Bacillus subtilis Strain CH3000; Exemption From The Requirement of a Tolerance, 7950-7953 [2022-02907]

Download as PDF 7950 Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations ensure normal powerline facility operations and to prevent wildfire in accordance with applicable reliability and safety standards and as identified in an approved operating plan or agreement. ■ 4. Amend § 251.56 by revising paragraphs (h)(2), (h)(3), (h)(5)(viii), (h)(7), and (h)(10)(v) to read as follows: § 251.56 Terms and Conditions lotter on DSK11XQN23PROD with RULES1 * * * * * (h) * * * (2) Use of operating agreements. Powerline facilities that are not subject to the mandatory reliability standards established by the Electric Reliability Organization and/or that sold less than or equal to 1,000,000 megawatt hours of electric energy for purposes other than resale during each of the 3 calendar years immediately preceding March 23, 2018, may be subject to an agreement, instead of an operating plan. Powerline facilities that are not subject to an agreement must be subject to an operating plan. (3) Existing operating plans and lack of an operating plan. The authorized officer shall determine, in consultation with the owner or operator of a powerline facility, whether the existing operating plan for that powerline facility is consistent with paragraph (h) of this section and shall notify the owner or operator of that determination. Within 18 months of the date of notification that the existing operating plan is inconsistent with paragraph (h) of this section, the owner or operator shall modify the existing operating plan to be consistent with paragraph (h) of this section or, if eligible, shall prepare a proposed operating agreement and shall submit the proposed modified operating plan or proposed operating agreement to the authorized officer for review and approval. Existing operating plans that are consistent with paragraph (h) of this section do not have to be submitted for reapproval by the authorized officer. If an owner or operator does not have an operating plan, within 18 months of the date of notification from the authorized officer that a proposed operating plan or agreement must be submitted, the owner or operator shall submit to the authorized officer a proposed operating plan or agreement consistent with paragraph (h) of this section for review and approval. The authorized officer shall provide notification of the requirement to submit a proposed modified operating plan or a proposed operating plan or agreement no later than September 30, 2026. The authorized officer has the discretion to determine the sequence of notification, VerDate Sep<11>2014 16:05 Feb 10, 2022 Jkt 256001 based on factors enumerated in implementing Forest Service directives. * * * * * (5) * * * (viii) Include the following procedures with regard to whether authorized officer approval is required for vegetation management: (A) Routine vegetation management. Routine vegetation management must have prior written approval from the authorized officer, unless all 3 of the following conditions are met: (1) The owner or operator has submitted a request for approval to the authorized officer in accordance with the specified timeframe in the approved operating plan or agreement; (2) The proposed routine vegetation management is covered by approval of a proposed operating plan or agreement or by subsequent case-by-case environmental analysis and consultation; and (3) The authorized officer has failed to respond to the request in accordance with the specified timeframe in the approved operating plan or agreement. (B) Emergency vegetation management. Emergency vegetation management does not require prior written approval from the authorized officer. The owner or operator shall notify the authorized officer by email of the location and type of emergency vegetation management as soon as practicable, but no later than 24 hours after completion. Within 30 days of completion, the owner or operator shall submit to the authorized officer a written report detailing at a minimum the location, type, and scope of emergency vegetation management conducted, the reason it was conducted, the methods used to conduct it, and the resulting benefit; * * * * * (7) Review and expiration of approved operating plans and agreements. At least every 10 years from the approval date of an operating plan or agreement, the owner or operator shall review and, as necessary or appropriate, propose updates to the operating plan or agreement to ensure consistency with changed conditions. Proposed updates to an approved operating plan or agreement that are deemed significant by the authorized officer shall be treated as proposed modifications and shall be submitted by the owner or operator for review and approval by the authorized officer in accordance with the procedures described in paragraph (h)(6) of this section. Proposed updates that are deemed non-significant by the authorized officer may be made by written agreement of the owner or PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 operator and the authorized officer. Upon expiration of a special use authorization for a powerline facility, the owner or operator shall prepare a new proposed operating plan or agreement, either solely or in consultation with the authorized officer, and shall submit it to the authorized officer for review and approval in accordance with the procedures described in paragraph (h)(6) of this section. * * * * * (10) * * * (v) Seek to minimize the need for case-by-case approvals for routine vegetation management (including hazard tree felling and pruning), powerline facility inspection, and operation and maintenance of powerline facilities; and * * * * * Dated: February 7, 2022. Meryl Harrell, Deputy Under Secretary, Natural Resources and Environment. [FR Doc. 2022–02889 Filed 2–9–22; 11:15 am] BILLING CODE 3411–15–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2020–0736; FRL–9093–01– OCSPP] Bacillus subtilis Strain CH3000; Exemption From The Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus subtilis strain CH3000 in or on all food commodities when used in accordance with label directions and good agricultural practices. Chr. Hansens Laboratory Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus subtilis strain CH3000 under FFDCA when used in accordance with this exemption. SUMMARY: This regulation is effective February 11, 2022. Objections and requests for hearings must be received on or before April 12, 2022 and must be filed in accordance with the instructions DATES: E:\FR\FM\11FER1.SGM 11FER1 Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations Register’s e-CFR site at https:// www.ecfr.gov/current/title-40. provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2020–0736, 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 Public Reading Room are 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: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information lotter on DSK11XQN23PROD with RULES1 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 180 through the Office of the Federal VerDate Sep<11>2014 16:05 Feb 10, 2022 Jkt 256001 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–2020–0736 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 April 12, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/ sites/production/files/2020-05/ documents/2020-04-10_-_order_urging_ electronic_service_and_filing.pdf. At this time, because of the COVID–19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/ EAB/EAB-ALJ_upload.nsf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to maximize telework due to the pandemic; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. If it is impossible for a person to submit documents electronically or receive service electronically, e.g., the person does not have any access to a computer, the person shall so advise OALJ by contacting the Hearing Clerk at (202) 564–6281. If a person is without access to a computer and must file documents by U.S. Mail, the person shall notify the Hearing Clerk every time it files a document in such a manner. The address for mailing documents is U.S. PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 7951 Environmental Protection Agency, Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460. 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– 2020–0736, 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/where-sendcomments-epa-dockets. 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 notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 0F8844) by Chr. Hansens Laboratory Inc., 9015 W Maple St., Milwaukee, WI 53214. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the fungicide and nematicide Bacillus subtilis strain CH3000 in or on all food commodities. That notice referenced a summary of the petition prepared by the petitioner Chr. Hansens Laboratory Inc. and available in the docket via https:// www.regulations.gov. No comments were received on 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 of a tolerance (the E:\FR\FM\11FER1.SGM 11FER1 lotter on DSK11XQN23PROD with RULES1 7952 Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations 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 or tolerance exemption 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 EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.’’ EPA evaluated the available toxicological and exposure data on Bacillus subtilis strain CH3000 and considered their validity, completeness, and reliability, as well as 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 ‘‘Human Health Risk Assessment of Bacillus paralicheniformis strain CH2970 and Bacillus subtilis strain CH3000, New Active Ingredients, in CH2970, CH3000, and CH2970/CH3000 Proposed for Registration and Associated Petitions Requesting Tolerance Exemptions’’ (Bacillus paralicheniformis strain CH2970 and Bacillus subtilis strain CH3000 Human Health Assessment). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. The available data and rationale demonstrated that, with regard to humans, Bacillus subtilis strain CH3000 is not toxic, pathogenic, or infective via the pulmonary route of exposure when administered intratracheally at a single dose of 1.03 x 109 colony-forming units per test animal; is not anticipated to be toxic, pathogenic, or infective via the oral route of exposure; and is not VerDate Sep<11>2014 16:05 Feb 10, 2022 Jkt 256001 anticipated to be toxic or irritating via the dermal route of exposure. Additionally, the acute pulmonary toxicity/pathogenicity study demonstrated a pattern of clearance of Bacillus subtilis strain CH3000 from the cecum contents and organs of the test animals. Although there may be minimal dietary exposure to residues of Bacillus subtilis strain CH3000 when used in accordance with label directions and good agricultural practices, there are no risks of human health concern due to the lack of potential for adverse effects. There are no current or proposed uses of Bacillus subtilis strain CH3000 that would result in non-occupational exposures. Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of Bacillus subtilis strain CH3000, EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted. Based upon its evaluation in the Bacillus paralicheniformis strain CH2970 and Bacillus subtilis strain CH3000 Human Health Assessment, which concludes that there are no risks of concern from aggregate exposure to Bacillus subtilis strain CH3000, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Bacillus subtilis strain CH3000. B. Analytical Enforcement Methodology An analytical method is not needed for Bacillus subtilis strain CH3000 due to the lack of potential adverse effects, which is the basis for EPA establishing an exemption from the requirement of a tolerance without any numerical limitation. C. Conclusion Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain CH3000 in or on all food commodities when used in accordance with label directions and good agricultural practices. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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, 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 tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require EPA’s consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (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 E:\FR\FM\11FER1.SGM 11FER1 Federal Register / Vol. 87, No. 29 / Friday, February 11, 2022 / Rules and Regulations 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 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 4, 2022. Edward Messina, Director, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.1388 to subpart D to read as follows: ■ § 180.1388 Bacillus subtilis strain CH3000; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain CH3000 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2022–02907 Filed 2–10–22; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2020–0737; FRL–9094–01– OCSPP] Bacillus paralicheniformis Strain CH2970; Exemption From the Requirement of a Tolerance The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2020–0737, 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 Public Reading Room are 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: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Environmental Protection Agency (EPA). ACTION: Final rule. I. General Information This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus paralicheniformis strain CH2970 in or on all food commodities when used in accordance with label directions and good agricultural practices. Chr. Hansens Laboratory Inc. submitted a petition to EPA under the Federal Food, 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 AGENCY: SUMMARY: lotter on DSK11XQN23PROD with RULES1 Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus paralicheniformis strain CH2970 under FFDCA when used in accordance with this exemption. DATES: This regulation is effective February 11, 2022. Objections and requests for hearings must be received on or before April 12, 2022 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). VerDate Sep<11>2014 16:05 Feb 10, 2022 Jkt 256001 A. Does this action apply to me? PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 7953 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 180 through the Office of the Federal Register’s e-CFR site at https:// www.ecfr.gov/current/title-40. 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–2020–0737 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 April 12, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/ sites/production/files/2020-05/ documents/2020-04-10_-_order_urging_ electronic_service_and_filing.pdf. At this time, because of the COVID–19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/ EAB/EAB-ALJ_upload.nsf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to maximize telework due to the E:\FR\FM\11FER1.SGM 11FER1

Agencies

[Federal Register Volume 87, Number 29 (Friday, February 11, 2022)]
[Rules and Regulations]
[Pages 7950-7953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02907]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0736; FRL-9093-01-OCSPP]


Bacillus subtilis Strain CH3000; Exemption From The Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Bacillus subtilis strain CH3000 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices. Chr. Hansens Laboratory Inc. submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Bacillus subtilis strain CH3000 under FFDCA when used 
in accordance with this exemption.

DATES: This regulation is effective February 11, 2022. Objections and 
requests for hearings must be received on or before April 12, 2022 and 
must be filed in accordance with the instructions

[[Page 7951]]

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-2020-0736, 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 Public Reading Room are 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:

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 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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-2020-0736 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 
April 12, 2022. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although EPA 
strongly encourages those interested in submitting objections or a 
hearing request to submit objections and hearing requests 
electronically. See Order Urging Electronic Service and Filing (April 
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. 
At this time, because of the COVID-19 pandemic, the judges and staff of 
the Office of Administrative Law Judges are working remotely and not 
able to accept filings or correspondence by courier, personal delivery, 
or commercial delivery, and the ability to receive filings or 
correspondence by U.S. Mail is similarly limited. When submitting 
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a 
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions during this time that the Agency 
continues to maximize telework due to the pandemic; therefore, EPA 
believes the preference for submission via electronic means will not be 
prejudicial. If it is impossible for a person to submit documents 
electronically or receive service electronically, e.g., the person does 
not have any access to a computer, the person shall so advise OALJ by 
contacting the Hearing Clerk at (202) 564-6281. If a person is without 
access to a computer and must file documents by U.S. Mail, the person 
shall notify the Hearing Clerk every time it files a document in such a 
manner. The address for mailing documents is U.S. Environmental 
Protection Agency, Office of Administrative Law Judges, Mail Code 
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    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-2020-0736, 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/where-send-comments-epa-dockets.
    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 notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance exemption 
petition (PP 0F8844) by Chr. Hansens Laboratory Inc., 9015 W Maple St., 
Milwaukee, WI 53214. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of the fungicide and nematicide Bacillus 
subtilis strain CH3000 in or on all food commodities. That notice 
referenced a summary of the petition prepared by the petitioner Chr. 
Hansens Laboratory Inc. and available in the docket via https://www.regulations.gov. No comments were received on 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 of a tolerance (the

[[Page 7952]]

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 or tolerance 
exemption 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 EPA consider ``available information 
concerning the cumulative effects of [a particular pesticide's] . . . 
residues and other substances that have a common mechanism of 
toxicity.''
    EPA evaluated the available toxicological and exposure data on 
Bacillus subtilis strain CH3000 and considered their validity, 
completeness, and reliability, as well as 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 ``Human Health Risk Assessment of Bacillus 
paralicheniformis strain CH2970 and Bacillus subtilis strain CH3000, 
New Active Ingredients, in CH2970, CH3000, and CH2970/CH3000 Proposed 
for Registration and Associated Petitions Requesting Tolerance 
Exemptions'' (Bacillus paralicheniformis strain CH2970 and Bacillus 
subtilis strain CH3000 Human Health Assessment). This document, as well 
as other relevant information, is available in the docket for this 
action as described under ADDRESSES.
    The available data and rationale demonstrated that, with regard to 
humans, Bacillus subtilis strain CH3000 is not toxic, pathogenic, or 
infective via the pulmonary route of exposure when administered 
intratracheally at a single dose of 1.03 x 10\9\ colony-forming units 
per test animal; is not anticipated to be toxic, pathogenic, or 
infective via the oral route of exposure; and is not anticipated to be 
toxic or irritating via the dermal route of exposure. Additionally, the 
acute pulmonary toxicity/pathogenicity study demonstrated a pattern of 
clearance of Bacillus subtilis strain CH3000 from the cecum contents 
and organs of the test animals. Although there may be minimal dietary 
exposure to residues of Bacillus subtilis strain CH3000 when used in 
accordance with label directions and good agricultural practices, there 
are no risks of human health concern due to the lack of potential for 
adverse effects. There are no current or proposed uses of Bacillus 
subtilis strain CH3000 that would result in non-occupational exposures. 
Because there are no threshold levels of concern with the toxicity, 
pathogenicity, or infectivity of Bacillus subtilis strain CH3000, EPA 
determined that no additional margin of safety is necessary to protect 
infants and children as part of the qualitative assessment conducted. 
Based upon its evaluation in the Bacillus paralicheniformis strain 
CH2970 and Bacillus subtilis strain CH3000 Human Health Assessment, 
which concludes that there are no risks of concern from aggregate 
exposure to Bacillus subtilis strain CH3000, EPA concludes that there 
is a reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposure to 
residues of Bacillus subtilis strain CH3000.

B. Analytical Enforcement Methodology

    An analytical method is not needed for Bacillus subtilis strain 
CH3000 due to the lack of potential adverse effects, which is the basis 
for EPA establishing an exemption from the requirement of a tolerance 
without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of Bacillus subtilis strain CH3000 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. 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, 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 tolerance 
exemption in this action, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (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

[[Page 7953]]

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 180

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

    Dated: February 4, 2022.
Edward Messina,
Director, Office of Pesticide Programs.

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

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Add Sec.  180.1388 to subpart D to read as follows:


Sec.  180.1388   Bacillus subtilis strain CH3000; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus subtilis strain CH3000 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2022-02907 Filed 2-10-22; 8:45 am]
BILLING CODE 6560-50-P
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