Rule2024-14351
B.F. Strain 11604; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 2, 2024
Effective
July 2, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus velezensis strain 11604 in or on all food and feed commodities when used in accordance with label directions and good agricultural practices. BioConsortia, Inc., submitted a petition to the 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 velezensis strain 11604 under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 89 Issue 127 (Tuesday, July 2, 2024)</title>
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[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Rules and Regulations]
[Pages 54721-54723]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14351]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0083; FRL-11889-01-OCSPP]
B.F. Strain 11604; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Bacillus velezensis strain 11604 in or
on all food and feed commodities when used in accordance with label
directions and good agricultural practices. BioConsortia, Inc.,
submitted a petition to the 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 velezensis strain 11604
under FFDCA when used in accordance with this exemption.
DATES: This regulation is effective July 2, 2024. Objections and
requests for hearings must be received on or before September 3, 2024
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-2023-0083, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 20004. 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 and OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Madison H. Le, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#fdbfadadb9bbafb39289949e988ebd988d9cd39a928b"><span class="__cf_email__" data-cfemail="256775756163776b4a514c464056654055440b424a53">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://ecfr.federalregister.gov/current/title-40">https://ecfr.federalregister.gov/current/title-40</a>.
[[Page 54722]]
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 the EPA, you must
identify docket ID number EPA-HQ-OPP-2023-0083 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 September 3, 2024.
The EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Filing and
Service,'' dated June 22, 2023, which can be found at <a href="https://www.epa.gov/alj/revised-order-urging-electronic-filing-and-service">https://www.epa.gov/alj/revised-order-urging-electronic-filing-and-service</a>.
Although the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the EPA believes the
preference for submission via electronic means will not be prejudicial.
When submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf</a>.
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 the EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2023-0083, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background
In the Federal Register of March 24, 2023 (88 FR 17778) (FRL-10579-
02-OCSPP), the 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 2F8991) by BioConsortia, Inc., 279 Cousteau
Place, Davis, CA 95618. 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 bactericide Bacillus
velezensis strain 11604 in or on all food and feed commodities. That
notice referenced a summary of the petition prepared by the petitioner
BioConsortia, Inc., and available in the docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The EPA received two comments on the notice of
filing. The EPA's response to these comments is discussed in Unit
III.C.
Based upon review of data and other information supporting the
petition, the EPA modified the active ingredient name. In addition, the
EPA also changed the commodity to be reflected in the tolerance
exemption expression from ``in or on all raw agricultural crops'' to
``in or on all food and feed commodities.'' The reason for this change
is explained in Unit III.D.
III. Final Rule
A. The EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if the 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, the EPA must take into account the
factors set forth in FFDCA section 408(b)(2)(C), which require the 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 the EPA consider ``available information
concerning the cumulative effects of [a particular pesticide's] . . .
residues and other substances that have a common mechanism of
toxicity.''
The EPA evaluated the available toxicological and exposure data on
Bacillus velezensis strain 11604 and considered its validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
the EPA relied, and its risk assessment based on those data can be
found within the document entitled ``Human Health Risk Assessment of
Bacillus velezensis strain 11604, a New Active Ingredient, in Crimson
(End-use Product) Proposed for Registration and an Associated Petition
Requesting a Tolerance Exemption'' (Human Health Risk Assessment of
Bacillus velezensis strain 11604). This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
Based on its evaluation, EPA concludes that Bacillus velezensis
strain 11604 is not toxic, pathogenic, or infective via the injection
route of exposure. Bacillus velezensis strain 11604 is not anticipated
to be toxic, pathogenic, or infective via the oral or pulmonary routes
of exposure based on rationale supported by acute toxicity data
conducted with a mixture of Bacillus velezensis strain 11604 and other
(inert) ingredients. Additionally, the acute injection toxicity/
pathogenicity study demonstrated a pattern of clearance of Bacillus
velezensis strain 11604 from the test animals. Significant dietary and
non-occupational exposures to residues of Bacillus velezensis strain
11604 are not anticipated because levels of Bacillus velezensis strain
11604 after application on food and feed commodities will rapidly
decrease to naturally occurring background levels. Furthermore,
Bacillus velezensis is naturally present in the soil, on the surface of
a variety of plant-based foods, and in water processed through water
treatment facilities with no reported human
[[Page 54723]]
disease or illness. Even if dietary and non-occupational exposures to
residues of Bacillus velezensis strain 11604 were to occur, there is
not a concern due to the lack of potential for adverse effects. EPA
determined that the additional margin of safety referred to as the Food
Quality Protection Act Safety Factor is not necessary to protect
infants and children as part of the qualitative assessment conducted.
Based upon its evaluation in the Human Health Risk Assessment of
Bacillus velezensis strain 11604, which concludes that there are no
risks of concern from aggregate exposure to Bacillus velezensis strain
11604, the 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 velezensis
strain 11604.
B. Analytical Enforcement Methodology
An analytical method is not required for Bacillus velezensis strain
11604 because the EPA is establishing an exemption from the requirement
of a tolerance without any numerical limitation.
C. Response to Comments
Comments were not directly related to the petition for a tolerance
exemption for Bacillus velezensis strain 11604 and have been
acknowledged. The comments received were unrelated to Bacillus
velezensis strain 11604 and did not relate to the protection of human
health and the environment.
D. Revisions to the Requested Tolerance Exemption
EPA Revised the tolerance exemption expression to specifically
include the establishment of the exemption from the requirement of a
tolerance for residues of the microbial pesticide Bacillus velezensis
strain 11604 in or on all food and feed commodities. Although not
expressly stated in the petition, EPA interpreted the petition as
requesting an exemption covering all food and feed commodities.
E. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of Bacillus velezensis strain 11604 in or on
all food and feed 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 the 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, the 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, the 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 the 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.),
the 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 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 24, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the 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. 180.1408 to subpart D to read as follows:
Sec. 180.1408 Bacillus velezensis strain 11604; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacillus velezensis strain 11604 in or on all food and feed
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2024-14351 Filed 7-1-24; 8:45 am]
BILLING CODE 6560-50-P
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