Document ID: EPA-HQ-OPP-2021-0396-0004
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Peptide Derived from Harpin Protein
Posted Date: 2023-02-08T05:00Z

[Federal Register Volume 88, Number 26 (Wednesday, February 8, 2023)]
[Rules and Regulations]
[Pages 8233-8236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02536]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0396; FRL-10572-01-OCSPP]

Peptide Derived From Harpin 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 Peptide Derived from Harpin Protein 
(PDHP) 25279 in or on all food commodities when used in accordance with 
label directions and good agricultural practices. Plant Health Care 
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 PDHP 25279 under FFDCA when used in 
accordance with this exemption.

DATES: This regulation is effective February 8, 2023. Objections and 
requests for hearings must be received on or before April 10, 2023 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-2021-0396, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency

[[Page 8234]]

Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20004. 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 OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, 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) 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(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-2021-0396 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 
April 10, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although EPA 
strongly encourages those interested in submitting objections or a 
hearing request to submit objections and hearing requests 
electronically. See Order Urging Electronic Service and Filing (April 
10, 2020), https://www.epa.gov/sites//default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this 
time, because of the COVID-19 pandemic, the judges and staff of the 
Office of Administrative Law Judges are working remotely and not able 
to accept filings or correspondence by courier, personal delivery, or 
commercial delivery, and the ability to receive filings or 
correspondence by U.S. Mail is similarly limited. When submitting 
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a 
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions during this time that the Agency 
continues to maximize telework due to the pandemic; therefore, EPA 
believes the preference for submission via electronic means will not be 
prejudicial. If it is impossible for a person to submit documents 
electronically or receive service electronically, e.g., the person does 
not have any access to a computer, the person shall so advise OALJ by 
contacting the Hearing Clerk at (202) 564-6281. If a person is without 
access to a computer and must file documents by U.S. Mail, the person 
shall notify the Hearing Clerk every time it files a document in such a 
manner. The address for mailing documents is U.S. Environmental 
Protection Agency, Office of Administrative Law Judges, Mail Code 
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    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-2021-0396, 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/ets/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

    In the Federal Register of June 17, 2022 (87 FR 36438) (FRL-9929-
01), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance exemption 
petition (PP 1F8901) by Plant Health Care Inc., 2626 Glenwood Ave., 
Suite 350, Raleigh, NC 27608. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of fungicide PDHP 25279 in or on growing crops 
or seeds. That notice referenced a summary of the petition prepared by 
the petitioner Plant Health Care Inc., and available in the docket via 
https://www.regulations.gov. EPA received one comment on the notice of 
filing. EPA's response to this comment is discussed in Unit III.C.

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 of 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

[[Page 8235]]

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 or tolerance exemption 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 EPA 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 toxicological and exposure data on PDHP 
25279 and considered their validity, completeness, and reliability, as 
well as the relationship of this information to human risk. A full 
explanation of the data upon which EPA relied and its risk assessment 
based on those data can be found within the document entitled ``Human 
Health Risk Assessment, Review of Product Characterization and 
Manufacturing Processes of the New End-Use Product PHC 25279 Containing 
the New Active Ingredient Harpin Protein PDHP 25279. Data was Provided 
in Support of a FIFRA Section 3 Registration and Establishment of a 
Permanent Tolerance Exemption'' (Human Health Risk Assessment). This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES.
    Available data have demonstrated that, with regard to humans, 
Peptide Derived from Harpin Protein (PDHP) 25279 is not anticipated to 
be toxic or allergenic via any reasonably foreseeable route of 
exposure. The active ingredient in PDHP 25279 is a 28 amino acid 
peptide derived from the harpinW protein found in the phytopathogenic 
bacterium Erwinia amylovora, a plant pathogen responsible for causing 
fire blight in plants such as apple, pear, and raspberry. PDHP 25279 is 
a third-generation PDHP that does not directly affect the target pest. 
Instead, the mode of action for PDHP 25279 is proposed to be through 
the induction of natural defense mechanisms in the plant by way of 
salicylic acid (SA) and ethylene/jasmonic acid-dependent signaling, 
which in turn activate the ``hypersensitive response'' (HR) and 
ultimately elicit systemic acquired resistance in the plant. HR is 
characterized as rapid, localized cell death in plant tissue after 
infiltration of the peptide into the intercellular spaces of plant 
leaves. This reaction initiates a complex set of metabolic responses in 
the treated plant, causing systemic gene expression and eliciting a 
plant's natural growth and defense system, which results in enhanced 
resistance of the plant to fungal and bacterial diseases.
    The Agency has concluded that any potential dietary risk from the 
use of PDHP 25279 to human health is considered negligible for the 
following reasons: (1) PDHP 25279 was found to have low toxicity via 
the oral route of exposure, did not show any homology to known or 
putative allergens, and is rapidly degraded in simulated gastric 
fluids. The submitted mammalian toxicity studies and the studies that 
are bridged from similar already registered harpin proteins to support 
the tolerance exemption for the active ingredient PDHP 25279 are 
summarized with their classifications in the Human Health Risk 
Assessment, Table 2; (2) Dietary exposure to residues of the active 
ingredient in food and drinking water is expected to be negligible. 
PDHP 25279 is a protein and as such is generally expected to be 
biodegradable through microbial activity in the soil. Supporting this 
conclusion is the observation that PDHP 25279 is degraded within 5 
minutes by subtilisin A, an environmental protease. It is therefore 
expected that biological processes will reduce run-off and potential 
exposure of drinking water to negligible levels. The presence of PDHP 
25279 on treated crops is likely to be further reduced through normal 
washing and handling processes. For non-occupational exposure, there is 
a potential for dermal exposure by handling of plants treated with PDHP 
25279. However, PDHP 25279 is expected to be of low toxicity through 
the dermal route of exposure given the low toxicity through the oral 
and inhalation routes and dermal studies conducted with the similar 
harpin protein Ea peptide 91398, which was found to be of low toxicity 
and not a skin sensitizer.
    Based upon the evaluation in the Human Health Risk Assessment, 
which found no risks of concern from aggregate exposure to PDHP 25279, 
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 PDHP 25279. In addition, because no 
threshold effects have been identified for infants and children, EPA 
determined that an additional Food Quality Protection Act (FQPA) safety 
factor is not necessary to protect infants and children from 
anticipated residues of PDHP 25279.

B. Analytical Enforcement Methodology

    An analytical method is not needed for PDHP 25279 since the Agency 
is establishing an exemption from the requirement of a tolerance 
without any numerical limitation based on a lack of adverse effects.

C. Response to Comment

    One comment was received during the public comment period for the 
notice of filing. The commentor supported the proposed tolerance 
exemption and noted the low toxicity, the mode of action, rapid 
degradation, and low anticipated dietary exposure of PDHP 25279. Based 
on its review of the data and other information submitted for the 
proposed tolerance exemption, EPA agrees with the comment in support of 
the petition to establish a tolerance exemption for residues of PDHP 
25279 applied to food commodities.

D. Conclusion

    Based on the conclusions detailed in Unit III.A. an exemption from 
the requirement of a tolerance is established for residues of PDHP 
25279 in or on all food commodities when used in accordance with label 
directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. 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, 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

[[Page 8236]]

the tolerance exemption in this action, do not require the issuance of 
a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (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 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 1, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR part 180 as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1398 to subpart D to read as follows:

Sec.  180.1398  Peptide Derived from Harpin Protein (PDHP) 25279; 
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Peptide Derived from Harpin Protein (PDHP) 25279 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices.

[FR Doc. 2023-02536 Filed 2-7-23; 8:45 am]
BILLING CODE 6560-50-P