Rule2025-02997
Bacillus Thuringiensis Cry1B.34 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
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 the Bacillus thuringienisis Cry1B.34 protein (hereafter Cry1B.34 protein) in or on the food and feed commodities of corn, field; corn, sweet; and corn, pop when used as a Plant-Incorporated Protectant (PIP). Pioneer Hi-Bred International, 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 Cry1B.34 protein.
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 10597-10599]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02997]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2022-0988; FRL-12514-01-OCSPP]
Bacillus Thuringiensis Cry1B.34 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 thuringienisis Cry1B.34
protein (hereafter Cry1B.34 protein) in or on the food and feed
commodities of corn, field; corn, sweet; and corn, pop when used as a
Plant-Incorporated Protectant (PIP). Pioneer Hi-Bred International,
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 Cry1B.34 protein.
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-2022-0988, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</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>.
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#397b69697d7f6b77564d505a5c4a795c4958175e564f"><span class="__cf_email__" data-cfemail="2e6c7e7e6a687c60415a474d4b5d6e4b5e4f00494158">[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
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 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. 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 EPA, you must identify docket ID number EPA-HQ-OPP-
2022-0988, 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).
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 and Statutory Findings
In the Federal Register of February 23, 2023 (88 FR 11401 (FRL-
10579-01-OCSPP)), 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 by Pioneer Hi-Bred International, Inc., requesting
that 40 CFR part 174 be amended by establishing an exemption from the
requirement of a tolerance for residues of Bacillus thuringiensis
Cry1B.34 protein in maize. That document incorrectly noted the petition
number as PP 2F29001 and the address of Pioneer as 8325 NW 62nd Avenue,
Johnston, IA 50131. The correct petition number is PP 2F9001, and the
correct address is 7100 NW 62nd Avenue, P.O. Box 1000, Johnston, Iowa
50131. 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>. One comment was received on
the notice of filing. EPA's response to this comment is discussed in
Unit III.C.
[[Page 10598]]
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of the 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, among other things, ``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.34
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, Cry1B.34, and the Genetic Material Necessary
(PHP79620) for its Production in Event DP910521 maize (OECD Unique
Identifier: DP-91[Oslash]521-2), and in Support of a Permanent
Tolerance Exemption for Residues of this Protein 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-2022-0988.
Cry1B.34 is a modified protein derived from the bacterium Bacillus
thuringiensis (Bt) and, when expressed in corn plants, provides
protection against feeding damage caused by certain susceptible
lepidopteran insect pests. Cry1B.34 is a chimeric protein comprising
sequences from the Bt cry1B-class, cry1Ca1, and cry9Db1 genes. The
Agency used a ``weight of evidence'' approach and determined that,
Cry1B.34 protein represents a negligible risk to humans that consume
Cry1B.34 maize products. Although there may be dietary exposure to
residues of Cry1B.34 protein, such exposure presents no concern for
adverse effects. Submitted data showed that no adverse toxic effects
were observed in acute oral toxicity studies conducted with Cry1B.34
protein in mice. Additionally, a bioinformatics analysis found that
Cry1B.34 protein does not exhibit homology to any known mammalian
toxins. Likewise, the potential for allergenicity is low because: (1)
the Cry1B.34 protein is a novel protein that was derived via
biotechnology from the encoding genes of three other proteins. The
bacterial source of those proteins is Bacillus thuringiensis, which has
a long history of safe use, including use as a pesticide, and is not
considered to be a source of allergenic proteins; (2) bioinformatic
analysis indicates no similarity between Cry1B.34 protein and any known
allergens; (3) Cry1B.34 protein is rapidly digested when exposed to
gastric proteases; (4) Cry1B.34 protein shows loss of function under
high temperatures (>=75 [deg]C), indicating that it is heat labile and
will likely denature in the course of normal thermal treatment during
food preparation; and (5) Cry1B.34 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 Cry1B.34 protein is dietary through
consumption of food products made from corn containing the protein.
However, such exposure is expected to be very low given the very low
level of expression of Cry1B.34 protein in grain (7.7 nanograms (ng)/
milligrams (mg) dry weight). Oral exposure to the Cry1B.34 protein via
drinking water specifically is considered unlikely. When a plant dies
or a part is removed from the living plant, microorganisms colonize the
tissue immediately and begin to degrade it. Microorganisms utilize the
plant components, including any residues of Cry1B.34 that are the
subject of the tolerance exemption, as building blocks for their own
metabolisms. This biodegradation is expected to occur in rapid fashion
and is likely to preclude residues of Cry1B.34, which is already
present only at low levels within the whole corn plant (320ng/mg dry
weight), from persisting in the environment long enough to reach the
drinking water supply. Importantly, in the unlikely event that Cry1B.34
does enter drinking water, exposure to this protein would not be
expected to result in a human health risk based on the lack of toxicity
and minimal potential for allergenicity.
The Cry1B.34 protein is not proposed for use in residential
settings; therefore, EPA does not expect much, if any, residential
exposures. The most likely non-dietary, non-occupational route of
exposure is through the inhalation of corn pollen; however, since corn
pollen is typically many sizes greater than respirable particles, it is
unlikely that people living in residential areas around commercial corn
fields will inhale corn pollen containing the Cry1B.34 protein. Even if
inhalation of dust-like particles were to occur, the protein is
contained within plant cells, which essentially eliminates the
likelihood of any actual exposure to the protein itself. 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.34 protein has been identified as no toxicity or
allergenicity has been shown for this protein in the submitted studies.
Therefore, EPA has concluded that Cry1B.34 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 Cry1B.34 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
[[Page 10599]]
result to the U.S. population, including infants and children, from
aggregate exposure to residues of Cry1B.34 protein. Therefore, an
exemption from the requirement of a tolerance is established for
residues of Cry1B.34 protein in or on the food and feed commodities of
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 method was submitted for an enzyme-linked immunosorbent
assay (ELISA) to detect the presence of Cry1B.34 protein in extracts
from different plant parts. The submitted ELISA methodology was
determined to be a valid method of detecting Cry1B.34 protein in the
tissues of corn.
C. Response to Comment
One comment was received during the public comment period for the
notice of filing. The commentor provided general objections to EPA
establishing exemptions from the requirement of a tolerance for
pesticides but did not provide any specific or substantive objections
to the petition to exempt the Cry1B.34 protein. Based on its review of
the data and other information submitted in support of the tolerance
exemption petition (as described above in Unit III.A), EPA has
determined that a tolerance exemption for Cry1B.34 protein is safe
under the FFDCA. Therefore, EPA is establishing an exemption from the
requirement of a tolerance for residues of Cry1B.34 protein in or on
the feed and food commodities 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.
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 (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 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 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 11, 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 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. 174.553 to subpart W to read as follows:
Sec. 174.553 Bacillus thuringiensis Cry1B.34 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry1B.34 protein in or on the
food and feed commodities of corn, field; corn, sweet; and corn, pop
are exempt from the requirement when used as a plant-incorporated
protectant in corn.
[FR Doc. 2025-02997 Filed 2-24-25; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.