[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Rules and Regulations]
[Pages 34359-34361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11549]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0686; FRL-10007-57]
Ea peptide 91398; 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 Ea peptide 91398 on all food
commodities when applied/used as a biochemical pesticide. 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 Ea peptide 91398.
DATES: This regulation is effective June 4, 2020. Objections and
requests for hearings must be received on or before August 3, 2020, 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-2018-0686, is available at http://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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; 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 Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-
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idx?[supreg]&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2018-0686 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
August 3, 2020. 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-2018-0686, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of February 6, 2019 (84 FR 2115) (FRL-9987-
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 8F8698) by Plant Health Care, Inc., 2626 Glenwood Ave.,
Suite 350, Raleigh, NC 26708. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of ``Peptides Derived from Harpin Protein''
(PDHP), a class of peptides that includes Ea peptide 91398. That
document referenced a summary of the petition prepared by the
petitioner Plant Health Care, Inc., which is available in the docket,
http://www.regulations.gov. Three comments were received on the notice
of filing. EPA's response to these comments is discussed in Unit III.C.
The petitioner defined PDHP as ``(1) consists of a peptide less
than 5 kD in size, less than 40 amino acids in length, that is acidic
(pI<7.0) and contains no cysteine residues; (2) the source(s) of
genetic material encoding the protein are bacterial plant pathogens not
known to be mammalian pathogens or any structurally, functionally
similar peptide produced synthetically; (3) elicits the Natural Defense
Mechanism (NDM), which is characterized as rapid, localized cell death
in plant tissue after infiltration of the peptide into the
intercellular spaces of plant leaves or roots; (4) is heat stable
(retains NDM activity when heated to 65 [deg]C for 20 minutes); (5) is
readily degraded by a proteinase representative of environmental
conditions as well as degradation by environmental factors such as
oxidation and hydrolysis; (6) exhibits a rat acute oral toxicity
(LD50) of greater than 5,000 mg product/kg body weight.''
However, after review, the Agency determined that the petition and
submitted data support an exemption from the requirement of tolerance
only for Ea peptide 91398, and not the broader class of PDHP.
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 Ea
peptide 91398 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 ``Federal Food, Drug, and Cosmetic Act (FFDCA) Safety
Determination for Ea Peptide 91398'' (Safety Determination). This
document, as well as other relevant information, is available in the
docket for this action as described under ADDRESSES.
Ea peptide 91398 is a short synthetic peptide derived from harpin
protein. The peptide has a non-toxic mode of action and functions as a
plant response elicitor when applied to growing plants. Ea 91398
stimulates natural plant defense, growth, and metabolic mechanisms to
provide protection against fungal and bacterial pathogens and against
nematodes. The proposed uses include treatment of a wide range of
agricultural crops by seed treatment or foliar applications.
Harpin proteins are sourced from a naturally-occuring bacterial
plant pathogen, Erwinia amylovora, that has no known pathogenicity to
mammals. EPA has previously registered other harpin proteins under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for similar
uses and application methods. An exemption from the requirement of
tolerance has been previously established for harpin proteins with a
secondary structure consisting of [alpha] and [beta] units (40 CFR
180.1204), although this exemption does not include Ea peptide 91398.
Data and scientific information submitted in support of the
petition demonstrated that, with regard to humans, Ea peptide 91398 is
not toxic, mutagenic, or allergenic via any route of exposure. Although
there may be some exposure to residues when Ea peptide 91398 is used on
food commodities in accordance with label directions and
[[Page 34361]]
good agricultural practices, dietary exposure to such residues presents
no concern for adverse effects. Because no adverse effects to infants,
children, and adults are anticipated, EPA determined that an additional
Food Quality Protection Act (FQPA) safety factor is not necessary to
protect infants and children from anticipated residues of Ea peptide
91398. These findings are discussed in more detail in the Safety
Determination.
Based upon its evaluation in the Safety Determination, 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 Ea peptide 91398. Therefore, an exemption from
the requirement of a tolerance is established for residues of Ea
peptide 91398 in or on all food commodities when used in accordance
with label directions and good agricultural practices.
B. Analytical Enforcement Methodology
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.
C. Response to Comments
Three comments were received in response to the notice of filing.
One expressed support for issuing the exemption from the requirement of
a tolerance. Two commenters expressed support for rigorous testing of
pesticides urged the Agency to consider effects on plants, animals, and
humans or the ``collateral damage'' of pesticides. Under FIFRA and
FFDCA, pesticide developers are required to submit data to EPA to
determine potential effects to humans and the environment. Pesticides
approved under FIFRA must be shown not to cause unreasonable adverse
effects to humans or the environment. As described in the Safety
Determination, such data have been submitted and reviewed for Ea
peptide 91398. The Agency has concluded that these data support
registration under FIFRA and an exemption from the requirement of a
tolerance under FFDCA.
IV. Statutory and Executive Order Reviews
This action establishes 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 14, 2020.
Richard Keigwin,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Add Sec. 180.1376 to subpart D to read as follows:
Sec. 180.1376 Ea peptide 91398; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of Ea peptide 91398 in or on all food commodities when used in
accordance with label directions and good agricultural practices.
[FR Doc. 2020-11549 Filed 6-3-20; 8:45 am]
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