[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Rules and Regulations]
[Pages 44618-44620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17184]
[[Page 44618]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0066; FRL-8671-01-OCSPP]
Emamectin benzoate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
emamectin benzoate in or on soybean, seed. Syngenta Crop Protection,
LLC, requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective August 13, 2021. Objections and
requests for hearings must be received on or before October 12, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0066, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
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, 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 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, 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-2021-0066 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
October 12, 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-2019-0387, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), 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
9F8817) by Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro,
NC 27409. The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of insecticide emamectin benzoate
(a mixture of a minimum of 90% 4'-epi-methylamino-4'- deoxyavermectin
B1a and a maximum of 10% 4'-epi-methylamino-4'deoxyavermectin B1b
benzoate), and its metabolites 8,9 isomer of the B1a and B1b component
of the parent insecticide in or on soybean, seed at 0.01 parts per
million (ppm). That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket, https://www.regulations.gov/docket/EPA-HQ-OPP-2021-0066. There were no comments received in response to the notice of
filing.
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
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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 emamectin including exposure
resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with emamectin follows.
In an effort to streamline Federal Register publications, EPA is
not reprinting sections of the rule that would repeat what has been
previously published in tolerance rulemakings for 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 a number of tolerance rulemakings for
emamectin, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to emamectin 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. The Toxicological Profile of emamectin
remains unchanged from the Toxicological Profile in Unit III.A. of the
August 27, 2019 rulemaking (84 FR 44718) (FRL-9997-10). Refer to that
section for a discussion of the Toxicological Profile of emamectin.
Toxicological points of departure/Levels of concern. The
Toxicological Points of Departure/Levels of Concern used for the safety
assessment remain unchanged from Unit III.B. of the August 27, 2019
rulemaking. For a summary, refer to that discussion.
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, see Unit III. C. of the August 27, 2019
rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of emamectin on soybean, seed. All
other assumptions in the exposure assessments for emamectin remain the
same as in the August 27, 2019 rulemaking.
Drinking water and non-occupational exposures. Drinking water
exposures and residential (non-occupational) exposures are not impacted
by the new use, and thus have not changed since the last assessment.
There are no proposed residential uses of emamectin that would
result in residential exposures. As a result, there are no residential
risk estimates recommended for use in the aggregate risk assessment for
emamectin.
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.'' For the new uses
of emamectin, the quantitative exposures to residues of emamectin
remain unchanged, and the cumulative exposures remain identical to
those as assessed within the 2021 cumulative assessment. There are no
risks of concern resulting from these cumulative exposures.
Safety factor for infants and children. The scientific information
underpinning EPA's prior safety factor determination remains unchanged
from the August 27, 2019 rulemaking. EPA continues to conclude that
there is reliable data to support the reduction of the Food Quality
Protection Act (FQPA) safety factor. See Unit III.D. of the August 27,
2019 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 PAD (aPAD) and chronic PAD
(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: 30% of
the acute population adjusted dose (aPAD) for children 1 to 2 years
old, the population group of concern. Chronic dietary risks are below
the Agency's level of concern: 3.8% of the chronic population adjusted
dose (cPAD) for children 1 to 2 years old, the group with the highest
exposure. Emamectin is classified as ``Not likely to be Carcinogenic to
Humans'', therefore, a cancer dietary exposure analysis was not
performed.
There are no registered uses of emamectin that would result in
residential exposure; therefore, aggregate exposure and risk estimates
are equivalent to the dietary exposure and risk estimates and are not
of concern. Using the exposure assumptions described for acute and
chronic exposures, EPA has concluded the combined dermal and inhalation
exposures result in aggregate margins of exposures for handler
scenarios ranging from 200 to 27,000 and post-application scenarios
ranging from 48,000 to 750,000, which are not of concern because they
exceed EPA's level of concern (MOEs less than or equal to 100).
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children from
aggregate exposure to emamectin residues. More detailed information
about the Agency's analysis can be found at http://www.regulations.gov
in the document titled ``Emamectin Benzoate; Human Health Risk
Assessment for a Proposed New Use on Soybean'' in docket ID number EPA-
HQ-OPP-2021-0066.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the August 27, 2019 rulemaking.
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).
The Codex has not established MRLs for residues of emamectin on
soybeans.
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V. Conclusion
Therefore, tolerances are established for residues of emamectin
benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and a maximum of 10% 4'-epi-methlyamino-
4'deoxyavermectin B1b benzoate) and its metabolites in or on in or on
the soybean, seed at 0.01 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 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: July 29, 2021.
Marietta Echeverria,
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. 180.505, add alphabetically the entry ``Soybean, seed'' to
table 1 to paragraph (a)(1) to read as follows:
Sec. 180.505 Emamectin; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Soybean, seed............................................... 0.01
* * * * *
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* * * * *
[FR Doc. 2021-17184 Filed 8-12-21; 8:45 am]
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