[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Rules and Regulations]
[Pages 57619-57621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23360]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0062; FRL-9999-56]


Mandipropamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mandipropamid in or on cacao, dried bean. Syngenta Crop Protection, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective October 28, 2019. Objections and 
requests for hearings must be received on or before December 27, 2019 
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-2019-0062, 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., 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.

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-2019-0062 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 
December 27, 2019. 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-2019-0062, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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 
9F8733) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.637 be amended by 
establishing tolerances for residues of the fungicide mandipropamid in 
or on cocoa bean at 0.05 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, 
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 the tolerance at 0.06 ppm in or on cacao, dried bean. The 
reason for this change 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

[[Page 57620]]

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 mandipropamid including 
exposure resulting from the tolerances established by this action.

A. Risk Assessment

    In the Federal Register of March 22, 2019 (84 FR 10695) (FRL-9987-
25), EPA established tolerances for residues of mandipropamid in or on 
several commodities. Because much of the safety assessment of 
mandipropamid for the current action remains the same, EPA is 
incorporating several aspects of that previous rule and relying in part 
upon the findings made in the March 22, 2019 final rule in support of 
this action.
    A summary of the toxicological profile and endpoints used for human 
risk assessment is discussed in Units III.A. and III.B of the March 22, 
2019 final rule. In evaluating dietary exposure for this action, EPA 
considered exposure under the petitioned-for tolerances as well as all 
existing mandipropamid tolerances in 40 CFR 180.637. The exposure 
assumptions used to assess the mandipropamid tolerances remain the same 
as discussed in the March 22, 2019 final rule, except to incorporate 
the exposure associated with the tolerance on cacao, dried beans, for 
which the Agency assumed 100 percent crop treated and tolerance-level 
residues. For a summary of those exposure assumptions, see Unit III.C.1 
of the March 22, 2019 final rule. In addition, because there is no U.S. 
registration associated with the use of mandipropamid on cacao, dried 
beans, the estimated drinking water exposures reported in the March 22, 
2019 final rule remain the same for this rule. A summary of EPA's 
assessment of drinking water exposure is discussed in Unit III.C.2. of 
the March 22, 2019 final rule. Similarly, the Agency's assessment of 
cumulative risks remains the same as in the March 22, 2019 final rule.
    Because there have been no changes to the potential for prenatal 
and postnatal toxicity or in the completeness of data with respect to 
toxicity and exposure, EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
additional tenfold (10X) margin of safety required under section 
408(b)(2)(C) (``FQPA safety factor'') were reduced to 1X. A summary of 
EPA's rationale for this determination is discussed in Unit III.D. of 
the March 22, 2019 final rule.

B. 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 (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 to ensure 
that an adequate margin of exposure exists.
    No acute effects were identified in the toxicological studies for 
mandipropamid; therefore, a quantitative acute dietary exposure 
assessment was not conducted. The chronic dietary risk is 31% of the 
cPAD for the general U.S. population and 49% of the cPAD for children 1 
to 2 years old, the population subgroup with the highest estimated 
chronic dietary exposure to mandipropamid. The Agency level of concern 
is percentage numbers greater than 100% of the cPAD. Mandipropamid is 
not registered for any specific use patterns that would result in 
residential exposure. Therefore, all aggregate risk estimates are 
expected to be equivalent to the dietary (food and drinking water) risk 
estimates mentioned above.
    Therefore, 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 mandipropamid residues.
    Mandipropamid is classified as ``Not Likely to be Carcinogenic to 
Humans.'' Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer both to the 
March 22, 2019 final rule and its supporting documents, available at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2017-0671, 
and to the risk assessment for this current action, ``Mandipropamid. 
Human Health Risk Assessment to Support the Proposed Establishment of a 
Tolerance for the Fungicide (without Section 3 Registration) in/on 
Imported Cacao Beans.'' in docket ID number EPA-HQ-OPP-2019-0062.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using method RAM 415/02, for the 
determination of mandipropamid using high-performance liquid 
chromatography with tandem mass spectrometric detection (LC/MS/MS), is 
available to enforce the tolerance. The method has been adequately 
validated by an independent laboratory, with a validated limit of 
quantitation (LOQ) of 0.010 ppm and a limit of detection (LOD) of 0.002 
ppm in the crops tested.
    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: 
residuemethods@epa.gov.

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.
    The Codex has not established an MRL for mandipropamid in cacao, 
dried bean.

C. Revisions to Petitioned-For Tolerances

    The tolerance definition was revised from ``cocoa bean'' to 
``cacao, dried bean'' in accordance with tolerance naming conventions. 
EPA has revised the tolerance level for mandipropamid residues in 
cacao, dried bean based on the review conducted by the European Food 
Safety Authority (EFSA) (Setting

[[Page 57621]]

of an import tolerance for mandipropamid in cocoa beans; A. Brancato et 
al; 31 October 2018). The EFSA review addresses the same use pattern 
and residue data submitted to the EPA to support this use, so the 
tolerance being established is harmonized with EFSA's recommended MRL 
(0.06 mg/kg).

V. Conclusion

    Therefore, tolerances are established for residues of 
mandipropamid, in or on cacao, dried bean at 0.06 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 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 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: October 11, 2019.
Daniel Rosenblatt,
Acting 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.  180.637, add alphabetically the commodity ``Cacao, dried 
bean'' to the table in paragraph (a) to read as follows:


Sec.  180.637  Mandipropamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cacao, dried bean \1\.......................................        0.06
 
                               * * * * *
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\1\ There are no U.S. registrations allowing use of mandipropamid on
  cacao as of October 28, 2019.

* * * * *
[FR Doc. 2019-23360 Filed 10-25-19; 8:45 am]
 BILLING CODE 6560-50-P


