Document ID: EPA-HQ-OPP-2009-0325-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Hexythiazox
Posted Date: 2010-07-14T04:00Z

[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Rules and Regulations]               
[Page 40741-40745]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy10-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0325; FRL-8833-6]

 
Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective July 14, 2010. Objections and 
requests for hearings must be received on or before September 13, 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 site at http://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 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

[[Page 40742]]

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 September 13, 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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of August 19, 2009 (74 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 
tolerances for 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, as follows: Revising the tolerance ``fruit, stone, 
group 12, except plums'' to read `` fruit, stone, group 12; removing 
the existing separate tolerance for fresh, prune, plums at 0.1 parts 
per million (ppm); revising the tolerance in or on plum, prune, dried 
from 0.4 to 1.3 ppm; and by revising the tolerance in or on grapes from 
0.75 to 1.0 ppm. That notice referenced a summary of the petition 
prepared by Gowan Company, the registrant, which is available 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 issued 
a notice in the Federal Register of March 17, 2010 (75 FR 12691) (FRL-
8813-7), revising the tolerance for grapes and revising the tolerance 
expression for hexythiazox. In that notice the Agency also announced 
that the residue chemistry data were insufficient to support the 
proposed revisions of the tolerances for the stone fruit use. Gowan 
Company, the registrant, has submitted additional data to adequately 
support the requested revisions to the stone fruit tolerances. This 
action addresses the updated aggregate risk assessment incorporating 
the revised dietary assessment on stone fruit.

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 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. 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.'' EPA has determined that a non-quantitative risk assessment 
approach (i.e., nonlinear, reference dose (RfD) approach) was 
appropriate and 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 no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the final rule 
published in the Federal Register of March 17, 2010 (75 FR 12691), and 
at http://www.regulations.gov in document ``Hexythiazox. Human Health 
Risk Assessment to Support Amended Use on Stone Fruit Reducing the 
Preharvest Interval from 28-Days to 7-Days,'' p. 28 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 no adverse effects are

[[Page 40743]]

observed (the NOAEL) and the lowest dose at which adverse effects of 
concern are identified (the LOAEL). Uncertainty/safety factors are used 
in conjunction with the POD to calculate a safe exposure level - 
generally referred to as a population-adjusted dose (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 in the final rule published in the 
Federal Register of March 17, 2010 (75 FR 12691), and at http://
www.regulations.gov in document ``Hexythiazox. Human Health Risk 
Assessment to Support Amended Use on Stone Fruit Reducing the 
Preharvest Interval from 28-Days to 7-Days,'' p. 13 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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 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 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 estimate of drinking water concentrations 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.
    Both adults and children may be exposed to hexythiazox residues 
from contact with treated lawns or treated plants. The exposure and 
risk assessment included risks to adult handlers from inhalation 
exposures. The exposure assessment for children included risks from 
incidental oral exposure resulting from transfer of residues from the 
hands or objects to the mouth, and from incidental ingestion of soil. 
Details of the residential exposure and risk assessment are contained 
in the final rule published in the Federal Register of March 17, 2010 
(75 FR 12691), and at http://www.regulations.gov in document 
``Hexythiazox. Human Health Risk Assessment to Support Amended Use on 
Stone Fruit Reducing the Preharvest Interval from 28-Days to 7-Days,'' 
p. 19 in docket ID number EPA-HQ-OPP-2009-0325.
    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 Food Quality 
Protection Act Safety Factor (FQPA 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

[[Page 40744]]

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 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. 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. 
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 PAD (aPAD) and chronic PAD (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 1-2 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 2,000 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 2,200 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. As discussed in Unit 
III.A., and the Federal Register of March 17, 2010, (75 FR 12691), EPA 
concluded that regulation based on the chronic reference dose 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 ultra violet 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the U.S. is 
a party. EPA may establish a tolerance that is different from a Codex 
MRL; however, FFDCA section 408(b)(4) requires that EPA explain the 
reasons for departing from the Codex level.
    Codex MRLs are established for residues of hexythiazox in or on 
cherry and peach at 1.0 ppm, and plum (including prune) at 0.2 ppm. 
There are no currently established Canadian or Mexican MRLs for 
residues of hexythiazox for these crops. The Agency

[[Page 40745]]

has harmonized the residue level with established Codex MRLs on cherry 
and peach, but notes that it is not possible to harmonize the tolerance 
expression at this time as the Codex MRL includes parent only. 
Additionally, it is not possible to harmonize with the codex MRL for 
plums as the established Codex MRL of 0.2 ppm is too low to cover 
residues that could result from the use of hexythiazox in the U.S.

V. Conclusion

    Therefore, the tolerance for residues of hexythiazox, in or on 
plum, prune, dried is revised from 0.4 ppm to 1.3 ppm; and the 
tolerance for fruit, stone, group 12, except plum is revised to read 
fruit, stone, group 12. The established tolerances for plum and for 
plum, prune, fresh can be removed as these commodities are addressed by 
the stone fruit group tolerance.

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 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: July 1, 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. In Sec.  180.448, the table in paragraph (a) is amended as follows:
    i. Remove the entry for plum at 0.10 ppm and for plum, prune, fresh 
at 0.10 ppm;
    ii. Revise the entry for Fruit, stone, group 12, except plum; and
    iii. Revise the entry for plum, prune, dried.
     The revisions read as follows:

Sec.  180.448  Hexythiazox; tolerances for residues.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Fruit, stone, group 12...............................                1.0
                                * * * * *
Plum, prune, dried...................................                1.3
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-17034 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-S