Rule2024-10848
Bacillus Thuringensis Cry1B.868 and Cry1Da_7 Proteins; 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
May 17, 2024
Effective
May 17, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringensis Cry1B.868 and Cry1Da_7 proteins (hereafter Cry1B.868 and Cry1Da_7) when used as a Plant-Incorporated Protectant (PIP) in or on the food and feed commodities of corn: corn, field; corn, sweet, and corn, pop. Bayer U.S.--Crop Science 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 Cry1B.868 and Cry1Da_7 proteins.
Full Text
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<title>Federal Register, Volume 89 Issue 97 (Friday, May 17, 2024)</title>
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[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Rules and Regulations]
[Pages 43328-43331]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10848]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2020-0546; FRL-11674-01-OCSPP]
Bacillus Thuringensis Cry1B.868 and Cry1Da_7 Proteins; 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 the Bacillus thuringensis Cry1B.868 and
Cry1Da_7 proteins (hereafter Cry1B.868 and Cry1Da_7) when used as a
Plant-Incorporated Protectant (PIP) in or on the food and feed
commodities of corn: corn, field; corn, sweet, and corn, pop. Bayer
U.S.--Crop Science 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
[[Page 43329]]
establish a maximum permissible level for residues of Cry1B.868 and
Cry1Da_7 proteins.
DATES: This regulation is effective May 17, 2024. Objections and
requests for hearings must be received on or before July 16, 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-2020-0546, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 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) 564-5754; email address:
<a href="/cdn-cgi/l/email-protection#317361617577637f5e4558525442715441501f565e47"><span class="__cf_email__" data-cfemail="6e2c3e3e2a283c20011a070d0b1d2e0b1e0f40090118">[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-2020-0546 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
July 16, 2024. 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-2020-0546, 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">https://www.epa.gov/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 and Statutory Findings
In the Federal Register of December 23, 2020 (85 FR 83880) (FRL-
10017-71), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F8839) by Bayer Crop Science LP, 800 N Lindbergh Blvd.,
St. Louis, Missouri 63167. The petition requested that 40 CFR part 174
be amended by establishing an exemption from the requirement of a
tolerance for residues of Cry1B.868 and Cry1Da_7 proteins derived from
Bacillus thuringienisis when used as a PIP in or on the following food
and feed commodities: corn, field; corn, sweet; and corn, pop. That
document referenced a summary of the petition prepared by the
petitioner Bayer U.S.--Crop Science, which is available in the docket
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in
response to the notice of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. '' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA evaluated the available toxicity and exposure data on Cry1B.868
and Cry1Da_7 proteins and considered their validity, completeness, and
reliability, as well as the relationship of this information to human
risk. EPA has also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children. A summary of the data upon
which EPA relied and its risk assessment based on those data can be
found within the document entitled ``Review of the Application for a
FIFRA Section 3 Seed Increase Registration of MON 95379 Corn Expressing
Transgenic Insecticidal Plant-Incorporated Protectants Bacillus
thuringiensis Cry1B.868 and Cry1Da_7 Proteins and associated FFDCA
Petition to Establish a Permanent Exemption from the Requirement of a
Tolerance for Residues
[[Page 43330]]
of Cry1B.868 and Cry1Da_7 Proteins when used as Plant-Incorporated
Protectants in Food and Feed Commodities of Corn'' (hereafter Human
Health Risk Assessment). This document, as well as other relevant
information, is available in the docket for this action EPA-HQ-OPP-
2020-0546.
Cry1Da_7 and Cry1B.868 are modified proteins derived from the
bacterium Bacillus thuringiensis (Bt) and are active against
lepidopteran pests of corn. Available data demonstrated that, with
regard to humans, Cry1B.868 and Cry1Da_7 proteins are not toxic or
allergenic via any route of exposure. The most likely route of exposure
is dietary, via products produced from corn expressing the Cry1B.868
and Cry1Da_7 proteins. Oral exposure from ingestion of drinking water
is unlikely because the Cry1Da_7 and Cry1B.868 proteins are present at
very low levels within the plant cells and the amounts likely to enter
the water column from leaves, pollen or plant detritus are low.
Further, if Cry1Da_7 and Cry1B.868 proteins do enter the water column,
they are expected to degrade rapidly through natural processes.
Although there may be dietary exposure to residues of Cry1B.868 and
Cry1Da_7 proteins, such exposure presents no concern for adverse
effects. Submitted data show that the Cry1B.868 and Cry1Da_7 proteins
are not toxic via the oral route of exposure. Likewise, the potential
for allergenicity is low because: (1) bioinformatic analysis indicates
little similarity between Cry1B.868 and Cry1Da_7 proteins and known
allergens; (2) Cry1B.868 and Cry1Da_7 proteins degrade rapidly when
digested or exposed to heat; and (3) Cry1B.868 and Cry1Da_7 proteins
are not glycosylated, which further reduces their allergenicity
potential. Glycosylation is an enzymatic post-translational process in
which carbohydrates (glycans) link to proteins, creating structures
which could lead to an immune response in humans. In addition,
pesticidal applications of Bt and its insecticidal proteins, including
PIPs, have been safely used as commercial biological pesticides for
over 50 years. The domain structure and the mode-of-action for
Cry1B.868 and Cry1Da_7 proteins are similar to other Bt Cry
insecticidal proteins that have been safely used in agriculture.
Non-dietary occupational or residential exposure via inhalation is
not likely since Cry1B.868 and Cry1Da_7 proteins are contained within
plant cells, and corn pollen is not respirable nor is it present in
commercial corn products. Exposure via the skin may be possible via
contact with corn products which might have been processed in a way
that disrupts cellular structure. However, naturally occurring
proteases are likely to degrade proteins in contact with the skin and,
as described above, the Cry1B.868 and Cry1Da_7 proteins have little or
no potential toxicity or allergenicity. These findings are discussed in
more detail in the Human Health Risk Assessment.
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 or
effects from Cry1B.868 and Cry1Da_7 proteins have been identified as no
toxicity or allergenicity has been shown for these proteins in the
submitted studies. Therefore, EPA has concluded that Cry1B.868 and
Cry1Da_7 proteins do not have a common mechanism of toxicity with other
substances.
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 Cry1B.868 and Cry1Da_7 proteins. As a
result, an additional margin of safety for the protection of infants
and children is unnecessary.
Based upon its evaluation described above and in the Human Health
Risk Assessment, 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 Cry1B.868 and Cry1Da_7
proteins. Therefore, an exemption from the requirement of a tolerance
is established for residues of Cry1B.868 and Cry1Da_7 proteins in or on
the food and feed commodities of corn: corn, field; corn, sweet; and
corn, pop when used as a plant-incorporated protectant in corn.
B. Analytical Enforcement Methodology
EPA has determined that an analytical method is not required for
enforcement purposes since the Agency is establishing an exemption from
the requirement of a tolerance without any numerical limitation.
Nonetheless, Enzyme-Linked Immunosorbent Assays (ELISA) were submitted
for the detection of Cry1B.868 and Cry1Da_7 proteins. These assays have
been demonstrated to reliably detect the levels of the Cry1B.868 and
Cry1Da_7 proteins in the tissues of corn.
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 the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption from
the requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In
[[Page 43331]]
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 10, 2024.
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 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 174.546 to subpart W to read as follows:
Sec. 174.546 Bacillus thuringensis Cry1B.868 and Cry1Da_7 proteins;
exemption from the requirement of a tolerance.
Residues of Bacillus thuringensis Cry1B.868 and Cry1Da_7 proteins
in or on the food and feed commodities of corn: corn, field; corn,
sweet; and corn, pop are exempt from the requirement of a tolerance
when used as a plant-incorporated protectant in corn.
[FR Doc. 2024-10848 Filed 5-16-24; 8:45 am]
BILLING CODE 6560-50-P
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