[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]



40 CFR Part 180

[EPA-HQ-OPP-2020-0512; FRL-8668-01-OCSPP]

Pyriproxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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].


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 
     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-
    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 

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-

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-

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, 

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:


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

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

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
                                * * * * *
Egg.....................................................             0.1
                                * * * * *
Poultry, fat............................................             0.1
Poultry, meat...........................................             0.1
Poultry, meat byproducts................................             0.1
                                * * * * *

* * * * *
[FR Doc. 2021-24793 Filed 11-12-21; 8:45 am]