[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Rules and Regulations]
[Pages 40741-40745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17034]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I 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: [email protected].
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