[Federal Register Volume 85, Number 127 (Wednesday, July 1, 2020)]
[Rules and Regulations]
[Pages 39491-39494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13048]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0046; FRL-10009-25]
Cyflumetofen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyflumetofen in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July 1, 2020. Objections and
requests for hearings must be received on or before August 31, 2020 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-2019-0046, 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. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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
Printing 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-2019-0046 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 31, 2020. 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
[[Page 39492]]
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-2019-0046, 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 April 19, 2019 (84 FR 16430) (FRL-9991-
14), 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
8E8724) 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 part 180 be amended by establishing tolerances
for residues of the insecticide cyflumetofen, 2-methoxyethyl a-cyano-a-
[4-(1,1-dimethylethyl)phenyl]-b-oxo-2-
(trifluoromethyl)benzenepropanoate, including its metabolites and
degradates, to be determined by measuring only cyflumetofen, in or on
the agricultural commodities: Cucumber at 0.15 parts per million (ppm);
fruit, stone, group 12-12 at 2.0 ppm; plum, prune, dried at 0.41 ppm;
strawberry at 0.80 ppm; and vegetable, fruiting, group 8-10 at 2.0 ppm.
The petition also requested that upon approval of the above tolerances
that 40 CFR 180.677 be amended by revising or removing the existing
tolerances for residues of the insecticide cyflumetofen, in or on the
agricultural commodities strawberry at 0.60 ppm and tomato at 0.40 ppm.
That document referenced a summary of the petition prepared by BASF,
the registrant, which is available in the docket, http://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 some tolerances at different levels than requested and in
some cases is establishing tolerances for different commodities than
requested. The reason for these changes 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 cyflumetofen including exposure
resulting from the tolerances established by this action.
On May 8, 2019, EPA published in the Federal Register a final rule
establishing a tolerance for residues of the insecticide cyflumetofen
in or on tea, dried. See 84 FR 20037 (FRL-9990-60). That document
contains a summary of the toxicological profile, assumptions for
dietary exposure assessment, cumulative risk, and the safety factor for
children, which have not changed. Further information about EPA's risk
assessment and determination of safety supporting the tolerances
established in the May 8, 2019 Federal Register action can be found at
http://www.regulations.gov in the document titled, ``Cyflumetofen.
Human Health Risk Assessment to Support New Uses on Imported Tea''
dated March 4, 2019. The document can be found in docket ID EPA-HQ-OPP-
2017-0532.
The Agency conducted a revised risk assessment to incorporate
exposure to residues of cyflumetofen from use on the cucumber, the
stone fruit group 12-12, strawberries, and the fruiting vegetable group
8-10. EPA's aggregate exposure assessment incorporated this additional
dietary exposure, as well as exposure in drinking water, although
drinking water exposures are not impacted by the new uses. In addition,
the aggregate exposure assessment no longer includes residential
handler exposures; no post-application exposures were assessed due to a
lack of residential post-application exposures and lack of dermal
hazard.
As indicated in the supporting documents, no acute dietary exposure
and risk analysis was performed for cyflumetofen since there were no
appropriate studies identified in the toxicology database that
demonstrated evidence of toxicity attributable to a single dose.
Chronic dietary (food and water) risks are below the Agency's level of
concern of 100% of the chronic population adjusted dose (cPAD); they
are 3% of the cPAD for children 1-2 years old, the group with the
highest exposure level. Because EPA has determined there are no
residential exposures, the chronic dietary risk is the same as the
overall aggregate risk for cyflumetofen.
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 cyflumetofen residues.
More detailed information on the subject action to establish a
tolerance in or on cucumber, the stone fruit group 12-12, prunes,
strawberries, and the fruiting vegetable group 8-10 can be found in the
document titled, ``Cyflumetofen. Human Health Risk Assessment for the
Section 3 Registration Action for New Uses on Fruiting Vegetable (Crop
Group 8-10), Stone Fruits (Crop Group 12-12), and Greenhouse Uses on
Fruiting Vegetable, Cucumber, and Strawberry'', dated April 29, 2020,
by going to http://www.regulations.gov. The referenced document is
available in the docket established by this action, which is described
under ADDRESSES. Locate and click on the hyperlink for docket ID number
EPA-HQ-OPP-2019-0046.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is available to enforce the Agency-
recommended tolerances for
[[Page 39493]]
cyflumetofen in plant commodities. The high-performance liquid
chromatography with tandem mass spectrometry (HPLC-MS/MS) method, BASF
D1003, has been adequately validated, has undergone a successful ILV
(independent laboratory validation), is considered adequately radio-
validated and has been reviewed by the Agency for appropriateness as an
enforcement method. Cyflumetofen has also been subjected to analysis by
the Food and Drug Administration (FDA) multi-residue method (MRM)
protocols. Cyflumetofen is not adequately recovered through any of the
FDA multi-residue protocols.
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). The Codex Alimentarius 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.
There are Codex MRLs established for cyflumetofen residues in/on
strawberry (0.6 ppm) and tomato (0.3 ppm). The strawberry tolerance is
harmonized with Codex. The tolerance for tomato is not harmonized with
Codex; harmonization is not possible at this time since lowering the
newly established U.S. tolerance may result in over-tolerance residues
in the United States.
C. Revisions to Petitioned-For Tolerances
EPA is establishing the tolerance for cucumber at 0.3 ppm rather
than the petitioned-for tolerance level of 0.15 ppm to fully account
for residue loss from the field trial samples during freezer storage
from the time of harvest to the time of analysis.
EPA is establishing tolerances for the subgroups in the stone fruit
crop group 12-12 rather than the whole crop group based on the highest
maximum residue limit (MRL) calculated for each of the representative
crops: Cherry (1.5 ppm), peaches (0.4 ppm), and plums (0.3 ppm) to
harmonize with Canada's MRLs.
A tolerance is not required for dried plums (prune) because this
commodity is covered under the plum subgroup 12-12C tolerance.
For strawberry, the Agency is maintaining the existing tolerance to
remain harmonized with Codex. Although the Organization for Economic
Cooperation and Development (OECD) MRL calculator produces a tolerance
of 0.8 ppm for (greenhouse) strawberry, the currently established
tolerance level for strawberry (0.60 ppm) is adequate for foliar and
greenhouse uses. EPA is revising the strawberry tolerance to 0.6 ppm
based on OECD rounding classes.
EPA is establishing tolerances for the tomato subgroup 8-10A at 0.7
ppm and pepper/eggplant subgroup 8-10B at 2 ppm rather than the full
crop group vegetable, fruiting, group 8-10 in order to harmonize with
the Canadian tolerances on tomato and pepper.
V. Conclusion
Therefore, tolerances are established for residues of cyflumetofen,
(2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), in or on cherry
subgroup 12-12A at 1.5 ppm; cucumber at 0.3 ppm; peach subgroup 12-12B
at 0.4 ppm; pepper/eggplant subgroup 8-10B at 2 ppm; plum subgroup 12-
12C at 0.3 ppm; and tomato subgroup 8-10A at 0.7 ppm.
Additionally, the existing tolerance on tomato is removed as
unnecessary due to the establishment of the above tolerances. Also, the
existing tolerance for strawberry is modified to 0.6 ppm.
VI. Statutory and Executive Order Reviews
This action establishes and modifies 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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.
[[Page 39494]]
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: June 8, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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. 180.677amend the table in paragraph (a) by:
0
i. Adding alphabetically the commodities ``Cherry subgroup 12-12A'';
``Cucumber''; ``Peach subgroup 12-12B''; ``Pepper/eggplant subgroup 8-
10B''; ``Plum subgroup 12-12C''; and ``Tomato subgroup 8-10A'';
0
ii. Revise the tolerance entry for ``Strawberry''; and
0
iii. Remove the commodity ``Tomato'' from the table in paragraph (a).
The additions and revisions read as follows:
Sec. 180.677 Cyflumetofen; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cherry subgroup 12-12A...................................... 1.5
* * * * *
Cucumber.................................................... 0.3
* * * * *
Peach subgroup 12-12B....................................... 0.4
Pepper/eggplant subgroup 8-10B.............................. 2
Plum subgroup 12-12C........................................ 0.3
Strawberry.................................................. 0.6
* * * * *
Tomato subgroup 8-10A....................................... 0.7
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-13048 Filed 6-30-20; 8:45 am]
BILLING CODE 6560-50-P