[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Rules and Regulations]
[Pages 12207-12213]
[FR Doc No: 2012-4478]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0717; FRL-9334-2]

Pyroxasulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyroxasulfone, including its metabolites and degradates, in or on field
corn, pop corn, and sweet corn commodities. K-I Chemical U.S.A., Inc.,
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective February 29, 2012. Objections and
requests for hearings must be received on or before April 30, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0717. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER> email 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under the FFDCA section 408(g), 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0717 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 30, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0717, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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. Summary of Petitioned-For Tolerance

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9F7560)
by K-I Chemical U.S.A., Inc., c/o Landis International, Inc., P.O. Box
5126, Valdosta, GA 31603-5126. The petition requested that 40 CFR part
180 be amended by adding a section for the herbicide pyroxasulfone and
establishing tolerances therein for residues of pyroxasulfone, 3-[[[5-
(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-
yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and its
metabolites M-1, 5-difluoromethoxy-1-methyl-3-trifluoromethyl-1H-
pyrazol-4-ylmethanesulfonic acid; M-3, 5-difluoromethoxy-1-methyl-3-
trifluoromethyl-1H-pyrazol-4-carboxylic-acid; and M-25, (5-
difluoromethoxy-3-trifluoromethyl-1H-pyrazol-4-yl)methanesulfonic acid
in or on field corn kernel at 0.01 parts per million (ppm); field corn
forage at 0.15 ppm; field corn stover at 0.15 ppm; field corn meal at
0.01 ppm; field corn grits at 0.01 ppm; field corn flour at 0.01 ppm;
field corn starch at 0.01 ppm; field corn oil (wet and dry milled) at
0.01 ppm; sweet corn ears at 0.02 ppm; sweet corn forage at 0.15 ppm;
sweet corn stover at 0.15 ppm; wheat grain at 0.02 ppm; wheat forage at
0.2 ppm; wheat straw at 0.2 ppm; soybean seed at 0.05 ppm; soybean
forage at 1.0 ppm; soybean hay at 2.0 ppm; soybean meal at 0.05 ppm;
soybean hulls at 0.02 ppm; and soybean refined oils at 0.01 ppm. That
notice referenced a summary of the petition prepared by K-I Chemical
U.S.A., Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance expression, commodity terms, and tolerance levels
for corn commodities. The Agency has also determined that the submitted
data are not adequate to support tolerances on soybean or wheat
commodities and is, therefore, not establishing tolerances on these
commodities at this time. 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 pyroxasulfone, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyroxasulfone
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.
    Pyroxasulfone acute toxicity to mammals is low by all routes of
exposure. Subchronic and chronic oral toxicity testing of pyroxasulfone
in mice, rats, and dogs produced a variety of adverse effects in
several target organs. Effects seen in animal studies included cardiac
toxicity (increased cardiomyopathy in mice and rats), liver toxicity
(centrilobular hepatocellular hypertrophy, histopathological, and/or
clinical pathological indicators), neurotoxicity characterized by
axonal/myelin degeneration in the sciatic nerve (dog, mouse, and rat)
and spinal cord sections (dog), skeletal muscle

myopathy, kidney toxicity (increased incidence of chronic progressive
nephropathy in dogs and retrograde nephropathy in mice), urinary
bladder mucosal hyperplasia, inflammation, and urinary bladder
transitional cell papillomas (rats). Decreased body weight and enzyme
changes were noted in some studies. Immunotoxicity studies in rats and
mice showed no evidence of immunotoxic effects from pyroxasulfone.
    Pyroxasulfone was moderately toxic to rats following a 4-week
dermal exposure producing local inflammation and systemic effects of
minimal to mild cardiac myofiber degeneration at the limit dose. No
adverse effects were noted in a 28-day inhalation study at the highest-
dose tested.
    Pyroxasulfone did not exhibit developmental toxicity in the rat
developmental toxicity study and exhibited only slight developmental
toxicity in rabbits (reduced fetal weight and resorptions) at the limit
dose. However, developmental effects were noted in post-natal day (PND)
21 offspring in the rat developmental neurotoxicity (DNT) study
characterized as decreased brain weight and morphometric changes.
Developmental effects in the rabbit developmental study and DNT study
occurred in the absence of maternal toxicity, indicating potential
increased quantitative susceptibility of offspring. In a reproductive
toxicity in rats reduced pup weight and body weight gains during
lactation occurred at similar or higher doses causing pronounced
maternal toxicity (reduced body weight, body weight gain, and food
consumption and increased kidney weight, cardiomyopathy, and urinary
bladder mucosal hyperplasia with inflammation).
    In cancer studies in mice and rats, renal tubular adenomas were
observed in male mice and urinary bladder transitional cell papillomas
were observed in male rats. The kidney adenomas in male mice were
determined to be spontaneous and not treatment-related based on the
following considerations:
    1. Absence of any cytotoxicity (degeneration or individual cell
necrosis) in studies ranging from 14 days to 18 months at doses up to
15,000 ppm.
    2. Absence of cell regeneration leading to precursor lesions such
as atypical tubular hyperplasia at all time points and doses up to
15,000 ppm.
    3. Lack of exacerbation of chronic progressive nephropathy, a
spontaneous disease in rodents that results in cell regeneration which
can result in renal tubule tumors in chronic studies.
    4. Lack of a clear dose response in the distribution of tumors
between test substance treated groups.

The urinary bladder tumors seen in male rats were determined to be a
threshold effect. Pyroxasulfone exposure causes the growth of crystals
in the urinary tract with subsequent calculi formation resulting in
cellular damage. Crystal formation in the absence of calculi is not
associated with hyperplasia or urinary bladder tumors; therefore, the
formation of urinary bladder calculi is the prerequisite for subsequent
hyperplasia and neoplasia. In other words, urinary bladder tumors do
not develop at doses too low to produce calculi. There is also a clear
threshold of 1,000 ppm (42.55 milligrams/kilogram/day (mg/kg/day)) for
development of calculi and tumorigenesis. The point of departure (POD)
of 50 ppm (2.0 mg/kg/day) selected for chronic risk assessment is not
expected to result in urinary bladder calculi formation, which is a
prerequisite for subsequent hyperplasia and neoplasia. Therefore, the
Agency has determined that the quantification of risk using a non-
linear approach (i.e., Reference dose (RfD)) will adequately account
for all chronic toxicity, including carcinogenicity, that could result
from exposure to pyroxasulfone. There is no concern for mutagenicity.
    Specific information on the studies received and the nature of the
adverse effects caused by pyroxasulfone 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 ``Pyroxasulfone Human Health Risk
Assessment for Use of New Active Ingredient Pyroxasulfone on Corn,'' p.
34, in docket ID number EPA-HQ-OPP-2009-0717.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological POD and levels of concern to use in evaluating
the risk posed by human exposure to the pesticide. For hazards that
have a threshold below which there is no appreciable risk, the
toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a RfD--and a safe margin of exposure (MOE). For
non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyroxasulfone used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Pyroxasulfone for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk         Study and
                                               factors                 assessment         toxicological effects
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Acute dietary (General population      NOAEL = 100 mg/kg/day..  Acute RfD = 1 mg/kg/day  Developmental
 including infants and children and    UFA = 10x..............  aPAD = 1 mg/kg/day.....   neurotoxicity in rats
 females 13-50 years of age).          UFH = 10x..............                           LOAEL = 300 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                brain weight in both
                                                                                sexes, reduced
                                                                                thickness of the
                                                                                hippocampus, corpus
                                                                                callosum, and
                                                                                cerebellum in PND 21
                                                                                female offspring.

Chronic dietary (All populations)....  NOAEL= 2 mg/kg/day.....  Chronic RfD = 0.02 mg/   1 year chronic dog
                                       UFA = 10x..............   kg/day.                  study LOAEL = 10 mg/kg/
                                       UFH = 10x..............  cPAD = 0.02 mg/kg/day..   day based on impaired
                                       FQPA SF = 1x...........                            hind limb function,
                                                                                ataxia, hind limb
                                                                                twitching and tremors;
                                                                                clinical pathology:
                                                                                Increased creatine
                                                                                kinase, aspartate
                                                                                aminotransferase;
                                                                                axonal/myelin
                                                                                degeneration of the
                                                                                sciatic nerve and
                                                                                spinal cord sections.
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Cancer (Oral, dermal, inhalation)....  ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause
                                        crystals with subsequent calculi formation resulting in cellular damage
                                        of the urinary tract. Risk is quantified using a non-linear (i.e., RfD)
                                        approach.
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DNT = neurotoxicity study, FQPA SF = Food Quality Protection Act Safety Factor.
LOAEL = lowest-observed-adverse-effect-level. LOC = Levels of Concern.
mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level.
PAD = population adjusted dose (a = acute, c = chronic). PND = post-natal day.
RfD = reference dose. UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyroxasulfone, EPA considered exposure under the
petitioned-for tolerances on corn commodities only. EPA is not
establishing the petitioned-for tolerances on soybean and wheat
commodities and no other tolerances have previously been established
for pyroxasulfone. EPA assessed dietary exposures from pyroxasulfone 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. Such effects were identified
for pyroxasulfone. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intakes by Individuals (CSFII). As to residue levels in food, EPA
assumed that 100% of field, pop and sweet corn commodities are treated
with pyroxasulfone and that residues on these commodities are present
at tolerance levels, adjusted upward to account for metabolites of
concern (M-1, M-3, and M-25) that are not included in the tolerance
expression.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA made the same
assumptions (adjusted tolerance-level residues and 100 percent crop
treated (PCT)) as in the acute dietary exposure assessment.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to pyroxasulfone. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
pyroxasulfone. Tolerance level residues (adjusted upward to account for
additional metabolites of concern) and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyroxasulfone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyroxasulfone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
pyroxasulfone for acute exposures are estimated to be 17 parts per
billion (ppb) for surface water and 210 ppb for ground water. EDWCs of
pyroxasulfone for chronic exposures for non-cancer assessments are
estimated to be 3.2 ppb for surface water and 174 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 210 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 174 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). Pyroxasulfone 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 pyroxasulfone to share a common mechanism of
toxicity with any other substances, and pyroxasulfone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyroxasulfone 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 Web site 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 pre-natal
and post-natal toxicity and the completeness of the database on
toxicity and exposure unless EPA determines based on reliable data that
a different margin of safety will be safe for infants and children.
This additional margin of safety is commonly referred to as the Food
Quality Protection Act (FQPA) Safety Factor (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. Pre-natal and post-natal sensitivity. The pre-natal and post-
natal toxicity database for pyroxasulfone includes developmental
toxicity studies in rats and rabbits, a DNT study in rats, and a 2-
generation reproduction toxicity study in rats. As discussed in Unit
III.A, evidence of increased susceptibility of fetuses and offspring
was seen in the DNT study and developmental toxicity study in rabbits
following in utero or post-natal exposure to pyroxasulfone. No
increased susceptibility was seen in the rat developmental or
reproduction toxicity studies. In rabbits, developmental toxicity was
only seen at the limit dose of 1,000 mg/kg/day as reduced fetal weight
and increased fetal resorptions with a NOAEL of 500 mg/kg/day for these
effects, compared to no maternal toxicity at these doses. In a DNT
study in rats, offspring toxicity (decreased brain weight and
morphometric changes on PND 21) was seen at 300 mg/kg/day compared to
no maternal toxicity at 900 mg/kg/day. The degree of concern for the
increased susceptibility seen in these studies is low and there are no
residual uncertainties based on the following considerations:
    i. The increased susceptibility is occurring at high doses.
    ii. NOAELs and LOAELs have been identified for all effects of
concern, and thus a clear dose response has been well defined.
    iii. The PODs selected for risk assessment are protective of the
fetal/offspring effects.
    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 pyroxasulfone is complete.
    ii. Pyroxasulfone is a neurotoxic chemical and there is evidence of
increased susceptibility of offspring with regard to neurotoxic effects
in the rat DNT study. There is also evidence of increased
susceptibility of fetuses/offspring with regard to non-neurotoxic
effects in the rabbit developmental toxicity study. However, the
concern for the increased susceptibility is low and EPA did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors (UFs) to be used in the
risk assessment for pyroxasulfone.
    iii. There are no residual uncertainties in the exposure database.
The dietary food exposure assessments were performed based on 100 PCT
and tolerance-level residues (adjusted upward to account for additional
metabolites of concern not included in the tolerance expression), and
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to pyroxasulfone in
drinking water. These assessments will not underestimate the exposure
and risks posed by pyroxasulfone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) +and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to pyroxasulfone will occupy 4.2% of the aPAD for infants less than 1
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyroxasulfone from food and water will utilize 60% of the cPAD for
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for pyroxasulfone.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). A short-term
adverse effect was identified; however, pyroxasulfone is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
pyroxasulfone.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
pyroxasulfone is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term

risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for pyroxasulfone.
    5. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to pyroxasulfone. Therefore, based on the results of the
chronic risk assessment discussed in Unit III.E.2., pyroxasulfone is
not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure pyroxasulfone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) method) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for pyroxasulfone.

C. Revisions to Petitioned-For Tolerances

    The petitioner proposed tolerances for residues of pyroxasulfone on
corn, soybean, and wheat commodities. EPA is not establishing the
proposed tolerances on soybean and wheat commodities at this time due
to inadequate supporting data. In the case of soybeans, the residue
analyses from the field trials did not measure the major metabolite M-
28, which comprised approximately 50% of the total residue in soybean
metabolism studies. Without data on M-28, an appropriate tolerance
level for soybean cannot be determined. The submitted data for wheat
were collected from field trials conducted in Australia and, therefore,
are not considered to be geographically representative of wheat growing
areas of the United States. Additionally, EPA requires that data be
collected on wheat hay, and hay data were not collected in any of the
submitted field trials. Further, the petitioner did not conduct
processing studies with wheat, so the Agency cannot determine whether
separate tolerances are needed for the processed commodities of wheat.
The petitioner must address these deficiencies before the proposed
soybean and wheat tolerances can be established.
    The petitioner proposed tolerances for residues of pyroxasulfone
and its metabolites M-1, M-3, and M-25 on ``field corn grain,'' ``field
corn forage,'' ``field corn stover,'' ``sweet corn ears,'' ``sweet corn
forage,'' ``sweet corn stover,'' and several processed field corn
commodities (grits, meal, flour, starch, and oil). EPA has concluded
that the metabolites M-1, M-3, and M-25 should be included as residues
of concern for risk assessment purposes for all corn commodities;
however, to harmonize with its global review partners, Australia and
Canada, U.S. tolerances for corn grain commodities will be enforced by
measuring only parent pyroxasulfone and the M-3 metabolite. Tolerances
for corn forage and stover will be enforced by measuring the parent
pyroxasulfone and all three metabolites. EPA has determined that the
proposed tolerances on processed field corn commodities (grits, meal,
flour, starch, and oil) are unnecessary, since residues on these
commodities are not expected to exceed those in the raw agricultural
commodities (RACs) and thus will be covered by the RAC tolerances.
    EPA has revised the commodity terms for all field and sweet corn
commodities and is establishing tolerances on pop corn commodities,
separate from those on field corn, as follows to agree with the
Agency's Food and Feed Vocabulary: ``Corn, field, grain;'' ``Corn,
field, forage;'' ``Corn, field, stover;'' ``Corn sweet, kernel plus cob
with husks removed;'' ``Corn, sweet, forage;'' ``Corn, sweet, stover;''
``Corn, pop, grain;'' ``Corn, pop, stover.''
    Finally, EPA has revised the tolerance levels for corn grain and
forage commodities as follows based on analysis of the field trial data
using the tolerance MRL calculator in accordance with the Organization
for Economic Cooperation and Development's ``MRL Calculator User Guide
Standard Operating Procedure (SOP).'' Field (and pop) corn grain was
increased from 0.01 ppm to 0.015 ppm. Field corn forage was decreased
from 0.15 ppm to 0.06 ppm. Sweet corn grain was decreased from 0.02 ppm
to 0.015 ppm. Sweet corn forage was decreased from 0.15 ppm to 0.10
ppm.

V. Conclusion

    Therefore, tolerances are established for residues of
pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole,
including its metabolites and degradates, as set forth in the
regulatory text.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d) 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 FFDCA section 408(n)(4). 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) (Pub. L. 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: February 15, 2012.
Steven Bradbury,
 Director, Office of Pesticide Programs.

    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 180.659 is added to subpart C to read as follows:

Sec.  180.659  Pyroxasulfone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
herbicide pyroxasulfone, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and
its metabolite, 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4-carboxylic acid (M-3), calculated as the stoichiometric
equivalent of pyroxasulfone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, grain..........................................       0.015
Corn, pop, grain............................................       0.015
Corn, sweet, kernel plus cob with husks removed.............       0.015
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the herbicide
pyroxasulfone, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and
its metabolites, 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4-yl]methanesulfonic acid (M-1); 5-(difluoromethoxy)-1-methyl-
3-(trifluoromethyl)-1H-pyrazol-4-carboxylic acid (M-3); and [5-
(difluoromethoxy)-3-(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic
acid (M-25), calculated as the stoichiometric equivalent of
pyroxasulfone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.06
Corn, field, stover.........................................        0.15
Corn, pop, stover...........................................        0.15
Corn, sweet, forage.........................................        0.10
Corn, sweet, stover.........................................        0.15
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-4478 Filed 2-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Notices]
[Page 27549-27550]
[DOCID:fr16my07-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-441-000]

Kinder Morgan Interstate Gas Transmission LLC; Notice of Tariff
Filing

May 8, 2007.
    Take notice that on May 3, 2007, Kinder Morgan Interstate Gas
Transmission LLC (KMIGT) tendered for filing as part of its FERC Gas
Tariff, Fourth Revised Volume No. 1-B, the following tariff sheets, to
be effective June 3, 2007:

Fourth Revised Sheet No. 2
Second Revised Sheet No. 34
Original Sheet No. 34A
Fifth Revised Sheet No. 37
Second Revised sheet No. 37A
Original sheet no. 37B

    KMIGT states that the purpose of this filing is to permit KMIGT to
negotiate contractual right of first refusal (ROFR) and rollover
provisions under Section 18 of the General Terms and Conditions of
KMIGT's tariff on a nondiscriminatory basis, consistent with current
Commission policy.
    KMIGT further states that a copy of this filing has been served
upon all of its customers and affected state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will

not serve to make protestants parties to the proceeding. Any person
wishing to become a party must file a notice of intervention or motion
to intervene, as appropriate. Such notices, motions, or protests must
be filed in accordance with the provisions of Section 154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-9319 Filed 5-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 12, 2007 (Volume 72, Number 112)]
[Notices]
[Page 32291-32292]
[DOCID:fr12jn07-34]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2006-0750; FRL-8325-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Gasoline Distribution
Facilities (Renewal), EPA ICR Number 1659.06, OMB Control Number 2060-
0325

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before July 12, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2006-0750, to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mar[iacute]a Malav[eacute], Compliance
Assessment and Media Programs Division (Mail Code 2223A), Office of
Compliance, Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 5, 2006 (71 FR 58853), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-OECA-2006-0750, which is available for public viewing online
at http://www.regulations.gov, or in person viewing at the Enforcement

and Compliance Docket and Information Center in the EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Enforcement and Compliance Docket and
Information Center is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
 to submit or view public comments, access the index

listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``docket search,'' then key in the docket ID number identified
above. Please note that EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing at http://www.regulations.gov, as EPA receives them and without

change, unless the comment contains copyrighted material, Confidential
Business Information (CBI), or other information whose public
disclosure is restricted by statute. For further information about the
electronic docket, go to http://www.regulations.gov.

    Title: NESHAP for Gasoline Distribution Facilities (Renewal).
    ICR Numbers: EPA ICR Number 1659.06, OMB Control Number 2060-0325.
    ICR Status: This ICR is scheduled to expire on June 30, 2007. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP), for the regulations published at 40 CFR part 63,
subpart R, were promulgated on December 14, 1994 (59 FR 64318). The
standards were revised on June 26, 1995 (60 FR 32913), to correct
errors in the printing of the emission screening equation in the final
standards, and amended on February 29, 1996 (61 FR 7723), to extend the
initial compliance date for the equipment leak standard. The standards
were amended again June 12, 1996 (61 FR 29875), to clarify the coverage
of gasoline loading racks at refineries with through-puts greater than
75,700 liters/day. Updated direct final standards were promulgated on
February 28, 1997 (62 FR 9092), to implement a proposed settlement with
the American Petroleum Institute. These regulations apply to facilities
that are new or existing pipeline breakout stations or bulk gasoline
terminals with through-puts greater than 75,700 liters/day, commencing
construction, modification or reconstruction after the date of
proposal.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. These notifications, reports, and records are essential in
determining compliance, and are required of all sources subject to
NESHAP. Specifically, data is being collected on performance of the
continuous monitoring systems for gasoline vapor and related hazardous
air pollutants (HAPs), any excess emissions, and any operating
parameter exceedances.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance
reports, and records. All reports are sent to the delegated State or
local authority. In the event that there is no such delegated
authority, the reports are sent directly to the United States
Environmental Protection Agency (EPA) regional office.

    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 29
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of facilities
that are new or existing pipeline breakout stations or bulk gasoline
terminals.
    Estimated Number of Respondents: 447.
    Frequency of Response: Initially, semiannually and annually.
    Estimated Total Annual Hour Burden: 15,756 hours.
    Estimated Total Annual Cost: $1,755,864, which includes $0
annualized Capital Startup costs, $357,000 annualized Operating and
Maintenance Costs (O&M), and $1,398,864 annualized Labor Costs.
    Changes in the Estimates: There are two categories of burden in
this ICR, major sources and area sources. There is a net decrease in
burden hours from the most recently approved ICR due to a decrease in
the number of major sources subject to the standard. The decrease
occurred because major sources reduced their emissions or otherwise
demonstrated that their emissions were below the threshold level for
applicability in the standard. However, it should be noted that the
previous ICR did not include the burden hours for area sources.
    After the calculations were updated to include managerial and
clerical hours for major sources, and we added the burden associated
with area sources, the sum total of the increases did not offset burden
hours associated with the decrease in the number of major sources
required to comply with the standard. Hence, there is a net overall
decrease in the burden hours to comply with this standard.

    Dated: June 4, 2007.
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-11310 Filed 6-11-07; 8:45 am]

BILLING CODE 6560-50-P


j. OPfl 2Dd2 d@ o49 003 % b Dibasic Esters GroupDBE 1850M Street, N. W., Suite 700, Washington, D. C. 20036 ( 202) 721 4160 Fax ( 202) 296 8120 February 4,2003 ViaMessenger/ RETURNRECEIPT U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics Document Control Office 1201 Constitution Avenue NW EPA East Building, Room 6428 Washington, DC 20004 " I

. 2 " rlr 1 wLI Dibasic Esters ( DBEs) Testing Docket No: OPPT 42190B Attention: Document Control Office / TSCA Section 4 Requestfor Minor Modification  Notice of Company Transfer Pursuant to 40 CFR Chapter I  Part 790.55( b)( 3) the Dibasic Esters ( DBE) Group comprised of: Aceto Corporation, E. I. du Pont de Nemours & Company, and Solutia, Inc. requests a minor modification to the Enforceable Consent Agreement ( ECA) in regards to a company transfer. The Enforceable Consent Agreement was entered into between the United States Environmental Protection Agency and the Dibasic Esters Group on August 5, 1999.

E. I. du Pont de Nemours & Company was an original signatory and test sponsor of the EPA ECA. On February 1,2003, as per the attached letter, E. I. du Pont de Nemours & Company transferred to DuPont Textiles & Interiors the rights and liabilities associated with the manufacture, use, and sale of Dibasic Esters. DuPont Textiles & Interiors remains committed to meeting its obligations under the ECA and therefore has forwarded a new Company Test Sponsor forrn signed by Kenneth W. Wall the Vice President & General Manager of DuPont Nylon Intermediates, Specialties & Polymers who is responsible for the newly formed DuPont Textiles & Interiors.

The Dibasic Esters ( DBE) Group will henceforth be comprised of Aceto Corporation, DuPont Textiles & Interiors, and Solutia, Inc.

Please contact me at ( 202) 721 4145 if there are questions relating to this submission.

Sincerely,

Edward W. Kordoski, MBA, Ph. D. I DBE Executive Director  2 OPPT 2002 0009 0037 cc: DBE Group M. Wine, T. Hardy, Kirkland & Ellis, DBE Group Legal Counsel Enclosure: 4 Copies 2 Copies were also sent to our ECA Coordinator Dr. George M. Semeniuk DuPont Textiles & Interiors Chestnut Run Plaza 722 1065 P. O. Box 80722 Wilmington, DE 19880 0722 February 3,2003 U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics Document Control Office 1201Constitution Avenue NW EPA East Building, Room 6428 Washington, DC 20004 Dibasic Esters ( DBEs) Testing Docket No: OPPT 4219OB Attention: Document Control Office / TSCA Section 4 Notice of Company Transfer Effective February 1,2003, E. I. du Pont de Nemours and Company transferred to DuPont Textiles & Interiors the rights and liabilitiesassociatedwith the manufactureof Dibasic Esters which is governed by an EnforceableConsent Agreement issued by the U. S. Environmental ProtectionAgency ( EPA) under the authority of section 4 of the Toxic Substances Control Act ( TSCA, 15 U. S. C. 2603).

Kathleen E. OKeefe DuPontTextiles and Interiors Product Stewardship Competency Manager L .' It  4 TEST SPONSOR DuPontTextiles & Interiors Title: VP& GM DuPont Nylon Intermediates, Specialties& Polymer DuPont Textiles & Interiors Chestnut Run Plaza 722 4417 Lancaster Pike Wilmington, DE 19805


[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80084-80086]
[FR Doc No: 2010-31994]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63550; File No. SR-NYSEArca-2010-115]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending NYSE Arca
Options Rule 5.3(j) To Permit Trading Options on Leveraged Exchange-
Traded Notes and Broaden the Definition of Futures Linked Securities

December 15, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 9, 2010, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a et seq.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Arca Options Rule 5.3(j) to:
(1) Permit trading options on leveraged (multiple or inverse) exchange-
traded notes, and (2) broaden the definition of ``Futures-Linked
Securities [sic]. The text of the proposed rule change is available at
the Exchange, the Commission's Public Reference Room, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Arca Options Rule 5.3(j) to:
(1) Permit trading options on leveraged (multiple or inverse) exchange-
traded notes (``ETNs''), and (2) broaden the definition of ``Futures-
Linked Securities.'' \4\ ETNs are also known as ``Index-Linked
Securities,'' which are designed for investors who desire to
participate in a specific market segment by providing exposure to one
or more identifiable underlying securities, commodities, currencies,
derivative instruments, or market indexes of the foregoing. Index-
Linked Securities are the nonconvertible debt of an issuer that have a
term of at least one (1) year but not greater than thirty (30) years.
Despite the fact that Index-Linked Securities are linked to an
underlying index, each trade as a single exchange-listed security.
Accordingly, rules pertaining to the listing and trading of standard
equity options apply to Index-Linked Securities.
---------------------------------------------------------------------------

    \4\ The amendments proposed herein are similar to changes
approved for the Chicago Board Options Exchange (``CBOE''). See
Securities Exchange Act Release No. 63202 (October 28, 2010), 75 FR
67794 (November 3, 2010) (SR-CBOE-2010-080).
---------------------------------------------------------------------------

Leveraged ETN Options
    The Exchange proposes to amend NYSE Arca Options Rule 5.3(j) to
permit the listing of options on leveraged (multiple or inverse) ETNs.
Multiple leveraged ETNs seek to provide investment results that
correspond to a specified multiple of the percentage performance on a
given day of a particular Reference Asset. Inverse leveraged ETNs seek
to provide investment results that correspond to the inverse (opposite)
of the percentage performance on a given day of a particular Reference
Asset by a specified multiple. Multiple leveraged ETNs and inverse
leveraged ETNs differ from traditional ETNs in that they do not merely
correspond to the performance of a given Reference Asset, but rather
attempt to match a multiple or inverse of a Reference Asset's
performance.
    The Barclays Long B Leveraged S&P 500 TR ETN (``BXUB''), the
Barclays Long C Leveraged S&P 500 TR ETN (``BXUC''), and the UBS AG 2x
Monthly Leveraged Long Exchange-Traded Access Securities (E-TRACS)
linked to the Alerian MLP Infrastructure Index due July 9, 2040
(``MLPL'') currently trade on the NYSE Arca equity platform and are
examples of multiple leveraged ETNs. In addition, the Barclays ETN +
Inverse S&P 500 VIX Short-Term Futures ETN (``XXV'') currently trades
on the NYSE Arca equity platform and is an example of an inverse
leveraged ETN. The NYSE Arca equity platform also lists several other
inverse leveraged ETNs for trading.\5\
---------------------------------------------------------------------------

    \5\ These ETNs include the Barclays Short B Leveraged Inverse
S&P 500 TR ETN (``BXDB''), the Barclays Short C Leveraged Inverse
S&P 500 TR ETN (``BXDC'') and the Barclays Short D Leveraged Inverse
S&P 500 TR ETN (``BXDD'').
---------------------------------------------------------------------------

    Currently, NYSE Arca Options Rule 5.3 provides that securities
deemed appropriate for options trading shall include shares or other
securities (``Equity Index-Linked Securities,'' ``Commodity-Linked
Securities,'' ``Currency-Linked Securities,'' ``Fixed Income Index-
Linked Securities,'' ``Futures-Linked Securities,'' and ``Multifactor
Index-Linked Securities,'' collectively known as ``Index-Linked
Securities''), as defined in NYSE Arca Equities Rule 5.2(j)(6), that
are principally traded on a national securities exchange and an ``NMS
stock'' (as defined in Rule 600 of Regulation NMS under the Securities
Exchange Act of 1934), and represent ownership of a security that
provides for the payment at maturity, as described below:
     Equity Index-Linked Securities are securities that provide
for the payment at maturity of a cash amount based on the performance
of an underlying index or indexes of equity securities (``Equity
Reference Asset'');
     Commodity-Linked Securities are securities that provide
for the payment at maturity of a cash amount based on the performance
of one or more physical commodities or commodity futures, options on
commodities, or other commodity derivatives or Commodity-Based Trust
Shares or a basket or index of any of the foregoing (``Commodity
Reference Asset'');
     Currency-Linked Securities are securities that provide for
the payment at maturity of a cash amount based on the performance of
one or more currencies, or options on currencies or currency futures or
other currency derivatives or Currency Trust Shares (as defined in NYSE
Arca Equities Rule 8.202(c)), or a basket or index of any of

the foregoing (``Currency Reference Asset'');
     Fixed Income Index-Linked Securities are securities that
provide for the payment at maturity of a cash amount based on the
performance of one or more notes, bonds, debentures or evidence of
indebtedness that include, but are not limited to, U.S. Department of
Treasury securities (``Treasury Securities''), government-sponsored
entity securities (``GSE Securities''), municipal securities, trust
preferred securities, supranational debt and debt of a foreign country
or a subdivision thereof or a basket or index of any of the foregoing
(``Fixed Income Reference Asset'');
     Futures-Linked Securities are securities that provide for
the payment at maturity of a cash amount based on the performance of an
index of: (a) Futures on Treasury Securities, GSE Securities,
supranational debt and debt of a foreign country or a subdivision
thereof, or options or other derivatives on any of the foregoing; (b)
interest rate futures or options or derivatives on the foregoing in
this subparagraph (b); or (c) CBOE Volatility Index (``VIX'') futures
(``Futures Reference Asset''); and
     Multifactor Index-Linked Securities are securities that
provide for the payment at maturity of a cash amount based on the
performance of any combination of two or more Equity Reference Assets,
Commodity Reference Assets, Currency Reference Assets, Fixed Income
Reference Assets, or Futures Reference Assets (``Multifactor Reference
Asset'').
    For purposes of NYSE Arca Options Rule 5.3(j), Equity Reference
Assets, Commodity Reference Assets, Currency Reference Assets, Fixed
Income Reference Assets, Futures Reference Assets, and Multifactor
Reference Assets collectively are referred to as ``Reference Assets.''
    In addition, Index-Linked Securities must meet the criteria and
guidelines for underlying securities set forth in NYSE Arca Options
Rule 5.3 or the Index-Linked Securities must be redeemable at the
option of the holder at least on a weekly basis through the issuer at a
price related to the applicable underlying Reference Asset. In
addition, the issuing company is obligated to issue or repurchase the
securities in aggregation units for cash, or cash equivalents,
satisfactory to the issuer of the Index-Linked Securities that underlie
the option as described in the Index-Linked Securities prospectus.
    The Exchange proposes to amend NYSE Arca Options Rule 5.3 to expand
the type of Index-Linked Securities that may underlie options to
include leveraged (multiple or inverse) ETNs. To effect this change,
the Exchange proposes to amend NYSE Arca Options Rule 5.3(j) by adding
the phrase, ``or the leveraged (multiple or inverse) performance'' to
each of the subparagraphs ((A) through (F)) in that section, which sets
forth the different eligible Reference Assets.\6\
---------------------------------------------------------------------------

    \6\ The Exchange also proposes a technical correction to the
Rule to conform a definition. In particular, we are changing the
defined term ``NMS Stock'' to ``NMS stock'' to conform to how it is
defined in Rule 600 of Regulation NMS under the Securities and
Exchange Act of 1934.
---------------------------------------------------------------------------

    The Exchange's current continuing listing standards for ETN options
will continue to apply. Specifically, under NYSE Arca Options Rule
5.4(m), ETN options shall not be deemed to meet the Exchange's
requirements for continued approval, and the Exchange shall not open
for trading any additional series of option contracts of the class
covering such Index-Linked Securities whenever the underlying
securities are delisted and trading in the Index-Linked Securities is
suspended on a national securities exchange, or the Index-Linked
Securities are no longer an ``NMS stock'' (as defined in Rule 600 of
Regulation NMS under the Securities Exchange Act of 1934). In addition,
the Exchange shall consider the suspension of opening transactions in
any series of options of the class covering Index-Linked Securities in
any of the following circumstances: (1) The underlying Index-Linked
Security fails to comply with the terms of NYSE Arca Options Rule
5.3(j); (2) in accordance with the terms of NYSE Arca Options Rule
5.4(b), in the case of options covering Index-Linked Securities when
such options were approved pursuant to NYSE Arca Options Rule 5.3(j),
except that, in the case of options covering Index-Linked Securities
approved pursuant to NYSE Arca Options Rule 5.3(j)(3)(B) that are
redeemable at the option of the holder at least on a weekly basis, then
option contracts of the class covering such Securities may only
continue to be open for trading as long as the Securities are listed on
a national securities exchange and are ``NMS stock'' as defined in Rule
600 of Regulation NMS; (3) in the case of any Index-Linked Security
trading pursuant to NYSE Arca Options Rule 5.3(j), the value of the
Reference Asset is no longer calculated or available or (4) such other
event shall occur or condition exist that in the opinion of the
Exchange make further dealing in such options on the Exchange
inadvisable. Expanding the eligible types of ETNs for options trading
under NYSE Arca Options Rule 5.3 will not have any effect on the rules
pertaining to position and exercise limits \7\ or margin.\8\
---------------------------------------------------------------------------

    \7\ See Rules 5.15, Position Limits, and 5.18, Exercise Limits.
    \8\ See Rule 5.25, Margins.
---------------------------------------------------------------------------

    This proposal is necessary to enable the Exchange to list and trade
options on shares of BXUB, BXUC, XXV, BXDB, BXDC, BXDD and MLPL. The
Exchange believes the ability to trade options on leveraged (multiple
or inverse) ETNs will provide investors with greater risk management
tools. The proposed amendment to the Exchange's listing criteria for
options on ETNs is necessary to ensure that the Exchange will be able
to list options on the above listed leveraged (multiple and inverse)
ETNs as well as other leveraged (multiple and inverse) ETNs that may be
introduced in the future.
    The Exchange represents that its existing surveillance procedures
applicable to trading in options are adequate to properly monitor the
trading in leveraged (multiple and inverse) ETN options.
    It is expected that The Options Clearing Corporation will seek to
revise the Options Disclosure Document to accommodate the listing and
trading of leveraged (multiple and inverse) ETN options.
    Broaden the Definition of ``Futures-Linked Securities''
    The second change proposed by this filing is to amend the
definition of ``Futures-Linked Securities'' set forth in NYSE Arca
Options Rule 5.3(j)(1)(E). Currently, the definition of ``Futures-
Linked Securities'' is limited to securities that provide for the
payment at maturity of a cash amount based on the performance of an
index of: (a) futures on Treasury Securities, GSE Securities,
supranational debt and debt of a foreign country or a subdivision
thereof, or options or other derivatives on any of the foregoing; (b)
interest rate futures or options or derivatives on the foregoing; or
(c) CBOE VIX futures.
    NYSE Arca Options Rule 5.3 sets forth generic listing criteria for
securities that may serve as underlyings for listed options trading.
The Exchange believes that the current definition of ``Futures-Linked
Securities'' is unnecessarily restrictive and requires the Exchange to
submit a filing to amend the definition each time a new ETN is issued
that tracks the performance of an index of futures/options on futures
that is not enumerated in the existing rule. To address this issue, the
Exchange is proposing to revise the definition of ``Futures-Linked
Securities'' to provide that they are securities that provide for the
payment at maturity of a cash

amount based on the performance or the leveraged (multiple or inverse)
performance of an index or indexes of futures contracts or options or
derivatives on futures contracts (``Futures Reference Asset''). The
Exchange notes that all ETNs eligible for options trading must be
principally traded on a national securities exchange and an ``NMS
stock.'' As a result, the Exchange believes that broadening the
definition of ``Futures-Linked Securities'' by no longer specifically
listing the types of futures and options on futures contracts that may
be tracked by an ETN is appropriate.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest. The
Exchange believes the proposed rules applicable to trading pursuant to
generic listing and trading criteria serve to foster investor
protection.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6)
thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange requested that the Commission waive
the 30-day operative delay so that the Exchange can list and trade
options on leveraged (multiple or inverse) ETNs and implement the
amended definition of ``Futures-Linked Securities'' immediately. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public
interest.\13\ The Commission notes the proposal is substantively
identical a proposal that was recently approved by the Commission, and
does not raise any new regulatory issues.\14\ For these reasons, the
Commission designates the proposed rule change as operative upon
filing.
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ See supra note 4.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2010-115 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2010-115. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange.\15\ All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2010-115 and should be submitted on or before January 11,
2011.
---------------------------------------------------------------------------

    \15\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31994 Filed 12-20-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Proposed Rules]
[Pages 28942-28944]
[FR Doc No: 2011-12443]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0460; FRL-9309-5]

Revisions to the California State Implementation Plan, Sacramento
Metropolitan Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing both an approval and a limited approval and
limited disapproval of permitting rules submitted for the Sacramento
Metropolitan Air Quality Management District (SMAQMD or District)
portion of the California State Implementation Plan (SIP). The District
is required under Parts C and D of title I of the Clean Air Act (CAA)
to adopt and implement SIP-approved New Source Review (NSR) and
Prevention of Significant Deterioration (PSD) permit programs. These
rules update and revise the District's NSR and PSD permitting programs
for new and modified major sources of air pollution. If EPA finalizes
the limited approval and limited disapproval action, as proposed, then
a sanctions clock would be triggered. We are taking comments on this
proposal and plan to follow with a final action.

DATES: Any comments must arrive by June 20, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0460, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: EPA has established a docket for this action under EPA-R09-
OAR-2011-0460. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents are listed at http://www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps, multi-volume reports), and
some may not be publicly available in either location (e.g., CBI). To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Proposed Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal, including the
dates they were adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                Rule
                 Local agency                    No.              Rule title              Amended     Submitted
----------------------------------------------------------------------------------------------------------------
SMAQMD.......................................     214  Federal New Source Review......     10/28/10     12/07/10
SMAQMD.......................................     203  Prevention of Significant            1/27/11      1/28/11
                                                        Deterioration.
----------------------------------------------------------------------------------------------------------------

    On January 13, 2011 and May 12, 2011, EPA determined that the
submittals for SMAQMD Rules 214 and 203, respectively, met the
completeness criteria in 40 CFR Part 51, Appendix V, which must be met
before formal EPA review.

B. Are there other versions of these rules?

    There are no previous versions of Rules 203 or 214 in the SIP, but
SIP approved Rule 202 (New Source Review), which these rules will
replace in the SIP, was approved on June 19, 1985 (50 FR 25417).
    The SMAQMD originally adopted new Rule 203 on February 26, 1991,
and CARB submitted the rule to EPA on October 30, 2001, however EPA has
not taken action on this submittal. While we can act on only the most
recently submitted version, we have reviewed materials provided with
the previous submittal.

C. What is the purpose of the submitted rules?

    Section 110(a) of the CAA requires states to submit regulations
that include a pre-construction permit program for certain new or
modified stationary sources of pollutants, including a permit program
as required by Parts C and D of Title I of the CAA.
    The purpose of District Rule 214 (Federal New Source Review) and
Rule 203 (Prevention of Significant Deterioration) is to implement a
federal preconstruction permit program for new and modified sources.
These two new rules will replace in its entirety, the existing SIP
approved NSR/PSD programs contained in Rule 202. The basic NSR program
requirements from Rule 202 have been included in Rule 214, with
revisions made to clarify that the rule only applies to major sources
and all modifications at such sources, major agricultural sources and
only applies to pollutants for which the District is designated as
nonattainment. In accordance with the District's May 5, 2010 (75 FR
24409) reclassification as a severe ozone nonattainment area, the rule
lowers the BACT \1\ and offset applicability thresholds to 25 tpy or
less, and increases the required offset ratio to 1.3 to 1. Pursuant to
the 2002 NSR Reforms adopted by EPA (67 FR 80186), the rule adds
provisions for calculating emission increases from proposed
modifications by adding a definition for ``Federal Major
Modifications'' which incorporates the necessary provisions to perform
this calculation. The rule does not contain a provision for the
implementation of Plantwide Applicability Limits (PALs) as required by
40 CFR 51.165(f).
---------------------------------------------------------------------------

    \1\ While the District uses the term BACT as the level of
control required, a review of the definition has shown that it is
equivalent to the requirements for federal LAER.
---------------------------------------------------------------------------

    The basic PSD program requirements from Rule 202 have been included
in Rule 203. This rule mainly incorporates by reference the federal PSD
program as codified in 40 CFR 52.21 which only applies to new major
sources and major modifications at existing major sources. The rule
also revises several terms used within 40 CFR 52.21 to replace NSR
Reform provisions with pre-reform language and requirements. (67 FR
80186)

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    The relevant statutory provisions for our review of the submitted
rules include Parts C and D of Title I of the CAA, section
110(a)(2)(C), section 110(l) and section 182(d). Section 110(a)
requires a pre-construction permit programs for certain new or modified
stationary sources of pollutants, including a permit program as
required by Parts C and D of Title I, while section 110(l) precludes
EPA approval of SIP revisions that would interfere with any applicable
requirement concerning attainment and reasonable further progress or
any other applicable requirement of the Act. Section 182(d) (together
with section 182(f) for NOX), requires NSR SIPs in
``severe'' nonattainment areas to define ``major sources'' and ``major
modifications'' to be sources that emit 25 tpy or more of VOC or
NOX, and have an offset ratio of at least 1.3 to 1. In
addition, we have reviewed the submitted rules for compliance with EPA
implementing regulations for NSR, including 40 CFR 51.160 through 40
CFR 51.166.

B. Do the rules meet the evaluation criteria?

    EPA has reviewed the submitted rules in accordance with the Rule
Evaluation criteria described above. The TSD for this action contains a
complete discussion of our evaluation. EPA is proposing to find that
these rules meet the statutory requirements for SIPs as specified in
sections 110(a), 110(l), 182(d) and 193 of the CAA. In addition, except
for the deficiencies noted in the TSD and summarized in the Proposed
Action section of this notice, we are proposing to find that the rules
meet the regulatory requirements of 40 CFR 51.160 through 40 CFR
51.166. EPA is proposing to find that it is acceptable for SMAQMD to
not incorporate the NSR Reform provisions of 40 CFR 51.165 and 51.166
into their SIP approved NSR programs because the same level of control
will be required for modified sources, with or without inclusion of
these provisions in the SIP, and SMAQMD's program will not be any less
stringent than the federal program.
    The TSD has more information on our evaluation.

C. Public Comment and Proposed Action

    For the reasons given above, under CAA section 110(k)(3) and
301(a), we are proposing a limited approval and limited disapproval of
Rule 214 because, although it would strengthen the SIP and meets the
applicable requirements for SIPs in general, it contains certain
deficiencies related to NSR SIPs in particular that prevent our full
approval. The primary deficiencies pertain to missing definitions, the
removal of public notice requirements for the minor source program from
the SIP, and missing provisions pursuant to 40 CFR 51.165(a)(5)(ii) and
40 CFR 51.307(b)(2). Please refer to the TSD for this action for
additional information. The deficiencies in Rule 214 can be remedied by
the District by revising Rule 214 to provide the missing definitions,
and necessary provisions pursuant to the 40 CFR part 51 sections cited
above. The minor source public notice program deficiency can be
remedied by either adding such provisions to Rule 201 or 214,
submitting an analysis showing why a

minor NSR program for minor sources is not needed, submitting an
approvable justification for why a chosen level of public notice is
appropriate, or submitting local District Rule 202 (State New Source
Review) to EPA for SIP approval. If EPA finalizes the limited approval
and limited disapproval action, as proposed, then a sanctions clock,
and EPA's obligation to promulgate a Federal implementation plan, would
be triggered because the revisions to the District rule for which a
limited approval and limited disapproval is proposed is required under
the 8-hour ozone standard.
    Because EPA has determined that Rule 203 fulfills all relevant
requirements, we are proposing to fully approve it as described in
section 110(k)(3) of the Act. We will accept comments from the public
on this proposal for the next 30 days. Unless we receive convincing new
information during the comment period, we intend to publish a final
action that will incorporate these rules into the federally enforceable
SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: May 13, 2011.
Keith Takata,
Acting Regional Administrator, Region IX.
[FR Doc. 2011-12443 Filed 5-18-11; 8:45 am]
BILLING CODE 6560-50-P