[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Rules and Regulations]
[Page 44162-44164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy08-14]
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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: stanton.susan@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).
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),
[[Page 44163]]
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:
residuemethods@epa.gov.
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
[[Page 44164]]
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) * * *
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Commodity Parts per million
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* * * * *
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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