[Federal Register Volume 85, Number 166 (Wednesday, August 26, 2020)]
[Rules and Regulations]
[Pages 52483-52488]
[FR Doc No: 2020-18661]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0038; FRL-10011-32]

Inpyrfluxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
inpyrfluxam in or on multiple commodities that are identified and
discussed later in this document. Valent requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 26, 2020. Objections and
requests for hearings must be received on or before October 26, 2020,
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-2018-0038, 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>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance

regulations at 40 CFR part 180 through the Government Publishing
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-2018-0038 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 26, 2020. 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-2018-0038, 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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 18, 2019 (84 FR 9735) (FRL-9989-
90), 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
7F8634) by Valent U.S.A. LLC, 1600 Riviera Avenue, Suite 200, Walnut
Creek, CA 94596. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the fungicide inpyrfluxam,
S-2399, in or on apple at 0.01 parts per million (ppm); apple, wet
pomace at 0.03 ppm; beet, sugar, dried pulp at 0.05 ppm; beet, sugar,
molasses at 0.03 ppm; beet, sugar, roots at 0.01 ppm; corn, field,
forage at 0.02 ppm; corn, field, grain at 0.01 ppm; corn, field, stover
at 0.02 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.02
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm;
peanut at 0.01 ppm; peanut, hay at 2.0 ppm; rice, grain at 0.01 ppm;
rice, bran at 0.02 ppm; rice, hulls at 0.05 ppm; and soybean, seed at
0.01 ppm. That document referenced a summary of the petition prepared
by Valent U.S.A. LLC, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-10008-
38), 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
7F8634) by Valent U.S.A. LLC, 1600 Riviera Avenue, Suite 200, Walnut
Creek, CA 94596. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the fungicide inpyrfluxam,
S-2399, in or on corn, sweet, stover at 0.02 ppm; corn, sweet, forage
at 0.02 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle,
meat byproducts at 0.01 ppm; eggs at 0.01 ppm; goat, fat at 0.01 ppm;
goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, fat at
0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm;
horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts
at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm; poultry, meat
at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep, fat at 0.01
ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.01 ppm.
That document referenced a summary of the petition prepared by Valent
U.S.A. LLC, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received in response to the notice
of filing. EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than were
requested. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for inpyrfluxam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with inpyrfluxam 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.
    The target organs of inpyrfluxam are the liver and thyroid (rats,
mice, and dogs). Liver effects include increased liver weight, elevated
liver enzymes, and increased incidences of diffuse hepatocellular
hypertrophy. Thyroid effects include increased incidences of follicular
cell hypertrophy.
    Decreased motor activity was seen in the acute neurotoxicity study
in female rats, but no gross or microscopic morphological changes
occurred. There was no neurotoxicity observed in the subchronic
neurotoxicity in rats or in any other studies. No dermal hazard was
identified in the 28-day dermal toxicity study.
    There was evidence of quantitative sensitivity in the developmental
toxicity study in rats. In this study, decreased fetal weights were
observed at a dose

lower than the presence of maternal toxicity. No quantitative
susceptibility was observed in the developmental toxicity study in
rabbits and the 2-generation reproduction study in rats. In the 2-
generation reproduction study in rats, no reproductive effects were
observed, and offspring toxicity (decreased pup weights in F1 and F2
generations) was observed in the presence (same dosage) of parental
toxicity (thyroid weight changes and histopathology in P and F1
generations).
    In the chronic toxicity/carcinogenicity studies in rats and mice,
there was no evidence of carcinogenicity. The mutagenicity battery was
negative. Inpyrfluxam is classified as ``Not likely to be carcinogenic
to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by inpyrfluxam 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 ``Inpyrfluxam. Human Health
Risk Assessment for the Section 3 Registration Action of the New Active
Ingredient, Inpyrfluxam, for Foliar Application on Apple, Peanut, Rice,
Soybean, and Sugar Beet; Soil Application on Corn; and Seed Treatment
Uses on Canola, Cereal Grains, Legume Vegetables, and Sugar Beet''
(hereinafter ``Inpyrfluxam Human Health Risk Assessment'') on pages 42-
46 in docket ID number EPA-HQ-OPP-2018-0038.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for inpyrfluxam used for
human risk assessment can be found in the Inpyrfluxam Human Health Risk
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to inpyrfluxam, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from inpyrfluxam in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for inpyrfluxam. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the United States Department of Agriculture's (USDA) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to residue levels in food, the acute analysis assumed
tolerance-level residues or higher by combining residues of the parent
and residues of the applicable metabolites of concern, adjusting for
molecular weight. In addition, the assessment used 100 percent crop
treated (PCT) estimates and default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, the chronic analysis
assumed tolerance-level residues or higher by combining residues of the
parent and residues of the applicable metabolites of concern, adjusting
for molecular weight. In addition, the assessment used 100 PCT
estimates and default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that inpyrfluxam 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 for assessing the inpyrfluxam
exposures.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for inpyrfluxam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of inpyrfluxam. 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.
    Using the Pesticide Root Zone Model-Variable Volume Water Model
(PRZM-VVWM) and Pesticide Root Zone Model-Groundwater (PRZM-GW) models,
EPA calculated the estimated drinking water concentrations (EDWCs) of
inpyrfluxam for acute and chronic exposures in surface and ground
water. EPA used the modeled EDWCs directly in the dietary exposure
model to account for the contribution of inpyrfluxam residues in
drinking water as follows: 104.5 ppm was used in the acute assessment
and 69.5 ppb was used in the chronic assessment.
    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).
    Inpyrfluxam is not being proposed to be registered for any specific
use patterns that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to inpyrfluxam and any other
substances, and inpyrfluxam does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that inpyrfluxam has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common

mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. In the developmental
toxicity study in rats, decreased fetal weights were observed at a dose
lower than the presence of maternal toxicity. No quantitative
susceptibility was observed in the developmental toxicity study in
rabbits and the 2-generation reproduction study in rats. In the 2-
generation reproduction study in rats, no reproductive effects were
observed, and offspring toxicity (decreased pup weights in F1 and F2
generations) was observed in the presence (same dosage) of parental
toxicity (thyroid weight changes and histopathology in P and F1
generations).
    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 inpyrfluxam is complete.
    ii. Decreased motor activity was observed in females in the acute
neurotoxicity study; however, no neurotoxicity was observed in the
subchronic neurotoxicity or in any other studies in the inpyrfluxam
database; therefore, a developmental neurotoxicity study was not needed
with the absence of neuropathology.
    iii. In the 2-generation reproduction study in rats, no
reproductive effects were observed, and offspring toxicity (decreased
pup weights in F1 and F2 generations) was observed in the presence of
parental toxicity (thyroid weight changes and histopathology in P and
F1 generations). Although there were developmental effects (decreased
fetal weights) in the developmental study in rats in the absence of
maternal toxicity, a clear NOAEL and LOAEL were identified, and the
PODs selected for risk assessment purposes are protective of the
developmental effects seen in the database.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and anticipated residues to account for the metabolites of
concern. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to inpyrfluxam in
drinking water. These assessments will not underestimate the exposure
and risks posed by inpyrfluxam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to inpyrfluxam will occupy 6.4% of the aPAD for all infants less than
one year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
inpyrfluxam from food and water will utilize 1.7% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for inpyrfluxam.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified;
however, inpyrfluxam is not being proposed to be registered for any use
patterns that would result in either short- or intermediate-term
residential exposure. Short- and intermediate-term risk is assessed
based on short- and intermediate-term residential exposure plus chronic
dietary exposure. Because there is no short- or 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 short-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for inpyrfluxam.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, inpyrfluxam is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to inpyrfluxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a multi-residue method (quick, easy,
cheap, effective, rugged and safe; QuEChERS; Method No. VP-393940) for
the determination of inpyrfluxam in plant commodities. For livestock
commodities, adequate enforcement methodology using the high
performance liquid chromatography with tandem mass detection (HPLC-MS/
MS, or LC-MS/MS) is available for determination of residues of
inpyrfluxam and its metabolites.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to

which the United States is a party. EPA may establish a tolerance that
is different from a Codex MRL; however, FFDCA section 408(b)(4)
requires that EPA explain the reasons for departing from the Codex
level.
    The Codex has not established any MRLs for inpyrfluxam.

C. Response to Comments

    One comment was received to the notice of filing that stated in
part ``ban use of valent impyrfluxam [sic] on corn cattle meat and
other sites.''
    Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it
determines that the tolerance is safe. Upon consideration of the
validity, completeness, and reliability of the available data as well
as other factors the FFDCA requires EPA to consider, EPA has determined
that these inpyrfluxam tolerances are safe. The commenter has provided
no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    Some of the proposed commodity definitions for the tolerances being
established are different than requested to be consistent with Agency
nomenclature. EPA is not establishing a tolerance for residues in/on
rice hulls as requested; it is not necessary as rice hulls are no
longer considered a significant livestock feedstuff. Also, residues
were less than the LOQ in the processed commodities at exaggerated
rates; therefore, a tolerance for rice bran is not required. No
separate tolerance is needed for apple, wet pomace since the residues
on pomace will be adequately covered by the tolerance on ``apple'' due
to a lack of concentration during processing. Similarly, no separate
tolerances are needed for sugar beet molasses or sugar beet dried pulp
since residues on those commodities will be adequately covered under
``beet, sugar, roots.'' Finally, EPA revised the tolerance value for
``peanut, hay'' from 2.0 ppm (as requested) to 2 ppm, to be consistent
with OECD's rounding class practices.

V. Conclusion

    Therefore, tolerances are established for residues of inpyrfluxam,
including its metabolites and degradates, in or on the following plant
commodities: Apple at 0.01 ppm; beet, sugar, roots at 0.01 ppm; corn,
field, forage at 0.02 ppm; corn, field, grain at 0.01 ppm; corn, field,
stover at 0.02 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at
0.02 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm;
corn, sweet, forage at 0.02 ppm; corn, sweet, stover at 0.02 ppm;
peanut at 0.01 ppm; peanut, hay at 2 ppm; rice, grain at 0.01 ppm; and
soybean, seed at 0.01 ppm.
    Also, tolerances are established for residues of inpyrfluxam,
including its metabolites and degradates, in or on the following
livestock commodities: Cattle, fat at 0.01 ppm; cattle meat at 0.01
ppm; cattle, meat byproducts at 0.01 ppm; egg at 0.01 ppm; goat, fat at
0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm;
hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at
0.01 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse meat
byproducts at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm;
poultry, meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep,
fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep meat byproducts at
0.01 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 tolerances 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 11, 2020.
Edward Messina,
Acting Director, 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. Add Sec.  180.712 to subpart C to read as follows:

Sec.  180.712  Inpyrfluxam; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
fungicide inpyrfluxam, including its metabolites and degradates, in or
on the commodities in Table 1 to this section. Compliance with the
tolerance levels specified in Table 1 to this section is to be
determined by measuring only inpyrfluxam (3-(difluoromethyl)-N-[(3R)-
2,3-dihydro-1,1,3-trimethyl-1H-inden-4-yl]-1-methyl-1H-pyrazole-4-
carboxamide), in or on the following commodities:

                        Table 1 to Sec.   180.712
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.01
Beet, sugar, roots..........................................        0.01
Corn, field, forage.........................................        0.02
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.02
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.02
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, forage.........................................        0.02
Corn, sweet, stover.........................................        0.02
Peanut......................................................        0.01
Peanut, hay.................................................           2
Rice, grain.................................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of inpyrfluxam,
including its metabolites and degradates, in or on the commodities in
Table 2 to this section. Compliance with the tolerance levels specified
in Table 2 to this section is to be determined by measuring the free
and conjugated forms of the sum of inpyrfluxam (3-(difluoromethyl)-N-
[(3R)-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-yl]-1-methyl-1H-pyrazole-
4-carboxamide, and its metabolites 3-(difluoromethyl)-N-[1'-
(hydroxymethyl)-(1'S,3'R)-1',3'-dimethyl-2',3'-dihydro-1'H-inden-4'-
yl]-1-methyl-1H-pyrazole-4-carboxamide and 3-(difluoromethyl)-N-[1'-
(hydroxymethyl)-(1'R,3'S)-1',3'-dimethyl-2',3'-dihydro-1'H-inden-4'-
yl]-1-methyl-1H-pyrazole-4-carboxamid, calculated as the stoichiometric
equivalent of inpyrfluxam, in or on the commodity:

                        Table 2 to Sec.   180.712
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.01
Egg.........................................................        0.01
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.01
Hog, fat....................................................        0.01
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.01
Milk........................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.01
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2020-18661 Filed 8-25-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Notices]
[Page 43599]
[FR Doc No: 2016-15782]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1948-000]

Atlantic Energy MA LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Atlantic Energy MA LLC`s application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 18, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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>.

    Dated: June 27, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-15782 Filed 7-1-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Proposed Rules]
[Pages 54257-54259]
[FR Doc No: 2023-16975]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2022-0604; FRL-10574-01-R9]

Air Plan Approval; CA; San Joaquin Valley Air Pollution Control
District; Removal of Excess Emissions Provisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve State Implementation Plan (SIP) revisions to the San Joaquin
Valley Air Pollution Control District (SJVAPCD) portion of the
California State Implementation Plan (SIP). The revisions were
submitted by the California Air Resources Board (CARB), on behalf of
SJVAPCD, in response to EPA's May 22, 2015, finding of substantial
inadequacy and SIP call for certain provisions in the SIP related to
exemptions and affirmative defenses applicable to excess emissions
during startup, shutdown, and malfunction (SSM) events. EPA is
proposing approval of the SIP revisions because the Agency has
determined that they are in accordance with the requirements for SIP
provisions under the Clean Air Act (CAA or the Act).

DATES: Comments must be received on or before September 11, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0604 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'' or
``our'' is used, it refers to EPA.

Table of Contents

I. Background
II. Analysis of SIP Submission
III. Proposed Action
IV. Incorporation by Reference
V. Statutory and Executive Orders Review

I. Background

    On February 22, 2013, the EPA issued a Federal Register notice of
proposed rulemaking outlining EPA's policy at the time with respect to
SIP provisions related to periods of SSM. EPA analyzed specific SSM SIP
provisions and explained how each one either did or did not comply with
the CAA with regard to excess emission events.\1\ For each SIP
provision that EPA determined to be inconsistent with the CAA, EPA
proposed to find that the existing SIP provision was substantially
inadequate to meet CAA requirements and thus proposed to issue a SIP
call under CAA section 110(k)(5). On September 17, 2014, EPA issued a
document supplementing and revising what the Agency had previously
proposed on February 22, 2013, in light of a D.C. Circuit decision that
determined the CAA precludes authority of the EPA to create affirmative
defense provisions applicable to private civil suits. EPA outlined its
updated policy that affirmative defense SIP provisions are not
consistent with CAA requirements. EPA proposed in the supplemental
proposal document to apply its revised interpretation of the CAA to
specific affirmative defense SIP provisions and proposed SIP calls for
those provisions where appropriate (79 FR 55920, September 17, 2014).
---------------------------------------------------------------------------

    \1\ State Implementation Plans: Response to Petition for
Rulemaking; Findings of Substantial Inadequacy; and SIP Calls to
Amend Provisions Applying to Excess Emissions During Periods of
Startup, Shutdown, and Malfunction, 78 FR 12460 (Feb. 22, 2013).
---------------------------------------------------------------------------

    On June 12, 2015, pursuant to CAA section 110(k)(5), EPA finalized
``State Implementation Plans: Response to Petition for Rulemaking;
Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings
of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying
to Excess Emissions During Periods of Startup, Shutdown and
Malfunction,'' (80 FR 33839, June 12, 2015), hereafter referred to as
the ``2015 SSM SIP Action.'' The 2015 SSM SIP Action clarified,
restated, and updated EPA's interpretation that SSM exemption and
affirmative defense SIP provisions are inconsistent with CAA
requirements. The 2015 SSM SIP Action found that certain SIP provisions
in 36 states were substantially inadequate to meet CAA requirements and
issued a SIP call to those states to submit SIP revisions to address
the inadequacies. EPA established an 18-month deadline by which the
affected states had to submit such SIP revisions. States were required
to submit corrective revisions to their SIPs in response to the SIP
calls by November 22, 2016.
    EPA issued a Memorandum in October 2020 (2020 Memorandum), which
stated that certain provisions governing SSM periods in SIPs could be
viewed as consistent with CAA requirements.\2\ Importantly, the 2020
Memorandum stated that it ``did not alter in any way the determinations
made in the 2015 SSM SIP Action that identified specific state SIP
provisions that were substantially inadequate to meet the requirements
of the Act.'' Accordingly, the 2020 Memorandum had no direct impact on
the SIP call issued to SJVAPCD in 2015. The 2020 Memorandum did,
however, indicate EPA's intent at the time to review SIP calls that
were issued in the 2015 SSM SIP Action to determine whether EPA should
maintain, modify, or withdraw

particular SIP calls through future agency actions.
---------------------------------------------------------------------------

    \2\ October 9, 2020 memorandum ``Inclusion of Provisions
Governing Periods of Startup, Shutdown, and Malfunctions in State
Implementation Plans,'' from Andrew R. Wheeler, Administrator.
---------------------------------------------------------------------------

    On September 30, 2021, EPA's Deputy Administrator withdrew the 2020
Memorandum and announced EPA's return to the policy articulated in the
2015 SSM SIP Action (2021 Memorandum).\3\ As articulated in the 2021
Memorandum, SIP provisions that contain exemptions or affirmative
defense provisions are not consistent with CAA requirements and,
therefore, generally are not approvable if contained in a SIP
submission. This policy approach is intended to ensure that all
communities and populations, including minority, low-income, and
indigenous populations overburdened by air pollution, receive the full
health and environmental protections provided by the CAA.\4\ The 2021
Memorandum also retracted the prior statement from the 2020 Memorandum
of EPA's plans to review and potentially modify or withdraw particular
SIP calls. That statement no longer reflects EPA's intent. EPA intends
to implement the principles laid out in the 2015 SSM SIP Action as the
agency takes action on SIP submissions, including this SIP submittal
provided in response to the 2015 SIP call.
---------------------------------------------------------------------------

    \3\ September 30, 2021, memorandum ``Withdrawal of the October
9, 2020, Memorandum Addressing Startup, Shutdown, and Malfunctions
in State Implementation Plans and Implementation of the Prior
Policy,'' from Janet McCabe, Deputy Administrator.
    \4\ 80 FR 33985.
---------------------------------------------------------------------------

    With regard to the SJVAPCD SIP, in the 2015 SSM SIP Action, the EPA
determined that the rules in the following table were substantially
inadequate to meet CAA requirements (80 FR 33840, 33973):

----------------------------------------------------------------------------------------------------------------
               District                   Rule number       Adopted        Submitted           Rule title
----------------------------------------------------------------------------------------------------------------
San Joaquin Valley APCD (Fresno County             110       2/17/2022       4/14/2022  Equipment Breakdown.
 APCD).
San Joaquin Valley APCD (Stanislaus                110       2/17/2022       4/14/2022  Equipment Breakdown.
 County APCD).
San Joquin Valley APCD (Kern County                111       2/17/2022       4/14/2022  Equipment Breakdown.
 APCD).
San Joaquin Valley APCD (Kings County              111       2/17/2022       4/14/2022  Equipment Breakdown.
 APCD).
San Joaquin Valley APCD (Tulare County             111       2/17/2022       4/14/2022  Equipment Breakdown.
 APCD).
San Joaquin Valley APCD (Madera County             113       2/17/2022       4/14/2022  Equipment Breakdown.
 APCD).
----------------------------------------------------------------------------------------------------------------

    Each of these SIP provisions provide an affirmative defense
available to sources for excess emissions that occur during a breakdown
condition (i.e., malfunction). The rationale underlying EPA's
determination that the provisions were substantially inadequate to meet
CAA requirements, and therefore to issue a SIP call to SJVAPCD to
remedy the provisions, is detailed in the 2015 SSM SIP Action and the
accompanying proposals.
    CARB, on behalf of SJVAPCD, submitted the SIP revisions on April
14, 2022, in response to the SIP call issued in the 2015 SSM SIP
Action. In its submission, California is requesting that EPA revise the
SJVAPCD SIP by removing the rules in the table above from the
California SIP.

II. Analysis of SIP Submission

    EPA is proposing to approve SJVAPCD's April 14, 2022 SIP
submission. Affirmative defense provisions like these are inconsistent
with CAA requirements and removal of these provisions would strengthen
the SIP. This action, if finalized, would remove the affirmative
defense provisions from the SJVAPCD portion of the EPA-approved SIP for
California. EPA is proposing to find that these revisions are
consistent with CAA requirements and that they adequately address the
specific deficiencies that EPA identified in the 2015 SSM SIP Action
with respect to the SJVAPCD portion of the California SIP.

III. Proposed Action

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). EPA is
proposing to approve California's April 14, 2022 SIP submission
requesting removal of (i) Fresno County ``Rule 110 Equipment
Breakdown''; (ii) Kern County ``Rule 111 Equipment Breakdown''; (iii)
Kings County ``Rule 111 Equipment Breakdown''; (iv) Madera County
``Rule 113 Equipment Breakdown''; (v) Stanislaus County ``Rule 110
Equipment Breakdown''; and (vi) Tulare County ``Rule 111 Equipment
Breakdown'' from the California SIP. We are proposing approval of the
SIP revisions because we have determined that they are consistent with
the requirements for SIP provisions under the CAA. EPA is further
proposing to determine that such SIP revisions correct the deficiencies
identified in the May 22, 2015 SIP call. EPA is not reopening the 2015
SSM SIP Action and is only taking comment on whether these SIP
revisions are consistent with CAA requirements and whether they address
the ``substantial inadequacy'' of the specific SJVAPCD SIP provisions
identified in the 2015 SSM SIP Action.

IV. Incorporation by Reference

    In this document, EPA is proposing to amend regulatory text that
includes incorporation by reference. In accordance with the
requirements of 1 CFR 51.5, and as described in section I of the
preamble, EPA is proposing to remove provisions from Fresno County,
Kern County, Kings County, Madera County, Stanislaus County, and Tulare
County portions of the California SIP. EPA has made, and will continue
to make, these documents generally available through https://www.regulations.gov and at the EPA Region 9 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves removal of State law not meeting
Federal requirements and does not impose additional requirements beyond
those already imposed by State law. For that reason, this proposed
action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011).
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
     Is certified as not having a significant economic impact
on a

substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999).
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997).
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001).
    Is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with
the CAA.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
Feb. 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The State did not evaluate environmental justice considerations as
part of its SIP submittal; the CAA and applicable implementing
regulations neither prohibit nor require such an evaluation. EPA did
not perform an EJ analysis and did not consider EJ in this action.
Consideration of EJ is not required as part of this action, and there
is no information in the record inconsistent with the stated goal of
E.O. 12898 of achieving environmental justice for people of color, low-
income populations, and Indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides.

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

    Dated: July 25, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2023-16975 Filed 8-9-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60393-60394]
[FR Doc No: 2015-25352]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-1064, FDA-2015-M-1065, FDA-2015-M-1177, FDA-
2015-M-1178, FDA-2015-M-1325, FDA-2015-M-1326, FDA-2015-M-1460, FDA-
2015-M-1461, FDA-2015-M-1557, FDA-2015-M-1708, FDA-2015-M-1709, FDA-
2015-M-1956, FDA-2015-M-1957, FDA-2015-M-1958, FDA-2015-M-1959, FDA-
2015-M-2077, FDA-2015-M-2078, FDA-2014-M-2247]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.

FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that

FDA may, for good cause, extend this 30-day period. Reconsideration of
a denial or withdrawal of approval of a PMA may be sought only by the
applicant; in these cases, the 30-day period will begin when the
applicant is notified by FDA in writing of its decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from April 1, 2015, through June 30, 2015.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2015 Through
                                                  June 30, 2015
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                   Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P140003, FDA-2015-M-1177..............  ABIOMED, Inc.............  Impella[supreg] 2.5 System...       3/23/2015
P130014, FDA-2015-M-1065..............  HyperBranch Medical        Adherus[supreg] AutoSpray           3/30/2015
                                         Technology, Inc.           Dural Sealant.
P130021/S010, FDA-2015-M-1064.........  Medtronic CoreValve, LLC.  Medtronic CoreValve[supreg]         3/30/2015
                                                                    System.
P110015, FDA-2015-M-1178..............  Advanced Breath            Gastric Emptying Breath Test         4/6/2015
                                         Diagnostics, LLC.          (GEBT).
P040020/S050, FDA-2015-M-1325.........  Alcon Research, Ltd......  AcrySof IQ ReSTOR +2.5 D            4/13/2015
                                                                    Multifocal Intraocular Lens.
P120023, FDA-2015-M-1326..............  AcuFocusTM, Inc..........  KAMRATM inlay................       4/17/2015
H130007, FDA-2014-M-2247..............  CVRx[supreg], Inc........  Barostim neoTM Legacy System.      12/12/2014
P140011, FDA-2015-M-1460..............  Siemens Medical Solutions  MAMMOMAT Inspiration with           4/21/2015
                                         USA, Inc.                  Tomosynthesis Option.
P120017, FDA-2015-M-1461..............  Medtronic, Inc...........  Model 5071 Lead..............       4/27/2015
P130012, FDA-2015-M-1557..............  Greatbatch Medical.......  Myopore Sutureless Myocardial       4/30/2015
                                                                    Pacing Lead.
P140023, FDA-2015-M-1708..............  Roche Molecular Systems,   cobas[supreg] KRAS Mutation          5/7/2015
                                         Inc.                       Test.
P130022, FDA-2015-M-1709..............  Nevro Corp...............  Nevro Senza Spinal Cord              5/8/2015
                                                                    Stimulation (SCS) System.
P140026, FDA-2015-M-1956..............  Silk Road Medical, Inc...  ENROUTETM Transcarotid Stent        5/18/2015
                                                                    System.
P140004, FDA-2015-M-1957..............  Vertiflex[supreg], Inc...  Superion[supreg] InterSpinous       5/20/2015
                                                                    Spacer.
P140002, FDA-2015-M-1958..............  Terumo Medical Corp......  Misago[supreg] Peripheral           5/22/2015
                                                                    Self-expanding Stent System.
P120005/S031, FDA-2015-M-1959.........  Dexcom, Inc..............  Dexcom G4[supreg]PLATINUM           5/22/2015
                                                                    (Pediatric) Continuous
                                                                    Glucose Monitoring System.
P110010/S096, FDA-2015-M-2077.........  Boston Scientific Corp...  PROMUS[supreg] ElementTM Plus        6/1/2015
                                                                    and Promus PREMIERTM
                                                                    Everolimus-Eluting Platinum
                                                                    Chromium Coronary Stent
                                                                    System (MonorailTM and Over-
                                                                    the-Wire).
P050052/S049, FDA-2015-M-2078.........  Merz North America.......  Radiesse[supreg] Injectable          6/4/2015
                                                                    Implant.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25352 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P