[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Rules and Regulations]
[Pages 9356-9358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4373]


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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: [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 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: 
[email protected].

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

[[Page 9358]]

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.

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 180.474 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) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
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