Rule2024-29132
Bacillus Thuringiensis Cry1Da2 Protein; Exemption From the Requirement of a Tolerance
Primary source
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Published
December 13, 2024
Effective
December 13, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1Da2 protein in or on the food and feed commodities of corn: corn, field; corn, sweet; and corn, pop, when used as a plant-incorporated protectant (PIP). Pioneer Hi-Bred International, Inc., (Pioneer) 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 Cry1Da2 protein.
Full Text
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<title>Federal Register, Volume 89 Issue 240 (Friday, December 13, 2024)</title>
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[Federal Register Volume 89, Number 240 (Friday, December 13, 2024)]
[Rules and Regulations]
[Pages 100746-100749]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29132]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2023-0022; FRL-12380-01-OCSPP]
Bacillus Thuringiensis Cry1Da2 Protein; 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 thuringiensis Cry1Da2
protein in or on the food and feed commodities of corn: corn, field;
corn, sweet; and corn, pop, when used as a plant-incorporated
protectant (PIP). Pioneer Hi-Bred International, Inc., (Pioneer)
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 Cry1Da2 protein.
DATES: This regulation is effective December 13, 2024. Objections and
requests for hearings must be received on or before February 11, 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-2023-0022, 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. 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 (7511P), 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#571507071311051938233e3432241732273679303821"><span class="__cf_email__" data-cfemail="b4f6e4e4f0f2e6fadbc0ddd7d1c7f4d1c4d59ad3dbc2">[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).
[[Page 100747]]
<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 174 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, 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-2023-0022, 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
February 11, 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-2023-0022, 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 and Statutory Findings
In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01), 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 0F9003) by Pioneer Hi-Bred International, Inc., 7100 NW
62nd Avenue, P.O. Box 1000, Johnston, Iowa 50131. The petition
requested that 40 CFR part 174 be amended by establishing an exemption
from the requirement of a tolerance for residues of Cry1Da2 protein.
That document referenced a summary of the petition prepared by the
petitioner Pioneer Hi-Bred International, Inc., which is available in
the docket, <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 Cry1Da2
protein and considered its 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 ``Product Characterization Review and Human Health
Risk Assessment of the Insecticidal Plant-Incorporated Protectant
Active Ingredient, Bacillus thuringiensis Cry1Da2 and Plant-
Incorporated Inert Ingredient DGT-28 EPSPS, and the Genetic Material
Necessary (PHP88492) for their Production in Event DAS-1131-3 Maize,
and Establishment of a Permanent Tolerance Exemption for Residues of
these Proteins when used as a plant-incorporated protectant in 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-2023-0022.
The gene for the insecticidal protein Cry1Da2 was derived from the
bacterium Bacillus thuringiensis (Bt) and contains sequences from Bt
crystal toxins, Cry1Ab and Cry1D. The Cry1Da2 protein is intended to
provide protection from certain lepidopteran pests of corn. In
assessing the safety of the protein, the Agency used a ``weight of
evidence'' approach and determined that, Cry1Da2 is not expected to
pose any risk of toxicity to humans and the likelihood of the protein
to be a food allergen is minimal. Submitted data show that the Cry1Da2
protein is not toxic via the oral route of exposure and a
bioinformatics analysis did not indicate any homology to known toxins.
Likewise, the potential for allergenicity is low because: (1) The
bacterium source of Cry1Da2 protein, Bacillus thuringiensis, has a long
history of safe use and is not considered to be a source of allergenic
proteins; (2) bioinformatic analysis indicates no similarity between
Cry1Da2 protein and known allergens; (3) Cry1Da2 protein degrades
rapidly when exposed to simulated gastric fluid and completely digested
within one minute when exposed to simulated intestinal fluid; (4)
Cry1Da2 is inactivated when heated to high temperatures (>=75 [deg]C)
that are typical of food cooking; and (5) Cry1Da2 protein is not
glycosylated, which further reduces its 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.
The most likely exposure to the Cry1Da2 protein is dietary through
consumption of food products made
[[Page 100748]]
from corn containing the protein. Oral exposure from ingestion of
drinking water is unlikely because the Cry1Da2 protein is 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.
Additionally, proteases and nucleases found in water and the
environment would likely degrade the biological material containing the
active ingredient and treatment process for municipal water plants are
likely to remove Cry1Da2 residues. While dietary exposure is expected
to be limited, even if there is dietary exposure to residues of Cry1Da2
protein, such exposure presents no concern for adverse effects due to
the lack of toxicity or allergenicity.
Non-dietary, non-occupational or residential exposure via
pulmonary, dermal, or ocular exposure is not likely since the Cry1Da2
protein is contained within plant cells and corn pollen is not
respirable, which essentially eliminates these exposure routes or
reduces them to negligible levels. Corn pollen is not considered
respirable, as it consists of spherical particles ranging in size from
90 to 100 [mu]m, whereas respirable particles are typically less than
10 [mu]m. In the case of agricultural dusts derived from activities
such as planting, cultivation, and harvest, these particles also tend
to be of non-respirable sizes. Additionally, the low expression of
Cry1Da2 in the grain of plants containing Cry1Da2 further supports the
expectation that exposure via seed dust would be negligible. If
exposure should occur, EPA concludes that such exposure would not be
expected to present any risk due to the lack of toxicity. Thus, adverse
effects are not expected due to non-occupational and residential
exposure to Cry1Da2 protein. 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 Cry1Da2 protein has been identified as no toxicity or
allergenicity has been shown for this protein in the submitted studies.
Therefore, EPA has concluded that Cry1Da2 protein does 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 Cry1Da2 protein. 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 Cry1Da2 protein.
Therefore, an exemption from the requirement of a tolerance is
established for residues of Cry1Da2 protein 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, a validated enzyme linked immunosorbent assay (ELISA) was
developed for detection of Cry1Da2 protein. This ELISA has been
demonstrated to reliably detect the level of Cry1Da2 protein in the
tissues of corn.
C. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of the Bacillus thuringiensis Cry1Da2 protein
in or on the food and feed commodities of corn: corn, field; corn,
sweet; and corn, pop when used as a plant-incorporated protectant (PIP)
in corn.
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 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 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 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).
[[Page 100749]]
List of Subjects in 40 CFR Part 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 4, 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. 174.549 to subpart W to read as follows:
Sec. 174.549 Bacillus thuringiensis Cry1Da2 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry1Da2 protein in or on the
food and feed commodities of corn, including 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. 2024-29132 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P
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