Document ID: EPA-HQ-OPP-2009-0325-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Hexythiazox
Posted Date: 2010-03-17T04:00Z

[Federal Register: March 17, 2010 (Volume 75, Number 51)]
[Rules and Regulations]               
[Page 12691-12695]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr10-19]                         

[[Page 12691]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0325; FRL-8813-7]

 
Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises the tolerance for combined residues of 
hexythiazox in or on grape. Gowan Company requested the tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 17, 2010. Objections and 
requests for hearings must be received on or before May 17, 2010, 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-2009-0325. 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: 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 Get Electronic Access to Other Related Information?

    You may 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-2009-0325 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 17, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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-2009-0325, 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 August 19, 2009 (FR 41898) (FRL-8426-7), 
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 9F7556) 
by Gowan Company, 370 South Main Street; Yuma, AZ 85364. The petition 
requested that 40 CFR 180.448 be amended by revising the established 
tolerance 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, in or on grape from 0.75 to 1.0 
part per million (ppm); plum from 0.10 to 1.0 ppm; and plum, prune, 
dried from 0.40 to 1.0 ppm. 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.
    Based upon review of the data supporting the petition, EPA has 
determined that there is insufficient residue chemistry data to support 
the proposed tolerances for the stone fruit use, therefore, this action 
only addresses the tolerance for grape. The Agency is also revising the 
tolerance expression for hexythiazox. The reason for these changes are 
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

[[Page 12692]]

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 hexythiazox including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with hexythiazox 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Hexythiazox has a low order of acute toxicity by the oral, 
dermal and inhalation routes of exposure. It produces mild eye 
irritation, is not a dermal irritant, and is negative for dermal 
sensitization.
    The target organs of hexythiazox are the liver and adrenal glands 
in dogs, rats and mice, with the dog being the most sensitive species. 
The chronic dog study showed increased liver and adrenal weights, along 
with associated hypertrophy of the liver and adrenal glands. The 
subchronic toxicity study in rats showed increased liver and adrenal 
weights, as well as fatty degeneration of the adrenal zona fasciculate. 
Effects observed in the chronic feeding/carcinogenicity studies in rats 
and mice included decreased body weight gain and increased liver 
weights.
    Hexythiazox is not a developmental or reproductive toxicant. The 
toxicology database for hexythiazox provides no indication of increased 
susceptibility in rats or rabbits from in utero and postnatal exposure 
to hexythiazox. The database does not show any evidence of treatment-
related effects on the nervous system or the immune system.
    Hexythiazox is classified as ``Likely to be Carcinogenic to 
Humans'' based upon increased incidences of benign and malignant liver 
tumors in high-dose female mice, and benign mammary gland tumors, 
observed in high-dose male rats. There was no evidence of 
carcinogenicity in male mice and female rats. However, EPA determined 
that a non-quantitative risk assessment approach (i.e., nonlinear, 
reference dose (RfD) approach) was appropriate for hexythiazox based on 
the following considerations:
    1. The liver tumors in mice are a very common tumor in that species 
were only observed in high-dose females.
    2. The mammary tumors in rats were benign and were only observed in 
high-dose male rats.
    3. Hexythiazox was shown to be non-mutagenic in mammalian somatic 
cells and germ cells.
    Additionally, the chronic no-observed-adverse-effect-level (NOAEL) 
used for establishing the chronic RfD (2.5 mg/kg/day, from the 1-year 
toxicity feeding study in the dog), is approximately 65-fold lower than 
the lowest dose that induced tumors (in female mice at 163 milligrams/
kilogram/day (mg/kg/day). Therefore, the chronic RfD of 0.025 mg/kg/day 
is judged to be protective of all chronic effects including potential 
carcinogenicity of hexythiazox.
    Specific information on the studies received and the nature of the 
adverse effects caused by hexythiazox as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document ``Hexythiazox. 
Human Health Risk Assessment to Support Amended Use on Grapes Reducing 
the Preharvest Interval from 28-Days to 7-Days and to Add Uses on Turf, 
Gardens and Ornamentals,'' page 27 in docket ID number EPA-HQ-OPP-2009-
0325.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which NOAEL and the LOAEL of concern are 
identified. Uncertainty/safety factors are used in conjunction with the 
POD to calculate a safe exposure level generally referred to as a PAD 
or a RfD and a safe margin of exposure (MOE). For non-threshold risks, 
the Agency assumes that any amount of exposure will lead to some degree 
of risk. Thus, the Agency estimates risk in terms of the probability of 
an occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for hexythiazox used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Hexythiazox.'' ``Human Health Risk Assessment to Support 
Amended Use on Grapes Reducing the Preharvest Interval from 28-Days to 
7-Days and to Add Uses on Turf, Gardens and Ornamentals,'' page 12 in 
docket ID number EPA-HQ-OPP-2009-0325

 C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR 
180.448. EPA assessed dietary exposures from hexythiazox in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
hexythiazox; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA used 
tolerance level residues, assumed 100 percent crop treated (PCT), and 
incorporated default processing factors.
    iii. Cancer. As discussed in this unit, EPA has determined that the 
chronic RfD is sufficient to evaluate all chronic

[[Page 12693]]

risks for this chemical, including carcinogenic potential. Cancer risk 
was quantified using the same estimates as discussed in Unit 
III.C.1.ii., chronic exposure.

    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for hexythiazox. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for hexythiazox in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of hexythiazox. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) the estimated drinking water concentration (EDWC) 
of hexythiazox for chronic exposures for non-cancer and cancer 
assessments is estimated to be 4.1 parts per billion (ppb) for surface 
water. Since surface water residue values greatly exceed groundwater 
EDWCs, surface water residues were used in the dietary risk assessment.
    The modeled EDWC was directly entered into the dietary exposure 
model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Hexythiazox is not currently registered for any specific use 
patterns that would result in residential exposure. However, the 
following uses that could result in residential exposures are pending 
registration in the near future and are included in this risk 
assessment: Turf, gardens, ornamental landscape plantings, ornamental 
plants, trees and vines in nurseries, residential fruit trees, nut 
trees and caneberries, and orchids. Residential handler exposures are 
expected to be short-term (1 to 30 days) via either the dermal or 
inhalation routes of exposures. Since a quantitative dermal risk 
assessment is not required for hexythiazox; MOEs were calculated for 
the inhalation route of exposure only. Both adults and children may be 
exposed to hexythiazox residues from contact with treated lawns or 
treated residential plants. Adult postapplication exposures were not 
assessed since no quantitative dermal risk assessment is required for 
hexythiazox and inhalation exposures are typically negligible in 
outdoor settings. The exposure assessment for children included 
incidental oral exposure resulting from transfer of residues from the 
hands or objects to the mouth, and from incidental ingestion of soil. 
No quantitative dermal risk assessment is required.
    Residential handler risks are not of concern as short-term 
inhalation MOEs range from 40,000,000 to 820,000,000. Postapplication 
risks for children are not of concern as incidental oral short-term 
MOEs range from 2,600 to 3,200,000 and intermediate-term MOEs range 
from 5,600 to 3,200,000 ( MOEs which exceed 100 are not of concern). 
None of the subject uses are expected to result in long-term 
residential exposures.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found hexythiazox to share a common mechanism of 
toxicity with any other substances, and hexythiazox does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
hexythiazox does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology data base indicates no increased susceptibility of rats or 
rabbits to in utero and/or postnatal exposure to hexythiazox.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
     i. The toxicity database for hexythiazox is incomplete under the 
new 40 CFR part 158 data requirements for conventional pesticides, 
which requires certain generic testing, including acute and subchronic 
neurotoxicity studies and an immunotoxicity study. However, the 
toxicology database does not show any evidence of treatment-related 
effects on the nervous system or the immune system. The overall weight 
of evidence suggests that this chemical does not directly target either 
system. Although acute and subchronic neurotoxicity studies and an 
immunotoxicity study are required as a part of new data requirements in 
the 40 CFR part 158 for conventional pesticide registrations, the 
Agency does not believe that conducting these studies will result in a 
lower POD than any currently used for risk assessment, and therefore, a 
database uncertainty factor (UFDB) is not needed to account 
for the lack of these studies.
    ii. There is no indication that hexythiazox is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that hexythiazox results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. The dietary risk assessment is 
highly conservative and not expected to underestimate risk. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to hexythiazox in drinking water. EPA

[[Page 12694]]

used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by hexythiazox.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population adjusted-dose (aPAD) and chronic population adjusted-
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-term, intermediate-term, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk An acute aggregate risk assessment takes into account 
acute exposure estimates from dietary consumption of food and drinking 
water. No adverse effect resulting from a single oral exposure was 
identified and no acute dietary endpoint was selected. Therefore, 
hexythiazox is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
hexythiazox from food and water will utilize 49% of the cPAD for 
(children 1 to 2 years old) the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
hexythiazox is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    There are potential short-term exposures from the pending 
residential uses for hexythiazox. The Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to hexythiazox.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 16,000 for adults 
and 1,300 for children. Because EPA's level of concern for hexythiazox 
is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    There are potential intermediate-term exposures from the pending 
residential uses for hexythiazox. The Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
intermediate-term residential exposure to hexythiazox.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 16,000 for adults and 1,700 for children. Because 
EPA's level of concern for hexythiazox is a MOE of 100 or below, these 
MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
hexythiazox as ``Likely to be Carcinogenic to Humans,'' but has 
determined that there is insufficient evidence to quantify risk using a 
cancer slope factor. As discussed in Unit III.A EPA concluded that 
regulation based on the chronic RfD will be protective for both chronic 
and carcinogenic risks. As noted in this unit there are no chronic 
risks of concern.
    6. Determination of safety. Based on these risk assessments, 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

    Adequate enforcement methodology (high performance liquid 
chromatography with UV detection (HPLC/UV)) 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

    A Codex MRL is established at 1.0 ppm for grape. The Agency has 
harmonized the residue level, but notes that it is not possible to 
harmonize the tolerance expression at this time as the Codex maxium 
residue limit (MRL) includes parent only. There are no currently 
established Canadian or Mexican MRLs for residues of hexythiazox in/on 
grape.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the tolerance expression to clarify 1. that, 
as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of hexythiazox not specifically mentioned; 
and 2. that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression. The Agency determined that there is insufficient 
residue chemistry data to support the proposed tolerances for the stone 
fruit use; therefore, this action only addresses the tolerance for 
grape.

V. Conclusion

    Therefore, the tolerance for residues of hexythiazox, in or on 
grape is revised from 0.75 ppm to 1.0 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, 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

[[Page 12695]]

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: March 8, 2010.
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. Sec.  180.448 revise the introductory text in paragraph (a), and 
revise the entry ``Grape`` in the table in paragraph (a), and revise 
introductory text in paragraphs (b), and (c) to read as follows:

Sec. 180.448  Hexythiazox; tolerance for residues.

    (a) General. Tolerances are established for residues of 
hexythiazox, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only hexythiazox and 
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, calculated as the stoichiometric equivalent of 
hexythiazox.

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                       Commodity                                            Parts per million
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                                                    * * * * *
Grape.................................................                                                       1.0
                                                    * * * * *
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    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of hexythiazox, including its metabolites and 
degradates, in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
hexythiazox and its metabolites containing the (4-chlorophenyl)-4-
methyl-2-oxo-3-thiazolidine moiety, calculated as the stoichiometric 
equivalent of hexythiazox. These tolerances will expire and are revoked 
on the dates specified in the following table:
* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations as defined by 40CFR 180.1(n), are established 
for residues of hexythiazox, including its metabolites and degradates, 
in or on the commodities in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
hexythiazox and its metabolites containing the (4-chlorophenyl)-4-
methyl-2-oxo-3-thiazolidine moiety, calculated as the stoichiometric 
equivalent of hexythiazox.
* * * * *
[FR Doc. 2010-5692 Filed 3-16-10; 8:45 am]
BILLING CODE 6560-50-S