[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Rules and Regulations]
[Pages 20333-20336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07277]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0154; FRL-9648-01-OCSPP]
Cyantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
cyantraniliprole in or on sugarcane, cane. Syngenta Crop Protection,
LLC requested this tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective April 7, 2022. Objections and
requests for hearings must be received on or before June 6, 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-2021-0154, 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 and the OPP Docket is (202) 566-1744.
Due to the public emergency, 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: (202) 566-2659; 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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
To access the OCSPP test guidelines referenced in this document
electronically, please go to https://www.epa.gov/ocspp and select
``Test Methods and Guidelines.''
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-2021-0154 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
June 6, 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-2021-0154, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically
[[Page 20334]]
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 April 22, 2021 (86 FR 21317) (FRL-10022-
59), 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
0F8868) by Syngenta Crop Protection, LLC, P.O. Box 18300 Greensboro, NC
27419. The petition requested that 40 CFR 180.672 be amended by
establishing a tolerance for inadvertent residues of the insecticide,
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[(methylamino)carbonyl] phenyl]-1H-pyrazole-5-carboxamide in or on
sugarcane 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 (EPA-HQ-OPP-2021-0154),
http://www.regulations.gov. One comment was received on the notice of
filing. EPA's response to this comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the commodity definition for sugarcane. The reason for this
change is explained in Unit IV.D.
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 cyantraniliprole including
exposure resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with cyantraniliprole
follows.
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 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 tolerance rulemakings for
cyantraniliprole in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to cyantraniliprole 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 cyantraniliprole, see Unit III.A of the cyantraniliprole
tolerance rulemaking published in the Federal Register of November 13,
2018, 83 FR 56262 (FRL-9985-32).
Toxicological Points of Departure/Levels of Concern. For a
discussion of the Toxicological Points of Departure/Levels of Concern
used for the safety assessment of cyantraniliprole, see Unit III.B of
the February 5, 2014, rulemaking (79 FR 5826) (FRL-9388-7).
Exposure Assessment. Much of the exposure assessment for
cyantraniliprole remains unchanged from the discussion in Unit III.C of
the November 13, 2018, rulemaking, except as described below.
EPA's current exposure assessment has been updated to include the
additional exposure from this petitioned-for tolerance for residues of
cyantraniliprole on sugarcane. The rotational crop use does not result
in an increase in the estimated residue levels in drinking water or in
exposure from residential sources relative to those used in the last
assessment. EPA's aggregate exposure assessment incorporated this
additional dietary exposure, as well as exposure from drinking water
and from residential sources. There are no changes to EPA's conclusions
in the November 13, 2018, rulemaking concerning cumulative effects.
Safety Factor for Infants and Children. EPA continues to conclude
that there is reliable data showing that the safety of infants and
children would be adequately protected if the Food Quality Protection
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for
that decision are articulated in Unit III.D of the November 13, 2018,
rulemaking.
Assessment of aggregate risks. 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 PODs 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. Since no
effects of concern have been identified for cyantraniliprole resulting
from 1-day or single exposures, a qualitative acute dietary exposure
assessment is unnecessary. Chronic dietary risks are likewise below the
Agency's level of concern: 64% of the cPAD for all infants (<1 year
old), the group with the highest exposure. EPA has concluded the
combined short-term food, water, and residential exposures result in
aggregate margins of exposure above the level of concern of 100 for all
scenarios assessed and are not of concern. All risk estimates for
intermediate-term aggregate risk are not of concern. An aggregate
cancer risk assessment was not conducted because cyantraniliprole is
not considered to be a carcinogen. The chronic aggregate assessment did
not result in risk estimates of concern.
[[Page 20335]]
Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyantraniliprole residues.
Further information about EPA's risk assessment and determination
of safety supporting the new cyantraniliprole tolerance can be found at
https://www.regulations.gov in the document titled ``Cyantraniliprole.
Human Health Risk Assessment for an Inadvertent Tolerance on
Sugarcane'' in docket ID EPA-HQ-OPP-2021-0154.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
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).
There are no Codex MRLs established for residues of
cyantraniliprole on sugarcane.
C. Response to Comments
EPA received one comment in response to the April 22, 2021, notice
of filing. The comment seems to express general concern about
pesticides, and specifically requests that EPA not permit the use of
``cyanide''--a completely unrelated chemical--on ``sugar''. No specific
concerns about EPA's current evaluation were raised. While the agency
recognizes that some people oppose the use of pesticides in or on food
commodities, the FFDCA allows EPA to establish tolerances for residues
of pesticides in or on food as long as the Agency can determine those
tolerances are safe. The Agency has evaluated the aggregate exposures
of cyantraniliprole and has determined that there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to cyantraniliprole
residues. The commenter has provided no information to support a
conclusion that the tolerance is not safe.
D. Revisions to Petitioned-For Tolerances
The Agency is establishing a tolerance for the commodity
``sugarcane, cane'' rather than ``sugarcane'', as requested, to be
consistent with the food commodity nomenclature.
V. Conclusion
Therefore, a tolerance is established for inadvertent residues of
cyantraniliprole in or on sugarcane, cane at 0.01 ppm.
VI. 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 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: March 31, 2022.
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. 180.672, the table in paragraph (d) is amended by:
0
a. Adding a table heading; and
0
b. Adding the commodity ``Sugarcane, cane'' to the table in
alphabetical order.
The additions read as follows:
[[Page 20336]]
Sec. 180.672 Cyantraniliprole; tolerances for residues.
(d) * * *
Table 2 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Sugarcane, cane............................................. 0.01
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[FR Doc. 2022-07277 Filed 4-6-22; 8:45 am]
BILLING CODE 6560-50-P