Bacillus Thuringiensis Cry1Da2 Protein; Exemption From the Requirement of a Tolerance, 100746-100749 [2024-29132]
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
Comment: One comment suggested
the proposed solution failed to account
for specific use cases where there is no
clear alternative to dual shipping labels.
Response: The Postal Service has
considered specific use cases and
determined that there are few, if any,
instances in which there are no
alternatives to dual shipping labels. The
shipper always has the option to simply
determine in advance of label creation
what carrier will ultimately deliver the
package. Alternatively, if a dual label
was created after the effective date of
the rule, such label could simply be
over labeled or the carrier markings
could be obliterated in such fashion as
to only display the selected delivery
carrier’s markings.
Comment: One comment suggests that
the definition of what constitutes a
‘‘dual shipping label’’ for purposes of
the enforcement of this rule is unclear.
Response: The Postal Service has
considered this comment. DMM section
602.10.0 currently states, ‘‘Dual
shipping labels are used by private
shipper[s] to identify both the Postal
Service and a private carrier as possible
delivery agents.’’ This definition will
now be reinserted into the new rule.
Consistent with this, under the new
rule, a label that identifies the Postal
Service as the carrier may also include
additional items of information so long
as none of those additional items of
information identify delivery agents
other than the Postal Service. In other
words, a label will not be considered a
prohibited ‘‘dual shipping label’’ simply
because it includes additional
information beyond what is required for
Postal Service label and address
formats. Instead, it will only be
considered a dual shipping label if any
of the additional information included
thereon identifies or can be used to
designate delivery agents other than the
Postal Service.
The Postal Service is discontinuing
the use of dual shipping labels. Items
bearing dual shipping labels should not
be accepted and may be returned to the
sender.
The Postal Service adopts the
described changes to Mailing Standards
of the United States Postal Service,
Domestic Mail Manual (DMM),
incorporated by reference in the Code of
Federal Regulations. We will publish an
appropriate amendment to 39 CFR part
111 to reflect these changes.
List of Subjects in 39 CFR Part 111
Administrative practice and
procedure, Postal Service.
Accordingly, the Postal Service
amends Mailing Standards of the United
States Postal Service, Domestic Mail
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Manual (DMM), incorporated by
reference in the Code of Federal
Regulations as follows (see 39 CFR
111.1):
PART 111—[AMENDED]
1. The authority citation for 39 CFR
part 111 continues to read as follows:
■
Authority: 5 U.S.C. 552(a); 13 U.S.C. 301–
307; 18 U.S.C. 1692–1737; 39 U.S.C. 101,
401–404, 414, 416, 3001–3018, 3201–3220,
3401–3406, 3621, 3622, 3626, 3629, 3631–
3633, 3641, 3681–3685, and 5001.
2. Revise Mailing Standards of the
United States Postal Service, Domestic
Mail Manual (DMM) as follows:
■
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
(DMM)
*
*
*
*
*
600 Basic Standards for All Mailing
Services
*
*
*
*
602
Addressing
*
*
10.0
*
*
*
*
Dual Shipping Labels
[Revise the text of 10.0 to read as
follows:]
Dual shipping labels are used by
private shipper to identify both the
Postal Service and a private carrier as
possible delivery agents. Mailers must
not use dual shipping labels. Items
bearing dual shipping labels should not
be accepted and may be returned to the
sender.
*
*
*
*
*
Colleen Hibbert-Kapler,
Attorney, Ethics and Legal Compliance.
[FR Doc. 2024–29435 Filed 12–12–24; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2023–0022; FRL–12380–01–
OCSPP]
Bacillus Thuringiensis Cry1Da2
Protein; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of the Bacillus
thuringiensis Cry1Da2 protein in or on
the food and feed commodities of corn:
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
40 CFR Part 174
PO 00000
corn, field; corn, sweet; and corn, pop,
when used as a plant-incorporated
protectant (PIP). Pioneer Hi-Bred
International, Inc., (Pioneer) submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Cry1Da2 protein.
DATES: This regulation is effective
December 13, 2024. Objections and
requests for hearings must be received
on or before February 11, 2025, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2023–0022, is
available at https://www.regulations.gov
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 https://www.epa.gov/dockets.
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: BPPDFRNotices@
epa.gov.
Sfmt 4700
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).
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
• 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.
khammond on DSK9W7S144PROD with RULES
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2023–0022, in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 11, 2025. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2023–0022, by one of the following
methods:
• 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-sendcomments-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.
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II. Background and Statutory Findings
In the Federal Register of February
23, 2023 (88 FR 11401) (FRL–10579–01),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 0F9003)
by Pioneer Hi-Bred International, Inc.,
7100 NW 62nd Avenue, P.O. Box 1000,
Johnston, Iowa 50131. The petition
requested that 40 CFR part 174 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of Cry1Da2 protein. That
document referenced a summary of the
petition prepared by the petitioner
Pioneer Hi-Bred International, Inc.,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Final Rule
A. EPA’s Safety Determination
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require EPA to give
special consideration to exposure of
infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue . . . . ’’ Additionally,
FFDCA section 408(b)(2)(D) requires
that the Agency consider ‘‘available
information concerning the cumulative
effects of a particular pesticide’s
residues’’ and ‘‘other substances that
have a common mechanism of toxicity.’’
EPA evaluated the available toxicity
and exposure data on Cry1Da2 protein
and considered its validity,
completeness, and reliability, as well as
the relationship of this information to
human risk. EPA has also considered
available information concerning the
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100747
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 PlantIncorporated Inert Ingredient DGT–28
EPSPS, and the Genetic Material
Necessary (PHP88492) for their
Production in Event DAS–1131–3
Maize, and Establishment of a
Permanent Tolerance Exemption for
Residues of these Proteins when used as
a plant-incorporated protectant in corn’’
(hereafter Human Health Risk
Assessment). This document, as well as
other relevant information, is available
in the docket for this action EPA–HQ–
OPP–2023–0022.
The gene for the insecticidal protein
Cry1Da2 was derived from the
bacterium Bacillus thuringiensis (Bt)
and contains sequences from Bt crystal
toxins, Cry1Ab and Cry1D. The Cry1Da2
protein is intended to provide
protection from certain lepidopteran
pests of corn. In assessing the safety of
the protein, the Agency used a ‘‘weight
of evidence’’ approach and determined
that, Cry1Da2 is not expected to pose
any risk of toxicity to humans and the
likelihood of the protein to be a food
allergen is minimal. Submitted data
show that the Cry1Da2 protein is not
toxic via the oral route of exposure and
a bioinformatics analysis did not
indicate any homology to known toxins.
Likewise, the potential for allergenicity
is low because: (1) The bacterium source
of Cry1Da2 protein, Bacillus
thuringiensis, has a long history of safe
use and is not considered to be a source
of allergenic proteins; (2) bioinformatic
analysis indicates no similarity between
Cry1Da2 protein and known allergens;
(3) Cry1Da2 protein degrades rapidly
when exposed to simulated gastric fluid
and completely digested within one
minute when exposed to simulated
intestinal fluid; (4) Cry1Da2 is
inactivated when heated to high
temperatures (≥75 °C) that are typical of
food cooking; and (5) Cry1Da2 protein is
not glycosylated, which further reduces
its allergenicity potential. Glycosylation
is an enzymatic post-translational
process in which carbohydrates
(glycans) link to proteins, creating
structures which could lead to an
immune response in humans.
The most likely exposure to the
Cry1Da2 protein is dietary through
consumption of food products made
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
from corn containing the protein. Oral
exposure from ingestion of drinking
water is unlikely because the Cry1Da2
protein is present at very low levels
within the plant cells and the amounts
likely to enter the water column from
leaves, pollen or plant detritus are low.
Additionally, proteases and nucleases
found in water and the environment
would likely degrade the biological
material containing the active ingredient
and treatment process for municipal
water plants are likely to remove
Cry1Da2 residues. While dietary
exposure is expected to be limited, even
if there is dietary exposure to residues
of Cry1Da2 protein, such exposure
presents no concern for adverse effects
due to the lack of toxicity or
allergenicity.
Non-dietary, non-occupational or
residential exposure via pulmonary,
dermal, or ocular exposure is not likely
since the Cry1Da2 protein is contained
within plant cells and corn pollen is not
respirable, which essentially eliminates
these exposure routes or reduces them
to negligible levels. Corn pollen is not
considered respirable, as it consists of
spherical particles ranging in size from
90 to 100 mm, whereas respirable
particles are typically less than 10 mm.
In the case of agricultural dusts derived
from activities such as planting,
cultivation, and harvest, these particles
also tend to be of non-respirable sizes.
Additionally, the low expression of
Cry1Da2 in the grain of plants
containing Cry1Da2 further supports the
expectation that exposure via seed dust
would be negligible. If exposure should
occur, EPA concludes that such
exposure would not be expected to
present any risk due to the lack of
toxicity. Thus, adverse effects are not
expected due to non-occupational and
residential exposure to Cry1Da2 protein.
These findings are discussed in more
detail in the Human Health Risk
Assessment.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ No risk of
cumulative toxicity or effects from
Cry1Da2 protein has been identified as
no toxicity or allergenicity has been
shown for this protein in the submitted
studies. Therefore, EPA has concluded
that Cry1Da2 protein does not have a
common mechanism of toxicity with
other substances.
Although FFDCA section 408(b)(2)(C)
provides for an additional tenfold
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margin of safety for infants and children
in the case of threshold effects, EPA has
determined that there are no such
effects due to the lack of toxicity of
Cry1Da2 protein. As a result, an
additional margin of safety for the
protection of infants and children is
unnecessary.
Based upon its evaluation described
above and in the Human Health Risk
Assessment, EPA concludes that there is
a reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of Cry1Da2
protein. Therefore, an exemption from
the requirement of a tolerance is
established for residues of Cry1Da2
protein in or on the food and feed
commodities of corn: corn, field; corn,
sweet; and corn, pop when used as a
plant-incorporated protectant in corn.
B. Analytical Enforcement Methodology
EPA has determined that an analytical
method is not required for enforcement
purposes since the Agency is
establishing an exemption from the
requirement of a tolerance without any
numerical limitation. Nonetheless, a
validated enzyme linked
immunosorbent assay (ELISA) was
developed for detection of Cry1Da2
protein. This ELISA has been
demonstrated to reliably detect the level
of Cry1Da2 protein in the tissues of
corn.
C. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of the Bacillus thuringiensis
Cry1Da2 protein in or on the food and
feed commodities of corn: corn, field;
corn, sweet; and corn, pop when used
as a plant-incorporated protectant (PIP)
in corn.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Because
this action has been exempted from
review under Executive Order 12866,
this action is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
PO 00000
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Risks’’ (62 FR 19885, April 23, 1997).
This action does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal governments, on the
relationship between the National
Government and the States or Tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
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 PLANTINCORPORATED PROTECTANTS
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.
2. Add § 174.549 to subpart W to read
as follows:
■
§ 174.549 Bacillus thuringiensis Cry1Da2
protein; exemption from the requirement of
a tolerance.
Residues of Bacillus thuringiensis
Cry1Da2 protein in or on the food and
feed commodities of corn, including
corn, field; corn, sweet; and corn, pop,
are exempt from the requirement of a
tolerance when used as a plantincorporated protectant in corn.
[FR Doc. 2024–29132 Filed 12–12–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 174
khammond on DSK9W7S144PROD with RULES
[EPA–HQ–OPP–2022–0990; FRL–12381–01–
OCSPP]
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 https://www.regulations.gov
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 https://www.epa.gov/dockets.
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: BPPDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
Streptomyces Sviceus DGT–28 EPSPS
this action if you are an agricultural
(5-Enolpyruvylshikimate-3-Phosphate
producer, food manufacturer, or
Synthase) Protein; Exemption From
pesticide manufacturer. The following
the Requirement of a Tolerance
list of North American Industrial
AGENCY: Environmental Protection
Classification System (NAICS) codes is
Agency (EPA).
not intended to be exhaustive, but rather
ACTION: Final rule.
provides a guide to help readers
determine whether this document
SUMMARY: This regulation establishes an
applies to them. Potentially affected
exemption from the requirement of a
entities may include:
tolerance for residues of the
• Crop production (NAICS code 111).
Streptomyces sviceus DGT–28 EPSPS (5• Animal production (NAICS code
enolpyruvylshikimate-3-phosphate
112).
synthase) protein (hereafter DGT–28
• Food manufacturing (NAICS code
EPSPS protein), in or on the food and
311).
feed commodities of corn: corn, field;
• Pesticide manufacturing (NAICS
corn, sweet; and corn, pop, when used
code 32532).
as a plant-incorporated protectant (PIP)
B. How can I get electronic access to
inert ingredient. Pioneer Hi-Bred
International, Inc., (Pioneer) submitted a other related information?
petition to EPA under the Federal Food,
You may access a frequently updated
Drug, and Cosmetic Act (FFDCA),
electronic version of 40 CFR part 174
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16:42 Dec 12, 2024
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100749
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
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:
• 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-sendcomments-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.
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
E:\FR\FM\13DER1.SGM
13DER1
]]>Agencies
[Federal Register Volume 89, Number 240 (Friday, December 13, 2024)]
[Rules and Regulations]
[Pages 100746-100749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29132]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2023-0022; FRL-12380-01-OCSPP]
Bacillus Thuringiensis Cry1Da2 Protein; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis Cry1Da2
protein in or on the food and feed commodities of corn: corn, field;
corn, sweet; and corn, pop, when used as a plant-incorporated
protectant (PIP). Pioneer Hi-Bred International, Inc., (Pioneer)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Cry1Da2 protein.
DATES: This regulation is effective December 13, 2024. Objections and
requests for hearings must be received on or before February 11, 2025,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0022, is available at
https://www.regulations.gov 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 https://www.epa.gov/dockets.
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:
[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).
[[Page 100747]]
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.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2023-0022, in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 11, 2025. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2023-0022, by one of
the following methods:
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.
II. Background and Statutory Findings
In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F9003) by Pioneer Hi-Bred International, Inc., 7100 NW
62nd Avenue, P.O. Box 1000, Johnston, Iowa 50131. The petition
requested that 40 CFR part 174 be amended by establishing an exemption
from the requirement of a tolerance for residues of Cry1Da2 protein.
That document referenced a summary of the petition prepared by the
petitioner Pioneer Hi-Bred International, Inc., which is available in
the docket, https://www.regulations.gov. There were no comments
received in response to the notice of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. . '' Additionally, FFDCA section 408(b)(2)(D) requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA evaluated the available toxicity and exposure data on Cry1Da2
protein and considered its validity, completeness, and reliability, as
well as the relationship of this information to human risk. EPA has
also considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. A summary of the data upon which EPA relied and
its risk assessment based on those data can be found within the
document entitled ``Product Characterization Review and Human Health
Risk Assessment of the Insecticidal Plant-Incorporated Protectant
Active Ingredient, Bacillus thuringiensis Cry1Da2 and Plant-
Incorporated Inert Ingredient DGT-28 EPSPS, and the Genetic Material
Necessary (PHP88492) for their Production in Event DAS-1131-3 Maize,
and Establishment of a Permanent Tolerance Exemption for Residues of
these Proteins when used as a plant-incorporated protectant in corn''
(hereafter Human Health Risk Assessment). This document, as well as
other relevant information, is available in the docket for this action
EPA-HQ-OPP-2023-0022.
The gene for the insecticidal protein Cry1Da2 was derived from the
bacterium Bacillus thuringiensis (Bt) and contains sequences from Bt
crystal toxins, Cry1Ab and Cry1D. The Cry1Da2 protein is intended to
provide protection from certain lepidopteran pests of corn. In
assessing the safety of the protein, the Agency used a ``weight of
evidence'' approach and determined that, Cry1Da2 is not expected to
pose any risk of toxicity to humans and the likelihood of the protein
to be a food allergen is minimal. Submitted data show that the Cry1Da2
protein is not toxic via the oral route of exposure and a
bioinformatics analysis did not indicate any homology to known toxins.
Likewise, the potential for allergenicity is low because: (1) The
bacterium source of Cry1Da2 protein, Bacillus thuringiensis, has a long
history of safe use and is not considered to be a source of allergenic
proteins; (2) bioinformatic analysis indicates no similarity between
Cry1Da2 protein and known allergens; (3) Cry1Da2 protein degrades
rapidly when exposed to simulated gastric fluid and completely digested
within one minute when exposed to simulated intestinal fluid; (4)
Cry1Da2 is inactivated when heated to high temperatures (>=75 [deg]C)
that are typical of food cooking; and (5) Cry1Da2 protein is not
glycosylated, which further reduces its allergenicity potential.
Glycosylation is an enzymatic post-translational process in which
carbohydrates (glycans) link to proteins, creating structures which
could lead to an immune response in humans.
The most likely exposure to the Cry1Da2 protein is dietary through
consumption of food products made
[[Page 100748]]
from corn containing the protein. Oral exposure from ingestion of
drinking water is unlikely because the Cry1Da2 protein is present at
very low levels within the plant cells and the amounts likely to enter
the water column from leaves, pollen or plant detritus are low.
Additionally, proteases and nucleases found in water and the
environment would likely degrade the biological material containing the
active ingredient and treatment process for municipal water plants are
likely to remove Cry1Da2 residues. While dietary exposure is expected
to be limited, even if there is dietary exposure to residues of Cry1Da2
protein, such exposure presents no concern for adverse effects due to
the lack of toxicity or allergenicity.
Non-dietary, non-occupational or residential exposure via
pulmonary, dermal, or ocular exposure is not likely since the Cry1Da2
protein is contained within plant cells and corn pollen is not
respirable, which essentially eliminates these exposure routes or
reduces them to negligible levels. Corn pollen is not considered
respirable, as it consists of spherical particles ranging in size from
90 to 100 [mu]m, whereas respirable particles are typically less than
10 [mu]m. In the case of agricultural dusts derived from activities
such as planting, cultivation, and harvest, these particles also tend
to be of non-respirable sizes. Additionally, the low expression of
Cry1Da2 in the grain of plants containing Cry1Da2 further supports the
expectation that exposure via seed dust would be negligible. If
exposure should occur, EPA concludes that such exposure would not be
expected to present any risk due to the lack of toxicity. Thus, adverse
effects are not expected due to non-occupational and residential
exposure to Cry1Da2 protein. These findings are discussed in more
detail in the Human Health Risk Assessment.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' No risk of cumulative toxicity or
effects from Cry1Da2 protein has been identified as no toxicity or
allergenicity has been shown for this protein in the submitted studies.
Therefore, EPA has concluded that Cry1Da2 protein does not have a
common mechanism of toxicity with other substances.
Although FFDCA section 408(b)(2)(C) provides for an additional
tenfold margin of safety for infants and children in the case of
threshold effects, EPA has determined that there are no such effects
due to the lack of toxicity of Cry1Da2 protein. As a result, an
additional margin of safety for the protection of infants and children
is unnecessary.
Based upon its evaluation described above and in the Human Health
Risk Assessment, EPA concludes that there is a reasonable certainty
that no harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of Cry1Da2 protein.
Therefore, an exemption from the requirement of a tolerance is
established for residues of Cry1Da2 protein in or on the food and feed
commodities of corn: corn, field; corn, sweet; and corn, pop when used
as a plant-incorporated protectant in corn.
B. Analytical Enforcement Methodology
EPA has determined that an analytical method is not required for
enforcement purposes since the Agency is establishing an exemption from
the requirement of a tolerance without any numerical limitation.
Nonetheless, a validated enzyme linked immunosorbent assay (ELISA) was
developed for detection of Cry1Da2 protein. This ELISA has been
demonstrated to reliably detect the level of Cry1Da2 protein in the
tissues of corn.
C. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of the Bacillus thuringiensis Cry1Da2 protein
in or on the food and feed commodities of corn: corn, field; corn,
sweet; and corn, pop when used as a plant-incorporated protectant (PIP)
in corn.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
[[Page 100749]]
List of Subjects in 40 CFR Part 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 4, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 174.549 to subpart W to read as follows:
Sec. 174.549 Bacillus thuringiensis Cry1Da2 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry1Da2 protein in or on the
food and feed commodities of corn, including corn, field; corn, sweet;
and corn, pop, are exempt from the requirement of a tolerance when used
as a plant-incorporated protectant in corn.
[FR Doc. 2024-29132 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P
