[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Rules and Regulations]
[Pages 63745-63751]
[FR Doc No: 2012-25548]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0759; FRL-9364-9]

Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide buprofezin in or on multiple commodities which are
identified and discussed later in this document. In addition, this
regulation removes established tolerances for certain commodities/
groups superseded by this action, and corrects the spelling of some
commodities. The Interregional Research Project 4 (IR-4) and
Nichino America Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 17, 2012. Objections and
requests for hearings must be received on or before December 17, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0759, is available at http://www.regulations.gov or in hard copy at the OPP Docket in the
Environmental Protection Agency Docket Center (EPA/DC), located in EPA
West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

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

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

    Under 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-2011-0759 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
December 17, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0759, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-
9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP)
1E7908 by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540, and PP 1F7905 by Nichino
America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE.
The petitions requested that 40 CFR 180.511 be amended by establishing
tolerances for residues of the insecticide buprofezin (2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H -1,3,5-
thiadiazin-4-one) in or on bean, succulent at 0.02 parts per million
(ppm); Brassica, leafy greens, subgroup 5B at 55 ppm; turnip, greens at
55 ppm; vegetable, fruiting, group 8-10 at 3.0 ppm; fruit, citrus,
group 10-10 at 2.5 ppm; fruit, pome, group 11-10 at 4.0 ppm; persimmon
at 1.9 ppm; and tea at 20 ppm (PP 1E7908) and PP 1F7905 requested
tolerances for residues in or on nut, tree, group 14 at 0.05 ppm and
pistachios at 0.05 ppm. PP 1E7908 also requested removal of tolerances
for non-bell pepper; fruiting vegetable group 8, except non-bell
pepper; fruit, citrus, group 10; and fruit, pome, group 11 which will
be covered by the newly requested tolerances. That notice referenced a
summary of the petition prepared by Nichino America, Inc., the
registrant, which is available in the docket, http://www.regulations.gov. Two general comments were received on the notice
of filings. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for several commodities. Due to
insufficient data, EPA is not establishing the citrus group 10-10
tolerance. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin 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.
    Buprofezin has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant; nor
is it a dermal sensitizer. In subchronic toxicity studies, the primary
effects of concern in the rat were increased microscopic lesions in
male and female liver and thyroid, increased liver weights in males and
females, and increased thyroid weight in males. 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. The increase in carcinomas was not
statistically significant when analyzed separately. Based on the
increased incidence of combined benign and malignant liver tumors in
female mice only, no evidence of carcinogenicity in rats, and no
evidence of genotoxicity in submitted guideline studies using in vitro
and in vivo genotoxicity assays, EPA classified buprofezin as having no
greater than suggestive evidence of carcinogenicity.
    Developmental and reproductive toxicity studies do not indicate
concern for increased susceptibility in offspring. Toxicity in the
offspring was found at dose levels that were also toxic to the parent
and the effects observed in the offspring were not more severe,
qualitatively, than the effects observed in the parent. No neurotoxic
effects were observed at any dose in a subchronic neurotoxicity study
in rats at the highest dietary doses of 5,000 ppm. An immunotoxicity
study did not demonstrate immunotoxic effects by buprofezin. A special
study is required to generate specific data on the thyroid to protect
the developing nervous

system from thyroid hormone disrupting chemicals.
    Specific information on the studies received and the nature of the
adverse 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 at http://www.regulations.gov in the document ``Buprofezin Human Health Risk
Assessment for Proposed Use of Buprofezin on Tree Nut Crop Group 14
including Pistachio, Brassica Leafy Greens Subgroup 5B, Turnip Greens,
Tea and Persimmon & Expanded Uses on Fruiting Vegetables, Succulent
Beans, Citrus Fruit, and Pome Fruit,'' pp. 40--42 in docket ID number
EPA-HQ-OPP-2011-0759.

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 buprofezin used for
human risk assessment is shown in the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Buprofezin 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 13-49 years   NOAEL = 200 mg/kg/day   Acute RfD = 2.0 mg/kg/  Developmental Toxicity
 of age).                            UFA = 10..............   day.                    Study-Rat.
                                     UFH = 10..............  aPAD = 2.0 mg/kg/day..  LOAEL = 800 mg/kg/day based
                                     FQPA SF = 1x..........                           on reduced ossification &
                                                                                decreased body weight in
                                                                                offspring.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population    No endpoint is available for this population because no effect attributable
 including infants and children).            to a single day oral exposure was observed in animal studies.
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Chronic dietary (All populations)..  NOAEL= 1.0 mg/kg/day    Chronic RfD = 0.033 mg/ Two-year Chronic Toxicity/
                                     UFA = 3...............   kg/day                  Carcinogenicity Study-Rat.
                                     UFH = 10..............  cPAD = 0.0033 mg/kg/    LOAEL = 8.7 mg/kg/day based
                                     FQPA SF = 10 UFDB.....   day.                    on increased incidence of
                                                                                follicular cell
                                                                                hyperplasia and
                                                                                hypertrophy in the thyroid
                                                                                of males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..    Suggestive Evidence of Carcinogenicity. The cRfD would be protective of
                                              potential carcinogenic effects from exposure to buprofezin.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to buprofezin, EPA considered exposure under the petitioned-
for tolerances as well as all existing buprofezin tolerances in 40 CFR
180.511. EPA assessed 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.
    Such effects were identified for buprofezin in the population
subgroup females age 13-49. In estimating acute dietary exposure, EPA
used food consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed tolerance level residues for buprofezin and estimated residue
levels of the BF4 Conjugate, a metabolite of concern, based on
buprofezin metabolism data. The BF4 Conjugate is not detectable by data
collection methods and thus is not included in the tolerance level.
Given the potential for the buprofezin metabolites BF9 and BF12 to
concentrate to a greater degree than buprofezin in processed
commodities, Dietary Exposure Evaluation Model (DEEM) (Version 7.81)
default processing factors were retained for all commodities, except
for tomato paste and puree, which were reduced based on empirical data.
Total residues of concern in meat and milk were based on feeding study
data. EPA also assumed 100 percent crop treated (PCT) for all
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. A refined chronic dietary analysis was conducted using
PCT estimates when available and 100 PCT for all other crops.
Buprofezin residues in crop commodities were estimated based on average
residue levels from field trial data, average residue levels from USDA
Pesticide Data Program (PDP) data, or tolerance level residues. As with
the acute exposure assessment,

EPA estimated residue levels of the metabolite BF4 Conjugate were based
on metabolism data. Given the potential for the buprofezin metabolites
BF9 and BF12 to concentrate to a greater degree than buprofezin in
processed commodities, DEEM (Version 7.81) default processing factors
were retained for all commodities, except for tomato paste and puree,
which were reduced based on empirical data. Total residues of concern
in meat and milk were based on feeding study data.
    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 nonlinear 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 buprofezin and the cRfD would be
protective of cancer effects.
    The cRfD was based on an endpoint of toxicity from a rat combined
chronic/oncogenicity study. The NOAEL in this study was 1.0 mg/kg/day
based on increased incidence of follicular cell hyperplasia and
hypertrophy in the thyroid of males at 8.7 mg/kg/day. Buprofezin was
not carcinogenic in rats. Administration of buprofezin in the diet was
associated with increased incidence of liver tumors in female mice only
at the mid- and high-doses but not at the low dose of 1.82 mg/kg/day
which was considered to be the NOAEL for the females. Because the
positive evidence of cancer was limited to one sex of one species
(female mice), there was no evidence of mutagenicity, and no
carcinogenic effects in rats, EPA concluded that the weight-of-the-
evidence indicated that the carcinogenic findings in female mice are a
threshold effect. The NOAEL of 1 mg/kg/day from the rat study on which
the cRfD is based on is lower than the NOAEL for liver tumors of 1.82
mg/kg/day from the mouse. Therefore, the cRfD would be protective of
potential carcinogenic effects from exposure to buprofezin.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    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:
     Condition a: 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Almond 1%; Cantaloupes 5%; Cotton 1%; Grapefruit 1%; Honeydew 2.5%:
Lemons 2.5%; Lettuce (head and leaf) 1%; Oranges 2.5%; Pears 15%;
Pistachio 5%; Pumpkins 1%; Squash (summer) 1%; Tomatoes 2.5%;
Watermelons 2.5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    Buprofezin has only been registered for use on some commodities
since late 2009. Therefore, PCT estimates based on actual usage data
were not deemed sufficient indicators of potential usage on these
recently registered crops. In 2009 the EPA used PCT estimates for these
commodities based on the market leader approach and has determined
these are still appropriate estimates to be used in risk assessment.
The Agency estimated the PCT for the uses registered in 2009 as
follows:
    Spinach 30%; Celery 18%; Broccoli 55%; Cabbage 40%, Celery 18%,
Chinese Broccoli 55%; Brussel Sprouts 61%; Cauliflower 48%; Kohlrabi
5%; Apple 5%; Apricot 51%; Cherry 72%; Nectarine 51%; Peach 13%; Plum
37%; Grape 15%; Strawberry 39%;
    For additional information regarding the PCT estimates for these
commodities refer to the final rule published in the Federal Register
of July 10, 2009 (74 FR 33153) (FRL-8421-3).
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, 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 reliable 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 used screening
level water exposure models in the dietary exposure analysis and risk
assessment for buprofezin in drinking water. These simulation models
take into account

data on the physical, chemical, and fate/transport 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 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
buprofezin for acute exposures are estimated to be 58.2 parts per
billion (ppb) for surface water and 0.09 ppb for ground water. The
EDWCs for chronic exposures are estimated to be 18.6 ppb for surface
water and 0.09 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 58.2 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 18.6 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). Buprofezin is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found buprofezin to share a common mechanism of
toxicity with 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 assumed that
buprofezin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased quantitative or qualitative susceptibility following in utero
(rats and rabbits) and pre-and post-natal exposure (rats) to
buprofezin.
    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 for acute exposures. However, the 10x FQPA
safety factor has been retained for chronic exposure. These decisions
are based on the following findings:
    i. The toxicity database for buprofezin is complete except for
submission of the thyroid toxicity study that will inform the Agency's
understanding of buprofezin's chronic effects. A chronic POD of 1.0 mg/
kg/day (NOAEL) was selected for the general population from a 2-year
chronic feeding study in rats based on increased incidence of
follicular cell hyperplasia and hypertrophy in the thyroid in males at
the LOAEL of 8.7 mg/kg/day. A UF 300x (10x for intraspecies variation;
3x for interspecies extrapolation--reduced from 10x based on
demonstrated evidence that rats are more susceptible to thyroid effects
than humans; 10x for protection of infants and children) was applied to
the dose to obtain a cPAD. The 10x FQPA Safety Factor was retained due
to uncertainty caused by the lack of a thyroid assay in young rats. In
rat chronic, subchronic, and reproductive toxicity studies effects such
as thyroid enlargement and follicular cell hyperplasia were seen in
adult animals. However, hormone levels, thyroid organ weights, and
histopathology were not evaluated for pups in any reproductive studies.
To assess the potential toxic characteristics to thyroid structure or
hormone homeostasis during development, the Agency is requiring a
developmental thyroid study.
    ii. There is no indication that buprofezin is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that buprofezin results in increased
susceptibility to in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment was performed
based on 100 PCT and a conservative estimate of total residues of
concern for buprofezin. The chronic dietary food exposure assessment
was performed based, in part on, average field trial residues, average
USDA PDP residues, and PCT were used where available. Nonetheless, the
chronic exposure assessment is conservative and is likely to
overestimate risks based on a number of factors including, use of 100
PCT assumptions for several crops for which data were unavailable, use
of a conservative factor to account for the BF4 Conjugate, use of
default processing factors, and use of drinking water exposure
estimates for application of buprofezin to coffee, which is grown in
limited areas of the U.S. (e.g., Puerto Rico, Hawaii). Likewise, EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to buprofezin in drinking water.
These assessments will not underestimate the exposure and risks posed
by buprofezin.

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 PAD (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 buprofezin will occupy 5% of the aPAD for females 13-49 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
buprofezin from food and water will utilize 91% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for buprofezin.
    3. Short and intermediate-term risk. Short and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level). A short and intermediate-term adverse effect was
identified; however, buprofezin is not registered for any use patterns
that would result in short-term residential exposure. Short and
intermediate-term risk is assessed based on short and intermediate-term
residential exposures plus chronic dietary exposure. Because there is
no short and intermediate-term residential exposures and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short and intermediate-term risk), no further assessment of
short and intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short and intermediate-
term risk for buprofezin.
    4. 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. Based on the limited evidence
of carcinogenicity (driven by benign liver tumors) of buprofezin to
female mice only and not males or rats, and no mutagenicity, EPA
concluded a threshold approach is appropriate for the risk assessment.
Therefore, the chronic assessment is considered protective for the
cancer risk estimate.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatography with nitrogen phosphorus detection (GC/
NPD) and a GC/mass spectrometry (MS) method for confirmation of
buprofezin residues in plant commodities is available to enforce the
tolerance. These methods are available in the Pesticide Analytical
Manual (PAM) Volumes I & II for enforcement of buprofezin tolerances.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The tolerance level
being established by this action for tree nut group 14 is harmonized
with the Codex MRL for almond. There is an established Codex MRL of 2.0
ppm in/on pepper and 1.0 ppm in/on tomato. The petitioner proposed a
tolerance of 3.0 ppm for the Fruiting vegetable group 8-10, which
contains both peppers and tomatoes. EPA cannot harmonize the U.S.
tolerance on tomatoes with the tomato MRL because the residue field
trial data submitted to support the fruiting vegetable group 8-10
tolerance reported residues higher than the 1.0 ppm level established
by Codex for tomato. However, the residue field trial data was
consistent with a tolerance of 2.0 ppm for the fruiting vegetable group
8-10, so EPA was able to harmonize with the Codex MRL for peppers. For
pome fruit, the Codex MRLs and the U.S. tolerances are harmonized for
``fruit, pome (except pear and pear, Asian) at 3.0 ppm and pear and
pear, Asian at 6.0 ppm. There are currently no established Codex MRLs
for buprofezin in/on the remainder of the tolerances being established.

C. Response to Comments

    EPA received two comments to the notice of filings PP 1E7908 and
1F7905, which said that toxic chemicals should not be allowed on food
that Americans eat. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework.

D. Revisions to Petitioned-for Tolerances

    The tolerance for fruit, citrus, group 10-10 is not being
established at this time due to a lack of residue chemistry data. Based
on the data supporting the petition, EPA has revised the proposed
tolerance on Brassica, leafy greens, subgroup 5B and turnip greens from
55 ppm to 60 ppm. The Agency revised these tolerance levels based on
analysis of the residue field trial data using the Organization for
Economic Co-operation and Development (OECD) tolerance calculation
procedures.
    Additionally, the Agency revised the proposed tolerance in or on
vegetables, fruiting, group 8-10 from 3.0 to 2.0 to harmonize with the
Codex MRL on pepper and will establish separate tolerances for fruit,
pome, group 11-10 (except pear and pear, Asian) at 3.0 ppm and pear and
pear, Asian oriental at 6.0 ppm to harmonize with Codex. A tolerance is
not needed for pistachio since there is already a pistachio tolerance
in Sec.  180.511. Finally, the Agency is correcting language for
established commodities that are spelled incorrectly--Llama should be
Ilama and Loganberry should be Logan.

V. Conclusion

    Therefore, tolerances are established for residues of buprofezin 2-
[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H -
1,3,5-thiadiazin-4-one, in or on bean, succulent at 0.02 ppm; Brassica,
leafy greens, subgroup 5B at 60 ppm; fruit, pome, group 11-10 (except
pear and pear, Asian) at 3.0 ppm; nut, tree, group 14 at 0.05 ppm; pear
at 6.0 ppm; pear, Asian at 6.0 ppm; persimmon at 1.9 ppm; tea at 20
ppm; Turnip, greens at 60 ppm; vegetable, fruiting, group 8-10 at 2.0
ppm. Additionally, this regulation removes tolerances of buprofezin in
or on almond at 0.05 ppm, fruit, pome group 11 at 4.0 ppm, okra at 4.0
ppm, nonbell pepper at 4.0 ppm and vegetable, fruiting group 8, except
nonbell pepper at 1.3 ppm as they will be superseded by the tolerances
being established with this action.

VI. Statutory and Executive Order Reviews

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

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: October 4, 2012.
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. In Sec.  180.511 the table in paragraph (a) is amended as follows:
0
i. Remove the entries for Almond; Fruit, pome, group 11; Okra; Pepper,
nonbell and Vegetable, fruiting, group 8, except nonbell pepper;
0
ii. Revising the entries for Llama and Loganberry to read Ilama and
Logan respectively; and
0
iii. Add alphabetically new entries.
    The revisions and additions read as follows:

Sec.  180.511  Buprofezin; tolerances of residues.

    (a) * * *

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

                                * * * * *
Bean, succulent.........................................            0.02

                                * * * * *
Brassica, leafy greens, subgroup 5B.....................           60

                                * * * * *
Fruit, pome, group 11-10, except pear and pear, Asian...            3.0

                                * * * * *
Ilama...................................................            0.30

                                * * * * *
Logan...................................................            0.30

                                * * * * *
Nut, tree group 14......................................            0.05

                                * * * * *
Pear....................................................            6.0
Pear, Asian.............................................            6.0
Persimmon...............................................            1.9

                                * * * * *
Tea\1\..................................................           20
Turnip, greens..........................................           60

                                * * * * *
Vegetable, fruiting, group 8-10.........................            2.0

                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations at this time.

* * * * *
[FR Doc. 2012-25548 Filed 10-16-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Proposed Rules]
[Pages 58224-58226]
[FR Doc No: 2015-24424]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3636; Directorate Identifier 2015-NM-043-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Defense and Space S.A. (Formerly
Known as Construcciones Aeronauticas, S.A.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Defense and Space S.A. (formerly known as Construcciones
Aeronauticas, S.A.) Model CN-235, CN-235-100, CN-235-200, and CN-235-
300 airplanes. This proposed AD was prompted by a report of cracks on
the lugs of the inboard and outboard control rod fittings of the right
hand (RH) and left hand (LH) side ailerons. This proposed AD would
require a one-time non-destructive test (NDT) inspection of the inboard
and outboard control rod fittings of the RH and LH side ailerons for
cracks and corrosion, and repair if necessary. We are proposing this AD
to detect and correct cracks and corrosion on the lugs of the inboard
and outboard control rod fittings of the RH and LH side ailerons, which
could lead to reduced controllability of the airplane.

DATES: We must receive comments on this proposed AD by November 12,
2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to 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 W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
EADS-CASA, Military Transport Aircraft Division (MTAD), Integrated
Customer Services (ICS), Technical Services, Avenida de Arag[oacute]n
404, 28022 Madrid, Spain; telephone: +34 91 585 55 84; fax: +34 91 585
55 05; email<EMAIL_ADDRESS>Internet http://www.eads.net. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3636; or in person at the Docket Management Facility 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:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
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-2015-3636;
Directorate Identifier 2015-NM-043-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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0040, dated March 6, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Defense
and Space S.A. (formerly known as Construcciones Aeronauticas, S.A.)
Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes. The
MCAI states:

    A CN-235 operator recently reported finding, during scheduled
maintenance tasks, cracks on the lugs of the control rod fittings
(inboard and outboard) of the ailerons [Right Hand (RH) and Left
Hand (LH) side] of two aeroplanes. At the time of the finding, the
two affected aeroplanes had accumulated between 16,000 and 17,000
flight hours (FH), around 6,000 flight cycles and had been in
service for 20 years. Following the investigation results, it was
determined that these cracks were due to stress corrosion.
    This condition, if not detected and corrected, could lead to
aileron fittings

failure, possibly resulting in reduced control of the aeroplane.
    To address this unsafe condition and verify the integrity of the
fittings, EADS-CASA (Airbus Military) issued Alert Operators
Transmission (AOT) CN235-57-0001 to provide instructions for a one-
time Non-Destructive (NDT) inspection of the affected fittings for
cracks and corrosion.
    For the reasons described above, this [EASA] AD requires a one-
time NDT inspection of the affected aileron fittings and, if
discrepancies are detected, accomplishment of applicable corrective
action(s) [repair of any cracked or corroded parts].

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3636.

Related Service Information Under 1 CFR part 51

    Airbus Defense and Space S.A. (formerly known as Construcciones
Aeronauticas, S.A.) has issued Airbus Military Alert Operators
Transmission (AOT) AOT-CN235-57-0001, Revision 1, dated March 14, 2014.
The service information describes procedures for a one-time NDT
inspection of the inboard and outboard control rod fittings of the RH
and LH side ailerons for cracks and corrosion, and repair if necessary.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section of this NPRM.

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.

Costs of Compliance

    We estimate that this proposed AD affects 24 airplanes of U.S.
registry.
    We also estimate that it would take about 30 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $61,200, or $2,550
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);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

List of Subjects in 14 CFR Part 39

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

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

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

Sec.  39.13  [Amended]

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

Airbus Defense and Space S.A. (Formerly Known as Construcciones
Aeronauticas, S.A.): Docket No. FAA-2015-3636; Directorate
Identifier 2015-NM-043-AD.

(a) Comments Due Date

    We must receive comments by November 12, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Defense and Space S.A. (formerly known
as Construcciones Aeronauticas, S.A.) Model CN-235, CN-235-100, CN-
235-200, and CN-235-300 airplanes, certificated in any category, all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by a report of cracks on the lugs of the
inboard and outboard control rod fittings of the right hand (RH) and
left hand (LH) side ailerons. We are issuing this AD to detect and
correct cracks and corrosion on the lugs of the inboard and outboard
control rod fittings of the RH and LH side ailerons, which could
lead to reduced controllability of the airplane.

(f) Compliance

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

(g) One-Time Non-Destructive Test (NDT) Inspection

    (1) At the later of the compliance times specified in paragraph
(g)(1)(i) or (g)(1)(ii) of this AD: Do a one-time NDT inspection of
the inboard and outboard control rod fittings of the RH and LH side
ailerons for cracks, and a one-time general visual inspection for
corrosion, in accordance with Airbus Military Alert Operators
Transmission (AOT) AOT-CN235-57-0001, Revision 1, dated March 14,
2014.
    (i) Before exceeding 8,000 flight hours or 10 years since first
flight of the airplane, whichever occurs first.
    (ii) Within 3 months after the effective date of this AD.
    (2) If any crack or corrosion is found during any inspection
required by paragraph (g)(1) of this AD, before further flight,
contact the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus Defense and Space S.A.'s (formerly known as
Construcciones Aeronauticas, S.A.) EASA Design Organization Approval
(DOA) for approved repair instructions, and before further flight,
accomplish the repair accordingly.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Airbus Defense and Space S.A.'s (formerly known as Construcciones
Aeronauticas, S.A.) EASA DOA. If approved by the DOA, the approval
must include the DOA-authorized signature.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0040, dated March 6, 2015,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-3636.
    (2) For service information identified in this AD, contact EADS-
CASA, Military Transport Aircraft Division (MTAD), Integrated
Customer Services (ICS), Technical Services, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone +34 91 585 55 84;
fax +34 91 585 55 05; email<EMAIL_ADDRESS>
Internet http://www.eads.net. You may view this service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 16, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-24424 Filed 9-25-15; 8:45 am]
 BILLING CODE 4910-13-P


39074 Federal Register / Vol. 68, No. 126 / Tuesday, July 1, 2003 / Notices the reporting year, and that the chemical was manufactured, processed, or otherwise used in an amount not exceeding 1 million pounds during the reporting year. Use of the Form A Certification Statement represents a substantial savings to respondents, both in burden hours and in labor costs. The Form A Certification Statement provides communities with information that the chemical is being manufactured, processed or otherwise used at facilities. Additionally, the Form A Certification Statement provides compliance monitoring and enforcement programs and other interested parties with a means to track chemical management activities and verify overall compliance with the rule. Responses to this collection of information are mandatory ( see 40 CFR part 372) and facilities subject to reporting must submit either a Form A Certification Statement or a Form R.

VII. What Are EPA's Burden and Cost Estimates for This ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection, it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The annual public burden for this collection of information, which is approved under OMB Control No. 2070   0143, is estimated to average 13.7 hours for facilities submitting a Form A Certification Statement for a single listed chemical. By comparison, the average time required for calculations, form completion and record keeping/ mailing for Form R is estimated to average 19.5 hours per form. Thus, for a facility filing a Form A certification for a single chemical, the alternate threshold yields an average savings of 5.8 hours. The ICR supporting statement provides a detailed explanation of the burden estimates that are summarized in this notice. The following is a summary of the estimates taken from the ICR supporting statement: Estimated No. of Respondents: 5,200. Frequency of Responses: Annual. Estimated Total Annual Burden Hours: 169,106. Estimated Total Annual Burden Costs: $ 7.56 million.

VIII. Are There Changes in the Estimates From the Last Approval? The estimated burden described above differs from what is currently in OMB's inventory for alternate threshold reporting: 5,121 responses ( Form A Certification Statements) and 463,670 burden hours. The burden estimated in this supporting statement differs from OMB's inventory as a result of adjustments to estimates of number of responses ( from 5,121 responses to 5,000 responses), changes to subsequent year unit reporting burden estimates ( from 30.2 to 9.2 burden hours per chemical certified on a Form A Certification Statement), and an adjustment for use of TRI   ME for those forms completed using TRI   ME. These changes are described in greater detail in the supporting statement for this ICR, available in the public version of the official record.

IX. What Is the Next Step in the Process for This ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person( s) listed in the FOR FURTHER INFORMATION CONTACT section.

Dated: June 25, 2003. Kimberly T. Nelson, Assistant Administrator, Office of Environmental Information. [ FR Doc. 03   16584 Filed 6   30   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OEI   2003   0025; FRL   7520   9]

Toxic Chemical Release Reporting; Request for Comment on Renewal Information and Proposed Changes to Part II of the Form R Collection AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this notice announces that EPA is planning to submit the following continuing Information Collection Request ( ICR) to the Office of Management and Budget ( OMB) pursuant to procedures described in 5 CFR 1320.12: Toxic Chemical Release Reporting ( EPA ICR No. 1363.13, OMB No. 2070   0093). This ICR involves a collection activity that is currently approved and scheduled to expire on October 31, 2003. EPA ICR No. 1363.12 was approved by OMB on March 10, 2003, with a shorter than usual clearance in order to provide the EPA an opportunity to examine in more detail the TRI burden estimates and opportunities for reducing burden and enhancing the practical utility of the data. A revised draft Form R is included in this ICR. The redesigned draft Form R collects all the same information as the prior form; however, it collects that information in a different format. EPA is proposing this draft Form R based on feedback received from stakeholders in an effort to collect information in a more logical, simplistic manner. Section V below and sections 1 ( b) and 3 ( b) of the ICR Supporting Statement discuss the proposed Form R changes in greater detail. Also, a copy of the proposed new Form R and a crosswalk between the proposed Form R and the previous version of the Form R are included as Attachment G of the ICR Supporting Statement. Before submitting this ICR to the Office of Management and Budget ( OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection as described below. DATES: Comments, identified by the docket control number OEI   2003   0025 must be submitted on or before September 2, 2003. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For general information contact: The Emergency Planning and Community Right to Know Hotline at ( 800) 424   9346 or ( 703) 412   9810, TDD ( 800) 553   7672, http:// www. epa. gov/ epaoswer/ hotline/. For technical information about this ICR renewal contact: Judith Kendall, Toxics Release Inventory Program Division, OEI, Environmental Protection Agency ( 2844T), 1200 Pennsylvania Ave., NW., Washington, DC 20460, Telephone: 202   566   0750;

VerDate Jan< 31> 2003 16: 39 Jun 30, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM 01JYN1 39075 Federal Register / Vol. 68, No. 126 / Tuesday, July 1, 2003 / Notices Fax: 202   566   0727; e mail: kendall. judith@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does This Notice Apply to Me?

Affected Entities: Entities that will be affected by this action are those facilities that manufacture, process, or otherwise use certain toxic chemicals listed on the Toxics Release Inventory ( TRI) and which are required under section 313 of the Emergency Planning and Community Right to Know Act of 1986 ( EPCRA) to report annually to EPA their environmental releases and other waste management activities involving such chemicals. Currently, those industries with the following SIC code designations ( that meet all other threshold criteria for TRI reporting) must report toxic chemical releases and other waste management activities:   20   39, manufacturing.   10, metal mining ( except for SIC codes 1011, 1081, and 1094).   12, coal mining ( except for SIC code 1241 and extraction activities).   4911, 4931 and 4939, electrical utilities that combust coal and/ or oil for the purpose of generating power for distribution in commerce.   4953, RCRA subtitle C hazardous waste treatment and disposal facilities.   5169, chemicals and allied products wholesale distributors.   5171, petroleum bulk plants and terminals.   7389, solvent recovery services, and   Federal facilities in any SIC code. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions at 40 CFR part 372 and section 3( a) of the Supporting Statement of the information collection. If you have any questions regarding the applicability of this action to a particular entity, consult the person( s) listed in the FOR FURTHER INFORMATION CONTACT section.

II. How Can I Get Additional Information or Copies of This Document and Other Support Documents?

A. In Person The Agency has established an official public docket for this action under Docket ID no. OEI   2003   0025. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of this official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the OEI Docket in the EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is ( 202) 566   1744, and the telephone number for the OEI Docket is ( 202) 566   1752.

B. Electronic Availability Electronic copies of the ICR are available from the EPA home page at the Federal Register   Environmental Documents entry for this document under `` Laws and Regulations'' ( http:// www. epa. gov/ fedrgstr/). An electronic copy of the collection instrument referenced in this ICR and instructions for its completion are available at http:// www. epa. gov/ triinter/# forms. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public dockets, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket identification number ( i. e., OEI   2003   0025). Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. For additional information about EPA's electronic public docket visit EPA Dockets online or see 67 FR 38102, May 31, 2002.

III. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket identification number ( i. e., `` OEI   2003   0025'') in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit IV. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the VerDate Jan< 31> 2003 16: 39 Jun 30, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM 01JYN1 39076 Federal Register / Vol. 68, No. 126 / Tuesday, July 1, 2003 / Notices comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet home page, select `` Information Sources,'' `` Dockets,'' and `` EPA Dockets.'' Once in the system, select `` search,'' and then key in Docket ID No. OEI   2003   0025. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by electronic mail ( e mail) to oei. docket@ epa. gov. Attention Docket ID No. OEI   2003   0025. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit III. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. All comments and data in electronic form must be identified by the docket control number OEI   2003   0025. Electronic comments on this document may also be filed online at many Federal Depository Libraries. 2. By Mail. Send three copies of your comments to: Document Control Office, Office of Environmental Information ( OEI), U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. By Hand Delivery or Courier. Comments may be delivered in person or by courier to: EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, attention Docket ID No. OEI   2003   0025.

IV. How Should I Handle CBI Information That I Want to Submit to the Agency?

All comments which contain information claimed as CBI must be clearly marked as such. Three sanitized copies of any comments containing information claimed as CBI must also be submitted and will be placed in the public record for this document. Persons submitting information any portion of which they believe is entitled to treatment as CBI by EPA must assert a business confidentiality claim in accordance with 40 CFR 2.203( b) for each such portion. This claim must be made at the time that the information is submitted to EPA. Information covered by such a claim will be disclosed by EPA only to the extent, and by means of the procedures set forth in 40 CFR part 2, subpart B. If a confidentiality claim does not accompany the information when it is received by EPA, the information may be made available to the public by EPA without further notice to the submitter.

V. What Information is EPA Particularly Interested in?

A. Pursuant to section 3506( c)( 2)( a) of the PRA, EPA specifically solicits comments and information to enable it to: ( i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; ( ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses. B. Proposed changes to the Form R: A revised draft Form R is included in this ICR. The draft Form R collects all the same information as the prior form; however, it collects that information in a different format. There are no changes to part I of the Form R. EPA is proposing changes to part II of the Form R based on feedback received from stakeholders through various venues ( e. g., Stakeholder Phase I process, ICR renewal process in 2002, letters, meetings, etc.). Specifically, stakeholders have been requesting that EPA provide more clarity in the organization of data that are collected. These changes do not collect any new or different information than has been previously collected. Instead part II now clearly identifies on the Form itself the categories for reporting releases and other waste management activities of toxic chemicals. The previous version of this form collected information using codes to specify categories of releases and other waste management activities ( e. g., M73 for Land Treatment). One code, U09   Other Energy Recovery Methods, has been dropped from the revised Form because this element is not applicable since the only energy recovery methods are combustion in a kiln, boiler or industrial furnace. Combustion units other than kilns, boilers and industrial furnaces are used for treatment of the toxic chemical ( except for metal and metal compounds). This proposed revision incorporates these codes into the form so it is easier to identify the appropriate release or other waste management activity for the toxic chemical reported, and thus provides greater clarity to the information collected. Also, in light of feedback received from stakeholders, EPA has broken the information collected on releases in section 8.1 of part II into four subcategories which are; total onsite uncontained releases; total onsite contained disposal; total offsite uncontained releases; and total offsite contained disposal. The category of contained disposal would include the quantities sent to on site or off site landfills and Class I Underground Injection Control wells. This would provide a more complete characterization of TRI chemicals in waste streams by distinguishing between releases to ambient media and releases to managed facilities consistent with environmental reporting requirements under other laws. The presence of only one of these factors is not considered enough to consider the release `` contained''; for example, regulated air stack emissions are clearly not contained releases. Therefore, all VerDate Jan< 31> 2003 16: 39 Jun 30, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM 01JYN1 39077 Federal Register / Vol. 68, No. 126 / Tuesday, July 1, 2003 / Notices release quantities other than quantities sent to on site or off site landfills and Class I Underground Inject Control wells would be included in the category of uncontained releases. This change and others are described in more detail in section 3( b) of the ICR Supporting Statement. Also, a draft of the proposed Form R and crosswalk table can be found in Appendix G of the ICR Supporting Statement. EPA is interested in receiving comments on the proposed changes to the Form R and is particularly interested in receiving comment on whether the individual waste streams in section 5 are appropriately classified as either contained or uncontained for section 8. In addition, the Agency is soliciting input on whether the headings used in section 8 are appropriate to describe the intended categories.

VI. To What Information Collection Activity or ICR Does This Notice Apply? EPA is seeking comments on the following ICR, as well as the Agency's intention to renew the corresponding OMB approval, which is currently scheduled to expire on October 31, 2003. Title: Toxic Chemical Release Reporting. ICR numbers: EPA ICR No. 1363.13, OMB No. 2070   0093. Abstract: EPCRA section 313 requires owners and operators of certain facilities that manufacture, process, or otherwise use any of over 650 listed toxic chemicals and chemical categories in excess of applicable threshold quantities to report annually to the Environmental Protection Agency and to the states in which such facilities are located on their environmental releases and transfers of and other waste management activities for such chemicals. In addition, section 6607 of the Pollution Prevention Act ( PPA) requires that facilities provide information on the quantities of the toxic chemicals in waste streams and the efforts made to reduce or eliminate those quantities. Annual reporting under EPCRA section 313 of toxic chemical releases and other waste management information provides citizens with a more complete picture of the total disposition of chemicals in their communities and helps focus industries' attention on pollution prevention and source reduction opportunities. EPA believes that the public has a right to know about the disposition of chemicals within communities and the management of such chemicals by facilities in industries subject to EPCRA section 313 reporting. This reporting has been successful in providing communities with important information regarding the disposition of toxic chemicals and other waste management information of toxic chemicals from manufacturing facilities in their areas. EPA collects, processes, and makes available to the public all of the information collected. The information gathered under these authorities is stored in a database maintained at EPA and is available through the Internet. This information, commonly known as the Toxics Release Inventory ( TRI), is used extensively by both EPA and the public sector. Program offices within EPA use TRI data, along with other sources of data, to establish priorities, evaluate potential exposure scenarios, and undertake enforcement activities. Environmental and public interest groups use the data in studies and reports, making the public more aware of releases of chemicals in their communities. Comprehensive publicly available data about releases, transfers, and other waste management activities of toxic chemicals at the community level are generally not available, other than under the reporting requirements of EPCRA section 313. Permit data are often difficult to obtain, are not cross media and present only a limited perspective on a facility's overall performance. With TRI, and the real gains in understanding it has produced, communities and governments know what toxic chemicals industrial facilities in their area release, transfer, or otherwise manage as waste. In addition, industries have an additional tool for evaluating efficiency and progress on their pollution prevention goals. Responses to the collection of information are mandatory ( see 40 CFR part 372). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

VII. What Are EPA's Burden and Cost Estimates for This ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection, it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR supporting statement provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to average 19.5 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: Entities potentially affected by this action are owners or operators of certain facilities that manufacture, process, or otherwise use certain specified toxic chemicals and chemical categories and are required to report annually on the environmental releases and transfers of waste management activities for such chemicals. Estimated total number of potential responses: 84,000. Frequency of response: Annual. Estimated total annual burden hours: 2,403,867. Estimated total annual burden costs: $ 106.2 million.

VIII. Are There Changes in the Estimates From the Last Approval? As a result of OMB's 03/ 10/ 2003 approval of the last ICR renewal, OMB's inventory reflects 88,117 responses and 5,566,564 hours for this information collection. This ICR supporting statement is for 84,000 responses and 2,403,867 hours. The reduction in burden of approximately 3.16 million hours is the result of three adjustments. The first adjustment is to the number of responses. The estimate of 88,117 responses in the existing OMB approval incorporated a predicted reporting increase from the economic analysis of the final rule to lower reporting thresholds for lead and lead compounds. This prediction overestimated actual reporting levels; EPA received about 70 percent of the additional lead and lead compound reports that were forecast. The number of responses in this ICR supporting statement have been adjusted to VerDate Jan< 31> 2003 16: 39 Jun 30, 2003 Jkt 200001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM 01JYN1 39078 Federal Register / Vol. 68, No. 126 / Tuesday, July 1, 2003 / Notices accurately reflect actual reporting levels ( rounded to the next highest thousand responses). This adjustment accounts for a decrease of about 218,000 hours. The second adjustment is to the unit burden hours. EPA has adjusted the estimate of unit burden hours for Form R completion in subsequent years from 47.1 hours to 14.5 hours based on responses from actual TRI reporting facilities. This adjustment accounts for a decrease of about 2.68 million hours. The third adjustment relates to the adoption of TRI   ME, an automated reporting software package. EPA has reduced the burden estimates related to Form R Completion and Recordkeeping/ Submission by 25 percent for the reports filed using TRI   ME. On an annualized basis, an estimated 60 percent of reports are expected to be filed using TRI   ME over the three years of the ICR. This adjustment accounts for a decrease of about 261,000 hours. The sum of these adjustments is a decrease of 4,117 responses and 3,162,697 burden hours from the current approved total. These adjustments are described in further detail in the supporting statement for this ICR, available in the public version of the official record.

IX. What Is the Next Step in the Process for This ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person( s) listed in the FOR FURTHER INFORMATION CONTACT section.

Dated: June 25, 2003.

Kimberly T. Nelson,

Assistant Administrator, Office of Environmental Information. [ FR Doc. 03   16585 Filed 6   30   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ FRL   7521   3]

Solicitation Notice; Children's Environmental Health Protection State Level Collaboration to Address Childhood Asthma Initiative, Fiscal Year 2003   USEPA   AO   OCHP   03   001 Fiscal Year 2003, Environmental Protection Agency, deadline for letter of intent, August 11, 2003; http:// yosemite. epa. gov/ ochp/ ochpweb. nsf/ content/ grants. htm.

Contents Section I   Overview Section II   Dates and Deadlines Section III   Addresses for Delivering Letters of Intent and Proposals Section IV   Eligible Applicants and Activities Section V   Funding Priorities Section VI   Application Process Section VII   Requirements for Letters of Intent and Full Proposals Section VIII   Review and Selection Process Section IX   Grantee Responsibilities Section X   Other Information and Shipping Attachment: Sample Letter of Intent Summary Sheet Section I. Overview A. Summary This action known as the Solicitation Notice for the Children's Environmental Health Protection State Level Collaboration to Address Childhood Asthma Initiative, Fiscal Year 2003 announces the availability of funds from the Environmental Protection Agency's ( EPA) Office of Children's Health Protection ( OCHP), to support the efforts of state environment and health agencies together to minimize the environmental factors that exacerbate asthma symptoms in children.

B. Authorities Section 103 of the Clean Air Act ( CAA) authorizes EPA's Administrator to conduct and promote the coordination and acceleration of research, investigations, experiments, demonstrations, surveys and studies relating to the causes, effects ( including health and welfare effects), extent, prevention, and control of air pollution by making grants to air pollution control agencies, to other public or nonprofit private agencies, institutions, and organizations for purposes stated in section 103( a)( 1) http:// www. epa. gov/ oar/ caa/ caa103. txt. The goal of the Children's Environmental Health Protection program ( hereinafter `` the Initiative'') is to minimize and/ or eliminate children's exposure to environmental health threats   recognizing children's special vulnerability to these threats and recognizing the possibility of preventable childhood exposures leading to lifelong, irreversible consequences. This program is included within the Catalogue for Domestic Assistance ( CFDA) listing number: 66.609 found at http:// www. cfda. gov. This funding initiative will support planning and/ or demonstration projects related specifically to the environmental triggers of childhood asthma.

C. Background In recent years, EPA's Office of Children's Health Protection has encouraged and supported collaboration between state level health and environment agencies toward the end of building state capacity to combat childhood asthma. Since the summer of 2001, the Environmental Council of the States ( ECOS) has collaborated with the Association of State and Territorial Health Officials ( ASTHO) and the U. S. Environmental Protection Agency to design a flexible template for state level strategies and actions to minimize environmental factors that contribute to asthma in children. This focus on environmental factors complements the on going Centers for Disease Control ( CDC) state asthma program which recognizes the need to address environmental factors but does not explicitly provide guidance or support for this aspect of disease prevention and control. This action may also complement Housing and Urban Development's ( HUD) Healthy Homes Initiative, which supports effective home assessment and intervention programs as well as public education. Throughout 2002, ECOS, ASTHO, and EPA hosted a series of four workshops to refine the details of a cooperative approach in four specific areas: Data, environmental factors in homes, environmental factors in schools and child care facilities, and outdoor environmental factors. The eligible funding categories and guiding principles of this Request for Applications are a reflection of the draft action agenda, Catching Your Breath, http:// www. astho. org/ pubs/ CatchingYourBreathReport. pdf that resulted from this intensive collaborative visioning process.

D. Proposal Categories The Initiative plans to award assistance agreements ( grants and cooperative agreements) to state health and environment agencies and/ or regional air authorities with formal delegated authorities with a project VerDate Jan< 31> 2003 16: 39 Jun 30, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 01JYN1. SGM 01JYN1