[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]
[Page 56383-56388]
[DOCID:fr27se06-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0016; FRL-8085-2]

Metconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
metconazole in or on bananas. BASF Agricultural Products requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 27, 2006. Objections and
requests for hearings must be received on or before November 27, 2006,
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-2005-0016. All documents in the
docket are listed in the index for the docket. 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 athttp://www.regulations.gov, or, if only available in hard

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, 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:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
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?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2005-0016 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 on or
before November 27, 2006.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2005-0016, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of April 8, 2005, (67 FR 18008) (FRL-7703-
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
9E5052) by BASF Agricultural Products, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528 agent for Kureha Corporation, 3-
3-2 Nihonbashi-Hamacho, Chuo-ku, Tokyo 103-8552, Japan. The petition
requested that 40 CFR be amended by establishing a tolerance for
residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on bananas
at 0.05 parts per million (ppm). That notice included a summary of the
petition prepared by BASF Agricultural Products, the agent for the
petitioner. Comments were received on the notice of filing. EPA's
response to these comments is discussed in Unit IV,C. below.
    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. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of metconazole on
banana at 0.1 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. Specific information on the studies received and the nature
of the toxic effects caused by metconazole 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
 under the docket ID number EPA-HQ-OPP-2005-0016.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
of concern are identified is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/oppfead1/trac/science/, and

http://www.epa.gov/pesticides/factsheets/riskassess.htm.

     A summary of the toxicological endpoints for metconazole used for
human risk assessment is shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for metconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
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Acute Dietary (Females 13-49 years of  NOAEL = 12 mg/kg/day     Special FQPA SF = 1X     Developmental toxicity
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA..    rats
                                       Acute RfD = 0.12 mg/kg/  SF = 0.12 mg/kg/day....  LOAEL = 30 mg/kg/day
                                        day.                                              based on increases in
                                                                                skeletal variations
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 4.3 mg/kg/day    Special FQPA SF = 1X     Chronic oral toxicity -
                                       UF = 100...............  cPAD = chronic RfD/       rats
                                       Chronic RfD = 0.04 mg/    Special FQPA.           LOAEL = 13.1 mg/kg/day
                                        kg/day.                 SF = 0.04 mg/kg/day....   based on increased
                                                                                liver (M) weights and
                                                                                associated
                                                                                hepatocellular lipid
                                                                                vacuolation (M) and
                                                                                centrilobular
                                                                                hypertrophy (M). Same
                                                                                effects seen (F) at 54
                                                                                mg/kg/day, plus
                                                                                increased speen weight
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)             Classification: ``Not Likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. There are currently no
tolerances established (40 CFR 180) for the residues of metconazole.
Use of metconazole on soybeans has been authorized under Section 18 of
FIFRA. Risk assessments were conducted by EPA to assess dietary
exposures from metconazole in/on imported bananas and soybeans 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.
    In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM, version 2.03), which
incorporates food consumption data as reported by respondents in the
United States Department of Agriculture (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the acute exposure assessment:
Tolerance level residues and 100% crop treated were assumed for bananas
and soybeans.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the software with the (DEEM-FCIDTM,
version 2.03), which incorporates food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: Tolerance
level residues and 100% crop treated were assumed for bananas and
soybeans.
    iii. Cancer. Metconazole is classified as ``Not Likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. A non-genotoxic mode
of action for mouse liver tumors was established. An exposure
assessment is not necessary.
    2. Dietary exposure from drinking water. There is no expectation
that

residues from metconazole use on imported banana would occur in surface
or ground water sources of drinking water. Because the Agency does not
have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling taking into
account data on the physical characteristics of metconazole. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/[fxsp0]oppefed1/

models/water/[fxsp0]models4.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
metconazole, resulting from use on soybeans for acute exposures are
estimated to be 1.57 parts per billion (ppb) for surface water and 0.04
ppb for ground water. The EDWCs for chronic exposures are estimated to
be 0.48 ppb for surface water and 0.04 ppb for ground water. Use on
imported bananas will not contribute to residues in water in the United
States.
    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).
     Metconazole is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
     Metconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between this pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events. A variable pattern of toxicological responses
are found for conazoles. Some are hepatotoxic and hepatocarcinogenic in
mice. Some induce thyroid tumors in rats. Some induce developmental,
reproductive, and neurological effects in rodents. Furthermore, the
conazoles have a diverse range of biochemical events including altered
cholesterol levels, stress responses, and altered DNA methylation. It
is not clearly understood whether these biochemical events are directly
connected to the toxicological outcomes. Thus, there is currently no
evidence to indicate that conazoles share common mechanisms of toxicity
and EPA is not following a cumulative risk approach based on a common
mechanism of toxicity for the conazoles. For information regarding
EPA's procedures for cumulating effects from substances found to have a
common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

    Metconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including metconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket

Identification (ID) Number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
Margin of Exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or FQPA safety factors, as
appropriate.
    2. Prenatal and postnatal sensitivity. The database for metconazole
is adequate for FQPA consideration. The two-generation reproduction
study was performed with cis-only metconazole (not cis/trans
metconazole). However, the database contains a sufficient number of
subchronic and developmental toxicity studies with cis/trans
metconazole to adequately assess cis/trans metconazole toxicity and to
bridge the data gap. In addition, acceptable development toxicity
studies are available in both rats and rabbits. The effect seen in
these studies do not indicate that pups are more susceptible: pup
effects were only seen in the presence of maternal toxicity and, in
general, were of comparable or less severity to the effects observed in
adults. Metconazole did not exhibit neurotoxicity in any of the
submitted data.
    3. Conclusion. There is a complete toxicity data base for
metconazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. There is no
evidence of susceptibility following in utero and/or postnatal exposure
in the developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
concerns. The acute and chronic dietary (food + drinking water)
exposure assessments are conservative assessments that are based on
reliable data and will not underestimate exposure/risk. There is no
potential for drinking water exposure from the proposed use on imported
bananas. Additionally, there is no potential for residential exposure.
Based on these data and conclusions, the FQPA Safety Factor is reduced
to 1X.

E. Aggregate Risks and Determination of Safety

    To assess aggregate risk, drinking water estimates were
incorporated directly into the dietary analysis, rather than using
back-calculated drinking water levels of comparison (DWLOCs).

 To better evaluate aggregate risk associated with exposure through
food and drinking water, EPA is no longer comparing Estimated Drinking
Water Concentrations (EDWCs) generated by water quality models with
DWLOC. Instead, EPA is now directly incorporating the actual water
quality model output concentrations into the risk assessment. This
method of incorporating water concentration into our aggregate
assessments relies on actual CSFII reported drinking water consumptions
and more appropriately reflects the full distribution of drinking water
concentrations.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to metconazole will occupy <  1% of the aPAD for females 13 years and
older, the only population subgroup of concern. EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, and therefore is below
the Agency's level of concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
metconazole from food and water will utilize 2% of the cPAD for the
U.S. population, 5% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup. There are no residential uses for
metconazole that result in chronic residential exposure to metconazole.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
and therefore is below the Agency's level of concern.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has
classified metconazole as ``Not Likely to be Carcinogenic to Humans''
based on convincing evidence that carcinogenic effects are not likely
below a defined dose range and that carcinogenic effects were seen in
animals only at higher doses. A non-genotoxic mode of action for mouse
liver tumors was established. Given that metconazole's cancer effects
are a threshold effect and that the threshold is well above other
chronic effects, the chronic RfD is protective against any cancer risk.
    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 and to infants and children from aggregate
exposure to metconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen
phosphorus detection (GC/NPD) method (American Cyanamid Method M 2722))
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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no Canadian, Mexican or Codex MRL or tolerances
for metconazole.

C. Response to Comments

    A private citizen responded to PP 9E5052. Comments were received on
April 17, 2005 objecting to the use and sale of this product, animal
testing, profiteering and lack of satisfactory combined and long-term
testing. The Agency response is as follows: The Agency has a toxicity
data base and it is considered sufficient to adequately assess
metconazole, which includes several long-term or chronic studies. The
commenter submitted no scientific information or data to support their
claims. EPA has responded to such generalized comments on numerous
previous occasions, for example, on January 7, 2005 (70 FR 1354) (FRL-
7681-9) and on October 29, 2004 (69 FR 63083) (FRL-7691-4).

V. Conclusion

    Therefore, a tolerance is established for residues of metconazole,
5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, in or on banana at 0.1 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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-). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 104-13, section 12(d) (15 U.S.C. 272 note). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that

have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: September 18, 2006.
James Jones,
Director, 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 180.617 is added to read as follows:

Sec.  180.617  Metconazole; tolerances for residues.

    (a) General. Tolerances are established for the residue of the
fungicide metconazole (5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-
1,2,4-triazol-1-ylmethyl)cyclopentanol) in or on the following
commodity:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Banana1........................................                      0.1
------------------------------------------------------------------------
\1\ No U.S. registration as of August 30, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
 [FR Doc. 06-8256 Filed 9-26-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 13, 2008 (Volume 73, Number 93)]
[Notices]
[Page 27527-27528]
[DOCID:fr13my08-29]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-466-001; Docket No. CP06-467-001]

Columbia Gas Transmission Corp.; Somerset Gas Gathering of
Pennsylvania, LLC; Notice of Application

May 6, 2008.
    Take notice that on March 31, 2008, Columbia Gas Transmission
Corporation (Columbia) and Somerset Gas Gathering of Pennsylvania, LLC
(Somerset), filed in Docket Nos. CP06-466-001 and CP06-467-001, to
amend the pending applications filed in Docket Nos. CP06-466-000 and
CP06-467-000 to modify Somerset's plan for future operations of the
facilities to be acquired and to provide additional technical and
factual details regarding the 1818/1862 System. Specifically, Somerset
clarifies that it plans to cut and cap certain portions of 1818/1862
System in order to better facilitate the functionalization of the
facilities as gathering lines while ensuring the limited nature of the

transportation service provided to Columbia as described in Columbia
and Somerset applications. Specifically, Columbia proposes to operate
two sections of the system independently--one offering limited
transportation service as described in the Columbia and Somerset
Applications and the other operating as part of a gathering system--
while two other sections will remain inactive, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, call (202)
502-8659 or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Gregory D. Russell, Vorys, Sater, Seymour and Pease, LLP, 52 East Gay
Street, P.O. Box 1008, Columbus, Ohio 43216-1008; telephone (614) 464-
5468, fax<PHONE_NUMBER>, and/or Fredric J. George, Lead Counsel,
Columbia Gas Transmission Corporation, P.O. Box 1273, Charleston, West
Virginia 25325-1273; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: May 27, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-10616 Filed 5-12-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 134 (Friday, July 16, 2021)]
[Rules and Regulations]
[Pages 37683-37686]
[FR Doc No: 2021-14376]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-HQ-OAR-2020-0292; FRL-7822-01-OAR]
RIN 2060-AU79

Redesignation of Certain Unclassifiable Areas for the 2010 1-Hour
Sulfur Dioxide (SO2) Primary National Ambient Air Quality Standard
(NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is redesignating the
Lancaster County, Nebraska and Milam County, Texas unclassifiable areas
initially designated during the EPA's Round 2 air quality designations
for the 2010 1-Hour Sulfur Dioxide (SO2) Primary National
Ambient Air Quality Standard (NAAQS). Specifically, the EPA now has
sufficient information to determine that these unclassifiable areas in
Nebraska and Texas are attaining the 2010 1-hour SO2 primary
NAAQS. Therefore, the EPA is redesignating these areas to attainment/
unclassifiable for the 2010 1-hour SO2 primary NAAQS. The
EPA is also approving these states' requests to redesignate the areas.

DATES: This final rule is effective on August 16, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2020-0292. All documents in the docket are
listed in the https://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information 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.
    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room are currently closed to
the public, with limited exceptions, to reduce the risk of transmitting
COVID-19. Our Docket Center staff will continue to provide remote
customer service via email, phone, and webform. For further information
on the EPA Docket Center services and the current status, please visit
us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For general questions concerning this
action, please contact Gobeail McKinley, U.S. EPA, Office of Air
Quality Planning and Standards, Air Quality Policy Division, C539-04,
Research Triangle Park, NC 27709, by email at<EMAIL_ADDRESS>
The following EPA Regional office contacts can answer questions
regarding the specific areas being redesignated:
    U.S. EPA REGIONAL OFFICE CONTACTS:

----------------------------------------------------------------------------------------------------------------
         Regional office            Affected state          Contact            Telephone             Email
----------------------------------------------------------------------------------------------------------------
Region VI.......................  Texas.............  Robert Imhoff.....<PHONE_NUMBER><EMAIL_ADDRESS>Region VII......................  Nebraska..........  Will Stone........<PHONE_NUMBER><EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

    Most EPA offices are closed to reduce the risk of transmitting
COVID-19, but staff remain available via telephone and email. The EPA
encourages the public to review information related to the
redesignations at https://www.epa.gov/sulfur-dioxide-designations and
in the public docket for these SO2 redesignations at https://www.regulations.gov under Docket ID No. EPA-HQ-OAR-2020-0292.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' means the EPA.

I. Background

    After the promulgation of a new or revised NAAQS, the EPA is
required to designate all areas of the country, pursuant to section
107(d)(1)-(2) of the Clean Air Act (CAA). For the 2010

 1-hour SO2 primary NAAQS,\1\ designations are based on the
EPA's application of the nationwide analytical approach to, and
technical assessment of, the weight of evidence for each area,
including but not limited to available air quality monitoring data and
air quality modeling results. Pursuant to a March 2, 2015, consent
decree and court-ordered schedule, the EPA finalized a second set of
initial area designations for the 2010 1-hour SO2 NAAQS in
2016 (also called, ``Round 2''). For the Round 2 designations, the EPA
designated the entirety of Lancaster County in Nebraska and the
entirety of Milam County in Texas as unclassifiable. The Round 2
intended designations for Lancaster County, Nebraska and Milam County,
Texas were published on March 1, 2016. (81 FR 10563). The final
designation for Lancaster County, Nebraska published on July 12, 2016.
(81 FR 45039). The final designation for Milam County, Texas was
published on December 13, 2016, as part of a supplement to the larger
Round 2 designation action. (81 FR 89870). Detailed rationale,
analyses, and other information supporting the designation for these
two areas can be found in the intended and final Round 2 designations'
technical support documents for Nebraska and Texas, respectively. These
Round 2 documents, along with all other supporting materials for the
initial 2010 1-hour SO2 primary NAAQS designations for these
areas, can be found on the EPA's SO2 designations
website.\2\
---------------------------------------------------------------------------

    \1\ The 2010 1-hour SO2 NAAQS is met when the design
value is 75 parts per billion (ppb) or less.
    \2\ https://www.epa.gov/sulfur-dioxide-designations.
---------------------------------------------------------------------------

    On May 6, 2020, Nebraska submitted a letter \3\ to the EPA
requesting that the entirety of Lancaster County be redesignated to
attainment/unclassifiable based on newly available monitoring
information, which demonstrates attainment of the 2010 1-hour
SO2 NAAQS. On June 26, 2020, Texas submitted a letter \4\ to
the EPA requesting that the entirety of Milam County be redesignated to
attainment/unclassifiable based on newly available monitoring
information, which demonstrates attainment of the 2010 1-hour
SO2 NAAQS.
---------------------------------------------------------------------------

    \3\ See letter dated May 6, 2020, from Pete Ricketts, Governor
of the State of Nebraska to Jim Gilliford, Regional Administrator,
EPA Region 7. This letter is included in the docket for this action.
    \4\ See letter dated June 26, 2020, from Toby Baker, Executive
Director of the Texas Commission of Environmental Quality to Ken
McQueen, Regional Administrator, EPA Region 6. This letter is
included in the docket for this action.
---------------------------------------------------------------------------

    In a notice of proposed rulemaking (NPRM) published on September 2,
2020 (85 FR 54517), the EPA proposed to redesignate to attainment/
unclassifiable the unclassifiable portions of Franklin and St. Charles
Counties in Missouri; the entirety of Lancaster County in Nebraska; the
entirety of Gallia County and the unclassifiable portion of Meigs
County in Ohio; and the entirety of Milam County in Texas. As discussed
in the NPRM, this final action is based on the currently available
monitoring data for two of the areas included in that NPRM that
demonstrate attainment of the 2010 1-hour SO2 primary NAAQS.
Additionally, in that NPRM, the EPA proposed to approve requests for
redesignation from the states of Nebraska, Ohio, and Texas for the
areas subject to the notice. The 30-day public comment period for the
NPRM closed on October 2, 2020. The EPA did not receive any comments
specific to the proposed redesignations of Lancaster County in Nebraska
and Milam County in Texas. This action only addresses the redesignation
of Lancaster County, Nebraska and Milam County, Texas. The areas in
Missouri and Ohio received adverse comments and will be addressed in
separate rulemaking actions. The details of each state's submittal and
the rationale for the EPA's actions are further explained in the NPRM.

II. Final Action

    In this action, the EPA is taking final action to redesignate
Lancaster County, Nebraska and Milam County, Texas to attainment/
unclassifiable for the 2010 1-hour SO2 primary NAAQS
pursuant to CAA section 107(d)(3)(D). The EPA is also taking final
action to approve a request for redesignation from unclassifiable to
attainment/unclassifiable for the 2010 SO2 primary NAAQS
from the state of Nebraska dated May 6, 2020, and from the state of
Texas dated June 26, 2020. This action changes the legal designation
for these areas, found at 40 CFR part 81, from unclassifiable to
attainment/unclassifiable for the 2010 1-hour SO2 primary
NAAQS.

III. Environmental Justice Concerns

    When the EPA establishes a new or revised NAAQS, the CAA requires
the EPA to designate all areas of the U.S. as either nonattainment,
attainment, or unclassifiable. This action addresses redesignation
determinations for two areas for the 2010 SO2 NAAQS. Under
CAA section 107(d)(3), the redesignation of an area to attainment/
unclassifiable is an action that affects the status of a geographical
area and does not impose any additional regulatory requirements on
sources beyond those imposed by state law. A redesignation to
attainment/unclassifiable does not in and of itself create any new
requirements. Accordingly, this final action merely redesignates areas
to attainment/unclassifiable and does not impose additional
requirements. Area redesignations address environmental justice
concerns by ensuring that the public is properly informed about the air
quality in an area. In locations where air quality does not meet the
NAAQS, the CAA requires relevant state authorities to initiate
appropriate air quality management actions to ensure that all those
residing, working, attending school, or otherwise present in those
areas are protected, regardless of minority and economic status.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is exempt from the Office of Management and Budget
(OMB) and was, therefore, not submitted to OMB for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. This action is a redesignation of two areas to attainment/
unclassifiable is an action that affects the status of a geographical
area and does not impose any additional regulatory requirements on
sources beyond those imposed by state law. Therefore, this final
rulemaking does not impose any new information collection burden under
the PRA.

C. Regulatory Flexibility Act (RFA)

    This redesignation action under CAA section 107(d) is not subject
to the RFA. The RFA applies only to rules subject to notice-and-comment
rulemaking requirements under the Administrative Procedures Act (APA),
5 U.S.C. 553, or any other statute. Redesignations under CAA section
107(d) are not among the list of actions that are subject to the
notice-and-comment rulemaking requirements of CAA section 307(d).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government. The
division of responsibility between the federal government and the
states for purposes of implementing the NAAQS is established under the
CAA.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000) because no tribal
lands are located within the areas covered in this action and the
redesignation does not create new requirements. The EPA notes this
final redesignation action will not impose substantial direct costs on
Tribal governments or preempt Tribal law.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The
documentation for this determination is contained in Section III of
this preamble, ``Environmental Justice Concerns.''

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 14, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See CAA section 307(b)(2).

V. Statutory Authority

    The statutory authority for this action is provided by 42 U.S.C.
7401, et seq.

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, Intergovernmental
relations, Sulfur oxides.

Michael S. Regan,
Administrator.

    For the reasons stated in the preamble, the EPA amends title 40 CFR
part 81as set forth below:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. In Sec.  81.328, the table titled, ``Nebraska-2010 Sulfur Dioxide
NAAQS [Primary]'' is amended by revising the entry for ``Lancaster
County'' and redesignating it alplabetically under ``Statewide'' before
the entry for ``Lincoln County'' to read as follows:

Sec.  81.328  Nebraska.

* * * * *

                                       Nebraska--2010 Sulfur Dioxide NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                                                    Designation
       Designated area \1\        ------------------------------------------------------------------------------
                                                  Date \2\                                  Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Lancaster County.................  August 16, 2021.......................  Attainment/Unclassifiable.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. The EPA is not determining
  the boundaries of any area of Indian country in this table, including any area of Indian country located in
  the larger designation area. The inclusion of any Indian country in the designation area is not a
  determination that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is April 9, 2018, unless otherwise noted.

* * * * *

0
3. In Sec.  81.344, the table titled ``Texas--2010 Sulfur Dioxide NAAQS
[Primary]'' is amended by revising the entry for ``Milam County, TX''
to read as follows:

Sec.  81.344  Texas.

* * * * *

                                        Texas--2010 Sulfur Dioxide NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                                                    Designation
         Designated area          ------------------------------------------------------------------------------
                                                    Date                                    Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Milam County, TX.................  August 16, 2021.......................  Attainment/Unclassifiable.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. The EPA is not determining
  the boundaries of any area of Indian country in this table, including any area of Indian country located in
  the larger designation area. The inclusion of any Indian country in the designation area is not a
  determination that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is April 9, 2018, unless otherwise noted.

* * * * *
[FR Doc. 2021-14376 Filed 7-15-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Proposed Rules]
[Page 70812-70815]
[DOCID:fr13de07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R09-OAR-2007-1150; FRL-8505-4]

Disapproval of Plan of Nevada: Clean Air Mercury Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to disapprove the State Plan submitted by
Nevada on November 15, 2006. The plan is intended to address the
requirements of EPA's Clean Air Mercury Rule (CAMR), promulgated on May
18, 2005 and subsequently revised on June 9, 2006. EPA is proposing to
determine that the submitted Nevada State Plan does not meet certain
CAMR requirements and, therefore, must be disapproved.
    CAMR requires States to regulate emissions of mercury (Hg) from
large coal-fired electric generating units (EGUs). CAMR establishes
State budgets for annual EGU Hg emissions and requires States to submit
State Plans that ensure that annual in-state EGU Hg emissions will not
exceed the applicable State budget. States have the flexibility to
choose which control measures to adopt to achieve the budgets,
including participating in the EPA-administered CAMR cap-and-trade
program. In the State Plan that EPA is proposing to disapprove, Nevada
has chosen to meet CAMR requirements by participating in the EPA-
administered CAMR cap-and-trade program addressing Hg emissions.
However, Nevada's plan does not meet the mandatory timing requirements
for allowance allocations, and differs substantively from certain
required provisions of EPA's model rule (including the provision
requiring unrestricted allowance transfer and trading).

DATES: Comments must be received on or before January 28, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2007-1150, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: EPA-R09-OAR-2007-1150, Andrew Steckel (Air-4), U.S.
Environmental Protection Agency, Region IX, 75 Hawthorne Street, San
Francisco, CA 94105-3901.
    4. Hand Delivery or Courier: Andrew Steckel (Air-4), U.S.
Environmental Protection Agency, Region IX, 75 Hawthorne Street, San
Francisco, CA 94105-3901. Such deliveries are only accepted during the
Regional Office's normal hours of operation. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R09-OAR-
2007-1150. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through http://www.regulations.gov or e-

mail, information that you consider to be CBI or otherwise protected.
The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters and any form of
encryption and should be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., 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. 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.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's proposal, please contact Lily Wong, 75 Hawthorne Street, San
Francisco, California 94105. The telephone number is<PHONE_NUMBER>.
Ms. Wong can also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What Action Is EPA Proposing To Take?
II. What Is the Regulatory History of CAMR?
III. What Are the General Requirements of CAMR State Plans?
IV. How Can States Comply With CAMR?
V. Analysis of Nevada's CAMR State Plan Submittal
VI. Implications of State Plan Disapproval
VII. Statutory and Executive Order Reviews

I. What Action Is EPA Proposing To Take?

    EPA is proposing to disapprove Nevada's State Plan, submitted on
November 15, 2006, because Nevada's submitted State Plan does not meet
certain CAMR requirements necessary for participation in the EPA-
administered CAMR cap-and-trade program. Nevada's plan requires EGUs to
participate in the EPA-administered CAMR cap-and-trade program
addressing Hg emissions. However, the State Plan does not meet the
mandatory allocation timing requirements under 40 CFR
60.24(h)(6)(ii)(C) and (D) and differs substantively from certain
required provisions of EPA's model rule at 40 CFR part 60, subpart HHHH
(including the requirement to provide for unrestricted allowance
transfer and trading). Furthermore, as an allowance system that does
not meet the above requirements, Nevada's State Plan fails to state
that Hg allowances issued under the Nevada CAMR program will not
qualify as Hg allowances under the EPA-administered cap-and-trade
program as required by 40 CFR 60.24(h)(7). Consequently, EPA is
proposing to determine that the State Plan does not meet the applicable
requirements of CAMR and to disapprove the plan on that basis.

II. What Is the Regulatory History of CAMR?

    CAMR was published by EPA on May 18, 2005 (70 FR 28606, ``Standards
of Performance for New and Existing Stationary Sources: Electric
Utility Steam Generating Units; Final Rule''). In this rule, acting
pursuant to its authority under section 111(d) of the Clean Air Act
(CAA), 42 U.S.C. 7411(d), EPA required that all States meet Statewide
annual budgets limiting Hg emissions from large coal-fired electric
generating units (i.e., EGUs, as defined in 40 CFR 60.24(h)(8)). EPA
further required all States to submit State Plans that include control
measures that ensure that total, annual Hg emissions from new and
existing EGUs do not exceed the applicable Statewide annual EGU Hg
emissions budget. Under CAMR, States may implement these emissions
limitations either by participating in the EPA-administered CAMR cap-
and-trade program or by adopting other effective and enforceable
control measures.
    CAMR explains what must be included in State Plans and sets a
deadline for submittal to EPA by November 17, 2006. Under 40 CFR
60.27(b), the Administrator will approve or disapprove the submitted
State Plans. The purpose of this action is to propose disapproval of
Nevada's CAMR State Plan.

III. What Are the General Requirements of CAMR State Plans?

    CAMR establishes Statewide annual EGU Hg emission budgets
implemented in two phases. The first phase starts in 2010 and continues
through 2017. The second phase starts in 2018 and continues thereafter.
CAMR requires States to implement the budgets by either: (1) Requiring
EGUs to participate in the EPA-administered CAMR cap-and-trade program;
or (2) adopting other EGU control measures of the respective State's
choosing and demonstrating that such control measures will result in
compliance with the applicable State annual EGU Hg emissions budget.
    Each State Plan must require EGUs to comply with the monitoring,
recordkeeping, and reporting provisions of 40 CFR part 75 concerning Hg
mass emissions. Each State Plan must also show that the State has the
legal authority to adopt the appropriate emission standards, compliance
schedules, and other requirements.

IV. How Can States Comply With CAMR?

    Many States have chosen to meet the CAMR requirements by requiring
new and existing EGUs to participate in the EPA-administered CAMR cap-
and-trade program while many other States have chosen to control
Statewide annual Hg emissions for new and existing EGUs through an
alternative mechanism. Each State that chooses an alternative mechanism
must include with its plan a demonstration that the State Plan will
ensure that the State will meet its assigned State annual EGU Hg
emission budget.
    A State submitting a State Plan that requires EGUs to participate
in the EPA-administered CAMR cap-and-trade program may either adopt
regulations that are substantively identical to the EPA model Hg
trading rule (40 CFR part 60, subpart HHHH) or incorporate by reference
the entire model rule. Alternatively, CAMR provides that a State
requiring participation in the cap-and-trade program may adopt
regulations, or an incorporation by reference, that make only limited
changes to the model rule and must otherwise be substantively identical
to the model rule. A State Plan may change the model rule only by
altering the allowance allocation provisions to provide for a State-
specific methodology for allocating Hg allowances. A State's
alternative allowance allocation provisions must meet certain mandatory
allocation timing requirements and must ensure that total allocations
for each calendar year will not exceed the State's annual EGU Hg budget
for that year.
    A State may submit a State Plan that establishes an allowance
system that does not meet the above-described requirements for
participation in the EPA-administered CAMR cap-and-trade program and
that does not require such participation, and EPA will review the State
Plan on a case-by-case basis to determine if the plan meets CAMR
requirements applicable to plans not involving such participation.
However, such State Plans must state that Hg allowances issued under
such an allowance system will not qualify as Hg allowances under the
EPA-administered CAMR cap-and-trade program.

V. Analysis of Nevada's CAMR State Plan Submittal

    The Nevada State Plan requires EGUs to participate in the EPA-
administered CAMR cap-and-trade program. The State Plan incorporates by
reference some provisions of the EPA model Hg trading rule (40 CFR part
60, subpart HHHH), but replaces other provisions of the model rule. In
particular, the State has chosen to replace model rule provisions
addressing retired units, the standard requirements for sources subject
to the EPA-administered CAMR cap-and-trade program, the allocation of
allowances, and the recordation of allowance allocations. Nevada's rule
also added certain definitions to those in the model rule and adopted
allowance allocation provisions establishing an alternate allowance
allocation methodology.

    Under CAMR, States may establish a different Hg allowance
allocation methodology and still participate in the EPA-administered
CAMR cap-and-trade program if certain mandatory requirements are met
concerning the timing of submission of allocations to EGUs to the
Administrator for recordation and the total amount of allowances
allocated for each control period and if the State Plan is otherwise
substantively identical to the model rule. In adopting alternative Hg
allowance allocation methodologies, States have flexibility with regard
to:
    1. The cost to recipients of the allowances, which may be
distributed for free or auctioned;
    2. The frequency of allocations (e.g., whether allocations for each
year will be determined in advance by an even longer period than under
the mandatory allowance allocation timing requirements);
    3. The basis for allocating allowances, which may be distributed,
for example, based on historical heat input or electric and thermal
output; and
    4. The use of allowance set-asides and, if used, their size. See 70
FR 28627.
    Nevada's alternative allowance allocation methodology effectively
distributes Hg allowances based upon a unit's actual emissions.
However, while Nevada's State Plan requires sources to participate in
the EPA-administered CAMR cap-and-trade program and so does not state
that Nevada-issued allowances will not qualify as Hg allowances under
the EPA-administered program, Nevada's method for the allocation of
allowances does not comply with the mandatory timing requirements of 40
CFR 60.24(h)(6)(ii)(C) and (D). Under 40 CFR 60.24(h)(6)(ii)(C) and
(D), allowances for existing units must be allocated generally three
years before, and allowances for new units must be allocated by October
31 of, the first control period for which the allowances may be used
for compliance. Nevada's State Plan also differs substantively from
certain other provisions of EPA's model rule that are required for
participation in the EPA-administered CAMR cap-and-trade program.
Specifically, Nevada's State Plan creates restrictions on allowance
transfer and trading, fails to state that an allowance does not
constitute a property right, substitutes the Director of the Nevada
Division of Environmental Protection for the Administrator, lacks
deadlines for recordation of allowance allocations, misstates the
requirements for compliance with the requirement to hold allowances
covering emissions, allows for Director's discretion to create an
exception to the requirement that sources maintain records on-site, and
allows for Director's discretion in specifying the content of CAMR
permit applications and permits. These inconsistencies of Nevada's rule
with the requirements of CAMR are discussed in detail in the Technical
Support Document (TSD) entitled EPA Proposed Analysis of Nevada Clean
Air Mercury Rule State Plan, which is included in the docket for this
notice.
    For these reasons, as discussed in detail in the TSD, Nevada's rule
is not approvable under 40 CFR 60.24(h)(6) and (7).\1\
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    \1\ EPA is acting on the final Nevada CAMR State Plan submitted
on November 15, 2006. EPA recognizes that Nevada has since proposed
revisions that would address some, but not all, of the approvability
issues identified above. EPA is not addressing in this notice
Nevada's proposed revisions as they have not yet been adopted or
submitted. However, EPA notes that these proposed revisions do not
address certain approvability issues, including those allocation
timing and restrictions on allowance transfer and trading.
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VI. Implications of State Plan Disapproval

    Under 40 CFR 60.27(b), the Administrator must approve or disapprove
timely submitted State Plans within four months of the deadline for
their submission to the Administrator, i.e., November 17, 2006 in the
case of CAMR State Plans. Moreover, under 40 CFR 60.27(c), the
Administrator must propose a Federal Plan for States that did not
submit State Plans by the submission deadline or whose timely submitted
State Plans the Administrator disapproves. The Administrator must
finalize a Federal Plan for such States under 40 CFR 60.27(d) within
six months of the deadline for their submission to the Administrator,
unless in the meantime the State submits a State Plan that the
Administrator determines to be approvable. EPA's review of Nevada's
State Plan continued beyond the deadline in 40 CFR 60.27(b) because of
the complexity of Nevada's rule and because EPA conducted an extended
dialogue with Nevada in order to understand the State's concerns and to
try to resolve the issues raised by Nevada's State Plan.
    In a separate action, EPA has proposed a Federal Plan and intends
to issue a final Federal Plan in the near future. Any final Federal
Plan will generally apply in those States that did not submit a State
Plan by November 17, 2006, whose State Plans submitted by November 17,
2006 have been disapproved by EPA, or whose State Plans submitted after
November 17, 2006 have not been approved. A final determination of the
categories of States to which the Federal Plan will apply will be made
in the notice finalizing a Federal Plan. If EPA finalizes the
disapproval of Nevada's CAMR State Plan and finalizes the Federal Plan
as described above, Nevada EGUs will be subject to the Federal Plan. It
is EPA's intention to work quickly to review any revision of a
disapproved State Plan, so that an approvable State Plan can be
approved and take the place of the Federal Plan.

VII. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely proposes to disapprove State law as not meeting Federal
requirements and would impose no additional requirements. Accordingly,
the Administrator certifies that this proposed rule would not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this action proposes to disapprove pre-existing requirements under
State law and would not impose any additional enforceable duty beyond
that required by State law, it 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).
    This proposal also does not have Tribal implications because it
would not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000).
    This proposed action also does not have Federalism implications
because it would not have substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This action merely proposes to disapprove a State
rule as failing to implement a Federal standard. It does not alter the
relationship or the distribution of power and responsibilities
established in the

CAA. This proposed rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant. It also does not concern an environmental health or safety
risk the EPA has reason to believe may have a disproportionate effect
on children.
    Executive Order 12898, ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations,'' requires
Federal agencies to consider the impact of programs, policies, and
activities on minority populations and low-income populations. EPA
guidance \2\ states that EPA is to assess whether minority or low-
income populations face risk or a rate of exposure to hazards that is
significant and that ``appreciably exceed[s] or is likely to
appreciably exceed the risk or rate to the general population or to the
appropriate comparison group.'' (EPA, 1998) Because this rule merely
proposes to disapprove a state rule as failing to implement the Federal
standard established by CAMR, EPA lacks the discretionary authority to
modify today's regulatory decision on the basis of environmental
justice considerations. However, EPA has already considered the impact
of CAMR, including this Federal standard, on minority and low-income
populations. In the context of EPA's CAMR published in the Federal
Register on May 18, 2005, in accordance with E.O. 12898, the Agency has
considered whether CAMR may have disproportionate negative impacts on
minority or low income populations and determined that it does not.
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    \2\ U.S. Environmental Protection Agency, 1998. Guidance for
Incorporating Environmental Justice Concerns in EPA's NEPA
Compliance Analyses. Office of Federal Activities, Washington, DC,
April, 1998.
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    In reviewing State Plan submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the CAA generally and
CAMR specifically. In this context, in the absence of a prior existing
requirement for the State to use voluntary consensus standards (VCS),
EPA has no authority to disapprove a State Plan for failure to use VCS.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State Plan submission, to use VCS in place of a State Plan
submission that otherwise satisfies the provisions of the CAA. Thus,
the requirements of section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This
proposed rule would not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Electric
utilities, Intergovernmental relations, Reporting and recordkeeping,
Mercury.

    Dated: December 3, 2007.
Wayne Nastri,
Regional Administrator, Region IX.
[FR Doc. E7-24167 Filed 12-12-07; 8:45 am]

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