[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Rules and Regulations]
[Pages 34206-34209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11558]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0434; FRL-9636-01-OCSPP]
Teflubenzuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
insecticide teflubenzuron in or on grape and grape, raisin. There is no
U.S. registration associated with these tolerances. BASF Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective June 6, 2022. Objections and
requests for hearings must be received on or before August 5, 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).
[[Page 34207]]
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0434, 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.
Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1030; 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.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0434 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
August 5, 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-2021-0434, 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/contacts.html.
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 August 24, 2021 (86 FR 47275) (FRL-8792-
02), 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
0E8874) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.687 be amended by
establishing tolerances for residues of the insecticide teflubenzuron,
(N-[[(3,5-dichloro-2,4-difluorophenyl)amino]carbonyl]-2,6-
difluorobenzamide), in or on grape at 0.7 parts per million (ppm) and
grape, raisin at 0.9 ppm. That document referenced a summary of the
petition prepared by BASF Corporation, which is available in docket ID
number EPA-HQ-OPP-2021-0434 in https://www.regulations.gov. No
substantive public comments were 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 of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for teflubenzuron including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with teflubenzuron 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
teflubenzuron in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to teflubenzuron and established
tolerances for residues of that chemical.
[[Page 34208]]
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 teflubenzuron, see Unit III.A of the teflubenzuron tolerance
rulemaking published in the Federal Register of October 30, 2015 (80 FR
66805) (FRL-9933-25).
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 teflubenzuron, see Unit III.B of the
October 30, 2015, rulemaking.
Exposure Assessment. Much of the exposure assessment for
teflubenzuron remains unchanged from the discussion in Unit III.C of
the October 30, 2015, rulemaking, except as described below.
The current exposure assessment incorporates the additional dietary
exposure from this petitioned-for tolerances. Because this action
establishes tolerances for residues of teflubenzuron in or on imported
commodities for which there are no associated U.S. registrations,
dietary exposure (food only) is the only anticipated exposure pathway.
There are no domestic agricultural or residential uses registered or
proposed for teflubenzuron that would result in drinking water or
residential exposures. This tolerance petition does not warrant an
occupational handler exposure assessment because the petition is for
import tolerances without a U.S. registration. There are no short- or
intermediate-term exposures from the use of teflubenzuron. An acute
risk assessment was not performed because there were no toxicological
effects attributable to a single dose identified.
The unrefined chronic dietary (food only) exposure estimates
represent the aggregate exposure assessment and assumed that
teflubenzuron residues are present in all commodities at tolerance
levels and that 100% of all crops are treated. Empirical processing
factors of 0.08 for apple juice and 0.04 for orange juice were
incorporated into the dietary exposure model and the Agency's 2018
default processing factors were used to estimate residues in other
processed commodities. The Agency's approach for assessing these
factors is discussed in detail in the document titled ``Chronic Dietary
(Food Only) Exposure and Risk Assessment for the Proposed Tolerances
Without a U.S. Registration for Residues in/on Grapes.'' in docket ID
number EPA-HQ-OPP-2021-0434.
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 October 30, 2015,
rulemaking.
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 chronic population-adjusted dose 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 (PODs) to ensure that an adequate
margin of exposure (MOE) exists.
An endpoint of concern attributable to a single dose was not
identified; therefore, an acute dietary assessment was not performed.
Chronic dietary risks are below the Agency's level of concern of 100%
of the cPAD for the U.S. general population and all population
subgroups. The most highly exposed population subgroup is children 1-2
years old with an estimated risk of 48% of the cPAD.
In accordance with the EPA's ``Final Guidelines for Carcinogen Risk
Assessment'' (March 2005), the Cancer Assessment Review Committee
(CARC) classified teflubenzuron as ``Suggestive Evidence of
Carcinogenic Potential'' based on the presence of rare liver tumors in
male mice only. The Agency has determined that quantification of risk
using a non-linear approach (i.e., reference dose [RfD]) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to teflubenzuron. Therefore, the
chronic dietary risks, which are not of concern, are considered
protective of both non-cancer and cancer effects.
Determination of Safety. 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 teflubenzuron
residues. More detailed information about the Agency's analysis can be
found at https://www.regulations.gov in the document titled ``Chronic
Dietary (Food Only) Exposure and Risk Assessment for the Proposed
Tolerances Without a U.S. Registration for Residues in/on Grapes.''
This document can be found in docket ID number EPA-HQ-OPP-2021-0434.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is available to enforce the
petitioned-for tolerances for residues of teflubenzuron in/on crop
commodities. Samples were analyzed for residues of teflubenzuron using
a high-performance liquid chromatography method with tandem mass
spectrometry detection (LC/MS/MS), SOP-PA.0250. Acceptable concurrent
recoveries were reported for samples of grape fortified with
teflubenzuron at 0.01-1.0 ppm, thus validating the method. The limit of
quantitation (LOQ; determined as the lowest level of method validation,
LLMV) was 0.01 ppm. The estimated LOD (limit of detection) was 20% of
the LOQ or 0.002 ppm.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, Fort 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). Codex is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
The U.S. tolerance level for grape residues established in this
action is harmonized with Codex. There are no established Canadian or
Mexican MRLs for residues of teflubenzuron on grape. Additionally,
there are no established Codex, Canadian, or Mexican MRLs for residues
of teflubenzuron on grape, raisin.
C. Revisions to Petitioned-For Tolerances
Based upon the submitted data, no revisions to the petitioned-for
tolerances proposed for residues in/on grape and grape, raisin are
needed.
[[Page 34209]]
V. Conclusion
Therefore, tolerances are established for residues of the
insecticide teflubenzuron, (N-[[(3,5-dichloro-2,4-
difluorophenyl)amino]carbonyl]-2,6-difluorobenzamide), in or on grape
at 0.7 ppm; and grape, raisin, at 0.9 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 tolerances 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: May 24, 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. 180.687:
0
a. Amend paragraph (a)(1) by:
0
i. Adding a table heading;
0
ii. Adding the commodities ``Grape'' and ``Grape, raisin'' to the table
in alphabetical order; and
0
iii. Revising footnote 1.
0
b. Add a reserved paragraph (a)(2).
0
c. Remove and reserve paragraphs (b), (c), and (d).
The additions and revision read as follows:
Sec. 180.687 Teflubenzuron; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Grape \1\............................................... 0.7
Grape, raisin \1\....................................... 0.9
* * * * *
------------------------------------------------------------------------
\1\ Tolerance without U.S. registration.
* * * * *
[FR Doc. 2022-11558 Filed 6-3-22; 8:45 am]
BILLING CODE 6560-50-P