as any medium in which the organism or article will be maintained.
    (c) Requirements following receipt of the shipment at the point of 
destination. (1) Packing material, including media and substrates, must 
be destroyed by incineration, be decontaminated using autoclaving or 
another approved method, or otherwise be disposed of in a manner 
specified in the permit itself.
    (2) Shipping containers may be reused, provided that the container 
has not been contaminated with plant pests, noxious weeds, biological 
control organisms, or associated articles. Shipping containers that 
have been in contact with or otherwise contaminated with any of these 
items must be sufficiently sterilized or disinfected prior to reuse, or 
otherwise disposed of.
    (d) Costs. Permittees who fail to meet the requirements of this 
section may be held responsible for all costs incident to inspection, 
rerouting, repackaging, subsequent movement, and any treatments.


Sec.  330.207  Cost and charges.

    The inspection services of APHIS inspectors during regularly 
assigned hours of duty and at the usual places of duty will be 
furnished without cost. APHIS will not be responsible for any costs or 
charges incidental to inspections or compliance with the provisions of 
this subpart, other than for the inspection services of the inspector.

[[Page 29966]]

Subpart C--[Removed and Reserved]

0
15. Subpart C, consisting of Sec. Sec.  330.300 through 330.302, is 
removed and reserved.

PART 352--PLANT QUARANTINE SAFEGUARD REGULATIONS

0
16. The authority citation for part 352 continues to read as follows:

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


0
17. In Sec.  352.1, paragraph (b) is amended as follows:
0
a. By adding, in alphabetical order, a definition for Biological 
control organism;
0
b. By revising the definition for Deputy Administrator;
0
c. By adding, in alphabetical order, a definition for Noxious weed; and
0
d. By revising the definitions for Person, Plant pest, and Soil.
    The additions and revisions read as follows:


Sec.  352.1  Definitions.

* * * * *
    (b) * * *
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
* * * * *
    Deputy Administrator. The Deputy Administrator of the Plant 
Protection and Quarantine Programs or any employee of the Plant 
Protection and Quarantine Programs delegated to act in his or her 
stead.
* * * * *
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
* * * * *
    Person. Any individual, partnership, corporation, association, 
joint venture, society, or other legal entity.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: 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 plant pests listed 
in this definition.
* * * * *
    Soil. The unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
* * * * *


Sec.  352.2  [Amended]

0
18. In Sec.  352.2, paragraph (a) introductory text, the first sentence 
is amended by removing the words ``plant pests, noxious weeds, soil,'' 
and adding the words ``plant pests, biological control organisms, 
noxious weeds, soil,'' in their place and removing the words ``contain 
plant pests or noxious weeds'' and adding the words ``contain plant 
pests, biological control organisms, or noxious weeds'' in their place.


Sec.  352.3  [Amended]

0
19. Section 352.3 is amended as follows:
0
a. In paragraphs (a) and (b), by adding the words ``biological control 
organisms,'' after the words ``plant pests,'' each time they appear; 
and
0
b. In paragraph (d), by removing the words ``plant pest or noxious weed 
dissemination'' and adding the words ``plant pest, noxious weed, or 
biological control organism dissemination'' in their place.


Sec.  352.5  [Amended]

0
20. Section 352.5 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,'' each time they appear.


Sec.  352.6  [Amended]

0
21. Section 352.6 is amended as follows:
0
a. In paragraph (b), by removing footnote 2 and removing the words ``as 
specified by'' and adding the words ``in accordance with'' in their 
place; and
0
b. In paragraph (c), by removing the reference to footnote 2 and 
removing the citation ``Sec.  330.300(b)'' and adding the citation 
``Sec.  330.203'' in its place.
0
c. In paragraph (e), by removing the words ``plant pest or noxious weed 
dissemination'' both times they appear and adding the words ``plant 
pest, noxious weed, or biological control organism dissemination'' in 
their place.


Sec.  352.9  [Amended]

0
22. Section 352.9 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,''.


Sec.  352.10  [Amended]

0
23. Section 352.10 is amended as follows:
0
a. By redesignating footnote 3 as footnote 2;
0
b. In paragraph (b)(1), by removing the words ``plant pest or noxious 
weed dissemination'' each time they appear and adding the words ``plant 
pest, noxious weed, or biological control organism dissemination'' in 
their place and adding the words ``biological control organisms,'' 
after the words ``Prohibited or restricted plants, plant products, 
plant pests,'';
0
c. In paragraph (b)(2) introductory text, by removing the words ``plant 
pest or noxious weed dissemination'' both times they appear and adding 
the words ``plant pest, noxious weed, or biological control organism 
dissemination'' in their place;
0
d. In paragraph (b)(2)(i), by adding the words ``or biological control 
organisms'' after the words ``plant pests'';
0
e. In paragraph (b)(2)(ii), by adding the words ``biological control 
organisms,'' after the words ``plant pests,'';
0
f. In paragraph (b)(2)(iii), by removing the words ``plant pest or 
noxious weed dissemination'' and adding the words ``plant pest, noxious 
weed, or biological control organism dissemination'' in their place;
0
g. In paragraph (b)(2)(iv), by removing the words ``plant pest 
dispersal'' and adding the words ``plant pest or biological control 
organism dispersal'' in their place; and
0
h. In paragraph (c)(1), by removing the words ``plant pest or noxious 
weed dissemination'' and adding the words ``plant pest, noxious weed, 
or biological control organism dissemination'' in their place.


Sec.  352.11  [Amended]

0
24. In Sec.  352.11, paragraph (a)(1) is amended by removing the words 
``plant pests, noxious weeds, and soil'' and adding the words ``plant 
pests, biological control organisms, noxious weeds, soil, or other 
products or articles'' in their place.

[[Page 29967]]

Sec.  352.13  [Amended]

0
25. Section 352.13 is amended by removing the words ``plant pests, 
noxious weeds, and soil'' and adding the words ``plant pests, 
biological control organisms, noxious weeds, soil, or other products or 
articles'' in their place and removing the word ``parts'' and adding 
the word ``part'' in its place.


Sec.  352.15  [Amended]

0
26. Section 352.15 is amended by removing the words ``plant pest or 
noxious weed dissemination'' and adding the words ``plant pest, noxious 
weed, or biological control organism dissemination'' in their place.


Sec.  352.30  [Amended]

0
27. Section 352.30 is amended by redesignating footnotes 4 and 5 as 
footnotes 3 and 4, respectively.

    Done in Washington, DC, this 17th day of June 2019.
Lorren E.S. Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2019-13246 Filed 6-21-19; 8:45 am]
BILLING CODE 3410-34-P

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