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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 [www.gpo.gov]
[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 
https://www.regulations.gov. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174.

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: https://www.regulations.gov. 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 
https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

[[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 https://www.regulations.gov. 
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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