[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Rules and Regulations]
[Page 65029-65034]
[DOCID:fr09de09-8]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0769; FRL-8799-6]

Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on bushberry subgroup 13-07B; Brassica, leafy greens,
subgroup 5B; turnip, greens; fruit, stone, group 12, except cherry;
cherry; and plum, prune, dried. This regulation additionally revises an
existing tolerance in or on egg and revises terminology for an existing
tolerance. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective December 9, 2009. Objections and
requests for hearings must be received on or before February 8, 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-2008-0769. 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: Laura Nollen, 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. To
access the OPPTS Harmonized Test Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gov/oppts and
select ``Test Methods & Guidelines'' on the left side navigation menu.

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-2008-0769 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 8, 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-2008-0769, 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 December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8E7425 and PP 8E7426) by IR-4, 500 College Road East, Suite 201 W.,
Princeton, NJ 08540. The petitions requested that 40 CFR 180.598 be
amended by establishing tolerances for residues of the insecticide
novaluron, N -[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide,
in or on bushberry, subgroup 13-07B at 7 parts per million (ppm) (PP
8E7425); fruit, stone, group 12 at 8 ppm (PP 8E7426); Brassica, leafy
greens, subgroup 5B at 25 ppm (PP 8E7426); and turnip, greens at 25 ppm
(PP 8E7426). PP 8E7426 additionally requested to increase the existing
tolerance for residues of novaluron in or on egg from 0.05 ppm to 0.07
ppm; however, the petition number associated with this request was
incorrectly reported. The correct petition number for the request to
increase the existing egg tolerance is PP 9F7630. The notice referenced
summaries of the petitions prepared on behalf of IR-4 by Makhteshim-
Agan of North America, Inc., the registrant, which are available to the
public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance on stone fruit and has determined that individual
tolerances in or on cherry; and plum, prune, dried are necessary. The
reasons for these changes are explained in Unit IV.C.

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
tolerances for residues of novaluron on bushberry subgroup 13-07B at
7.0 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; turnip, greens
at 25 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; cherry at
8.0 ppm; plum, prune, dried at 2.6 ppm; and egg at 0.07 ppm. EPA's
assessment of exposures and risks associated with establishing
tolerances 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.
    Novaluron has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a dermal sensitizer. In subchronic and chronic toxicity studies,
novaluron primarily produced hematotoxic effects such as
methemoglobinemia, decreased hemoglobin, decreased hematocrit, and
decreased RBCs (or erythrocytes) associated with increased
erythropoiesis. Increased spleen weights and/or hemosiderosis in the
spleen were considered to be due to enhanced removal of damaged
erythrocytes and not to an immunotoxic effect.
    There was no maternal or developmental toxicity seen in the rat and
rabbit developmental toxicity studies up to the limit doses. In the 2-
generation reproductive toxicity study in rats, both maternal and
offspring toxicity were evidenced by enlargement of the spleen.
Reproductive toxicity (decreases in epididymal sperm counts and
increased age at preputial separation in the F1 generation)
was observed only in males.
    Signs of neurotoxicity were seen in the rat acute neurotoxicity
study at the limit dose, including clinical signs (piloerection, fast/
irregular breathing), functional observation battery (FOB) parameters
(head swaying, abnormal gait) and neuropathology (sciatic and tibial
nerve degeneration). No signs of neurotoxicity or neuropathology were
observed in the subchronic neurotoxicity study in rats or in any other
subchronic or chronic toxicity study in rats, mice or dogs. Therefore,
there is no concern for neurotoxicity resulting from exposure to
novaluron.
    There was no evidence of carcinogenic potential in either the rat
or mouse carcinogenicity studies and no evidence of mutagenic activity
in the submitted mutagenicity studies, including a bacterial
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus
assay and a bacterial DNA damage or repair assay. Based on the results
of these studies, EPA has classified novaluron as ``not likely to be
carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by novaluron 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 document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Bushberry Crop Subgroup 13-
07B; Brassica, Leafy Greens, Crop Subgroup 5B; Turnip, Greens; and
Fruit, Stone, Crop Group 12,'' pages 28-31 in docket ID number EPA-HQ-
OPP-2008-0769.

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 novaluron used for
human risk assessment can be found at http://www.regulations.gov in
document ``Novaluron: Human-Health Risk Assessment for Proposed Section
3 Uses on Bushberry Crop Subgroup 13-07B; Brassica, Leafy Greens, Crop
Subgroup 5B; Turnip, Greens; and Fruit, Stone, Crop Group 12,'' pages
13-14 in docket ID number EPA-HQ-OPP-2008-0769.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to novaluron, EPA considered exposure under the petitioned-for
tolerances as well as all existing novaluron tolerances in 40 CFR
180.598. EPA assessed dietary exposures from novaluron 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 novaluron; 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 USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA incorporated anticipated residues from
average field trial residues for pome fruit, sugarcane, bushberries,
Brassica leafy greens, stone fruit and greenhouse tomatoes; empirical
processing factors for apple juice (translated to pear and stone fruit
juice), tomato paste and pur[eacute]e, and dried plums; and DEEM
default processing factors for the remaining processed commodities. In
estimating dietary exposure from secondary residues in livestock, EPA
relied on anticipated residues for meat and milk commodities but used
tolerance-level residues for poultry commodities. 100 percent crop
treated (PCT) was assumed for all existing and new uses of novaluron.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
novaluron as ``not likely to be carcinogenic to humans.'' Therefore, a
quantitative exposure assessment to evaluate cancer risk is
unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water are novaluron and its chlorophenyl urea and
chloroaniline degradates. The Agency used screening level water
exposure models in the dietary exposure analysis and risk assessment
for novaluron and its degradates in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of novaluron. 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.
    The following models were used to assess residues of concern in
drinking water: The Pesticide Root Zone Model /Exposure Analysis
Modeling System (PRZM/EXAMS) for parent novaluron in surface water; the
First Index Reservoir Screening Tool (FIRST) for chlorophenyl urea and
chloroaniline degradates in surface water; and the Screening
Concentration in Ground Water (SCI-GROW) model for novaluron,
chlorophenyl urea and chloroaniline in ground water. The estimated
drinking water concentrations (EDWCs) of novaluron, chlorophenyl urea
and chloroaniline for chronic exposures for non-cancer assessments are
estimated to be 0.76 parts per billion (ppb), 0.89 ppb and 2.6 ppb,
respectively, for surface water and 0.0056 ppb, 0.0045 ppb and 0.0090
ppb, respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The highest drinking water
concentrations were estimated for surface water. Of the three EDWC
values for surface water, the chronic EDWC for the terminal metabolite,
chloroaniline, is the highest (assuming 100% molar conversion from
parent to aniline). This is consistent with the expected degradation
pattern for novaluron. Therefore, for chronic dietary risk assessment,
the water concentration value for chloroaniline of 2.6 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). Novaluron 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 novaluron to share a common mechanism of toxicity
with any other substances, and novaluron does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that novaluron 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 FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for novaluron includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There was no evidence of increased quantitative or
qualitative susceptibility following in utero exposure to rats or
rabbits in the developmental toxicity studies and no evidence of
increased quantitative or qualitative susceptibility of offspring in
the reproduction study. Neither maternal nor developmental toxicity was
seen in the developmental studies up to the limit doses. In the
reproduction study, offspring and parental toxicity (increased absolute
and relative spleen weights) were similar and occurred at the same
dose; additionally, reproductive effects (decreases in epididymal sperm
counts and increased age at preputial separation in the F1
generation) occurred at a higher dose than that which resulted in
parental toxicity.
    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 novaluron is complete except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Test Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. Although effects were
seen in the spleen in two studies, as explained in Unit III.A., EPA has
concluded that novaluron does not directly target the immune system and
the Agency does not believe that conducting a functional immunotoxicity
study will result in a NOAEL lower than the regulatory dose for risk
assessment; therefore, an additional database uncertainty factor is not
needed to account for potential immunotoxicity.
    ii. There were signs of neurotoxicity in the acute neurotoxicity
study in rats, including clinical signs (piloerection, fast/irregular
breathing), FOB parameters (head swaying, abnormal gait), and
neuropathology (sciatic and tibial nerve degeneration). However, the
signs observed were not severe, were seen only at the limit dose (2,000
mg/kg/day) and were not reproducible. No signs of neurotoxicity or
neuropathology were observed in the subchronic neurotoxicity study in
rats at doses up to 1,752 mg/kg/day in males and 2,000 mg/kg/day in
females or in any other subchronic or chronic toxicity study in rats,
mice or dogs, including the developmental and reproduction studies.
Therefore, novaluron does not appear to be a neurotoxicant, and there
is no need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    iii. There is no evidence that novaluron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level or anticipated residues derived from
reliable residue field trials. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to novaluron in drinking water. Residential exposures are not
expected. These assessments will not underestimate the exposure and
risks posed by novaluron.

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 SFs. 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,
novaluron 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
novaluron from food and water will utilize 83% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for novaluron.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Novaluron is not
registered for any use patterns that would result in residential
exposure. Therefore, the short- and intermediate-term aggregate risk is
the sum of the risk from exposure to novaluron through food and water
and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. There was no evidence
of carcinogenic potential in either the rat or mouse carcinogenicity
studies and no evidence of mutagenic activity in the submitted
mutagenicity studies; therefore, novaluron is not expected to pose a
cancer risk to humans.
    5. 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 novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The following adequate enforcement methodologies are available to
enforce the tolerance expression: A gas chromatography/electron-capture
detection (GC/ECD) method and a high-performance liquid chromatography/
ultraviolet (HPLC/UV) method. The methods 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

    No Codex, Canadian or Mexican maximum residue limits (MRLs) have
been established for novaluron on bushberries; Brassica, leafy greens;
turnip greens; or stone fruit. Canada has reviewed the use of novaluron
on Brassica, leafy greens and stone fruit

(including cherry and plum, prune, dried). Canadian and U.S.
recommendations have been harmonized and MRLs for Brassica, leafy
greens, subgroup 5B at 7.0 ppm; stone fruit, group 12, except cherry at
1.9 ppm; cherry at 8.0 ppm; and plum, prune, dried at 2.6 ppm are
expected to be established in Canada.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance
for Setting Pesticide Tolerances Based on Field Trial Data, EPA revised
the proposed tolerance on fruit, stone, group 12 (excluding cherry; and
plum, prune, dried) from 8.0 ppm to 1.9 ppm and determined that
individual tolerances on cherry at 8.0 ppm and plum, prune, dried at
2.6 ppm are necessary. For peaches, fresh plums and cherries (the
representative commodities for fruit, stone, group 12) the tolerance
spreadsheet recommends tolerances of 1.8 ppm, 1.9 ppm, and 8.0 ppm,
respectively. For plum, prune, dried, the tolerance spreadsheet
recommends a tolerance of 2.6 ppm. Therefore, tolerances of novaluron
in or on fruit, stone, group 12, except cherry at 1.9 ppm; cherry at
8.0 ppm; and plum, prune, dried at 2.6 ppm are appropriate. EPA has
also revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of novaluron not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron, N-
[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide,
in or on bushberry subgroup 13-07B at 7.0 ppm; Brassica, leafy greens,
subgroup 5B at 25 ppm; turnip, greens at 25 ppm; fruit, stone, group
12, except cherry at 1.9 ppm; cherry at 8.0 ppm; plum, prune, dried at
2.6 ppm; and egg at 0.07 ppm. EPA also revised the commodity definition
for vegetables, tuberous and corn, subgroup 1C to vegetable, tuberous
and corm, subgroup 1C to reflect the correct commodity definition.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 13, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.598 is amended by:
    i. Revising the introductory text in paragraph (a);
    ii. Revising the existing entries for ``Egg'' and ``Vegetables,
tuberous and corn, subgroup 1C'' in the table in paragraph (a) and
alphabetically adding ``Brassica, leafy greens, subgroup 5B'';
``Bushberry subgroup 13-07B''; ``Cherry''; ``Fruit, stone, group 12,
except cherry''; ``Plum, prune, dried''; and ``Turnip, greens'' to the
table in paragraph (a); and
    iii. Revising the introductory text in paragraph (b).
    The amendments read as follows:

Sec.  180.598  Novaluron; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide novaluron, including its metabolites and degradates, in or
on the following commodities. Compliance with the tolerance levels
specified in the following table is to be determined by

measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide),
in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Brassica, leafy greens, subgroup 5B........................           25
Bushberry subgroup 13-07B..................................          7.0
                                * * * * *
Cherry.....................................................          8.0
                                * * * * *
Egg........................................................         0.07
                                * * * * *
Fruit, stone, group 12, except cherry......................          1.9
                                * * * * *
Plum, prune, dried.........................................          2.6
                                * * * * *
Turnip, greens.............................................           25
Vegetable, tuberous and corm, subgroup 1C..................         0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide novaluron, including its
metabolites and degradates, in connection with use of the pesticide
under section 18 emergency exemptions granted by EPA. Compliance with
the tolerance levels specified in the following table is to be
determined by measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-
trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-
difluorobenzamide). These tolerances will expire and are revoked on the
dates specified in the following table:
* * * * *

[FR Doc. E9-29212 Filed 12-8-09; 8:45 am]

BILLING CODE 6560-50-S


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life, if not prolonged my life. I am disabled w/ heart & lung disease from smoking analog cigarettes and Vaping has increased my health dramatically!  I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Notices]
[Page 17735-17737]
[DOCID:fr07ap10-55]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0723; FRL-8819-1]

Methidathion; Notice of Receipt of Requests to Voluntarily Cancel
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY:  In accordance with section 6(f)(1) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is
issuing a notice of receipt of requests by the registrants to
voluntarily cancel their methidathion registrations. The requests would
terminate the last methidathion products registered for use in the
United States. EPA intends to grant these requests at the close of the
comment period for this announcement unless the Agency receives
substantive comments within the comment period that would merit its
further review of the requests, or unless the registrants withdraw
their requests within this period. Upon acceptance of these requests,
any sale, distribution, or use of products listed in this notice will
be permitted only if such sale, distribution, or use is consistent with
the terms as described in the final order.

DATES:  Comments must be received on or before May 7, 2010.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0723, 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>.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0723. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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, any form of
encryption, and be free of any defects or viruses.
     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., 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 either 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 hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Jose Gayoso, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. 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. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.

    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel Registrations

     This notice announces receipt by EPA of requests from registrants
to cancel methidathion product registrations. Methidathion is a non-
systemic, organophosphate (OP) used as an insecticide/acaricide on a
wide variety of terrestrial food and feed crops and terrestrial non-
food crops. The pesticide acts through inhibition of
acetylcholinesterase and is used to kill a broad range of insects and
mites. In letters received by the Agency, the registrants have
requested EPA to cancel affected product registrations identified in
this notice in Table 1. Specifically, the registrants have requested
voluntary cancellation of all products containing methidathion. The
registrants requests will terminate the last methidathion products
registered in the United States.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel methidathion product registrations. The affected products and
the registrants making the requests are identified in Tables 1 and 2 of
this unit.
    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that their pesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA
requires that before acting on a request for voluntary cancellation,
EPA must provide a 30-day public comment period on the request for
voluntary cancellation or use termination. In addition, section
6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period
on a request for voluntary cancellation or termination of any minor
agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
    The methidathion registrants have requested that EPA waive the 180-
day comment period. EPA will provide a 30-day comment period on the
proposed requests.
    Unless a request is withdrawn by the registrant within 30 days of
publication of this notice, or if the Agency determines that there are
substantive comments that warrant further review of this request, an
order will be issued canceling the affected registrations.

 Table 1.--Methidathion Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name        Chemical Name
------------------------------------------------------------------------
100-530                           Methidathion        Methidathion
                                   Technical
------------------------------------------------------------------------
10163-236                         Supracide 2E        Methidathion
                                   Insecticide
---------------------------------=====================
---------------------------------
---------------------------------=====================
------------------------------------------------------------------------
10163-CA-01-0002                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-CA-01-0009                  Supracide 25-W      Methidathion
------------------------------------------------------------------------
10163-CA-01-0011                  Supracide 25-W      Methidathion
------------------------------------------------------------------------
10163-CA-02-0002                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-CA-04-0023                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-CO-01-0003                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-FL-99-0013                  Supracide 25-W      Methidathion
------------------------------------------------------------------------
10163-ID-00-0005                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-ID-04-0007                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-KS-05-0006                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-MT-00-0008                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-NV-00-0001                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-NV-01-0001                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-OK-05-0003                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-OR-00-0010                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-OR-02-0018                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------

10163-TX-05-0003                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-UT-00-0006                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-WA-00-0006                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------
10163-WY-05-0001                  Supracide 2E        Methidathion
                                   Insecticide
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
the registrants of the products listed in Table 1 of this unit.

     Table 2.--Registrants Requesting Voluntary Cancellation and/or
                               Amendments
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
000100                                      Sygenta Crop Protection,
                                             Inc.
                                            Attn: Regulatory Affairs,
                                            PO Box 18300,
                                            Greensboro, NC 27419-8300
------------------------------------------------------------------------
010163                                      Gowan Company,
                                            PO Box 5569,
                                            Yuma, AZ 85366-5569
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

V. Procedures for Withdrawal of Request and Considerations for
Reregistration of Methidathion

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked before May 7, 2010. This
written withdrawal of the request for cancellation will apply only to
the applicable FIFRA section 6(f)(1) request listed in this notice. If
the products(s) have been subject to a previous cancellation action,
the effective date of cancellation and all other provisions of any
earlier cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action.
    In any order issued in response to these requests for cancellation
of product registrations, EPA proposes to include the following
provisions for the treatment of any existing stocks of the products
identified or referenced in Table 1 in Unit III:
     After December 31, 2012, registrants are prohibited from selling
or distributing existing stocks of products containing methidathion.
     After December 31, 2014, persons other than registrants are
prohibited from selling or distributing existing stocks of products
containing methidathion.
     After December 31, 2014, existing stocks of products containing
methidathion already in the hands of users can be used legally until
they are exhausted, provided that such use complies with the EPA-
approved label and labeling of the affected product.
     If the request for voluntary cancellation is granted, the Agency
intends to publish the cancellation order in the Federal Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 26, 2010.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-7508 Filed 4-6-10; 8:45 a.m.]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9180]
[FR Doc No: 2016-03828]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14749-000]

Energy Resources USA Inc.; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On December 22, 2015, the Energy Resources USA Inc. filed an
application for a preliminary permit under section 4(f) of the Federal
Power Act proposing to study the feasibility of the proposed Caesar
Creek Lake Dam Hydroelectric Project No. 14749-000, to be located at
the existing Caesar Creek Dam on the Caesar Creek River, near the City
of Waynesville, in Warren County, Ohio. The Caesar Creek Lake Dam is
owned by the United States government and operated by the U.S. Army
Corps of Engineers.
    The proposed project would consist of: (1) A new 12-foot by 7.5-
foot by 9-foot concrete conduit fitted with a 7-foot by 8-foot
discharge gate; (2) a new 90-foot-long, 6-foot-diameter steel penstock
fitted with a butterfly valve; (3) a new 65-foot by 45-foot reinforced
concrete powerhouse containing two 1.4-megawatt (MW) horizontal Francis
turbine-generators having a total combined generating capacity of 2.8
MW; (4) a new 200-foot-long by 60-foot-wide tailrace; (5) a new 45-
foot-long by 30-foot-wide substation; (6) a new 2-mile-long, 69-
kilovolt transmission line; and (7) appurtenant facilities. The project
would have an estimated annual generation of 8.24 gigawatt-hours.
    Applicant Contact: Mr. Ander Gonzalez, 350 Lincoln Road, 2nd Floor,
Miami, FL 33139; telephone<PHONE_NUMBER>.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. The Commission strongly encourages electronic filing.
Please file comments, motions to intervene, notices of intent, and
competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14749-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14749) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: February 18, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-03828 Filed 2-23-16; 8:45 am]
 BILLING CODE 6717-01-P


202 and 205 of UMRA.
    EPA determined that this proposed rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. Moreover, WQS, including those proposed here, apply
broadly to dischargers and are not uniquely applicable to small
governments. Thus, this proposed rule is not subject to the
requirements of section 203 of UMRA.

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, as
specified in Executive Order 13132. EPA's authority and responsibility
to promulgate Federal WQS when state standards do not meet the
requirements of the CWA is well established and has been used on
various occasions in the past. The proposed rule would not
substantially affect the relationship between EPA and the states and
territories, or the distribution of power or responsibilities between
EPA and the various levels of government. The proposed rule would not
alter Florida's considerable discretion in implementing these WQS.
Further, this proposed rule would not

preclude Florida from adopting WQS that meet the requirements of the
CWA, either before or after promulgation of the final rule, thus
eliminating the need for Federal standards. Thus, Executive Order 13132
does not apply to this proposed rule.
    Although section 6 of Executive Order 13132 does not apply to this
action, EPA had extensive communication with the State of Florida to
discuss EPA's concerns with the State's nutrient water quality criteria
and the Federal rulemaking process. In the spirit of Executive Order
13132, and consistent with EPA policy to promote communications between
EPA and state and local governments, EPA specifically solicits comment
on this proposed rule from State and local officials.

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

    Subject to the Executive Order 13175 (65 FR 67249, November 9,
2000) EPA may not issue a regulation that has tribal implications, that
imposes substantial direct compliance costs, and that is not required
by statute, unless the Federal government provides the funds necessary
to pay the direct compliance costs incurred by tribal governments, or
EPA consults with tribal officials early in the process of developing
the proposed regulation and develops a tribal summary impact statement.
EPA has concluded that this action may have tribal implications.
However, the rule will neither impose substantial direct compliance
costs on tribal governments, nor preempt Tribal law.
    In the State of Florida, there are two Indian tribes, the Seminole
Tribe of Florida and the Miccosukee Tribe of Indians of Florida, with
lakes and flowing waters. Both tribes have been approved for treatment
in the same manner as a state (TAS) status for CWA sections 303 and 401
and have federally-approved WQS in their respective jurisdictions.
These tribes are not subject to this proposed rule. However, this rule
may impact the tribes because the numeric nutrient criteria for Florida
will apply to waters adjacent to the tribal waters.
    EPA has contacted the tribes to inform them of the potential future
impact this proposal could have on tribal waters. A meeting with tribal
officials has been requested to discuss the draft proposed rule and
potential impacts on the tribes. EPA specifically solicits additional
comment on this proposed rule from tribal officials.

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

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children.

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

    This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)), because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy.

I. National Technology Transfer Advancement Act of 1995

    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) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

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

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule does not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it would afford a
greater level of protection to both human health and the environment if
these numeric nutrient criteria are promulgated for Class I and Class
III waters in the State of Florida.

List of Subjects in 40 CFR Part 131

    Environmental protection, water quality standards, nutrients,
Florida.

    Dated: January 14, 2010.
Lisa P. Jackson,
Administrator.
    For the reasons set out in the preamble, EPA proposes to amend 40
CFR part 131 as follows:

PART 131--WATER QUALITY STANDARDS

    1. The authority citation for part 131 continues to read as
follows:

    Authority:  33 U.S.C. 1251 et seq.

Subpart D--[Amended]

    2. Section 131.43 is added as follows:

Sec.  131.43  Florida.

    (a) Scope. This section promulgates numeric nutrient criteria for
lakes, streams, springs, canals, estuaries, and coastal waters in the
State of Florida. This section also contains provisions for site-
specific criteria.
    (b) Definitions--
    (1) Canal means a trench, the bottom of which is normally covered
by water with the upper edges of its two sides normally above water,
excluding all secondary and tertiary canals, classified as Class IV
waters, wholly within Florida's agricultural areas.
    (2) Clear stream means a free-flowing water whose color is less
than 40 platinum cobalt units (PCU).
    (3) Lake means a freshwater water body that is not a stream or
other watercourse with some open contiguous water free from emergent
vegetation.
    (4) Lakes and flowing waters means inland surface waters that have
been classified as Class I (Potable Water Supplies) or Class III
(Recreation, Propagation and Maintenance of a Healthy, Well-Balanced
Population of Fish and Wildlife) water bodies pursuant to Rule 62-
302.400, F.A.C., excluding wetlands, and are predominantly fresh
waters.
    (5) Nutrient watershed region means an area of the State,
corresponding to coastal/estuarine drainage basin and differing
geographical conditions

affecting nutrient levels, as delineated in the Technical Support
Document for EPA's Proposed Rule for Numeric Nutrient Criteria for
Florida's Inland Surface Fresh Waters.
    (6) Predominantly fresh waters means surface waters in which the
chloride concentration at the surface is less than 1,500 milligrams per
liter.
    (7) Spring means the point where underground water emerges onto the
Earth's surface, including its spring run.
    (8) Spring run means a free-flowing water that originates from a
spring or spring group whose primary (>50%) source of water is from a
spring or spring group.
    (9) State shall mean the State of Florida, whose transactions with
the U.S. EPA in matters related to this regulation are administered by
the Secretary, or officials delegated such responsibility, of the
Florida Department of Environmental Protection (FDEP), or successor
agencies.
    (10) Stream means a free-flowing, predominantly fresh surface water
in a defined channel, and includes rivers, creeks, branches, canals
(outside south Florida), freshwater sloughs, and other similar water
bodies.
    (11) Surface water means water upon the surface of the earth,
whether contained in bounds created naturally or artificially or
diffused. Water from natural springs shall be classified as surface
water when it exits from the spring onto the Earth's surface.
(c) Criteria for Florida waters--
    (1) Criteria for lakes. The applicable criterion for chlorophyll a,
total nitrogen (TN), and total phosphorus (TP) for lakes within each
respective lake class is shown on the following table:

----------------------------------------------------------------------------------------------------------------
                                                       Baseline criteria \b\        Modified criteria  (within
Long-term average lake color and   Chlorophyll a --------------------------------        these bounds) \c\
           alkalinity              \f\ ([mu]g/L)                                 -------------------------------
                                        \a\        TP (mg/L) \a\   TN (mg/L) \a\   TP (mg/L) \a\   TN (mg/L) \a\
----------------------------------------------------------------------------------------------------------------
A                                              B               C               D               E               F
----------------------------------------------------------------------------------------------------------------
Colored Lakes > 40 PCU..........              20           0.050            1.23     0.050-0.157       1.23-2.25
Clear Lakes, Alkaline <= 40 PCU               20           0.030            1.00     0.030-0.087       1.00-1.81
 \d\ and > 50 mg/L CaCO3 \e\....
Clear Lakes, Acidic <= 40 PCU                  6           0.010           0.500     0.010-0.030     0.500-0.900
 \d\ and <= 50 mg/L CaCO3 \e\...
----------------------------------------------------------------------------------------------------------------
\a\ Concentration values are based on annual geometric mean not to be surpassed more than once in a three-year
  period. In addition, the long-term average of annual geometric mean values shall not surpass the listed
  concentration values. (Duration = annual; Frequency = not to be surpassed more than once in a three-year
  period or as a long-term average).
\b\ Baseline criteria apply unless data are readily available to calculate and apply lake-specific, modified
  criteria as described below in footnote c and the Florida Department of Environmental Protection issues a
  determination that a lake-specific modified criterion is the applicable criterion for an individual lake. Any
  such determination must be made consistent with the provisions in footnote c below. Such determination must
  also be documented in an easily accessible and publicly available location, such as an official State Web
  site.
\c\ If chlorophyll a is below the criterion in column B and there are representative data to calculate ambient-
  based, lake-specific, modified TP and TN criteria, then FDEP may calculate such criteria within these bounds
  from ambient measurements to determine lake-specific, modified criteria pursuant to CWA section 303(c).
  Modified TN and TP criteria must be based on at least three years of ambient monitoring data with (a) at least
  four measurements per year and (b) at least one measurement between May and September and one measurement
  between October and April each year. These same data requirements apply to chlorophyll a when determining
  whether the chlorophyll a criterion is met for purposes of developing modified TN and TP criteria. If the
  calculated TN and/or TP value is below the lower value, then the lower value is the lake-specific, modified
  criterion. If the calculated TN and TP value is above the upper value, then the upper value is the lake-
  specific, modified criterion. Modified TP and TN criteria may not exceed criteria applicable to streams to
  which a lake discharges. If chlorophyll a is below the criterion in column B and representative data to
  calculate modified TN and TP criteria are not available, then the baseline TN and TP criteria apply. Once
  established, modified criteria are in place as the applicable WQS for all CWA purposes.
\d\ Platinum Cobalt Units (PCU) assessed as true color free from turbidity. Long-term average color based on a
  rolling average of up to seven years using all available lake color data.
\e\ If alkalinity data are unavailable, a specific conductance of 250 micromhos/cm may be substituted.
\f\ Chlorophyll a is defined as corrected chlorophyll, or the concentration of chlorophyll a remaining after the
  chlorophyll degradation product, phaeophytin a, has been subtracted from the uncorrected chlorophyll a
  measurement.

    (2) Criteria for streams.
    (i) The applicable instream protection value (IPV) criterion for
total nitrogen (TN) and total phosphorus (TP) for streams within each
respective nutrient watershed region is shown in the following table:

------------------------------------------------------------------------
                                             Instream protection value
                                                     criteria
        Nutrient watershed region        -------------------------------
                                           TN (mg/L) \a\   TP (mg/L) \a\
------------------------------------------------------------------------
Panhandle \b\...........................           0.824           0.043
Bone Valley \c\.........................           1.798           0.739
Peninsula \d\...........................           1.205           0.107
North Central \e\.......................           1.479           0.359
------------------------------------------------------------------------
\a\ Concentration values are based on annual geometric mean not to be
  surpassed more than once in a three-year period. In addition, the long-
  term average of annual geometric mean values shall not surpass the
  listed concentration values. (Duration = annual; Frequency = not to be
  exceeded more than once in a three-year period or as a long-term
  average).
\b\ Panhandle region includes the following watersheds: Perdido Bay
  Watershed, Pensacola Bay Watershed, Choctawhatchee Bay Watershed, St.
  Andrew Bay Watershed, Apalachicola Bay Watershed, Apalachee Bay
  Watershed, and Econfina/Steinhatchee Coastal Drainage Area.
\c\ Bone Valley region includes the following watersheds: Tampa Bay
  Watershed, Sarasota Bay Watershed, and Charlotte Harbor Watershed.
\d\ Peninsula region includes the following watersheds: Waccasassa
  Coastal Drainage Area, Withlacoochee Coastal Drainage Area, Crystal/
  Pithlachascotee Coastal Drainage Area, Indian River Watershed,
  Caloosahatchee River Watershed, St. Lucie Watershed, Kissimmee River
  Watershed, St. John's River Watershed, Daytona/St. Augustine Coastal
  Drainage Area, Nassau Coastal Drainage Area, and St. Mary's River
  Watershed.
\e\ North Central region includes the Suwannee River Watershed.

    (ii) Criteria for protection of downstream lakes.
    (A) The applicable total phosphorus criterion-magnitude for a
stream that flows into downstream lakes is the more stringent of the
value from the preceding table in paragraph (c)(2)(i) of this section
or a downstream lake protection value derived from the following
equation to protect the downstream lake:
[GRAPHIC] [TIFF OMITTED] TP26JA10.003

where:

[TP]S is the total phosphorus (TP) downstream lake
protection value, mg/L
[TP]L is applicable TP lake criterion, mg/L
cf is the fraction of inflow due to all streamflow, 0 <=
cf <= 1
[tau]w is lake's hydraulic retention time (water volume
divided by annual flow rate)

The term
[GRAPHIC] [TIFF OMITTED] TP26JA10.006

expresses the net phosphorus loss from the water column (e.g., via
settling of sediment-sorbed phosphorus) as a function of the lake's
retention time.

    (B) The preset values for cf and [tau]w,
respectively, are 0.5 and 0.2. The State may substitute site-specific
values for these preset values where the State determines that they are
appropriate and documents the site-specific values in an easily
accessible and publicly available location, such as an official State
Web site.
    (iii) Criteria for protection of downstream estuarine waters.
    (A) The applicable criteria for a stream that flows into downstream
estuary is the more stringent of the values from the preceding table in
paragraph (c)(2)(i) of this section or downstream protection values
derived from the following equation to protect the downstream estuary.
EPA's preset DPVs are listed in the Technical Support Document (TSD)
for Florida's Inland Waters located at www.regulations.gov, Docket ID
No. EPA-HQ-OW-2009-0569, and calculated for each stream reach as the
average reach-specific concentration (Ci) equal to the average reach-
specific annual loading rate (Li) divided by the average
reach-specific flow (Qi) where:
[GRAPHIC] [TIFF OMITTED] TP26JA10.004

and where the terms are defined as follows for a specific or
(ith) stream reach:

Ci maximum flow-averaged nutrient concentration for a specific (the
ith) stream reach consistent with downstream use
protection (i.e., the DPV)
k fraction of all loading to the estuary that comes from the stream
network resolved by SPARROW
Lest protective loading rate for the estuary, from all sources
Qw combined average freshwater discharged into the estuary from the
portion of the watershed resolved by the SPARROW stream network
Fi fraction of the flux at the downstream node of the specific
(ith) reach that is transported through the stream
network and ultimately delivered to estuarine eceiving waters (i.e.
Fraction Delivered).
DPVs may not exceed other criteria established for designated use
protection in this section, nor result in an exceedance of other
criteria for other water quality parameters established pursuant to
Rule 62-302, F.A.C.

    (B) The State may calculate alternative DPVs as above for Ci except
that Li is determined as a series of values for each reach in the
upstream drainage area such that the sum of reach-specific incremental
loading rates equals the target loading rate to the downstream water
protective of downstream uses, taking into account that downstream
reaches must reflect loads established for upstream reaches.
Alternative DPVs may factor in additional nutrient attenuation provided
by already existing landscape modifications or treatment systems, such
as constructed wetlands or stormwater treatment areas. For alternative
DPVs to become effective for Clean Water Act purposes, the State must
provide public notice and opportunity for comment.
    (C) To use an alternative technical approach of comparable
scientific rigor to quantitatively determine the protective load to the
estuary and associated protective stream concentrations, the State must
go through the process for a Federal site-specific alternative
criterion pursuant to paragraph (e) of this section.
    (3) Criteria for springs, spring runs, and clear streams. The
applicable nitrate-nitrite criterion is 0.35 mg/L as an annual
geometric mean not to be surpassed more than once in a three year
period, nor surpassed as a long-term average of annual geometric mean
values. In addition to this nitrate-nitrite criterion, criteria
identified in paragraph (c)(2) of this section are applicable to clear
streams.
    (4) Criteria for south Florida canals. The applicable criterion for
chlorophyll a, total nitrogen (TN), and total phosphorus (TP) for
canals within each respective canal geographic classification area is
shown on the following table:

----------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                                   Chlorophyll a    phosphorus    Total nitrogen
                                                                   ([mu]g/L) \a\    (TP) (mg/L)     (TN) (mg/L)
                                                                                \a\ \b\           \a\
----------------------------------------------------------------------------------------------------------------
Canals..........................................................             4.0           0.042             1.6
----------------------------------------------------------------------------------------------------------------
\a\ Concentration values are based on annual geometric mean not to be surpassed more than once in a three-year
  period. In addition, the long-term average of annual geometric mean values shall not surpass the listed
  concentration values. (Duration = annual; Frequency = not to be surpassed more than once in a three-year
  period or as a long-term average).
\b\ Applies to all canals within the Florida Department of Environmental Protection's South Florida bioregion,
  with the exception of canals within the Everglades Protection Area (EvPA) where the TP criterion of 0.010 mg/L
  currently applies.

    (5) Criteria for estuaries. [Reserved]
    (6) Criteria for coastal waters. [Reserved]
    (d) Applicability.
    (1) The criteria in paragraphs (c)(1) through (4) of this section
apply to surface waters of the State of Florida designated as Class I
(Potable Water Supplies) or Class III (Recreation, Propagation and
Maintenance of a Healthy, Well-Balanced Population of Fish and
Wildlife) water bodies pursuant to Rule 62-302.400, F.A.C., excluding
wetlands, and apply concurrently with other applicable water quality
criteria, except when:
    (i) State regulations contain criteria which are more stringent for
a particular parameter and use;
    (ii) The Regional Administrator determines that site-specific
alternative criteria apply pursuant to the procedures in paragraph (e)
of this section;
    (iii) The State adopts and EPA approves a water quality standards
variance to the Class I or Class III designated use pursuant to Sec.
131.13 that meets the applicable provisions of State law and the
applicable Federal regulations at Sec.  131.10; or

    (iv) The State adopts and EPA approves restoration standards
pursuant to paragraph (g) of this section.
    (2) The criteria established in this section are subject to the
State's general rules of applicability in the same way and to the same
extent as are the other federally-adopted and State-adopted numeric
criteria when applied to the same use classifications.
    (i) For all waters with mixing zone regulations or implementation
procedures, the criteria apply at the appropriate locations within or
at the boundary of the mixing zones; otherwise the criteria apply
throughout the water body including at the point of discharge into the
water body.
    (ii) The State shall use an appropriate design flow condition,
where necessary, for purposes of permit limit derivation or load and
wasteload allocations that is consistent with the criteria duration and
frequency established in this section (e.g., average annual flow for a
criterion magnitude expressed as an average annual geometric mean
value).
    (iii) The criteria established in this section apply for purposes
of determining the list of impaired waters pursuant to section 303(d)
of the Clean Water Act, subject to the procedures adopted pursuant to
Rule 62-303, F.A.C., where such procedures are consistent with the
level of protection provided by the criteria established in this
section.
    (e) Site-specific alternative criteria.
    (1) Upon request from the State, the Regional Administrator may
determine that site-specific alternative criteria shall apply to
specific surface waters in lieu of the criteria established in
paragraph (c) of this section. Any such determination shall be made
consistent with Sec.  131.11.
    (2) To receive consideration from the Regional Administrator for a
determination of site-specific alternative criteria, the State must
submit a request that includes proposed alternative numeric criteria
and supporting rationale suitable to meet the needs for a technical
support document pursuant to paragraph (e)(3) of this section.
    (3) For any determination made under paragraph (e)(1) of this
section, the Regional Administrator shall, prior to making such a
determination, provide for public notice and comment on a proposed
determination. For any such proposed determination, the Regional
Administrator shall prepare and make available to the public a
technical support document addressing the specific surface waters
affected and the justification for each proposed determination. This
document shall be made available to the public no later than the date
of public notice issuance.
    (4) The Regional Administrator shall maintain and make available to
the public an updated list of determinations made pursuant to paragraph
(e)(1) of this section as well as the technical support documents for
each determination.
    (5) Nothing in this paragraph (e) shall limit the Administrator's
authority to modify the criteria in paragraph (c) of this section
through rulemaking.
    (f) Effective date. All criteria will be in effect [date 60 days
after publication of final rule].
    (g) Restoration Water Quality Standards (WQS). The State may, at
its discretion, adopt restoration WQS to allow attainment of a
designated use over phased time periods where the designated use is not
currently attainable as a result of nutrient pollution but is
attainable in the future. In establishing restoration WQS, the State
must:
    (1) Demonstrate that the designated use is not attainable during
the time periods established for the restoration phases based on one of
the factors identified in Sec.  131.10(g)(1) through (6);
    (2) Specify the designated use to be attained at the termination of
the restoration period, as well as the criteria necessary to protect
such use, provided that the final designated use and corresponding
criteria shall include, at a minimum, uses and criteria that are
consistent with CWA section 101(a)(2) ;
    (3) Establish interim restoration designated uses and water quality
criteria, that apply during each phase that will result in maximum
feasible progress toward the highest attainable designated use and the
use identified in paragraph (g)(2) of this section. Such interim uses
and criteria may not provide for further degradation of a water body
and may be revised prior to the end of each phase in accordance with
Sec. Sec.  131.10 and 131.20 and submitted to EPA for approval;
    (4) Establish the time periods for each restoration phase that will
result in maximum feasible progress toward the highest attainable use
and the designated use identified in paragraph (g)(2) of this section,
except that the sum of such time periods shall not exceed twenty years
from the initial date of establishment of the restoration WQS under
this section;
    (5) Specify the spatial extent of applicability for all affected
waters;
    (6) Meet the requirements of Sec. Sec.  131.10 and 131.20; and
    (7) Include, in its State water quality standards, a specific
provision that if the interim restoration designated uses and criteria
established under paragraph (g)(3) of this section are not met during
any phased time period established under paragraph (g)(4) of this
section, the restoration WQS will no longer be applicable and the
designated use and criteria identified in paragraph (g)(2) of this
section will become applicable immediately.
    (8) Provide that waters for which a restoration water quality
standard is adopted will be recognized as impaired for the purposes of
listing impaired waters under section 303(d) of the CWA until the use
designated identified in paragraph (g)(2) of this section is attained.

[FR Doc. 2010-1220 Filed 1-25-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83078-83079]
[FR Doc No: 2020-28115]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-10018-24-OAR]

Allocations of Cross-State Air Pollution Rule Allowances From New
Unit Set-Asides for 2020 Control Periods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of data availability (NODA).

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

SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of the availability of preliminary lists of units eligible for second-
round allocations of emission allowances for the 2020 control periods
from the new unit set-asides (NUSAs) established under the Cross-State
Air Pollution Rule (CSAPR) trading programs. EPA has posted
spreadsheets containing the lists on EPA's website. EPA will consider
timely objections to the lists before determining the amounts of the
second-round allocations.

DATES: Objections to the information referenced in this notice must be
received on or before January 21, 2021.

ADDRESSES: Submit your objections via email to<EMAIL_ADDRESS>
Include ``2020 NUSA allocations'' in the email subject line and include
your name, title, affiliation, address, phone number, and email address
in the body of the email.

FOR FURTHER INFORMATION CONTACT: Questions concerning this action
should be addressed to Jason Kuhns at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or Andrew Reighart at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under each CSAPR trading program where EPA
is responsible for determining

emission allowance allocations, a portion of each state's emissions
budget for the program for each control period is reserved in a NUSA
(and in an additional Indian country NUSA in the case of states with
Indian country within their borders) for allocation to certain units
that would not otherwise receive allowance allocations. The procedures
for identifying the eligible units for each control period and for
allocating allowances from the NUSAs and Indian country NUSAs to these
units are set forth in the CSAPR trading program regulations at 40 CFR
97.411(b) and 97.412 (NOX Annual), 97.511(b) and 97.512
(NOX Ozone Season Group 1), 97.611(b) and 97.612
(SO2 Group 1), 97.711(b) and 97.712 (SO2 Group
2), and 97.811(b) and 97.812 (NOX Ozone Season Group 2).
Each NUSA allowance allocation process involves up to two rounds of
allocations to eligible units, termed ``new'' units, followed by the
allocation to ``existing'' units of any allowances not allocated to new
units.
    This notice concerns EPA's preliminary identification of units
eligible to receive allowances in the second round of NUSA allocations
for the 2020 control periods. The units eligible for second-round
allocations for a given control period are CSAPR-affected units that
commenced commercial operation between January 1 of the year before
that control period and November 30 of the year of that control period.
In the case of the 2020 control periods, an eligible unit therefore
must have commenced commercial operation between January 1, 2019 and
November 30, 2020 (inclusive). Generally, where a unit is eligible to
receive a second-round NUSA allocation under a given CSAPR trading
program for a given control period, the unit's maximum potential
second-round allocation equals the positive difference (if any) between
the unit's emissions during the control period as reported under 40 CFR
part 75 and any first-round NUSA allocation the unit received. If the
total of such maximum potential allocations to all eligible units would
exceed the total allowances remaining in the NUSA, the allocations are
reduced on a pro-rata basis. EPA notes that under 40 CFR 97.406(c)(3),
97.506(c)(3), 97.606(c)(3), 97.706(c)(3), and 97.806(c)(3), a unit's
emissions occurring before its monitor certification deadline are not
considered to have occurred during a control period and consequently
are not included in the emission amounts used to determine NUSA
allocations.
    The preliminary lists of eligible units are set forth in Excel
spreadsheets titled
``CSAPR_NUSA_2020_NOx_Annual_2nd_Round_Prelim_Data,''
``CSAPR_NUSA_2020_NOx_Ozone_Season_2nd_Round_Prelim_Data,''
and ``CSAPR_NUSA_2020_SO2_2nd_Round_Prelim_Data'' available
on EPA's website at https://www.epa.gov/csapr/csapr-compliance-year-2020-nusa-nodas. Each spreadsheet contains a separate worksheet for
each state covered by that program showing each unit preliminarily
identified as eligible for a second-round NUSA allocation. Each state
worksheet also contains a summary showing (1) the quantity of
allowances initially available in that state's 2020 NUSA, (2) the sum
of the 2020 NUSA allowance allocations that were made in the first
round to new units in that state, if any, and (3) the quantity of
allowances in the 2020 NUSA available for second-round allocations to
new units (or ultimately for allocations to existing units), if any.
    Objections should be strictly limited to whether EPA has correctly
identified the units eligible for second-round 2020 NUSA allocations
according to the criteria established in the regulations and should be
emailed to the address identified in ADDRESSES. Objections must
include: (1) Precise identification of the specific data the commenter
believes are inaccurate, (2) new proposed data upon which the commenter
believes EPA should rely instead, and (3) the reasons why EPA should
rely on the commenter's proposed data and not the data referenced in
this notice.
    EPA notes that an allocation or lack of allocation of allowances to
a given unit does not constitute a determination that CSAPR does or
does not apply to the unit. EPA also notes that under 40 CFR 97.411(c),
97.511(c), 97.611(c), 97.711(c), and 97.811(c), allocations are subject
to potential correction if a unit to which NUSA allowances have been
allocated for a given control period is not actually an affected unit
as of the start of that control period.

(Authority: 40 CFR 97.411(b), 97.511(b), 97.611(b), 97.711(b), and
97.811(b).)

    Dated: December 2, 2020.
Reid P. Harvey,
Director, Clean Air Markets Division, Office of Atmospheric Programs,
Office of Air and Radiation.
[FR Doc. 2020-28115 Filed 12-18-20; 8:45 am]
BILLING CODE 6560-50-P