[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Rules and Regulations]
[Pages 44162-44164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17062]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0857; FRL-8370-7]


Cyfluthrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
cyfluthrin in or on alfalfa, forage and revises the existing tolerance 
for residues of cyfluthrin in or on alfalfa, hay. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective July 30, 2008. Objections and 
requests for hearings must be received on or before September 29, 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-2006-0857. 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.), 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail 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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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-2006-0857 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 29, 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-2006-0857, 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),

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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 Register of January 23, 2008 (73 FR 3964) (FRL-8345-
7), 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 
7F7226) by Bayer CropScience, 2.T.W. Alexander Drive, PO Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.436 be amended by establishing tolerances for residues of the 
insecticide cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on alfalfa, 
forage at 5.0 parts per million (ppm) and alfalfa, hay at 15.0 ppm. 
That notice referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available to the public at http://www.regulations.gov in the docket established for that action (EPA-HQ-
OPP-2007-0506). Comments were received on the notice of filing. EPA's 
response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance level for alfalfa, hay from 15.0 ppm to 13 ppm. 
The reason for this change is explained in Unit IV.D.

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 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 cyfluthrin on alfalfa, forage at 5.0 ppm and 
alfalfa, hay at 13 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances follows.
    On February 27, 2008, the Agency published a final rule in the 
Federal Register (73 FR 10390) (FRL-8350-3) establishing tolerances for 
residues of cyfluthrin in or on grass, forage, fodder and hay group 17, 
forage at 12 ppm; grass, forage, fodder and hay, group 17, hay at 50 
ppm; beet, sugar, roots at 0.10 ppm; and beet, sugar, dried pulp at 1.0 
ppm. When the Agency conducted the risk assessments in support of the 
February 27, 2008 tolerance action, it considered the proposed use of 
cyfluthrin on alfalfa, incorporating potential residues of cyfluthrin 
in afalfa commodities and secondary residues of cyfluthrin in livestock 
commodities from consumption of treated feedstuffs, including alfalfa 
forage and hay. Since EPA considered the alfalfa use in its most recent 
risk assessments, establishing the tolerances on alfalfa forage and hay 
will not change the estimated aggregate risks resulting from use of 
cyfluthrin, as discussed in the February 27, 2008 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 relies upon those risk 
assessments and the findings made in the Federal Register document in 
support of this action.
    Based on the risk assessments discussed in the final rule published 
in the Federal Register of February 27, 2008, 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 
cyfluthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using gas chromatography/electron-
capture (GC/EC) detection 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: 
[email protected].

B. International Residue Limits

    There are no CODEX, Canadian or Mexican MRLs (maximum residue 
limits) established for cyfluthrin on alfalfa commodities.

C. Response to Comments

    One comment was received from a private citizen in response to the 
notice of filing. The commenter stated ``We need to further explore 
this issue concerning the pesticide usage.'' The comment contained no 
scientific data or other substantive evidence to rebut the Agency's 
finding that there is a reasonable certainty that no harm will result 
from aggregate exposure to cyfluthrin from the establishment of these 
tolerances. In making this finding, EPA considered all available 
scientific data for cyfluthrin and the estimated aggregate exposure to 
the pesticide, including anticipated dietary (food and drinking water) 
and residential exposures. EPA, therefore, disagrees with the commenter 
that there is a need for further exploration.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has 
revised the tolerance level for alfalfa, hay from 15.0 ppm to 13 ppm. 
EPA revised the tolerance level based on analysis of the residue field 
trial data using the Agency's Tolerance Spreadsheet in accordance with 
the Agency's Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data.

V. Conclusion

    Therefore, tolerances are established for residues of cyfluthrin, 
cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on alfalfa, forage at 5.0 ppm 
and alfalfa, hay at 13 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

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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 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: July 16, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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2. Section 180.436 is amended by revising the tolerance for alfalfa, 
hay and alphabetically adding the commodity alfalfa, forage to the 
table in paragraph (a)(1) to read as follows:


Sec.  180.436  Cyfluthrin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Alfalfa, forage......................................                5.0
Alfalfa, hay.........................................                 13
                                * * * * *
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[FR Doc. E8-17062 Filed 7-29-08; 8:45 am]
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