
[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Rules and Regulations]               
[Page 63070-63074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de09-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0330; FRL-8799-9]

 
Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of hexythiazox in or on potato. The Interregional Research Project 
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 2, 2009. Objections and 
requests for hearings must be received on or before February 1, 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-2007-0330. 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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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

[[Page 63071]]

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?

    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-2007-0330 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 February 1, 2010.
    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-2007-0330, 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 May 9, 2007 (72 FR 26375) (FRL-8128-1), 
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 7E7182) 
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. 
The petition requested that 40 CFR 180.448 be amended by establishing 
tolerances for combined residues of the insecticide/miticide 
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 potato at 
0.02 parts per million (ppm). That notice referenced a summary of the 
petition prepared by Gowan, the registrant, on behalf of IR-4, 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 
tolerance for combined residues of hexythiazox in or on potato at 0.02 
ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance 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. 
Effects seen in the chronic dog study include increased liver and 
adrenal weights, along with associated histopathology of the liver 
(hypertrophy) and adrenal glands (adrenal cortex hypertrophy). 
Increased liver weights, along with decreased body weight and weight 
gain were also observed in the rat and the mouse studies. In the 
subchronic study in the rat, increased liver weights in both sexes were 
observed, in addition to increased ovarian and kidney weights, and 
adrenal histopathology (fatty degeneration of the adrenal zona 
fasciculata) in the females.
    Previously, an acute endpoint was selected for the acute dietary 
risk assessment for females ages 13 and above, based on delayed 
ossification observed in the rat developmental toxicity study. However, 
delayed ossification is not considered an appropriate endpoint 
attributable to a single exposure. No other endpoint attributable to a 
single exposure was identified from the available oral toxicity 
database.
    There was no qualitative or quantitative evidence of increased 
susceptibility of fetuses from in utero exposure in studies in rats and 
rabbits. Although the rat developmental study showed delayed 
ossification in the offspring, this occurred at the same or higher dose 
than the maternal LOAEL of 720 milligrams/kilograms/day (mg/kg/day), at 
which decreased body weight gain and food consumption were observed. No 
adverse effects were observed in the developmental rabbit study at the 
highest dose tested (HDT) of 1,080 mg/kg/day. There was no evidence of 
increased susceptibility through postnatal exposure of offspring to 
hexythiazox.
    Previously, carcinogenic risk for hexythiazox was assessed 
quantitatively

[[Page 63072]]

assuming the cancer response is linear at low doses. However, in June 
2009, the Agency re-evaluated the carcinogenic potential of hexythiazox 
following release of EPA's Final Guidelines for Carcinogen Risk 
Assessment in March, 2005. After considering the updated guidelines, 
EPA has classified hexythiazox 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. This 
change in position was based on a re-evaluation of the weight of the 
evidence taking into account the updated 2005 cancer risk assessment 
guidelines. EPA concluded that the evidence as a whole was not strong 
enough to warrant quantitative estimation of carcinogenic risk to 
humans, based on the following considerations:
    i. The liver tumors in mice are a very common tumor in that species 
were only observed in high dose females.
    ii. The mammary tumors in rats were benign and were only observed 
in high dose male rats.
    iii. Hexythiazox was shown to be non-mutagenic in mammalian somatic 
cells and germ cells. Additionally, the chronic 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 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.
    There is no evidence of neurotoxicity or potential immunotoxicity 
for hexythiazox in the toxicology database.
    Specific information on the studies received and the nature of the 
adverse effects caused by hexythiazox as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document ``Hexythiazox. Human Health Risk 
Assessment to Support New Use on Potatoes Grown in Oregon, Washington 
and Idaho Only,'' page 10 in docket ID number EPA-HQ-OPP-2007-0330.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    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 
greater than that 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 the 
document ``Hexythiazox. Human Health Risk Assessment to Support New Use 
on Potatoes Grown in Oregon, Washington and Idaho Only,'' page 10 in 
docket ID number EPA-HQ-OPP-2009- EPA-HQ-OPP-2007-0330.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerance 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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake 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. EPA has determined that the chronic reference dose is 
sufficient to evaluate all chronic risks for this chemical, including 
carcinogenic potential. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
hexythiazox. Tolerance level residues and 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) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
hexythiazox for chronic exposures, including cancer and non-cancer 
assessments are estimated to be 2.26 parts per billion (ppb) for 
surface water and 0.00503 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For

[[Page 63073]]

chronic dietary, including cancer, risk assessment, the highest modeled 
water concentration value of 2.26 ppb was used to assess the 
contribution to drinking water.
    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 
registered for any specific use patterns that would result in 
residential exposure.
    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 Food Quality 
Protection Act (FQPA) SF (safety factor). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for hexythiazox includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. As discussed in Unit III.A., there was no evidence of 
increased quantitative or qualitative susceptibility of fetuses or 
offspring following exposure to hexythiazox in these studies.
    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 that currently used for overall 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 of in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-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. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to hexythiazox in drinking water. There are no uses 
which would result in postapplication exposure of children or 
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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate UFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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 45% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for hexythiazox.
    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). Hexythiazox 
is not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to hexythiazox through food and water and will not 
be greater than the chronic aggregate risk.
    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). Hexythiazox is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to hexythiazox through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., the Agency has determined that the chronic reference dose is 
sufficient to evaluate all chronic risks for this chemical, including 
carcinogenic

[[Page 63074]]

potential. 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

    The existing enforcement method (high performance liquid 
chromatography using ultraviolet detection (HPLC/UV)) published in the 
Pesticide Analytical Manual (PAM) II is adequate 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 
levels) for residues of hexythiazox on potatoes.

V. Conclusion

    Therefore, a tolerance is established 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, in or on potato at 
0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 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: November 20, 2009.
Daniel J. Rosenblatt,
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 by alphabetically adding potato to the 
table in paragraph (c) to read as follows:


Sec.  180.448  Hexythiazox; tolerances for residues.

* * * * *
    (c) * * *

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

                                * * * * *
Potato..................................................            0.02
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-28673 Filed 12-01-09; 8:45 am]

BILLING CODE 6560-50-S
