[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Rules and Regulations]
[Pages 64777-64779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25543]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0636; FRL-9996-61]


Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of the 
insecticide cyflumetofen in or on coffee, green bean. OAT Agrio. Ltd., 
Tokyo, Japan c/o Landis International, Inc. requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 25, 2019. Objections and 
requests for hearings must be received on or before January 24, 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-2018-0636, 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.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Director, 
Registration Division (750P), 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 
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-2018-0636 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 
January 24, 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 
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-2018-0636, 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 October 24, 2018 (83 FR 53594) (FRL-
9983-46), 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 
8E8693) by OAT Agrio. Ltd., Tokyo, Japan, c/o Landis International, 
Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, Georgia 31603-
5126. The petition requested that 40 CFR 180.677 be amended by 
establishing a tolerance for residues of the insecticide cyflumetofen, 
(2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), in or on coffee, 
green bean at 0.08 parts per million (ppm). That document referenced a 
summary of the petition prepared by OAT Agrio. Ltd. c/o Landis 
International, Inc., the registrant, which is available in docket 
number EPA-HQ-OPP-2018-0636, http://www.regulations.gov. These 
tolerances were requested to cover residues of cyflumetofen in or on 
coffee, green bean resulting from use of this pesticide on coffee 
outside the United States. There is no current U.S. registration for 
use of cyflumetofen on coffee. There were no substantive comments 
received in response to the notice of filing for this pesticide 
petition.

[[Page 64778]]

    Based upon review of the data supporting the referenced petition, 
EPA is establishing a tolerance for residues of cyflumetofen on coffee, 
green bean.

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 in or on coffee, 
green bean.
    On May 8, 2019 (82 FR 20037) (FRL-9990-60), EPA published in the 
Federal Register a final rule establishing a tolerance for residues of 
the insecticide cyflumetofen in or on tea, dried is safe for the 
general population, including infants and children. See 84 FR 20037 
(FRL-9990-60). That document contains a summary of the toxicological 
profile and points of departure, assumptions for exposure assessment, 
and the safety factor for children, which have not changed. The Agency 
conducted a revised risk assessment to incorporate exposure to residues 
of cyflumetofen from use on coffee.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of cyflumetofen on coffee, i.e., reliance 
on tolerance-level residues and an assumption of 100 percent crop 
treated (PCT). Because the use on coffee is not an approved domestic 
use, there is no expectation of an increased exposure in drinking water 
or for non-dietary, non-occupational sources, although the additional 
dietary exposure contributes to overall aggregate exposure. Further 
information about EPA's risk assessment and determination of safety 
supporting the tolerances established in the May 8, 2019 Federal 
Register action, as well as the new cyflumetofen tolerance can be found 
at http://www.regulations.gov in the document entitled ``Cyflumetofen. 
Human Health Risk Assessment to Support New Uses on Imported Tea,'' 
dated March 4, 2019. The documents can be found in docket ID EPA-HQ-
OPP-2017-0532.
    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 risks are below the Agency's level of concern: 2.4% of 
the chronic population adjusted dose (cPAD) for children 1-2 years old, 
the group with the highest exposure level. Moreover, the short-term 
aggregate risk for the population with the highest total exposure 
(adults 50-99 years old) was chosen since this is protective for all 
other adult sub-populations. There are no residential exposures 
expected for children; therefore, a short-term aggregate risk 
assessment for children is equal to the chronic food and drinking water 
exposure and risk estimates and is not of concern. Using the exposure 
assumptions described for short-term exposures, EPA has concluded the 
combined short-term food, water, and residential exposures result in 
aggregate MOEs above the LOC of 100 for all scenarios assessed and are 
not of concern.
    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 coffee, green 
bean can be found in the document entitled, ``Cyflumetofen. Human 
Health Risk Assessment to Support New Uses without U.S. Registration 
in/on Imported Coffee,'' dated September 16, 2019, 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-2018-0636.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
HED-recommended tolerances for cyflumetofen in plant commodities. The 
high-performance liquid chromatography with tandem mass spectrometry 
(HPLC-MS/MS) method 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. The method limit of 
quantitation (LOQ) for residues of cyflumetofen in coffee is 0.01 ppm. 
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.
    Codex has not established maximum residue limits (MRLs) for 
residues of cyflumetofen in coffee commodities; therefore, there are no 
harmonization issues.

V. Conclusion

    Therefore, a tolerance is established for residues of the 
insecticide cyflumetofen, (2-methoxyethyl [alpha]-cyano-[alpha]-[4-
(1,1-dimethylethyl)phenyl]-[beta]-oxo-

[[Page 64779]]

2-(trifluoromethyl)benzenepropanoate), in or on coffee, green bean at 
0.08 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), nor is 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 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: November 8, 2019.
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.  180.677, add a footnote and alphabetically the entry for 
``Coffee, green bean \2\'' to the table in paragraph (a) to read as 
follows:


Sec.  180.677  Cyflumetofen; tolerances for residues.

    (a) * * *
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    \2\ There are no U.S. registrations for these commodities as of 
November 25, 2019.

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                                                              Parts per
                         Commodity                             million
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                                * * * * *
Coffee, green bean \ 2\....................................        0.08
 
                                * * * * *
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[FR Doc. 2019-25543 Filed 11-22-19; 8:45 am]
BILLING CODE 6560-50-P