Rule2024-17419
Ophioglossum pendulum IPD079Ea Protein; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2024
Effective
August 8, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Ophioglossum pendulum IPD079Ea protein (hereafter IPD079Ea protein) when used as a plant incorporated protectant (PIP) in or on the food and feed commodities of corn: corn, field; corn, sweet, and corn, pop. Pioneer Hi-Bred International, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of IPD079Ea protein.
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Rules and Regulations]
[Pages 64807-64810]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17419]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2022-0939; FRL-11911-01-OCSPP]
Ophioglossum pendulum IPD079Ea 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 Ophioglossum pendulum IPD079Ea protein
(hereafter IPD079Ea protein) when used as a plant incorporated
protectant (PIP) in or on the food and feed commodities of corn: corn,
field; corn, sweet, and corn, pop. Pioneer Hi-Bred International, Inc.,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of IPD079Ea protein.
DATES: This regulation is effective August 8, 2024. Objections and
requests for hearings must be received on or before October 7, 2024,
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-2022-0939, is
[[Page 64808]]
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room and for the OPP Docket is (202) 566-
1744. Please review the visitor instructions and additional information
about the docket available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Madison Le, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#f0b2a0a0b4b6a2be9f8499939583b0958091de979f86"><span class="__cf_email__" data-cfemail="a0e2f0f0e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6">[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 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0939 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
October 7, 2024. 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-2022-0939, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
In the Federal Register of January 3, 2023 (88 FR 38) (FRL-9410-
08), 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 2F9010 by Pioneer Hi-Bred International, Inc., 7100 NW 62
Avenue, P.O. Box 1000, Johnston, IA 50131-1000). The petition requested
that 40 CFR part 174 be amended by establishing an exemption from the
requirement of a tolerance for residues of Ophioglossum pendulum
IPD079Ea insecticidal protein in or on corn. That document referenced a
summary of the petition prepared by the petitioner Pioneer Hi-Bred
International, Inc., which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. '' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider, among other factors, ``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 IPD079Ea
protein 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 ``Product Characterization Review and Human Health
Risk Assessment of the Insecticidal Plant-Incorporated Protectant
Active Ingredient Ophioglossum pendulum IPD079Ea Protein and the
Genetic Material Necessary (PHP83175) for its Production in DP-915635-4
maize and Establishment of a Permanent Tolerance Exemption'' (hereafter
Human Health Risk Assessment). This document, as well as other relevant
information, is available in the docket for this action EPA-HQ-OPP-
2022-0939.
[[Page 64809]]
The IPD079Ea protein, encoded by the ipd079Ea gene from
Ophioglossum pendulum (common name: ribbon fern), a Southeast Asian
epiphyte, confers control of Diabrotica virgifera virgifera (Western
Corn Rootworm) when expressed in corn plants. An assessment of the
toxic and allergenic potential of the IPD079Ea protein indicates that
the IPD079Ea protein is not likely to be a potential toxin or allergen
by any route of exposure. Dietary exposure is deemed the most relevant
route for assessing human health risk of IPD079Ea protein, as corn
products are made from grains and are consumed regularly by the
American public. However, exposure to IPD079Ea protein through
consumption of corn products containing the protein is expected to be
very low given its very low levels of expression in grain. Oral
exposure to IPD079Ea protein via drinking water is considered unlikely
because the protein is already expressed at very low levels in the
whole corn plant. Further, leaching into the soil and groundwater,
combined with environmental conditions and microbial activity, is
expected to further reduce its presence in drinking water. Although
there may be dietary exposure to residues of IPD079Ea protein, such
exposure presents no concern for adverse effects. Acute oral toxicity
data demonstrated a lack of mammalian toxicity at high levels of
exposure to pure IPD079Ea protein, and a bioinformatics analysis showed
no similarities between the IPD079Ea protein and known toxic proteins
that would raise a safety concern. Likewise, the potential for
allergenicity is low because (1) there is no information in the
literature indicating that Ophioglossum pendulum is a known source of
allergenic proteins, (2) a bioinformatics analysis showed that the
IPD079Ea protein does not have significant homology with known or
putative allergens, (3) the IPD079Ea protein degrades rapidly (within
30 seconds) in the presence of simulated gastric fluid, indicating the
protein will not be intact after stomach digestion, (4) the IPD079Ea
protein is inactivated at high temperatures (50 [deg]C/122 [deg]F),
such as those experienced by cooking corn products, and (5) the 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.
Residential and non-occupational exposures are expected to be
minimal given that the IPD079Ea protein is a plant-incorporated
protectant in corn. The only possible route of non-occupational
exposure other than dietary is via handling of the plants and plant
products. Exposures via the skin or inhalation are expected to be
minimal given that the IPD079Ea protein is embedded in the matrix of
the plant, which essentially eliminates or reduces dermal and
inhalation routes of exposure to negligible levels. Furthermore,
IPD079Ea protein expression in leaf tissue, forage, and pollen is very
low. Together, there are no risks associated with these exposure routes
because IPD079Ea protein is present in the plant at low levels and is
not toxic or allergenic. 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.'' EPA has not found the IPD079Ea protein
to share a common mechanism of toxicity with any other substances, and
the IPD079Ea protein does not appear to produce a toxic metabolite
produced by other substances. Therefore, EPA has assumed that IPD079Ea
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 and allergenicity of the IPD079Ea 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 IPD079Ea protein.
Therefore, an exemption from the requirement of a tolerance is
established for residues of the IPD079Ea 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 protocol for a lateral flow test kit was submitted for
detection of IPD079Ea protein. The submitted protocol adequately
describes the methodology.
IV. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., 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 exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order
[[Page 64810]]
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: July 25, 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. 174.547 to subpart W to read as follows:
Sec. 174.547 Ophioglossum pendulum IPD079Ea protein; exemption from
the requirement of a tolerance.
Residues of Ophioglossum pendulum IPD079Ea 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. 2024-17419 Filed 8-7-24; 8:45 am]
BILLING CODE 6560-50-P
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