[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45844-45849]
[FR Doc No: 2018-19760]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0505; FRL-9982-21]

Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
spiromesifen in or on coffee. Bayer CropScience requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 11, 2018. Objections and
requests for hearings must be received on or before November 13, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0505, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
    Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0505 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
November 13, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0505, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8584) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of spiromesifen; 2-oxo-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate, and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one calculated as the
stoichiometric equivalent of spiromesifen in or on the raw agricultural
commodities: Coffee bean, green at 0.20 parts per million (ppm);
coffee, instant at 0.20 ppm; and coffee bean, roasted at 0.20 ppm. That
document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the commodities for which tolerances are being established.
The reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA

defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for spiromesifen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with spiromesifen 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.
    Following oral administration of spiromesifen, the target organs
included the thyroid gland for rats and dogs (increased thyroid-
stimulating hormone (TSH), increased thyroxine binding capacity,
decreased triiodothyronine (T3) and thyroxine
(T4) levels, colloidal alteration, and thyroid follicular
cell hypertrophy), the liver for rats and dogs (increased alkaline
phosphatase, alanine transaminase (ALT), and decreased cholesterol and
triglycerides), the spleen for rats (atrophy, decreased spleen cell
count, and increased macrophages), and the adrenal gland for mice
(discoloration, decrease in fine vesiculation, and the presence of
cytoplasmic eosinophilia in zona fasciculata cells). For rats,
additional effects included reduced body weights and clinical signs
(piloerection, reduced motility, spastic gait, and increased reactivity
when touched).
    There were no adverse effects in rats following dermal exposure up
to the limit dose (1,000 milligrams/kilograms/day (mg/kg/day)).
Decreased spleen weights were also observed for rats in a 5-day
inhalation toxicity study, along with gross pathological findings in
the lung (dark red areas or foci) and clinical signs (e.g., tremors,
clonic-tonic convulsions, reduced activity, bradypnea, etc.).
    While the clinical signs observed in rats following oral and
inhalation exposures could indicate neurotoxicity, there was no
evidence of neurotoxicity in the rest of the toxicological database,
including the acute neurotoxicity study up to the limit dose (2,000
milligrams/kilograms (mg/kg)) and the subchronic neurotoxicity study;
however, the doses tested in the subchronic neurotoxicity study were
lower than the doses causing clinical signs in the 90-day dietary study
in rats. There was no evidence of immunotoxicity in an antibody plaque-
cell forming assay.
    There was no evidence of increased pre- or post-natal
susceptibility. In the developmental toxicity studies in rats and
rabbits, maternal effects were observed in the absence of fetal
effects. In the rat two-generation reproductive toxicity study, the
reported parental effects, consisting of decreased spleen weights
(relative and absolute) and a decreasing number of ovarian follicles,
occurred at a dose level that also caused pup body weight decrements
during lactation.
    Spiromesifen is classified as ``Not likely to be Carcinogenic to
Humans'' based on the absence of treatment-related tumors in two
adequate rodent carcinogenicity studies. There was no concern for
mutagenicity or genotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled, ``Spiromesifen. Human
Health Risk Assessment in Support of Proposed Tolerance for Residues of
in/on Imported Coffee'' in docket ID number EPA-HQ-OPP-2017-0505.

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 the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for spiromesifen used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (All populations)....  No appropriate toxicological effect attributable to a single dose was
                                      observed. Therefore, a dose and endpoint were not identified for this risk
                                      assessment.
----------------------------------------------------------------------------------------------------------------

Chronic dietary (All populations)..  NOAEL = 2.2 mg/kg/day.  Chronic RfD = 0.022 mg/ Two-Generation Reproduction
                                     UFA = 10x.............   kg/day.                 Study--Rats
                                     UFH = 10x.............  cPAD = 0.022 mg/kg/day  Parental LOAEL = 8.8 mg/kg
                                     FQPA SF = 1x..........                           bw/day based on
                                                                                significantly decreased
                                                                                spleen weight (absolute
                                                                                and relative in parental
                                                                                females and F1 males) and
                                                                                significantly decreased
                                                                                growing ovarian follicles
                                                                                in females.
----------------------------------------------------------------------------------------------------------------
Oral short-term (1 to 30 days) and   NOAEL = 2.2 mg/kg/day.  LOC for MOE = 100.....  Two-Generation Reproduction
 intermediate-term (1-6 months).     UFA = 10x.............                           Study--Rats
                                     UFH = 10x.............                          Parental LOAEL = 8.8 mg/kg
                                     FQPA SF = 1x..........                           bw/day based on
                                                                                significantly decreased
                                                                                spleen weight (absolute
                                                                                and relative in parental
                                                                                females and F1 males) and
                                                                                significantly decreased
                                                                                growing ovarian follicles
                                                                                in females.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       Inhalation study NOAEC  LOC for MOE = 30        5-Day Inhalation Toxicity
 days) and intermediate-term (1-6     = 0.0794 mg/L/day.                              Study--Rats LOAEC = 0.5143
 months).                            UFA = 3x..............                           mg/L/day based on clinical
                                     UFH = 10x.............                           signs (tremors, clonic-
                                     FQPA SF = 1x..........                           tonic convulsions, reduced
                                                                                activity, bradypnea,
                                                                                labored breathing,
                                                                                vocalization, avoidance
                                                                                reaction, giddiness,
                                                                                piloerection, limp,
                                                                                emaciation, cyanosis,
                                                                                squatted posture, apathy
                                                                                and salivation), gross
                                                                                pathology (dark red areas
                                                                                or foci in the lungs and
                                                                                bloated stomachs and pale
                                                                                livers), and decreased
                                                                                spleen weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                      absence of treatment-related tumors in two adequate rodent carcinogenicity
                                      studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). NOAEC = non-observed adverse-effect concentration. LOAEC =
  lowest-observed adverse-effect concentration.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in 40
CFR 180.607. EPA assessed dietary exposures from spiromesifen 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 spiromesifen; 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) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008).
As to residue levels in food, the chronic (food and water) analysis
assumed 100 percent crop treated (PCT) and tolerance-level residues or
tolerance-level residues adjusted to account for the residue of
concern.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spiromesifen does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
spiromesifen. Tolerance level residues or tolerance-level residues
adjusted to account for the residue of concern and 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spiromesifen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spiromesifen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Provisional Cranberry model and Pesticide Water
Calculator--Groundwater (PWC-GW) model, the estimated drinking water
concentrations (EDWCs) of spiromesifen for chronic exposures are
estimated to be 188 parts per billion (ppb) for surface water and 116
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration of value 188 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).
    Spiromesifen is currently registered for the following uses that
could result in residential exposures: Ornamentals. EPA assessed
residential exposure using the following assumptions: Short-term
inhalation exposure to residential handlers is expected. A dermal
assessment (handler and post-

application) was not conducted since no hazard was identified via the
dermal route. Post-application inhalation exposures were not assessed
due to the low vapor pressure and the expected dilution in outdoor
sites. Post-application incidental oral exposure is considered unlikely
since the use is restricted to ornamental plants (turf treatment is not
permitted). Therefore, only short-term inhalation exposure to handlers
was assessed. Further information regarding EPA standard assumptions
and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found spiromesifen to share a common mechanism of
toxicity with any other substances, and spiromesifen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spiromesifen 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased pre- or post-natal susceptibility. In the developmental
toxicity studies in rats and rabbits, maternal effects were observed in
the absence of fetal effects. In the rat two-generation reproductive
toxicity study, the reported parental effects, consisting of decreased
spleen weights (relative and absolute) and a decreasing number of
ovarian follicles, occurred at a dose level that also caused pup body
weight decrements during lactation.
    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 spiromesifen is complete.
    ii. There is no indication that spiromesifen is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that spiromesifen 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 dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to spiromesifen in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
spiromesifen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spiromesifen 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
spiromesifen from food and water will utilize 68% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
spiromesifen is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Spiromesifen
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to spiromesifen.
    Because the level of concern (LOC) for inhalation (LOC for MOEs
<30) and oral (LOC for MOEs <100) exposure differ, the aggregate
assessment was calculated using the aggregate risk index (ARI)
approach. The ARI was devised as a way to aggregate MOEs that have
dissimilar uncertainty factors. The ARI is an extension of the MOE
concept and as with the MOE, risk increases as the ARI decreases. An
ARI that is greater than or equal to 1 is not of concern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate ARI of 1.87. Because
EPA's level of concern for spiromesifen is an ARI of 1 or below, this
ARI is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
spiromesifen is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no

intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for spiromesifen.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spiromesifen is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
res[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex has a MRL for residues of only spiromesifen in/on coffee
beans of 0.05 ppm. Since the residue expression for the U.S. and Codex
tolerances differ and since the maximum combined residues of
spiromesifen and BSN 2060-enol in/on coffee green bean from the field
trials was greater than 0.1 ppm, harmonization with the Codex
expression/value is not possible. Note that BSN 2060-enol is included
in the tolerance expression due to the demonstrated degradation of
parent to BSN 2060-enol during storage.

C. Response to Comments

    Three comments were submitted to the docket for this action. Two
comments, one about ``China's ongoing economic war against the United
States'' and another about air and water pollution in China relative to
that of the United States, are not relevant to this action. The third
comment stated in part that ``the people drinking coffee should not
have this toxic chemical as part of its drink.''
    The Agency recognizes that some individuals believe that pesticides
should be banned on agricultural crops; however, the existing legal
framework provided by section 408 of the FFDCA states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework nor have they provided any specific information or allegation
that would support a finding that these tolerances are unsafe.

D. Revisions to Petitioned-For Tolerances

    The green coffee bean tolerance being established is identical to
that proposed by the petitioner. EPA has determined that separate
tolerances for the processed commodities of roasted coffee bean and
instant coffee are unnecessary because the processing data indicates
that combined residues of spiromesifen and BSN 2060-enol do not
concentrate in roasted or instant coffee.

V. Conclusion

    Therefore, a tolerance is established for residues of spiromesifen,
including its metabolites and degradates, in or on coffee, green bean
at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 28, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.607, add alphabetically the commodity ``coffee, green
bean'' and footnote 1 to the table in paragraph (a)(1) to read as
follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) * * *
    (1) * * *

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

                                * * * * *
Coffee, green bean \1\.....................................         0.20

                                * * * * *
------------------------------------------------------------------------
\1\ This use has not been registered in the United States as of August
  28, 2018.

* * * * *

[FR Doc. 2018-19760 Filed 9-10-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Notices]
[Pages 61763-61764]
[FR Doc No: 2017-28140]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6530]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Prescription Drug User Fee Act Products;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products.'' This draft guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of drug or biological products (hereafter
referred to as products). The previous guidance for industry ``Formal
Meetings Between the FDA and Sponsors or Applicants'' published May 19,
2009, and the draft guidance for industry ``Formal Meetings Between the
FDA and Sponsors or Applicants of PDUFA Products'' published March 11,
2015, have been withdrawn.

DATES: Submit either electronic or written comments on the draft
guidance by March 29, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6530 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Prescription Drug User Fee
Act Products; Draft Guidance for Industry; Availability.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building,

4th Floor, Silver Spring, MD 20993-0002, or Office of Communication,
Outreach, and Development, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Rachel B. Kichline, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of products regulated by the
Center for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research. This draft guidance does not apply to
abbreviated new drug applications, applications for biosimilar
biological products, or submissions for medical devices. For the
purposes of this guidance, formal meeting includes any meeting that is
requested by a sponsor or applicant following the request procedures
provided in this guidance and includes meetings conducted in any format
(i.e., face to face, teleconference/videoconference, or written
response only).
    This guidance discusses the principles of good meeting management
practices and describes standardized procedures for requesting,
preparing for, scheduling, conducting, and documenting such formal
meetings. The general principles in this guidance may be extended to
other nonapplication-related meetings with external constituents,
insofar as this is possible.
    The previous guidance for industry ``Formal Meetings Between the
FDA and Sponsors or Applicants'' published May 19, 2009, and the draft
guidance for industry ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products'' published March 11, 2015, have been
withdrawn.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on formal
meetings between FDA and sponsors or applicants of PDUFA products. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information referred to in the guidance
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants''
have been approved under OMB control number 0910-0429. The collections
of information for Form FDA 1571 and end-of-phase 2 meetings have been
approved under OMB control number 0910-0014 and collections of
information for Form FDA 356h have been approved under OMB control
number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28140 Filed 12-28-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15787-15788]
[FR Doc No: 2015-06873]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0677; FRL-9924-68]

Receipt of Test Data Under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing its receipt of test data submitted pursuant
to a test rule issued by EPA under the Toxic Substances Control Act
(TSCA). As required by TSCA, this document identifies each chemical
substance and/or mixture for which test data have been received; the
uses or intended uses of such chemical substance and/or mixture; and
describes the nature of the test data received. Each chemical substance
and/or mixture related to this announcement is identified in Unit I.
under SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kathy Calvo, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Chemical Substances and/or Mixtures

    Information about the following chemical substances and/or mixtures
is provided in Unit IV.: 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-,
dinitrate (ester) (78-11-5).

II. Federal Register Publication Requirement

    Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a
notice in the Federal Register reporting the receipt of test data
submitted pursuant to test rules promulgated under TSCA section 4 (15
U.S.C. 2603).

III. Docket Information

    A docket, identified by the docket identification (ID) number EPA-
HQ-OPPT-2013-0677, has been established for this Federal Register
document that announces the receipt of data. Upon EPA's completion of
its quality assurance review, the test data received will be added to
the docket for the TSCA section 4 test rule that required the test
data. Use the docket ID number provided in Unit IV. to access the test
data in the docket for the related TSCA section 4 test rule.
    The docket for this Federal Register document and the docket for
each related TSCA section 4 test rule is available electronically at
http://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT

Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

IV. Test Data Received

    This unit contains the information required by TSCA section 4(d)
for the test data received by EPA.: 1,3-Propanediol, 2,2-
bis[(nitrooxy)methyl]-, dinitrate (ester) (78-11-5)
    1. Chemical Use(s): Manufacturing demolition explosives and
blasting caps.
    2. Applicable Test Rule: Chemical testing requirements for second
group of high production volume chemicals (HPV2), 40 CFR 799.5087.
    3. Test Data Received: The following listing describes the nature
of the test data received. The test data will be added to the docket
for the applicable TSCA section 4 test rule and can be found by
referencing the docket ID number provided. EPA reviews of test data
will be added to the same docket upon completion.
    Water Solubility. The docket ID number assigned to this data is
EPA-HQ-OPPT-2007-0531.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: March 18, 2015.
Lyn Vedinello,
Acting, Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2015-06873 Filed 3-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1722-1723]
[FR Doc No: 2019-00964]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2528-104]

Notice of Application Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Protests; Brookfield White Pine
Hydro, LLC

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:

    a. Application Type: Application for Non-Capacity Amendment of
license.
    b. Project No: 2528-104.
    c. Date Filed: January 4, 2019.
    d. Applicant: Brookfield White Pine Hydro, LLC.
    e. Name of Project: Cataract Hydroelectric Project.
    f. Location: The project is located on the Saco River in the cities
of Saco and Biddeford, York County, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kelly Maloney, License Compliance Manager,
150 Main Street, Lewiston, ME 04240,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    i. FERC Contact: Diana Shannon<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: February 28, 2019.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-2528-104. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee proposes to remove the
existing hinged flashboards on top of the East Channel (Cataract) dam
spillway and install 5-foot-high pneumatic crest gates. A control
building would be installed above the powerhouse intake to house the
associated control equipment. Construction is planned from July to
October 2019. A 1-foot drawdown from the normal full pond elevation
(i.e., 44 feet USGS) is necessary to complete the work. The drawdown is
expected to last from July through October 2019. No permanent changes
to project operations, headpond elevation, or spillway capacity are
proposed (after crest gate construction has been completed). The
licensee provided documentation of consultation with resource agencies
and stakeholders with its application.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website 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. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: January 29, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-00964 Filed 2-4-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 103 (Tuesday, May 30, 2023)]
[Notices]
[Page 34494]
[FR Doc No: 2023-11414]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP23-776-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Compliance filing: Rate Schedule S-2 OFO Refund Report
May 2023 to be effective N/A.
    Filed Date: 5/23/23.
    Accession Number: 20230523-5004.
    Comment Date: 5 p.m. ET 6/5/23.

    Docket Numbers: RP23-777-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Update (SRP July 2023) to be effective 7/1/2023.
    Filed Date: 5/23/23.
    Accession Number: 20230523-5093.
    Comment Date: 5 p.m. ET 6/5/23.

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

    Dated: May 23, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-11414 Filed 5-26-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Page 76712]
[FR Doc No: 2011-31503]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-2-002]

Pelico Pipeline, LLC; Notice of Motion for Extension of Rate Case
Filing Deadline

    Take notice that on November 30, 2011, Pelico Pipeline, LLC
(PELICO) filed a request for an extension consistent with the
Commission's revised policy of periodic review from a triennial to a
five-year period. The Commission in Order No. 735 modified its policy
concerning periodic reviews of rates charges by section 311 and Hinshaw
pipelines to extend the cycle for such reviews from three to five
years.\1\ Therefore, PELICO requests that the date for its next rate
filing be extended to November 1, 2014, which is five years from the
date of PELICO's most recent rate filing with this Commission.
---------------------------------------------------------------------------

    \1\ Contract Reporting Requirements of Intrastate Natural Gas
Companies, Order No. 735, 131 FERC ] 61,150 (May 20, 2010).
---------------------------------------------------------------------------

    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 13, 2011.

    Dated: December 2, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-31503 Filed 12-7-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Proposed Rules]
[Pages 51842-51844]
[FR Doc No: 2021-20033]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0216; Project Identifier 2018-CE-061-AD]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Gulfstream Aerospace Corporation (Gulfstream) Models GV and GV-
SP airplanes. This proposed AD was prompted by the omission of a life
limit in the airworthiness limitations section (ALS) of the maintenance
manual for a certain main landing gear (MLG) trunnion pin. This
proposed AD would require revising the ALS of your existing
instructions for continued airworthiness (ICA) or inspection program
for the airplane to establish a life limit of 20,000 flight cycles for
the affected MLG trunnion pin. The FAA is proposing this AD to address
the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by November 1,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Gulfstream
Aerospace Corporation, Technical Publications Dept., 500 Gulfstream
Road, Savannah, GA 31402-2206; phone:<PHONE_NUMBER>; fax: (912) 965-
3520; email<EMAIL_ADDRESS>website: https://www.gulfstream.com/en/customer-support/. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0216; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Miral Patel, Aviation Safety Engineer,
Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, GA 30337;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0216; Project Identifier
2018-CE-061-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be

placed in the public docket of this NPRM. Submissions containing CBI
should be sent to Miral Patel, Aviation Safety Engineer, Atlanta ACO
Branch, FAA, 1701 Columbia Avenue, College Park, GA 30337. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    Gulfstream notified the FAA that a life limit for replacing MLG
trunnion pin part number (P/N) 1159SCL566-15 had been omitted from the
ALS of the maintenance manual for Models GV and GV-SP airplanes.
Gulfstream revised the ALS for the applicable airplanes to establish a
life limit of 20,000 flight cycles for the affected MLG trunnion pin. A
trunnion pin remaining in service beyond its fatigue life could lead to
fracture and failure of the trunnion pin. This condition, if
unaddressed, could result in MLG failure and could lead to a runway
excursion.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information

    The FAA reviewed Gulfstream GV Aircraft Maintenance Manual,
Revision 53, dated March 15, 2021; Gulfstream G550 Aircraft Maintenance
Manual, Revision 34, dated March 15, 2021; and Gulfstream G500-5000
Aircraft Maintenance Manual, Revision 34, dated March 15, 2021. For the
applicable marketing designation specified on each document, the
revised service information adds a life limit for MLG trunnion pin P/N
1159SCL566-15.

Proposed AD Requirements in This NPRM

    This proposed AD would require revising the ALS of the existing ICA
or inspection program for the airplane to establish a life limit of
20,000 flight cycles for MLG trunnion pin P/N 1159SCL566-15.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 516 airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
             Action                   Labor cost              Parts cost              product        operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS..................  1 work-hour x $85   Not applicable............             $85         $43,860
                                   per hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Gulfstream Aerospace Corporation: Docket No. FAA-2021-0216; Project
Identifier 2018-CE-061-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 1, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Gulfstream Aerospace Corporation Models GV
and GV-SP airplanes, all serial numbers, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3200, Landing Gear
System.

(e) Unsafe Condition

    This AD was prompted by the omission of a life limit in the
airworthiness limitations section (ALS) for a certain main landing
gear (MLG) trunnion pin. The FAA is issuing this AD to prevent a MLG
trunnion pin from remaining in service beyond its fatigue life. This
unsafe condition, if not addressed, could result in MLG failure and
could lead to a runway excursion.

(f) Compliance

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

(g) Revise the ALS

    Within 12 months after the effective date of this AD, revise the
existing ALS of the instructions for continued airworthiness or
aircraft inspection program for your airplane by establishing a life
limit of 20,000 flight cycles for each MLG trunnion pin part number
1159SCL566-15.

    Note 1 to paragraph (g) of this AD: Table 5 in Section 05-10-10
of the following aircraft maintenance manuals contains the life
limit in paragraph (g) of this AD: Gulfstream GV Aircraft
Maintenance Manual,

Revision 53, dated March 15, 2021; Gulfstream G550 Aircraft
Maintenance Manual, Revision 34, dated March 15, 2021; or Gulfstream
G500-5000 Aircraft Maintenance Manual, Revision 34, dated March 15,
2021.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (i)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Miral Patel,
Aviation Safety Engineer, Atlanta ACO Branch, FAA, 1701 Columbia
Avenue, College Park, GA 30337; phone:<PHONE_NUMBER>; fax: (404)
474-5606; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., 500
Gulfstream Road, Savannah, GA 31402-2206; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>website: https://www.gulfstream.com/en/customer-support/. You may view this
referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City, MO
64106. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued on September 13, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-20033 Filed 9-16-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Rules and Regulations]
[Pages 2624-2626]
[FR Doc No: 2013-00502]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-8263]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information

identifying the current participation status of a community can be
obtained from FEMA's Community Status Book (CSB). The CSB is available
at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of   Current effective  map   Date certain  Federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in  SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region V

Michigan:
    Edenville, Township of,           260850  N/A, Emerg; June    Jan. 16, 2013.........  Jan. 16, 2013.
     Midland County.                           4, 2009, Reg;
                                               Jan.uary 16,
                                               2013, Susp.
    Greendale, Township of,           260870  March 13, 2009,     ......do..............   Do.
     Midland County.                           Emerg; May 4,
                                               2009, Reg;
                                               January 16, 2013,
                                               Susp.
    Jerome, Township of,              260853  October 20, 2008,   ......do..............   Do.
     Midland County.                           Emerg; May 4,
                                               2009, Reg;
                                               January 16, 2013,
                                               Susp.
    Lee, Township of, Midland         260855  N/A, Emerg;         ......do..............   Do.
     County.                                   December 30,
                                               2009, Reg;
                                               January 16, 2013,
                                               Susp.

    Lincoln, Township of,             260856  N/A, Emerg; May     ......do..............   Do.
     Midland County.                           24, 2012, Reg;
                                               January 16, 2013,
                                               Susp.
    Sanford, Village of,              260859  N/A, Emerg; August  ......do..............   Do.
     Midland County.                           11, 2009, Reg;
                                               January 16, 2013,
                                               Susp.

          Region VII

Iowa:
    Riverside, City of,               190648  May 6, 1981,        ......do..............   Do.
     Washington County.                        Emerg; August 1,
                                               1986, Reg;
                                               January 16, 2013,
                                               Susp.
    Wellman, City of,                 190276  September 18,       ......do..............   Do.
     Washington County.                        1995, Emerg;
                                               October 6, 2000,
                                               Reg; January 16,
                                               2013, Susp.
Missouri:
    Marshall, City of, Saline         290403  March 24, 1975,     ......do..............   Do.
     County.                                   Emerg; November
                                               4, 1988, Reg;
                                               January 16, 2013,
                                               Susp.
    Saline County,                    290834  May 1, 1984,        ......do..............   Do.
     Unincorporated Areas.                     Emerg; April 1,
                                               1989, Reg;
                                               January 16, 2013,
                                               Susp.
    Slater, City of, Saline           290406  July 22, 1975,      ......do..............   Do.
     County.                                   Emerg; September
                                               10, 1984, Reg;
                                               January 16, 2013,
                                               Susp.
----------------------------------------------------------------------------------------------------------------
* -do- =Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: December 21, 2012.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2013-00502 Filed 1-11-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Pages 70040-70041]
[FR Doc No: 2013-27979]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9903-22-ORD; Docket ID No. EPA-HQ-ORD-2013-0232]

Draft Integrated Science Assessment for Nitrogen Oxides--Health
Criteria

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Public Comment Period.

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

SUMMARY: EPA is announcing a 60-day public comment period for the draft
document titled, ``First External Review Draft Integrated Science
Assessment for Nitrogen Oxides--Health Criteria'' (EPA/600/R-13/202).
The draft document was prepared by the National Center for
Environmental Assessment (NCEA) within EPA's Office of Research and
Development as part of the review of the primary (health-based)
national ambient air quality standards (NAAQS) for nitrogen dioxide
(NO2). The Integrated Science Assessment (ISA), in
conjunction with additional technical and policy assessments, provide
the scientific basis for EPA decisions on the adequacy of the current
NAAQS and the appropriateness of possible alternative standards. EPA
intends to develop a separate ISA, and NAAQS review, for the secondary
(welfare-based) NAAQS for NO2, in conjunction with a review
of the secondary NAAQS for sulfur dioxide.
    EPA is releasing this draft document to seek review by the Clean
Air Scientific Advisory Committee (CASAC) and the public (meeting date
and location to be specified in a separate Federal Register notice).
This draft document is not final as described in EPA's information
quality guidelines, and it does not represent and should not be
construed to represent Agency policy or views. EPA will consider any
public comments submitted in response to this notice when revising the
document.

DATES: The 60-day public comment period begins November 22, 2013, and
ends January 21, 2014. Comments must be received on or before January
21, 2014.

ADDRESSES: The ``First External Review Draft Integrated Science
Assessment for Nitrogen Oxides--Health Criteria'' will be available
primarily via the Internet on NCEA's home page under the Recent
Additions and Publications menus at http://www.epa.gov/ncea or the
public docket at http://www.regulations.gov, Docket ID: EPA-HQ-ORD-
2013-0232. A limited number of CD-ROM copies will be available. Contact
Ms. Marieka Boyd by phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>to request a CD-ROM, and please provide your name,
your mailing address, and the document title, ``First External Review
Draft Integrated Science Assessment for Nitrogen Oxides--Health
Criteria'' to facilitate processing of your request.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>    For technical information, contact Dr. Molini Patel, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108 (a) of the Clean Air Act directs the Administrator to
identify certain pollutants which, among other things, ``cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air. . . .''
Under section 109 of the Act, EPA is then to establish NAAQS for each
pollutant for which EPA has issued criteria. Section 109 (d) of the Act
subsequently requires periodic review and, if appropriate, revision of
existing air quality criteria to reflect advances in scientific
knowledge on the effects of the pollutant on public health or welfare.
EPA is also required to review and, if appropriate, revise the NAAQS,
based on the revised air quality criteria (for more information on the
NAAQS review process, see http://www.epa.gov/ttn/naaqs/review.html).
    Nitrogen oxides are one of six criteria pollutants for which EPA
has established NAAQS. Periodically, EPA reviews the scientific basis
for these standards by preparing an ISA (formerly called an Air Quality
Criteria Document). The ISA, in conjunction with additional technical
and policy assessments, provides the scientific basis for EPA decisions
on the adequacy of the current NAAQS and the appropriateness of
possible alternative standards. The CASAC, an independent science
advisory committee whose review and advisory functions are mandated by
Section 109 (d) (2) of the Clean Air Act, is charged (among other
things) with independent scientific review of EPA's air quality
criteria.
    On February 10, 2012 (77 FR 7149), EPA formally initiated its
current review of the air quality criteria for the health effects of
nitrogen oxides and the primary (health-based) NO2 NAAQS,
requesting the submission of recent scientific information on specified
topics. EPA held a workshop February 29 to March 1, 2012, to discuss
with invited scientific experts from internal and external to EPA, key
science and policy issues relevant to the review of the health effects
of nitrogen oxides (77 FR 7149). EPA's ``Draft Plan for Development of
the Integrated Science Assessment for Nitrogen Oxides--Health
Criteria'' was made available for public comment on May 3, 2013 (78 FR
26026), and was discussed by the CASAC via a publicly accessible
teleconference consultation on June 5, 2013 (78 FR 27234). On June 11,
2013, EPA held a workshop to discuss, with invited scientific experts,
initial draft materials prepared in the development of the ISA (78 FR
27374).
    A draft Integrated Review Plan (IRP) is being developed that will
characterize all of the phases of the review of the primary NAAQS for
NO2, including the schedule for the entire review, the
process for conducting the various phases of the review, and the key
policy-relevant science issues that will guide the review. The draft
IRP will incorporate a revised plan for ISA development after
consideration of CASAC and public comments on the draft plan for
development of the ISA. The draft IRP will be reviewed by CASAC and the
public together with the first draft ISA at a public meeting. The
availability of the draft IRP for review by CASAC and the public, and
the date and location of the public meeting, will

be announced in separate Federal Register notices.
    The ``First External Review Draft Integrated Science Assessment for
Nitrogen Oxides--Health Criteria'' will be discussed at a public
meeting for review by CASAC and the public. In addition to the public
comment period announced in this notice, the public will have an
opportunity to address CASAC. A separate Federal Register notice will
inform the public of the exact date and time of the CASAC meeting and
of the procedures for public participation in that CASAC meeting.

II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2013-
0232, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460. The phone number is<PHONE_NUMBER>.
     Hand Delivery: The ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2013-0232. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

    Dated: October 30, 2013.
Debra B. Walsh,
Acting Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2013-27979 Filed 11-21-13; 8:45 am]
BILLING CODE 6560-50-P