[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38962-38970]
[DOCID:fr05au09-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0099; FRL-8428-6]

Sodium Alkyl Naphthalenesulfonate; Exemption from the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium alkyl naphthalenesulfonate,
herein referred to in this document as SANS, when used as an inert
ingredient at a maximum of 30% by weight in pesticide formulations for
pre-harvest and post-harvest uses, as well as, for application to
animals. The Joint Inerts Task Force (JITF), Cluster Support Team
Number 10, submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of SANS.

DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0099. 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<PHONE_NUMBER>.

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 those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0099 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or October 5, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0099, 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 April 15, 2009 (74 FR 17487) (FRL-8409-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7524) by The Joint Inerts Task Force (JITF), Cluster Support Team 10
(CST 10), c/o CropLife America, 1156 15th Street, NW., Suite 400,
Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by establishing exemptions from the requirement
of a tolerance for residues of the inert ingredient sodium alkyl
naphthalenesulfonate (SANS). That notice referenced a summary of the
petition prepared by JITF (CST 10), 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.
    Based upon review of the data supporting the petition, EPA has
modified the exemptions requested by adding a use limitation of not
more than 30% by weight in pesticide formulations applied pre-and post-
harvest and in pesticide formulations applied to animals. This
limitation is based on the Agency's risk assessment which can be found
at http://www.regulations.gov in document Sodium Alkyl
Naphthalenesulfonate (SANS) - JITF CST 10 Inert Ingredients). 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-2009-0099.
    This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (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 by a final rule published in the Federal Register of August 4,
2008 (73 FR 45312) (FRL-8372-7) to allow for data to be submitted to
support the establishment of tolerance exemptions for these inert
ingredients prior to the effective date of the tolerance exemption
revocation.

 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. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement of a tolerance for residues of SANS,
when used as an inert ingredient in pesticide formulations for pre-
harvest and post-harvest uses, as well as for application to animals
provided that the concentration of the SANS inerts is limited to no
more than 30% by weight in pesticide formulations. EPA's assessment of
exposures and risks associated with establishing tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The representative test compounds for the SANS cluster group
include (1) an aqueous mixture containing 80% 3-butyl-naphthalene- 1
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3); (2) a complex
mixture from a boiling distillate from petroleum catalytic reformer
fractionator residue that includes C9-rich C8-
C10-alkyl-sodium naphthalenesulfonate (CAS Reg. No. 908356-
16-1); and (3) naphthalenesulfonic acid, sodium salt, isopropylate (CAS
Reg. No. 68442-09-1), which is a mixture containing sodium diisopropyl
and triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of
mono-isopropyl-2-naphthalenesulfonates. The existing toxicology
database for the SANS inerts consists of an OPPTS Harmonized Guideline
870.3650 (combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats) on each of the
representative SANS, and several publicly-available studies on acute
toxicity. These data are adequate to apply to the SANS inerts when used
as inert ingredients in pesticide formulations and to characterize the
potential toxic effects of these surfactants.
    The sodium alkyl naphthalenesulfonates have low acute oral and
inhalation toxicity but are irritating to the skin and eye. No
mutagenicity data are available. The OPPTS Harmonized Guideline
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening tests on three representative
surfactants demonstrate local irritation effects on the forestomach/
stomach, reduced body-weight gain during mating (males), and/or
decrease in thymus weight and thymus atrophy and microscopic lesions in
the kidney (females) in the parental animals. No evidence of
neurotoxicity was observed in any of the studies.
    There was evidence of increased susceptibility to the offspring of
rats following prenatal or postnatal exposure to naphthalenesulfonic
acid, sodium salt, isopropylate. Increased post-implantation and
postnatal losses and reduced pup body weights were observed at 120 and
288 milligrams/kilograms/day (mg/kg/day), whereas maternal toxicity was
observed only at 288 mg/kg/day, as evidenced by mortality, and increase
in liver enzymes and creatinine, increased kidney weight, and
histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates and mucosal ulceration)
and liver (hepatic fatty change). Based on the fact that there is a
clear NOAEL for the pup effects, the point of departure is based on
this endpoint (increased post-implantation and postnatal losses and
reduced pup weight) and is protective of the effects seen in the study,
and because of the highly conservative inputs used in both the hazard
and exposure assessments, there is no residual concern for this
finding.
    No evidence of increased susceptibility was observed following
prenatal or postnatal exposure to the other representative inerts.
Following exposure to an aqueous mixture containing 3-butyl-
naphthalene-1 sulfonate and sodium di-3, 6-dibutyl naphthalene-1-
sulfonate, parental toxicity manifested as microscopic forestomach
lesions, and developmental toxicity manifested as decreased pup body
weight ([darr]7-8%). No other developmental effects or reproductive
effects were observed, and there was no evidence of neurotoxicity in
the adult animal. Following exposure to a complex mixture from a
boiling distillate from petroleum catalytic reformer fractionator
residue that includes C9-rich C8-C10-
alkyl-sodium naphthalenesulfonate, parental toxicity manifested as
decreased body-weight gain during premating (males), decreased testes
weight, increased incidence of hematopoiesis in the liver (females),
and an increased incidence of erosion in the glandular stomach (both
sexes) at the limit dose. No developmental or reproductive effects were
observed, and there was no

evidence of neurotoxicity in the adult animal at the limit dose.
    The SANS metabolism and elimination are contingent on both the
nature of the alkyl groups and the nature and extent of naphthalene
ring substituents. The Agency's August 1998 ``Toxicological Review of
Naphthalene (CAS Reg. No. 91-20-3)'' states that the in vivo and in
vitro metabolism of the parent unsubstituted naphthalene has been
studied extensively in mammalian systems. Without a functional group
for conjugation, it is expected that the majority of absorbed
unsubstituted naphthalene is eliminated and will proceed through
microsome cytochrome P-450 oxygenases to 1- and 2-napthols.
    However, in the case of the CST 10 SANS surfactants, in addition to
microsome cytochrome P-450 oxygenases, the 1- or 2-sulfonic acid sodium
salt moieties on the naphthalene ring may provide a handle by which
these compounds can be readily conjugated and eliminated.
    There is no evidence that the SANS inerts are carcinogenic. The
Agency used a qualitative structure activity relationship (SAR)
database, DEREK Version 11, to determine if there were structural
alerts. No structural alerts were identified. In addition, there was
little concern that any of the postulated metabolites would have
greater toxicity than the parent compounds.
    Specific information on the studies received and the nature of the
adverse effects caused by the SANS, as well as, the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Sodium Alkyl Naphthalenesulfonate
(SANS) - JITF CST 10 Inert Ingredients). Human Health Risk Assessment
to Support Proposed Exemption from the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide Formulations, pages 9-13 and 46-
53 in docket ID number EPA-HQ-OPP-2009-0099.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for SANS used for human
health risk assessment is shown in the following Table 1.

     Table 1.--Summary of Toxicological Doses and Endpoints for SANS for Use in Human Health Risk Assessment
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                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
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Acute dietary (all populations)            No appropriate endpoints identified for acute dietary assessment.
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Chronic dietary (all populations)      NOAEL = 50 mg/kg/day     Chronic RfD = 0.5 mg/kg/ OPPTS Harmonized
                                       UFA = 10x..............   day                      Guideline 870.3650
                                       UFH = 10x..............  cPAD = 0.5 mg/kg/day...  Combined Repeated Dose
                                       FQPA SF = 1x...........                            Toxicity Study with
                                                                                the Reproduction/
                                                                                Developmental Toxicity
                                                                                Screen in Rats
                                                                                LOAEL = 120 mg/kg/day,
                                                                                based on increased
                                                                                postnatal loss,
                                                                                reduced viability,
                                                                                decreased birth index
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Incidental Oral, (Short- and           NOAEL = 50 mg/kg/day     Residential LOC for MOE  OPPTS Harmonized
 Intermediate-Term), Dermal and        UFA = 10x..............   = 100                    Guideline 870.3650
 Inhalation (Short, Intermediate-,     UFH = 10x..............                           Combined Repeated Dose
 and Long-term)                        FQPA SF = 1x...........                            Toxicity Study with
                                        (5% dermal absorption;                            the Reproduction/
                                        inhalation hazard                                 Developmental Toxicity
                                        assumed to be                                     Screen in Rats
                                        equivalent to oral                               LOAEL = 120 mg/kg/day,
                                        hazard).                                          based on increased
                                                                                postnatal loss,
                                                                                reduced viability,
                                                                                decreased birth index.
----------------------------------------------------------------------------------------------------------------

Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                            Based on SAR analysis, SANS are not expected to be carcinogenic.
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 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

C. Exposure Assessment

    Very limited information is available for the sodium alkyl
naphthalenesulfonates (SANS) with respect to plant and animal
metabolism or environmental degradation. The Agency relied collectively
on information provided on the representative chemical structures, the
submitted physicochemical data, structure-activity relationship
information, as well as information on other surfactants and chemicals
of similar size and functionality to determine the residues of concern
for these inert ingredients. Based on SAR analysis the SANS inerts are
unlikely to degrade in the environment to compounds that are more toxic
than the parent compounds; therefore, the parent compounds SANS are the
residues of concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to SANS, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from SANS in food as follows:
    i. Acute exposure. No adverse effects attributable to a single
exposure of SANS was seen in the toxicity databases. Therefore, an
acute dietary risk assessment for SANS is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for SANS. In the absence
of specific residue data, EPA has developed an approach which uses
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 is contained in the memorandum entitled Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts
(D361707, S. Piper, 2/25/09) and can be found at http://
www.regulations.gov 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 is
generally at least 50 percent 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 in relation to that of
the active ingredient. In the case of SANS, EPA made a specific
adjustment to the dietary exposure assessment to account for the use
limitations of the amount of SANS that may be in formulations (no more
than 30% by weight in pesticide formulations) and assumed that the SANS
are present at the maximum limitations rather than at equal quantities
with the active ingredient. This remains a very conservative assumption
because surfactants are generally used at levels far below this
percentage.
    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 percent 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
residue could be on food, 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. SANS are not expected to be
carcinogenic. 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 SANS. Tolerance level residues and/or 100% CT
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 SANS in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of SANS. Further information regarding EPA drinking
water models used in the 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 SANS. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of SANS 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 Sodium Alkyl Naphthalenesulfonate (SANS) - JITF CST 10
Inert Ingredients. Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations, pages 14-15 and 56-58 in docket
ID number EPA-HQ-OPP-2009-0099.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for SANS, a conservative drinking water concentration value
of 100 ppb based on screening level modeling was used to assess the
contribution to drinking water for chronic dietary risk assessments for
the parent compounds and for the metabolites of concern. These values
were directly entered into the dietary exposure model.
    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). SANS may be used as
inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. A screening level residential exposure and risk assessment
was completed for products containing SANS as inert ingredients. In
this assessment, representative scenarios based on end-use product
application methods and labeled application rates were selected. The
SANS may be used as inert ingredients in pesticide formulations that
are used in and around the home. Additionally, uses are possible in
household cleaning products. For each of the use scenarios, the Agency
assessed residential handler (applicator) inhalation and dermal
exposure for indoor and outdoor 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 SANS. Similarly, residential post application dermal and
oral exposure assessments were also performed utilizing high end indoor
and outdoor exposure scenarios. Further details of this residential
exposure and risk analysis can be found at http://www.regulations.gov
in the memorandum entitled 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 (D364751, 5/7/09, Lloyd/LaMay in docket ID
number EPA-HQ-OPP-2008-0710.
    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 the SANS to share a common mechanism of toxicity
with any other substances, and the SANS do not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that the SANS do not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The representative test
compounds for the SANS cluster group includes:
    i. An aqueous mixture containing 80% 3-butyl-naphthalene-1
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3);
    ii. A complex mixture from a boiling distillate from petroleum
catalytic reformer fractionator residue that includes C9-
rich C8-C10-alkyl-sodium naphthalenesulfonate
(CAS Reg. No. 908356-16-1); and
    iii. Naphthalenesulfonic acid, sodium salt, isopropylate (CAS Reg.
No. 68442-09-1), which is a mixture containing sodium diisopropyl and
triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of mono-
isopropyl-2-naphthalenesulfonates. The existing toxicology database for
the SANS inerts consists of an OPPTS Harmonized Guideline 870.3650
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats on each of the
representative SANS.
    In the case of the SANS inerts, there was no increased
susceptibility to the offspring of rats following prenatal and
postnatal exposure in two of the three OPPTS Harmonized Guideline
870.3650 studies. There were no developmental effects at any dose level
up to the limit dose following exposure to (CAS Reg. No. 908356-16-1).
In that study, maternal toxicity was manifested as mortality, an
increase in liver enzymes and creatinine, increased kidney weight, and
histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates

and mucosal ulceration), and liver (hepatic fatty change) at 1,000 mg/
kg/day. Following exposure to (CAS Reg. No. 25638-17-9) and (CAS Reg.
No. 25417-20-3), developmental toxicity (decreased pup body weight;
[darr]7-8%) was observed at the same dose level where maternal/paternal
toxicity was observed, as evidenced by microscopic lesions in the
stomach at 540 mg/kg/day.
    Developmental toxicity was observed following exposure to (CAS Reg.
No. 68442-09-1) at a dose level where no significant effects were
observed in the parental animals. Offspring effects included increases
in post-implantation loss and postnatal loss and lower pup body weights
at dose levels of 120 and 288 mg/kg/day. Parental toxicity was observed
at 288 mg/kg/day, as evidenced by mortality, increased kidney weight
and histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates and mucosal ulceration),
and liver (hepatic fatty change), and increase in liver enzymes and
creatinine in females. Based on the fact that there is a clear NOAEL
(50 mg/kg/day), the point of departure is based on this endpoint
(increased postnatal loss, decreased pup viability, reduced birth
index) and is protective of the effects seen in the study, and because
of the highly conservative inputs used in both the hazard and exposure
assessments, there is no residual concern for this finding.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for SANS is considered adequate for
assessing the risks to infants and children (the available studies are
described in unit IV.D.2.). The Agency noted changes in thymus weight
and thymus atrophy. However, these were determined to be non-specific
changes not indicative of immunotoxicity. In addition, no blood
parameters were affected. Furthermore, these compounds do not belong to
a class of chemicals that would be expected to be immunotoxic.
Therefore, the Agency does not believe that an additional uncertainty
factor (UFdb) for database uncertainties needs to be applied. In
addition, this effect was not observed in the pups.
    ii. No increased susceptibility of the offspring or reproductive
toxicity was demonstrated in the OPPTS Harmonized Guideline 870.3650
reproductive/developmental toxicity studies in rats following prenatal
and postnatal exposure to two of the three representative compounds
(540 and 1,000 mg/kg/day). Increased susceptibility was demonstrated in
the rat offspring following prenatal and postnatal exposure to one of
the three representative compounds. Decreased pup body weight,
increased pup mortality, and a lower viability index were observed (120
and 288 mg/kg/day) at a dose level where no parental toxicity was
observed. A clear NOAEL was established for these effects, and the
point of departure is based on this endpoint. Reproductive toxicity was
observed following exposure to one of the representative inerts (120
and 288 mg/kg/day), as evidenced by the reduction in birth index. A
clear NOAEL was established for this effect and the point of departure
for risk assessment is significantly below the NOAEL for this effect.
The selected point of departure for the dietary, dermal and inhalation
risk assessments is protective of these offspring effects, thus there
are no residual concerns.
    iii. There is no indication that SANS are neurotoxic chemicals and
thus there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iv. While there is no chronic toxicity data, the Agency has
concluded that an additional uncertainty factor is not needed for the
use of a subchronic study for a chronic exposure assessment because the
adverse effects observed in the available toxicity studies are
attributable to the irritant nature of surfactants and would not be
expected to increase in severity from subchronic to chronic exposure
scenarios. Based on the lack of progression of severity of effects with
time, along with the considerable similarities of effects across the
species tested, the observation that the vast majority of the effects
observed are related to local irritation and corrosive effects, and the
highly conservative nature of the exposure assessment, EPA concludes
that an additional UF for extrapolation from subchronic toxicity study
to a chronic exposure scenario is not needed.
    v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100%
crop treated is assumed for all crops. EPA also made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to SANS in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
SANS.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk.There was no hazard attributable to a single exposure
seen in the toxicity database for SANS. Therefore, the SANS are not
expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure, and the use limitations of not more than 30% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to SANS is 23% of the cPAD for the U.S. population and
75% of the cPAD for children 1 to 2 years old, the most highly exposed
population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    SANS are used as inert ingredients in pesticide products that are
currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to SANS. Using the exposure
assumptions described in this unit, EPA has concluded that the combined
short-term food, water, and residential exposures aggregated result in
aggregate MOEs of

120 for both adult males and females, respectively. Adult residential
exposure combines high end dermal and inhalation handler exposure with
a high end post application dermal exposure. EPA has concluded that the
combined short-term aggregated food, water, and residential exposures
result in an aggregate MOE of 120 for children. Children's residential
exposure combines dermal and hand-to-mouth exposures. As the level of
concern is for MOEs that are lower than 100, these MOEs are not of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    SANS are currently registered for uses that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to SANS. Using the
exposure assumptions described in this unit, EPA has concluded that the
combined intermediate-term aggregated food, water, and residential
exposures result in aggregate MOEs of 520 for both adult males and
females, respectively. Adult residential exposure includes high end
post application dermal exposures. EPA has concluded that the combined
intermediate-term aggregated food, water, and residential exposures
result in an aggregate MOE of 130 for children. Children's residential
exposure combines dermal and hand-to-mouth exposures. As the level of
concern is for MOEs that are lower than 100, these MOEs are not of
concern.
    5.  Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to SANS.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of SANS.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for
SANS nor have any CODEX Maximum Residue Levels been established for any
food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of sodium alkyl naphthalenesulfonates when
used as inert ingredients applied to crops pre-harvest and post-
harvest, and to animals at a maximum of 30% by weight in pesticide
formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of
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 exemptions 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: July 29, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.910, the table is amended by adding alphabetically the
following 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
------------------------------------------------------------------------
                              * * * * * * *
Sodium alkyl                      Limited to no more  Surfactants,
 naphthalenesulfonates (CAS Reg.   than 30% by         related adjuvants
 Nos. 68909-83-1, 68909-84-2,      weight in           of surfactants
 68909-82-0, 27213-90-7, 26264-    pesticide end-use
 58-4, 27178-87-6, 111163-74-7,    products.
 908356-16-1, 25417-20-3, 25638-
 17-9, 145578-88-7, 1322-93-6,
 1323-19-9, 7403-47-6, 68442-09-
 1, 127646-44-0, 908356-18-3).
                              * * * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Sodium alkyl                      Limited to no more  Surfactants,
 naphthalenesulfonates (CAS Reg.   than 30% by         related adjuvants
 Nos. 68909-83-1, 68909-84-2,      weight in           of surfactants
 68909-82-0, 27213-90-7, 26264-    pesticide end-use
 58-4, 27178-87-6, 111163-74-7,    products.
 908356-16-1, 25417-20-3, 25638-
 17-9, 145578-88-7, 1322-93-6,
 1323-19-9, 7403-47-6, 68442-09-
 1, 127646-44-0, 908356-18-3).
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18702 Filed 8-4-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53648-53650]
[FR Doc No: 2022-19050]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1056; Project Identifier MCAI-2022-00895-P;
Amendment 39-22153; AD 2022-18-02]
RIN 2120-AA64

Airworthiness Directives; MT-Propeller Entwicklung GmbH
Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain MT-Propeller Entwicklung GmbH MTV-5-1-( ), MTV-9-( ), MTV-11-(
), MTV-12-( ), MTV-14-B, MTV-14-D, MTV-15-( ), MTV-16-( ), MTV-17-( ),
MTV-18-( ), MTV-20-( ), and MTV-27-( ) variable pitch propellers. This
AD was prompted by reports of certain propeller blade lag screws that
were manufactured with an improper surface finish, which results in
reduced fatigue strength of these lag screws. This AD requires
replacement of certain propeller blade lag screws with parts eligible
for installation. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective September 16, 2022
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
16, 2022.
    The FAA must receive comments on this AD by October 17, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact MT-
Propeller Entwicklung GmbH, MT-Propeller USA, Inc., 1180 Airport
Terminal Drive, DeLand, FL 32724; phone:<PHONE_NUMBER>; email:
propellerusa.com">[email protected]propellerusa.com. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available at www.regulations.gov under Docket No. FAA-2022-1056.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov under Docket
No. FAA-2022-1056; or in person at Docket Operations between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for the Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA
01803; phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-1056; Project Identifier MCAI-
2022-00895-P'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
www.regulations.gov, including any personal information you provide.
The agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent Michael
Schwetz, Aviation Safety Engineer, Boston ACO Branch, FAA, 1200
District Avenue, Burlington, MA 01803. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2022-0134, dated July 6, 2022 (referred to after this as ``the
MCAI''), to address an unsafe condition for certain MTV-5, MTV-9, MTV-
12, MTV-14, MTV-15, MTV-16, MTV-18, and MTV-27 variable pitch
propellers, all models, having a serial number (S/N) identified in MT-
Propeller Entwicklung GmbH Alert Service Bulletin (ASB) No. 30,
Revision 7, dated June 23, 2022 (MT-Propeller ASB No. 30, Rev. 7); and
MTV-5, MTV-9, MTV-11, MTV-12, MTV-14, MTV-15, MTV-16, MTV-17, MTV-18,
MTV-20, and MTV-27 variable pitch propellers, any model, on which a
propeller blade is installed, having an S/N identified in MT-Propeller
ASB No. 30, Rev. 7. The MCAI states that in 2014, it was discovered
that a batch of non-conforming propeller blade lag screws were
manufactured with an improper surface finish, which results in reduced
fatigue strength for these lag screws. Further investigation revealed
that the non-conforming propeller blade lag screws were installed on
the blades of propellers manufactured during the period of November
2013 to October 2014 and on certain propellers and propeller blades
that were overhauled or repaired by MT-Propeller or an MT-Propeller
approved Service Center during the same period. MT-Propeller published
Service Bulletin No. 30, Original Issue, dated November 4, 2014,
identifying the S/Ns of the affected propellers and propeller blades
and specifying the replacement of the propeller blade lag screws with
serviceable propeller blade lag screws. MT-Propeller later published
MT-Propeller Entwicklung GmbH ASB No. 30, Revision 7, updating the S/Ns
of the affected propellers and propeller blades. This condition, if not
corrected, could lead to in-flight blade detachment,

resulting in damage to the airplane and reduced control of the
airplane. The FAA is issuing this AD to address the unsafe condition.
    You may examine the MCAI in the AD docket at www.regulations.gov
under Docket No. FAA-2022-1056.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed MT-Propeller Entwicklung GmbH ASB No. 30, Revision
7, dated June 23, 2022. This ASB identifies the S/Ns of the affected
propellers and propeller blades and specifies replacement of the
propeller blade lag screw. This ASB is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI and service information described above. The FAA is issuing
this AD after determining that the unsafe condition described
previously is likely to exist or develop on other products of the same
type design.

AD Requirements

    This AD requires the removal from service of any installed
propeller blade lag screw with part number (P/N) A-983-C-85 and the
replacement with a part eligible for installation.

Differences Between This AD and the MCAI

    The MCAI applies to certain MT-Propeller Entwicklung GmbH MTV-5,
MTV-9, MTV-11, MTV-12, MTV-14, MTV-15, MTV-16, MTV-17, MTV-18, MTV-20,
and MTV-27 variable pitch propellers, which are identified on the FAA
type certificates as MTV-5-1-( ), MTV-9-( ), MTV-11-( ), MTV-12-( ),
MTV-14-B, MTV-14-D, MTV-15-( ), MTV-16-( ), MTV-17-( ), MTV-18-( ),
MTV-20-( ), and MTV-27-( ) propellers, respectively.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because the improper surface finish on a propeller blade lag screw
results in reduced fatigue strength of the propeller blade lag screw.
Reduced fatigue strength could lead to in-flight blade detachment,
damage to the airplane, and reduced control of the airplane, which is
an immediate safety of flight problem. For turboprop engines, the
propeller blade lag screw must be replaced within 120 days from the
effective date of this AD or before exceeding 50 flight hours (FHs)
from the effective date of this AD, whichever occurs first. For piston
engines, the propeller blade lag screw must be replaced within 60 days
from the effective date of this AD or before exceeding 25 FHs from the
effective date of this AD, whichever occurs first. The compliance time
for the required actions is shorter than the time necessary to allow
for public comment and for the FAA to publish a final rule.
Accordingly, notice and opportunity for prior public comment are
impracticable and contrary to the public interest pursuant to 5 U.S.C.
553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forego notice and
comment.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 275 propellers installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace propeller blade lag screws on   12 work-hours x $85 per           $2,500          $3,520         $98,560
 MTV-11-( ), MTV-15-( ), MTV-17-( ),     hour = $1,020.
 and MTV-20-( ) propellers (28
 propellers).
Replace propeller blade lag screws on   18 work-hours x $85 per            3,000           4,530         742,920
 MTV-9-( ), MTV-12-( ), and MTV-18-( )   hour = $1,530.
 propellers (164 propellers).
Replace propeller blade lag screws on   22 work-hours x $85 per            3,500           5,370         150,360
 MTV-14-B, MTV-14-D, and MTV-16-( )      hour = $1,870.
 propellers (28 propellers).
Replace propeller blade lag screws on   30 work-hours x $85 per            5,000           7,550         415,250
 MTV-5-1-( ) and MTV-27( ) propellers    hour = $2,550.
 (55 propellers).
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in

Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-18-02 MT-Propeller Entwicklung GmbH: Amendment 39-22153; Docket
No. FAA-2022-1056; Project Identifier MCAI-2022-00895-P.

(a) Effective Date

    This airworthiness directive (AD) is effective September 16,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to MT-Propeller Entwicklung GmbH:
    (1) MTV-5-1-( ), MTV-9-( ), MTV-12-( ), MTV-14-B, MTV-14-D, MTV-
15-( ), MTV-16-( ), MTV-18-( ), and MTV-27-( ) variable pitch
propellers with a propeller serial number (S/N) identified in MT-
Propeller Entwicklung GmbH Alert Service Bulletin (ASB) No. 30,
Revision 7, dated June 23, 2022 (MT-Propeller ASB No. 30, Rev. 7);
and
    (2) MTV-5-1-( ), MTV-9-( ), MTV-11-( ), MTV-12-( ), MTV-14-B,
MTV-14-D, MTV-15-( ), MTV-16-( ), MTV-17-( ), MTV-18-( ), MTV-20-(
), and MTV-27-( ) variable pitch propellers with a propeller blade
S/N identified in MT-Propeller ASB No. 30, Rev. 7, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6100, Propeller
System.

(e) Unsafe Condition

    This AD was prompted by reports of certain propeller blade lag
screws that were manufactured with an improper surface finish, which
results in reduced fatigue strength of these lag screws. The FAA is
issuing this AD to prevent in-flight blade detachment. The unsafe
condition, if not addressed, could lead to release of the propeller,
damage to the airplane, and reduced control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) If the affected propeller or propeller blade is installed on
a turboprop engine, before exceeding 120 days from the effective
date of this AD, or within 50 flight hours (FHs) from the effective
date of this AD, whichever occurs first, remove from service any
propeller blade lag screw with part number (P/N) A-983-C-85 and
replace with a part eligible for installation.
    (2) If the affected propeller or propeller blade is installed on
a piston engine, before exceeding 60 days from the effective date of
this AD, or within 25 FHs from the effective date of this AD,
whichever occurs first, remove from service any propeller blade lag
screw with P/N A-983-C-85 and replace with a part eligible for
installation.

(h) Definition

    For the purpose of this AD, a ``part eligible for installation''
is any propeller blade lag screw with P/N A-983-D-85 or P/N A-983-E-
85.

(i) Installation Prohibition

    After the effective date of this AD, do not install a propeller
blade lag screw with P/N A-983-C-85 onto any propeller or propeller
blade.

(j) Credit for Previous Actions

    You may take credit for the actions required by paragraph (g) of
this AD if the actions were performed before the effective date of
this AD using MT-Propeller Entwicklung GmbH Alert Service Bulletin
No. 30, Revision 6, dated January 18, 2022, or earlier versions of
this service information.

(k) Alternative Methods of Compliance (AMOCs)

    The following provisions also apply to this AD.
    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in Sec.  39.19. In accordance with Sec.  39.19, send your request to
your principal inspector or local Flight Standards District Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (l)(2) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Additional Related Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2022-0134, dated July 6, 2022, for related information. This EASA AD
may be found in the AD docket at www.regulations.gov under Docket
No. FAA-2022-1056.
    (2) For more information about this AD, contact Michael Schwetz,
Aviation Safety Engineer, Boston ACO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; email: [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) MT-Propeller Entwicklung GmbH Alert Service Bulletin No. 30,
Revision 7, dated June 23, 2022.
    (ii) [Reserved]
    (3) For MT-Propeller Entwicklung GmbH service information
identified in this AD, contact MT-Propeller Entwicklung GmbH, MT-
Propeller USA, Inc., 1180 Airport Terminal Drive, DeLand, FL 32724;
phone:<PHONE_NUMBER>; email: propellerusa.com">[email protected]propellerusa.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 17, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-19050 Filed 8-30-22; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Rules and Regulations]
[Pages 37103-37104]
[FR Doc No: 2013-14657]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0484; Airspace Docket No. 13-AGL-16]
RIN 2120-AA66

Amendment of VOR Federal Airways V-55 and V-169 in Eastern North
Dakota

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, technical amendment.

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

SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-55 and V-169 in eastern North Dakota. The FAA is taking this
action to amend the airway descriptions contained in Part 71 by
removing reference to special use airspace (SUA) exclusionary language
no longer needed.

DATES: Effective date 0901 UTC, August 22, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy and ATC
Procedures Group, Office of Mission Support Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    In 1979, the FAA took action to amend VOR Federal airways V-55 (44
FR 43714, July 26, 1979) and V-169 (44 FR 24543, April 26, 1979) by
adding airway segments that extended the airways through the Devils
Lake East and Devils Lake West Military Operations Areas (MOAs). The
amendments extended V-55 westward by adding an airway segment from
Grand Forks, ND, to Bismarck, ND, through the existing Devils Lake East
MOA and extended V-169 northward by adding an airway segment from
Bismarck, ND, to Devils Lake, ND, through the Devils Lake West MOA. At
that time, the Devils Lake East MOA existed from 3,500 feet mean sea
level (MSL) to 10,000 feet MSL and the Devils Lake West MOA existed
from 4,000 feet MSL to 10,000 feet MSL. As part of the amendment
actions to V-55 and V-169, the airway descriptions excluded the
airspace contained within the associated MOA lateral boundary and
altitudes from the affected airway.
    In 1980, the FAA circularized a proposal to change the boundary
between the Devils Lake East and Devils Lake West MOAs and to raise the
ceiling of the Devils Lake East MOA from 10,000 feet MSL to a ceiling
of to, but not including, flight level (FL) 180. Within the proposed
Devils Lake East MOA, V-55 would be available for non-participating
aircraft either at 11,000 feet and above during low level intercept
training (3,500 feet MSL to 10,000 feet MSL) or at 9,000 feet MSL and
below during Basic Fighter Maneuvers (BFM) training (10,000 feet MSL
and above) being conducted by the military. In 1981, the proposed
action was approved and the MOAs amended accordingly; unfortunately, no
action was taken with respect to the existing exclusionary language
contained in the V-55 description under Part 71 when the Devils Lake
East MOA was raised.
    In 1987, the FAA circularized a similar proposal to raise the
ceiling of the Devils Lake West MOA from 10,000 feet MSL to a ceiling
of to, but not including, FL 180. The proposed action was approved in
the same year and the MOA ceiling was amended accordingly. Again, no
action was taken with respect to the existing exclusionary language
contained in the V-169 description under Part 71 when the Devils Lake
West MOA ceiling was raised.
    The FAA notes there are numerous MOAs throughout the National
Airspace System (NAS) that have VOR Federal airways charted through
them, with no exclusionary language contained in those airway
descriptions. In fact, the Devils Lake East MOA has three VOR Federal
airways that extend through it, but only V-55 contains exclusionary
language relative to the MOA. It is standard procedure for air traffic
control (ATC) to re-route instrument flight rules (IFR) aircraft
operating on Federal airways when the airway lies within an active MOA
and IFR separation from

military activity in the MOA cannot be provided by ATC. The guidance
describing this procedure is published in FAA Order 7110.65, Air
Traffic Control, and the Aeronautical Information Manual for controller
and pilot awareness, respectively. Additionally, although pilots
operating under visual flight rules (VFR) should exercise extreme
caution while flying within a MOA when military activity is being
conducted, MOAs are not restrictive to VFR aircraft, which opt to fly
the same routing as a VOR Federal airway, at VFR altitudes, through an
active MOA. Removing the SUA exclusionary language contained in the V-
55 and V-169 legal descriptions, which is redundant to existing ATC
procedures does not affect the operational use or services provided by
ATC to aircraft operating on the airways.
    Accordingly, since this amendment is administrative in nature,
having no impact to the operational use or ATC services provided to
pilots flying on V-55 and V-169, notice and public procedures under
Title 5 U.S.C. 553(b) are unnecessary.

The Rule

    The FAA amends Title 14, Code of Federal Regulations part 71 by
amending the legal descriptions of VOR Federal airways V-55 and V-169
in the vicinity of Devils Lake, ND. Specifically, the FAA amends the V-
55 description by removing the exclusionary language associated with
the Devils Lake East MOA and amends the V-169 description by removing
the exclusionary language associated with the Devils Lake West MOA.
    VOR Federal airways are listed in paragraph 6010 of FAA Order
7400.9W dated August 8, 2012, and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document will be revised subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that only affects air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it amends existing VOR Federal airways within the NAS.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with 311a, FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures.'' This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6010 VOR Federal Airways.

    (a) Domestic VOR Federal airways.
* * * * *

V-55

    From Dayton, OH; Fort Wayne, IN; Goshen, IN; Gipper, MI; Keeler,
MI; Pullman, MI; Muskegon, MI; INT Muskegon 327[deg] and Green Bay,
WI, 116[deg] radials; Green Bay; Stevens Point, WI; INT Stevens
Point 281[deg] and Eau Claire, WI, 107[deg] radials; Eau Claire;
Siren, WI; Brainerd, MN; Park Rapids, MN; Grand Forks, ND; INT Grand
Forks 239[deg] and Bismarck, ND, 067[deg] radials; to Bismarck.
* * * * *

V-169

    From Tobe, CO; 69 MSL, Hugo, CO; 38 miles, 67 MSL, Thurman, CO;
Akron, CO; Sidney, NE; Scottsbluff, NE; Toadstool, NE; Rapid City,
SD; Dupree, SD; Bismarck, ND; to Devils Lake, ND.

    Issued in Washington, DC, June 13, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-14657 Filed 6-19-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 28, 2007 (Volume 72, Number 166)]
[Proposed Rules]
[Page 49243-49244]
[DOCID:fr28au07-44]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2007-0285; FRL-8460-1]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Shipyard Facilities and Provisions for Distance Limitations,
Setbacks, and Buffers in Standard Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision for the State of Texas. This revision adds provisions which
incorporate the evaluation of emissions from dockside vessels when
reviewing applications for permits for new and modified sources and
certain other administrative changes to its air permitting
requirements. It also adds provisions concerning compliance with
distance limitations, setbacks, and buffers at facilities that are
authorized to construct or modify under an air quality standard permit.
The Commission submitted this amendment to EPA to process as a revision
to the Texas SIP. This action is being taken under section 110 of the
Federal Clean Air Act (the Act).

DATES: Written comments must be received on or before September 27,
2007.

ADDRESSES: Comments may be mailed to Mr. Stanley M. Spruiell, Air
Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Mr. Stanley M. Spruiell, Air Permits
Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>;
fax number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action, no further activity is contemplated. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should 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.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: August 16, 2007.
Richard E. Greene,
Regional Administrator, Region 6.
[FR Doc. E7-16830 Filed 8-27-07; 8:45 am]

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