Fluoride Action Network

Cyflumetofen; Pesticide Tolerances. Final Rule.

Source: Federal Register | July 1st, 2020 | Environmental Protection Agency
Industry type: Pesticides

Note from Fluoride Action Network:
Cyflumetofen is a new pesticide as of October 2004.
See EU database
Molecular structure

Original Final Rule online at 
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: RDFRNotices@epa.gov.


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

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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 
     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-
(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-
    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 
    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 

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available to enforce the Agency-
recommended tolerances for

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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: 

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.

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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. 

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:


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.  180.677amend the table in paragraph (a) by:
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'';
ii. Revise the tolerance entry for ``Strawberry''; and
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]

*Original Final Rule online at