Document ID: EPA-HQ-OPP-2007-0096-0003
Agency: epa
Document Type: Rule
Title: Gamma-cyhalothrin; Pesticide Tolerances
Posted Date: 2008-07-09T04:00Z

[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]               
[Page 39261-39264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy08-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0096; FRL-8372-6]

 
Gamma-cyhalothrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of Gamma-
cyhalothrin in or on all food commodities (other than those already 
covered by a higher tolerance as a result of use on growing crops) in 
food-handling establishments where food products are held, processed or 
prepared, pistachio and okra. Pytech Chemicals GmbH and Interregional 
Research Project No. 4 (IR-4) requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and 
requests for hearings must be received on or before September 8, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0096. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.),

[[Page 39262]]

2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: BeWanda Alexander, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7460; e-mail address: 
alexander.bewanda@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0096 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before September 8, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0096, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Registers of February 28, 2007 (72 FR 9000) (FRL-
8115-5) and February 6, 2008 (73 FR 6964) (FRL-8350-9), EPA issued a 
notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 6H7114) by Pytech 
Chemicals GmbH, 9330 Zionsville Road, Indianapolis, IN 46268 and PP 
7E7287 by IR-4, 500 College Road East, Suite 201 W. Princeton, NJ 
08540-6635 respectively. The petitions requested that 40 CFR 180.438 be 
amended by establishing tolerances for residues of the insecticide 
gamma-cyhalothrin, (S)-alpha-cyano-3-phenoxybenzy-(Z)-(1R, 3R)-3-(2-
chloro-3,3,3-trifluoroprop-1-enyl-2,2-dimethycyclopropanecarboxylate, 
in all food commodities (other than those already covered by a higher 
tolerance as a result of use on growing crops) in food-handling 
establishments where food products are held, processed or prepared, at 
0.01 parts per million (ppm), pistachio at 0.05 ppm, and okra at 0.20 
ppm. These notices referenced a summary of the petitions prepared by 
Dow Agro Sciences (on behalf of Pytech Chemicals), which is available 
to the public in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    The tolerance expression under 40 CFR 180.438(a)(3) currently 
identifies the tolerance as a ``food additive'' and also lists specific 
instructions for use in food handling establishments under paragraphs, 
180.438(a)(3)(ii) thru (v). The term ``food additive tolerance'' is 
obsolete since EPA no longer regulates pesticide residues under section 
409 of the Federal Food Drug and Cosmetic Act. In addition it is no 
longer necessary to identify specific instructions for use in food 
handling establishments since these instructions are identified on the 
pesticide label. Therefore EPA is revising the tolerance expression 
under 40 CFR 180.438(a)(3) to read, ``A tolerance of 0.01 part per 
million is established for residues of the insecticide lambda-
cyhalothrin and an isomer gamma-cyhalothrin as follows:'', and is 
deleting sections 180.438(a)(3)(ii) thru (v).

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

[[Page 39263]]

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
tolerances for residues of gamma-cyhalothrin on all food commodities 
(other than those already covered by a higher tolerance as a result of 
use on growing crops) in food-handling establishments where food 
products are held, processed or prepared, at 0.01 ppm, pistachio at 
0.05 ppm, and okra at 0.20 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances follows.
    Gamma-cyhalothrin is a single, resolved isomer of the pyrethroid 
insecticide cyhalothrin. As such, it shares physical, chemical and 
biological properties with both cyhalothrin and lambda-cyhalothrin, 
which are mixtures of 4 and 2 isomers, respectively. Gamma-cyhalothrin 
is the most insecticidally active isomer of cyhalothrin/lambda-
cyhalothrin, and thus the gamma-cyhalothrin technical product is 
considered a refined form of cyhalothrin/lambda-cyhalothrin that has 
been purified by removal of less-active and inactive isomers. 
Therefore, similar levels of insecticidal efficacy for gamma-
cyhalothrin can be obtained with significantly reduced application 
rates as compared with either cyhalothrin or lambda-cyhalothrin. EPA 
has previously concluded that residue data supporting registered uses 
of lambda-cyhalothrin are sufficient to support registration of gamma-
cyhalothrin for the same uses, as long as the use rates of gamma-
cyhalothrin are no greater than half the corresponding use rates of 
lambda-cyhalthrin. The proposed application rates of gamma-cyhalthrin 
for the requested new uses (considered herein) are no greater than half 
of the corresponding, existing application rates for similar registered 
uses of lambda-cyhalthrin.
    Tolerances are currently established under 40 CFR 180.438 for 
residues of lambda-cyhalothrin in food-handling establishments.Through 
the use of bridging data, the toxicology database for gamma-cyhalothrin 
is complete using developmental, reproduction, chronic (rodent), and 
oncogenicity studies conducted with cyhalothrin and lambda-cyhalothrin. 
The nature of the toxic effects caused by lambda-cyhalothrin as well as 
gamma-cyhalthrin are discussed in detail in the Federal Register of 
September 27, 2002 (67 FR 60902)(FRL-7200-1). Therefore the toxicology 
database for gamma-cyhalothrin when bridged with cyhalothrin and 
lambda-cyhalothrin are complete for purposes of supporting the proposed 
use in food handling establishments.
    In the August 15, 2007 final rule, establishing tolerances for 
lambda-cyhalothrin on a number of crops including pistachios. EPA 
included residuesat the tolerance level 0.05 ppm in assessing the use 
of lambda-cyhalothrin in/on pistachios. Since EPA considered the 
pistachio use in this most recent risk assessment establishing the 
tolerance on pistachios for gamma-cyhalothrin will not change the 
estimated aggregate risks resulting from use of lambda-cyhalothrin as 
discussed in the August 15, 2007 (72 FR 45656) Federal Register. Refer 
to this Federal Register document available at http://
www.regulations.gov for a detailed discussion of the aggregate risk 
assessments and determination of safety.
    A tolerance for residues of lambda-cyhalothrin in okra has not been 
established; however, there are adequate residue data for lambda-
cyhalothrin on fruiting vegetables (crop group 8) to support a 
tolerance for residues of gamma-cyhalothrin in okra; and EPA included 
residues on okra at the fruiting vegetable tolerance level (0.20 ppm) 
in the risk assessments supporting the August 15, 2007 final rule 
discussed in the previous paragraph. Since EPA considered the okra use 
in this most recent assessment establishing the tolerance on okra for 
gamma-cyhalothrin will not change the aggregate risks resulting from 
use of lambda-cyhalothrin as discussed in the August 15, 2007 (72 FR 
45656) Federal Register. Refer to this Federal Register document 
available at http://www.regulations.gov for a detailed discussion of 
the aggregate risk assessments and determination of safety.
    EPA concludes that the previous risk assessments on lambda-
cyhalothrin sufficiently covers the proposed gamma-cyhalothrin uses and 
no new aggregate risk assessment is needed for gamma-cyhalothrin. Based 
on the risk assessments discussed in the final rule published in the 
Federal Register August 15, 2007 (72 FR 45656, FRL 8143-1) EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population and to infants and children from aggregate 
exposure to gamma-cyhalothrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography/electron 
capture detector (GC/ECD), (ICI Method 81 (PRAM 81)) is available to 
enforce the tolerance expression. 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; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no established Mexican, Canadian, or Codex MRLs (maximum 
residue limits) for gamma-cyhalothrin.

V. Conclusion

    Therefore, tolerances are established for residues of gamma-
cyhalothrin, (S)-alpha-cyano-3-phenoxybenzy-(Z)-(1R, 3R)-3-(2-chloro-
3,3,3-trifluoroprop-1-enyl-2,2-dimethycyclopropanecarboxylate, in or on 
all food commodities (other than those already covered by a higher 
tolerance as a result of use on growing crops) in food-handling 
establishments where food products are held, processed or prepared, at 
0.01 ppm, pistachio at 0.05 ppm, and okra at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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, 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

[[Page 39264]]

Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: June 30, 2008.
Lois Rossi,
Direction, Registration Division, Office of Pesticide Programs.

0
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. Section 180.438 is amended by:
0
i. Alphabetically adding okra and pistachios to the table in paragraph 
(a)(2).
0
ii. Revising paragraph (a)(3).
    The amendments read as follows:

Sec.  180.438  Lamba-cyhalothrin and an isomer gamma-cyhalothrin; 
tolerances for residues.

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

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                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Okra..................................................                                                      0.20
                                                    * * * * *
Pistachio.............................................                                                      0.05
                                                    * * * * *
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    (3) A tolerance of 0.01 part per million is established for 
residues of the insecticide lamba-cyhalothrin and an isomer gamma-
cyhalothrin in or on all food commodities (other than those already 
covered by a higher tolerance as a result of use on growing crops) in 
food-handling establishments where food products are held, processed, 
or prepared.
* * * * *
[FR Doc. E8-15518 Filed 7-8-08; 8:45 am]

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