Rule2024-29133
Brevibacillus Laterosporus Mpp75Aa1.1 and Bacillus Thuringiensis Vpb4Da2 Proteins; Exemptions 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 17, 2024
Effective
December 17, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of the Brevibacillus laterosporus Mpp75Aa1.1 and Bacillus thuringiensis Vpb4Da2 proteins (hereafter Mpp75Aa1.1 and Vpb4Da2 proteins) in or on the food and feed commodities of corn: corn, field; corn, sweet, and corn, pop when used as plant-incorporated protectants (PIP) in corn. Bayer CropScience LP., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these exemptions. These regulations eliminate the need to establish maximum permissible levels for residues of Mpp75Aa1.1 and Vpb4Da2 proteins.
Full Text
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<title>Federal Register, Volume 89 Issue 242 (Tuesday, December 17, 2024)</title>
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[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Rules and Regulations]
[Pages 101938-101941]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29133]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2022-0231; FRL-12399-01-OCSPP]
Brevibacillus Laterosporus Mpp75Aa1.1 and Bacillus Thuringiensis
Vpb4Da2 Proteins; Exemptions From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of the Brevibacillus laterosporus Mpp75Aa1.1
and Bacillus thuringiensis Vpb4Da2 proteins (hereafter Mpp75Aa1.1 and
Vpb4Da2 proteins) in or on the food and feed commodities of corn: corn,
field; corn, sweet, and corn, pop when used as plant-incorporated
protectants (PIP) in corn. Bayer CropScience LP., submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting these exemptions. These regulations eliminate the need to
establish maximum permissible levels for residues of Mpp75Aa1.1 and
Vpb4Da2 proteins.
DATES: This regulation is effective December 17, 2024. Objections and
requests for hearings must be received on or before February 18, 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-2022-0231, 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#c18391918587938faeb5a8a2a4b281a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="531103031715011d3c273a303620133623327d343c25">[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/chapter-I/subchapter-E/part-174">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174</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-2022-0231, 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 18, 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-2022-0231, by one of
the following methods:
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.
Mail: OPP Docket, Environmental Protection Agency Docket Center
(EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001.
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>.
[[Page 101939]]
II. Background and Statutory Findings
In the Federal Register of December 19, 2023 (88 FR 87733) (FRL-
10579-11-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 (PP 3F9076) by Bayer CropScience 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 the plant-incorporated
protectants (PIPs) Brevibacillus laterosporus Mpp75Aa1.1 and Bacillus
thuringienisis Vpb4Da2 in or on corn. That document referenced a
summary of the petition prepared by the petitioner Bayer Crop Science
LP, which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
There was one comment 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 it 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
Mpp75Aa1.1 and Vpb4Da2 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 an Experimental Use Permit to Test MON 95275 Corn (OECD
Unique Identifier MON-95275-7) Expressing Transgenic Plant-Incorporated
Protectants Mpp75Aa1.1, Vpb4Da2, and Double Stranded RNA DvSnf7.1 and
the Genetic Material Necessary for their Production (Vector PV-
ZMIR525664)'' (hereafter Human Health Risk Assessment). This document,
as well as other relevant information, is available in the docket for
this action EPA-HQ-OPP-2022-0231.
Mpp75Aa1.1 is a modified protein derived from the bacterium
Brevibacillus laterosporus and is active against certain coleopteran
pests of corn. Available data demonstrated that, with regard to humans,
the Mpp75Aa1.1 protein does not pose a toxic or allergenic risk. An
acute oral toxicity study using purified Mpp75Aa1.1 protein shows that
the protein is not toxic to mammals via the oral route of exposure at
levels well above those that are reasonably anticipated through normal
dietary consumption of the crop. In addition, a bioinformatics analysis
of the primary protein sequence did not identify any significant
homologies of the Mpp75Aa1.1 protein to known mammalian toxins.
Likewise, the potential for allergenicity is low because: (1) the
bacterial source of the Mpp75Aa1.1 protein, Brevibacillus laterosporus,
is ubiquitous in the environment, which implies widespread human and
animal exposure, and a scientific literature search of the bacterium
did not indicate any allergenic history; (2) bioinformatic analyses
indicate no biologically relevant similarity between the Mpp75Aa1.1
protein and any known allergens; (3) the Mpp75Aa1.1 protein degrades
rapidly when exposed to digestive enzymes (gastric proteases) present
in the human gastrointestinal tract; (4) the Mpp75Aa1.1 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) the Mpp75Aa1.1
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 route of exposure to this plant-incorporated
protectant is dietary, via products produced from corn expressing the
Mpp75Aa1.1 protein. Oral exposure from ingestion of drinking water is
unlikely because the Mpp75Aa1.1 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. Further, if
Mpp75Aa1.1 protein were to enter the water column, it is expected to
break down rapidly through natural processes (e.g., microbial or UV
degradation) or normal communal water-treatment procedures. Even if
there may be dietary exposure to residues of the Mpp75Aa1.1 protein,
such exposure presents no concern for adverse effects based on the
available toxicity and allergenicity analysis mentioned above.
Non-dietary non-occupational exposure via dermal or ocular routes
is not likely since the Mpp75Aa1.1 protein is contained within plant
cells. The most likely non-dietary route of exposure to the Mpp75Aa1.1
protein may be through inhalation of corn pollen. However, exposure to
the Mpp75Aa1.1 protein through this route of exposure is expected to be
negligible for several reasons: (1) its presence in pollen was
demonstrated to be very low (below the limit of quantification), and
(2) corn pollen is not respirable, as it consists of spherical
particles ranging in size from 80 to 125 [mu]m, in contrast with
respirable particles that are less than 10 [mu]m. Even if inhalation of
dust-like particles were to occur, the Mpp75Aa1.1 protein is contained
within plant cells, which essentially eliminates pulmonary exposure to
the proteins. Further, as described above, such exposure would not be
expected to present any risk due to the lack of toxicity or
allergenicity observed for the Mpp75Aa1.1 protein. These findings are
discussed in more detail in the Human Health Risk Assessment.
Vpb4Da2 is derived from the bacterium Bacillus thuringiensis (Bt)
and is active against certain coleopteran pests of corn. Available data
demonstrated that, with regard to humans, the Vpb4Da2 protein does not
pose a toxic or allergenic risk. An acute oral toxicity study using
purified Vpb4Da2 protein shows that the protein is not toxic to mammals
via the oral route of exposure at levels well above those that are
reasonably anticipated through normal dietary consumption of the crop.
In addition, a bioinformatics analysis of the primary protein sequence
[[Page 101940]]
did not identify any significant homologies of the Vpb4Da2 protein to
known mammalian toxins. Likewise, the potential for allergenicity is
low because: (1) the bacterial source of the Vpb4Da2 protein, Bacillus
thuringiensis, 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 analyses indicate no biologically relevant similarity
between the Vpb4Da2 protein and any known allergens; (3) the Vpb4Da2
protein degrades rapidly when exposed to digestive enzymes (gastric
proteases) present in the human gastrointestinal tract; (4) the Vpb4Da2
protein shows loss of function under high temperatures (>=55 [deg]C),
indicating that it is heat labile and will likely denature in the
course of normal thermal treatment during food preparation; and (5) the
Vpb4Da2 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 route of exposure to this plant-incorporated
protectant is dietary, via products produced from corn expressing the
protein. Oral exposure from ingestion of drinking water is unlikely
because the Vpb4Da2 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. Further, if protein were to
enter the water column, it is expected to break down rapidly through
natural processes (e.g., microbial or UV degradation) or normal
communal water-treatment procedures. Even if there may be dietary
exposure to residues of the Vpb4Da2 protein, such exposure presents no
concern for adverse effects based on the toxicity and allergenicity
discussion above.
Non-dietary non-occupational exposure via dermal or ocular routes
is not likely since the Vpb4Da2 protein is contained within plant
cells. The most likely non-dietary route of exposure to the Vpb4Da2
protein may be through inhalation of corn pollen. However, exposure to
the Vpb4Da2 protein through this route of exposure is expected to be
negligible for several reasons: (1) its presence in pollen was
demonstrated to be very low (below the limit of quantification), and
(2) corn pollen is not respirable, as it consists of spherical
particles ranging in size from 80 to 125 [mu]m, in contrast with
respirable particles that are less than 10 [mu]m. Even if inhalation of
dust-like particles were to occur, the Vpb4Da2 protein is contained
within plant cells, which essentially eliminates pulmonary exposure to
the proteins. Further, as described above, such exposure would not be
expected to present any risk due to the lack of toxicity or
allergenicity observed for the Vpb4Da2 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 the Mpp75Aa1.1 protein has been identified as no toxicity
or allergenicity has been shown for this protein in the submitted
studies. Therefore, EPA has concluded that the Mpp75Aa1.1 protein does
not have a common mechanism of toxicity with other substances.
Similarly, no risk of cumulative toxicity or effects from the Vpb4Da2
protein has been identified as no toxicity or allergenicity has been
shown for this protein in the submitted studies. Therefore, EPA has
concluded that the Vpb4Da2 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 the Mpp75Aa1.1 protein. As a result, an
additional margin of safety for the protection of infants and children
is unnecessary. Similarly, EPA has determined that there are no such
effects due to the lack of toxicity of the Vpb4Da2 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 Mpp75Aa1.1 protein
derived from the bacterium Brevibacillus laterosporus. Therefore, an
exemption from the requirement of a tolerance is established for
residues of the Mpp75Aa1.1 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.
Similarly, 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
Vpb4Da2 protein derived from the bacterium Bacillus thuringiensis (Bt).
Therefore, an exemption from the requirement of a tolerance is
established for residues of the Vpb4Da2 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 validated Enzyme-Linked Immunosorbent
Assays (ELISA) are available for the detection of Mpp75Aa1.1 and
Vpb4Da2 proteins. These assays have been demonstrated to reliably
detect the levels of the Mpp75Aa1.1 and Vpb4Da2 proteins 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 tolerances for pesticides but did not
provide any specific or substantive objections to the petition to
exempt the Mpp75Aa1.1 and Vpb4Da2 proteins when used as plant-
incorporated protectants. 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 Mpp75Aa1.1 and Vpb4Da2 proteins, when used as plant-
incorporated protectants, is safe under the FFDCA. Therefore, EPA is
establishing an exemption from the requirement of a tolerance for
residues of Mpp75Aa1.1 and Vpb4Da2 proteins in or on the food and feed
commodities of corn.
IV. Statutory and Executive Order Reviews
This action establishes exemptions 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
[[Page 101941]]
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 exemptions 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 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 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. Sec. 174.551 and 174.552 to subpart W to read as follows:
Subpart W--Tolerances and Tolerance Exemptions
* * * * *
Sec. 174.551 Brevibacillus laterosporus Mpp75Aa1.1 protein; exemption
from the requirement of a tolerance.
Residues of Brevibacillus laterosporus Mpp75Aa1.1 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 a
plant-incorporated protectant in corn.
Sec. 174.552 Bacillus thuringiensis Vpb4Da2 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Vpb4Da2 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 a
plant-incorporated protectant in corn.
[FR Doc. 2024-29133 Filed 12-16-24; 8:45 am]
BILLING CODE 6560-50-P
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