Rule2024-29362
Streptomyces Sviceus DGT-28 EPSPS (5-Enolpyruvylshikimate-3-Phosphate Synthase) Protein; 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
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 Streptomyces sviceus DGT-28 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase) protein (hereafter DGT-28 EPSPS 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) inert ingredient. 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 DGT-28 EPSPS 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 100749-100751]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29362]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2022-0990; FRL-12381-01-OCSPP]
Streptomyces Sviceus DGT-28 EPSPS (5-Enolpyruvylshikimate-3-
Phosphate Synthase) 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 Streptomyces sviceus DGT-28 EPSPS
(5-enolpyruvylshikimate-3-phosphate synthase) protein (hereafter DGT-28
EPSPS 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) inert ingredient. 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 DGT-28 EPSPS 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-2022-0990, 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) 564-5754; email address:
<a href="/cdn-cgi/l/email-protection#357765657173677b5a415c565046755045541b525a43"><span class="__cf_email__" data-cfemail="723022223634203c1d061b111701321702135c151d04">[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 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-2022-0990, 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-2022-0990, 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 March 24, 2023 (88 FR 17778) (FRL-10579-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of an FFDCA petition (IN
11746) by
[[Page 100750]]
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 DGT-28 EPSPS protein derived from
Streptomyces sviceus when used as an inert ingredient in a plant-
incorporated protectant in or on maize. 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 DGT-28
EPSPS 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-2022-0990.
The gene for the inert plant-incorporated protectant protein DGT-28
EPSPS was derived from the soil bacterium Streptomyces sviceus and is
intended to confer tolerance to glyphosate herbicides. The Agency used
a ``weight of evidence'' approach and determined that DGT-28 EPSPS
protein 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 DGT-28 EPSPS protein is not toxic via the oral route
of exposure and bioinformatics analysis did not indicate any homology
to known toxins. Likewise, the potential for allergenicity is low
because: (1) A literature search for the bacterium source of DGT-28
EPSPS protein, Streptomyces sviceus, did not yield any results that
would indicate that S. sviceus is a known source of mammalian toxic or
allergenic proteins; (2) DGT-28 EPSPS has been demonstrated to catalyze
the same reaction as other EPSPS enzymes covered under current
tolerance exemptions and have not been found to be associated with
adverse health effects; (3) bioinformatic analysis indicates no
biologically relevant similarity between DGT-28 EPSPS protein and known
allergens; (4) DGT-28 EPSPS protein degrades rapidly when exposed to
simulated gastric fluid and is completely digested in simulated
intestinal fluid; DGT-28 EPSPS is heat labile at temperatures exceeding
50 [deg]C, indicating that it will likely denature in the course of
normal thermal treatment during food preparation; and (5) DGT-28 EPSPS
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 DGT-28 EPSPS protein is dietary
through consumption of food products made from corn containing the
protein. Oral exposure from ingestion of drinking water is unlikely
because the DGT-28 EPSPS 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 ingredients and treatment
process for municipal water plants are likely to remove DGT-28 EPSPS
residues. While dietary exposure is expected to be limited, even if
there is dietary exposure to residues of DGT-28 EPSPS 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
or ocular exposure is not likely since DGT-28 EPSPS protein is
contained within plant cells, and corn pollen is not respirable.
Exposure via the skin is somewhat more likely via the 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 DGT-28 EPSPS protein has little or no potential toxicity to mammals
and minimal potential for allergenicity. Thus, adverse effects are not
expected due to non-occupational and residential exposure to DGT 28-
EPSPS 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 DGT-28 EPSPS protein has been identified as no toxicity or
allergenicity has been shown for this protein in the submitted studies.
Therefore, EPA has concluded that DGT-28 EPSPS 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
[[Page 100751]]
DGT-28 EPSPS 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 the DGT-28 EPSPS
protein. Therefore, an exemption from the requirement of a tolerance is
established for residues of DGT-28 EPSPS 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 inert ingredient in corn.
B. Analytical Enforcement Methodology
Validated enzyme linked immunosorbent assays (ELISAs) are available
analytical methods for detection of DGT-28 EPSPS protein. These ELISAs
have been demonstrated to reliably detect the levels of protein in the
tissues of corn.
C. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of the Streptomyces sviceus DGT-28 EPSPS (5-
enolpyruvylshikimate-3-phosphate synthase) protein in or on the food
and feed commodities of corn: corn, field; corn, sweet; and corn, pop
when used as an inert ingredient in 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
exemption 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).
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 5, 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. 174.550 to subpart W to read as follows:
Sec. 174.550 Streptomyces sviceus DGT-28 EPSPS (5-
enolpyruvylshikimate-3-phosphate synthase) protein; exemption from the
requirement of a tolerance.
Residues of Streptomyces sviceus DGT-28 EPSPS (5-
enolpyruvylshikimate-3-phosphate synthase) protein 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 an inert
ingredient in a plant-incorporated protectant in corn.
[FR Doc. 2024-29362 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P
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