[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]
[Page 55307-55313]
[DOCID:fr22se06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0170; FRL-8092-2]

Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
or residues of buprofezin in or on almond hulls; cotton, gin
byproducts: Cottonseed; and tomato. Nichino America, Inc., Linden Park
Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19908 requested
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
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-2006-0170. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kevin Sweeney, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the

submission of objections and requests for hearings appear in 40 CFR
part 178. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0170. in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before November 21, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0170, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of June 21, 2000 (65 FR 38549) (FRL-6557-
3), 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
0F6087) by Nichino America, Inc., Linden Park, Suite 501, 4550 New
Linden Road, Wilmington, DE, 19808. The petition requested that 40 CFR
180. 511 be amended by establishing a tolerance for combined residues
or residues of the insecticide buprofezin, 2[(1,1-di-
methylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadizin-4-one, in or on almond hulls at 0.7 parts per million (ppm);
cotton, gin byproducts at 23 ppm; cotton, undelinted seed at 1.0 ppm;
and tomato at 0.8 ppm at tolerance level ppm. That notice included a
summary of the petition prepared by Aventis CropScience USA LP
(formerly AgrEvo USA Company), 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709, the registrant. There were no comments
received in response to the notice of filing. Subsequently, in the
Federal Register of September 5, 2001 (66 FR 46381) (FRL-6696-6), EPA
issued a Final Rule to section 408 of FFDCA, 21 U.S.C. 345a(d)(3), that
established time limited tolerances for residues of the insecticide
[buprofezin, 2-[(1,1-di- methylethyl)imino]tetrahydro-3(1-methylethyl)-
5-phenyl-4H-1,3,5-thiadiazin-4-1], in or on almond hulls at 0.7 ppm;
cotton, gin byproducts at 15.0 ppm; cotton, undelinted seed at 0.4 ppm;
and tomato at 0.40 ppm. These tolerances expired on December 31, 2005.
The conditions for these time limited tolerances were as follows: A
comparative thyroid assay (young/adult rat), a revised section B, a
revised section F, Plant Enforcement Method (BF/10/97)- Confirmatory
Method, Interference Study, and successful Agency Validation, Plant
Enforcement Method (BF/02/96) - Confirmatory Method and Interference
Study, Livestock Enforcement Method - successful Agency Validation and
Radiovalidation, Storage Stability Data, validation of frozen storage
intervals, petition method validation, an interference study,
Additional almond, banana, citrus, cotton, and tomato field trial data,
and a citrus processing study. EPA reevaluated the available thyroid
toxicity data in regard to the severity of effects and hormonal
measurements and concluded that a study evaluating thyrioid levels in
adult rats would be more appropriate. This study is confirmatory and is
not a condition of granting these tolerances. All of the conditions
above have been addressed and the Agency is issuing permanent
tolerances based on the registrant's proposed final rule request dated
August 25, 2005 (November 30, 2005 (70 FR 71838) (FRL-7735-7)).
    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. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/
[fxsp0]EPA-PEST/1997/November/[fxsp0]Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues or residues
of buprofezin on almond, hulls at 2.0 ppm; cotton, gin byproducts at 20
ppm; cotton, undelinted seed at 0.35 ppm; and tomato at 0.40 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance 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. Specific information on the studies received and the nature
of the toxic effects caused by buprofezin 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 in the OPP
Regulatory Public Docket number EPA-HQ-OPP-2006-0170.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL

identified is sometimes used for risk assessment if no NOAEL was
achieved in the toxicology study selected. An uncertainty factor (UF)
is applied to reflect uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for buprofezin used for
human risk assessment is shown in the following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Buprofezin for Use in Human Risk Assessment
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                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and      Level of Concern (LOC)  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of  NOAEL = 200 mg/kg/day    Special FQPA SF = 1      LOAEL = 800 mg/kg/day
 age)                                  UF = 100...............  aPAD = acute RfD/         based on incomplete
                                       Acute RfD = 2.0 mg/kg/    Special FQPA SF = 2.0    ossification and
                                        day.                     mg/kg/day.               reduced pup weight
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = NA1 mg/kg/day    Special FQPA SF = NA1    No appropriate endpoint
 including infants and children)       UF = NA................  aPAD = acute RfD.......   was identified for the
                                       Acute RfD = NA mg/kg/    Special FQPA SF = NA mg/  general population
                                        day.                     kg/day.                 LOAEL = NA mg/kg/day
                                                                                based on NA
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 1.0 mg/kg/day    Special FQPA SF = 1      Two-year chronic
                                       UF = 300...............   cPAD = chronic RfD       feeding study - rat
                                       Chronic RfD = 0.0033 mg/ Special FQPA SF =        LOAEL = 8.7 mg/kg/day
                                        kg/day.                  0.0033 mg/kg/day.        based on organ weight
                                                                                changes and
                                                                                microscopic findings
                                                                                in the liver and
                                                                                thyroid of both males
                                                                                and females and in the
                                                                                kidney of males
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral (1-30       Oral NOAEL = 13.0 mg/kg/ Residential = NA2        90-day oral toxicity
 days)                                  day                                               study -rat
(Residential = NA2)..................                                                    LOAEL 68.6 mg/kg/day
                                                                                based on
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days)       Dermal NOAEL = 300 mg/   Occupational LOC for     24-Day dermal toxicity
(Residential = NA2...................   kg/day (dermal           MOE = < 100               study - rat
                                        absorption rate =       (Residential = NA2)....  LOAEL = 1,000 mg/kg/day
                                        NA2%)                                             based on inflammatory
                                                                                infiltrate of the
                                                                                liver in females and
                                                                                increase in acanthosis
                                                                                and hyperkeratosis of
                                                                                the skin in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Dermal NOAEL = 300 mg/   Occupational LOC for     24-Day dermal toxicity
 several months)                        kg/day (dermal           MOE = < 100               study - rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 1,000 mg/kg/day
                                        NA2%)                                             based on inflammatory
                                                                                infiltrate of the
                                                                                liver in females and
                                                                                increase in acanthosis
                                                                                and hyperkeratosis of
                                                                                the skin in females
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral NOAEL = 1.0 mg/kg/  Occupational LOC for     Two-year chronic
 lifetime)                              day (dermal absorption   MOE = < 300               feeding study - rat
(Residential = NA2)..................   rate = 10%)             (Residential = NA2)....  LOAEL = 8.7 mg/kg/day
                                                                                based on based on
                                                                                increased incidence of
                                                                                follicular cell
                                                                                hyperplasia and
                                                                                hypertrophy in the
                                                                                thyroid in males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Oral study NOAEL = 13.0  Occupational LOC for     90-Day oral toxicity
 (residential = NA2)                    mg/kg/day (inhalation    MOE = < 300               study - rat
                                        absorption rate =       (Residential = NA2)....  LOAEL = 68.6 mg/kg/day
                                        100%)                                             based on organ weight
                                                                                changes and
                                                                                microscopic findings
                                                                                in the liver and
                                                                                thyroid of both males
                                                                                and females and in the
                                                                                kidney of males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Oral study NOAEL = 13.0  Occupational LOC for     90-Day oral toxicity
 to several months)                     mg/kg/day (inhalation    MOE = < 300               study - rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 68.6 mg/kg/day
                                        100%)                                             based on organ weight
                                                                                changes and
                                                                                microscopic findings
                                                                                in the liver and
                                                                                thyroid of both males
                                                                                and females and in the
                                                                                kidney of males
----------------------------------------------------------------------------------------------------------------

Long-term inhalation (several months   Oral study NOAEL = 1.0   Occupational LOC for     Two-year chronic
 to lifetime)                           mg/kg/day (inhalation    MOE = < 300               feeding study -rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 8.7 mg/kg/day
                                        100%)                                             based on increased
                                                                                incidence of
                                                                                follicular cell
                                                                                hyperplasia and
                                                                                hypertrophy in the
                                                                                thyroid of males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      No quantification        No quantification        No quantification is
                                                                                appropriate because
                                                                                the evidence was
                                                                                limited to one sex in
                                                                                one species of animal.
                                                                                The data show no
                                                                                greater than
                                                                                suggestive evidence of
                                                                                carcinogenicity.
----------------------------------------------------------------------------------------------------------------
1NA = Not applicable.
2NA = Not applicable. There are no residential uses for buprofezin.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.511) for the combined residues or residues of
buprofezin, in or on a variety of raw agricultural commodities.
Tolerances of buprofezin are established in milk at 0.01 ppm and in
ruminant fat (0.05 ppm), meat byproducts (0.05 ppm), and liver at 0.05
ppm. Risk assessments were conducted by EPA to assess dietary exposures
from buprofezin 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.
    The Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: The acute analysis assumed DEEM (ver. 7.76)
default processing factors and 100% crop treated (CT) for all
commodities. Tolerance level residues were assumed for all commodities
excluding meat and milk. Since meat and milk (LOQ tolerances) residues
were only detected in the feeding study at 6.8-9.3x the Maximum
Theoretical Dietary Burden (MTDB), residues in these commodities were
normalized to 1x the MTDB. The acute analysis also incorporated the
acute Pesticide Root Zone Model/Exposure Analysis Modeling System
(PRZM-EXAMS) surface drinking water estimate resulting from application
of buprofezin to citrus in Florida (highest acute drinking water
estimate). No acute endpoint was identified for the remaining
population subgroups.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEMTM software with the FCID, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The chronic analysis assumed DEEM (ver. 7.76) default
processing factors for all commodities and incorporated percent crop
treated (PCT) estimates or projected PCT estimates. Tolerance level or
average field trial residues were assumed for all crop commodities and
since meat and milk (LOQ tolerances) residues were only detected in the
feeding study at 6.8-9.3x the MTDB, residue in these commodities were
normalized to 1x the MTDB. The chronic analysis also incorporated the
chronic PRZM-EXAMS surface drinking water estimate resulting from
application of buprofezin to citrus in Florida (highest chronic
drinking water estimate).
    iii. Cancer. Due to the fact that the data showed no greater than
suggestive evidence of carcinogenicity, the chronic exposure and risk
assessment was deemed protective of any cancer effect.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if the Agency can
make the following findings: Condition 1, that the data used are
reliable and provide a valid basis to show what percentage of the food
derived from such crop is likely to contain such pesticide residue;
Condition 2, that the exposure estimate does not underestimate exposure
for any significant subpopulation group; and Condition 3, if data are
available on pesticide use and food consumption in a particular area,
the exposure estimate does not understate exposure for the population
in such area. In addition, the Agency must provide for periodic
evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows: 10% CT for cantaloupes;
5% CT for cauliflower; 2.5% CT for cotton, grapefruit, grapes,
honeydew, lemons, oranges, tomatoes, and watermelon; market share PCT
was projected not to exceed 5% for apples, and 13% for peaches for the
first four to five years buprofezin is on the market. All other crops
currently registered and/or proposed commodities were assumed to be
100% CT. The Agency believes that the three conditions listed in Unit
C.1.iv. have been met. With respect to Condition 1, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. For previously registered crops, EPA used an
average of the values from these surveys over the last 5 years for
estimating PCT for chronic dietary exposure assessments. For most newly
registered crops, the Agency assumed 100% CT. In estimating PCT for the
apples, EPA assumed that the PCT for

buprofezin would at least equal or exceed the PCT for the leading
comparable insect growth regulator pesticide alternative on that crop.
For peaches, PCT for buprofezin was projected to potentially exceed the
leading alternative's PCT because buprofezin has a slight cost
advantage over the alternative on that crop. With regards to apples,
buprofezin was projected to slightly exceed sales of the leading
alternative's PCT because buprofezin is an excellent technical fit as
an insect pest management insecticide for apples. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions 2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which buprofezin may be applied in a particular
area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for buprofezin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of buprofezin. 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 PRZM/EXAMS and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated environmental concentrations (EECs) of
buprofezin for acute exposures are estimated to be 19.2 parts per
billion (ppb) for surface water and 0.1 ppb for ground water. The EECs
for chronic exposures are estimated to be 4.5 ppb for surface water and
0.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the DEEMTM/FCID. For chronic dietary risk
assessment, the annual average concentration of 4.5 ppb was used to
access 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).
    Buprofezin is not registered for use on any sites that would result
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to buprofezin and any other
substances and buprofezin does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that buprofezin has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Prenatal and postnatal
sensitivity is not of concern for buprofezin based on the results of
the developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats. The results indicate that there
is no increased susceptibility of rats or rabbits following in utero
exposure or of rats following prenatal/postnatal exposure to
buprofezin. The toxicology data do not indicate a basis for concern for
neurotoxicity, therefore, acute, subchronic, and developmental
neurotoxicity studies are not required.
    3. Conclusion. Oral exposure to buprofezin produced marginal
thyroid toxicity in adult rats manifested as increased incidence of
follicular cell hyperplasia, increased in thyroid weights and
microscopic findings in the thyroid. Although rats are very susceptible
to thyroid hormone disruption and thyroid follicular cell
carcinogenesis, no thyroid tumors were observed in chronic and
carcinogenicity studies in mice and rats. It is unknown to what extent
buprofezin alters thyroid hormones (T3, T4 and Thyroid-Stimulating
hormone levels) because these were not measured. Given the marginal
thyroid toxicity found, it is anticipated that any effects of
buprofezin on thyroid hormones may also be marginal. Thus, a
measurement of thyroid hormones in adult rats is viewed as a
confirmatory test to evaluate its effect on thyroid homeostasis. A FQPA
factor of 10X in the form of database UF is applied to chronic
Referance Dose (cRfD), chronic dermal exposure (endpoint based on oral
study) and all inhalation exposure durations as a conservative approach
to address any residual uncertainty associated with potential
susceptibility of the young to thyroid disruption. This FQPA factor in
the form of database uncertainty is not applicable to acute oral RfD
because a single dose of a chemical would not be expected to perturb
thyroid homeostasis in the adult or young due to the buffering of
thyroid hormone concentrations by homeostatic mechanisms for compound
with short half lives, like buprofezin (half-life of a couple of days).
This FQPA factor in the

form of database uncertainty is not applicable to short-and
intermediate-term dermal exposure because the endpoint of concern is
based on dermal study where liver toxicity was the critical effect
(thyroid effects were not observed). Since the thyroid effects were
seen in rats and it has been established that rats are more susceptible
to thyroid effects than humans, the Agency concluded that the
interspecies extrapolation factor for these assessments may be reduced
to 3X. The intraspecies variability factor remains as 10x. There is no
evidence of increased susceptibility due to postnatal exposure to
buprofezin in rats and rabbits or prenatal and postnatal exposure in
two-generation reproduction study. Therefore, there is no need to
retain the FQPA safety factor (SF) based on prenatal or postnatal
toxicity issues. Based on the conservative residue assumptions used in
the dietary risk assessment (there are currently no residential
exposures), and the completeness of the residue chemistry and
environmental fate databases, there is no need to retain the FQPA SF
based on exposure issues.
     The total UF for chronic dietary, inhalation assessments (all
durations) and long-term dermal assessment is 300X (10X FQPA database
uncertainty, 3X interspecies variation, and 10X intraspecies variation)
and the total UF for acute dietary and dermal assessments (short-term
and intermediate-term) is 100X (10X interspecies variation and 10x
intraspecies variation).

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to buprofezin will occupy 5% of the acute population adjusted dose
(aPAD) for females 13-49 years old. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
buprofezin from food will utilize 40% of the chronic population
adjusted dose (cPAD) for the U.S. population, 56% of the cPAD for all
infants less than 1-year old, and 87% of the cPAD for children 1-2
years old. There are no residential uses for buprofezin that result in
chronic residential exposure to buprofezin. Therefore, the EPA does not
expect the aggregate exposure to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. In chronic studies in
the rat, an increased incidence of follicular cell hyperplasia and
hypertrophy in the thyroid of males was reported. Increased relative
liver weights were reported in female dogs. Buprofezin was not
carcinogenic to male and female rats. In the mouse, increased absolute
liver weights in males and females, along with an increased incidence
of hepatocellular adenomas and hepatocellular adenomas plus carcinomas
in females were reported. Buprofezin was negative in vitro and in vivo
genotoxicity assays. The findings from the published literature
indicate that buprofezin causes cell transformation and induces
micronuclei in vitro. In the absence of a positive response in an in
vivo micronucleus assay, the Agency concluded that buprofezin may have
aneugenic potential, which is not expressed in vivo. In summary,
buprofezin was negative in the rat, negative for mutagenicity and
negative for male mice; however, in female mice, a slight or marginal
increase in combined adenomas and carcinomas was observed. Given these
findings in the cancer and mutagenicity studies, EPA regards the
carcinogenic potential of buprofezin as very low and concludes that it
poses no greater than a negligible cancer risk to humans.
    4. 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, and to infants and children from aggregate
exposure to buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology-Plants

    Adequate enforcement methodology using gas chromatography with
nitrogen phosphorous detection (GC/NPD) 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

    There are no Canadian, Mexican, or Codex maximum residue limits
established for buprofezin in/on any of the commodities associated with
the current petition.

V. Conclusion

    Therefore, the tolerance is established for combined residues or
residues of buprofezin, in or on almond, hulls at 2.0 ppm; cotton, gin
byproducts at 20 ppm; cotton, undelinted seed at 0.35 ppm; and tomato
at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various

levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of 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: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.511 is amended by alphabetically revising commodities
and adding cotton seed to the table in paragraph (a) to read as
follows:

Sec.  180.511  Buprofezin; tolerance for residues

    (a) * * *

------------------------------------------------------------------------
                                                  Expiration/revocation
          Commodity           Parts per million           dates
------------------------------------------------------------------------
                                * * * * *
Almond hulls................                2.0                     None
------------------------------------------------------------------------
                                * * * * *
Cotton, gin byproducts......               20.0                     None
------------------------------------------------------------------------
Cotton seed.................               0.35                     None
------------------------------------------------------------------------
                                * * * * *
Tomato......................               0.40                     None
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-8065 Filed 9-21-06; 8:45 am]

BILLING CODE 6560-50-S


                                              AGENDA
U.S. EPA FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT                              SCIENTIFIC ADVISORY PANEL (FIFRA SAP)
                      PREPARATORY VIRTUAL PUBLIC MEETING
                                August 25, 2020
                                  1pm-4pm EDT
        MEETING URL: https://epawebconferencing.acms.com/sciencereview
   MEETING CONFERENCE CALL#: 1-(888) 344-4439 (Attendee line without Audio)
                        MEETING CONFERENCE ID#: 2099312
                  FIFRA SAP WEB SITE: https://www.epa.gov/sap
                DOCKET ID NUMBER: EPA - HQ - OPP - 2020 - 0263

 Preparatory Virtual Meeting: Administrative Orientation Session on the Scope and Clarity of the Draft Charge Questions for the Peer Review of the Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment

        Please note that all times are approximate (see note at end of agenda)
                             Tuesday, August 25, 2020

                           Tuesday, August 25, 2020

1:00 P.M. 	Welcome to the Public and Administrative Remarks  -  Tamue L. Gibson, M.S.,
		Designated Federal Official (DFO), FIFRA SAP, Office of Science Coordination and
      Policy (OSCP)/EPA

1:10 P.M. 	Introduction and Identification of Panel Members  -  Robert E. Chapin, Ph.D.,
      FIFRA SAP Chair, EPA

1:20 P.M. 	Overview of the Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment  -  Monique Perron, Ph.D., Health Effects Division (HED)/Office of Pesticides Program (OPP)/EPA

1:40 P.M.	Overview of the Charge Questions  -  Monique Perron, Ph.D., Health Effects Division (HED)/Office of Pesticides Program (OPP)/EPA

2:00 P.M.	Oral Public Commenters (5 minutes each)

2:20 P.M. 	Panel Discussion on Scope and Clarity of Draft Charge Questions

3:50 P.M. 	Meeting Wrap up  -  Tamue L. Gibson, M.S., DFO/FIFRA SAP/OSCP/EPA

4:00 P.M. 	Adjourn


[Federal Register: January 22, 2009 (Volume 74, Number 13)]
[Rules and Regulations]
[Page 3965-3967]
[DOCID:fr22ja09-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30645; Amdt. No 3302]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Rule.

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

SUMMARY: This establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective January 22, 2009. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of January 22, 2009.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
    For Examination-
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to:http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability-All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or

    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums, and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums, and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums, and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule '' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3)does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on December 26, 2008.
John M. Allen,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal Regulations, part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 12 FEB 2009

Sylvania, GA, Plantation Airpark, Takeoff Minimums and Obstacle DP,
Orig
Charlotte, NC, Charlotte/Douglas Intl, ILS OR LOC RWY 36C, ILS RWY
36C (CAT II), ILS RWY 36C (CAT III), Amdt 15D
Charlotte, NC, Charlotte/Douglas Intl, RNAV (GPS) RWY 18C, Amdt 2B
Charlotte, NC, Charlotte/Douglas Intl, RNAV (GPS) RWY 36C, Amdt 2B
Philadelphia, PA, Philadelphia Intl, CONVERGING ILS RWY 17, Amdt 5
Philadelphia, PA, Philadelphia Intl, ILS OR LOC RWY 17, Amdt 7
Philadelphia, PA, Philadelphia Intl, RNAV (GPS) RWY 17, Amdt 2
Philadelphia, PA, Philadelphia Intl, RNAV (GPS) RWY 35, Amdt 2
Manning, SC, Santee Cooper Regional, Takeoff Minimums and Obstacle
DP, Orig

Effective 12 MAR 2009

Shishmaref, AK, Shishmaref, Takeoff Minimums and Obstacle DP, Orig
Talladega, AL, Talladega Muni, Takeoff Minimums and Obstacle DP,
Amdt 1
Dubuque, IA, Dubuque Rgnl, RNAV (GPS) RWY 36, Orig
Grangeville, ID, Idaho County, GPS RWY 7, Orig-A, CANCELLED
Grangeville, ID, Idaho County, GPS RWY 25, Orig-A, CANCELLED
Grangeville, ID, Idaho County, RNAV (GPS) RWY 7, Orig
Grangeville, ID, Idaho County, RNAV (GPS) RWY 25, Orig
Bloomington/Normal, IL, Central IL Regl Arpt at Bloomington-Normal,
RNAV (GPS) RWY 20, Amdt 1
Bloomington/Normal, IL, Central IL Regl Arpt at Bloomington-Normal,
RNAV (GPS) RWY 29, Amdt 1
St Louis, MO, Lambert-St Louis Intl, RNAV (GPS) RWY 12L, Amdt 2
Tunica, MS, Tunica Muni, Takeoff Minimums and Obstacle DP, Orig
Marysville, OH, Union County, NDB RWY 27, Amdt 5B, CANCELLED
Aguadilla, PR, Rafael Hernandez, Takeoff Minimums and Obstacle DP,
Orig
Sparta, TN, Upper Cumberland Rgnl, ILS OR LOC RWY 4, Amdt 1
Sparta, TN, Upper Cumberland Rgnl, NDB RWY 4, Amdt 4
Bowie, TX, Bowie Muni, RNAV (GPS) RWY 35, Amdt 1
Bowie, TX, Bowie Muni, Takeoff Minimums and Obstacle DP, Orig
Price, UT, Carbon County Rgnl/Buck Davis Field, Takeoff Minimums and
Obstacle DP, Amdt 4
Dublin, VA, New River Valley, Takeoff Minimums and Obstacle DP, Amdt
2

Franklin, VA, Franklin Muni-John Beverly Rose, Takeoff Minimums and
Obstacle DP, Amdt 2
Clintonville, WI, Clintonville Muni, NDB RWY 32, Amdt 7, CANCELLED
Manitowoc, WI, Manitowoc County, ILS OR LOC RWY 17, Amdt 5
Medford, WI, Taylor County, GPS RWY 27, Orig-A, CANCELLED
Medford, WI, Taylor County, NDB RWY 34, Amdt 7
Medford, WI, Taylor County, RNAV (GPS) RWY 27, Orig
Medford, WI, Taylor County, Takeoff Minimums and Obstacle DP, Amdt 2

[FR Doc. E9-324 Filed 1-21-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31085-31087]
[DOCID:fr30my08-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 21, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC08-89-000.
    Applicants: Trans Bay Funding LLC, Trans Bay Holdings LLC, Trans
Bay Holdings II LLC, Trans Bay Cable LLC, Babcock & Brown
Infrastructure Group US.
    Description: Babcock & Brown Infrastructure Group LLC et al (BBIG)
requests authorization for the indirect disposition jurisdictional
facilities owned by TransBay Cable resulting from the sales of BBIG of
its ownership interests.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0248.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: EC08-90-000.
    Applicants: Noble Environmental Power, LLC.
    Description: Application For Order Under Section 203 of the FPA
Authorizing Disposition Of Jurisdictional Facilities Resulting From An
Initial Public Offering, And Request For Waivers And 21 Day Comment
Period Of Noble Environmental Power, LLC.
    Filed Date: 05/19/2008.
    Accession Number: 20080519-5044.
    Comment Date: 5 p.m. Eastern Time on Monday, June 09, 2008.

    Docket Numbers: EC08-91-000.
    Applicants: Horizon Asset Management, Inc.
    Description: Horizon Asset Management submits a petition for
disclaimer of jurisdiction.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0128.
    Comment Date: 5 p.m. Eastern Time on Monday, June 09, 2008.

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

    Docket Numbers: ER00-2268-026; ER07-428-005; ER99-4122-027; ER99-
4124-023; Arizona Public Service Company.
    Applicants: Pinnacle West Capital Corporation; Pinnacle West
Marketing & Trading Co, LL; APS Energy Services Co Inc;
    Description: Pinnacle West Capital Corp et al submits a compliance
filing of additional information on their mitigation proposal for sales
during the mitigated summer period in the Phoenix Valley Load Pocket.
    Filed Date: 05/20/2008.
    Accession Number: 20080521-0405.
    Comment Date: 5 p.m. Eastern Time on Friday, May 30, 2008.

    Docket Numbers: ER01-205-026; ER98-2640-024; ER98-4590-022; ER99-
1610-030.
    Applicants: Xcel Energy Services Inc.; Northern States Power
Company, Northern States Power Company-Wisconsin; Public Service
Company of Colorado; Southwestern Public Service Company.
    Description: NSP Companies submits change in status report relating
to the NSP companies market-based rate authority.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0244.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER02-136-010.
    Applicants: Allegheny Power.
    Description: Settlement Agreement by and between West Penn Power
Company (dba Allegheny Power) and Allegheny Electric Cooperative, Inc.
    Filed Date: 05/16/2008.
    Accession Number: 20080516-5092.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 27, 2008.

    Docket Numbers: ER07-521-003.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
their compliance revisions to its Open Access Transmission Tariff and
Market Administration and Control Area Services Tariff to address the
requirements of the 4/16/08 Order.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0289.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-617-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits a
compliance filing re FERC's 4/29/08 Order.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0246.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-899-001.
    Applicants: Ohio Power Company.
    Description: Ohio Power Co submits an amendment to its 5/1/08
filing.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0131.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 22, 2008.

    Docket Numbers: ER08-961-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits informational
filing of its Annual Update of transmission service rates to the APS
Open Access Transmission Tariff.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0231.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-962-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corp submits the
second revised Interconnection and Local Delivery Service Agreement.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0232.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-963-000.
    Applicants: Commonwealth Edison Company, Commonwealth Edison Co. of
Indiana, Inc.
    Description: Commonwealth Edison Company et al. submits
Informational Filing of 2008 Formula Rate Annual Update Pursuant to
Approved Settlement Agreement.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0245.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-964-000.
    Applicants: Outback Power Marketing, Inc.

    Description: Outback Power Marketing, Inc submits a Notice of
Cancellation of its FERC Electric Tariffs.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0233.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-965-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits proposed revisions to its OATT and Energy Market Tariff.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0234.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-966-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities submits their application seeking
two return on equity incentives for the Middletown-to-Norwalk
transmission project.
    Filed Date: 05/16/2008.
    Accession Number: 20080520-0293.
    Comment Date: 5 p.m. Eastern Time on Friday, June 06, 2008.

    Docket Numbers: ER08-967-000.
    Applicants: Nevada Power Company.
    Description: Nevada Power Co submits a Notice of Cancellation of
two Service Agreements for Long-Term Firm Point-to-Point Transmission
Service with Mirant Americas Energy Marketing, LP.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0235.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-968-000.
    Applicants: Nevada Power Company.
    Description: Nevada Power Company submits Notice of Cancellation of
two Service Agreements for Long-Term Firm Point-to Point Transmission
Service between Nevada Power Company and Mirant Las Vegas, LLC etc.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0236.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-969-000.
    Applicants: UGI Utilities, Inc.
    Description: UGI Utilities, Inc submits a Formula Rate
Informational Filing.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0237.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-970-000.
    Applicants: Duquesne Light Company.
    Description: Duquesne Light Company submits Annual Update to
recalculate its annual transmission revenue requirement pursuant to the
formula rate accepted by the Commission for Filing in that proceeding
etc.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0288.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-971-000.
    Applicants: Commonwealth Edison Company.
    Description: Commonwealth Edison Company et al. submits revise
Attachment H-13 (Network Integration Transmission Service for the ComEd
Zone) of the PJM Interconnection, LLC Open Access Transmission Tariff
effective 6/1/08.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0238.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-972-000.
    Applicants: California Independent System Operator Company.
    Description: California Independent System Operator Co submits a
Transmission Access Charge Informational filing.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0239.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-973-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corporation submits a
fully executed generation interconnection agreement dated 5/5/08
between AEP Texas North Company and Jackson Mountain Wind, LLC.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0240.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-974-000.
    Applicants: Baltimore Gas and Electric Company.
    Description: Baltimore Gas and Electric Company submits an
Informational filing of its 2008 Formula Rate Annual Update.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0241.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-975-000.
    Applicants: American Electric Power Service Corporation.
    Description: The American Electric Power Service Corporation agent
for AEP Operating Companies submits a second revision to the
Interconnection and Local Delivery Service Agreement 1418 with the City
of Bryan.
    Filed Date: 05/15/2008.
    Accession Number: 20080520-0242.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 05, 2008.

    Docket Numbers: ER08-984-000.
    Applicants: Chien Energy, LLC.
    Description: Chien Energy, LLC submits a notice of cancellation
under ER08-984.
    Filed Date: 05/19/2008.
    Accession Number: 20080521-0139.
    Comment Date: 5 p.m. Eastern Time on Monday, June 09, 2008.

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

    Docket Numbers: ES08-45-001.
    Applicants: American Transmission Company LLC, ATC Management Inc.
    Description: Amended Application for Authorization to Issue
Securities Under Section 204 of the Federal Power Act of American
Transmission Company LLC and ATC Management Inc.
    Filed Date: 05/19/2008.
    Accession Number: 20080520-5007.
    Comment Date: 5 p.m. Eastern Time on Friday, May 30, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-39-001.
    Applicants: Xcel Energy Services Inc.
    Description: Xcel Energy Services Inc. submits Order No. 890, FPA
Section 206 Compliance Filing.
    Filed Date: 05/19/2008.
    Accession Number: 20080520-5003.
    Comment Date: 5 p.m. Eastern Time on Monday, June 09, 2008.

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

    Docket Numbers: RR06-1-016; RR07-3-004; RR07-8-004.
    Applicants: North American Electric Reliability Corp.
    Description: Compliance Filing of North American Electric
Reliability Corp, et al., Coordinating Council to Paragraph 174 of Mar
21 2008 Order, and Compliance Filing of NERC and Florida Reliability
Coord Council to Paragraph 252 of Mar 21 2008 Order.
    Filed Date: 05/19/2008.
    Accession Number: 20080519-5121.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 18, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a

compliance filing if you have previously intervened in the same docket.
Protests will be considered by the Commission in determining the
appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Anyone filing a motion to intervene or
protest must serve a copy of that document on the Applicant. In
reference to filings initiating a new proceeding, interventions or
protests submitted on or before the comment deadline need not be served
on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-12040 Filed 5-29-08; 8:45 am]

BILLING CODE 6717-01-P