[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Rules and Regulations]
[Page 9356-9358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr09-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0097; FRL-8399-3]
Tebuconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation revises the existing tolerance for residues of
tebuconazole in or on cherry, pre- and post-harvest. Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 4, 2009. Objections and
requests for hearings must be received on or before May 4, 2009, 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-2005-0097. All documents in the
docket are listed in the docket index available at http://
www.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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@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 electronically available documents 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 e-CFR cite
at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2005-0097 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 May 4, 2009.
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
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may be disclosed publicly by EPA without prior notice. Submit this
copy, identified by docket ID number EPA-HQ-OPP-2005-0097, 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 Facility'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 December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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
8E7428) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.474 be amended by raising the existing tolerance for
residues of the fungicide tebuconazole, alpha-[2-(4-
Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on the raw agricultural commodity cherry from 4.0 parts
per million (ppm) to 5.0 ppm. That notice referenced a summary of the
petition prepared on behalf of IR-4 by Bayer CropScience LP, the
registrant, which is available to the public in the docket, http://
www.regulations.gov.
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 tebuconazole in or on the raw agricultural
commodity cherry, sweet, pre- and post-harvest, and cherry, tart, pre-
and post-harvest, at 5.0 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.
In the Federal Register of August 13, 2008 (73 FR 47065) (FRL-
8376-2), the Agency published a Final Rule establishing tolerances for
residues of the fungicide tebuconazole in or on apple, wet pomace at
0.1 ppm; asparagus at 0.05 ppm; bean, succulent at 0.1 ppm; bean, dry
seed at 0.1 ppm; beet, garden, tops at 7.0 ppm; beet, garden, roots at
0.70 ppm; Brassica, leafy greens, subgroup 5B at 2.5 ppm; coffee, green
bean at 0.15 ppm; coffee, roasted bean at 0.3 ppm; corn, field, grain
at 0.05 ppm; corn, field, forage at 4.0 ppm; corn, field, stover at 3.5
ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 3.5 ppm; corn,
sweet, kernel plus cob with husks removed at 0.5 ppm; corn, sweet,
forage at 7.0 ppm; corn, sweet, stover at 6.0 ppm; cotton, undelinted
seed at 2.0 ppm; cotton, gin byproducts at 25.0 ppm; Fruit, pome, group
11 at 0.05 ppm; fruit, stone, group 12, except cherry at 1.0 ppm;
grain, aspirated fractions at 16.0 ppm; hop, dried cones at 35.0 ppm;
lychee at 1.6 ppm; mango, postharvest at 0.15 ppm; okra at 1.2 ppm;
onion, bulb, subgroup 3-07A at 0.2 ppm; onion, green, subgroup 3-07B at
1.3 ppm; plum, pre- and post-harvest at 1.0 ppm; soybean, forage at 25
ppm; soybean, hay at 50 ppm; soybean, seed at 0.08 ppm; sunflower, seed
at 0.05 ppm; sunflower, meal at 0.2 ppm; sunflower, refined oil at 0.2
ppm; vegetable, cucurbit, group 9 at 0.09 ppm; turnip, roots at 0.5
ppm; and turnip, tops at 7.0 ppm. When the Agency conducted the risk
assessment in support of the August, 2008 tolerance action, it
considered the proposed use of tebuconazole on cherry, pre- and post-
harvest. Since EPA considered the cherry use in its most recent risk
assessments, establishing the tolerance on cherry, pre- and post-
harvest will not change the estimated aggregate risks resulting from
use of tebuconazole, as discussed in the August 13, 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 August 13, 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
tebuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/nitrogen
phosphorus detection and liquid chromatography/mass spectrometry/mass
spectrometry (GC/NPD and LC/MS/MS)) is available for enforcing
tolerances for tebuconazole and its metabolites in plant commodities,
livestock matrices and processing studies. The methods have been
adequately validated by an independent laboratory in conjunction with a
previous petition. 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
Codex maximum residue limits (MRLs) have been established for
residues of tebuconazole in or on cherry at 5.0 ppm. Establishing a
permanent U.S. tolerance for tebuconazole in or on cherry, pre- and
post-harvest at 5.0 ppm results in MRL harmonization between Codex and
the United States.
V. Conclusion
Therefore, a tolerance is established for residues of tebuconazole,
alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, in or on cherry, sweet, pre- and post-harvest,
cherry, tart, pre- and post-harvest at 5.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in
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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 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: February 12, 2009.
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 180.474 is amended by revising the entry for the commodity
``Cherry'' in the table in paragraph (a)(1) to read as follows:
Sec. 180.474 Tebuconazole; tolerances for residues.
(a) General. * * *
(1) * * *
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Commodity Parts per million
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* * * * *
Cherry, sweet, pre- and post-harvest................. 5.0
Cherry, tart, pre- and post-harvest.................. 5.0
* * * * *
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[FR Doc. E9-4373 Filed 3-3-09; 8:45 am]
BILLING CODE 6560-50-S