[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Rules and Regulations]
[Page 27443-27452]
[DOCID:fr17my10-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0890; FRL-8824-3]

 [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene); Time-Limited Exemption from the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited exemption from the
requirement of a tolerance for residues of [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) when used as
an inert ingredient at levels not to exceed 7% in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest. The Joint Inerts Task Force, Cluster Support Team Number
5 requested an exemption for the requirement of a tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA). The exemption from the
requirement of a tolerance expires on May 17, 2012. This regulation
eliminates the need to establish a maximum permissible level for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene).

DATES: This regulation is effective May 17, 2010. Objections and
requests for hearings must be received on or before July 16, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0890. 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: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 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 provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

 B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://
www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0890 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 July
16, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0890, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background

    In the Federal Register of March 25, 2009 (74 FR 12856) (FRL-8399-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7466) by the Joint Inerts Task Force, Cluster Support Team 5, c/o
CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC
20005. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70
(herein referred to in this document as octylphenol ethoxylate or OPE)
when used as an inert ingredient in pesticide formulations applied to
growing crops and raw agricultural commodities after harvest. That
notice referenced a summary of the petition prepared by the Joint
Inerts Task Force, Cluster Support Teams 5, the petitioner, which is
available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.
These tolerances expire on May 17, 2012.
    Based upon review of the data supporting the petition, EPA has
determined that the 40 CFR 180.910 exemption from the requirement of a
tolerance for octylphenol ethoxylate should be time-limited for a
period of two years and include a use limitation of not to exceed 7% by
weight of the pesticide formulation. This limitation is discussed
further in Units IV.C. and V.C. and is based on the Agency's risk
assessment which can be found at http://www.regulations.gov in the
document ``Alkylphenol Ethoxylates (APEs - JITF CST 5 Inert
Ingredients). Revised Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2008-0890.
    This petition was submitted in response to a final rule that was
published in the Federal Register of August 9, 2006 (71 FR 45415) (FRL-
8084-1) in which the Agency revoked, under section 408(e)(1) of FFDCA,
the existing exemptions from the requirement of a tolerance for
residues of certain inert ingredients because of insufficient data to
make the determination of safety required by section 408(b)(2) of
FFDCA. The expiration date for the tolerance exemptions subject to
revocation was August 9, 2008, which was later extended to August 9,
2009, in the Federal Register of August 4, 2008 (73

FR 45317) (FRL-8373-6) to allow for data to be submitted to support the
establishment of tolerance exemptions for those inert ingredients prior
to the effective date of the tolerance exemption revocation. The
effective date of the revocation for [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) was
subsequently extended on August 7, 2009 (74 FR 39543) (FRL-8431-8),
October 9, 2009 (74 FR 52148) (FRL-8794-1), and February 9, 2010 (75 FR
6314) (FRL-8812-3). The current effective date of the revocation is May
9, 2010.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for octylphenol ethoxylate
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
octkylphenol ethoxylate 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.
    Octylphenol ethoxylate has low to moderate acute oral and dermal
toxicity, is a mild to moderate skin irritant, and an eye irritant.
Based on the analysis of the studies in the open literature, there is
both positive and negative evidence that octylphenol ethoxylate is
mutagenic in bacteria (Salmonella typhimurium) and mammalian (Chinese
hamster ovary, mouse lymphoma) cells. In the Harmonized Guideline
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats with octylphenol
ethoxylate, there was no evidence of increased susceptibility.
Additionally, there was no evidence of neurotoxicity, developmental
toxicity, or reproductive toxicity in that same study. The Agency has
identified octylphenol as a potential metabolite/degradate of concern.
The Agency considered available toxicity data on octylphenol as well as
toxicity data on the structurally related nonylphenol when assessing
the hazard for this potential metabolite/degradate. The major effects
seen in the octylphenol/nonylphenol databases are consistent with
potential disturbances in estrogenic activity, but a complete mode of
action analysis has not been conducted. These effects are the most
sensitive endpoints for both substances and were considered the key
findings for regulatory purposes. The Agency has used available data on
the nonylphenol and octylphenol, which specifically look at these
effects, to establish toxicity endpoints for both octylphenol
ethoxylate and degradates of concern. The Agency considers the toxicity
database to be sufficient to address potential hazards, and the Agency
is regulating on the most sensitive endpoints seen in the database;
effects which are well characterized with clear no-observed-adverse-
effect levels (NOAEL).
     Specific information on the studies received and the nature of the
toxic effects caused by octylphenol ethoxylate as well as the NOAEL and
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in document
``Alkylphenol Ethoxylates (APEs - JITF CST 5 Inert Ingredients).
Revised Human Health Risk Assessment to Support Proposed Exemption from
the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations,'' pp. 9-20 in docket ID number EPA-HQ-OPP-2008-
0890.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) 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 (UF/SF) are used in conjunction
with the POD to calculate a safe exposure level - generally referred to
as a population-adjusted dose (PAD (a = acute, c = chronic)) or a
reference dose (RfD), and a safe margin of exposure (MOE) or level of
concern. 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 octylphenol ethoxylate
used for human risk assessment is shown in the Table of this unit.

Table -- Summary of Toxicological Doses and Endpoints for Octylphenol Ethoxylates and its Metabolites (Including
                                  Octylphenol) for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 15.6 milligrams/ Acute RfD = 0.156 mg/kg/  Initiation and
 (Females 13-50 years of age)........   kilograms/day (mg/kg/    day                      maintenance of
                                        day) UFA = 10x          aPAD = 0.156 mg/kg/day.   pregnancy in rats
                                       UFH = 10x..............                            (octylphenol)
                                       Food Quality Protection                           LOAEL = 31.3 mg/kg/day
                                        Act Safety Factor                                 based on on increased
                                        (FQPA SF) = 1x.                                   % post-implantation
                                                                                loss following
                                                                                exposure of dams
                                                                                during gestation days
                                                                                0-8.
----------------------------------------------------------------------------------------------------------------
Acute dietary                              An endpoint attributable to a single exposure was not seen in the
(General population including infants          database; therefore a point of departure was not selected.
 and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 10 mg/kg/day UFA  Chronic RfD = 0.1 mg/kg/ 2-Generation
(All populations)....................   = 10x                    day                      reproduction study in
                                       UFH = 10x..............  cPAD = 0.1 mg/kg/day...   rats (octylphenol)
                                       FQPA SF = 1x...........                           LOAEL = 50 mg/kg/day
                                                                                based on significant
                                                                                increases in pituitary
                                                                                weight ([uarr]12%,
                                                                                males), decreases in
                                                                                ovary weight
                                                                                ([darr]18%) in F0
                                                                                animals; timing of
                                                                                vaginal opening
                                                                                significantly
                                                                                accelerated in F1
                                                                                females; decreases in
                                                                                the numbers of
                                                                                implants and live F2
                                                                                pups born
----------------------------------------------------------------------------------------------------------------
Incidental oral and inhalation (short- NOAEL= 150 mg/kg/day     Residential LOC for MOE  Harmonized Guideline
 term (1 to 30 days) and intermediate-  UFA = 10x                = 1,000.                 870.3650 combined
 term (1 to 6 months)                  UFH = 10x..............  Occupational LOC for      repeated dose toxicity
                                       FQPA SF = 10x..........   MOE = 100.               study with the
                                                                                reproduction/
                                                                                developmental toxicity
                                                                                screening test in rats
                                                                                (octylphenol
                                                                                ethoxylate)
                                                                                LOAEL = 300 mg/kg/day
                                                                                based on clinical
                                                                                signs (pushing head
                                                                                through bedding after
                                                                                dosing), decreased
                                                                                body-weight gain in
                                                                                both sexes during the
                                                                                premating period,
                                                                                decreased thymus
                                                                                weight in females,
                                                                                increased liver weight
                                                                                in males, and
                                                                                increased incidence of
                                                                                centrilobular
                                                                                hepatocyte hypertrophy
                                                                                in males.
----------------------------------------------------------------------------------------------------------------
Dermal short-term                      Oral study NOAEL = 150   Residential LOC for MOE  Harmonized Guideline
(1 to 30 days) and intermediate-term    mg/kg/day (dermal        = 1,000                  870.3650 combined
 (1 to 6 months).                       absorption rate =       Occupational LOC for      repeated dose toxicity
                                        1%Dermal equivalent      MOE = 100.               study with the
                                        dose = 10,000 mg/kg/                              reproduction/
                                        day                                               developmental toxicity
                                       UFA = 10x..............                            screening test in rats
                                       UFH = 10x..............                            (octylphenol
                                       FQPA SF = 10x = UFDB...                            ethoxylate)
                                                                                LOAEL = 300 mg/kg/day
                                                                                based on clinical
                                                                                signs (pushing head
                                                                                through bedding after
                                                                                dosing), decreased
                                                                                body-weight gain in
                                                                                both sexes during the
                                                                                premating period,
                                                                                decreased thymus
                                                                                weight in females,
                                                                                increased liver weight
                                                                                in males, and
                                                                                increased incidence of
                                                                                centrilobular
                                                                                hepatocyte hypertrophy
                                                                                in males
----------------------------------------------------------------------------------------------------------------
Cancer                                     Classification: Not classified; no alerts identified in structure-
(Oral, dermal, inhalation)...........     activity database (DEREK Version 11) with respect to carcinogenicity;
                                            potential mutagenicity concern identified in open literature for
                                        octylphenol ethoxylate and metabolite. Based on a weight of the evidence
                                          consideration of the available data, the Agency believes that cancer
                                                               risks would be negligible.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFDB = to account for the absence of data or other data deficiency.

C. Exposure Assessment

    Very limited information is available for octylphenol ethoxylate
with respect to plant and animal metabolism/degradation. There is
extensive information in the literature on environmental degradation,
and some information on bacterial and mammalian metabolism, all of
which indicate similar degradation of the octylphenol ethoxylate
compounds. The ethoxylate moiety is degraded by sequential removal of
the ethoxylate groups, eventually degrading to octylphenol. There are
studies in the literature that suggest that plants have the ability to
take up octylphenol ethoxylate residues from treated soil.

While the Agency does not expect that the use of octylphenol ethoxylate
as an inert ingredient in pesticide formulations would result solely in
exposure to octylphenol, there are no available data on the exact
nature of octylphenol ethoxylate residues in food and drinking water
resulting from the use of octylphenol ethoxylate as an inert
ingredient. Therefore, the Agency has concluded that the residues of
concern in food and drinking water are the octylphenol ethoxylate
compounds, their partially de-ethoxylated degradation products, as well
as the degradation product octylphenol, and has conservatively assumed
that in the case of food and drinking water exposures all exposure will
be in the form of exposure to octylphenol, the potential metabolite/
degradate of greatest toxicological concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to octylphenol ethoxylate, EPA considered exposure from the
petitioned-for exemption from the requirement of a tolerance. EPA
assessed dietary exposures from octylphenol ethoxylate 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 octylphenol ethoxylate. A hazard endpoint for acute exposure to
octylphenol ethoxylate was identified only for females ages 13-49; no
hazard endpoints for acute exposure were identified for any other
population group. 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 Intake by Individuals (CSFII).
    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, in the absence of specific residue
data, both the acute and chronic dietary exposure assessments are
conducted using surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high-use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data can be found at http://
www.regulations.gov in the document ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts'' in docket ID
number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product relative to that of the active
ingredient. EPA made a specific adjustment to the dietary exposure
assessment to account for the use limitations of the amount of the
surfactant octylphenol ethoxylate that may be in formulations (no more
than 7%) and assumed that octylphenol ethoxylate is at the maximum
limitation rather than at equal quantities with the active ingredient.
This remains a very conservative assumption because surfactants are
generally used at levels far below these percentages. For example, EPA
examined several of the pesticide products associated with the
tolerance/commodity combination which are the driver of the risk
assessment and found that these products did not contain surfactants at
levels greater than 2.25% and that none of the surfactants was
octylphenol ethoxylate.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
ingredient residue could be on food, and then used this methodology to
choose the highest possible residue that could be found on food and
assumed that all food contained this residue. No consideration was
given to potential degradation between harvest and consumption even
though monitoring data shows that tolerance level residues are
typically one to two orders of magnitude higher than actual residues in
food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. Based on a weight of the evidence
consideration of the available data, the Agency believes that cancer
risks would be negligible. Therefore, a cancer dietary exposure
assessment is not necessary to assess cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for octylphenol ethoxylate. Tolerance level residues
and/or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for octylphenol ethoxylate. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of octylphenol ethoxylate. 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.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model / Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of octylphenol ethoxylate. Modeling runs on four surrogate
inert ingredients using a range of physical chemical properties that
would bracket those of octylphenol ethoxylate were conducted. Modeled
acute drinking water values ranged from 0.001 parts per billion (ppb)
to 41 ppb. Modeled chronic drinking water values ranged from 0.0002 ppb
to 19 ppb. Further details of this drinking water analysis can be found
at http://www.regulations.gov in the document ``Alkylphenol Ethoxylates
(APEs - JITF CST 5 Inert Ingredients). Revised Human Health Risk
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations,''
p. 22 and Appendix C in docket ID number EPA-HQ-OPP-2008-0890.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for octylphenol ethoxylate, a conservative drinking water
concentration value of 100 ppb based on screening level modeling was
used to assess the contribution to drinking water for acute and chronic
dietary risk assessments for the parent compounds and for the
metabolites of concern. These values, which are 10 to 1,000 times
greater than the highest levels of these substance seen in numerous
surface and ground water monitoring studies, were directly entered into
the acute and chronic dietary exposure models.
    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). Octylphenol
ethoxylate may be used as an inert ingredient in pesticide products
that are registered for specific uses that may result in residential
exposures. A screening level residential exposure and risk assessment
was completed for pesticide products containing octylphenol ethoxylate
as an inert ingredient. In this assessment, representative scenarios,
based on end-use product application methods and labeled application
rates, were selected. For each of the use scenarios, the Agency
assessed residential handler (applicator) inhalation and dermal
exposure for use scenarios with high exposure potential (i.e., exposure
scenarios with high-end unit exposure values) to serve as a screening
assessment for all potential residential pesticides containing
octylphenol ethoxylate. Similarly, residential postapplication dermal
and oral exposure assessments were also performed utilizing high-end
exposure scenarios. In the case of octylphenol ethoxylate, non-dietary
exposures are to octylphenol ethoxylate only as there is no appreciable
metabolism or degradation of octylphenol ethoxylate in any of the
representative residential use scenarios. Further details of this
residential exposure and risk analysis can be found at http://
www.regulations.gov in the document ``JITF Inert Ingredients.
Residential and Occupational Exposure Assessment Algorithms and
Assumptions Appendix for the Human Health Risk Assessments to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2008-0710.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found octylphenol ethoxylate to share a common
mechanism of toxicity with any other substances, and octylphenol
ethoxylate does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that octylphenol ethoxylate does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for 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 FQPA
SF. In applying this provision, EPA either retains the default value of
10X, or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Pre-natal and post-natal sensitivity. In the case of octylphenol
ethoxylate, there was no increased susceptibility to the offspring of
rats following pre-natal and post-natal exposure in the Harmonized
Guideline 870.3650 combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test. The offspring
effects (decreased body weight in male and female offspring) occurred
at 300 mg/kg/day in the presence of maternal toxicity, which was
manifested as clinical signs, decreased body-weight gain, increased
liver weight and liver hypertrophy in males, and decreased thymus
weight in females at 300 mg/kg/day. However, a study referenced in the
petition (Hazelden and Wilson, 1986) suggests more severe developmental
effects (supernumerary rib) following gestational exposure via the diet
during gestation days 6-17. The Harmonized Guideline 870.3650 study did
not include a skeletal examination of the offspring. Since the
Harmonized Guideline 870.3650 study with octylphenol ethoxylate did not
assess its impact on the estrogen system, it cannot be used alone to
properly assess the most sensitive endpoint. However, selecting the POD
from the Harmonized Guideline 870.3650 study, which is based on a NOAEL
of 150 mg/kg/day and decreased body-weight gain in both sexes during
the premating period, decreased thymus weight in females, and increased
liver weight and liver hypertrophy in males at the LOAEL of 300 mg/kg/
day, and retaining the FQPA SF of 10X is comparable to using the POD
from the reproduction studies on the most toxicologically potent
compound (nonylphenol) that assessed estrogenic activity (endpoint:
Accelerated vaginal opening; POD: 10 mg/kg/day). The endpoint
(accelerated vaginal opening) and point of departure (10 mg/kg/day) are
considered health protective of effects not assessed in the Harmonized
Guideline 870.3650 studies on the octylphenol ethoxylate.

    For the octylphenol metabolite, the 2-generation reproduction study
in rats showed a delay in the acquisition of preputial separation in
both the F1 and F2 pups, and the timing of
vaginal opening was accelerated in a study in prepubertal female rats.
For the related nonylphenol, two of the multigeneration reproduction
studies in rats and two studies in prepubertal female rats showed
acceleration in the acquisition of vaginal patency. A delay in
preputial separation was observed in male rats in a pubertal onset
assay. The combined toxicology databases currently available on
octylphenol and nonylphenol identify accelerated vaginal opening as the
most consistent and sensitive endpoint, and a clear NOAEL of 10 mg/kg/
day has been demonstrated.
    In a developmental toxicity study with octylphenol ethoxylate,
developmental toxicity was demonstrated, as evidenced by the increased
incidence of supernumerary ribs following exposure to the dams during
gestation days 6-17. However, the low pregnancy rate among all groups
(56%-70%) in this study makes interpretation of the results difficult.
Additionally, the Harmonized Guideline 870.3650 study did not include a
skeletal examination of the offspring. A developmental toxicity study
was identified in the octylphenol database, and a clear NOAEL of 15.6
mg/kg/day (post-implantation loss) was established. The POD for
octylphenol was selected from this study for the acute dietary (females
13+) exposure. This study is considered appropriate and health
protective of effects observed in the developmental toxicity study with
octylphenol ethoxylate.
    Since the rat reproduction studies on the most toxicologically
potent compound (nonylphenol) identified a clear NOAEL of 10 mg/kg/day
for the most sensitive endpoint (accelerated vaginal opening), and the
selected POD of 10 mg/kg/day (NOAEL for accelerated vaginal opening)
for the dietary risk assessment is protective of offspring effects,
there are no residual concerns.
    3. Conclusion. EPA has determined that the FQPA SF can be reduced
to 1X for the octylphenol metabolite upon which the dietary assessment
is based. This decision is based on the following findings:
    i. The most sensitive endpoint from the most toxicologically potent
compound (nonylphenol) was selected for risk assessment and is
considered health protective. The database for nonylphenol is
protective of octylphenol, which has a limited database. There are
several studies on nonylphenol (two multigeneration reproduction
studies, pubertal onset assays, uterotrophic assays), which demonstrate
acceleration of vaginal opening in the rat. Accelerated vaginal opening
is the most consistent and sensitive endpoint identified. Clear NOAELs
for this endpoint have been identified following exposure to
nonylphenol.
    ii. While endpoints were not selected from the Harmonized Guideline
870.3650 study in rats following pre-natal and post-natal exposure to
octylphenol ethoxylate based on concerns that the study did not look
for impacts on the estrogen system, the Agency does note that no
increased susceptibility was demonstrated in the offspring in the
Harmonized Guideline 870.3650 study in rats following pre-natal and
post-natal exposure to octylphenol ethoxylate.
    iii. Although a developmental toxicity study was identified in the
open literature for octylphenol ethoxylate with a developmental NOAEL
of 70/mg/kg/day, a developmental study on octylphenol demonstrated an
increase in post-implantation loss following exposure to the dams from
gestation day 0-8. A clear NOAEL of 15.6 mg/kg/day was established for
the offspring effects. Since the POD selected from that study for acute
dietary exposure to the octylphenol metabolite is 15.6 mg/kg/day, this
value is considered health protective of offspring effects that might
be found following octylphenol ethoxylate exposure.
    iv. There is a 2-generation reproduction study in rats on
octylphenol that demonstrates no adverse effects on reproductive
function.
    v. Although the available mammalian toxicity database does not
include any chronic toxicity data, there is one 2-generation
reproduction study on octylphenol and several multigeneration
reproduction studies on the most toxicologically potent compound in the
risk assessment, nonylphenol, in which test animals were dosed for
extended periods of time and across generations.
    vi. No evidence of neurotoxicity was demonstrated in the database
for octylphenol ethoxylate, octylphenol, or nonylphenol and thus there
is no need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    vii. The exposure assessments used in this risk assessment are
considered to be highly conservative. In the absence of substantial
information on environmental degradation, the Agency has conducted an
assessment which assumes that 100% of octylphenol ethoxylate is
degradated to the more toxic degradate, octylphenol. Further, the
assessment assumed residues of octylphenol will be present in all foods
consumed at levels consistent with the highest established pesticide
tolerance, and in drinking water at a high-end estimated level of 100
ppb. The Agency anticipates that this assessment will signifcantly
overestimate risk.
    EPA has determined that the FQPA safety factor should be retained
(10X) for octylphenol ethoxylate, the compound upon which the
residential assessment is based. This decision is based on the
following findings:
    a. Although endpoints from the Harmonized Guideline 870.3650 study
in rats following pre-natal and post-natal exposure to the octylphenol
ethoxylate were selected for the residential and occupational exposure
risk assessments, there are concerns that the study did not look for
the most sensitive endpoints for the estrogen system.
    b. The Agency does note that no increased susceptibility was
demonstrated in the offspring in the Harmonized Guideline 870.3650
study in rats following pre-natal and post-natal exposure to
octylphenol ethoxylate.

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
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-term, intermediate-term, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, including the limitation of use of octylphenol
ethoxylate to not more than 7% of the pesticide product, the acute
dietary exposure from food and water to octylphenol ethoxylate willl
occupy 37% of the aPAD for females 13 to 49 years old, the only
population group for which an acute toxicity endpoint was established.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, including the limitation of use of
octylphenol ethoxylate to not more than 7% of the pesticide product,
EPA has concluded that chronic exposure to octylphenol ethoxylate from
food and water will utilize 90% of the cPAD for children 1-2 years old
the population group

receiving the greatest exposure. Based on the explanation in Unit
IV.C.3., regarding residential use patterns, chronic residential
exposure to residues of octylphenol is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Short-term
and intermediate-term aggregate risk assessments for octylphenol
ethoxylate combine high end residential short-term or intermediate-term
exposures with average food and drinking water exposures, and compare
this total to a short-term or intermediate-term POD.
    The POD for the dietary risk assessment is 10 mg/kg/day and the LOC
when examining the MOE is 100 for octylphenol ethoxylate. The POD for
the residential risk assessment is 150 mg/kg/day and the LOC is 1,000
for octylphenol ethoxylate. For the purpose of aggregating risks from
dietary and residential exposure, the Agency is using the Aggregate
Risk Index (ARI) approach for aggregate risk assessment. This approach
allows for combining exposures which must be compared to different
NOAELs and different LOCs. Potential risks of concerns are identified
by an ARI of less than 1. Short-term and intermediate-term aggregate
risks for octylphenol ethoxylate are not of concern (values ranging
from 1.0 to 4.3 for children and adults, respectively).
    4. Aggregate cancer risk for U.S. population. The Agency has
carefully considered the weight of the evidence with respect to
carcinogenicity for both the parent compounds and for the degradate.
There were no structral alerts for carcinogenicity amd there were
equivocal mutagenicity findings in the literature studies. Based on a
weight of the evidence consideration of the available data, the Agency
believes that cancer risks would be negligible. However, due to the
equivocal findings in the mutagenicity data base, the Agency is asking
for confirmatory data.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to octylphenol ethoxylate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
octylphenol ethoxylate in or on any food commodities. EPA is
establishing a limitation on the amount of octylphenol ethoxylate that
may be used in pesticide formulations applied to growing crops and raw
agricultural commodities. That limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any such pesticide for sale or distribution that
contains greater than 7% of octylphenol ethoxylate by weight in the
pesticide formulation.

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 U.N. 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 octylphenol ethoxylate.

C. Revisions to Petitioned-For Exemption from the Requirement of a
Tolerance

    EPA is revising the petitioned-for octylphenol ethoxylate exemption
from the requirement of a tolerance under 40 CFR 180.910 by including a
limitation of ``not to exceed 7% of the pesticide formulation.'' As
discussed in Unit IV.C., this limitation will ensure that there are no
aggregate risks of concern. Additionally, EPA is also revising the
octylphenol ethoxylate exemption from the requirement of a tolerance
under 40 CFR 180.910 to include a 2-year time limitation. The exemption
from the requirement of a tolerance for octylphenol ethoxylate will
expire on May 17, 2012. This two-year time limitation is being
established for two purposes:
    1. To provide time for the development and submission of
confirmatory toxicity data to address the equivocal results in the
available genotoxicity studies conducted on octylphenol ethoxylate; and
    2. To provide additional time, should the initial testing not
confirm EPA's conclusion regarding the lack of a cancer concern, for
registrants to attain EPA approval of registration amendments for
reformulation of their pesticide products to remove octylphenol
ethoxylate and to replace existing products with reformulated products.
    EPA believes that its cancer conclusion can be confirmed by
negative results in either in vitro or in vivo mutagenicity studies.
EPA is recommending that supporters of the octylphenol ethoxylate
tolerance exemption perform the following studies for confirmatory
purposes:
    A new Ames assay (Harmonized Guideline 870.5100 -- Bacterial
reverse mutation test) and a mouse lymphoma assay (Harmonized Guideline
870.5300 -- In vitro mammalian cell gene mutation test).
    A bone marrow assay (Harmonized Guideline 870.5395 -- Mammalian
erythrocyte micronucleus test).
     Since in vivo mutagenicity studies such as the bone marrow assay
are generally regarded as more definitive than in vitro studies, and a
negative result in the bone marrow test may outweigh whatever results
are found in the Ames test and mouse lymphoma assay, supporters of the
octylphenol ethoxylate tolerance exemption may opt to conduct the
mammalian erythrocyte micronucleus test in lieu of the two in vitro
mutagenicity studies. If these data do not confirm EPA's cancer
conclusion, then EPA will need two-year cancer bioassays in the mouse
and rat (Harmonized Guideline 870.4200 -- Carcinogenicity (mouse) and
Harmonized Guideline 870.4300 -- combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety finding in support of this
tolerance exemption.
    In conducting confirmatory testing, supporters of the octylphenol
ethoxylate tolerance exemption should keep the following information in
mind. EPA believes that the minimum time period for registrants to
obtain approval of reformulated products and to replace existing
products is 15 months. Thus, EPA plans to alert the registrant
community no later than February 17, 2011 whether confirmatory data has
been received and demonstrates that EPA's cancer conclusion was
correct. If submitted data do confirm EPA's conclusion, EPA will notify
registrants that it intends to remove the expiration date from the
tolerance exemption prior to expiration of the exemption. If the

submitted data do not confirm the conclusion, EPA will inform
registrants that they should assume that the tolerance exemption will
expire on May 17, 2012 and that they should take all appropriate steps
to insure that they do not release for shipment product that may result
in food containing residues inconsistent with the dictates of the
FFDCA. EPA does not intend to extend the expiration date for the
exemption if it is determined that two-year cancer bioassays are needed
to evaluate potential cancer risk. Additionally, if no confirmatory
data are submitted by November 17, 2010. EPA will not have time to make
a decision on any confirmatory data by February 17, 2011 and thus, at
that time, EPA will inform registrants that they should assume that the
tolerance exemption will expire on May 17, 2012 and that they should
take all appropriate steps as indicated above.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) when used as an inert ingredient at levels not
to exceed 7% in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest under 40 CFR 180.910 is
established with an expiration date of May 17, 2012.

VII. Statutory and Executive Order Reviews

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

VIII. 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: May 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.910 is amended by adding alphabetically the following
entry in the table of inert ingredients to read as follows:

Sec.  180.910  Inert ingredients used pre and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * ..................
[alpha]-[p-(1,1,3,3-              Not to exceed 7%    Surfactants,
 tetramethylbutyl)phenyl]-         of pesticide        related adjuvants
 [omega]-                          formulation.        of surfactants
 hydroxypoly(oxyethylene)          Expires May 17,
 produced by the condensation of   2012.
 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with a
 range of 1-14 or 30-70 moles of
 ethylene oxide: If a blend of
 products is used, the average
 range number of moles of
 ethylene oxide reacted to
 produce any product that is a
 component of the blend shall be
 in the range of 1-14 or 30-70
 (CAS Reg. Nos. 9036-19-5, 9002-
 93-1).
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-11686 Filed 5-14-10; 8:45 am]
BILLING CODE 6560-50-S


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

General Comment:Dear Mr. Zeller:

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

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

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

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

Ben Jewell Ready Set Vape, LLC. Castro Valley, CA<PHONE_NUMBER>


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Parts 52 and 97

	[EPA-R03-OAR-2007-0448; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; West
Virginia;

Clean Air Interstate Rule

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Direct final rule.

SUMMARY:  EPA is taking direct final action to approve a revision to the
West Virginia State Implementation Plan (SIP) submitted on June 8, 2007.
 This revision incorporates provisions related to the implementation of
EPA’s Clean Air Interstate Rule (CAIR), promulgated on May 12, 2005
and subsequently revised on April 28, 2006 and December 13, 2006, and
the CAIR Federal Implementation Plan (CAIR FIP) concerning sulfur
dioxide (SO2), nitrogen oxides (NOx) annual, and NOX ozone season
emissions for the State of West Virginia, promulgated on April 28, 2006
and subsequently revised on December 13, 2006.  In this direct final
action, EPA is not making any changes to the CAIR FIP, but is amending
the appropriate appendices in the CAIR FIP trading rules simply to note
that approval.  In accordance with the Clean Air Act, EPA is approving
this West Virginia SIP revision as an abbreviated SIP revision which
addresses the methodology to be used to allocate annual and ozone season
NOX allowances under the CAIR FIPs.

DATES:  This rule is effective on [Insert date 60 days after publication
in the Federal Register]  without further notice, unless EPA receives
adverse written comment by [Insert date 30 days after publication in the
Federal Register].  If  EPA receives such comments, it will publish a
timely withdrawal of the direct final rule in the Federal Register and
inform the public that the rule will not take effect.

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2007-0448 by one of the following methods:

A.  Follow the on-line instructions for submitting comments.

B.    E-mail<EMAIL_ADDRESS>
C.    Mail:   EPA-R03-OAR-2007-0448, Marilyn Powers, Acting Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.   Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2007-0448.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.  Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov or
e-mail.  The www.regulations.gov website is an (anonymous access(
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment.  If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.  Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the West Virginia Department of Environmental
Protection, Division of Air Quality, 601 57th Street SE, Charleston,
West Virginia 25304.

FOR FURTHER INFORMATION CONTACT:  Marilyn Powers,<PHONE_NUMBER> or by
      e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

What Action is EPA Taking?

What is the Regulatory History of CAIR and the CAIR FIPs?

What are the General Requirements of CAIR and the CAIR FIPs?

What is an Abbreviated CAIR SIP Revision?

Analysis of West Virginia’s Abbreviated CAIR SIP Submittal

VI.   	Final Action

VII.   Statutory and Executive Order Reviews

I.  What Action is EPA Taking?

EPA is approving a revision to West Virginia’s SIP, submitted on June
8, 2007 that will modify the application of certain provisions of the
CAIR FIP concerning SO2, NOX annual and NOX ozone season emissions.  As
discussed below, this less comprehensive CAIR SIP is termed an
abbreviated SIP.  West Virginia is subject to the CAIR FIPs that
implement the CAIR requirements by requiring certain EGUs to participate
in the EPA-administered Federal CAIR SO2, NOX annual, and NOX ozone
season cap-and-trade programs.

The West Virginia SIP revision provides a methodology for allocating NOX
allowances for the NOX annual and NOX ozone season trading programs.
The CAIR FIPs provide that this methodology, if approved as EPA is
proposing, will be used to allocate NOX allowances to sources in West
Virginia, instead of the federal allocation methodology otherwise
provided in the FIP.   EPA is not proposing to make any changes to the
CAIR FIP, but is proposing, to the extent EPA approves West Virginia’s
SIP revision, to amend the appropriate appendices in the CAIR FIP
trading rules simply to note that approval.

II.  What is the Regulatory History of CAIR and the CAIR FIPs?

CAIR was published by EPA on May 12, 2005 (70 FR 25162).  In this rule,
EPA determined that 28 States and the District of Columbia contribute
significantly to nonattainment and/or interfere with maintenance of the
national ambient air quality standards (NAAQS) for fine particles
(PM2.5) and/or 8-hour ozone in downwind States in the eastern part of
the country.  As a result, EPA required those upwind States to revise
their SIPs to include control measures that reduce emissions of SO2,
which is a precursor to PM2.5 formation, and/or NOX, which is a
precursor to both ozone and PM2.5 formation.  For jurisdictions that
contribute significantly to downwind PM2.5 nonattainment, CAIR sets
annual State-wide emission reduction requirements (i.e., budgets) for
SO2 and annual State-wide emission reduction requirements for NOX.
Similarly, for jurisdictions that contribute significantly to 8-hour
ozone nonattainment, CAIR sets State-wide emission reduction
requirements for NOX for the ozone season (May 1st to September 30th).
Under CAIR, States may implement these emission budgets by participating
in the EPA-administered cap-and-trade programs or by adopting control
measures.

Section 110(a)(2)(D) of the Clean Air Act requires that States prohibit
emissions that contribute significantly to nonattainment of, or
interfere with, maintenance of the NAAQS in downwind States.  CAIR
explains to subject States what must be included in SIPs to address the
requirements of section 110(a)(2)(D) of the Clean Air Act with regard to
interstate transport with respect to the 8-hour ozone and PM2.5 NAAQS.
EPA made national findings, effective May 25, 2005, that the States had
failed to submit SIPs meeting the requirements of section 110(a)(2)(D).
The SIPs were due in July 2000, 3 years after the promulgation of the
8-hour ozone and PM2.5 NAAQS.  These findings started a 2-year clock for
EPA to promulgate a Federal Implementation Plan (FIP) to address the
requirements of section 110(a)(2)(D).  Under Clean Air Act section
110(c)(1), EPA may issue a FIP anytime after such findings are made and
must do so within two years unless a SIP revision correcting the
deficiency is approved by EPA before the FIP is promulgated.

On April 28, 2006, EPA promulgated FIPs for all States covered by CAIR
in order to ensure the emissions reductions required by CAIR are
achieved on schedule.  Each CAIR State is subject to the FIPs until the
State fully adopts, and EPA approves, a SIP revision meeting the
requirements of CAIR.  The CAIR FIPs require certain EGUs to participate
in the EPA-administered CAIR SO2, NOX annual, and NOX ozone-season model
trading programs, as appropriate.  The CAIR FIP SO2, NOX annual, and NOX
ozone season trading programs impose essentially the same requirements
as, and are integrated with, the respective CAIR SIP trading programs.
The integration of the CAIR FIP and SIP trading programs means that
these trading programs will work together to create effectively a single
trading program for each regulated pollutant (SO2, NOX annual, and NOX
ozone season) in all States covered by CAIR FIP or SIP trading program
for that pollutant.  The CAIR FIPs also allow States to submit
abbreviated SIP revisions that, if approved by EPA, will automatically
replace or supplement the corresponding CAIR FIP provisions (e.g., the
methodology for allocating NOX allowances to sources in the state),
while the CAIR FIP remains in place for all other provisions.  The CAIR
FIP trading rules include appendices in which EPA intends to list each
State for which EPA approves an abbreviated SIP revision.  The
appendices will indicate which provisions of the CAIR FIP are
automatically replaced or supplemented by each approved, abbreviated
SIP.

On April 28, 2006, EPA published two CAIR-related final rules that added
the States of Delaware and New Jersey to the list of States subject to
CAIR for PM2.5 and announced EPA’s final decisions on reconsideration
of five issues without making any substantive changes to the CAIR
requirements.

III.  What are the General Requirements of CAIR and the CAIR FIPs?

CAIR establishes State-wide emission budgets for SO2 and NOX and is to
be implemented in two phases.  The first phase of NOX reductions starts
in 2009 and continues through 2014, while the first phase of SO2
reductions starts in 2010 and continues through 2014.  The second phase
of reductions for both NOX and SO2 starts in 2015 and continues
thereafter.  CAIR requires States to implement the budgets by either:
(1) requiring EGUs to participate in the EPA-administered cap-and-trade
programs or, (2) adopting other control measures of the State's choosing
and demonstrating that such control measures will result in compliance
with the applicable State SO2 and NOX budgets.

The May 12, 2005 and April 28, 2006 CAIR rules provide model rules that
States must adopt (with certain limited changes, if desired) if they
want to participate in the EPA-administered trading programs.  With two
exceptions, only States that choose to meet the requirements of CAIR
through methods that exclusively regulate EGUs are allowed to
participate in the EPA-administered trading programs.  One exception is
for States that adopt the opt-in provisions of the model rules to allow
non-EGUs individually to opt into the EPA-administered trading programs.
 The other exception is for States that include all non-EGUs from their
NOX SIP Call trading programs in their CAIR NOX ozone season trading
programs.

IV.  What is an Abbreviated CAIR SIP Revision?

States have the flexibility to choose the type of control measures they
will use to meet the requirements of CAIR.  EPA anticipates that most
States will choose to meet the CAIR requirements by selecting an option
that requires EGUs to participate in the EPA-administered CAIR
cap-and-trade programs.  For such States, EPA has provided two
approaches for submitting and obtaining approval for CAIR SIP revisions.
 States may submit full SIP revisions that adopt the model CAIR
cap-and-trade rules.  If approved, these SIP revisions will fully
replace the CAIR FIPs.  Alternatively, States may submit abbreviated SIP
revisions.  These SIP revisions will not replace the CAIR FIPs; however,
the CAIR FIPs provide that, when approved, the provisions in these
abbreviated SIP revisions will be used instead of or in conjunction
with, as appropriate, the corresponding provisions of the CAIR FIPs
(e.g., the NOX allowance allocation methodology).

A State submitting an abbreviated SIP revision may submit limited SIP
revisions to tailor the CAIR FIP cap-and-trade programs to the state
submitting the revision.  Specifically, an abbreviated SIP revision may
establish certain applicability and allowance allocation provisions
that, as the CAIR FIPs provide, will be used instead of, or in
conjunction with, the corresponding provisions in the CAIR FIP rules in
that State.  Specifically, the abbreviated SIP revisions may:

1.  Include NOX SIP Call trading sources that are not EGUs under CAIR in
the CAIR FIP NOX ozone season trading program;

2.  Provide for allocation of NOx annual or ozone season allowances by
the State, rather than the Administrator, and using a methodology chosen
by the State;

3.  Provide for allocation of NOx annual allowances from the compliance
supplement pool (CSP) by the State, rather than by the Administrator,
and using the State’s choice of allowed alternative methodologies; or

4.  Allow units that are not otherwise CAIR units to opt individually
into the CAIR FIP cap-and-trade program under the opt-in provisions in
the CAIR FIP rules.

With approval of an abbreviated SIP revision, the CAIR FIP remains in
place, as tailored to sources in the State by that approved SIP
revision.  Abbreviated SIP revisions can be submitted in lieu of, or as
part of, CAIR full SIP revisions.  States may want to designate part of
their full SIP as an abbreviated SIP for EPA to act on first when the
timing of the State’s submission might not provide EPA with sufficient
time to approve the full SIP prior to the deadline for recording NOX
allocations.  This will help ensure that the elements of the trading
programs where flexibility is allowed are implemented according to the
State’s decisions.  Submission of an abbreviated SIP revision does not
preclude future submission of a CAIR full SIP revision.

As discussed below, West Virginia is requesting approval of only one of
the four provisions for which a State may request an abbreviated SIP.
The State is requesting that its allocation of NOx annual and NOx ozone
season allowances for EGUs under the CAIR FIP be used instead of the
corresponding provisions of the CAIR FIPs in effect in the State.

V.  Analysis of West Virginia’s Abbreviated CAIR SIP Submittal

On June 1, 2006, West Virginia submitted a full SIP revision to meet the
requirements of CAIR as promulgated on May 12, 2005.  The SIP revision
is comprised of three regulations:  45CSR39, 45CSR40 and 45CSR41 for the
NOx annual trading program, the NOx ozone season trading program, and
the SO2 annual trading program, respectively.  The regulations adopted
the part 96 model rules as set forth in the May 12, 2005 rulemaking,
but, because revisions to part 96 were finalized after the State had
started its rulemaking process, did not include the changes to the model
rules that were made as part of the April  28, 2006 CAIR FIP.
Consistent with the provisions of the CAIR FIP as discussed above, West
Virginia submitted a letter on June 8, 2007, requesting that portions of
its June 1, 2006 SIP revision be considered as an abbreviated SIP
revision.  The June 8, 2007 letter designated the NOx allocation
methodology provisions applicable to EGUs under the CAIR FIP and
originally submitted as part of its June 1, 2006 CAIR SIP revision as
replacing the corresponding provisions of the CAIR FIPs.  Consistent
with this request, EPA is treating the following provisions of West
Virginia’s CAIR rules an abbreviated SIP revision: §§45-39-40,
45-39-41, and 45-39-42 ; and §§45-40-40, 45-40-41, and 45-40-42,
except for paragraphs 40.3, 42.2.c, 42.2.d, 42.2.e, 42.3.a.2, and
42.4.b.  The NOx allowance allocation methodology in these provisions of
West Virginia’s June 1, 2006 SIP revision is consistent with the
methodology in part 96 and the FIP, under which units that have operated
for five years will receive allowances, based on heat input data from a
three-year period adjusted for fuel type by using fuel factors of 1.0
for coal, 0.6 for oil, and 0.4 for other fuels.  Based on this
methodology, West Virginia determined NOx allocations for EGUs in the
State under the CAIR FIP, and submitted its allocations to EPA on
October 30, 2006.

West Virginia’s abbreviated SIP revision does not affect the CAIR
budgets, which are total amounts of allowances available for allocation
for each year under the EPA-administered cap-and-trade programs under
the CAIR FIPs.  The abbreviated SIP revision only affects allocations of
allowances under the established budgets.  Information on how the
budgets were developed may be found in the May 12, 2005 CAIR rulemaking
(70 FR 25162).

EPA is today taking action only on this request for an abbreviated SIP
revision and not the full CAIR SIP revision originally submitted, which
will be the subject of a separate rulemaking action.  In the June 8,
2007 letter, West Virginia states that it will revise and promulgate its
CAIR rules 45CSR39, 45CSR40, and 45CSR41 to incorporate the revisions to
part 96 and indicates that it plans to submit an amended CAIR SIP
revision to EPA in 2008.

VI.  Final Action

EPA is approving West Virginia’s abbreviated CAIR SIP revision
submitted on June 8, 2007, as discussed above.  West Virginia is subject
to the CAIR FIPs, which require participation in the EPA-administered
SO2, NOx annual, and NOx ozone season cap-and-trade programs.  Under
this abbreviated SIP revision and, consistent with the flexibility given
to States in the FIPs, West Virgnia has adopted provisions for
allocating allowances under the CAIR FIP NOX annual and ozone season
trading programs.  As provided for in the CAIR FIPs, these provisions in
the abbreviated SIP revision will replace or supplement the
corresponding provisions of the CAIR FIPs in West Virginia.  The
abbreviated SIP revision meets the applicable requirements in 40 CFR
51.123(p) and (ee), with regard to NOX annual and NOX ozone season
emissions.  In this final action, EPA is not making any changes to the
CAIR FIP, but is amending the appropriate appendices in the CAIR FIP
trading rules simply to note approval of West Virginia’s abbreviated
CAIR SIP.

EPA is publishing this rule without prior proposal because the Agency
views this as a noncontroversial amendment and anticipates no adverse
comment.  However, in the (Proposed Rules( section of today(s Federal
Register, EPA is publishing a separate document that will serve as the
proposal to approve the SIP revision if adverse comments are filed.
This rule will be effective on [Insert date 60 days from date of
publication in the Federal Register] without further notice unless EPA
receives adverse comment by [Insert date 30 days from date of
publication in the Federal Register].  If EPA receives adverse comment,
EPA will publish a timely withdrawal in the Federal Register informing
the public that the rule will not take effect.  EPA will address all
public comments in a subsequent final rule based on the proposed rule.
EPA will not institute a second comment period on this action.  Any
parties interested in commenting must do so at this time.  Please note
that if EPA receives adverse comment on an amendment, paragraph, or
section of this rule and if that provision may be severed from the
remainder of the rule, EPA may adopt as final those provisions of the
rule that are not the subject of an adverse comment.

VII.  Statutory and Executive Order Reviews

A.   General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Public Law 104-4).   This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).  This action also
does not have Federalism implications because it does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).  This
action merely approves a state rule implementing a Federal requirement,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This rule also is
not subject to Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks( (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.   EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
(major rule( as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.  This action to approve West Virginia’s abbreviated
CAIR SIP revision may not be challenged later in proceedings to enforce
its requirements.  (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Particulate matter, Reporting and recordkeeping requirements,
Sulfur oxides.

40 CFR Part 97

Environmental protection, Administrative practice and procedure, Air
pollution control, Intergovernmental relations, Nitrogen oxides, Ozone,
Reporting and recordkeeping requirements.

August 30, 2007
_____/s/_____________________

Dated:                                				Donald S. Welsh,

                                      				Regional Administrator,

                                      				Region III.

40 CFR parts 52 and 97 are amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for 40 CFR part 52 continues to read as
follows:

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

Subpart XX ( West Virginia

2.  In ( 52.2520, the table in paragraph (c) is amended by adding
entries for 45 CSR 39 and 40 at the end of the table.  The table in
paragraph (e) is amended by adding the entry for Article 3, Chapter 64
of the Code of West Virginia at the end of the table.  The amendments
read as follows:

( 52.2520  	Identification of plan.

*	*	*	*	*

(c) * * *

	EPA-APPROVED REGULATIONS IN THE WEST VIRGINIA SIP

State citation

[Chapter 16(20 or 45 CSR ]

Title/subject

State effective date

EPA approval date

Additional explanation/

citation at 40 CFR ( 52.2565

*******

[45 CSR]

Series 39	Control of Annual Nitrogen Oxide Emissions to Mitigate
Interstate Transport of Fine Particulate Matter and Nitrogen Ozides

Section 45-39-40

CAIR NOx Annual Trading Budget

5/1/06

[Insert Federal Register publication date] [Insert page number where the
document begins]

Only Phase I (2009 – 2014)

Section 45-39-41

Timing Requirements for CAIR NOx Annual Allowance Allocations

5/1/06	[Insert Federal Register publication date] [Insert page number
where the document begins]

Only Phase I (2009 – 2014)

Section 45-39-42

CAIR NOx Annual Allowance Allocations

5/1/06	[Insert Federal Register publication date] [Insert page number
where the document begins]

Only for Phase I (2009 – 2014)

[45 CSR]

Series 40	Control of Ozone Season Nitrogen Oxide Emissions to Mitigate
Interstate Transport of Ozone and Nitrogen Ozides

Section 45-40-40

CAIR NOx Ozone Season Trading Budget

5/1/06

[Insert Federal Register publication date] [Insert page number where the
document begins]

1.  Except for subsection 40.3, and non-EGUs in subsection 40.1 table

2.  Only Phase I (2009 – 2014)

Section 45-40-41

Timing Requirements for CAIR NOx Ozone Season Allowance Allocations

5/1/06	[Insert Federal Register publication date] [Insert page number
where the document begins]	Only Phase I (2009 – 2014)

Section 45-40-42

CAIR NOx Ozone Season Allowance Allocations

5/1/06	[Insert Federal Register publication date] [Insert page number
where the document begins]	1.  Except for subsections 42.2.d, 42.2.e,
42.3.a.2, and 42.4.b.

2.  Only Phase I (2009 – 2014)

*     *     *     *     *

(e)* * *

Name of non-regulatory SIP revision

Applicable geographic area

State submittal date

EPA approval date

Additional explanation

*     *     *     *     *     *     *

Article 3, Chapter 64 of the Code of West Virginia, 1931

Statewide	5/1/06

[Insert Federal Register publication date]

[Insert page number where the document begins]

Effective date of March 11, 2006

PART 97 - [AMENDED]

3.  The authority citation for 40 CFR part 97 continues to read as
follows:

               Authority:  42 U.S.C. 7401, 7403, 7410, 7426, 7601, and
7651, et seq.

4.  Appendix A to Subpart EE is amended by adding the entry for “West
Virginia” in alphabetical order under paragraph 1 to read as follows:

Appendix A to Subpart EE of Part 97 – States With Approved State
Implementation Plan Revisions Concerning Allocations

1. *  *  *

	West Virginia (for control periods 2009 – 2014)

	    *  *  *

5.  Appendix A to Subpart EEEE is amended by adding the entry for West
Virginia in alphabetical order under paragraph 1 to read as follows:

Appendix A to Subpart EEEE of Part 97 – States With Approved State
Implementation Plan Revisions Concerning Allocations

	*  *  *

	West Virginia (for control periods 2009 – 2014)

*  *  *  *  *

 EPA promulgated the NOx SIP Call on October 27, 1998 (63 FR 57356) to
address transported emissons of ozone in 22 States and the District of
Columbia that significantly contributed  to downwind nonattainment of
the one-hour ozone standard.  The NOx SIP Call trading program applied
to large EGUs and large industrial units.

 PAGE

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[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Page 57672]
[FR Doc No: 2013-22749]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee Meeting on Transport
Airplane and Engine Issues

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a public meeting of the FAA's Aviation
Rulemaking Advisory Committee (ARAC) Transport Airplane and Engine
(TAE) Subcommittee to discuss TAE issues.

DATES: The meeting is scheduled for Wednesday, October 2, 2013,
starting at 9:00 a.m. Eastern Daylight Time. The public must make
arrangements by September 27, 2013, to present oral statements at the
meeting.

ADDRESSES: The Boeing Company, 1200 Wilson Boulevard, Room 234,
Arlington, Virginia 22209.

FOR FURTHER INFORMATION CONTACT: Ralen Gao, Office of Rulemaking, ARM-
209, FAA, 800 Independence Avenue SW., Washington, DC 20591, Telephone
(202) 267-3168, FAX<PHONE_NUMBER>, or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. app. 2), notice is
given of an ARAC meeting to be held October 2, 2013.
    The agenda for the meeting is as follows:

 Opening Remarks, Review Agenda and Minutes
 FAA Report
 ARAC Report
 Transport Canada Report
 EASA Report
 Flight Controls Working Group Report
 Airworthiness Assurance Working Group Report
 Engine Harmonization Working Group Report
 Flight Test Harmonization Working Group Report
 Any Other Business
 Action Items Review

    Attendance is open to the public, but will be limited to the
availability of meeting room space. Please confirm your attendance with
the person listed in the FOR FURTHER INFORMATION CONTACT section no
later than September 27, 2013. Please provide the following
information: Full legal name, country of citizenship, and name of your
industry association, or applicable affiliation. If you are attending
as a public citizen, please indicate so.
    The FAA will arrange for teleconference service for individuals
wishing to join in by teleconference if we receive notice by September
27, 2013. For persons participating by telephone, please contact the
person listed in FOR FURTHER INFORMATION CONTACT by email or phone for
the teleconference call-in number and passcode. Anyone calling from
outside the Arlington, VA, metropolitan area will be responsible for
paying long-distance charges.
    The public must make arrangements by September 27, 2013, to present
oral statements at the meeting. Written statements may be presented to
the Subcommittee at any time by providing 25 copies to the person
listed in the FOR FURTHER INFORMATION CONTACT section or by providing
copies at the meeting. Copies of the documents to be presented to the
Subcommittee may be made available by contacting the person listed in
the FOR FURTHER INFORMATION CONTACT section.
    If you need assistance or require a reasonable accommodation for
the meeting or meeting documents, please contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Sign and oral
interpretation, as well as a listening device, can be made available if
requested 10 calendar days before the meeting.

    Issued in Washington, DC on September 13, 2013.
Lirio Liu,
Designated Federal Officer.
[FR Doc. 2013-22749 Filed 9-18-13; 8:45 am]
BILLING CODE 4910-13-P