
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45435-45438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18737]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0889; FRL-9929-74]


Zeta-Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for residues of zeta-
cypermethrin in or on corn, field, forage; corn, field, stover; and 
corn, pop, stover. FMC Corporation requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 30, 2015. Objections and 
requests for hearings must be received on or before September 28, 2015, 
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-2014-0889, 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: Susan Lewis, 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

[[Page 45436]]

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-2014-0889 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 
September 28, 2015. 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-2014-0889, 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 January 28, 2015 (80 FR 4525) (FRL-9921-
55), 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 
4F8290) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. 
The petition requested to amend the tolerances in 40 CFR 180.418 for 
residues of the insecticide zeta-cypermethrin, S-cyano (3-
phenoxyphenyl) methyl ())(cis-trans 3-(2-2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate, in or on corn, 
field, forage from 0.2 parts per million (ppm) to 9.0 ppm; corn, field, 
stover from 3.0 ppm to 30.0 ppm; and corn, pop, stover from 3.0 ppm to 
30.0 ppm. That document referenced a summary of the petition prepared 
by FMC Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Instead of the proposed tolerances in field corn stover (30.0 ppm) 
and popcorn stover (30.0 ppm), the Agency is establishing the 
tolerances at 30 ppm. The Agency establishes tolerances using whole 
numbers for tolerances of 10 ppm or more, per the OECD's User Guide 
ENV/JM/MONO (2011)2 for the OECD tolerance calculation procedure.

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 zeta-cypermethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with zeta-
cypermethrin follows.
    Zeta-cypermethrin is an enriched isomer of the pyrethroid 
insecticide cypermethrin. In addition, alpha-cypermethrin is also an 
enriched isomer of cypermethrin. Although cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin are separate active ingredients 
with different end-use products, they are included together in the 
hazard evaluation for the purpose of human health risk assessment. The 
toxicology database for the cypermethrins includes studies with 
cypermethrin and both of its enriched isomers, and is considered 
complete for the purpose of risk assessment.
    The aggregate risk assessment for zeta-cypermethrin must consider 
potential exposure from all cypermethrins (i.e., cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin), since the three active 
ingredients are considered to be essentially the same from the 
mammalian toxicity perspective. The revised tolerances are associated 
with decreased pre-harvest intervals (PHIs) for field corn and 
popcorn--from 30 days for grain and stover and 60 days for forage to 7 
days for all these commodities--and have no impact on the existing 
dietary exposure assessment for the cypermethrins. Corn forage and 
stover are livestock feed items and are not directly entered into the 
dietary exposure assessment, and EPA has determined that the existing 
tolerances for livestock commodities are adequate to support the 
changed use pattern. The existing zeta-cypermethrin use on corn was 
included in previous dietary exposure assessments. Decreasing the PHI 
and increasing the zeta-cypermethrin tolerances for field corn forage, 
field corn stover, and popcorn stover will have no impact on the 
dietary risk estimates, as they are already covered in the existing 
dietary assessment.
    In the final rule published in the Federal Register of December 7, 
2012

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(77 FR 72975) (FRL-9371-7), EPA established tolerances for residues of 
zeta-cypermethrin in multiple commodities. Since the publication of 
that final rule, the toxicity profile of zeta-cypermethrin has not 
changed, and since the revised tolerances associated with decreased 
PHIs for field corn and popcorn have no impact on the existing dietary 
and aggregate risk determinations, the risk assessments that supported 
the establishment of the zeta-cypermethrin tolerances published in the 
December 7, 2012 Federal Register final rule remain valid. Therefore, 
EPA is relying on those risk assessments in order to support the 
revised tolerances for zeta-cypermethrin in field corn forage, field 
corn stover, and popcorn stover.
    An updated aggregate risk assessment was not needed to support the 
proposed increased tolerances for residues in field corn forage, field 
corn stover, and popcorn stover, and the increased tolerances will not 
result in a change in the previously estimated dietary (food and water) 
or residential exposure estimates for zeta-cypermethrin. For a detailed 
discussion of the aggregate risk assessments and determination of 
safety, refer to the December 7, 2012 Federal Register final rule and 
its supporting documents, available at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2010-0472. EPA is relying on those 
supporting risk assessments and findings to support this final rule.
    Based on the risk assessments and information described in this 
unit, 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 zeta-cypermethrin residues. Additional 
information can be found in the document: ``Zeta-Cypermethrin--Human 
Health Risk Assessment for a Petition to Amend (Increase) the 
Established Tolerances for the Insecticide in Field Corn and Popcorn 
Stover, and in Field Corn Forage,'' available in docket ID number EPA-
HQ-OPP-2014-0889.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance enforcement methods are available in Pesticide 
Analytical Manual (PAM) Volume II for determining residues of alpha-
cypermethrin, cypermethrin, and zeta-cypermethrin in plant (Method I) 
and livestock (Method II) commodities. Both methods are gas 
chromatographic methods with electron-capture detection (GC/ECD), and 
have undergone successful Agency petition method validations (PMVs). 
These methods are not stereospecific; thus no distinction is made 
between residues of cypermethrin (all 8 stereoisomers), alpha-
cypermethrin (enriched in 2 isomers), and zeta-cypermethrin (enriched 
in 4 isomers). The January 1994 Food and Drug Administration (FDA) 
PESTDATA database (PAM Volume I) indicates that residues of 
cypermethrin are completely recovered (>80%) using multi-residue method 
sections 302 (Luke), 303 (Mills, Onley, and Gaither), and 304 (Mills 
fatty food).

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 no Codex MRLs for cypermethrin, which includes both 
alpha- and zeta-cypermethrin, established in corn forage or stover.

C. Response to Comments

    One comment was received from the general public, urging the Agency 
to deny the request. The commenter particularly addressed toxicity to 
bees and other insects, and human toxicological and reproductive 
effects.
    The Agency understands the commenter's concerns, and recognizes 
that some individuals believe that certain pesticide chemicals should 
not be permitted in food. Regarding effects to bees and other insects, 
the safety standard for approving tolerances under section 408 of FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on other species or the environment. The 
existing legal framework provided by section 408 of FFDCA states that 
tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. When new or amended tolerances are 
requested for residues of a pesticide in food or feed, the Agency, as 
is required by Section 408 of FFDCA, estimates the risk of the 
potential exposure to these residues by performing an aggregate risk 
assessment. Such a risk assessment integrates the individual 
assessments that are conducted for food, drinking water, and 
residential exposures. Additionally, the Agency, as is further required 
by Section 408 of the FFDCA, considers available information concerning 
what are termed the cumulative toxicological effects of the residues of 
that pesticide and of other substances having a common mechanism of 
toxicity. Therefore, these assessments consider both exposure and 
toxicological effects--including information concerning the 
reproductive effects of the pesticide--in reaching a conclusion as to 
whether or not the reasonable certainty of no harm decision can be 
made. The Agency has concluded after this assessment that there is a 
reasonable certainty that no harm will result from exposure to the 
residues of zeta-cypermethrin. Therefore, the proposed tolerances are 
found to be acceptable.

 V. Conclusion

    Therefore, tolerances are established for residues of zeta-
cypermethrin, S-cyano (3-phenoxyphenyl) methyl ())(cis-
trans 3-(2-2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate, in 
or on corn, field, forage at 9.0 ppm; corn, field, stover at 30 ppm; 
and corn, pop, stover at 30 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

[[Page 45438]]

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: July 22, 2015.
Susan Lewis,
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.  180.418, revise the entries for ``corn, field, forage,'' 
``corn, field, stover,'' and ``corn, pop, stover'' in the table in 
paragraph (a)(2) to read as follows:


Sec.  180.418  Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, forage.....................................             9.0
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, stover.....................................              30
------------------------------------------------------------------------
 
                                * * * * *
Corn, pop, stover.......................................              30
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-18737 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P


