[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 [www.gpo.gov]
[FR Doc No: 2024-17419]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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).
     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 
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-2022-0939 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:
     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 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, 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, 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