[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Rules and Regulations]
[Pages 27337-27342]
[FR Doc No: 2016-10738]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0035; FRL-9945-68]

Clethodim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
clethodim in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 6, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, 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-2015-0035, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2015-0035 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2016. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0035, 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 CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (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.html.
    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 Wednesday, May 20, 2015 (80 FR 28925)
(FRL-9927-39), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 4E8334) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.458 be amended by establishing tolerances for
residues of the herbicide clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-
propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one, and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones,
calculated as the stoichiometric equivalent of clethodim, in or on
stevia at 12 parts per million (ppm); pome fruit group 11-10 at 0.2
ppm; stone fruit group 12-12 at 0.2 ppm; bulb onion subgroup 3-07A at
0.2 ppm; low growing berry subgroup 13-07G, except cranberry at 3.0
ppm; rapeseed subgroup 20A, except flax 0.5 ppm;

sunflower subgroup 20B at 5.0 ppm; cottonseed subgroup 20C at 1.0 ppm;
and fruiting vegetable group 08-10 at 1.0 ppm. Also, this notice
further requests amending 40 CFR 180.458 by removing the following
commodity listings: canola seed at 0.5 ppm, cotton, undelinted seed at
1.0 ppm, peach at 0.2 ppm, onion, bulb at 0.2 ppm, strawberry at 3.0
ppm, and sunflower, seed at 5.0 ppm, upon establishment of the
aforementioned tolerances. That document referenced a summary of the
petition prepared by Valent USA Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has made
some modifications to petitioned-for crop tolerances. The reasons for
these changes are explained in Unit IV.C.

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 clethodim including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clethodim follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The liver is the target organ based on repeated dosing by either
oral or dermal routes in rats, mice, and dogs. The observed liver
effects are characterized by increased liver weights, clinical
chemistry changes, and centrilobular hepatic hypertrophy. Most of the
liver effects that occurred at or below 100 milligrams/kilogram body
weight (mg/kg bw) were considered as adaptive effects and not adverse.
Decreased body weight was also a common finding across studies and
species. In the 1-year dog oral toxicity study, hematological changes
such as increased platelet and leukocyte counts were also noted.
    Developmental effects were not present in rabbits; the rat
developmental toxicity study showed reduced fetal body weights and an
increase in the incidence of delayed ossification of the lower
vertebrae at the same dose where maternal toxicity was found. Neither
reproductive nor offspring effects were seen in the 2-generation rat
reproduction study. Therefore, the data did not show an increased
susceptibility in the young. The clethodim database also showed no
potential for neurotoxicity or immunotoxicity.
    The rat and mouse carcinogenicity studies did not show treatment-
related increases in tumor incidence. Clethodim is not genotoxic and is
classified as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by Clethodim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document'', Clethodim. Human Health Aggregate
Risk Assessment for the Proposed New Uses on Stevia, Pome Fruit Group
11-10, Stone Fruit Group 12-12, Bulb Onion Subgroup 3-07A, Low Growing
Berry Subgroup 13-07G, (except Cranberry); Rapeseed Subgroup 20A
(except Flax Seed), Sunflower Subgroup 20B, Cottonseed Subgroup 20C,
and Fruiting Vegetable Group 8-10, pages number 29 through 34 in docket
ID number EPA-HQ-OPP-2015-0035.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for clethodim used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations)..  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity studies--rats.
                                    day.                  day.                LOAEL = 1,000 mg/kg based on
                                   UFA = 10x...........  aPAD = 1 mg/kg/day.   clinical observation from two
                                   UFH = 10x...........                        acute neurotoxicity studies (one
                                   FQPA SF = 1x........                        study was conducted in 2006 and
                                                                               another was completed in 2012).
                                                                               The clinical observation included
                                                                               decreased spontaneous activity,
                                                                               ruffled fur, head tilt, and
                                                                               hunched posture.
Chronic dietary (All populations)  NOAEL = 30 mg/kg/day  Chronic RfD = 0.3    Carcinogenicity study--mice.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 150 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.3 mg/kg/     reduced survival; decreased red
                                   FQPA SF = 1x........   day.                 cell mass; and increased
                                                                               incidences of bile duct
                                                                               hyperplasia, of pigmentation of
                                                                               the liver, and of foci of
                                                                               amphophilic macrophages in the
                                                                               lung.
Incidental Oral Short-Term (1-30   NOAEL = 75 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity--dogs.
 days).                            UFA = 10X...........                       LOAEL = 125 mg/kg/day based on
                                   UFH = 10X...........                        increased absolute and relative
                                   FQPA SF = 1X........                        liver weights, and histological
                                                                               changes characterized by
                                                                               cytoplasmic vesiculation and
                                                                               vacuolation of the central
                                                                               lobular hepatocytes in both
                                                                               sexes.
Inhalation Short-Term (1 to 30     NOAEL = 75 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity--dogs
 days).                            UFA = 10X...........                       LOAEL = 125 mg/kg/day based on
                                   UFH = 10X...........                        increased absolute and relative
                                   FQPA SF = 1X........                        liver weights, and histological
                                                                               changes characterized by
                                                                               cytoplasmic vesiculation and
                                                                               vacuolation of the central
                                                                               lobular hepatocytes in both
                                                                               sexes.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      Clethodim is classified as ``Not Likely'' to be carcinogenic based no
                                           treatment-related increase in tumor incidence in rat and mouse
                                                              carcinogenicity studies.
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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). 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 clethodim, EPA considered exposure under the petitioned-for
tolerances as well as all existing clethodim tolerances in 40 CFR
180.458. EPA assessed dietary exposures from clethodim 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 clethodim. In estimating acute
dietary exposure, EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID), Version
3.16, which incorporates 2003-2008 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA conducted unrefined acute dietary analyses
assuming tolerance-level residues for all commodities and 100 percent
crop treated (PCT). Unless tolerances were established for processed
commodities, DEEM version 7.81 default processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID, Version 3.16, which incorporates
2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to
residue levels in food, EPA conducted unrefined chronic dietary
analyses assuming tolerance-level residues for all commodities and 100
PCT. Unless tolerances were established for processed commodities, DEEM
version 7.81 default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clethodim does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for clethodim. Tolerance-level residues and 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for clethodim in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clethodim. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated
drinking water concentrations (EDWCs) of clethodim for acute exposures
are 330 parts per billion (ppb) for surface water and 1,430 ppb for
ground water.
    For chronic exposures for non-cancer assessments are estimated to
be 137 ppb for surface water and 1,150 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
1,430 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 1,150 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).
    Clethodim is currently registered for the following uses that could
result in residential exposures: In and around ornamental plant beds,
landscaped area, trees, and ground covers (mulch). There are no
residential uses associated with proposed new uses. EPA has previously
assessed clethodim residential exposure using the following
assumptions: Short-term residential handler inhalation exposures
represent the ``worst case'' high-end exposure. Because a dermal hazard
was not identified, residential handler and post-application dermal
risk assessments were not conducted. No other post-application
exposures were assessed either because the potential for exposure via
non-dietary ingestion for young children is unlikely due to the limited
residential uses for clethodim products. The extent to which young
children engage in the types of activities associated with these areas
(i.e., ornamental landscapes) or utilize these areas for prolonged
periods of play is low. No intermediate-term or chronic exposures are
expected from the currently registered residential uses.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 clethodim to share a common mechanism of toxicity
with any other substances, and clethodim does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that clethodim 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 susceptibility of fetuses as compared to maternal animals
following in utero and/or postnatal exposure to clethodim in the
developmental toxicity studies in rats or rabbits, and no increased
sensitivity in pups as compared to adults in the 2-generation rat
reproduction toxicity study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
concerns.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for clethodim is complete.
    ii. There is no indication that clethodim 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 of increased susceptibility of fetuses as
compared to maternal animals following in utero and/or postnatal
exposure to clethodim in the developmental toxicity studies in rats or
rabbits, and no increased sensitivity in pups as compared to adults in
the 2-generation rat reproduction toxicity study. In the rat
developmental study, reduced ossification seen at the same dose that
resulted in maternal toxicity is considered secondary to reduced
maternal body weight, and is not considered qualitative susceptibility.
There are no residual uncertainties concerning prenatal and postnatal
toxicity and no neurotoxicity concerns.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to clethodim in drinking water. Post application
exposure of children and incidental oral exposures to toddlers are
expected to be negligible. All exposure estimates are based on
conservative assumptions that will not underestimate the exposure and
risks posed by clethodim.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Acute exposure is not expected for the residential
exposure pathway. Therefore, the acute aggregate risk would be
equivalent to the acute dietary exposure estimates.
    Using the exposure assumptions discussed in this unit for acute
exposure, the acute dietary exposure from food and water to clethodim
will occupy 29% of the aPAD for all infants <1 year old, the population
group receiving the greatest exposure.
    2. Chronic risk. There are no chronic residential exposure
scenarios. Therefore, the chronic aggregate risk would be equivalent to
the chronic dietary exposure (food and drinking water) estimate. Using
the exposure assumptions described in this unit for chronic exposure,
EPA has concluded that chronic exposure to clethodim from food and
water will utilize 30% of the cPAD for all infants <1 year old, the
population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Clethodim is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to

clethodim. Using the exposure assumptions described in this unit for
short-term exposures, EPA has concluded the combined short-term food,
water, and residential exposures result in the short-term aggregate
risk estimate for adults ages 20-49 is a MOE of 2,200. Because EPA's
level of concern for clethodim is a MOE of 100 or below, this MOE is
not of concern.
    4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, clethodim is not registered for any use patterns
that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure 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 intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for clethodim.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clethodim is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available: FDA Multiresidue
Methods, gas chromatography/flame photometric detection in the sulfur
mode (GC/FPD-S) and gas chromatography method with mass selective
detection (GC/MSD).
    These methods have been adequately validated for the analyses of
residues of clethodim in/on crop matrices.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint 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 Codex has established MRLs for clethodim in or on onion bulb
and garlic at 0.5 ppm, tomato at 1 ppm, rapeseed at 0.5 ppm, sunflower
seed at 0.5 ppm, and cotton seed at 0.5 ppm. The U.S. tolerances for
rapeseed subgroup 20A, fruiting vegetables crop group 8-10, and onion,
bulb, subgroup 3-07A are harmonized with the Codex MRLs for rapeseed,
tomato, and bulb onion and garlic, respectively.
    However, the U.S. tolerances for sunflower subgroup 20B and
cottonseed subgroup 20C are not harmonized with the corresponding Codex
MRLs for sunflower seed and cotton seed since the MRL values are lower
than the U.S tolerances. The U.S. tolerances cannot be lowered to
harmonize because doing so could result in residues above the
tolerances when following the U.S. approved label directions.

C. Revisions to Petitioned-for Tolerances

    The Agency made changes to the naming of certain petitioned-for
commodities to reflect the current commodity definitions and
significant figures used by the Agency. Although the petitioner
requested a tolerance on stevia only, EPA established a tolerance on
stevia, dried leaves because the dried commodity represents stevia that
will be found in the U.S. trade market. Moreover, the Agency is
removing certain commodities from the table at Sec.  180.458(a) in
order to eliminate redundancies upon the establishment of new crop
group tolerances that were not identified in the petition: mustard,
seed at 0.5 ppm, safflower, seed at 5.0 ppm, sesame, seed at 0.35 ppm,
vegetable, fruiting group 8 at 1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of clethodim, 2-
[(1E)-1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites
containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-
ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their
sulphoxides and sulphones, calculated as the stoichiometric equivalent
of clethodim, in or on berry, low growing, subgroup 13-07G, except
cranberry at 3.0 ppm; cottonseed subgroup 20C at 1.0 ppm; fruit, pome,
group 11-10 at 0.20 ppm; fruit, stone, group 12-12 at 0.20 ppm; onion,
bulb, subgroup 3-07A at 0.50 ppm; rapeseed subgroup 20A, except flax
seed at 0.50 ppm; stevia, dried leaves at 12 ppm; sunflower subgroup
20B at 5.0 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm. EPA is
also removing the following established tolerances that are superseded
by this action: Canola seed, at 0.50 ppm; cotton, undelinted seed at
1.0 ppm; mustard, seed at 0.50 ppm; peach at 0.20 ppm; onion, bulb at
0.20 ppm; strawberry at 3.0 ppm; safflower, seed at 5.0 ppm; sesame,
seed at 0.35 ppm; sunflower, seed at 5.0 ppm; vegetable, fruiting group
8 at 1.0 ppm. Finally, as a housekeeping measure, the Agency is
removing two individual tolerances that are subsumed within other crop
group tolerances contained in Sec.  180.458: Bean, dry, seed at 2.5 ppm
is covered by the entry for vegetable, legume, group 6, except soybean
at 3.5 ppm and potato at 0.5 ppm is covered by the entry for vegetable,
tuberous and corm, subgroup 1C at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action 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: April 28, 2016.
Susan Lewis,
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.  180.458, in the table in paragraph (a):
0
a. Remove the entry for ``Bean, dry, seed;''
0
b. Add alphabetically an entry for ``Berry, low growing, subgroup 13-
07G, except cranberry;''
0
c. Remove the entry for ``Canola seed;''
0
d. Add alphabetically an entry for ``Cottonseed subgroup 20C;''
0
e. Remove the entry for ``Cotton, undelinted seed;''
0
f. Add alphabetically entries for ``Fruit, pome, group 11-10'' and
``Fruit, stone, group 12-12;''
0
g. Remove the entries for ``Mustard, seed'' and ``Onion, bulb;''
0
h. Add alphabetically an entry for ``Onion, bulb, subgroup 3-07A;''
0
i. Remove the entries for ``Peach'' and ``Potato;''
0
j. Add alphabetically an entry for ``Rapeseed subgroup 20A, except flax
seed;''
0
k. Remove the entries for ``Safflower, seed,'' ``Sesame, seed,'' and
``Strawberry;''
0
l. Add alphabetically an entry for ``Stevia, dried leaves;''
0
m. Remove the entries for ``Sunflower, seed,'' and ``Vegetable,
fruiting group 8;'' and
0
n. Add alphabetically the entries for ``Sunflower subgroup 20B'' and
``Vegetable, fruiting, group 8-10.''
    The additions read as follows:

Sec.  180.458  Clethodim; tolerance for residues.

    (a) * * *

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

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry.......         3.0

                                * * * * *
Cottonseed subgroup 20C.....................................         1.0

                                * * * * *
Fruit, pome, group 11-10....................................        0.20
Fruit, stone, group 12-12...................................        0.20

                                * * * * *
Onion, bulb, subgroup 3-07A.................................        0.50

                                * * * * *
Rapeseed subgroup 20A, except flax seed.....................        0.50

                                * * * * *
Stevia, dried leaves........................................          12

                                * * * * *
Sunflower subgroup 20B......................................         5.0

                                * * * * *
Vegetable, fruiting, group 8-10.............................         1.0

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

* * * * *
[FR Doc. 2016-10738 Filed 5-5-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 109 (Wednesday, June 9, 2021)]
[Rules and Regulations]
[Pages 30543-30545]
[FR Doc No: 2021-11925]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0321; FRL-10023-81-Region 3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standards Second Maintenance Plan for the Tioga
County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Pennsylvania. The revision pertains to the Commonwealth's plan,
submitted by the Pennsylvania Department of Environmental Protection
(PADEP), for maintaining the 1997 8-hour ozone national ambient air
quality standard (NAAQS) (referred to as the ``1997 ozone NAAQS'') in
the Tioga County, Pennsylvania area (Tioga County Area). EPA is
approving these revisions to the Pennsylvania SIP in accordance with
the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on July 9, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2020-0321. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Adam Yarina, Planning & Implementation
Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
The telephone number is<PHONE_NUMBER>. Mr. Yarina can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On February 8, 2021 (86 FR 8569), EPA published a notice of
proposed rulemaking (NPRM) for the Commonwealth of Pennsylvania. In the
NPRM, EPA proposed approval of Pennsylvania's plan for maintaining the
1997 ozone NAAQS in the Tioga County Area through July 6, 2027, in
accordance with CAA section 175A. The formal SIP revision was submitted
by PADEP on March 10, 2020.

II. Summary of SIP Revision and EPA Analysis

    On July 6, 2007 (72 FR 36892, effective same day), EPA approved a
redesignation request and maintenance plan from PADEP for the Tioga
County Area. In accordance with CAA section 175A(b), at the end of the
eighth year after the effective date of the redesignation, the state
must also submit a second maintenance plan to ensure ongoing
maintenance of the standard for an additional 10 years, and in South
Coast Air Quality Management District v. EPA,\1\ the D.C. Circuit held
that this requirement cannot be waived for areas--like the Tioga County
Area--that had been redesignated to attainment for the 1997 8-hour
ozone NAAQS prior to revocation and that were designated attainment for
the 2008 ozone NAAQS. CAA section 175A sets forth the criteria for
adequate maintenance plans. In addition, EPA has published longstanding
guidance that provides further insight on the content of an approvable
maintenance plan, explaining that a maintenance plan should address
five elements: (1) An attainment emissions inventory; (2) a maintenance
demonstration; (3) a commitment for continued air quality monitoring;
(4) a process for verification of continued attainment; and (5) a
contingency plan.\2\ PADEP's March 10, 2020 submittal fulfills
Pennsylvania's obligation to submit a second maintenance plan and
addresses each of the five necessary elements.
---------------------------------------------------------------------------

    \1\ 882 F.3d 1138 (D.C. Cir. 2018).
    \2\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
---------------------------------------------------------------------------

    As discussed in the February 8, 2021 NPRM, EPA allows the submittal
of a limited maintenance plan (LMP) to meet the statutory requirement
that the area will maintain for the statutory period. Qualifying areas
may meet the maintenance demonstration by showing that the area's
design value \3\ is well below the NAAQS and that the historical
stability of the area's air quality levels indicates that the area is
unlikely to violate the NAAQS in the future. EPA evaluated PADEP's
March 10, 2020 submittal for consistency with all applicable EPA
guidance and CAA requirements. EPA found that the submittal met CAA
section 175A and all CAA requirements and proposed approval of the LMP
for the Tioga County Area as a revision to the Pennsylvania SIP.
---------------------------------------------------------------------------

    \3\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
---------------------------------------------------------------------------

    Other specific requirements of PADEP's March 10, 2020 submittal and
the rationale for EPA's proposed action are explained in the NPRM and
will not be restated here.

III. EPA's Response to Comments Received

    EPA received comments on the February 8, 2021 NPRM from two
commenters. All comments received are in the docket for this rulemaking
action. A summary of the comments and EPA's responses are provided
herein.
    The first commenter asserts that EPA cannot approve this plan
because air quality levels were not at or below 85% of the NAAQS, and
that one of EPA's methods for demonstrating continued future
maintenance of the NAAQS is flawed.
    Comment 1: The commenter asserts that EPA cannot approve this plan
``because the air quality has not been below 85% of the NAAQS for the
time period EPA claims.'' The commenter claims that the following
statement in EPA's proposed approval of the limited maintenance plan is
incorrect: ``The Tioga County Area has maintained air quality levels
below the 1997 ozone NAAQS since the Area first attained the NAAQS in
2006, and maintained air quality levels at or below 85% of the NAAQS
since 2009.'' The commenter claims that this statement is refuted by
EPA's own data, which shows the air quality was at 0.071 for the years
2010-2012.

    Response 1: The cited statement from the proposal is factually
accurate, and EPA does not agree with the commenter that it is
unsupported by the air quality data, nor do we agree that the commenter
has identified a valid basis for disapproval. As discussed in the
February 8, 2021 NPRM, based on the rounding convention described in 40
CFR part 50, appendix I, the 1997 ozone NAAQS is attained if the design
value is 0.084 parts per million (ppm) or below (see 86 FR 8571); 85%
of this standard would be a design value of 0.071 ppm. The data
therefore supports EPA's statement in the NPRM that the Tioga County
Area has maintained air quality levels below the 1997 ozone NAAQS since
the Area first attained the NAAQS in 2006, and maintained air quality
levels at or below 85% of the NAAQS since 2009. It is worth noting that
even if the commenter's assertion were correct, the Area would have
been below 85% of the standard since 2012 and the Area's LMP would
still be approvable consistent with EPA's long-standing guidance.\4\
---------------------------------------------------------------------------

    \4\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate
PM10 Nonattainment Areas'' from Lydia Wegman, OAQPS,
dated August 9, 2001.
---------------------------------------------------------------------------

    Comment 2: The commenter also asserts that one of EPA's methods for
demonstrating continued future maintenance of the standard--
specifically, the method that adds the greatest recent design value
increase to the current design value--is ``arbitrary and has no basis
in scientific fact.'' The commenter goes on to assert that ``not only
is the highest increase during a certain point in time in the past not
indicative of potential future conditions, but EPA arbitrarily chooses
a time period with seemingly no bounds . . . EPA's use of this
arbitrary formula to determine whether an area will not violate the
NAAQS at some point in the future is based in science hope, not science
fact and EPA should re-evaluate its use in approving the Tioga County
Limited Maintenance Plan.''
    Response 2: As discussed in the February 8, 2021 NPRM, states may
demonstrate continued maintenance of the NAAQS by showing stable or
improving air quality trends in one or more ways (see 86 FR 8571). The
method that the commenter refers to was relied on by EPA as additional
support that the Tioga County LMP demonstrates continued maintenance of
the 1997 ozone NAAQS. Consistent with EPA's long-standing guidance, the
primary evidence EPA relied upon in determining that the Area would
continue to maintain the standard throughout the ten years of the LMP
was the clear downward trend of ozone levels in the Tioga County Area
since 2006, including levels at or below 85% of the NAAQS since
2009.\5\ Additionally, EPA notes the Tioga County Area is currently in
attainment for the more-stringent 2008 and 2015 ozone NAAQS, which have
design values of 0.075 ppm and 0.070 ppm, respectively; and future year
design value projections from EPA show that the design value for the
Tioga County Area is expected to be 0.0573 ppm (see 86 FR 8572). The
data cited in the comment, taken together with these other factors,
strengthen EPA's considered judgement that the plan adequately
demonstrates continued maintenance of the 1997 ozone NAAQS.
---------------------------------------------------------------------------

    \5\ Id.
---------------------------------------------------------------------------

    Comment 3: The second commenter asserts that EPA cannot approve the
Tioga County Area LMP because ``it would do something that is not
authorized under the rules.'' The commenter then advances various
policy and legal theories that do not appear to be related to
hypothetical future litigation in federal court regarding the legality
of the Tioga LMP. The comment makes assertions about what factors the
court will consider in resolving this hypothetical action and
speculates how the court will rule against EPA.
    Response 3: EPA has no knowledge of any lawsuit involving the Tioga
LMP in federal court and has not reason to believe any such litigation
exists. Because the comment is addressed to hypothetical litigation,
also because EPA's authority to approve this plan is well-established
in the NPRM, it is EPA's judgment it has no obligation to respond to
commenter's speculation as to the actions that EPA will need to take to
address the ruling of a hypothetical lawsuit.

IV. Final Action

    EPA is approving PADEP's second maintenance plan for the Tioga
County Area for the 1997 ozone NAAQS as a revision to the Pennsylvania
SIP.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices if
they meet the criteria of the CAA. Accordingly, this action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement

Fairness Act of 1996, generally provides that before a rule may take
effect, the agency promulgating the rule must submit a rule report,
which includes a copy of the rule, to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this action and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. A major rule cannot take effect until 60 days after it is
published in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 9, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action, approving PADEP's second maintenance plan for the
Tioga County Area for the 1997 ozone NAAQS, may not be challenged later
in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: May 28, 2021.
Diana Esher,
Acting Regional Administrator, Region III.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
the entry ``Second Maintenance Plan for the State College 1997 8-Hour
Ozone Nonattainment Area'' at the end of the table to read as follows:

Sec.  52.2020   Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Name of non-regulatory SIP                                      State                            Additional
           revision              Applicable geographic area  submittal date  EPA approval date     explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Second Maintenance Plan for     Tioga County Area..........         3/10/20  6/9/21, [insert    The Tioga County
 the State College 1997 8-Hour                                                Federal Register   area consists
 Ozone Nonattainment Area.                                                    citation].         solely of Tioga
                                                                                County.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-11925 Filed 6-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Notices]
[Page 42362]
[DOCID:fr21au09-121]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Meeting With Interested Persons To Discuss the Proposed
Federal Aviation Administration Policy (Draft AC 21.101A) Establishing
the Certification Basis for Changed Aeronautical Products

AGENCY: Federal Aviation Administration (DOT)

ACTION: Notice of public meetings.

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

SUMMARY: The Federal Aviation Administration (FAA), along with
Transport Canada Civil Aviation (TCCA), and the European Aviation
Safety Agency (EASA), will hold two informational meetings to discuss
the interpretations, applications, and harmonization of the Title 14 of
the Code of Federal Regulations (14 CFR) Sec.  21.101, derived advisory
circular (AC) 21.101, Establishing the Certification Basis of Changed
Aeronautical Products (a.k.a. Change Product Rule (CPR)).
    Beginning in October 2007, the FAA, TCCA, and EASA chartered an
International Implementation Team (IIT) to revise the current CPR AC
21.101, by incorporating the lessons learned since the rule's
inception, by improving and clarifying the guidance in Revision ``A''
of the CPR AC.
    Meeting Dates and Locations:

Europe (EASA): September 23, 2009 in Cologne, Germany.
North America (FAA, TCCA): October 7, 2009 in Washington, DC.

    The North American meeting is intended to include interested
persons for both the United States of America and Canada.
    If you plan to attend either or both of the meetings, please
forward your preferred location(s) via the following e-mail address:
<EMAIL_ADDRESS>before August 31, 2009. Specific
information pertaining to the meeting locations and times will be
forwarded to those who respond to the above email address as it
develops.

DATES: These meetings will be held on September 23, 2009, in Cologne,
Germany, and on October 7, 2009, in Washington, DC.

ADDRESSES: The addresses for the specific meetings will be provided to
those individuals planning to attend at a later date.

FOR FURTHER INFORMATION CONTACT: To obtain additional details on the
two meetings, please contact the following:
    Federal Aviation Administration (FAA): Mr. Randall Petersen, AIR-
110, Federal Aviation Administration, Certification Procedure Branch,
AIR-110, 950 L'Enfant Plaza, SW., Fifth floor, Washington, DC 20024,
Telephone<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>    European Aviation Safety Agency (EASA): Mr. Jan Nov[aacute]k,
Rulemaking Directorate, Initial Airworthiness Rulemaking Officer,
European Aviation Safety Agency, Postfach 10 12 53, D-50452 K[ouml]ln
Germany Telephone: +49 221 89990 5015, Fax: +49 221 89990 5515, E-mail:
<EMAIL_ADDRESS>    Transport Canada Civil Aviation (TCCA): Mr. Eric Lucas, Standards
Branch, AARTC, Transport Canada Civil Aviation, 330 Sparks Street, 2nd
Floor, Ottawa, Ontario, Canada K1A 0N8, Telephone<PHONE_NUMBER>, Fax:
(613) 952-3298, E-mail<EMAIL_ADDRESS>
    Issued in Washington, DC, on August 18, 2009.
Susan J. M Cabler,
Assistant Manager, Aircraft Engineering Division, Aircraft
Certification Service.
[FR Doc. E9-20126 Filed 8-20-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: April 15, 2010 (Volume 75, Number 72)]
[Notices]
[Page 19634-19637]
[DOCID:fr15ap10-38]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

April 01, 2010.

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-524-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Trunkline Gas Company, LLC submits Fourth Revised
Sheet No. 28 et al. to FERC Gas Tariff, Third Revised Volume No.1, to
be effective 4/1/10.c
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0218.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-525-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: National Fuel Gas Supply Corporation submits the 134th
Revised Sheet 9 to FERC Gas tariff, Fourth Revised Volume 1, to become
effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0225.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-526-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits a report
supporting its gas compressor fuel factors and los and unaccounted-for
gas factors for calendar year 2009.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0224.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-527-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
First Revised Sheet 34L et al. to its FERC Gas Tariff, Seventh Revised
Volume 1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0255.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-528-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Original Sheet 35C.13 et al. to its FERC Gas Tariff, Seventh Revised
Volume 1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0256.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-529-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Third Revised Sheet 33D.01 et al. to its FERC Gas Tariff, Seventh
Revised Volume 1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0257.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-530-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with a negotiated rate exhibit to an existing maximum
recourse rate Storage Rate Schedule NNS agreement.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0258.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-531-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits a
new negotiated rate storage Rate Schedule NNS agreement with Anadarko
Energy Service Company.

    Filed Date: 03/31/2010.
    Accession Number: 20100331-0259.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-532-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with a negotiated rate exhibit to an existing maximum
recourse rate Storage Rate Schedule NNS agreement.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0260.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-533-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
First Revised Sheet 33I to its FERC Gas Tariff, Seventh Revised Volume
1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0261.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-534-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Original Sheet 35C.14 to its FERC Gas Tariff, Seventh Revised Volume 1
to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0262.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-535-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLS submits
First Revised Sheet 33J et al. to FERC Gas Tariff, Seventh revised
Volume 1, to become effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0263.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-536-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Original Sheet 34C.06 et al. to its FERC Gas Tariff, Seventh Revised
Volume 1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0264.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-537-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Third Revised Sheet 35C et al. to its FERC Gas Tariff, Seventh Revised
Volume 1 to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0265.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-538-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
report of the refunds of penalty revenues to its FERC Gas Tariff,
Seventh Revised Volume 1.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0266.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-539-000.
    Applicants: Discovery Gas Transmission LLC.
    Description: Discovery Gas Transmission LLC submits First Revised
Sheet No. 1 et al. to FERC Gas Tariff, Original Volume No. 1, to be
effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0241.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-540-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
First Revised Sheet No. 35C.08 to FERC Gas Tariff, Seventh Revised
Volume No. 1, to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0235.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-541-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
Original Sheet No. 35C.10 to FERC Gas Tariff, Seventh Revised Volume
No. 1, to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0236.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-542-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Company LLC submits Third Revised
Sheet No. 11 to FERC Gas Tariff, Fourth Revised Volume No. 1, to be
effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0237.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-543-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Transwestern Pipeline Company LLC submits Seventh
Revised Sheet No. 6 to FERC Gas Tariff, Third Revised Volume No. 1, to
be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0238.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-544-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits Fifth Revised
Sheet No. 66B.01b et al. to FERC Gas Tariff, Fifth Revised Volume No.
1, to effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0233.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-545-000.
    Applicants: Quest Pipelines (KPC).
    Description: Quest Pipelines (KPC) submits First Revised Sheet No.
112 to FERC Gas Tariff, Second Revised Volume No. 1, to be effective 5/
1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0239.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-546-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits Fourteenth
Revised Sheet No. 66B.01a et al. to FERC Gas Tariff, Fifth Revised
Volume No. 1, to be effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0234.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-547-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits Eighteenth
Revised Sheet No. 10 to FERC Gas Tariff, Second Revised Volume No. 1,
to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100331-0240.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-548-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: East Tennessee Natural Gas, LLC submits its cashout
report for November 2008 through October 2009.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0223.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-549-000.
    Applicants: Equitrans, LP.
    Description: Equitrans, LP submits First Revised Sheet 319 et al.
to its FERC Gas Tariff, Original Volume 1, to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0224.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-550-000.
    Applicants: Gas Transmission Northwest Corporation.
    Description: Gas Transmission Northwest Corporation submits First
Revised Sheet 0 et al. to its FERC Gas Tariff, Original Volume 1, to be
effective 4/30/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0215.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-551-000.
    Applicants: Northern Border Pipeline Company.
    Description: Northern Border Pipeline Company submits Fifteenth
Revised Sheet 99 et al. to its FERC Gas Tariff, First Revised Volume 1,
to be effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0216.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-552-000.
    Applicants: Tuscarora Gas Transmission Company.
    Description: Tuscarora Gas Transmission Company submits First
Revised Sheet No. 0, 66, 120, 204, 213, 222, and 229 to FERC Gas
Tariff, First Revised Volume No. 1, to be effective 4/30/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0217.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-553-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Midcontinent Express Pipeline, LLC submits Second
Revised Sheet 7 et al. to its FERC Gas Tariff, Original Volume 1, to be
effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0218.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-554-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Transcontinental Gas Pipe Line Company, LLC submits
Fifth Revised Sheet 81 et al. to its FERC Gas Tariff, Fourth Revised
Volume 1, to be effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0219.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-555-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits amendments to the
negotiated rate agreements, Rate Schedule ETS, Rate Schedule NNS et
al., to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0220.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-556-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits Rate Schedule FSS, Rate
Schedule ETS, and Rate Schedule FTS-1 negotiated rate service
agreements, to be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0221.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-557-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits Seventeenth Revised Sheet
17A et al. to its FERC Gas Tariff, Second Revised Volume 1, to be
effective 5/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0222.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-558-000.
    Applicants: Kinder Morgan Interstate Gas Transmission.
    Description: Kinder Morgan Interstate Gas Transmission LLC submits
Sixth Revised Sheet 4O to FERC Gas Tariff, Fourth Revised Volume 1A, to
be effective 4/1/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0228.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-559-000.
    Applicants: Tuscarora Gas Transmission Company.
    Description: Tuscarora Gas Transmission Company submits Original
Sheet 7 et al. to FERC Gas Tariff, First Revised Volume 1, to be
effective 4/30/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0227.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-560-000.
    Applicants: North Baja Pipeline, LLC.
    Description: North Baja Pipeline, LLC submits Second Revised Sheet
9A to FERC Gas Tariff, Original Volume 1, to be effective 4/30/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0229.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Docket Numbers: RP10-561-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, LLC submits Eighteenth Revised
Sheet 1300 et al. to FERC Gas Tariff, Third Revised Volume 1, to be
effective 4/30/10.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0230.
    Comment Date: 5 p.m. Eastern Time on Monday, April 12, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For

assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-8611 Filed 4-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48092-48093]
[FR Doc No: 2017-22284]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Registration of Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
November 15, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0777.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Registration of Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act OMB Control Number 0910-0777--Extension

    This information collection supports the above captioned Agency
guidance. A facility that compounds drugs may elect to register with
FDA as an outsourcing facility under section 503B of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353b), as added by the
Drug Quality and Security Act (DQSA). Drug products compounded in a
registered outsourcing facility can qualify for exemptions from the FDA
approval requirements in section 505 of the FD&C Act (21 U.S.C. 355),
the requirement to label products with adequate directions for use
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and drug
supply chain security requirements in section 582 of the FD&C Act (21
U.S.C. 360eee) if the requirements in section 503B of the FD&C Act are
met.
    After the initial registration, under section 503B(b) of the FD&C
Act, a facility that elects to register with FDA as an outsourcing
facility must also do so annually between October 1 and December 31.
Upon registration, the outsourcing facility must provide its name,
place of business, a unique facility identifier, and a point of contact
email address and phone number. The outsourcing facility must also
indicate whether it intends to compound, within the next calendar year,
a drug that appears on FDA's drug shortage list in effect under section
506E of the FD&C Act (21 U.S.C. 356e), and whether it compounds from
bulk drug substances, and, if so, whether it compounds sterile or non-
sterile drugs from bulk drug substances.
    Outsourcing facilities that elect to register should submit the
following registration information to FDA for each facility:
     Name of the facility;
     Place of business;
     Unique facility identifier;
     Point of contact email address and phone number;
     Whether the facility intends to compound drugs that appear
on FDA's drug shortage list in effect under section 506E of the FD&C
Act; and
     An indication of whether the facility compounds from bulk
drug substances, and if so, whether it compounds sterile or nonsterile
drugs from bulk drug substances.
    Registration information should be submitted to FDA electronically
using the Structured Product Labeling (SPL) format and in accordance
with section IV of the FDA guidance entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' Under the final guidance, outsourcing facilities may
request a waiver from the SPL electronic submission process by
submitting a written request to FDA explaining why the use of
electronic means is not reasonable.
    In the Federal Register of June 20, 2017 (82 FR 28076), FDA
published a 60-day notice requesting public

comment on the proposed collection of information. No comments were
received.
    We therefore estimate the burden associated with the information
collection as follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Compounding outsourcing facility     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Electronic Submission of                      62               1              62             4.5             279
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We estimate that approximately 62 outsourcing facilities (``number
of respondents'' and ``total annual responses'' in table 1, row 1) will
annually submit to FDA registration information using the SPL format as
specified in the guidance, and that preparing and submitting this
information will take approximately 4.5 hours per registrant (``average
burden per response'' in table 1, row 1). We expect to receive no more
than one waiver request from the electronic submission process annually
(``number of respondents'' and ``total annual responses'' in table 1,
row 2), and that each request should take approximately 1 hour to
prepare and submit to us (``average burden per response'' in table 1,
row 2).

    Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22284 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P