Defensin Proteins Derived From Spinach in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance, 51001-51004 [2021-18786]

Download as PDF Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Rules and Regulations environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov Regulatory Flexibility Act The Secretary hereby certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601–612). Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector. Paperwork Reduction Act This interim final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). Catalog of Federal Domestic Assistance tkelley on DSK125TN23PROD with RULES1 The Catalog of Federal Domestic Assistance program numbers and titles for this rule are: 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.109, Veterans Compensation for Service-Connected Disability. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2). VerDate Sep<11>2014 17:05 Sep 13, 2021 Jkt 253001 List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Pensions, Veterans. Signing Authority Denis McDonough, Secretary of Veterans Affairs, approved this document on July 26, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Luvenia Potts, Regulation Development Coordinator, Office of Regulation Policy & Management, Office of General Counsel, Department of Veterans Affairs. For the reasons set forth in the preamble, 38 CFR part 3 is amended as follows: PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for subpart A continues to read as follows: ■ Authority: 38 U.S.C. 501(a), unless otherwise noted. 2. In § 3.317, paragraph (a)(1)(i) is revised to read as follows: ■ § 3.317 Compensation for certain disabilities occurring in Persian Gulf veterans. (a) * * * (1) * * * (i) Became manifest either during active military, naval, or air service in the Southwest Asia theater of operations, or to a degree of 10 percent or more not later than December 31, 2026; and * * * * * (Authority: 38 U.S.C. 1117, 1118). [FR Doc. 2021–19712 Filed 9–13–21; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA–HQ–OPP–2021–0170; FRL–8908–01– OCSPP] Defensin Proteins Derived From Spinach in Citrus Plants; Temporary Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 51001 This regulation establishes a temporary exemption from the requirement of a tolerance for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 in or on citrus when used as a plant-incorporated protectant in accordance with the terms of Experimental Use Permit (EUP) No. 88232–EUP–1. Southern Gardens Citrus Nursery, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8. The temporary tolerance exemption expires on May 31, 2025. SUMMARY: This regulation is effective September 14, 2021. Objections and requests for hearings must be received on or before November 15, 2021, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2021–0170, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\14SER1.SGM 14SER1 51002 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Rules and Regulations I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). tkelley on DSK125TN23PROD with RULES1 B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 174 through the Government Publishing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2021–0170 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 15, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2021–0170, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online VerDate Sep<11>2014 17:05 Sep 13, 2021 Jkt 253001 instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Background In the Federal Register of March 22, 2021 (86 FR 15162) (FRL–10021–44), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1G8896) by Southern Gardens Citrus Nursery, LLC., 1820 Country Road 833, Clewiston, Florida 33440. The petition requested that the temporary tolerance exemption established in 40 CFR 174.535 be amended and extended for residues of defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach. Because the temporary tolerance exemption expired before we could complete this action, we are treating this as a petition to reestablish a temporary tolerance exemption. The notice of filing referenced a summary of the petition prepared by the petitioner Southern Gardens Citrus, LLC., which is available in the docket for this action at https://www.regulations.gov. There were no comments received in response to the notice of filing. III. Final Rule A. EPA’s Safety Determination Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’ Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider ‘‘available information concerning the cumulative effects of a particular pesticide’s residues’’ and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has reviewed the available toxicity and exposure data on spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 and considered its validity, completeness and reliability, and the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled ‘‘Review of the application for renewal and extension of experimental use permit 88232–EUP–1 and extension of the associated temporary tolerance exemption for the defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea L.) used as a plant-incorporated protectant in citrus plants at 40 CFR part 174.535 for additional 4 years, until May 31, 2025’’ dated June 24, 2021 (Ref. 1). This document, as well as other relevant information, is available in docket for this action as described under ADDRESSES. Based upon available data, EPA concludes that spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8, do not show evidence of toxicity (Ref. 2). Moreover, there is no significant similarity between spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 and known toxins and allergens. In addition, the spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 readily digest in simulated gastric fluids and therefore cumulative, chronic, and acute effects are unlikely. Furthermore, the source of the defensin proteins, spinach, has long been part of the human diet and there have been no findings that indicate toxicity or allergenicity of spinach proteins (Ref. 2). Given the lack of toxicity or allergenicity of the spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8, the Agency has not identified any toxicological endpoints for assessing risk. Due to the lack of any threshold effects, EPA has determined that the E:\FR\FM\14SER1.SGM 14SER1 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Rules and Regulations provision under FFDCA section 408(b)(2)(C) to retain a 10X safety factor for the protection of infants and children does not apply. Similarly, the lack of any toxic mode of action or toxic metabolites means that the provision requiring an assessment of cumulative effects does not apply. Oral exposure to spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 may occur from ingestion of citrus products, such as fruit and juice. In addition, people have had a long history of consumption of spinach and will continue to be exposed to defensin proteins through consumption of spinach. Based on the lack of adverse effects and the rapid digestibility of the proteins, however, the Agency does not anticipate any risk from reasonably foreseeable levels of exposure. Since the plant-incorporated protectant is integrated into the plant’s genome, the Agency has concluded, based upon previous science reviews, that residues in drinking water will be extremely low or non-existent (Ref. 2). Nonoccupational exposure via the skin or inhalation is not likely since the plantincorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. In any event, there are no non-dietary non-occupational uses of SoD2, SoD2*, SoD7, and SoD8 as they are only used in agricultural settings. tkelley on DSK125TN23PROD with RULES1 B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. Conclusion Based on its evaluation, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, there is no indication of toxicity or allergenicity potential for the plantincorporated protectant. Therefore, a temporary exemption from the requirement of a tolerance is established for residues of spinach defensin SoD2, SoD2*, SoD7, and SoD8 proteins in or on citrus when the proteins are used as a plant-incorporated protectant in citrus plants. This exemption is being established concurrently with an VerDate Sep<11>2014 17:05 Sep 13, 2021 Jkt 253001 extension to the experimental use permit (EUP) No. 88232–EUP–1 and is therefore being established on a temporary basis. Both the EUP and temporary tolerance exemption will expire on May 31, 2025. D. References The following is a listing of documents that are specifically referenced in this document. These documents are available in the listed dockets at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) via the direct links below. 1. U.S. EPA, ‘‘Review of the application for renewal and extension of experimental use permit 88232–EUP–1 and extension of the associated temporary tolerance exemption for the defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea L.) used as a plant-incorporated protectant in citrus plants at 40 CFR part 174.535 for additional 4 years, until May 31, 2025.’’ June 24, 2021. https:// www.regulations.gov/document/EPAHQ-OPP-2021-0170. 2. U.S. EPA, ‘‘Review of Product Characterization, Toxicity Waiver Requests, Allergenicity, and Human Health Data for Plant-Incorporated Protectants (PIPs): Defensin proteins derived from spinach (Spinach oleracea L.) Sod2, Sod2*, Sod7, Sod8.’’ April 24, 2018. https://www.regulations.gov/ document/EPA-HQ-OPP-2018-00400007. IV. Statutory and Executive Order Reviews This action establishes a temporary exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 51003 Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the temporary tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). V. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. E:\FR\FM\14SER1.SGM 14SER1 51004 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Rules and Regulations Dated: August 25, 2021. Charles Smith, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 174—PROCEDURES AND REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS 1. The authority citation for part 174 continues to read as follows: ■ Authority: 7 U.S.C. 136–136y; 21 U.S.C. 321(q), 346a and 371. ■ 2. Revise § 174.535 to read as follows: § 174.535 Spinach Defensin proteins; temporary exemption from the requirement of a tolerance. Residues of the defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea L.) in or on citrus food commodities are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in citrus plants in accordance with the terms of Experimental Use Permit No. 88232– EUP–1. This temporary exemption from the requirement of a tolerance expires on May 31, 2025. [FR Doc. 2021–18786 Filed 9–13–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 281 and 282 [EPA–R04–UST–2020–0611; FRL–8784–01– R4] Alabama: Final Approval of State Underground Storage Tank Program Revisions, Codification, and Incorporation by Reference Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: The State of Alabama (Alabama or State) has applied to the Environmental Protection Agency (EPA) for final approval of revisions to its Underground Storage Tank Program (UST Program) under subtitle I of the Resource Conservation and Recovery Act (RCRA). Pursuant to RCRA, the EPA is taking direct final action, subject to public comment, to approve revisions to the UST Program. The EPA has reviewed Alabama’s revisions and has determined that these revisions satisfy all requirements needed for approval. In addition, this action also codifies the tkelley on DSK125TN23PROD with RULES1 SUMMARY: VerDate Sep<11>2014 17:05 Sep 13, 2021 Jkt 253001 EPA’s approval of Alabama’s revised UST Program and incorporates by reference those provisions of the State statutes and regulations that the EPA has determined meet the requirements for approval. DATES: This rule is effective November 15, 2021, unless the EPA receives adverse comment by October 14, 2021. If the EPA receives adverse comment, it will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of November 15, 2021. ADDRESSES: Submit your comments by one of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov (our preferred method). Follow the online instructions for submitting comments. • Email: self.terry@epa.gov. Include the Docket ID No. EPA–R04–UST–2020– 0611 in the subject line of the message. Instructions: Submit your comments, identified by Docket ID No. EPA–R04– UST–2020–0611, via the Federal eRulemaking Portal at https:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from https:// www.regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit: https://www.epa.gov/dockets/ commenting-epa-dockets. Out of an abundance of caution for members of the public and our staff, the public’s access to the EPA Region 4 Offices is by appointment only to reduce the risk of transmitting COVID– 19. We encourage the public to submit comments via https:// www.regulations.gov or via email. The EPA encourages electronic comment submittals, but if you are unable to PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 submit electronically or need other assistance, please contact Terry Self, the contact listed in the FOR FURTHER INFORMATION CONTACT provision below. The index to the docket for this action is available electronically at https:// www.regulations.gov. The documents that form the basis of this codification and associated publicly available docket materials are available for review on the https://www.regulations.gov website. The EPA encourages electronic reviewing of these documents, but if you are unable to review these documents electronically, please contact Terry Self to schedule an appointment to view the documents at the Region 4 Offices. Interested persons wanting to examine these documents should make an appointment at least two weeks in advance. EPA Region 4 requires all visitors to adhere to the COVID–19 protocol. Please contact Terry Self for the COVID–19 protocol requirements for your appointment. Please also contact Terry Self if you need assistance in a language other than English or if you are a person with disabilities who needs a reasonable accommodation at no cost to you. For further information on EPA Docket Center services and the current status, please visit us online at https:// www.epa.gov/dockets. The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID–19. FOR FURTHER INFORMATION CONTACT: Terry Self, RCRA Programs and Cleanup Branch, Land, Chemicals and Redevelopment Division, U.S. Environmental Protection Agency, Region 4, Atlanta Federal Center, 61 Forsyth Street SW, Atlanta, Georgia 30303–8960; Phone number: (404) 562– 9396; email address: self.terry@epa.gov. Please contact Terry Self by phone or email for further information. SUPPLEMENTARY INFORMATION: I. Approval of Revisions to Alabama’s Underground Storage Tank (UST) Program A. Why are revisions to state UST programs necessary? States that have received final approval from the EPA under section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain a UST program that is no less stringent than the Federal program. When the EPA makes revisions to the regulations that govern the UST program, states must revise their programs to comply with the updated E:\FR\FM\14SER1.SGM 14SER1

Agencies

[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Rules and Regulations]
[Pages 51001-51004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18786]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2021-0170; FRL-8908-01-OCSPP]


Defensin Proteins Derived From Spinach in Citrus Plants; 
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of spinach defensin proteins 
SoD2, SoD2*, SoD7, and SoD8 in or on citrus when used as a plant-
incorporated protectant in accordance with the terms of Experimental 
Use Permit (EUP) No. 88232-EUP-1. Southern Gardens Citrus Nursery, 
LLC., submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. 
This regulation eliminates the need to establish a maximum permissible 
level for residues of spinach defensin proteins SoD2, SoD2*, SoD7, and 
SoD8. The temporary tolerance exemption expires on May 31, 2025.

DATES: This regulation is effective September 14, 2021. Objections and 
requests for hearings must be received on or before November 15, 2021, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0170, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 51002]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 174 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0170 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 15, 2021. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0170, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 1G8896) by Southern Gardens Citrus Nursery, LLC., 1820 
Country Road 833, Clewiston, Florida 33440. The petition requested that 
the temporary tolerance exemption established in 40 CFR 174.535 be 
amended and extended for residues of defensin proteins SoD2, SoD2*, 
SoD7, and SoD8 derived from spinach. Because the temporary tolerance 
exemption expired before we could complete this action, we are treating 
this as a petition to reestablish a temporary tolerance exemption. The 
notice of filing referenced a summary of the petition prepared by the 
petitioner Southern Gardens Citrus, LLC., which is available in the 
docket for this action at https://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .'' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues'' and ``other substances that have a 
common mechanism of toxicity.''
    EPA has reviewed the available toxicity and exposure data on 
spinach defensin proteins SoD2, SoD2*, SoD7, and SoD8 and considered 
its validity, completeness and reliability, and the relationship of 
this information to human risk. A full explanation of the data upon 
which EPA relied and its risk assessment based on those data can be 
found within the document entitled ``Review of the application for 
renewal and extension of experimental use permit 88232-EUP-1 and 
extension of the associated temporary tolerance exemption for the 
defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach 
(Spinacia oleracea L.) used as a plant-incorporated protectant in 
citrus plants at 40 CFR part 174.535 for additional 4 years, until May 
31, 2025'' dated June 24, 2021 (Ref. 1). This document, as well as 
other relevant information, is available in docket for this action as 
described under ADDRESSES.
    Based upon available data, EPA concludes that spinach defensin 
proteins SoD2, SoD2*, SoD7, and SoD8, do not show evidence of toxicity 
(Ref. 2). Moreover, there is no significant similarity between spinach 
defensin proteins SoD2, SoD2*, SoD7, and SoD8 and known toxins and 
allergens. In addition, the spinach defensin proteins SoD2, SoD2*, 
SoD7, and SoD8 readily digest in simulated gastric fluids and therefore 
cumulative, chronic, and acute effects are unlikely. Furthermore, the 
source of the defensin proteins, spinach, has long been part of the 
human diet and there have been no findings that indicate toxicity or 
allergenicity of spinach proteins (Ref. 2).
    Given the lack of toxicity or allergenicity of the spinach defensin 
proteins SoD2, SoD2*, SoD7, and SoD8, the Agency has not identified any 
toxicological endpoints for assessing risk. Due to the lack of any 
threshold effects, EPA has determined that the

[[Page 51003]]

provision under FFDCA section 408(b)(2)(C) to retain a 10X safety 
factor for the protection of infants and children does not apply. 
Similarly, the lack of any toxic mode of action or toxic metabolites 
means that the provision requiring an assessment of cumulative effects 
does not apply.
    Oral exposure to spinach defensin proteins SoD2, SoD2*, SoD7, and 
SoD8 may occur from ingestion of citrus products, such as fruit and 
juice. In addition, people have had a long history of consumption of 
spinach and will continue to be exposed to defensin proteins through 
consumption of spinach. Based on the lack of adverse effects and the 
rapid digestibility of the proteins, however, the Agency does not 
anticipate any risk from reasonably foreseeable levels of exposure. 
Since the plant-incorporated protectant is integrated into the plant's 
genome, the Agency has concluded, based upon previous science reviews, 
that residues in drinking water will be extremely low or non-existent 
(Ref. 2). Non-occupational exposure via the skin or inhalation is not 
likely since the plant-incorporated protectant is contained within 
plant cells, which essentially eliminates these exposure routes or 
reduces these exposure routes to negligible. In any event, there are no 
non-dietary non-occupational uses of SoD2, SoD2*, SoD7, and SoD8 as 
they are only used in agricultural settings.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Conclusion

    Based on its evaluation, EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to the U.S. 
population, including infants and children, to the spinach defensin 
proteins SoD2, SoD2*, SoD7, and SoD8. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion because, as 
previously discussed, there is no indication of toxicity or 
allergenicity potential for the plant-incorporated protectant. 
Therefore, a temporary exemption from the requirement of a tolerance is 
established for residues of spinach defensin SoD2, SoD2*, SoD7, and 
SoD8 proteins in or on citrus when the proteins are used as a plant-
incorporated protectant in citrus plants. This exemption is being 
established concurrently with an extension to the experimental use 
permit (EUP) No. 88232-EUP-1 and is therefore being established on a 
temporary basis. Both the EUP and temporary tolerance exemption will 
expire on May 31, 2025.

D. References

    The following is a listing of documents that are specifically 
referenced in this document. These documents are available in the 
listed dockets at https://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) via the direct 
links below.

1. U.S. EPA, ``Review of the application for renewal and extension 
of experimental use permit 88232-EUP-1 and extension of the 
associated temporary tolerance exemption for the defensin proteins 
SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea 
L.) used as a plant-incorporated protectant in citrus plants at 40 
CFR part 174.535 for additional 4 years, until May 31, 2025.'' June 
24, 2021. https://www.regulations.gov/document/EPA-HQ-OPP-2021-0170.
2. U.S. EPA, ``Review of Product Characterization, Toxicity Waiver 
Requests, Allergenicity, and Human Health Data for Plant-
Incorporated Protectants (PIPs): Defensin proteins derived from 
spinach (Spinach oleracea L.) Sod2, Sod2*, Sod7, Sod8.'' April 24, 
2018. https://www.regulations.gov/document/EPA-HQ-OPP-2018-0040-0007.

IV. Statutory and Executive Order Reviews

    This action establishes a temporary exemption from the requirement 
of a tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the temporary 
tolerance exemption in this final rule, do not require the issuance of 
a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 51004]]


    Dated: August 25, 2021.
Charles Smith,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED 
PROTECTANTS

0
1. The authority citation for part 174 continues to read as follows:

    Authority:  7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.


0
2. Revise Sec.  174.535 to read as follows:


Sec.  174.535  Spinach Defensin proteins; temporary exemption from the 
requirement of a tolerance.

    Residues of the defensin proteins SoD2, SoD2*, SoD7, and SoD8 
derived from spinach (Spinacia oleracea L.) in or on citrus food 
commodities are temporarily exempt from the requirement of a tolerance 
when used as a plant-incorporated protectant in citrus plants in 
accordance with the terms of Experimental Use Permit No. 88232-EUP-1. 
This temporary exemption from the requirement of a tolerance expires on 
May 31, 2025.

[FR Doc. 2021-18786 Filed 9-13-21; 8:45 am]
BILLING CODE 6560-50-P
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