[Federal Register Volume 86, Number 217 (Monday, November 15, 2021)]
[Rules and Regulations]
[Pages 62922-62925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24793]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0512; FRL-8668-01-OCSPP]
Pyriproxyfen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
pyriproxyfen, including its metabolites and degradates, in or on egg;
poultry, fat; poultry, meat; and poultry, meat byproducts. McLaughlin
Gormley King Company D/B/A MGK requested tolerances for these
commodities under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 15, 2021. Objections and
requests for hearings must be received on or before January 14, 2022
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-2020-0512, 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. 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&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(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-2020-0512 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
January 14, 2022. 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-2020-0512, 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.
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. Summary of Petitioned-For Tolerance
In the Federal Register of October 27, 2020 (85 FR 68030) (FRL-
10015-86), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F8870) by McLaughlin Gormley King Company D/B/A MGK, 7325 Aspen Lane
N, Minneapolis, MN 55428. The petition requested that 40 CFR 180.510 be
amended by establishing tolerances for residues of the insecticide
pyriproxyfen in or on eggs and all tissues (except poultry fat) at 0.03
parts per million (ppm) and poultry fat at 0.04 ppm. That document
referenced a summary of the petition prepared by McLaughlin Gormley
King Company D/B/A MGK, the registrant, which is available in the
[[Page 62923]]
docket for this action, docket ID EPA-HQ-OPP-2020-0512, at http://www.regulations.gov. No substantive public comments were received in
response to the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing tolerances that vary from what the petitioners sought.
The reasons for these changes are explained in detail in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the 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.
Section 408(b)(2)(C) of the FFDCA requires 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D) and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for pyriproxyfen in or on egg; poultry, fat;
poultry, meat; and poultry, meat byproducts. In an effort to streamline
its publications in the Federal Register, EPA is not reprinting
sections that repeat what has been previously published for tolerance
rulemakings of the same pesticide chemical. Where scientific
information concerning a particular chemical remains unchanged, the
content of those sections would not vary between tolerance rulemakings
and republishing the same sections is unnecessary. EPA considers
referral back to those sections as sufficient to provide an explanation
of the information EPA considered in making its safety determination
for the new rulemaking.
EPA has previously published several tolerance rulemakings for
pyriproxyfen, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to pyriproxyfen and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of pyriproxyfen, see Unit III.A. of the February 22, 2016
rulemaking (81 FR 8658) (FRL-9941-68).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment, please refer to the September 25, 2017 risk
assessment supporting the Registration Review for pyriproxyfen
entitled, ``Pyriproxyfen: Human Health Draft Risk Assessment for
Registration Review'' by going to http://www.regulations.gov. The
referenced document is available in docket ID number EPA-HQ-OPP-2011-
0677.
Exposure assessment. Much of the exposure assessment remains the
same, although updates have occurred to accommodate exposures from the
petitioned-for tolerances. These updates are discussed in this section;
for a detailed description of the rest of the EPA approach to and
assumptions for the exposure assessment, please refer to the 2017 draft
human health risk assessment for Registration Review.
Since the recommended tolerance levels (0.1 ppm) are equal to, and
not aggregated with, the existing food handling establishment (FHE)
tolerance levels (0.1 ppm) for all food commodities established as part
of a 2001 rulemaking (66 FR 14852) (FRL-6766-6) included in the dietary
(food + drinking water) exposure and risk assessment supporting this
rule, no updates to the dietary assessment are required. An unrefined
chronic dietary (food + drinking water) exposure assessment was
conducted using tolerance-level residues recommended under the 2017
pyriproxyfen draft human health risk assessment for Registration
Review. This 2017 assessment assumed 100% crop treated and EPA's 2018
default processing factors. Drinking water was incorporated directly
into the chronic dietary assessment. The chronic dietary (food +
drinking water) exposures were estimated at 5.8% of the cPAD for the
U.S. general population and 15% of the cPAD for the most highly exposed
population subgroup (children 1 to 2 years old) and are below EPA's
level of concern (LOC), less than 100% of the cPAD (<100% cPAD).
Since no short- or intermediate-term dermal and inhalation points
of departure (PODs) were selected for pyriproxyfen and there are no
long-term inhalation exposure scenarios for the registered uses of
pyriproxyfen, the only exposure scenarios are for post-application
incidental oral exposures for children 1 to less than 2 years old (1 to
<2 years old) for all durations of exposure and long-term dermal
exposures for children 1 to <2 years old and adults. Residential post-
application short-, intermediate-, and long-term incidental oral risk
estimates from contact with treated lawns, treated indoor areas and
contact with pets treated with shampoo and spot-on applications to pets
for children 1 to <2 years old result in no risks of concern (i.e., all
margins of exposure (MOEs) are greater than the LOC (> LOC of 100);
MOEs range from 4,700 to 9,000,000.
With use of chemical-specific dust torsion exposure data for
pyriproxyfen pet collars, long-term combined (dermal + incidental oral)
risk estimates for children 1 to <2 years old also result in no risks
of concern (i.e., all combined MOEs are >100); MOEs range from 570 to
2,300. Further, long-term adult dermal risks are not of concern; MOEs
range from 1,600 to 6,400.
Cumulative exposures. 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's assessment
of cumulative exposures has not changed since the February 22, 2016
rulemaking (81 FR 8658) (FRL-9941-68). Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not found a common mechanism of toxicity
as to pyriproxyfen and any other substances and pyriproxyfen does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this action, therefore, EPA has not assumed that
pyriproxyfen has a common mechanism of toxicity with other substances.
Safety factor for infants and children. The scientific information
underpinning EPA's prior safety factor determination remains unchanged
from the February 22, 2016 rulemaking (81 FR 8658) (FRL-9941-68).
Therefore, EPA continues to conclude that there is reliable data to
support the reduction of the Food Quality Protection Act (FQPA) safety
[[Page 62924]]
factor for pyriproxyfen. See Unit III.D. of the February 22, 2016
rulemaking for a discussion of the Agency's rationale for that
determination.
IV. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
population adjusted dose (aPAD) and the cPAD. Short-, intermediate-,
and chronic-term risks are evaluated by comparing the estimated
aggregate food, water, and residential exposure to the appropriate
points of departure to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Acute risk. An acute dietary risk assessment was not conducted
because an acute endpoint could not be established.
Short-term and Intermediate-term risk. The short- and intermediate-
term aggregate risk assessment remains unchanged from the 2017 draft
human health risk assessment for Registration Review.
Chronic risk. In aggregating chronic risk, EPA considered
background chronic dietary exposure (food + drinking water) and long-
term residential combined (dermal + incidental oral) children 1 to <2
years old exposures from contact with small dogs treated with a
pyriproxyfen collar. The chronic dietary (food + drinking water)
exposures were estimated at 5.8% of the cPAD for the U.S. general
population and 15% of the cPAD for the most highly exposed population
subgroup (children 1-2 years old) and are below EPA's LOC (<100% cPAD).
The total long-term dietary and residential aggregate (incidental oral
+ dermal) MOE is 320 for children 1 to <2 years. The total long-term
dietary and residential aggregated (dermal) MOE is 1,000 for adults. As
all these MOEs are greater than 100, the chronic aggregate risk is not
of concern.
Aggregate cancer risk for U.S. population. Pyriproxyfen is
classified as having no evidence for carcinogenicity to humans, based
on the absence of evidence of carcinogenicity in male and female rats
as well as in male and female mice. Therefore, cancer risk is not a
concern and cancer risks are not quantified.
Based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to
the U.S. general population, or to infants and children, from aggregate
exposure to pyriproxyfen residues. More detailed information on the
subject action to establish tolerances in or on egg; poultry, fat;
poultry, meat; and poultry, meat byproducts can be found at http://www.regulations.gov in the document entitled ``Pyriproxyfen. Human
Health Risk Assessment for Establishment of Permanent Tolerances in Egg
and Poultry Tissue and Amendment to Remove Restrictions Against the
Presence of Animals in Poultry Houses During Premise Treatment,'' dated
September 15, 2021. This document can be found in docket ID number EPA-
HQ-OPP-2020-0512.
V. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 22, 2016 rulemaking (81 FR 8658) (FRL-
9941-68).
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
No Codex maximum residue limits (MRLs) have been established for
residues of pyriproxyfen in/on the proposed commodities in this action.
Canada has a default tolerance of 0.1 ppm on egg and poultry tissue.
C. Revisions to Petitioned-For Tolerances
The proposed amended use involves the establishment of permanent
tolerances of pyriproxyfen in/on poultry egg and tissue. While OECD
calculations procedures determined overall tolerances to be 0.03 ppm
for poultry egg, muscle and liver, and 0.04 ppm for poultry fat, there
is already an existing tolerance of 0.1 ppm under 40 CFR 180.510(a)(2)
for FHE. EPA believes it would be inappropriate to set tolerances in/on
poultry egg and tissue commodities below the currently established FHE
tolerance. EPA is establishing tolerances of 0.1 ppm for residues in/on
egg and poultry tissue under a new listing in the CFR (i.e., 40 CFR
180.510 (a)(3)) for residues of pyriproxyfen and its metabolite 4'-OH-
Pyr (free and conjugated), which would account for additional
pyriproxyfen residues that could result from any subsequent FHE use of
pyriproxyfen, as well as negligible residues on feed. For egg and
poultry tissue, the proposed tolerance of 0.1 ppm is equal to the FHE
tolerance and would be appropriate and protective.
Additionally, based upon review of the data supporting the petition
as submitted by the petitioner, EPA recommends revisions to the
commodity definitions in section G of the petition to specify poultry,
fat; poultry, meat; and poultry, meat byproducts, rather than poultry,
tissue.
VI. Conclusion
Tolerances are established for residues of pyriproxyfen, including
its metabolites and degradates, in or on egg at 0.1 parts per million
(ppm); poultry, fat at 0.1 ppm; poultry, meat at 0.1 ppm; and poultry,
meat byproducts at 0.1 ppm.
VII. Statutory and Executive Order Reviews
This action establishes tolerances 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
[[Page 62925]]
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).
VIII. 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: November 5, 2021.
Catherine Aubee,
Acting Director, Registration Division, 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. In Sec. 180.510, designate the table in paragraph (a)(1) as ``Table
1 to Paragraph (a)(1) and amend it by adding in alphabetical order the
following commodities ``Egg''; ``Poultry, fat''; ``Poultry, meat''; and
``Poultry, meat byproducts'' to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Egg..................................................... 0.1
* * * * *
Poultry, fat............................................ 0.1
Poultry, meat........................................... 0.1
Poultry, meat byproducts................................ 0.1
* * * * *
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[FR Doc. 2021-24793 Filed 11-12-21; 8:45 am]
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