Acequinocyl; Pesticide Tolerances, 48507-48511 [2021-18716]
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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Rules and Regulations
Authority: 42 U.S.C. 7401 et seq.
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
not be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
Subpart J—District of Columbia
C. Petitions for Judicial Review
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by November 1, 2021. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action.
This action pertaining to the District’s
regional haze state implementation plan
for the second implementation period
and correction for the RACT rule for
major stationary sources of NOX may
List of Subjects in 40 CFR Part 52
■
Environmental protection, Air
pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone,
Particulate matter, Sulfur oxides.
2. Amend § 52.470:
a. In the table in paragraph (c), by
revising the entry for ‘‘Section 805’’; and
■ b. In the table in paragraph (e), by
adding the entry ‘‘Regional Haze State
Implementation Plan for the Second
Implementation Period’’ at the end of
the table.
The revision and addition read as
follows:
■
Dated: August 11, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
For the reasons stated in the
preamble, the EPA amends 40 CFR part
52 as follows:
§ 52.470
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
*
Identification of plan.
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(c) * * *
*
*
1. The authority citation for part 52
continues to read as follows:
■
EPA—APPROVED REGULATIONS AND STATUTES IN THE DISTRICT OF COLUMBIA
State citation
State effective
date
Title/subject
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EPA approval date
*
Additional explanation
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Chapter 8 Asbestos, Sulfur and Nitrogen Oxides
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Section 805 .............
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Reasonably Available Control Technology for Major Stationary Sources
of Nitrogen Oxides.
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Name of non-regulatory SIP
revision
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12/14/2018
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8/31/2021, [insert
Federal Register
citation].
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Applicable geographic area
[FR Doc. 2021–17952 Filed 8–30–21; 8:45 am]
BILLING CODE 6560–50–P
State submittal
date
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11/8/2019
EPA approval date
*
8/31/2021, [insert Federal
Register citation].
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 180
[EPA–HQ–OPP–2020–0475; FRL–8763–01–
OCSPP]
Acequinocyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
19:07 Aug 30, 2021
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(e) * * *
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Regional Haze State ImpleStatewide ...............................
mentation Plan for the Second Implementation Period.
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Amended 805.1(a), 805.1(a)(2), and
805.4 (a) and (b). Previous approval
(see the Federal Register of 2/24/
2020) corrected to include accurate
citation of amendments to DC NOx
RACT rule.
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Additional explanation
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For the Regional Haze Second Implementation Period.
This regulation establishes
tolerances for residues of acequinocyl in
or on tropical and subtropical, medium
to large fruit, smooth, inedible peel
subgroup 24B. The Interregional Project
Number 4 (IR–4) requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 31, 2021. Objections and
requests for hearings must be received
on or before November 1, 2021, and
must be filed in accordance with the
SUMMARY:
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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Rules and Regulations
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–2020–0475, is
available at https://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.
Due to the public health concerns
relating to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide customer service via email,
phone, and webform. For the latest
status information on EPA/DC services,
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
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
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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-
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CFR site at https://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, 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–2020–0475 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
November 1, 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–
2020–0475, 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/dockets/where-sendcomments-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. Summary of Petitioned-For
Tolerance
In the Federal Register of December
21, 2020 (85 FR 82998) (FRL–10016–93),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
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pesticide petition (PP 0E8860) by IR–4,
Rutgers, The State University of New
Jersey, 500 College Road East, Suite
201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.599 be
amended by establishing a tolerance for
the residue of the miticide acequinocyl
[2-(acetyloxy)-3-dodecyl-1,4naphthalenedione] and its metabolite
acequinocyl-OH [2-dodecyl-3-hydroxy1,4-naphthoquinone], expressed as
acequinocyl, in or on tropical and
subtropical, medium to large fruit,
smooth, inedible peel subgroup 24B at
7 parts per million (ppm). That
document referenced a summary of the
petition prepared by IR–4, the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA is
establishing the tolerance for the
tropical and subtropical, medium to
large fruit, smooth, inedible peel
subgroup 24B at 4 ppm. The reason for
this change is explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of 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 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 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 in
FFDCA section 408(b)(2)(D), 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 acequinocyl
including exposure resulting from the
tolerance established by this action.
EPA’s assessment of exposures and risks
associated with acequinocyl follows.
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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Rules and Regulations
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 rulemaking of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemaking 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 a
number of tolerance rulemakings for
acequinocyl, in which EPA concluded,
based on the available information, that
there is a reasonable certainty that no
harm would result from aggregate
exposure to acequinocyl 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
acequinocyl, see Unit III.A. of the June
7, 2018 rulemaking (83 FR 26369) (FRL–
9978–20).
Toxicological Points of Departure/
Levels of Concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern for acequinocyl used
for human risk assessment, please
reference Unit III.B. of the January 18,
2017 rulemaking (82 FR 5409) (FRL–
9956–85).
Exposure assessment. Much of the
exposure assessment remains the same
although updates have occurred to
accommodate exposures from the
petitioned-for tolerance. These updates
are discussed in this section; for a
description of the rest of the EPA
approach to and assumptions for the
exposure assessment, please reference
Unit III.C. of the June 7, 2018
rulemaking.
EPA’s dietary exposure assessments
have been updated to include the
additional exposure from the new use of
acequinocyl on the commodities in
tropical and subtropical, medium to
large fruit, smooth, inedible peel
subgroup 24B. The assessment used the
same assumptions as the June 7, 2018
final rule concerning tolerance-level
residues, default processing factors for
all processed commodities and 100
percent crop treated.
Drinking water exposure. EPA has
revised the acequinocyl drinking water
assessment since the June 7, 2018
rulemaking to reflect the water
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solubility limits of acequinocyl and its
hydroxylated degradate acequinocyl-OH
(R1) due to uncertainty in the
environmental fate study data. The
recommended acute estimated drinking
water concentration (EDWC) is 21 parts
per billion (ppb) based on the water
solubility limits of acequinocyl and
acequinocyl-OH added together. The
recommended chronic EDWC is 14 ppb,
which is the maximum amount of
acequinocyl residues of concern that
may be present over a year. This level
is based on the solubility of the
degradate acequinocyl-OH (R1), which
persists over the chronic exposure
period.
Non-occupational exposure. There are
no new residential (non-occupational)
exposures associated with the new
proposed use. The assessment of
exposures to the currently registered
uses on residential sites (e.g.,
ornamentals for landscapes, gardens,
and trees) has not changed since the
June 7, 2018 rulemaking.
Cumulative exposure. Unlike other
pesticides for which EPA has followed
a cumulative risk approach based on a
common mechanism of toxicity, EPA
has not made a common mechanism of
toxicity finding as to acequinocyl and
any other substances and acequinocyl
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
action, therefore, EPA has not assumed
that acequinocyl has a common
mechanism of toxicity with other
substances.
Safety Factor for Infants and
Children. EPA continues to conclude
that there are reliable data to support
the reduction of the Food Quality
Protection Act (FQPA) safety factor. See
Unit III.D. of the June 7, 2018
rulemaking for a discussion of the
Agency’s rationale for that
determination.
Aggregate Risks and Determination of
Safety. EPA determines whether acute
and chronic dietary pesticide exposures
are safe by comparing aggregate
exposure estimates to the acute
population adjusted dose (aPAD) and
the chronic population adjusted dose
(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 dietary risks are below the
Agency’s level of concern of 100% of
the aPAD; they are 96% of the aPAD for
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children 1 to 2 years old, the population
subgroup with the highest exposure
estimate. Chronic dietary risks are
below the Agency’s level of concern of
100% of the cPAD; they are 90% of the
cPAD for children 1 to 2 years old, the
population subgroup with the highest
exposure estimate.
As explained in the June 7, 2018
rulemaking, the Agency has assumed
that there will be no residential handler
exposure; therefore, a residential
handler assessment was not conducted.
The Agency only anticipates short-term
post-application dermal exposures from
registered uses of acequinocyl in
residential areas. Using the exposure
assumptions described for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 1,800 in adults and 1,400 for
children 6 to 11 years old. Because
EPA’s level of concern for acequinocyl
is an MOE of 100 or below, these MOEs
are not of concern.
As stated in the June 7, 2018
rulemaking, acequinocyl is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Because there is
no intermediate-term residential
exposure and chronic dietary exposure
has been assessed under the
appropriately protective cPAD, EPA
relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for acequinocyl.
Based on the lack of evidence of
carcinogenicity in two adequate rodent
carcinogenicity studies, acequinocyl is
not expected to pose a cancer risk to
humans.
Therefore, based on the risk
assessments and information described
above, EPA concludes there is
reasonable certainty that no harm will
result to the general population, or to
infants and children, from aggregate
exposure to acequinocyl residues. More
detailed information can be found at
https://www.regulations.gov in the
document titled ‘‘Acequinocyl. Human
Health Risk Assessment for the
Proposed New Use on Tropical and
Subtropical, Medium to Large Fruit,
Smooth, Inedible Peel (Subgroup 24B)’’
in docket ID number EPA–HQ–OPP–
2020–0475.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the June 7, 2018 rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
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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).
The Codex has not established an
MRL for residues of acequinocyl in/on
tropical and subtropical, medium to
large fruit, inedible peel, subgroup 24B.
C. Revisions to Petitioned-For
Tolerances
FFDCA section 408(d)(4)(A)(i) permits
the Agency to finalize a tolerance that
varies from that sought by the petition.
The petitioner initially requested a
tolerance of 7 ppm for tropical and
subtropical, medium to large fruit,
smooth, inedible peel (crop subgroup
24B). However, upon review of the
requested tolerance, the Agency noticed
that the petitioner incorrectly calculated
the residues for whole fruit. Whole fruit
residues were calculated as the sum of
residues for pulp and peel combined
and did not account for total sample
weight. Residue concentrations are
expressed in ppm, which is equivalent
to mg/kg; therefore, residues from pulp
and peel cannot simply be combined
together to determine whole fruit
residues without accounting for total
sample weight. The corrected residue
concentrations for the whole fruit were
approximately half of the initially
calculated concentrations and produced
a recommended tolerance of 4 ppm
when entered into the OECD calculator.
V. Conclusion
Therefore, a tolerance is established
for residues of acequinocyl, including
its metabolites and degradates, in or on
tropical and subtropical, medium to
large fruit, smooth, inedible peel
subgroup 24B at 4 ppm.
VI. 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 to
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).
VII. 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: August 18, 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 1 as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.599, amend the table in
paragraph (a) by adding a table heading
and in alphabetical order an entry for
‘‘Tropical and subtropical, medium to
large fruit, smooth, inedible peel
subgroup 24B’’ to read as follows:
■
§ 180.599 Acequinocyl; tolerances for
residues.
(a) * * *
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TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
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PART 61—INSURANCE COVERAGE
AND RATES
[FR Doc. 2021–18716 Filed 8–30–21; 8:45 am]
BILLING CODE 6560–50–P
Appendix A(1) to Part 61 [Corrected]
1. On page 43961, in the first column,
in Appendix A(1) to Part 61, article
III.A.5.a, ‘‘(see II.B.6.a)’’ is corrected to
read ‘‘(see II.C.6.a)’’.
■ 2. On page 43963, in the second
column, in Appendix A(1) to Part 61,
article IV.4, ‘‘(see II.B.6.c)’’ is corrected
to read ‘‘(see II.C.6.c)’’.
■
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Parts 59, 61, and 62
Appendix A(2) to Part 61 [Corrected]
3. On page 43970, in the first column,
in Appendix A(2) to Part 61, article
III.A.6.a, ‘‘(see II.B.6.a.)’’ is corrected to
read ‘‘(see II.C.6.a)’’.
[Docket ID FEMA–2018–0026]
■
RIN 1660–AA95
National Flood Insurance Program:
Conforming Changes To Reflect the
Biggert-Waters Flood Insurance
Reform Act of 2012 (BW–12) and the
Homeowners Flood Insurance
Affordability Act of 2014 (HFIAA), and
Additional Clarifications for Plain
Language; Correction
Federal Emergency
Management Agency; DHS.
AGENCY:
ACTION:
4. On page 43978, in the first column,
in Appendix A(3) to Part 61, article
III.A.6.a, ‘‘(see II.B.6.a.)’’ is corrected to
read ‘‘(see II.C.6.a)’’.
■
Deanne B. Criswell,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2021–18262 Filed 8–30–21; 8:45 am]
BILLING CODE 9111–52–P
Final rule; correction.
On July 20, 2020, FEMA
published in the Federal Register a final
rule revising the National Flood
Insurance Program (NFIP) regulations to
codify certain provisions of the BiggertWaters Flood Insurance Reform Act of
2012 and the Homeowner Flood
Insurance Affordability Act of 2014, and
to clarify certain existing NFIP rules
relating to NFIP operations and the
Standard Flood Insurance Policy. This
final rule provides corrections to those
instructions, to be used in lieu of the
information published July 20.
SUMMARY:
This correction is effective
October 1, 2021.
DATES:
The docket for this
rulemaking is available for inspection
using the Federal eRulemaking Portal at
https://www.regulations.gov and can be
viewed by following that website’s
instructions.
FOR FURTHER INFORMATION CONTACT:
Kelly Bronowicz, Director, Policyholder
Services Division, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
557–9488.
In FR Doc.
2020–09260, beginning on page 43946
in the Federal Register of Monday,
July 20, 2020, the following corrections
are made:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:07 Aug 30, 2021
Jkt 253001
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 0 and 64
[WC Docket Nos. 17–97 and 21–291; FCC
21–93; FR ID 45192]
Call Authentication Trust Anchor;
Appeals of the STIR/SHAKEN
Governance Authority Token
Revocation Decisions
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this document, the Federal
Communications Commission (the
Commission) adopts rules establishing a
process for voice service providers
aggrieved by a token revocation decision
of the private STIR/SHAKEN
Governance Authority to file a request
for review to the Commission. Without
this process the private STIR/SHAKEN
Governance Authority can place other
private entities out of compliance with
the Commission’s STIR/SHAKEN
implementation rules without oversight
from the Commission. The adopted
rules will provide appropriate oversight
and ensure due process for voice service
providers aggrieved by a Governance
Authority token revocation decision.
DATES: Effective September 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Alexander Hobbs, Attorney Advisor,
SUMMARY:
ADDRESSES:
khammond on DSKJM1Z7X2PROD with RULES
Appendix A(3) to Part 61 [Corrected]
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
48511
Competition Policy Division, Wireline
Competition Bureau, at (202) 418–7433,
or email: Alexander.Hobbs@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Report
and Order in WC Docket Nos. 17–97,
21–291, FCC 21–93, adopted on August
5, 2021, and released on August 6, 2021.
The complete text of this document is
available for download at https://
docs.fcc.gov/public/attachments/FCC21-93A1.pdf. To request materials in
accessible formats for people with
disabilities (Braille, large print,
electronic files, audio format), send an
email to fcc504@fcc.gov or call the
Consumer and Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (TTY).
Synopsis
I. Introduction
Caller ID authentication using the
STIR/SHAKEN framework is a key
component of our multi-pronged effort
to combat the scourge of illegal
robocalls. STIR/SHAKEN is a set of
technological standards that helps to
prevent illegal ‘‘spoofing,’’ a practice
that involves falsifying caller ID
information in order to trick
unsuspecting Americans into thinking
that calls are trustworthy because the
caller ID information appears as if the
call came from a neighbor or a familiar
or reputable source. With voice service
providers required by our rules to
implement STIR/SHAKEN in the
internet Protocol (IP) portions of their
networks by June 30, 2021, Americans
are now in a position to answer their
phones with greater confidence that the
number displayed is correct.
To guard against bad actors and
preserve trust within the distributed
caller ID authentication system, the
ability of a voice service provider to
participate in STIR/SHAKEN can be
revoked by the private Governance
Authority that oversees the STIR/
SHAKEN framework. This revocation
process effectively allows the private
Governance Authority to make
decisions that render voice service
providers noncompliant with our rules.
To provide appropriate oversight and
ensure due process, today we establish
a process for voice service providers to
appeal such revocation decisions to the
Commission.
II. Background
To address the issue of illegal caller
ID spoofing, technologists from the
internet Engineering Task Force (IETF)
and the Alliance for
Telecommunications Industry Solutions
(ATIS) developed standards to allow for
E:\FR\FM\31AUR1.SGM
31AUR1
]]>Agencies
[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Rules and Regulations]
[Pages 48507-48511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18716]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0475; FRL-8763-01-OCSPP]
Acequinocyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
acequinocyl in or on tropical and subtropical, medium to large fruit,
smooth, inedible peel subgroup 24B. The Interregional Project Number 4
(IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective August 31, 2021. Objections and
requests for hearings must be received on or before November 1, 2021,
and must be filed in accordance with the
[[Page 48508]]
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-2020-0475, is available at https://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.
Due to the public health concerns relating to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide customer service via
email, phone, and webform. For the latest status information on EPA/DC
services, 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 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at https://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, 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-2020-0475 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
November 1, 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-2020-0475, 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/dockets/where-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. Summary of Petitioned-For Tolerance
In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-
10016-93), 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
0E8860) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.599 be amended by establishing a tolerance
for the residue of the miticide acequinocyl [2-(acetyloxy)-3-dodecyl-
1,4-naphthalenedione] and its metabolite acequinocyl-OH [2-dodecyl-3-
hydroxy-1,4-naphthoquinone], expressed as acequinocyl, in or on
tropical and subtropical, medium to large fruit, smooth, inedible peel
subgroup 24B at 7 parts per million (ppm). That document referenced a
summary of the petition prepared by IR-4, the petitioner, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing the tolerance for the tropical and subtropical, medium to
large fruit, smooth, inedible peel subgroup 24B at 4 ppm. The reason
for this change is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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 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 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 in FFDCA section 408(b)(2)(D), 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 acequinocyl including exposure
resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with acequinocyl follows.
[[Page 48509]]
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 rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking 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 a number of tolerance rulemakings for
acequinocyl, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to acequinocyl 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 acequinocyl, see Unit III.A. of the June 7, 2018 rulemaking
(83 FR 26369) (FRL-9978-20).
Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
acequinocyl used for human risk assessment, please reference Unit
III.B. of the January 18, 2017 rulemaking (82 FR 5409) (FRL-9956-85).
Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate exposures from the
petitioned-for tolerance. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the June
7, 2018 rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of acequinocyl on the commodities
in tropical and subtropical, medium to large fruit, smooth, inedible
peel subgroup 24B. The assessment used the same assumptions as the June
7, 2018 final rule concerning tolerance-level residues, default
processing factors for all processed commodities and 100 percent crop
treated.
Drinking water exposure. EPA has revised the acequinocyl drinking
water assessment since the June 7, 2018 rulemaking to reflect the water
solubility limits of acequinocyl and its hydroxylated degradate
acequinocyl-OH (R1) due to uncertainty in the environmental fate study
data. The recommended acute estimated drinking water concentration
(EDWC) is 21 parts per billion (ppb) based on the water solubility
limits of acequinocyl and acequinocyl-OH added together. The
recommended chronic EDWC is 14 ppb, which is the maximum amount of
acequinocyl residues of concern that may be present over a year. This
level is based on the solubility of the degradate acequinocyl-OH (R1),
which persists over the chronic exposure period.
Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed use. The
assessment of exposures to the currently registered uses on residential
sites (e.g., ornamentals for landscapes, gardens, and trees) has not
changed since the June 7, 2018 rulemaking.
Cumulative exposure. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
acequinocyl and any other substances and acequinocyl does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this action, therefore, EPA has not assumed that
acequinocyl has a common mechanism of toxicity with other substances.
Safety Factor for Infants and Children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
June 7, 2018 rulemaking for a discussion of the Agency's rationale for
that determination.
Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and the chronic population adjusted dose (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 dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 96% of the aPAD for children 1 to 2 years old,
the population subgroup with the highest exposure estimate. Chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD; they are 90% of the cPAD for children 1 to 2 years old, the
population subgroup with the highest exposure estimate.
As explained in the June 7, 2018 rulemaking, the Agency has assumed
that there will be no residential handler exposure; therefore, a
residential handler assessment was not conducted. The Agency only
anticipates short-term post-application dermal exposures from
registered uses of acequinocyl in residential areas. Using the exposure
assumptions described for short-term exposures, EPA has concluded the
combined short-term food, water, and residential exposures result in
aggregate MOEs of 1,800 in adults and 1,400 for children 6 to 11 years
old. Because EPA's level of concern for acequinocyl is an MOE of 100 or
below, these MOEs are not of concern.
As stated in the June 7, 2018 rulemaking, acequinocyl is not
registered for any use patterns that would result in intermediate-term
residential exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has been assessed under the
appropriately protective cPAD, EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for acequinocyl.
Based on the lack of evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, acequinocyl is not expected to pose a
cancer risk to humans.
Therefore, based on the risk assessments and information described
above, EPA concludes there is reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to acequinocyl residues. More detailed information
can be found at https://www.regulations.gov in the document titled
``Acequinocyl. Human Health Risk Assessment for the Proposed New Use on
Tropical and Subtropical, Medium to Large Fruit, Smooth, Inedible Peel
(Subgroup 24B)'' in docket ID number EPA-HQ-OPP-2020-0475.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the June 7, 2018 rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with
[[Page 48510]]
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).
The Codex has not established an MRL for residues of acequinocyl
in/on tropical and subtropical, medium to large fruit, inedible peel,
subgroup 24B.
C. Revisions to Petitioned-For Tolerances
FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a
tolerance that varies from that sought by the petition. The petitioner
initially requested a tolerance of 7 ppm for tropical and subtropical,
medium to large fruit, smooth, inedible peel (crop subgroup 24B).
However, upon review of the requested tolerance, the Agency noticed
that the petitioner incorrectly calculated the residues for whole
fruit. Whole fruit residues were calculated as the sum of residues for
pulp and peel combined and did not account for total sample weight.
Residue concentrations are expressed in ppm, which is equivalent to mg/
kg; therefore, residues from pulp and peel cannot simply be combined
together to determine whole fruit residues without accounting for total
sample weight. The corrected residue concentrations for the whole fruit
were approximately half of the initially calculated concentrations and
produced a recommended tolerance of 4 ppm when entered into the OECD
calculator.
V. Conclusion
Therefore, a tolerance is established for residues of acequinocyl,
including its metabolites and degradates, in or on tropical and
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B
at 4 ppm.
VI. 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 to 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).
VII. 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: August 18, 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 1 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. 180.599, amend the table in paragraph (a) by adding a table
heading and in alphabetical order an entry for ``Tropical and
subtropical, medium to large fruit, smooth, inedible peel subgroup
24B'' to read as follows:
Sec. 180.599 Acequinocyl; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Tropical and subtropical, medium to large fruit, 4
smooth, inedible peel subgroup 24B....................
* * * * * * *
------------------------------------------------------------------------
[[Page 48511]]
* * * * *
[FR Doc. 2021-18716 Filed 8-30-21; 8:45 am]
BILLING CODE 6560-50-P
