[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Rules and Regulations]
[Page 62468-62469]
[DOCID:fr12oc10-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0861]

Drawbridge Operation Regulations; Saugatuck River, Saugatuck, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Saga Railroad Bridge across the Saugatuck River, mile 1.1, at
Saugatuck, Connecticut. The deviation is necessary to facilitate
scheduled rehabilitation maintenance at the bridge. Under this
deviation the bridge may remain in the closed position from October 1,
2010 through October 17, 2010.

DATES: This deviation is effective with constructive notice from
October 12, 2010 through October 17, 2010, and for enforcement with
actual notice from October 1, 2010 through October 12, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0861 and are available online
at http://www.regulations.gov, inserting USCG-2010-0861 in the
``Keyword'' and then clicking ``Search.'' They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Ms. Judy K. Leung-Yee, Project Officer, First Coast
Guard District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Saga Railroad Bridge across the
Saugatuck River at mile 1.1, has a vertical clearance of 13 feet at
mean high water and 20 feet at mean low water. The drawbridge operation
regulations are listed at 33 CFR 117.221(b).
    The owner of the bridge, Metro North Railroad, requested a
temporary deviation from the regulations to facilitate scheduled
maintenance, track tie replacement, from October 1, 2010 through
October 17, 2010.
    The normal waterway users are predominantly recreational craft of
various sizes.
    Under this temporary deviation the Saga Railroad Bridge may remain
in the closed position from October 1, 2010 through October 17, 2010,
to facilitate rehabilitation maintenance at the bridge.
    Vessels that can pass under the bridge in the closed position may
do so at any time.
    Waterway users were advised of the requested bridge and channel
closure and offered no objection.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 28, 2010.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2010-25494 Filed 10-8-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27261-27268]
[FR Doc No: 2011-11564]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 180

[EPA-HQ-OPP-2009-1009; FRL-8873-2]

Propiconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
propiconazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project
4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). In addition, this action establishes a
time-limited tolerance for residues of propiconazole in or on avocado,
in response to the approval of a quarantine exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use to
control the disease, laurel wilt (caused by Raffaelea lauricola) in the
state of Florida. This regulation establishes a maximum permissible
level of residues of propiconazole in this food commodity. The time-
limited tolerance expires and is revoked on December 31, 2013.

DATES: This regulation is effective May 11, 2011. Objections and
requests for hearings must be received on or before July 11, 2011, 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-2009-1009. 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: Andrew Ertman, 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://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. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-1009 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 11, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-1009, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), 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
9E7659) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.434 be amended by
establishing tolerances for residues of the fungicide propiconazole,
(1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-
1,2,4-triazole) and its metabolites determined as 2,4-dichlorobenzoic
acid and expressed as parent compound, in or on onion, bulb, subgroup
3-07A at 0.2 parts per million (ppm); onion, green, subgroup 3-07B at
9.0 ppm; caneberry subgroup 13-07A at 1.0 ppm; bushberry subgroup 13-
07B at 1.0 ppm; and low growing berry subgroup 13-07G, except cranberry
at 1.3 ppm. The petition also proposed to amend the tolerances in 40
CFR 180.434 by increasing the tolerances in or on peppermint, tops and
spearmint, tops from 3.5 ppm to 10 ppm; and by removing the tolerances
for berry group 13 at 1.0 ppm; onion, bulb at 0.2 ppm; onion, green at
9.0 ppm and strawberry at 1.3 ppm. That notice referenced a summary of
the petition prepared by Syngenta, the registrant, which is available
in the docket, http://www.regulations.gov. Comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit IV.C.
    EPA is also establishing a time-limited tolerance for residues of
propiconazole in or on avocado at 10 ppm. This tolerance expires and is
revoked on December 31, 2013. The Agency is establishing this time-
limited tolerance in response to a quarantine exemption request under
FIFRA section 18 on behalf of the Florida Department of Agriculture and
Consumer Services for emergency use of propiconazole to control the
disease, laurel wilt, in avocado.
    According to the applicant, an emergency situation exists due to
the introduction of laurel wilt, a disease affecting avocado trees
caused by the pathogenic fungus Raffaelea lauricola. This fungus is
vectored by the redbay ambrosia beetle, a newly introduced species,
native to Asia, which has moved rapidly toward the avocado production
area since its initial discovery in Georgia in 2002. Avocado tree death
from laurel wilt has been documented and research has demonstrated that
the redbay ambrosia beetle attacks healthy avocado trees from all 22
cultivars tested so far. Control of the vector, the redbay ambrosia
beetle, is problematic since inoculation of a tree requires only 1
beetle, the beetle is capable of flight to escape insecticide
treatments, and the two currently registered insecticides will not
provide the necessary year-round control due to limits in residual
activity and number of applications allowed. Once a tree is infected
with the disease, there is no cure and the tree will die. For these
reasons, the applicant states that the potential impact of this disease
on avocado growing and production could be devastating. The applicant
states that the avocado producing areas are under severe threat from
laurel wilt, and control through a suitable fungicide, such as the
requested material, is essential to protecting

continued production of avocado in Florida as well as protecting other
susceptible tree species in the U.S. EPA has authorized under FIFRA
section 18 the use of propiconazole on avocado in Florida. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this state.
    As part of its assessment of the emergency exemption request, EPA
assessed the potential risks presented by the residues of propiconazole
in avocado, as discussed below. In doing so, EPA considered the safety
standard in section 408(b)(2) of the FFDCA and EPA decided that the
necessary time-limited tolerance under section 408(l)(6) of the FFDCA
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address the urgent non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing this time-limited
tolerance without notice and opportunity for public comment as provided
in section 408(l)(6) of the FFDCA. Although, this time-limited
tolerance expires and is revoked on December 31, 2013, under section
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the
amount specified in the tolerance remaining in or on avocado after that
date will not be unlawful provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this time-limited tolerance at the time of
application. EPA will take action to revoke this time-limited tolerance
earlier if any experience with, scientific data, or other relevant
information on this pesticide indicates that the residues are not safe.
    Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decision about whether
propiconazole meets EPA's registration requirements for use on avocado
or whether a permanent tolerance for this use would be appropriate.
Under this circumstance, EPA does not believe that the time-limited
tolerance serves as a basis for registration of propiconazole by a
State for special local needs under FIFRA section 24(c). Nor does the
time-limited tolerance serve as the basis for any State other than
Florida to use this pesticide on this crop under section 18 of FIFRA
without following all provisions of EPA's regulations implementing
FIFRA section 18 as identified in 40 CFR part 166.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
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.
    Propiconazole has low to moderate toxicity in experimental animals
by the oral, dermal and inhalation routes. It is moderately irritating
to the eyes, and minimally irritating to the skin. It is a dermal
sensitizer. Propiconazole is readily absorbed by the rat skin with 40%
absorption within 10 hours of dermal application.
    The primary target organ for propiconazole toxicity in animals is
the liver. Increased liver weights were seen in mice after subchronic
or chronic oral exposures to propiconazole at doses greater than 50
milligrams/kilograms/day (mg/kg/day). Liver lesions such as vacuolation
of hepatocytes, ballooned liver cells, foci of enlarged hepatocytes,
hypertrophy and necrosis are characteristic of propiconazole toxicity
in rats and mice. Mice appear to be more susceptible to its toxicity
than rats. Decreased body weight gain in experimental animals was seen
in subchronic, chronic, developmental and reproductive studies. Dogs
appeared to be more sensitive to the localized toxicity of
propiconazole as manifested by stomach irritation at 6 mg/kg/day and
above.
    In rabbits, developmental toxicity occurred at a higher dose than
the maternal toxic dose, while in rats, developmental toxicity occurred
at lower doses than maternal toxic doses. Increased incidences of
rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats developmental effects (incomplete ossification
of the skull, caudal vertebrae and digits, extra rib (14th rib) and
missing sternebrae, malformations of the lung and kidneys) were
reported at doses that were not maternally toxic.
    In the 2-generation reproduction study in rats, offspring toxicity
occurred at a higher dose than the parental toxic dose suggesting lower
susceptibility of the offspring to the toxic doses of propiconazole in
this study.
    Propiconazole was negative for mutagenicity in the in vitro BALB/C
3T3 cell transformation assay, bacterial reverse mutation assay,
Chinese hamster bone marrow chromosomal aberration assay, unscheduled
DNA synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay and the dominant lethal assay in mice.
Hepatocellular proliferation studies in mice suggest that propiconazole
induces cell proliferation followed by treatment-related hypertrophy in
a manner similar to the known hypertrophic agent phenobarbital.
    Propiconazole was carcinogenic to male mice. Propiconazole was not
carcinogenic to rats nor to female mice. The Agency classified
propiconazole as Group C possible human carcinogen and recommended that
for the purpose of risk characterization the reference dose (RfD)
approach be used for quantification of human risk. Propiconazole is not
genotoxic and this fact, together with special mechanistic studies,
indicate that propiconazole is a threshold carcinogen. Propiconazole
produced liver tumors in male mice only at a high dose that was toxic
to the liver. At doses below the RfD liver

toxicity is not expected, and therefore tumors are also not expected.
    Specific information on the studies received and the nature of the
adverse effects caused by propiconazole 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 docket ID number EPA-HQ-OPP-2009-1009 on pages
34-40 in the document titled ``Revised Propiconazole Human Health Risk
Assessment for a Section 3 Registration on Mint, Bulb Vegetables,
Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, and Low Growing
Berry Subgroup 13-07G''

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

  Table--Summary of Toxicological Doses and Endpoints for Propiconazole 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 (Females 13-50 years   NOAEL = 30 milligrams/  Acute RfD =0.3 mg/kg/   DNT Study--Rat.
 of age).                             kilograms/day (mg/kg/   day.                   LOAEL = 90 mg/kg/day based
                                      day).                  aPAD = 0.3 mg/kg/day..   on increased incidence of
                                     UFA = 10x.............                           rudimentary ribs, un-
                                     UFH = 10x.............                           ossified sternebrae, as
                                     FQPA SF = 1x..........                           well as increased
                                                                                incidence of shortened and
                                                                                absent renal papillae and
                                                                                increased cleft palate.
Acute dietary (General population    NOAEL = 30 mg/kg/day..  Acute RfD = 0.3 mg/kg/  Acute neurotoxicity study
 including infants and children).    UFA = 10x.............   day.                    Rat.
                                     UFH = 10x.............  aPAD = 0.3 mg/kg/day..  LOAEL = 100 mg/kg/day based
                                     FQPA SF = 1x..........                           on clinical signs of
                                                                                toxicity (piloerection in
                                                                                one male, diarrhea in one
                                                                                female, tip toe gait in 3
                                                                                females).
Chronic dietary (All populations)..  NOAEL= 10 mg/kg/day...  Chronic RfD = 0.1 mg/   24-month oncogenicity study
                                     UFA = 10x.............   kg/day.                 on CD-1 mice.
                                     UFH = 10x.............  cPAD = 0.1 mg/kg/day..  LOAEL = 50 mg/kg/day based
                                     FQPA SF = 1x..........                           on non-neoplastic liver
                                                                                effects (increased liver
                                                                                weight in males and
                                                                                increase in liver lesions:
                                                                                masses/raised areas/
                                                                                swellings/nodular areas
                                                                                mainly).
Incidental Oral Exposure (Short-     Oral study............  LOC for MOE = 100.....  Acute Neurotoxicity Study--
 Term) and Dermal short-term (1 to   NOAEL = 30 mg/kg/day                             Rats.
 30 days).                            dermal absorption                              LOAEL = 100 mg/kg/day based
                                      rate = 40% exposures.                           on clinical signs of
                                     UFA = 10x.............                           toxicity (piloerection in
                                     UFH = 10x.............                           one male, diarrhea in one
                                     FQPA SF = 1x..........                           female, tip toe gait in 3
                                                                                females).
Incidental Oral Exposure             Oral study............  LOC for MOE = 100.....  24 Month Oncogenicity
 (Intermediate-Term) and Dermal      NOAEL= 10 mg/kg/day                              Study--Mice.
 intermediate-term (1 to 6 months).   dermal absorption                              LOAEL = 50 mg/kg/day based
                                      rate = 40% for dermal                           on non-neoplastic liver
                                      exposures.                                      effects (increased liver
                                     UFA = 10x.............                           weight in males and
                                     UFH = 10x.............                           increase in liver lesions:
                                     FQPA SF = 1x..........                           masses/raised areas/
                                                                                swellings/nodular areas
                                                                                mainly).
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  Acute Neurotoxicity Study--
 days).                               study.                                          Rats.
                                     NOAEL= 30 mg/kg/day                             LOAEL = 100 mg/kg/day based
                                      (inhalation                                     on clinical signs of
                                      absorption rate =                               toxicity (piloerection in
                                      100%).                                          one male, diarrhea in one
                                     UFA = 10x.............                           female, tip toe gait in 3
                                     UFH = 10x.............                           females).
                                     FQPA SF = 1x..........
                                    ----------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)..   Classification: Group C, possible human carcinogen, RfD approach for risk
                                                                   characterization.
----------------------------------------------------------------------------------------------------------------
 UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole 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 propiconazole. In estimating acute
dietary exposure, 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, EPA used tolerance levels and 100 percent crop treated
(PCT) for all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance levels
and 100 PCT for all existing and proposed uses.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to propiconazole. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for propiconazole. 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 propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
propiconazole for acute exposures are estimated to be 55.78 parts per
billion (ppb) for surface water and 0.64 ppb for ground water, for
chronic exposures for non-cancer assessments are estimated to be 21.61
ppb for surface water and 0.64 ppb for ground water and for chronic
exposures for cancer assessments are estimated to be 13.24 ppb for
surface water and 0.64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 55.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 21.6 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Propiconazole is
currently registered for the following uses that could result in
residential exposures: Turf, ornamentals and in paint. EPA assessed
residential exposure using the following assumptions: Short-term risk
to toddlers was assessed for incidental oral and dermal exposure. The
highest incidental oral and dermal exposure scenarios are expected from
residential use on turf. Short-term risk to adults was assessed for
dermal and inhalation residential handler exposure as well as dermal
exposure for residential post-application. Adult handlers have some
inhalation exposure however, based on the low vapor pressure of
propiconazole, negligible post application inhalation exposure is
anticipated to occur. The highest post application exposure from
residential use on turf was used to assess risk to short term aggregate
exposures.
    The only residential use scenario that will result in potential
intermediate-term exposure to propiconazole is dermal and incidental
oral post application exposure to children from wood treatment
(antimicrobial use).
    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.''
    Propiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same,

or essentially the same, sequence of major biochemical events (EPA,
2002). In conazoles, however, a variable pattern of toxicological
responses is found. Some are hepatotoxic and hepatocarcinogenic in
mice. Some induce thyroid tumors in rats. Some induce developmental,
reproductive, and neurological effects in rodents. Furthermore, the
conazoles produce a diverse range of biochemical events including
altered cholesterol levels, stress responses, and altered DNA
methylation. It is not clearly understood whether these biochemical
events are directly connected to their toxicological outcomes. Thus,
there is currently no evidence to indicate that conazoles share common
mechanisms of toxicity and EPA is not following a cumulative risk
approach based on a common mechanism of toxicity for the conazoles. For
information regarding EPA's procedures for cumulating effects from
substances found to have a common mechanism of toxicity, see EPA's Web
site at http://www.epa.gov/pesticides/cumulative.
    Propiconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including propiconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X Food Quality Protection Act (FQPA) safety
factor (SF) for the protection of infants and children. The assessment
includes evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment is found in the propiconazole reregistration docket at
http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-
OPP-2005-0497 and an update to assess the addition of the commodities
included in this action may be found in docket ID number EPA-HQ-OPP-
2009-1009 in the documents titled ``Common Triazole Metabolites:
Updated Dietary (Food + Water) Exposure and Risk Assessment to Address
The Section 3 Request for Propiconazole on Mint, Bulb Vegetables
Subgroups 3-07A and 3-07B, Caneberry Subgroup 13-07A, Bushberry
Subgroup 13-07B, and Low growing Berry Subgroup 13-07G'' and ``Common
Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk
Assessment to Address The Section 18 Request for Propiconazole on
Avocado in Florida.''

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is low concern for
prenatal and/or postnatal toxicity resulting from exposure to
propiconazole. In the developmental toxicity study in rats, fetal
effects observed in this study at a dose lower than that evoking
maternal toxicity are considered to be quantitative evidence of
increased susceptibility of fetuses to in utero exposure to
propiconazole. In the developmental toxicity study in rabbits, neither
quantitative nor qualitative evidence of increased susceptibility of
fetuses to in utero exposure to propiconazole was observed in this
study. In the 2-generation reproduction study in rats, neither
quantitative nor qualitative evidence of increased susceptibility of
neonates (as compared to adults) to prenatal and/or postnatal exposure
to propiconazole was observed in this study. There is no evidence of
neuropathology or abnormalities in the development of the fetal nervous
system from the available toxicity studies conducted with
propiconazole. In the rat acute neurotoxicity study, there was evidence
of mild neurobehavioral effects at 300 mg/kg, but no evidence of
neuropathology from propiconazole administration. Since there was
quantitative evidence of increased susceptibility of the young
following exposure to propiconazole in the developmental rat study, the
Agency performed a Degree of Concern Analysis and concluded that the
degree of concern for the effects observed in this study was low and no
residual uncertainties were identified, for the reasons explained in
this Unit.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for propiconazole is complete except for
the lack of immunotoxicity and subchronic neutotoxicity studies. In the
absence of specific immunotoxicity studies, EPA has evaluated the
available propiconazole toxicity data to determine whether an
additional database uncertainty factor is needed to account for
potential immunotoxicity. There was no evidence of adverse effects on
the organs of the immune system in any propiconazole study. In
addition, propiconazole does not belong to a class of chemicals (e.g.,
the organotins, heavy metals, or halogenated aromatic hydrocarbons)
that would be expected to be immunotoxic. Based on the considerations
in this Unit, EPA does not believe that conducting a special Harmonized
Guideline 870.7800 immunotoxicity study will result in a POD less than
the NOAEL of 10.0 mg/kg/day used in calculating the cPAD for
propiconazole, and therefore, an additional database uncertainty factor
is not needed to account for potential immunotoxicity.
    In the absence of the subchronic neurotoxicity study, EPA has
evaluated the available propiconazole toxicity data to determine
whether an additional database uncertainty factor is needed to account
for potential neurotoxicity after repeated exposures. With the
exception of the developmental studies in the rat, there were no
indications in any of the repeated dose studies that propiconazole is
neurotoxic. In the developmental studies in the rat, there were some
clinical signs of neurotoxicity at 300 mg/kg/day but not at lower
doses. Based on the considerations in this Unit, EPA does not believe
that conducting a Harmonized Guideline 870.6200b subchronic
neurotoxicity study will result in a POD less than the NOAEL of 10 mg/
kg/day used in calculating the cPAD for propiconazole, and therefore,
an additional database uncertainty factor is not needed to account for
potential neurotoxicity from repeated exposures. There is no indication
in the developmental and reproduction studies, or in the acute
neurotoxicity

study that a developmental neurotoxicity study should be required.
    ii. There is no evidence of neuropathology or abnormalities in the
development of the fetal nervous system from the available toxicity
studies conducted with propiconazole. In the rat acute neurotoxicity
study, there was evidence of mild neurobehavioral effects at 300 mg/kg,
but no evidence of neuropathology from propiconazole administration.
    iii. Although an apparent increased quantitative susceptibility was
observed in fetuses and offspring based on minimal toxicity at high
doses of administration, clear NOAELs and LOAELs have been identified
for all effects of concern, and a clear dose-response has been well
defined. Since this increased susceptibility is occurring at high doses
and a clear dose response has been well defined for all effects of
concern, residual uncertainties or concerns for prenatal and/or
postnatal toxicity are minimal.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propiconazole in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
propiconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propiconazole will occupy 17% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propiconazole from food and water will utilize 18% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
propiconazole is not expected.
    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).
    Propiconazole is 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 propiconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 160 for toddlers
(children 1 to 2 years old), between 120 and 4,400 for adults from
handler activities, and 330 for adults from post-application
activities. Because EPA's level of concern for propiconazole is a MOE
of 100 or below, 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).
    Propiconazole is 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 propiconazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 120 for toddlers (children 1 to 2 years old). Because
EPA's level of concern for propiconazole is a MOE of 100 or below,
these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to propiconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (HPLC/UV Method AG-671A) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    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 propiconazole for any of
the subject crops in this document.

C. Response to Comments

    A comment was received from a private citizen objecting to
establishment of tolerances stating that residues should be zero. The
Agency has received similar comments from this commenter on numerous
previous occasions. Refer to Federal Register 70 FR 37686, June 30,
2005; 70 FR 1354, January 7, 2005; 69 FR 63096, October 29, 2004 for
the Agency's response to these objections.

V. Conclusion

    Therefore, tolerances are established for residues of
propiconazole, (1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole) and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound as set forth in
the regulatory text. In addition this regulation establishes a time-
limited tolerance for residues of propiconazole in or on avocado at 10
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 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 (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 (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995, Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 2, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Amend Sec.  180.434 as follows:
0
i. In the table to paragraph (a), remove the entries for ``berry group
13,'' ``onion, bulb,'' ``onion, green,'' and ``strawberry''; revise the
entries for ``peppermint, tops'' and ``spearmint, tops'', and add
alphabetically entries for ``bushberry, subgroup 13-07B,'' ``caneberry,
subgroup 13-07A,'' ``low growing berry subgroup 13-07G, except
cranberry,'' ``onion, bulb subgroup 3-07A,'' and ``onion, green,
subgroup 3-07B.''
0
ii. In the table to paragraph (b) add alphabetically and entry for
``avocado.''
    The added and revised text reads as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Bushberry, subgroup 13-07B.................................          1.0
Caneberry, subgroup 13-07A.................................          1.0

                                * * * * *
Low growing berry subgroup 13-07G, except cranberry........          1.3

                                * * * * *
Onion, bulb subgroup 3-07A.................................          0.2
Onion, green, subgroup 3-07B...............................          9.0

                                * * * * *
Peppermint, tops...........................................         10.0

                                * * * * *
Spearmint, tops............................................         10.0

                                * * * * *
------------------------------------------------------------------------

     (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
Avocado.....................................            10      12/31/13

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-11564 Filed 5-10-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2908-2909]
[FR Doc No: 2023-00844]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-55-026.
    Applicants: Homer City Generation, L.P.
    Description: Triennial Market Power Analysis for Northeast Region
of Homer City Generation, L.P.
    Filed Date: 12/30/22.
    Accession Number: 20221230-5391.
    Comment Date: 5 p.m. ET 3/13/23.

    Docket Numbers: ER17-1217-001.
    Applicants: Total Gas & Power North America, Inc.
    Description: Supplement to October 28, 2022, Notice of Non-Material
Change in Status of TotalEnergies Gas & Power North America, Inc., et
al.
    Filed Date: 1/10/23.
    Accession Number: 20230110-5180.
    Comment Date: 5 p.m. ET 1/31/23.

    Docket Numbers: ER22-1165-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Order No. 676-J Compliance
Revisions to be effective 6/2/2022.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5144.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-277-002.
    Applicants: Westlake US 2 LLC.
    Description: Tariff Amendment: Amendment to Region Status Update in
Docket ER23-277 to be effective 1/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5051.
    Comment Date: 5 p.m. ET 1/23/23.

    Docket Numbers: ER23-425-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Request to Defer Action on Amendment
to WMPA, SA No. 6062 to be effective 12/31/9998.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5037.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-481-000.
    Applicants: TotalEnergies Gas & Power North America, Inc.
    Description: Supplement and Clarification of Request for Waiver of

Prior Notice to November 22, 2022 TotalEnergies Gas & Power North
America, Inc. submits tariff filing Updated Market Based Rate Tariff
submitted on 11/22/2022.
    Filed Date: 1/10/23.
    Accession Number: 20230110-5177.
    Comment Date: 5 p.m. ET 1/31/23.

    Docket Numbers: ER23-803-000.
    Applicants: Invenergy Solar Project Development LLC.
    Description: Invenergy Solar Project Development LLC Requests a
Prospective Waiver of Section <IP_ADDRESS>.1 of Attachment S of the New
York Independent System Operator, Inc. OATT.
    Filed Date: 1/10/23.
    Accession Number: 20230110-5179.
    Comment Date: 5 p.m. ET 1/20/23.

    Docket Numbers: ER23-804-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original NSA, Service
Agreement No. 6761; Queue No. AF1-021 to be effective 12/13/2022.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5013.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-805-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Tariff Clean-Up Filing
Effective 20211001 to be effective 10/1/2021.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5043.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-806-000.
    Applicants: Wolverine Power Supply Cooperative, Inc.
    Description: Sec.  205(d) Rate Filing: Second Amended and Restated
Transmission Interconnection Facilities Agreement to be effective 3/13/
2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5047.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-807-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: GIA & DSA, BCE Los Alamitos
2 1st Amend (WDT1583-SA Nos. 1141-1142) to be effective 3/13/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5052.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-808-000.
    Applicants: Black Hills Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to GDEMA with MDU
Related to WEIS Integration to be effective 4/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5053.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-809-000.
    Applicants: Black Hills Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to GDEMA with BHW
Related to WEIS Integration to be effective 4/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5062.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-810-000.
    Applicants: Black Hills Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to GDEMA with
BHCOE Related to WEIS Integration to be effective 4/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5064.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-811-000.
    Applicants: Black Hills Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to GDEMA with
Gillette Related to WEIS Integration to be effective 4/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5066.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-812-000.
    Applicants: Black Hills Power, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to GDEMA with CLFP
Related to WEIS Integration to be effective 4/1/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5070.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-813-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 6740;
Queue No. AC1-194 & Cancellation of IISA, SA No. 6156 to be effective
12/15/2022.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5077.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-814-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 6756;
Queue No. AF1-105 to be effective 12/16/2022.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5081.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-815-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Sec.  205(d) Rate Filing: Attachment H Clean Up Filing
to be effective 9/1/2021.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5082.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-816-000.
    Applicants: System Energy Resources, Inc.
    Description: Sec.  205(d) Rate Filing: SERI Compliance Report and
Limited Extension Request (EL18-152) to be effective 12/31/9998.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5117.
    Comment Date: 5 p.m. ET 2/1/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 11, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-00844 Filed 1-17-23; 8:45 am]
BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, OECA, Manufacturing, Energy, and Trans. Div. 2. OMB control number b. G None a 2060 0114 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS  Wool Fiberglass Insulation Manufacturing Plants, 40 CFR Part 60, Subpart PPP NESHAP  MACT  Wool Fiberglass Manufacturing Plants, 40 CFR Part 63, Subpart NNN 8. Agency form number( s) ( If applicable) 1160.06 9. Keywords Environmental Protection, Air pollution control, Clean Air Act 10. Abstract This ICR includes two Clean Air Act standards for the wool fiberglass industry; NSPS Subpart PPP and MACT Subpart NNN. Both the NSPS and MACT standards include basic recordkeeping and reporting including initial notifications, performance testing, semiannual excess emission reports, and occurrence of any startup, shutdown, or malfunction in the operation of an affected facility.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 29 b. Total annual responses 128 1. Percentage of these responses collected electronically % c. Total annual hours requested 19,098 d. Current OMB inventory 19,210 e. Difference ( 112) f. Explanation of difference 1. Program Change 2. Adjustment ( 112) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 204 b. Total annual costs ( O& M) 485 c. Total annualized cost requested 689 d. Current OMB inventory 625 e. Difference 64 f. Explanation of difference 1. Program change 2. Adjustment 64 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. X Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initial & semiannual 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Gregory Fried Phone: ( 202) 564 7016 OMB 83 I 12/ 99 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official John B. Rasnic, Director Manufacturing, Energy, and Transportation Division Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Information ( OPPE) Date OMB 83 I 12/ 99


[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36321-36322]
[FR Doc No: 2023-11751]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1729]

Migraine: Developing Drugs for Preventive Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Migraine: Developing Drugs for Preventive Treatment.'' This draft
guidance document is intended to assist sponsors in the clinical
development of drugs for the preventive treatment of migraine. The
draft guidance is intended to complement, not replace, the guidance for
industry ``Migraine: Developing Drugs for Acute Treatment,'' and
focuses on specific drug development and trial design issues that are
unique to the study of drugs for the preventive treatment of migraine.
This draft guidance is intended to serve as a focus for continued
discussions among FDA's Division of Neurology II, sponsors, the
academic community, and the public.

DATES: Submit either electronic or written comments on the draft
guidance by August 1, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-1729 for ``Migraine: Developing Drugs for Preventive
Treatment.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management

Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Heather Fitter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4362, Silver Spring, MD 20993, 301-796-
3984.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Migraine: Developing Drugs for Preventive Treatment.'' The
draft guidance is intended to assist sponsors with developing drugs for
the preventive treatment of migraine. The draft guidance provides FDA's
current thinking regarding the overall development program and clinical
trial designs to support approval of drugs for the preventive treatment
of migraine.
    Migraine is a chronic neurovascular disorder characterized by
recurrent attacks of often severe headache, typically accompanied by
nausea and sensitivity to light and/or sound. Pharmacological
approaches to the treatment of migraine include drugs to abort migraine
attacks as they arise (acute treatment of migraine) and drugs to reduce
the frequency of migraine attacks (preventive treatment). This draft
guidance addresses the development of drugs for the preventive
treatment of migraine, including trial population, trial design, dose
selection, efficacy endpoints, and statistical considerations. This
draft guidance does not address the development of drugs intended for
the acute treatment of migraine, as this has been covered by the
previously published guidance for industry ``Migraine: Developing Drugs
for Acute Treatment,'' available at https://www.fda.gov/media/89829/download.\1\
---------------------------------------------------------------------------

    \1\ We update guidances periodically. For the most recent
version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
---------------------------------------------------------------------------

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Migraine:
Developing Drugs for Preventive Treatment.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 201 have been approved under OMB control
number 0910-0572, and the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11751 Filed 6-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Proposed Rules]
[Page 23990-23992]
[DOCID:fr01my08-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0178; Directorate Identifier 2007-NM-366-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model DHC-8-400 Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier NPRM for the products listed above.
This action revises the earlier NPRM by expanding the scope. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank safety standards * * *.
    [A]ssessment showed that supplemental maintenance tasks
[inspections of various fuel system components such as shields,
harnesses, sleeves, and sealant] are required to prevent potential
ignition sources inside the fuel system, which could result in a
fuel tank explosion. * * *

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by May 21, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The

street address for the Docket Operations office (telephone (800) 647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Rocco Viselli, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0178;
Directorate Identifier 2007-NM-366-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We proposed to amend 14 CFR part 39 with an earlier NPRM for the
specified products, which was published in the Federal Register on
February 19, 2008 (73 FR 9053). That earlier NPRM proposed to require
actions intended to address the unsafe condition for the products
listed above.
    Since that earlier NPRM was issued, we have determined that the
initial compliance times for doing the tasks specified in paragraph
(f)(1) of the earlier NPRM must be reduced. That earlier NPRM resulted
from Canadian Airworthiness Directive CF-2007-33, dated December 17,
2007 (referred to after this as ``the MCAI'').
    The MCAI does not provide an initial compliance time for doing the
tasks. In the earlier NPRM, we proposed an initial compliance time that
started from the effective date of the AD; or the date of issuance of
the original Canadian standard airworthiness certificate or the date of
issuance of the original Canadian export certificate of airworthiness;
whichever occurs later. Although unstated in the MCAI, we have
determined that the intent of the MCAI is for the initial compliance
time to start from the initial delivery date of the airplane in order
to address the identified unsafe condition in a timely manner. We have
also revised the initial compliance times for clarity by providing a
threshold and grace period for the tasks. We have revised paragraphs
(f)(1)(i) and (f)(1)(ii) of this supplemental NPRM accordingly. You may
obtain further information by examining the MCAI in the AD docket.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the earlier
NPRM. As a result, we have determined that it is necessary to reopen
the comment period to provide additional opportunity for the public to
comment on this proposed AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 38 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $3,040, or $80 per product.

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.
    We are 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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc. (Formerly de Havilland, Inc.): Docket No. FAA-2008-
0178; Directorate Identifier 2007-NM-366-AD.

Effective Date

    (a) We must receive comments by May 21, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Bombardier Model DHC-8-400, DHC-8-
401, and DHC-8-402 airplanes, certificated in any category, all
serial numbers.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank standards introduced in
Chapter 525 of the Airworthiness Manual through Notice of Proposed
Amendment (NPA) 2002-043. The identified non-compliances were then
assessed using Transport Canada Policy Letter No. 525-001, to
determine if mandatory corrective action is required.
    The assessment showed that supplemental maintenance tasks
[inspections of various fuel system components such as shields,
harnesses, sleeves, and sealant] are required to prevent potential
ignition sources inside the fuel system, which could result in a
fuel tank explosion. Revision has been made to Part 2
``Airworthiness Limitation Items'' of the DHC-8-400 Maintenance
Requirements Manual to introduce the required maintenance tasks.
    The corrective action is revising the Airworthiness Limitations
Section of the Instructions for Continued Airworthiness to
incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 60 days after the effective date of this AD, or
before December 16, 2008, whichever occurs first, revise the ALS of
the Instructions for Continued Airworthiness to incorporate the
inspection requirements of Bombardier Temporary Revision ALI-69,
dated February 9, 2007, to Section 4, ``Fuel System Limitations,''
of Part 2, ``Airworthiness Limitations Items,'' of the Bombardier
Dash 8 Q400 Maintenance Requirements Manual, Product Support Manual
(PSM) 1-84-7 (``the TR to the MRM''). For all fuel system
limitations tasks contained in the TR to the MRM, the initial
compliance times start at the later of the ``Threshold'' and ``Grace
Period'' times specified in Table 1 of this AD, and the repetitive
inspections must be accomplished thereafter at the interval
specified in the TR to the MRM, except as provided by paragraphs
(f)(2) and (g)(1) of this AD.

         Table 1.--Initial Compliance Times for Limitation Tasks
------------------------------------------------------------------------
                               Compliance time (whichever occurs later)
         Description         -------------------------------------------
                                    Threshold           Grace period
------------------------------------------------------------------------
Tasks with 18,000 flight      Before the            Within 6,000 flight
 hours/108 month inspection    accumulation of       hours or 36 months
 intervals.                    18,000 total flight   after the effective
                               hours, or within      date of this AD,
                               108 months since      whichever occurs
                               new, whichever        first.
                               occurs first.
------------------------------------------------------------------------

    Note 2: The actions required by paragraph (f)(1) of this AD may
be done by inserting a copy of Bombardier TR ALI-69 into the
Airworthiness Limitations section of the Dash 8 Q400 MRM 1-84-7.
When this TR has been included in general revisions of the MRM, the
general revisions may be inserted in the PSM, provided the relevant
information in the general revision is identical to that in
Bombardier TR ALI-69.

    (2) After accomplishing the actions specified in paragraph
(f)(1) of this AD, no alternative inspections or inspection
intervals may be used unless the inspections or inspection intervals
are part of a later revision of Bombardier Dash 8 Q400 MRM, PSM 1-
84-7, Revision 4, dated October 30, 2003, that is approved by the
Manager, New York Aircraft Certification Office (ACO), FAA, or
Transport Canada Civil Aviation (TCCA) (or its delegated agent); or
unless the inspections or inspection intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (g)(1) of this AD.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Rocco Viselli, Aerospace Engineer, Airframe and
Propulsion Branch, ANE-171, FAA, New York Aircraft Certification
Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2007-33,
dated December 17, 2007; and Bombardier Temporary Revision ALI-69,
dated February 9, 2007, to Section 4, ``Fuel System Limitations,''
of Part 2, ``Airworthiness Limitations Items'' of the Bombardier
Dash 8 Q400 MRM PSM 1-84-7.

    Issued in Renton, Washington, on April 24, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-9577 Filed 4-30-08; 8:45 am]

BILLING CODE 4910-13-P