[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73210-73213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28934]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0601; FRL-9918-88]


Alpha-cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of alpha-
cypermethrin in or on food

[[Page 73211]]

commodities/feed commodities in food/feed handling establishments. BASF 
on behalf of Whitmire Micro-Gen Research Laboratories requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 10, 2014. Objections and 
requests for hearings must be received on or before February 9, 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-2014-0601, 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-2014-0601 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 
February 9, 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-2014-0601, 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 September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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 
3F8189) by BASF on behalf of Whitmire Micro-Gen Research Laboratories, 
3568 Tree Court Industrial Blvd., St. Louis, MO 63122-6682. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the insecticide alpha-cypermethrin, in or on 
food/feed handling establishments at 0.05 parts per million (ppm). That 
document referenced a summary of the petition prepared by BASF on 
behalf of Whitmire Micro-Gen Research Laboratories, 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.
    EPA has corrected the proposed commodity definition to read food 
commodities/feed commodities (other than those covered by a higher 
tolerance as a result of use on growing crops) in food/feed handling 
establishments.

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

[[Page 73212]]

aggregate exposure for alpha-cypermethrin including exposure resulting 
from the tolerances established by this action. EPA's assessment of 
exposures and risks associated with alpha-cypermethrin follows.
    Alpha-cypermethrin is an enriched isomer of the pyrethroid 
insecticide cypermethrin. In addition, zeta-cypermethrin is also an 
enriched isomer of cypermethrin. 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. When considering alpha-cypermethrin the EPA also considers 
potential exposures from the other registered cypermethrins (i.e., 
cypermethrin and zeta-cypermethrin), since the 3 active ingredients are 
essentially the same active from the mammalian toxicity perspective. 
The recommended tolerance of 0.05 ppm associated with the food handling 
establishment use of alpha-cypermethrin is at the same level as the one 
currently established for zeta-cypermethrin. Based on the available 
alpha-cypermethrin residue data submitted for the food handling 
establishment use, this use will not result in alpha-cypermethrin 
residues higher than 0.05 ppm and is the same as the existing tolerance 
of 0.05 ppm established to support the food handling establishment uses 
for zeta-cypermethrin. The existing dietary and aggregate risk 
assessments already account for the impact of the existing zeta-
cypermethrin food handling establishment use (i.e. 100% crop treated 
for all commodities without an existing tolerance). Therefore, the 
addition of the food handling establishment use for alpha-cypermethrin 
will have no impact on the dietary risk estimates, as they are already 
covered in the existing dietary and aggregate risk assessments.
    In the Federal Register of February 1, 2013 (78 FR 7266) (FRL-9376-
1), the EPA published a final rule to establish tolerances for residues 
of the insecticide alpha-cypermethrin in or on alfalfa, hay at 15 ppm; 
citrus, dried pulp at 1.8 ppm; citrus fruit, Group 10 at 0.35 ppm; 
citrus, oil at 4.0 ppm; corn, grain; cottonseed; cucurbit vegetables, 
Group 9; dried shelled pea and bean, except soybean, subgroup 6C; 
edible podded legume vegetable, subgroup 6A; fruiting vegetables, Group 
8; head and stem Brassica, subgroup 5A at 2.0 ppm; leafy vegetable, 
except Brassica, Group 4 at 10 ppm; pop-corn; rice, grain at 1.5 ppm; 
root and tuber vegetables, Group 1 at 0.1 ppm; sorghum, grain at 0.5 
ppm; soybeans; succulent shelled pea and bean, subgroup 6B; sugar beet, 
roots at 0.05 ppm; sugar beet, tops; sweet corn; tree nuts, Group 14; 
and wheat, grain at 0.2 ppm. Since the publication of the February 1, 
2013 final rule, the toxicity profile of alpha-cypermethrin has not 
changed and since the food handling establishment use for alpha-
cypermethrin will have no impact on the dietary or aggregate risk 
estimates, the risk assessments that supported the establishment of 
those alpha-cypermethrin tolerances published in the February 1, 2013 
Federal Register remain valid. Therefore, EPA is relying on those risk 
assessments in order to support the new food handling tolerance for 
alpha-cypermethrin.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for the food handling tolerance, please refer 
to the February 1, 2013 Federal Register document and its supporting 
documents, available at http://www.regulations.gov in Docket ID number 
EPA-HQ-OPP-2010-0234. EPA relies upon those supporting risk assessments 
and the findings made in the Federal Register document in support of 
this final rule.
    Based on the risk assessments and information described above, 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 alpha-cypermethrin residues. Further information can also 
be found in the document, ``Alpha-Cypermethrin--Human Health Risk 
Assessment for Two New Proposed Products for Use in Commercial/
Residential Settings'' in docket ID number EPA-HQ-OPP-2014-0601.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in Pesticide 
Analytical Manual (PAM) Volume II for determining residues of 
cypermethrin, zeta-cypermethrin and alpha-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). 
Method I has a limit of detection (LOD) of 0.01 ppm, and Method II has 
LODs of 0.005 ppm in milk, and 0.01 ppm in livestock tissues. These 
methods are not stereospecific; thus no distinction is made between 
residues of cypermethrin (all eight stereoisomers), zeta-cypermethrin 
(enriched in four isomers) and alpha-cypermethrin (two isomers).
    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.
    There is no Codex MRL for residues of alpha-cypermethrin in or on 
food commodities/feed commodities (other than those covered by a higher 
tolerance as a results of use on growing crops) in food/feed handling 
establishments.

C. Response to Comments

    The EPA received 4 comments in response to this Notice of Filing. 
Two commenters were opposed to increasing the amount of pesticides 
being used and did not approve of the proposal. The Agency understands 
the commenter's concerns and recognizes that some individuals believe 
that certain pesticide chemicals should not be permitted in our food. 
However, the existing legal framework provided by section 408 of the 
FFDCA states that tolerances may be set when EPA determines that 
aggregate exposure to that pesticide is safe, i.e., that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue. When making this determination, EPA 
considers the toxicity, including any potential carcinogenicity, of the 
pesticide and all anticipated dietary exposures and all other exposures 
for which there is reliable information. EPA also gives special 
consideration to the potential susceptibility and exposures of infants 
and children to the pesticide

[[Page 73213]]

chemical residue when making this determination. For alpha-
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 alpha-cypermethrin.
    Two additional commenters raised concerns regarding exposure to 
bees. However, the proposed use is for pesticide applications to be 
made indoors to food/feed handling establishments and therefore, there 
should be no exposure to bees from the proposed application.

V. Conclusion

    Therefore, the tolerance is established for residues of alpha-
cypermethrin, in or on food commodities/feed commodities (other than 
those covered by a higher tolerance as a results of use on growing 
crops) in food/feed handling establishments at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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 26, 2014.
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 section heading and add alphabetically 
the following commodity to the table in paragraph (a)(3) to read as 
follows:


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

    (a) * * *
    (3) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Food commodities/feed commodities (other than those                0.05
 covered by a higher tolerance as a results of use on
 growing crops) in food/feed handling establishments...
 
                              * * * * * * *
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[FR Doc. 2014-28934 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P