Rule2025-02998
Beauveria Bassiana Strain BW149; 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 Beauveria bassiana strain BW149 in or on all food commodities when used in accordance with label directions and good agricultural practices. BioWorks, 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 Beauveria bassiana strain BW149 under FFDCA when used in accordance with good agricultural practices.
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 10603-10605]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02998]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0255; FRL-12251-02-OCSPP]
Beauveria Bassiana Strain BW149; 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 Beauveria bassiana strain BW149 in or on
all food commodities when used in accordance with label directions and
good agricultural practices. BioWorks, 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 Beauveria bassiana strain BW149 under FFDCA when used
in accordance with good agricultural practices.
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-2023-0255, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in person,
is 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#e1a3b1b1a5a7b3af8e9588828492a1849180cf868e97"><span class="__cf_email__" data-cfemail="f9bba9a9bdbfabb7968d909a9c8ab99c8998d79e968f">[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).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
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
[[Page 10604]]
EPA, you must identify docket ID number EPA-HQ-OPP-2023-0255, 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.
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/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</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>.
II. Background
In the Federal Register of July 5, 2023 (88 FR 42935 (FRL-10579-05-
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 2F9027) by BioWorks, Inc., 100 Rawson Road,
Suite 205, Victor, NY 14564. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of the microbial pesticide Beauveria bassiana
strain BW149 in or on all food and feed commodities. That notice
referenced a summary of the petition prepared by the petitioner
BioWorks, Inc., and available in the docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The EPA received no comments in response to the
notice of filing.
III. Final Rule
A. 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
Beauveria bassiana strain BW149 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
the EPA relied and its risk assessment based on those data can be found
within the document entitled ``Human Health Risk Assessment of
Beauveria bassiana strain BW149, a New Active Ingredient, in BW149
Technical, BW149 ESO, BW149 WPO Proposed for Registration and an
Associated Petition Requesting a Tolerance Exemption'' (Beauveria
bassiana BW149 Human Health Risk Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
The toxicological profile of Beauveria bassiana BW149 is described
in the Beauveria bassiana BW149 Human Health Risk Assessment. Based
upon its evaluation, EPA concludes that with regards to humans,
Beauveria bassiana BW149 is not anticipated to be toxic, pathogenic, or
infective. Significant dietary and non-occupational exposure to
residues of Beauveria bassiana BW149 are not expected as the products
will be applied in agricultural settings and has not been approved for
any residential uses. Other non-occupational exposure through drift or
other means is possible but considered unlikely, and toxic effects are
not anticipated because drift concentrations would be below levels that
would elicit effects. The active ingredient is also known to degrade in
UV and sunlight and above 37[deg]C. Even if dietary and non-
occupational exposures to residues of Beauveria bassiana BW149 were to
occur, there is no risks of concern due to the lack of adverse effects
from toxicity, pathogenicity, or infectivity of Beauveria bassiana
BW149. EPA determined that no additional margin of safety is necessary
to protect infants and children as part of the qualitative assessment
conducted, as data and rationale demonstrated that Beauveria bassiana
strain BW149 is not toxic, pathogenic or infective.
Based upon its evaluation in the Beauveria bassiana BW149 Human
Health Risk Assessment, which concludes that there are no risks of
concern from aggregate exposure to Beauveria bassiana strain BW149, 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 Beauveria bassiana strain BW149.
B. Analytical Enforcement Methodology
An analytical method is not required for Beauveria bassiana strain
BW149 because the 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 Beauveria bassiana strain BW149 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 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
[[Page 10605]]
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.
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 (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of Congress and to the
Comptroller General of the United States. 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 7, 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. 180.1414 to subpart D to read as follows:
Sec. 180.1414 Beauveria bassiana BW149; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Beauveria bassiana strain BW149 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2025-02998 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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