
[Federal Register: September 10, 2008 (Volume 73, Number 176)]
[Rules and Regulations]               
[Page 52594-52597]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se08-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0507; FRL-8378-8]

 
Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the established tolerances for combined 
residues of hexythiazox in or on citrus dried pulp; citrus oil; pome 
fruit, crop group 11; wet apple pomace; and meat byproducts of cattle, 
goat, horse, and sheep. Gowan Company requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 10, 2008. Objections and 
requests for hearings must be received on or before November 10, 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-2007-0507. 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

[[Page 52595]]

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: Olga Odiott, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9369; e-mail address: odiott.olga@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-2007-0507 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 November 10, 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-2007-0507, 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 Register of October 24, 2007 (72 FR 60367) (FRL-
8154-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
7F7211 and PP 7F7223) by Gowan Company, 370 S. Main Street, Yuma, AZ 
85364. The petitions requested that 40 CFR 180.448 be amended by 
revising the established tolerances for combined residues of the 
insecticide hexythiazox, trans-5-(4-chlorophenyl)-N-cyclohexyl-4-
methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing 
the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as 
parent), in or on citrus dried pulp from 1.5 parts per million (ppm) to 
0.6 ppm; and citrus oil from 0.9 ppm to 24 ppm (PP 7F7223); pome fruit, 
crop group 11 from 1.7 ppm to 0.25 ppm; wet apple pomace from 2.5 ppm 
to 0.40 ppm; and meat byproducts of cattle, goat, horse, and sheep from 
0.12 ppm to 0.02 ppm (PP 7F7211). That notice referenced a summary of 
the petition prepared by Gowan Company, the registrant, 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.

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 combined residues of hexythiazox on citrus dried pulp; 
citrus oil; pome fruit, crop group 11; wet apple

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pomace; and meat byproducts of cattle, goat, horse, and sheep. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.
    On March 22, 2006 the Agency published in the Federal Register a 
final rule (71 FR 14409, FRL-7768-3) establishing tolerances for 
combined residues of hexythiazox on apple, wet pomace at 2.5 ppm; 
citrus, dried pulp at 1.5 ppm; citrus, oil at 0.90 ppm; fruit, pome, 
group 11 at 1.7 ppm; and cattle, goat, horse, and sheep meat by 
products at 0.12 ppm. The tolerances were based on an exaggerated use 
rate from the wettable powder (WP) formulation residue trials and the 
maximum factor by which the emulsifiable concentrate (EC) formulation 
exceeded the WP formulation in the apple side-by-side field trials. 
Since the tolerances were likely to overestimate actual expected 
residues following application of hexythiazox as labeled, the Agency 
requested an orange processing study and apple and pear field trial 
data for the EC formulation as conditions of registration.
    On May 28, 2008 the Agency published in the Federal Register a 
final rule (73 FR 30498, FRL-8365-2) establishing tolerances for 
combined residues of hexythiazox on corn, field, grain at 0.02 ppm; 
corn, field, stover at 2.5 ppm; and corn, field, forage at 6.0 ppm.
    When the Agency conducted the acute dietary risk assessments in 
support of the 2006 and 2008 tolerance actions it assumed residues of 
hexythiazox would be present in the aforementioned commodities at the 
currently published levels. For the chronic/cancer dietary assessments 
the Agency assumed that average field trial residue levels of 
hexythiazox would be present. The data submitted to fulfill the 
conditions of registration mentioned above indicate that with the 
exception of citrus oil, the subject petitioned-for tolerances should 
be reduced. Acute, chronic, and cancer dietary analyses conducted to 
address the increase in the citrus oil tolerance resulted in no 
exposure for all subpopulations and scenarios from citrus oil. 
Therefore, the increase in the orange oil tolerance from 0.90 to 24 ppm 
will not result in an increased dietary human health risk and the 
assumptions used for the 2006 and 2008 risk assessments remain 
appropriate. EPA relies upon those risk assessments and the findings 
made in the Federal Register documents in support of this action.
    Based on the risk assessments discussed in the final rules 
published in the Federal Register of May 28, 2008 and March 22, 2006, 
EPA concludes that there is a reasonable certainty that no harm will 
result to the general population, or to infants and children from 
aggregate exposure to hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual Volume II (PAM II) of the Food and 
Drug Administration (FDA) includes suitable analytical methods for the 
determination of hexythiazox and metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (AMR-985-87) in pome 
fruits, citrus, and livestock tissue.

B. International Residue Limits

    Codex maximum residues limits (MRLs) for apple, pear, and citrus 
are established for residues of hexythiazox per se. The Agency has 
previously determined that the residues of concern for application of 
hexythiazox to fruit crops are hexythiazox and its metabolites 
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety 
(expressed as parent). Since the Codex and EPA tolerance expression 
differ, harmonization is not possible.

V. Conclusion

    Therefore, 40 CFR 180.448 is amended by revising the established 
tolerances for combined residues of hexythiazox, trans-5-(4-
chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and 
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety (expressed as parent), in or on citrus dried pulp 
to 0.60 ppm; citrus oil to 24 ppm; pome fruit, crop group 11 to 0.25 
ppm; wet apple pomace to 0.40 ppm; and meat byproducts of cattle, goat, 
horse, and sheep at 0.02 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 
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

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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: August 26, 2008.
Donald R. Stubbs,
Acting 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 180.448 is amended in paragraph (a), in the table by 
revising the entries for the following commodities to read as follows:


Sec. 180.448  Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Apple, wet pomace..........................................         0.40
                                * * * * *
Cattle, meat byproducts....................................         0.02
Citrus, dried pulp.........................................         0.60
Citrus, oil................................................           24
                                * * * * *
Fruit, pome, group 11......................................         0.25
                                * * * * *
Goat, meat byproducts......................................         0.02
                                * * * * *
Horse, meat byproducts.....................................         0.02
                                * * * * *
Sheep, meat byproducts.....................................         0.02
                                * * * * *
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[FR Doc. E8-20513 Filed 9-9-08; 8:45 am]

BILLING CODE 6560-50-S
