[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Rules and Regulations]
[Page 63070-63074]
[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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining

whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    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<PHONE_NUMBER>.

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

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

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

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:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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


these allergenic foods can induce anaphylaxis, research, education, and clear food
ingredient labeling information are critical for managing food allergies.

Page 10-6
Healthy People 2010: Objectives for Improving Health


[Federal Register: September 30, 2008 (Volume 73, Number 190)]
[Notices]
[Page 56830-56831]
[DOCID:fr30se08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0270] (formerly Docket No. 2007N-0357)

Medical Device User Fee and Modernization Act; Notice to Public
of Web Location of 2009 Proposed Guidance Development

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the Web
location where the agency will post a list of guidance documents the
Center for Devices and Radiological Health (CDRH) is considering for
development in fiscal year (FY) 2009. In addition, FDA has established
a docket where stakeholders may provide comments and/or draft language
for those topics as well as suggestions for new or different guidances.

DATES:  Submit written or electronic comments at any time.

ADDRESSES:  Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Deborah A. Wolf, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations over the reauthorization of the Medical Device
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for
additional funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of guidance documents that CDRH is considering for
development and providing stakeholders an opportunity to provide
comments and/or draft language for those topics, or suggestions for new
or different guidances. This notice announces the Web location of the
list of guidances (see Sec.  10.115(c)(1) (21 CFR 10.115(c)(1))) on
which CDRH is intending to work over the next FY. We note that the
agency is not required to issue every guidance on the list, nor is it
precluded from issuing guidance documents that are not on the list. The
list includes topics that currently have no guidance associated with
them, topics where updated guidance may be helpful, and topics for
which CDRH has already issued level 1 drafts that may be finalized
following review of public comments. We will consider stakeholder
comments as we prioritize our guidance efforts.
    FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. We also note that CDRH's experience over
the years has shown that there are many reasons CDRH staff does not
complete the entire annual agenda of guidances it undertakes. Staff are
frequently diverted from guidance development to other activities,
including review of premarket submissions or postmarket problems. In
addition, the Center is required each year to issue a number of
guidances that it cannot anticipate at the time the annual list is
generated. These may involve newly identified public health issues as
well as special control guidance documents for de novo classifications
of devices. It will be helpful, therefore, to receive comments that
indicate the relative priority of different guidance topics to
interested stakeholders.
    Through feedback from stakeholders, including draft language for
guidance documents, CDRH expects to be able to better prioritize and
more efficiently draft guidances that will be useful to industry and
other stakeholders. This will be the second annual list CDRH has
posted. FDA intends to update the list each year.
    FDA invites interested persons to submit comments on any or all of
the guidance documents on the list. FDA has established a specific
docket (see docket number found in brackets in the heading of this
document) where comments about the FY 2009 list, draft language for
guidance documents on those topics, and suggestions for new or
different guidances may be submitted. FDA believes this docket is an

important tool for receiving information from interested parties and
for sharing this information with the public. Similar information about
planned guidance development is included in the annual agency-wide
notice issued by FDA under its good guidance practices (Sec.
10.115(f)(5)). The CDRH list, however, will be focused exclusively on
device-related guidances and will be made available on FDA's Web site
prior to the beginning of each FY from 2008 to 2012.
    To access the list of the guidance documents CDRH is considering
for development in 2009, visit the FDA Web Site at http://www.fda.gov/
cdrh/mdufma/guidance/agenda/fy09.html.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Comments submitted to this docket may include draft
guidance documents that stakeholders have prepared for FDA's
consideration.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22911 Filed 9-29-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 25, 2008 (Volume 73, Number 187)]
[Proposed Rules]
[Page 55466-55469]
[DOCID:fr25se08-21]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0705; FRL-8720-5]

Approval and Promulgation of Implementation Plans; Nevada;
Vehicle Inspection and Maintenance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: Under the Clean Air Act, EPA is proposing to approve certain
revisions, and to disapprove certain other revisions, of the Nevada
State Implementation Plan submitted by the Nevada Division of
Environmental Protection. These revisions relate to the application of
the State's vehicle inspection and maintenance program to vehicles
operated on Federal installations. EPA is also proposing to correct
certain plan revisions related to this subject that EPA previously
approved in error. The intended effect is to ensure that vehicles
operated on Federal installations are subject only to those
requirements of the State's vehicle inspection and maintenance program
that apply in the same manner and to the same extent to nongovernmental
entities.

DATES: Any comments must arrive by October 27, 2008.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0705, by one of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the on-line instructions.
     E-mail<EMAIL_ADDRESS>     Mail or deliver: Eleanor Kaplan (AIR-2), U.S.
Environmental Protection Agency Region IX, 75 Hawthorne Street, San
Francisco, CA 94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or e-mail.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT: Eleanor Kaplan, Air Planning Office
(AIR-2), U.S. Environmental Protection Agency, Region IX, (415) 947-
4147<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Background
II. The State's SIP Revision Submittal
    A. What revisions did the State submit?
    B. What is our evaluation of the revisions?
III. Correction of Previously-Approved Provisions
    A. What provisions did we previously approve?
    B. What is our evaluation of the approved provisions?
IV. Public Comment and Final Action
V. Statutory and Executive Order Reviews

I. Background

    On January 7, 2008 (73 FR 1175), EPA proposed, under the Clean Air
Act (CAA or ``Act''), to approve certain submittals by the Nevada
Division of Environmental Protection (NDEP) of revisions to the Nevada
state implementation plan (SIP). The submittals that were the subject
of our January 7, 2008 proposed rule primarily relate to attainment and
maintenance of the carbon monoxide (CO) national ambient air quality
standard (NAAQS) in the Truckee Meadows nonattainment area. In our
January 7, 2008 proposed rule, we also proposed to approve the State's
submittal of an update to the regulatory element of the State's mobile
source SIP, including statutory provisions and rules related to the
State's vehicle inspection and maintenance (I/M) programs administered
in Truckee Meadows (located within Washoe County) and Las Vegas Valley
and Boulder City (located within Clark County).
    As part of our January 7, 2008 proposed rule, we proposed to
approve all of the State's vehicle I/M rules with the exception of a
particular subsection (subsection (2)) of a single rule, Nevada
Administrative Code (NAC) section 445B.595 (``Inspections of vehicles
owned by State or political subdivisions or operated on federal
installations'') (``NAC 445B.595(2)''), for which we proposed neither
approval nor disapproval. We explained our ``no action'' proposal for
NAC 445B.595(2) as follows:

    The Federal I/M rule requires that vehicles operated on Federal
installations located within an I/M program area be tested
regardless of whether the vehicles are registered in the state or
local I/M area. See 40 CFR 51.356(a)(4). However, we are not
requiring states to implement 40 CFR 51.356(a)(4) at this time. The
Department of Justice has recommended to EPA that this Federal
regulation be revised since it appears to grant states authority to
regulate Federal installations in circumstances where the Federal
government has not waived sovereign immunity. It would not be
appropriate to require compliance with this regulation if it is not
constitutionally authorized. EPA will be revising this provision in
the future and will review state I/M SIPs with respect to this issue
when this

new rule is final. Therefore, for these reasons, EPA is neither
approving nor disapproving the specific requirements which apply to
Federal facilities at this time. Specifically, we are taking no
action on submitted rule NAC 445B.595(2), which extends the State's
I/M requirements to motor vehicles operated on Federal installations
located within I/M areas.

See 73 FR 1175, at 1182. See also 73 FR 1175, at 1176 and 1194 for
summaries of our proposed action in this regard. The recommendation by
the Department of Justice (DOJ) referred to in the above excerpt was
made in a letter from Lois J. Schiffer, Assistant Attorney General, DOJ
Environment and Natural Resources Division, to Scott Fulton, Acting
General Counsel, EPA, dated July 29, 1998.
    In our January 7, 2008 proposed rule, we also proposed, under CAA
section 110(k)(6), to rescind our previous approval of an earlier
codification of NAC 445B.595(2), once again, based on sovereign
immunity concerns. We had approved the earlier codification of NAC
445B.595(2) in connection with our approval of the State's vehicle I/M
program as administered in Las Vegas Valley and Boulder City. See 69 FR
56351, at 56354 (September 21, 2004).
    Our January 7, 2008 proposed rule provided for a 30-day public
comment period, and we received comments related to our proposal from
NDEP concerned about our proposed error correction related to NAC
445B.595(2). On July 3, 2008, we took final action on all aspects of
the January 7, 2008 proposed rule with the exception of our proposed
action on NAC 445B.595(2) for which we agreed to reconsider action in a
future proposed rule. See 73 FR 38124 (July 3, 2008). We have now
reconsidered the issue of sovereign immunity in relation to the State's
vehicle I/M program and propose, in today's action, to approve
paragraphs (a), (b) and (c) of NAC 445B.595(2) (``NAC 445B.595(2)(a),
(b), and (c)''), to disapprove paragraph (d) of NAC 445B.595(2) (``NAC
445B.595(2)(d)''), to rescind our previous approval of NAC
445B.595(2)(d) and our previous approvals of another State vehicle I/M
requirement, NAC 445B.461(3)(d).

II. The State's SIP Revision Submittal

A. What revisions did the State submit?

    On May 11, 2007, NDEP submitted, among other provisions, rules
implementing the State's vehicle I/M program in Truckee Meadows and Las
Vegas Valley/Boulder City. Among the rules are NAC 445B.461
(``Compliance by Federal Government, state agencies and political
subdivisions'') and NAC 445B.595 (``Inspections of vehicles owned by
State or political subdivisions or operated on federal
installations''). NAC 445B.461 provides in relevant part:

    1. A license may be issued to the Federal Government * * * to
inspect motor vehicles * * * for the purpose of compliance with NAC
445B.400 to 445B.735, inclusive.
    2. * * *.
    3. The holder of a license issued pursuant to subsection 1 is
exempt from the requirements set forth in the following sections for
the limited purposes indicated: (a) Bond, NAC 445B.465; (b) Evidence
of compliance, NAC 445B.583 to 445B.586, inclusive; (c) Sign, NAC
445B.469; and (d) Use of waiver, NAC 445B.590.

NAC 445B.595 provides in relevant part:

    1. * * *.
    2. Motor vehicles operated on federal installations located
within an area requiring a program for the inspection of exhaust
emissions must be inspected and certified annually. The provisions
of this subsection:
    (a) Apply to all motor vehicles which are owned, leased or
operated by an employee of, or military personnel stationed at, a
federal installation;
    (b) Apply to all motor vehicles which are owned, leased or
operated by any agency of the Federal Government on a federal
installation;
    (c) Do not apply to tactical military vehicles operated on a
federal installation; and
    (d) Do not apply to motor vehicles which are owned, leased or
operated on a federal installation by visiting federal employees or
military personnel when the visit does not exceed 60 days within any
1 calendar year. A federal installation shall annually submit to the
Department evidence showing that it has complied with the provisions
of this paragraph, in a form prescribed by the Department.

    We approved NAC 445B.461 in 2004 in connection with our approval of
the State's I/M program in Las Vegas Valley and Boulder City (see 69 FR
56351, at 56354 (September 21, 2004)), and again on July 3, 2008 in
connection with our final approval of the State's update (submitted on
May 11, 2007) to the regulatory element of the State's mobile source
SIP, including the rules for the State's vehicle I/M program in Truckee
Meadows and Las Vegas Valley/Boulder City. We also approved NAC
445B.595 in connection with our approval of the State's I/M program in
Las Vegas Valley and Boulder City but, as noted above, proposed to
rescind our previous approval of NAC 445B.595(2) in our January 7, 2008
proposed rule, and have as yet taken no action on NAC 445B.595(2) as
submitted to us on May 11, 2007. The versions of NAC 445B.461 and NAC
445B.595 approved by us in 2004 and those submitted to us on May 11,
2007 are identical.

B. What is our evaluation of the revisions?

    CAA section 118(a) requires that each agency and employee of the
Federal government comply with all Federal, State, interstate, and
local requirements, administrative authority, and process and sanctions
respecting the control and abatement of air pollution in the same
manner, and to the same extent as any nongovernmental entity. In our
evaluation of the State's I/M program as it relates to Federal
installations, we also rely upon EPA's guidance document, ``Interim
Guidance for Federal Facility Compliance with Clean Air Act Sections
118(c) and 118(d) and Applicable Provisions of State Vehicle Inspection
and Maintenance Programs,'' Draft, December 1999.
    Generally, the State of Nevada has made the State's mobile source
rules, including many such rules related to the vehicle I/M program,
applicable to Federal installations by including the Federal Government
in the State's rule defining ``person'' for the purposes of the State's
mobile source regulations. See NAC 445B.443.\1\ With respect to
specific testing, standards, and certification requirements, the State
has made the vehicle I/M program applicable to the Federal Government
through adoption of NAC 445B.595(2) (including paragraphs (a) through
(d)), which is set forth above. Through NAC 445B.595(2), the same types
of emission tests and the same emissions standards apply to the motor
vehicles owned by the Federal Government as apply to motor vehicles
owned by nongovernmental entities. Thus, with the exception of the two
specific provisions discussed below, we find that the State's I/M
program complies with CAA section 118(a) and must be complied with by
Federal installations and employees. We therefore propose to approve
NAC 4454B.595(2)(a), (b), and

(c), as submitted by NDEP on May 11, 2007.
---------------------------------------------------------------------------

    \1\ Under NAC 445B.443, ``Person'' includes the Federal
Government, the State of Nevada, or any of its political
subdivisions and any other administrative agency, public or quasi-
public corporation, or other legal entity. NDEP and the Nevada
Department of Motor Vehicles (DMV) interpret NAC 445B.443 in light
of the ``basic'' definition of the term ``person'' as codified at
NRS 0.039: ``Except as otherwise expressly provided in a particular
statute or required by the context, ``person'' means a natural
person, any form of business or social organization and any other
nongovernmental legal entity including, but not limited to, a
corporation, partnership, association, trust or unincorporated
organization. The term does not include a government, governmental
agency or political subdivision of a government.'' EPA approved NRS
0.039 into the Nevada SIP in 2006. See 71 FR 51766 (August 31,
2006). To clarify that NAC 445B.443 builds upon the ``basic''
definition of person, we understand that NDEP and Nevada DMV intend
to amend NAC 445B.443 to include a specific reference to NRS 0.039.
---------------------------------------------------------------------------

    Under the State's vehicle I/M program, there are only two
significant requirements that apply to Federal installations and
employees that do not also apply in the same manner, and to the same
extent to nongovernmental entities. These requirements are found in NAC
445B.595(2)(d) and NAC 445B.461(3)(d). NAC 445B.595(2)(d) requires I/M
testing and certification for non-resident Federal employees whose
visits to Federal installations in I/M areas exceed 60 days. No such
requirement under the State's vehicle I/M program applies to
nonresident visitors who are not Federal employees. Likewise, NAC
445B.461(3)(d) disqualifies the Federal Government from eligibility for
a waiver that nongovernmental entities, under the same circumstances,
are eligible. Waivers are generally allowed under the I/M program for
vehicles that cannot pass the emissions test but for which qualifying
repairs costing over certain thresholds have been made. Both provisions
discriminate against Federal installations or employees relative to the
requirements for nongovernmental entities and thus are inconsistent
with the limits on the waiver of sovereign immunity established in CAA
section 118(a).
    Therefore, we propose to approve NDEP's submittal on May 11, 2007
of NAC 445B.595(2)(a), (b), and (c) but to disapprove paragraph (d) of
the same subsection. We recently approved NDEP's submittal on May 11,
2007 of NAC 445B.461 and address NAC 445B.461(3)(d) in the following
section of this document.

III. Correction of Previously Approved Provisions

A. What provisions did we previously approve?

    We approved NAC 445B.461, including NAC 445B.461(3)(d), and NAC
445B.595, including NAC 445B.595(2)(d), in connection with our 2004
approval of the State's vehicle I/M program in Las Vegas Valley and
Boulder City. Moreover, we approved NAC 445B.461 again in our July 3,
2008 final rule.

B. What is our evaluation of the approved provisions?

    Section 110(k)(6) of the Clean Air Act, as amended in 1990,
provides, ``Whenever the Administrator determines that the
Administrator's action approving, disapproving, or promulgating any
plan or plan revision (or part thereof), area designation,
redesignation, classification or reclassification was in error, the
Administrator may in the same manner as the approval, disapproval, or
promulgation revise such action as appropriate without requiring any
further submission from the State. Such determination and the basis
thereof shall be provided to the State and the public.''
    We interpret this provision to authorize the Agency to make
corrections to a promulgated regulation when it is shown to our
satisfaction that (1) we clearly erred in failing to consider or in
inappropriately considering information made available to EPA at the
time of the promulgation, or the information made available at the time
of promulgation is subsequently demonstrated to have been clearly
inadequate, and (2) other information persuasively supports a change in
the regulation. See 57 FR 56762, at 56763 (November 30, 1992).
    In this instance, we have found clear error in our 2004 approval of
NAC 445B.461(3)(d) and NAC 445B.595(2)(d), and our subsequent 2008
approval of NAC 445B.461(3)(d), as a part of the Nevada SIP because at
the time of our 2004 and 2008 actions such discriminatory provisions
were not authorized under CAA section 118(a). Moreover, since such
provisions remain unauthorized under CAA section 118(a), we believe
that an error correction action under CAA section 110(k)(6) under these
circumstances is appropriate. Therefore, we propose to rescind our
previous approvals of NAC 445B.461(3)(d) and NAC 445B.595(2)(d) since
they would otherwise set forth additional requirements under the I/M
program for Federal installations and employees that do not apply to
nongovernmental entities and thus would be inconsistent with the limits
of sovereign immunity established in CAA section 118(a).\2\
---------------------------------------------------------------------------

    \2\ We have discussed this issue with NDEP and Nevada DMV, and
on April 30, 2008, NDEP submitted a letter to EPA expressing its
agreement that the subject provisions are not consistent with CAA
section 118(a) and its support for EPA's proposal to remove the
provisions from the Nevada SIP. See letter from Michael Elges,
Chief, NDEP Bureau of Air Quality Planning, to Jeff Wehling, Office
of Regional Counsel, EPA Region IX, dated April 30, 2008.
---------------------------------------------------------------------------

IV. Public Comment and Final Action

    Under section 110(k)(3) of the Clean Air Act, we propose to approve
NDEP's submittal on May 11, 2007 of NAC 445B.595(2)(a), (b), and (c) as
consistent with all applicable CAA requirements but to disapprove NAC
445B.595(2)(d) as inconsistent with the limits on sovereign immunity
established in CAA section 118(a). In addition, under CAA section
110(k)(6), we propose to rescind our previous approvals of NAC
445B.461(3)(d) and 445B.595(2)(d) since they would otherwise set forth
additional requirements under the I/M program for Federal installations
and employees that do not apply to nongovernmental entities and thus
would be inconsistent with CAA section 118(a).
    EPA is soliciting public comments on the issues discussed in this
document and will accept comments for the next 30 days. These comments
will be considered before taking final action.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely proposes to approve state law as
meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would

be inconsistent with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: September 15, 2008.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. E8-22557 Filed 9-24-08; 8:45 am]

BILLING CODE 6560-50-P


Proposed Rule: Revisions to Reporting and Recordkeeping Requirements,
and Proposed Confidentiality Determinations under the Greenhouse Gas
Reporting Program

Meeting Documentation : American Chemistry Council Meeting with US EPA

Date	Staff Contact Information (Name, email, phone #)	Name of
Organization (Attach list of all attendees names and emails if possible)
	Summary of Discussion (e.g., applicability, reporting requirements,
etc.)	Written Comments Provided?

Did they also submit to Docket?	Date sent to EPA- CCD

November 19, 2013	Lisa Grogan-McCulloch

Grogan- HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
617-918-1481	American Chemistry Council:

 Leslie Hulse<EMAIL_ADDRESS>
Lorraine Gershman<EMAIL_ADDRESS>A meeting
was held where American Chemistry Council provided comments regarding
the proposed rule.  Key issues covered included the inputs verification
tool and emission data.

  	No written comments were provided during meeting.  Comments submitted
to docket.	N/A (comments submitted to docket.)