[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Rules and Regulations]
[Pages 77391-77394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29788]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0210; FRL-9920-23]


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 alfalfa, forage and alfalfa, hay. FMC Corporation 
requested the amendment of the tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 24, 2014. Objections and 
requests for hearings must be received on or before February 23, 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)

[[Page 77392]]

number EPA-HQ-OPP-2014-0210, 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: [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-2014-0210 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 February 
23, 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-2014-0210, 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 May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3F8214) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. 
The petition requested EPA 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 alfalfa, 
forage from 5.0 parts per million (ppm) to 15.0 ppm and alfalfa, hay 
from 15.0 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 alfalfa hay at 30.0 ppm and 
alfalfa forage at 15.0 ppm, EPA is establishing these tolerances at 30 
ppm and 15 ppm, respectively. The Agency establishes tolerances using 
whole numbers for tolerances of 10 ppm or more, per the Organization 
for Economic Cooperation and Development (OECD) 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, alpha-
cypermethrin, and zeta-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

[[Page 77393]]

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, alpha-
cypermethrin, and zeta-cypermethrin), since the three active 
ingredients are considered to be essentially the same from the 
mammalian toxicity perspective. The revised tolerances associated with 
the increased use rate on alfalfa forage and hay have no impact on the 
existing dietary exposure assessment for the cypermethrins. Alfalfa 
forage and hay are livestock feed items that are not directly entered 
into the dietary exposure assessment. In addition, the increased 
tolerances in the alfalfa forage and hay will not have an impact on the 
existing livestock commodity tolerances; these tolerances were 
established at levels determined largely due to the potential for 
residues in other commodities (such as clover and trefoil) with higher 
tolerances and which also constitute a greater percentage of the 
estimated livestock diet for zeta-cypermethrin. Therefore, the proposed 
increased use rates on alfalfa grown for hay and forage will not result 
in the need to increase the tolerances in livestock commodities. 
Consequently, the previously conducted dietary exposure assessment will 
not be affected by the proposed increased use rate and corresponding 
tolerances for alfalfa hay and forage. Furthermore, the drinking water 
estimates used in the existing dietary exposure assessment are more 
protective (higher) than those recently estimated based on the proposed 
use pattern and using updated drinking water models.
    In the final rule published in the Federal Register of December 7, 
2012 (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 the increased use rate on alfalfa forage and hay 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 alfalfa forage and hay.
    An updated aggregate risk assessment was not needed to support the 
proposed increased tolerances for residues in alfalfa forage and hay, 
since these are livestock feed items, 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, please 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 
also relying on those supporting risk assessments and findings to 
support of 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. Further information 
can also be found in the document: ``Zeta-Cypermethrin--Human Health 
Risk Assessment to Support Increased Tolerances and Use Rate on Alfalfa 
Hay and Forage'' in docket ID number EPA-HQ-OPP-2014-0210.

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.
    Currently established U.S. tolerances for cypermethrin, alpha-
cypermethrin, and zeta-cypermethrin are included in the same part in 
title 40 of the Code of Federal Regulations (CFR), but have separate 
sections and different crops listed. There are multiple Codex MRLs for 
zeta-cypermethrin, but all are in conjunction with MRLs for total 
cypermethrin isomers (no MRLs have been established solely for zeta-
cypermethrin). However, although the definitions differ formally, they 
are effectively harmonized since the tolerance-enforcement methods are 
not stereospecific, and thus do not distinguish between residues of 
cypermethrin, alpha-cypermethrin, and zeta-cypermethrin. For 
enforcement purposes, the same moiety is being regulated.
    There is a Codex MRL established in alfalfa fodder at 30 ppm, which 
would be harmonized with the proposed tolerance in alfalfa hay. Codex 
has not established an MRL in alfalfa forage.

C. Response to Comments

    One comment was received from the general public urging the Agency 
to tighten regulations for pesticides tolerances and uses. The 
commenter particularly addressed carcinogenic chemicals and their 
effects on children's health.
    Cypermethrin is classified as a ``Possible human carcinogen'' based 
on the presence of benign tumors (lung adenomas) in an adequate mouse 
carcinogenicity study with cypermethrin. The presence of common benign 
tumors (lung adenomas), in one species (mice) and one sex (female), 
with no increase in the proportion of malignant tumors or decrease in 
the time-to-tumor occurrence, together with the lack of mutagenic 
activity, was not considered strong enough to warrant a linear or no-
threshold approach to quantitation of human cancer risk. Quantification 
of risk using a non-linear

[[Page 77394]]

approach (i.e., acute population adjusted dose (aPAD), acute reference 
dose (aRfD)) will adequately account for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
cypermethrin. The Agency is using the acute dietary endpoint because, 
due to the rapid reversibility of the most sensitive neurotoxicity 
endpoint used for quantifying risks, there is no increase in hazard 
with increasing dosing duration; therefore, the acute dietary endpoint 
is protective of the endpoints from repeat dosing studies, including 
cancer dietary exposures.
    No evidence of carcinogenicity was observed in carcinogenicity 
studies in rats with cypermethrin or in mice with alpha-cypermethrin. 
Carcinogenicity studies are not available for zeta-cypermethrin; 
however, based on the structural and toxicological similarities to 
alpha cypermethrin and cypermethrin the carcinogenic potential is 
expected to be similar. Therefore, the Agency considers conclusions 
regarding the carcinogenic potential of cypermethrin to be applicable 
to alpha-cypermethrin and zeta-cypermethrin.
    The Agency has considered all the available data, including all 
available data concerning the potential for carcinogenicity and 
concluded after conducting a risk assessment, that there is a 
reasonable certainty that no harm will result from aggregate human 
exposure to zeta-cypermethrin. EPA gives special consideration to the 
potential susceptibility and exposures of infants and children to 
pesticide chemical residues and is confident that it has chosen 
endpoints, points of departure, and uncertainty factors that are 
protective for all populations, including infants and children, and 
that have a strong scientific foundation. In addition, there are 
ongoing efforts to develop data to gain more information concerning the 
potential sensitivity of infants and young children to pyrethroids as a 
class.

V. Conclusion

    Therefore, tolerances are amended for residues of zeta-
cypermethrin, S-cyano(3-phenoxyphenyl)methyl ())(cis-
trans3-(2-2-dichloroethenyl)-2,2dimethylcyclopropanecarboxylate, 
including its metabolites and degradates in or on alfalfa, forage at 15 
ppm and alfalfa, hay 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 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: December 10, 2014.
G. Jeffrey Herndon,
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,place the entries ``Alfalfa, hay'' and ``Alfalfa, 
forage'' in alphabetical order in the table in paragraph (a)(2) and 
revise them to read as follows:


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

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................              15
Alfalfa, hay............................................              30
 
                                * * * * *
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[FR Doc. 2014-29788 Filed 12-23-14; 8:45 am]
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