Rule2021-12610
Purpureocillium Lilacinum Strain PL11; 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
June 16, 2021
Effective
June 16, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Purpureocillium lilacinum strain PL11 in or on all food commodities when used in accordance with label directions and good agricultural practices. LAM International Corporation 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 Purpureocillium lilacinum strain PL11 under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 86 Issue 114 (Wednesday, June 16, 2021)</title>
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[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Rules and Regulations]
[Pages 31948-31950]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12610]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0073; FRL-10023-91]
Purpureocillium Lilacinum Strain PL11; 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 Purpureocillium lilacinum strain PL11 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. LAM International
Corporation 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 Purpureocillium lilacinum
strain PL11 under FFDCA when used in accordance with this exemption.
DATES: This regulation is effective June 16, 2021. Objections and
requests for hearings must be received on or before August 16, 2021,
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-2016-0073, is available at <a href="http://www.regulations.gov">http://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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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:
<a href="/cdn-cgi/l/email-protection#0c4e5c5c484a5e426378656f697f4c697c6d226b637a"><span class="__cf_email__" data-cfemail="307260607476627e5f4459535543705540511e575f46">[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 Government Publishing Office's e-CFR site at
<a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</a>.
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-2016-0073 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 16, 2021. 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-2016-0073, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://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="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
II. Background
In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
37), 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 8F8690) by LAM International Corporation, 117 South
Parkmont St., Butte, MT 59701. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of Purpureocillium lilacinum strain PL11 in or
on all food commodities. That document referenced a summary of the
petition prepared by the petitioner LAM International Corporation,
which is available in the docket via <a href="http://www.regulations.gov">http://www.regulations.gov</a>. One
comment was received on the notice of filing. EPA's
[[Page 31949]]
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 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
making a safety determination to establish 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 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 toxicity and exposure data on
Purpureocillium lilacinum strain PL11 and considered its 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 that data can be found
within the May 20, 2021, document entitled ``Federal Food, Drug, and
Cosmetic Act (FFDCA) Safety Determination for Purpureocillium lilacinum
strain PL11.'' This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
The available data demonstrated that, with regard to humans,
Purpureocillium lilacinum strain PL11 is not toxic, pathogenic, or
infective via any reasonably foreseeable route of exposure. Although
there may be dietary and non-occupational exposure to residues when
Purpureocillium lilacinum strain PL11 is used on food commodities,
there is not a concern due to the lack of potential for adverse
effects. EPA also determined that retention of the Food Quality
Protection Act safety factor for infants and children under FFDCA
408(b)(2)(C) was not necessary as part of the qualitative assessment
conducted for Purpureocillium lilacinum strain PL11.
Based upon its evaluation, 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
Purpureocillium lilacinum strain PL11. Therefore, an exemption from the
requirement of a tolerance is established for residues of
Purpureocillium lilacinum strain PL11 in or on all food commodities
when used in accordance with label directions and good agricultural
practices.
B. Analytical Enforcement Methodology
An analytical method for enforcement purposes is not required
because EPA has determined that reasonably foreseeable exposure to
residues of Purpureocillium lilacinum strain PL11 from use of the
pesticide will be safe, due to lack of toxicity, pathogenicity, and
infectivity. Under those circumstances, it is unnecessary to have an
analytical method to monitor for residues.
C. Response to Comments
One comment was received in response to the notice of filing. The
comment discusses concerns regarding the use of ``GRAS'' (generally
recognized as safe) determinations to support decisions regarding
pesticide products and promotes a complete review of data. Consistent
with FFDCA section 408(b)(2)(D), EPA reviews the available scientific
data and other relevant information and considers their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. EPA also considers available information
concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children. EPA relied on a
variety of data and information to make a risk determination on
Purpureocillium lilacinum strain PL11. For more information on the
human health risk assessment of Purpureocillium lilacinum strain PL11,
please see the supporting documentation provided in the associated
regulatory docket (search for ``EPA-HQ-OPP-2016-0079'' at
<a href="http://www.regulations.gov">www.regulations.gov</a>).
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 (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
exemption in this action, 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. 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
[[Page 31950]]
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 EPA's 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: June 10, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I 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. 180.1382 to subpart D to read as follows:
Sec. 180.1382 Purpureocillium lilacinum strain PL11; exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Purpureocillium lilacinum strain PL11 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2021-12610 Filed 6-15-21; 8:45 am]
BILLING CODE 6560-50-P
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