[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Rules and Regulations]
[Pages 50893-50898]
[FR Doc No: 2011-20835]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0725; FRL-8884-4]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
fluoxastrobin in or on squash/cucumber subgroup 9B. Arysta LifeScience
North America, LLC requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 17, 2011. Objections and
requests for hearings must be received on or before October 17, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0725. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://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-2010-0725 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
October 17, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0725, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 23, 2010 (75 FR 57942) (FRL-
8845-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7726) by Arysta LifeScience North America, LLC, 15401 Weston Pkwy.,
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609
be amended by establishing a tolerance for residues of the fungicide,
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on raw agricultural commodities listed under crop
squash/cucumber subgroup 9B at 0.50 parts per million (ppm). That
notice referenced a summary of the petition prepared by Arysta
LifeScience, North America, LLC, 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
the following changes to the proposed fluoxastrobin tolerance. A minor
change has been made to the commodity name to conform to the Agency's
Food and Feed Commodity Vocabulary.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for fluoxastrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluoxastrobin
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.
    Fluoxastrobin has a low order of acute toxicity via the oral,
dermal and inhalation routes of exposure. Fluoxastrobin is a moderate
eye irritant but is neither a dermal irritant nor a skin sensitizer.
    Fluoxastrobin appears to have mild or low toxicity following
repeated administration in all tested species other than the dog. In
both the 90-day and 1-year oral feeding dog studies, there was liver
toxicity in the form of cholestasis as evidenced by hepatocytomegaly
and cytoplasmic granular changes associated with increased liver weight
and increased serum liver alkaline phosphatase (ALP). In addition,
several phase I and phase II liver drug metabolizing enzymes were
induced.
    In the rat and rabbit developmental toxicity studies and the 2-
generation reproduction rat study, there was no increased
susceptibility to prenatal or postnatal exposure to fluoxastrobin and
no effects on reproduction.
    Fluoxastrobin is not acutely neurotoxic in rats up to a single high
dose of 2,000 milligrams/kilogram/day (mg/kg/day) or by repeated
dietary feeding in the rat subchronic neurotoxicity screening study
where the top dose was nearly half the limit dose of 1,000 mg/kg/day.
Other studies in rats including the subchronic, chronic toxicity/
carcinogenicity, 2-generation reproduction, and developmental toxicity
were tested to or above the limit dose with no indication of clinical
signs, histopathology or other signs of toxicity that could be
attributed to neurotoxicity. Also, in both the 90-day and 1-year dog
studies, neurologic examinations, including mental status/behavior,
gait characteristics, postural status and reactions, and spinal/cranial
reflexes, were carried out and were found to be within normal limits.
    Fluoxastrobin is not immunotoxic based on repeated dosing studies
in rats and mice. In the 90-day oral toxicity rat study, there was no
difference between the controls and treated animals in spleen cell
count, macrophage activities after phorbol myristate acetate (PMA)
stimulation and plaque-forming cell assay after challenge with sheep
erythrocytes. Slight decreases were noted in immunoglobulin G
concentration in the high dose males but not females. An unacceptable
subchronic immunotoxicity study in mice found no apparent decrease on
B-cell activated, T-cell mediated immunoglobulin M (IgM) response to
sheep red blood cell (SRBC) at doses as high as 2,383 mg/kg/day.
    Fluoxastrobin and major metabolites were negative in a battery of
genotoxicity tests. The carcinogenic potential of fluoxastrobin was
adequately tested in rats and mice of both sexes. The results
demonstrated a lack of treatment-related increase in tumor incidence in
rats or mice. There was no mutagenicity concern and no structure
activity relationship alert. It was concluded that there was no
incidence of carcinogenicity for fluoxastrobin.
    Specific information on the studies received and the nature of the
adverse effects caused by fluoxastrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of September 16, 2005 (70 FR 54640)
(FRL-7719-9).

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 fluoxastrobin used for
human risk assessment is shown in Table 1. of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin 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
                                               factors                 assessment         toxicological effects
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Acute dietary (Females 13-50 years of  None: There was no indication of an adverse effect attributable to a
 age).                                  single dose. An aRfD was not established.
Acute dietary (General population      None: There was no indication of an adverse effect attributable to a
 including infants and children).       single dose. An aRfD was not established.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 1.5 mg/kg/day..  Chronic RfD = 0.015 mg/  Chronic toxicity in the
                                       UFA = 10x..............   kg/day.                  dog.
                                       UFH = 10x..............  cPAD = 0.015 mg/kg/day.  LOAEL = M/F 8.1/7.7 mg/
                                       FQPA SF = 1x...........                            kg/day based on body
                                                                                weight reductions and
                                                                                hepatocytomegaly and
                                                                                cytoplasmic changes
                                                                                associated with
                                                                                increased serum liver
                                                                                alkaline phosphatase
                                                                                indicative of
                                                                                cholestasis.
Incidental oral short-term (1 to 30    NOAEL = 3.0 mg/kg/day..  LOC for MOE = 100......  90-day subchronic dog
 days) and intermediate-term (1 to 6   UFA = 10x..............                            LOAEL = M/F 24.8/24.2
 months).                              UFH = 10x..............                            mg/kg/day (800 ppm)
                                       FQPA SF = 1x...........                            based on dose-related
                                                                                reductions in net body
                                                                                weight gain and food
                                                                                efficiency in addition
                                                                                to toxicity findings
                                                                                in the liver
                                                                                (cholestasis) in both
                                                                                sexes, and kidneys
                                                                                (increased relative
                                                                                weights in females and
                                                                                degeneration of the
                                                                                proximal tubular
                                                                                epithelium in males).
                                      --------------------------------------------------------------------------
Dermal short-term (1 to 30 days).....  None: There were no systemic or dermal toxicity findings in a 28-day
                                        dermal toxicity study in the rat up to the limit dose (1000 mg/kg/day)
                                        and there were no developmental or neurotoxicity concerns raised in
                                        other studies.
                                      --------------------------------------------------------------------------
Dermal intermediate-term (1 to 6       NOAEL = 3.0 mg/kg/day    LOC for MOE = 100......  90-day subchronic dog
 months).                               (dermal absorption                                LOAEL = M/F 24.8/24.2
                                        rate = 2.3%).                                     mg/kg/day (800 ppm)
                                       UFA = 10x..............                            based on dose-related
                                       UFH = 10x..............                            reductions in net body
                                       FQPA SF = 1x...........                            weight gain and food
                                                                                efficiency in addition
                                                                                to toxicity findings
                                                                                in the liver
                                                                                (cholestasis) in both
                                                                                sexes, and kidneys
                                                                                (increased relative
                                                                                weights in females and
                                                                                degeneration of the
                                                                                proximal tubular
                                                                                epithelium in males).
Inhalation short-term (1 to 30 days)   NOAEL = 3.0 mg/kg/day..  LOC for MOE = 100......  90-day subchronic dog
 and intermediate-term (1 to 6         UFA = 10x..............                            LOAEL = M/F 24.8/24.2
 months).                              UFH = 10x..............                            mg/kg/day (800 ppm)
                                       FQPA SF = 1x...........                            based on dose-related
                                                                                reductions in net body
                                                                                weight gain and food
                                                                                efficiency in addition
                                                                                to toxicity findings
                                                                                in the liver
                                                                                (cholestasis) in both
                                                                                sexes, and kidneys
                                                                                (increased relative
                                                                                weights in females and
                                                                                degeneration of the
                                                                                proximal tubular
                                                                                epithelium in males).
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be carcinogenic to humans.''
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerance as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin 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.
    No such effects were identified in the toxicological studies for
fluoxastrobin; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys
of Food Intake by Individuals (CSFII). As to residue levels in food,
EPA conducted a conservative dietary exposure assessment for
fluoxastrobin. The assumptions of this dietary assessment included
tolerance level residues and 100 percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluoxastrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. Based on laboratory
studies, fluoxastrobin persists in soils for several months to several
years and is slightly to moderately mobile in soil.
    The Agency used screening level water exposure models in the
dietary exposure analysis and risk assessment for fluoxastrobin in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of
fluoxastrobin. 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
fluoxastrobin for chronic exposures for non-cancer assessments are
estimated to be 52.9 parts per billion (ppb) for surface water and 0.23
ppb for ground water. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of value
53 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). Fluoxastrobin is
currently registered for the following uses that could result in
residential exposures: Spot treatment and/or broadcast control of
diseases on turf, including lawns and golf courses. EPA assessed
residential exposure using the following assumptions: Because of the
potential for application four times per year, exposure duration is
expected to be short-term and intermediate-term. A short-term dermal
endpoint was not identified; therefore, only intermediate-term dermal
risks as well as short-and intermediate-term inhalation risks were
assessed. Homeowner residential applicators are expected to be adults.
    There is also the potential for homeowners and their families (of
varying ages) to be exposed as a result of entering areas that have
previously been treated with fluoxastrobin. Exposure might occur on
areas such as lawns used by children or recreational areas such as golf
courses used by adults and youths. Potential routes of exposure include
dermal (adults and children) and incidental oral ingestion (children).
Since no acute hazard has been identified, an assessment of episodic
granular ingestion was not conducted. While it is assumed that most
residential use will result in short-term (1 to 30 days) post-
application exposures, it is believed that intermediate-term exposures
(greater than 30 days up to 180 days) are also possible. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin 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. The toxicity database for
fluoxastrobin, including acceptable developmental toxicity studies in
rats and rabbits, as well as a 2-generation reproductive toxicity
study, provides no indication of prenatal and/or postnasal sensitivity.
    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 fluoxastrobin is complete except for a
functional immunotoxicity study as required by the recent changes to
the pesticide data requirements. The Agency does have an immunotoxicity
study for fluoxastrobin but it has deficiencies that make it
unacceptable at this time. Nonetheless, the Agency does not believe
that conducting a new immunotoxicity study will result in a lower NOAEL
than the regulatory dose for risk assessment. First, the available data
do not indicate that fluoxastrobin results in primary immune system
effects; a NOAEL for decreased spleen weight in the absence of
histopathological findings (male rats) was 53 mg/kg/day. Secondly, no
apparent decrease in B-cell activated, T-cell mediated IgM response to
SRBC was seen in mice at doses as high as

2,383 mg/kg/day. The Agency therefore believes that no additional
safety factor is needed to account for the lack of this study, but the
registrant will be required to upgrade it.
    ii. There is no indication that fluoxastrobin 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 fluoxastrobin results in increased
susceptibility in 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 chronic dietary food exposure assessment utilized
tolerance-level residues and 100 PCT information for all commodities.
Use of these screening-level assessment values helps ensure that
chronic exposures and risks will not be underestimated. EPA
additionally made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluoxastrobin in
drinking water. EPA used similarly conservative assumptions to assess
residential post-application exposure of children as well as incidental
oral exposure of toddlers to fluoxastrobin. These assessments will not
underestimate the exposure and risks posed by fluoxastrobin.

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
aPAD and 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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluoxastrobin from food and water will utilize 47% of the cPAD for
children (1-2 years old), the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Fluoxastrobin is
currently registered for uses that could result in both short- and
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short- and intermediate-term residential exposures of adults
and children to fluoxastrobin. Because all short- and intermediate-term
quantitative hazard assessments (via the dermal and incidental oral
routes) for fluoxastrobin are based on the same endpoint, a screening-
level, conservative aggregate risk assessment was conducted that
combined the short-term incidental oral and intermediate-term exposure
estimates (i.e., the highest exposure estimates) in the risk
assessments for adults. The Agency believes that most residential
exposure will be short-term, based on the use pattern.
    There is potential short- and intermediate-term exposure to
fluoxastrobin via the dietary (which is considered background exposure)
and residential (which is considered primary) pathways. For adults,
these pathways lead to exposure via the oral (background), and dermal
and inhalation (primary) routes. For children, these pathways lead to
exposure via the oral (background), and incidental oral and dermal
(primary) routes.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short- and intermediate-
term food, water, and residential exposures result in aggregate MOEs of
630 for adults; 170 for children (1-2 years old). Because EPA's level
of concern for fluoxastrobin is a MOE of 100 or below, these MOEs are
not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. Method No. 00604 is available for plant commodities and
Method No. 00691 is available for animal commodities. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are currently no established Mexican, Canadian, or Codex
maximum residue limits (MRLs) or tolerances for fluoxastrobin on the
squash/cucumber subgroup 9B.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``crop subgroup 9B squash/cucumbers'' to ``squash/
cucumber subgroup 9B'' to conform it to the Agency's Food and Feed
Commodity Vocabulary.

V. Conclusion

    Therefore, a tolerance is established for residues of
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, including its metabolites

and degradates, in or on squash/cucumber subgroup 9B at 0.50 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (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: August 10, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.609 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

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

                                * * * * *
Squash/cucumber subgroup 9B.................................        0.50

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

* * * * *
[FR Doc. 2011-20835 Filed 8-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4872-4874]
[FR Doc No: 2023-01403]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96711; File No. SR-NYSEAMER-2023-06]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Change To Amend the NYSE
American Equities Price List

January 19, 2023.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on January 12, 2023, NYSE American LLC (``NYSE American'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE American Equities Price
List (the ``Price List'') with respect to certain regulatory fees
related to the Central Registration Depository (``CRD'' or ``CRD
system''), which are collected by the Financial Industry Regulatory
Authority, Inc. (``FINRA''). The Exchange proposes to implement the fee
change on January 12, 2023. The proposed rule change is available on
the Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Price List with respect to
certain regulatory fees collected by FINRA for use of CRD.\4\ The
Exchange proposes to implement the fee changes effective January 12,
2023.\5\
---------------------------------------------------------------------------

    \4\ CRD is the central licensing and registration system for the
U.S. securities industry. The CRD system enables individuals and
firms seeking registration with multiple states and self-regulatory
organizations to do so by submitting a single form, fingerprint
card, and a combined payment of fees to FINRA. Through the CRD
system, FINRA maintains the qualification, employment, and
disciplinary histories of registered associated persons of broker-
dealers.
    \5\ The Exchange originally filed to amend the Price List on
January 3, 2023 (SR-NYSEAmer-2023-01). On January 12, 2023, SR-
NYSEAmer-2023-01 was withdrawn and replaced by this filing.
---------------------------------------------------------------------------

    FINRA collects and retains certain regulatory fees via CRD for the
registration of associated persons of Exchange ETP Holders that are not
FINRA members (``Non-FINRA ETP Holders'').\6\ CRD fees are user-based,
and there is no distinction in the cost incurred by FINRA if the user
is a FINRA member or a Non-FINRA ETP Holders.
---------------------------------------------------------------------------

    \6\ The Exchange originally adopted fees for use of the CRD
system in 2003 and amended those fees in 2013 and 2022. See
Securities Exchange Act Release No. 48066 (June 19, 2003), 68 FR
38409 (June 27, 2003) (SR-Amex-2003-49); Securities Exchange Act
Release No. 68630 (January 11, 2013), 78 FR 6152 (January 29, 2013)
(SR-NYSEMKT-2013-01); Securities Exchange Act Release No. 93902
(January 5, 2022), 87 FR 1461 (January 11, 2022) (SR-NYSEAmer-2021-
47). While the Exchange lists these fees in its Price List, it does
not collect or retain these fees.
---------------------------------------------------------------------------

    FINRA recently amended two of the fees assessed for use of the CRD
system.\7\ Accordingly, the Exchange proposes to amend the Price List
to mirror the fees assessed by FINRA, which will be implemented
concurrently with the amended FINRA fee as of January 2023.\8\
Specifically, the Exchange proposes to amend the Price List to modify
the fee charged to Non-FINRA ETP Holders for additional processing of
each initial or amended Form U4, Form U5 or Form BD that includes the
initial reporting, amendment, or certification of one or more
disclosure events or proceedings from $110 to $155 \9\ and the fee for
processing and posting to the CRD system each set of fingerprints
submitted electronically to FINRA, plus any other charge that may be
imposed by the U.S. Department of Justice for processing each set of
fingerprints, from $15 to $20.\10\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 90176 (October 14,
2020), 85 FR 66592 (October 20, 2020) (SR-FINRA-2020-032).
    \8\ The Exchange notes that it has only adopted the CRD system
fees charged by FINRA to Non-FINRA ETP Holders when such fees are
applicable. In this regard, certain FINRA CRD system fees and
requirements are specific to FINRA members, but do not apply to NYSE
American-only ETP Holders. Non-FINRA ETP Holders have been charged
CRD system fees since 2003. See note 5, supra. ETP Holders that are
also FINRA members are charged CRD system fees according to Section
4 of Schedule A to the FINRA By-Laws.
    \9\ See Section (4)(b)(3) of Schedule A to the FINRA By-laws.
    \10\ See Section (4)(b)(4) of Schedule A to the FINRA By-laws.
---------------------------------------------------------------------------

    The Exchange notes that the proposed change is not otherwise
intended to address any other issues surrounding regulatory fees, and
the Exchange is not aware of any problems that ETP Holders would have
in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Section 6(b)(4) \12\ of the Act, in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges. The Exchange also believes that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\13\
in that it is designed to promote just and equitable principles of
trade, to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed fee change is reasonable
because the fee will be identical to that adopted by FINRA as of
January 2023 for use of the CRD system to submit an initial or amended
Form U4, Form U5 or Form BD that includes the initial reporting,
amendment, or certification of one or more disclosure events or
proceedings and the posting to CRD each set of fingerprints submitted
electronically to FINRA. The costs of operating and improving the CRD
system are similarly borne by FINRA when a Non-FINRA ETP Holder uses
the CRD system; accordingly, the fees collected for such use should, as
proposed by the Exchange, mirror the fees assessed to FINRA members. In
addition, as FINRA noted in amending its fees, it believes that its
proposed pricing structure is reasonable and correlates fees with the
components that drive its regulatory costs to the extent feasible. The
Exchange further believes that the change is reasonable because it will
provide greater specificity regarding the CRD system fees that are
applicable to Non-FINRA ETP Holders. All similarly situated ETP Holders
are subject to the same fee structure, and every ETP Holder must use
the CRD system for registration and disclosure. Accordingly, the
Exchange believes that the fees collected for such use should likewise
increase in lockstep with the fees assessed to FINRA members, as is
proposed by the Exchange.
    The Exchange also believes that the proposed fee change provides
for the equitable allocation of reasonable fees and other charges, and
does not unfairly discriminate between customers, issuers, brokers, and
dealers. The fee applies equally to all individuals and firms required
to report information the CRD system, and the proposed change will
result in the same regulatory fees being charged to all ETP Holders
required to report information to CRD

and for services performed by FINRA regardless of whether such ETP
Holders are FINRA members. Accordingly, the Exchange believes that the
fee collected for such use should increase in lockstep with the fee
adopted by FINRA as of January 2023, as is proposed by the Exchange.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\14\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Specifically, the Exchange believes that the
proposed change will reflect fees that will be assessed by FINRA as of
January 2023 and will thus result in the same regulatory fees being
charged to all ETP Holders required to report information to the CRD
system and for services performed by FINRA, regardless of whether or
not such ETP Holders are FINRA members.
---------------------------------------------------------------------------

    \14\ See 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \15\ of the Act and paragraph (f) thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2023-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to: Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File Number SR-NYSEAMER-2023-06. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2023-06 and should be submitted
on or before February 15, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-01403 Filed 1-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61621-61622]
[FR Doc No: 2018-26007]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-16-000]

Chattanooga Gas Company; Notice of Application

    Take notice that on November 9, 2018, Chattanooga Gas Company
(CGC), 2207 Olan Mills Drive, Chattanooga, TN 37421, filed in Docket
No. CP19-16-000, an application pursuant to section 7(f) of the Natural
Gas Act (NGA) and the Commission's regulations requesting a service
area determination allowing CGC to expand or enlarge its facilities,
without further authorization from the Commission. CGC requests a
service area determination with respect to its entire Tennessee local
distribution company (LDC) service area as well as a few small
geographic areas in Georgia into which CGC's mainline and service lines
extend. CGC also requests: (i) A finding that CGC qualifies as an LDC
for the purposes of section 311 of the Natural Gas Policy Act of 1978
(NGPA); (ii) a waiver of the Commission's accounting and reporting
requirements and other regulatory requirements ordinarily applicable to
natural gas companies under the NGA and the NGPA; and (iii) such
further relief as the Commission may deem appropriate, all as more
fully described in the application which is on file with the Commission
and open to public inspection. The filing may also be viewed on the web
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Elizabeth Wade, Senior Counsel, AGL Resources Inc., Ten Peachtree Place
NE, Atlanta, GA 30309, by telephone at<PHONE_NUMBER> or by email at
[email protected] or Daniel P. Archuleta, Troutman Sanders LLP, 401
Ninth Street NW, Suite 1000, Washington, DC 20004, by telephone at
(202) 274-2926 or by email at [email protected].
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made in the proceeding with the Commission
and must provide a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commentors will not be required to serve
copies of filed documents on all other parties. However, the non-party
commentors will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.

    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new Natural Gas Act
section 3 or section 7 proceeding.\1\ Persons desiring to become a
party to a certificate proceeding are to intervene in a timely manner.
If seeking to intervene out-of-time, the movant is required to ``show
good cause why the time limitation should be waived,'' and should
provide justification by reference to factors set forth in Rule
214(d)(1) (18 CFR 385.214(d)(1)) of the Commission's Rules and
Regulations.
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC ] 61,167 at
P 50 (2018).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests, and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern time on December 14, 2018.

    Dated: November 23, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26007 Filed 11-29-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26104-26106]
[FR Doc No: 2019-11675]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0014; FRL-9994-17]

Notice of Receipt of Requests to Voluntarily Cancel Certain
Pesticide Registrations and Amend Registrations To Terminate Certain
Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests
by the registrants to voluntarily cancel certain pesticide product
registrations and to amend certain product registrations to terminate
uses. EPA intends to grant these requests at the close of the comment
period for this announcement unless the Agency receives substantive
comments within the comment period that would merit its further review
of the requests, or unless the registrants withdraw their requests. If
these requests are granted, any sale, distribution, or use of products
listed in this notice will be permitted after the registrations have
been cancelled and uses terminated only if such sale, distribution, or
use is consistent with the terms as described in the final order.

DATES: Comments must be received on or before December 2, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0014, 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), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
    Submit written withdrawal request by mail to: Information
Technology and Resources Management Division (7502P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001. ATTN: Christopher Green.
     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.

FOR FURTHER INFORMATION CONTACT: Christopher Green, Information
Technology and Resources Management Division (7502P), 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?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the Agency taking?

    This notice announces receipt by EPA of requests from registrants
to cancel certain pesticide products and amend product registrations to
terminate certain uses registered under FIFRA section 3 (7 U.S.C. 136a)
or 24(c) (7 U.S.C. 136v(c)). The affected products and the registrants
making the requests are identified in Tables 1-3 of this unit.

    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order in the Federal
Register canceling and amending the affected registrations.

                      Table 1--Product Registrations With Pending Requests for Cancellation
----------------------------------------------------------------------------------------------------------------
           Registration No.              Company No.           Product name               Active ingredients
----------------------------------------------------------------------------------------------------------------
5481-79..............................            5481  Alco Sta-Gon Insecticidal     Boric acid.
                                                        Dust.
5481-132.............................            5481  Cryolite 93.................  Cryolite.
39967-82.............................           39967  Preventol PTAP..............  4-tert-Amylphenol.
73049-9..............................           73049  DeVine Mycoherbicide........  Live Chlamydospores of
                                                                                Phytophthora palmivora
                                                                                MWV.
CA-070018............................           60256  Lorsban 30 Flowable.........  Chlorpyrifos.
WY-070004............................             400  Acramite-4SC................  Bifenazate.
----------------------------------------------------------------------------------------------------------------

                       Table 2--Product Registrations With Pending Requests for Amendment
----------------------------------------------------------------------------------------------------------------
                                                                   Active
     Registration No.         Company No.     Product name       ingredient           Uses to be terminated
----------------------------------------------------------------------------------------------------------------
81964-4...................           81964  Tide Triadimefon  Triadimefon.....  Pineapple use.
                                             Technical.
----------------------------------------------------------------------------------------------------------------

    Table 3 of this unit includes the names and addresses of record for
all the registrants of the products listed in Table 1 and Table 2 of
this unit, in sequence by EPA company number. This number corresponds
to the first part of the EPA registration numbers of the products
listed in Table 1 and Table 2 of this unit.

Table 3--Registrants Requesting Voluntary Cancellation and/or Amendments
------------------------------------------------------------------------
      EPA company No.                  Company name and address
------------------------------------------------------------------------
400........................  Macdermid Agricultural Solutions, Inc., C/O
                              Arysta LifeScience North America, LLC,
                              15401 Weston Parkway, Suite 150, Cary, NC
                              27513.
5481.......................  Amvac Chemical Corporation, 4695 Macarthur
                              Court, Suite 1200, Newport Beach, CA 92660-
                              1706.
39967......................  Lanxess Corporation, 111 RIDC Park West
                              Drive, Pittsburgh, PA 15275-1112.
60256......................  California Seed Association, 1521 ``I''
                              Street, Sacramento, CA 95814.
73049......................  Valent U.S.A., LLC, 1600 Riviera Avenue,
                              Suite 200, Walnut Creek, CA 94596-8025.
81964......................  Chemstarr, LLC, Agent Name: Pyxis
                              Regulatory Consulting, Inc., 4110 136TH
                              Street Ct., NW, Gig Harbor, WA 98332.
------------------------------------------------------------------------

III. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a
registrant of a pesticide product may at any time request that any of
its pesticide registrations be canceled or amended to terminate one or
more uses. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of any such request in the Federal
Register.
    Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that
before acting on a request for voluntary cancellation, EPA must provide
a 30-day public comment period on the request for voluntary
cancellation or use termination. In addition, FIFRA section 6(f)(1)(C)
(7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment
period on a request for voluntary cancellation or termination of any
minor agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The registrants listed in Table 3 of Unit II have not requested
that EPA waive the 180-day comment period. Accordingly, EPA will
provide a 180-day comment period on the proposed requests.

IV. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use termination should submit the withdrawal in writing
to the person listed under FOR FURTHER INFORMATION CONTACT. If the
products have been subject to a previous cancellation or termination
action, the effective date of cancellation or termination and all other
provisions of any earlier cancellation or termination action are
controlling.

V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the requests for voluntary cancellation and amendments to
terminate uses are granted, the Agency intends to publish the
cancellation order in the Federal Register.
    In any order issued in response to these requests for cancellation
of product registrations and for amendments to terminate uses, EPA
proposes to include the following provisions for the treatment of any
existing stocks of the products listed in Tables 1 and 2, of Unit II.
    For voluntary product cancellations, identified in Table 1 of Unit
II, registrants will be permitted to sell and distribute existing
stocks of voluntarily canceled products for 1 year after the effective
date of the cancellation, which will be the date of publication of the
cancellation order in the Federal Register. Thereafter, registrants
will be prohibited from selling or distributing the products identified
in Table 1 of Unit II, except for export consistent with FIFRA section
17 (7 U.S.C. 136o) or for proper disposal.
    Once EPA has approved product labels reflecting the requested
amendments to terminate uses,

identified in Table 2 of Unit II, registrants will be permitted to sell
or distribute products under the previously approved labeling for a
period of 18 months after the date of Federal Register publication of
the cancellation order, unless other restrictions have been imposed.
Thereafter, registrants will be prohibited from selling or distributing
the products whose labels include the terminated uses identified in
Table 2 of Unit II, except for export consistent with FIFRA section 17
or for proper disposal.
    Persons other than the registrant may sell, distribute, or use
existing stocks of canceled products and products whose labels include
the terminated uses until supplies are exhausted, provided that such
sale, distribution, or use is consistent with the terms of the
previously approved labeling on, or that accompanied, the canceled
products and terminated uses.

    Authority: 7 U.S.C. 136 et seq.

    Dated: May 23, 2019.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2019-11675 Filed 6-4-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Notices]
[Pages 88694-88695]
[FR Doc No: 2016-29378]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4291-DR; Docket ID FEMA-2016-0001]

Virginia; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the

Commonwealth of Virginia (FEMA-4291-DR), dated November 2, 2016, and
related determinations.

DATES: Effective Date: November 17, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Virginia is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of November 2, 2016.

    The independent city of Hampton for Individual Assistance.
    The independent cities of Portsmouth and Suffolk for Individual
Assistance (already designated for Public Assistance).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-29378 Filed 12-7-16; 8:45 am]
 BILLING CODE 9111-23-P


Congratulations on being identified as a potential top finisher in
EPA’s 2014 ENERGY STAR National Building Competition! EPA is compiling
a report to highlight the energy- and water-saving strategies of
buildings that most successfully worked off their waste. EPA will
distribute this report during the winner announcement, and also refer
media and others to it throughout the year for real-world examples of
energy and water efficiency in action. Examples of past “wrap up”
reports are available at   HYPERLINK
"https://www.energystar.gov/buildings/learn-past-winners"
https://www.energystar.gov/buildings/learn-past-winners

Please send your completed questionnaire and a high-resolution photo of
your building or team to   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>by Friday, April 17, 2015.

Please provide the following information so that it can be included in
the wrap up report.

Building Name:

City, State, Zip Code:

Contact Name:

Contact Email Address:

Contact Phone #:

What’s the best advice you would give to someone starting an energy
management program?

(50 word maximum)

Describe the project that saved the most energy for your building during
the competition period.

(200 word maximum)

Briefly describe your other efforts to save energy that resulted in your
impressive savings.

	   (200 word maximum)

Please attach a high resolution (min 300 dpi) photo of one of the
following subjects with your response email. (You may submit multiple
photos, but only one will be used in the report.)

Your building

Your energy team

Example communications promoting your participation in the competition
(e.g., banners, posters, signs)

The public reporting and recordkeeping burden for this collection of
information is estimated to average 30 minutes per response.  Send
comments on the Agency's need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection
techniques to the Director, Collection Strategies Division, U.S.
Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW,
Washington, D.C. 20460.  Include the OMB control number in any
correspondence.  Do not send the completed form to this address.

 PAGE   2

2014 ENERGY STAR® National Building Competition Final Report
Questionnaire – Energy Savings

OMB Control No. 2060-0347

 HYPERLINK "../../Preparing the Supporting Statement/Forms/Forms
Submissions/AppData/Local/Microsoft/AppData/Local/Microsoft/Windows/TO10
3/Shared Documents/0005_NBC/Operational Support and Data
Analysis/FINAL/Documents/lpitcher/My Documents/01. WORK/01. Current
Projects/NBC - Season 2/Flyers/www.energystar.gov/benchmark"
www.energystar.gov/benchmark

EPA Form No. 5900-377


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42664-42666]
[FR Doc No: 2018-18212]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0377]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Tobacco Health Document Submissions.

DATES: Submit either electronic or written comments on the collection
of information by October 22, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 22, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0377 for ``Tobacco Health Document Submission.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests

or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Tobacco Health Document Submission

OMB Control Number 0910-0654--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding, among other things, a new
chapter granting FDA important authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public
health generally and to reduce tobacco use by minors. Additionally,
section 101 of the Tobacco Control Act amended the FD&C Act by adding,
among other things, new section 904(a)(4) (21 U.S.C. 387d(a)(4)).
    Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives'' (herein referred to as
``tobacco health documents'').
    FDA announced the availability of a guidance on this collection in
the Federal Register of April 4, 2010 (75 FR 20606) (revised December
5, 2016 (81 FR 87565) and August 10, 2017 (82 FR 37459) (extending
compliance dates)), and requested health documents that were created
during the period of June 23, 2009, through December 31, 2009 based on
the statutory requirements. The guidance stated that information
required under section 904(a)(4) of the FD&C Act must be submitted to
FDA beginning December 22, 2009. However, FDA also explained that it
did not intend to enforce the December 22, 2009, deadline provided that
the documents were submitted by April 30, 2010, for all health
documents developed between June 23, 2009 and December 31, 2009.
Further, FDA stated it would publish a revised guidance specifying the
timing of subsequent reporting.
    FDA has been collecting the information submitted pursuant to
section 904(a)(4) of the FD&C Act through a facilitative electronic
form and through a paper form (Form FDA 3743) for those individuals who
choose not to use the electronic method. On both forms, FDA is
requesting the following information from firms that have not already
reported or still have documents to report:

 Submitter identification
 Submitter type, company name, address, country, company
headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned
Facility Establishment Identifier (FEI) number
 Submitter point of contact
 Contact name, title, position title, email, telephone, and fax
 Submission format and contents (as applicable)
 Electronic documents: Media type, media quantity, size of
submission, quantity of documents, file type, and file software
 Paper documents: Quantity of documents, quantity of volumes,
and quantity of boxes
 Whether or not a submission is being provided
 Confirmation statement
 Identification and signature of submitter including name,
company name, address, position title, email, telephone, and fax
 Document categorization (as applicable): Relationship of the
document or set of documents to the following:
[cir] Health, behavioral, toxicological, or physiological effects
[cir] Uniquely identified current or future tobacco product(s)
[cir] Category of current or future tobacco product(s)
[cir] Specific ingredient(s), constituent(s), component(s), or
additive(s)
[cir] Class of ingredient(s), constituent(s), component(s), or
additive(s)
     Document readability and accessibility: Keywords; glossary
or explanation of any abbreviations, jargon, or internal (e.g., code)
names; special instructions for loading or compiling submission.
     Document metadata: Date document was created, document
author(s), document recipient(s), document custodian, document title or
identification number, beginning and ending Bates numbers, Bates number
ranges for documents attached to a submitted email, document type, and
whether the document is present in the University of California San
Francisco's Truth Tobacco Documents database.
    In addition to the electronic and paper forms, FDA issued guidance
documents intended to assist persons making tobacco health document
submissions (draft guidance: December 28, 2009 (74 FR 68629); final
guidance: April 20, 2010 (75 FR 20606); revised December 5, 2016 (81 FR
87565) and August 10, 2017 (82 FR 37459) (extending compliance dates)).
For further assistance, FDA is providing a technical guide, embedded
hints, and a web tutorial on the electronic portal.
    FDA issued a final rule to deem products meeting the statutory
definition of ``tobacco product'' to be subject to the FD&C Act on May
10, 2016 (81 FR 28973), which became effective on August 8, 2016. The
FD&C Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject to
the law. This final rule extends the Agency's ``tobacco product''
authorities to all other categories of products that meet the statutory
definition of ``tobacco product'' in the FD&C Act, except accessories
of such deemed tobacco products.
    For tobacco products subject to the deeming rule, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after August 8, 2016, or products in any
stage of research or development at any time after August 8, 2016,
including experimental products and developmental products intended for
introduction into the market for consumer use. For cigarettes,
cigarette tobacco, RYO, and smokeless tobacco, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after

June 23, 2009, or products in any stage of research or development at
any time after June 23, 2009, including experimental products and
developmental products intended for introduction into the market for
consumer use.
    All manufacturers and importers of tobacco products are now subject
to the FD&C Act and are required to comply with section 904(a)(4),
which requires immediate and ongoing submission of health documents
developed after June 22, 2009 (the date of enactment of the Tobacco
Control Act). However, FDA generally does not intend to enforce the
requirement at this time with respect to all such health documents
relating to the deemed tobacco products, so long as a specified set of
documents, those developed between June 23, 2009, and December 31,
2009, were submitted by February 8, 2017, or in the case of small-scale
deemed tobacco product manufacturers (small-scale manufacturers), by
November 8, 2017 (81 FR 28974 at 29008-09). Additionally, FDA extended
the compliance deadlines by an additional 6 months for small-scale
manufacturers in the areas impacted by recent natural disasters to May
8, 2018. Thereafter, FDA's compliance plan requests deemed
manufacturers provide tobacco health document submissions from the
specified period, at least 90 days prior to the delivery for
introduction into interstate commerce of tobacco products to which the
health documents relate. Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless tobacco products must provide all
health documents developed between June 23, 2009, and December 31,
2009, at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce. FDA estimates the burden of
this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Health Document Submissions and Form FDA 3743..............              10              3.2               32               50            1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of documents received each year since the original
collection period has fallen to less than 5 percent of what was
received in the original collection period. FDA expects this is because
documents created within the specified period should have already been
submitted. The Agency bases this estimate on the total number of
tobacco firms it is aware of and its experience with document
production and the number of additional documents that have been
reported each year since the original estimate of the reporting burden.
    FDA estimates that a tobacco health document submission for cigars,
pipe and waterpipe tobacco, electronic nicotine delivery systems
(ENDS), and other tobacco products as required by section 904(a)(4) of
the FD&C Act, will take approximately 50 hours per submission based on
the existing collection that applies to tobacco products currently
subject to the FD&C Act and FDA experience. To derive the number of
respondents for this provision, FDA assumes that very few manufacturers
or importers of deemed tobacco products, or agents thereof, would have
health documents to submit. In addition to the existing 4 respondents,
the Agency estimates that approximately 6 submissions (2 for cigar
manufacturers, 1 for pipe and waterpipe tobacco manufacturers, 1 for
other tobacco product manufacturers, 1 for tobacco importers, and 1 for
importers of ENDS who are considered manufacturers) will be submitted
on an annual basis for a total of 10 respondents. FDA estimates the
total annual reporting burden to be 1,600 hours.
    Based on a review of the information collection of our current OMB
approval, we have made no adjustments to our burden estimate.

    Dated: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18212 Filed 8-22-18; 8:45 am]
BILLING CODE 4164-01-P