[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]]



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.


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].


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 
     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 

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

[[Page 44619]]

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 
    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 
    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 
    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 
    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-

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 

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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:


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.  180.505, 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
                                * * * * *

* * * * *
[FR Doc. 2021-17184 Filed 8-12-21; 8:45 am]