Rule2025-02999
Inactivated Burkholderia Rinojensis Strain A396 Cells and Spent Fermentation Media; 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
February 25, 2025
Effective
February 25, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media in or on all food commodities when used in accordance with label directions and good agricultural practices. Marrone Bio Innovations, 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 Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 36 (Tuesday, February 25, 2025)</title>
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[Federal Register Volume 90, Number 36 (Tuesday, February 25, 2025)]
[Rules and Regulations]
[Pages 10608-10610]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02999]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0143; FRL-12383-01-OCSPP]
Inactivated Burkholderia Rinojensis Strain A396 Cells and Spent
Fermentation Media; 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 Inactivated Burkholderia rinojensis
strain A396 cells and spent fermentation media in or on all food
commodities when used in accordance with label directions and good
agricultural practices. Marrone Bio Innovations, 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 Inactivated Burkholderia rinojensis strain A396 cells
and spent fermentation media under FFDCA when used in accordance with
this exemption.
DATES: This regulation is effective February 25, 2025. Objections and
requests for hearings must be received on or before April 28, 2025 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-2023-0143, 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 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, and for the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services and docket access, visit <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#8bc9dbdbcfcdd9c5e4ffe2e8eef8cbeefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="783a28283c3e2a36170c111b1d0b381d0819561f170e">[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://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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-2023-0143, 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 28, 2025. 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-2023-0143, by one of
the following methods:
[[Page 10609]]
<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), 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 1F8955) by Marrone Bio Innovations, Inc., 1540 Drew Ave.,
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 insecticide, fungicide, miticide, and nematicide
Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media in or on all agricultural commodities. That notice
referenced a summary of the petition prepared by the petitioner Marrone
Bio Innovations, Inc., and is available in the docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 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.''
Consistent with FFDCA section 408(b)(2)(D), EPA has evaluated the
available toxicological and exposure data on Inactivated Burkholderia
rinojensis strain A396 cells and spent fermentation media 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 ``Microbial Human
Health Risk Assessment for Inactivated Burkholderia rinojensis strain
A396 cells and spent fermentation media''. 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, Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media has low toxicity via oral, dermal, or inhalation
routes of exposure. Additionally, it was found to be minimally
irritating to the skin and to the eye and is not a skin sensitizer. In
a 90-day oral toxicity study conducted with Inactivated Burkholderia
rinojensis strain A396 cells and spent fermentation media, there were
no adverse effects observed at the maximum dose of 900mg/kg/day. The
90-day dermal, 90-day inhalation, prenatal developmental toxicity, and
genotoxicity data requirements were addressed with rationale using a
weight of the evidence (WOE) approach that considered the lack of
adverse effects in the toxicity data, among other considerations. Based
on the lack of adverse effects seen in the available toxicity/
pathogenicity data, EPA did not identify any points of departure for
assessing risk; thus, no quantitative risk assessment was conducted.
Significant dietary and non-occupational exposures to residues of
Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media are not anticipated because of its rapid
biodegradability and it is not expected to remain at high levels on
plant surfaces or readily percolate through soil before reaching ground
water. Even if dietary and non-occupational exposures to residues of
Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media were to occur, there is no risk of concern due to
the lack of potential for adverse effects.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, 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.'' No risk of cumulative toxicity/effects
from Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media has been identified as no toxicity has been shown
for Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media in the submitted studies. Therefore, EPA has not
assumed that Inactivated Burkholderia rinojensis strain A396 cells and
spent fermentation media has a common mechanism of toxicity with other
substances.
Additionally, although FFDCA section 408(b)(2)(C) provides for an
additional tenfold margin of safety for infants and children in the
case of threshold effects, EPA has determined that there are no such
effects due to the lack of toxicity of Inactivated Burkholderia
rinojensis strain A396 cells and spent fermentation media. Because
there are no threshold levels of concern with the toxicity of
Inactivated Burkholderia rinojensis strain A396 cells and spent
fermentation media, 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 described above and in the Microbial
Human Health Risk Assessment for Inactivated Burkholderia rinojensis
strain A396 cells and spent fermentation media, which concludes that
there are no risks of concern from aggregate exposure to Inactivated
Burkholderia rinojensis strain A396 cells and spent fermentation media,
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 Inactivated Burkholderia rinojensis
strain A396 cells and spent fermentation media.
[[Page 10610]]
B. Analytical Enforcement Methodology
An analytical method is not required for Inactivated Burkholderia
rinojensis strain A396 cells and spent fermentation media because EPA
is 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 Inactivated Burkholderia rinojensis strain
A396 cells and spent fermentation media in or on all agricultural food
commodities when used in accordance with label directions and good
agricultural practices.
IV. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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 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: January 8, 2025.
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. 180.1415 to subpart D to read as follows:
Sec. 180.1415 Inactivated Burkholderia rinojensis strain A396 cells
and spent fermentation media; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of Inactivated Burkholderia rinojensis strain A396 cells and
spent fermentation media in or on all agricultural commodities when
used in accordance with label directions and good agricultural
practices.
[FR Doc. 2025-02999 Filed 2-24-25; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on February 25, 2025.
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