[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46929-46934]
[FR Doc No: 2017-21797]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0309; FRL-9967-72]

Tolfenpyrad; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of tolfenpyrad in or on dry bulb onion and watermelon. This
action is in response to EPA's granting of emergency exemptions under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on dry bulb onion and watermelon. This
regulation establishes maximum permissible levels for residues of
tolfenpyrad in or on these commodities. The time-limited tolerances
expire on December 31, 2020.

DATES: This regulation is effective October 10, 2017. Objections and
requests for hearings must be received on or before December 11, 2017,
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-2017-0309, 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. 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_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 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select
``Test Guidelines for Pesticides and Toxic Substances.''

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2017-0309 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before December 11, 2017. 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-2017-0309, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing time-limited tolerances for residues of tolfenpyrad (4-
chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-
carboxamide), including its metabolites and degradates, in or on dry
bulb onion at 0.09 parts per million (ppm), and watermelon at 0.7 ppm.
These time-limited tolerances expire on December 31, 2020.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
    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. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Tolfenpyrad on Dry Bulb Onion and
Watermelon, and FFDCA Tolerances

    The Texas Department of Agriculture (TDA) stated that an emergency
situation required the use of tolfenpyrad on dry bulb onions (Allium
cepa) to control onion thrips (Thrips tabaci Lindeman) in the Texas
counties of Cameron, Dimmitt, Frio, Hidalgo, Maverick, Starr, Uvalde,
Willacy and Zavala. According to TDA, this year's exceptionally mild
winter and record high heat caused the development of large populations
of onion thrips, a principle pest of onions, early in the onion crop
cycle. The threshold level for applying pesticides to control thrips in
onions is 5 to 25 thrips per plant, and TDA stated that over 100 thrips
per plant were observed in Texas' dry bulb onion fields in early March,
2017. TDA stated that multiple applications of registered pesticides
were not controlling these extreme population levels which can reduce
yields and bulb size by as much as 50%. In addition, the transmission
of iris yellow spot virus in onions, exclusively vectored by onion
thrips, is a concern, and several onion fields have been observed with
positive symptoms. TDA stated that this virus severely affects the
shipping quality of onions, and can be more devastating than damage
from the thrips themselves. Upon EPA concurrence, TDA allowed the use
of tolfenpyrad under the provisions of a crisis exemption beginning on
March 17, 2017, and

subsequently requested a specific exemption to allow the use of
tolfenpyrad in dry bulb onions to continue beyond the 15 days provided
by a crisis exemption alone.
    Separately, the Hawaii Department of Agriculture (HDA) stated that
an emergency developed due to outbreaks of melon thrips in watermelon
fields at unusually high levels, (up to 200 thrips per leaf), which
registered pesticides were not controlling. HDA stated that above-
average rainfall caused rapid growth of host plants, leading to
development of very high levels of melon thrips in areas near
watermelon fields. Subsequently, a 6-week drought caused early dry-down
of this rainy-season vegetation, prompting massive migrations of melon
thrips into neighboring watermelon fields. HDA stated that the melon
thrips infestations have caused stunted vines, foliage discoloration,
and in some instances have caused such severe damage that the plants no
longer produce fruit. The melon aphid also transmits the tomato spotted
wilt virus, which causes silver mottle disease in watermelon, further
damaging the plants and causing additional yield losses. HDA stated
that some watermelon acreage was abandoned due to the high level of
damage from melon thrips infestations, and that significant yield and
economic losses would occur in the remaining watermelon acreage without
the requested use of tolfenpyrad. Upon EPA concurrence, HDA allowed the
use of tolfenpyrad under the provisions of a crisis exemption,
beginning on May 31, 2017, subsequently requesting a specific exemption
to allow the use of tolfenpyrad in watermelon to continue beyond the 15
days provided under a crisis exemption alone.
    After having reviewed the submissions, EPA determined that
emergency conditions exist for these States, and that the criteria for
approval of the emergency exemptions had been met. Therefore, EPA
authorized specific exemptions under FIFRA section 18 for the use of
tolfenpyrad on dry bulb onion for control of onion thrips in Texas, and
on watermelon for control of melon thrips in Hawaii.
    As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of tolfenpyrad
in or on dry bulb onion and watermelon. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address
urgent, non-routine situations and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although these time-limited tolerances expire on December 31, 2020,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on dry bulb
onion or watermelon after that date will not be unlawful, provided the
pesticide was applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these time-
limited tolerances at the time of that application. EPA will take
action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
tolfenpyrad meets FIFRA's registration requirements for use on dry bulb
onion and watermelon or whether permanent tolerances for these uses
would be appropriate. Under these circumstances, EPA does not believe
that these time-limited tolerance decisions serve as bases for
registration of tolfenpyrad by a State for special local needs under
FIFRA section 24(c), nor do these tolerances by themselves serve as the
authority for persons in any States other than Texas and Hawaii to use
this pesticide on the applicable crops under FIFRA section 18, absent
the issuance of an emergency exemption applicable within that State.
For additional information regarding the emergency exemptions for
tolfenpyrad, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of these emergency exemptions and the
time-limited tolerances for residues of tolfenpyrad on dry bulb onion
at 0.09 ppm, and watermelon at 0.7 ppm. EPA's assessment of exposures
and risks associated with establishing the time-limited tolerances
follows.

A. 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 to humans by 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological profile and endpoints for
tolfenpyrad used for human health risk assessment is discussed in Table
1 of the final rule published in the Federal Register of January 9,
2014, (79 FR 1599) (FRL-9904-70).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tolfenpyrad, EPA considered exposures under the time-
limited tolerances established by this action as well as all existing
tolfenpyrad tolerances in 40 CFR 180.675. EPA assessed dietary
exposures from tolfenpyrad in food as follows:
    i. Acute exposure. Acute dietary exposure is quantified 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey/What We

Eat in America (NHANES/WWEIA). For the purposes of this acute exposure
assessment, EPA assumed tolerance-level residues and 100 percent crop
treated (PCT) for those crops on which tolfenpyrad use is registered
and proposed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. For the purposes of this chronic exposure assessment, EPA
assumed 100 PCT and incorporated average residue levels from crop field
trials for registered and proposed uses of tolfenpyrad.
    iii. Cancer. No evidence of carcinogenicity was observed in cancer
studies with mice and rats. For further detail on the results of these
studies see ``Tolfenpyrad. Human Health Risk Assessment'' at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0909.
Therefore, in accordance with EPA's Final Guidelines for Carcinogen
Risk Assessment (March 2005), tolfenpyrad is classified as ``not likely
to be carcinogenic to humans'' and a cancer risk assessment is
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for tolfenpyrad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tolfenpyrad. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
tolfenpyrad are 26.9 ppb for acute exposure and 12.2 ppb for chronic
exposure. These modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model.
    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).
    Tolfenpyrad is not registered for any specific use patterns that
would result in residential exposure. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at: https://www.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 tolfenpyrad to share a common mechanism of
toxicity with any other substances, and tolfenpyrad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tolfenpyrad does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. 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 SF when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased
quantitative or qualitative susceptibility was observed in
developmental toxicity studies in rats or rabbits or a reproduction
toxicity study in rats. However, the developmental immunotoxicity study
(DIT) in rats suggests increased qualitative susceptibility in the
young since toxicity observed in offspring animals was more pronounced
than toxicity seen in maternal animals at the same dose. No evidence of
quantitative susceptibility was seen in the study. There is low concern
and there are no residual uncertainties regarding the increased
qualitative prenatal and/or postnatal susceptibility observed for
tolfenpyrad. When the DIT and the reproduction study are considered
together, the offspring toxicity in the DIT is comparable in severity
to maternal toxicity observed at the same dose in the reproduction
study. Since the adverse effects in young occurred at exposure levels
that have shown comparable effects in adults, EPA does not consider the
DIT persuasive evidence of an increased susceptibility of infants or
children to tolfenpyrad. Additionally, the effects observed in the DIT
study are well-characterized, a clear NOAEL was identified, and the
endpoints chosen for risk assessment are protective of potential
offspring effects since a dermal hazard was not identified for
tolfenpyrad, inhalation risk assessments are based on a route specific
inhalation study, and the POD used for chronic dietary risk assessment
is lower than where offspring effects were seen in the DIT study.
    3. Conclusion. EPA has determined that reliable data show that 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 tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although there is possibly increased qualitative
susceptibility in the young in the DIT study in rats, there are no
residual uncertainties regarding increased susceptibility for
tolfenpyrad since, (1) comparable maternal toxicity was observed at the
same dose in the

reproduction study, (2) the offspring effects observed in the DIT study
are well characterized and there is a clear NOAEL for the effects seen,
(3) no evidence of quantitative susceptibility was seen in the DIT
study and susceptibility was not observed (quantitative or qualitative)
in rat or rabbit developmental toxicity or reproduction studies tested
at similar doses, (4) the endpoints and PODs selected for risk
assessment are protective, and (5) direct non-dietary exposure to
children is not anticipated since there are no residential uses for
tolfenpyrad. Thus, an additional FQPA safety factor is not necessary to
protect infants and children.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to tolfenpyrad in
drinking water. Accordingly, these assessments will not underestimate
the exposure and risks posed by tolfenpyrad.

D. 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,
drinking water and relevant residential exposure scenarios. Since there
are no residential uses for tolfenpyrad, acute residential exposure is
not anticipated and acute aggregate exposure results from dietary
exposure to residues in food and drinking water alone. Therefore, acute
aggregate risk estimates are equivalent to the acute dietary risk
estimates. Using the exposure assumptions discussed in this unit for
acute exposure, the acute dietary exposure from food and water to
tolfenpyrad will occupy 56% of the aPAD for the general U.S.
population. Children 3-5 years old are the highest-exposed population
subgroup with an estimated acute dietary exposure of 80% of the aPAD.
Typically, EPA has concerns when estimated exposures exceed 100% of the
acute or chronic population-adjusted dose (aPAD or cPAD). Acute dietary
risk estimates are below EPA's level of concern for all populations.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water and relevant residential exposure scenarios. Since there
are no residential uses for tolfenpyrad, chronic residential exposure
is not anticipated and chronic aggregate exposure to tolfenpyrad
results from dietary exposure to residues in food and drinking water
alone. Therefore, chronic aggregate risk estimates for tolfenpyrad are
equivalent to the chronic dietary risk estimates. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that chronic exposure to tolfenpyrad from food and water will
utilize 32% of the cPAD for the general U.S. population, and 81% of the
cPAD for children 1-2 years old (the population group receiving the
greatest exposure).
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic dietary exposure
from food and water (considered to be a background (average) exposure
level). A short-term adverse effect was identified; however,
tolfenpyrad is not registered for any use patterns that would result in
short-term residential exposure. Because there is no short-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-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
tolfenpyrad.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
dietary exposure from food and water (considered to be a background
exposure level). An intermediate-term adverse effect was identified;
however, tolfenpyrad is not registered for any use patterns that would
result in intermediate-term residential 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 tolfenpyrad.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tolfenpyrad 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 tolfenpyrad residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/tandem 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:
<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 MRLs for tolfenpyrad residues in dry bulb onion or
watermelon.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
tolfenpyrad (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide), including its metabolites and
degradates, in or on onion, dry bulb at 0.09 ppm, and watermelon at 0.7
ppm. These tolerances expire on December 31, 2020.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).

VIII. 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: September 25, 2017.
Michael L. 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.  180.675, revise paragraph (b) to read as follows:

Sec.  180.675  Tolfenpyrad; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of
tolfenpyrad, (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, including its metabolites and
degradates, in or on the specified agricultural commodities, resulting
from use of the pesticide pursuant to FIFRA section 18 emergency
exemptions. Compliance with the tolerance levels specified below is to
be determined by measuring only tolfenpyrad, 4-chloro-3-ethyl-1-methyl-
N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide. The tolerances expire
on the dates specified in the table.

------------------------------------------------------------------------
                                             Parts per      Expiration
                Commodity                     million          date
------------------------------------------------------------------------
Onion, dry bulb.........................            0.09      12/31/2020
Vegetable, fruiting, group 8-10.........            0.70        12/31/19
Watermelon..............................            0.70      12/31/2020
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-21797 Filed 10-6-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43141-43142]
[FR Doc No: 2019-17924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]

Request for Nominations for Voting Members on a Public Advisory
Committee; Blood Products Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Blood Products Advisory
Committee (the Committee) in the Center for Biologics Evaluation and
Research. Nominations will be accepted for upcoming vacancies effective
with this notice. FDA seeks to include the views of women and men,
members of all racial and ethnic groups, and individuals with and
without disabilities on its advisory committees and, therefore
encourages nominations of appropriately qualified candidates from these
groups.

DATES: Nominations received on or before October 21, 2019 will be given
first consideration for membership on the Blood Products Advisory
Committee. Nominations received after October 21, 2019 will be
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website at https://www.fda.gov/advisory-committees.

FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the Blood Products Advisory
Committee.

I. General Description of the Committee Duties

    The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which FDA has regulatory
responsibility, and advises the Commissioner of Food and Drugs (the
Commissioner) of its findings regarding screening and testing (to
determine eligibility) of donors and labeling of the products, on
clinical and laboratory studies involving such products, on the
affirmation or revocation of biological products licenses, and on the
quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the
Committee recommends classification of devices subject to its review
into regulatory categories; recommends the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.

II. Criteria for Voting Members

    The Committee consists of a core of 17 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of clinical
and administrative medicine, hematology, immunology, blood banking,
surgery, internal medicine, biochemistry, engineering, biological and
physical sciences, biotechnology, computer technology, statistics,
epidemiology, sociology/ethics, and other related professions. Almost
all non-Federal members of this committee serve as Special Government
Employees. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and email address if
available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must specify the advisory committee for which the nominee
is recommended. Nominations must also acknowledge that the nominee is
aware of the nomination unless self-nominated. FDA will ask

potential candidates to provide detailed information concerning such
matters related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflicts
of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17924 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20692-20693]
[FR Doc No: 2021-08256]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0083; FRL-10022-58]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients--April 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before May 21, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090, email address<EMAIL_ADDRESS>The mailing address for
this contact person is: Office of Pesticide

Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.
Washington, DC 20460-0001. As part of the mailing address, include the
contact person's name, division, and mail code.

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).

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

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

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications. For actions being evaluated under EPA's public
participation process for registration actions, there will be an
additional opportunity for public comment on the proposed decisions.
Please see EPA's public participation website for additional
information on this process (https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions).

A. Notice of Receipt--New Active Ingredients

    1. File Symbol: 2375-E. Docket ID number: EPA-HQ-OPP-2020-0734.
Applicant: Chr. Hansen, Inc., 9015 W Maple St., Milwaukee, WI 53214.
Product name: CH2970/CH3000. Active ingredients: Fungicide and
nematicide--Bacillus paralicheniformis strain CH2970 at 20.0% and
Bacillus subtilis strain CH3000 at 31.0%. Proposed use: Seed treatment
and soil application.
    2. File Symbol: 2375-E. Docket ID number: EPA-HQ-OPP-2020-0734.
Applicant: Chr. Hansen, Inc., 9015 W Maple St., Milwaukee, WI 53214.
Product name: CH3000. Active ingredient: Fungicide and nematicide--
Bacillus subtilis strain CH3000 at 100.0%. Proposed use: For
manufacturing use.
    3. File Symbol: 2375-R. Docket ID number: EPA-HQ-OPP-2020-0734.
Applicant: Chr. Hansen, Inc., 9015 W Maple St., Milwaukee, WI 53214.
Product name: CH2970. Active ingredient: Fungicide and nematicide-
Bacillus paralicheniformis strain CH2970 at 100.0%. Proposed use: For
manufacturing use.
    4. File Symbol: 29964-GR. Docket ID number: EPA-HQ-OPP-2021-0218.
Applicant: Pioneer Hi-Bred International, Inc., 7100 NW 62nd Ave., P.O.
Box 1000, Johnston, IA 50131-1000. Product name: DP915635 Maize. Active
ingredient: Insecticide--Ophioglossum pendulum IPD079Ea insecticidal
protein and the genetic material necessary for its production in corn
event DP-915635-4 at <0.000046%. Proposed use: Plant-incorporated
protectant.
    5. File Symbol: 70506-GIT. Docket ID number: EPA-HQ-OPP-2021-0225.
Applicant: UPL NA Inc., 630 Freedom Business Center, Suite 402, King of
Prussia, PA 19406. Product name: G1957aa. Active ingredients:
Biochemicals for tobacco sucker control--n--Nonanol (C9) at 16.2% and
n-Undecanol (C11) at 32.4%. Proposed use: Biochemical spray.
    6. File Symbols: 92188-R, 92188-E, 92188-G, 92188-U, 92188-L,
92188-A, and 92188-T. Docket ID number: EPA-HQ-OPP-2021-0226.
Applicant: Elemental Enzymes Ag & Turf LLC, 1685 Galt Industrial Blvd.,
St. Louis, MO 63132. Product names: Vismax Tree & Vine, Fig22-Bt
Peptide Technical, Vismax Spectrum, Vismax Row Crop, Vismax Injection,
Vismax Specialty Crop, and Vismax Seed Treatment. Active ingredient:
Biochemical plant regulator and local and systemic resistance inducer--
Fig22-Bt Peptide at 0.012% (Vismax Tree & Vine, Vismax Spectrum, and
Vismax Specialty Crop), at 70% (Fig22-Bt Peptide Technical), at 0.0020%
(Vismax Row Crop), and at 0.0048% (Vismax Injection and Vismax Seed
Treatment). Proposed use: Biochemical plant regulator and local and
systemic resistance inducer for use on food and non-food crops and
plants, for use as a seed treatment, and for manufacturing.
    7. File Symbols: 94218-R and 94218-E. Docket ID number: EPA-HQ-OPP-
2021-0219. Applicant: Biofungitek, S.L., c/o Compliance Services
International, 7501 Bridgeport Way West, Lakewood, WA 94899. Product
names: (0178) Thyme Oil, Red and NSTKI-014. Active ingredient:
Biochemical fungicide--Thyme Oil at 100% (0178) Thyme Oil, Red) and
1.75% (NSTKI-014). Proposed use: Biochemical fungicide for use on
agricultural crops, turf, and ornamentals.
    8. File Symbol: 95220-E. Docket ID number: EPA-HQ-OPP-2021-0211.
Applicant: Ag Chem Resources, LLC, 10120 Dutch Iris Dr., Bakersfield,
CA 93311. Product name: AgChem1-EP1. Active ingredient: Nematicide--
Extract of Caesalpinia spinosa at 99.1%. Proposed use: For use in or on
raw agricultural products and food products.
    9. File Symbol: 95220-R. Docket ID number: EPA-HQ-OPP-2021-0211.
Applicant: Ag Chem Resources, LLC, 10120 Dutch Iris Dr., Bakersfield,
CA 93311. Product name: AgChem1. Active ingredient: Nematicide--Extract
of Caesalpinia spinosa at 99.1%. Proposed use: For manufacturing use.

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

    Dated: April 8, 2021.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2021-08256 Filed 4-20-21; 8:45 am]
BILLING CODE 6560-50-P


Appendix C  Occupational Post Application Risks of MCPB Exposures Chemical: MCPB Reason: Short/ Intermediate Term Exposure Assessor: TD Date 06/ 30/ 2005 Crops Applicable TC Groups Spreadsheet Number Peas Field Row/ Low Medium C1 DFR Data Defaults:

Initial Percent of Rate as DFR (%): 20 Dissipation Rate per day (%): 10 Toxicology & Exposure Factor Inputs:

Uncertainty Factor: 100 NOAEL ( mg/ kg/ day): 100 Source of NOAEL: Dermal Tox Study Adult Exposure Duration ( hrs/ day): 8 Adult Body Weight ( kg): 70 Dermal Abs. (%): N/ A Appendix C  Occupational Post Application Risks of MCPB Exposures Spreadsheet C1 Chemical: MCPB Reason: Short/ Intermediate Term Exposure Transfer Coefficient Group: Field/ row crop, low/ medium Specific Crop( s) Considered: Peas Application Rate of Crop ( lb ai/ A): 1.5 Application Rate Source: Max Label Rate DFR Data Summary Data Source ( enter 1 if data available, 0 if defaults): 0 Source: N/ A Slope of Semilog Regression: N/ A [ Initial] ( ug/ cm2): N/ A Study Application Rate ( lb ai/ A): N/ A Limit of Quantification ( ug/ cm2): N/ A Exposure Inputs Summary Exposure Potential Transfer Coefficients ( cm2/ hour) Activities Used For RA Range Very Low N/ A N/ A N/ A Low 100 TBD Irrigation, scouting, thinning, weeding immature/ low foliage plants Medium 1500 486 to 2760 Irrigation, scouting, weeding mature/ high foliage plants Label Recommendations: Do not apply later than 3 nodes before pea flowering or after pea flower buds appear.

DAT DFR LEVELS DOSE MOES ( ug/ cm2) ( mg/ kg/ day)

Default Adjusted For Rate Low Exposure Medium Exposure Low Medium 0 3.366 N/ A 0.0385 0.5770 2600 173


[Federal Register Volume 84, Number 92 (Monday, May 13, 2019)]
[Notices]
[Pages 20878-20879]
[FR Doc No: 2019-09715]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-220-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on April 24, 2019, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221, filed in Docket No. CP19-220-000, a Prior Notice Request
pursuant to sections 157.205, 157.208, 157.210, and 157.216 of the
Commission's regulations under the Natural Gas Act (NGA), and National
Fuel's blanket certificate issued in Docket No. CP83-4-000, requesting
authorization to abandon and replace 9.6 miles of 12-inch-diameter bare
steel pipeline (Line FM100) and construct certain related natural gas
facilities located in Jefferson and Elk Counties, Pennsylvania, as part
of its Brockway Modernization Project. National Fuel states the
proposed replacement is part of a multi-year modernization program to
enhance the reliability and safety of its system, all as more fully
described in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this prior notice should be directed to
Jeffrey B. Same, Attorney, National Fuel Gas Supply Corporation, 6363
Main Street, Williamsville, New York 14221-5887, by telephone at (716)
857-7507, or by email at<EMAIL_ADDRESS>    Specifically, National Fuel proposes that the replacement project
will include: (i) The installation of approximately 9.7 miles of 12-
inch-diameter coated steel pipeline; (ii) the

installation of approximately 0.4 miles of 6-inch-diameter pipeline
lateral; (iii) the installation of a remote controlled mainline block
valve; (iv) the installation of a new pig launcher/receiver; and (v)
modifications to an existing metering station. National Fuel plans to
begin construction commencing in summer 2019 and anticipates the
facilities will be placed in-service by December 2019. National Fuel
estimates the cost of the Brockway Modernization Project to be $24.2
million.
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: May 6, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-09715 Filed 5-10-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30528-30529]
[FR Doc No: 2015-12865]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2015-29]

Petition for Exemption; Summary of Petition Received

June 12, 2015
AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATE: Comments on this petition must identify the petition docket
number and must be received on or before June 17, 2015.

ADDRESSES: You may send comments identified by Docket Number FAA-2015-
1081 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building

Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Alphonso Pendergrass<PHONE_NUMBER>.
This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 22, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-1081.
    Petitioner: Mr. Michael Young, SimCom Training Centers.
    Section of 14 CFR Affected: Sec.  91, SFAR No. 108, 5.(4), (b),
(3)(iii).
    Description of Relief Sought: On behalf of SimCom Training Centers,
Mr. Michael Young petitions the FAA for an exemption from 14 CFR 91,
SFAR No. 108, Sec. Sec.  5(a)(4) and 5(b)(3)(ii) to allow candidate
instructor pilots not qualified in the Mitsubishi MU-2B to become
simulator only instructor pilots without meeting the pilot-in-command
experience requirements of Sec.  91, SFAR No. 108.
[FR Doc. 2015-12865 Filed 5-27-15; 8:45 am]
 BILLING CODE 4910-13-P


                        Analysis of Demographic Factors
                         For Populations Living Near
                   Steel Plants Using Electric Arc Furnaces

                                 Prepared by:

                             SC&A Incorporated

                         1414 Raleigh Road, Suite 450
                            Chapel Hill, NC  27517

                           GSA BPA No. 68HERD21A0003
                         Task Order No. 68HERH22F0003

                                 Prepared for:

                          Air Toxics Assessment Group
                   Health and Environmental Impacts Division
                 Office of Air Quality Planning and Standards
                     U.S. Environmental Protection Agency
                 Research Triangle Park, North Carolina 27711

                                 June 21, 2023
	Disclaimer

            Although the analysis described in this document has been funded wholly or in part by the United States Environmental Protection Agency under GSA contract 47QRAA20D002W / BPA 68HERD21A0003 to SC&A Incorporated, it has not been subject to the Agency's review and therefore does not necessarily reflect the views of the Agency, and no official endorsement should be inferred.
                                   Contents

1.	Introduction	1
2.	Census Data	2
3.	Calculation Methods	3
3.1	Race, Ethnicity and Age Categories	3
3.2	Level of Education	4
3.3	Poverty Level	4
3.4	Linguistic Isolation	5
3.5	Defaults	5
4.	Results	6
5.	Uncertainty Discussion	8
Appendix: Analyzed Facilities	9

 Introduction
	This document provides summary results and describes the approach used to evaluate the different socio-economic demographic groups within the population living near Electric Arc Furnace (EAF) Steel Plants in the United States (U.S.). The demographic analysis is for 88 facilities identified by the U.S. Environmental Protection Agency (EPA) as producing carbon, alloy or specialty steels using electric arc furnaces. The current analysis evaluates census blocks surrounding these facilities with census-based demographic data. This analysis presents the demographic composition of the population located within close proximity at 5 kilometers (km) and within 50 km of these EAF Steel Plants. The following demographic groups were included in this proximity analysis:

 Total population;
 White;
 People of Color;
 African American (or Black);
 Native Americans;
 Other races and multiracial;
 Hispanic or Latino;
 Children 17 years of age and under;
 Adults 18 to 64 years of age;
 Adults 65 years of age and over;
 Adults 25 years of age and older without a high school diploma;
 People living below the poverty level; and
 Linguistically isolated people.

	The current analysis used the Proximity Tool to (1) identify all census blocks with centroids located within specified radii of the latitude/longitude location of each facility, and then (2) link each block with census-based demographic data. It should be noted that, if the centroid of a census block is located within the specified radius, the entire population of that census block is counted as within the radius. In addition to facility-specific demographics, the Proximity Tool also computes the demographic composition of the populations within the specified radii for all facilities as a whole (e.g., source category-wide). The source category-wide computation takes into account neighboring facilities with overlapping study areas and ensures populations in common are counted only once in this demographic analysis. Finally, this analysis compares these source category-wide demographics at each specified radius (i.e., 5 km, 50 km) to the demographic composition of the nationwide population.

	The census data used in this analysis is described in Section 2. The algorithms used to compute the population of each demographic category surrounding the facility are presented in Section 3. The summary results of this analysis are presented in Section 4. The Appendix points to a supplemental workbook of spreadsheets containing the detailed facility-specific results.
 Census Data
	The total population within a specified radius around each facility is the sum of the population for every census block within that radius, based on each block's population provided by the 2010 Decennial Census. For the demographic analysis, statistics on total population, race, ethnicity, age, education level, poverty status and linguistic isolation are obtained from the Census' American Community Survey (ACS) 5-year averages for 2015-2019. These data are provided at the block group level. A census block group contains about 28 blocks on average, or about 1,400 people. Table 1 summarizes the census data used in the analysis, showing the source of each dataset and the level of geographic resolution.

             Table 1.  Summary of Census Data used for Different
                              Demographic Groups
Type of population category
Source of data
Level of geographic resolution
Total population (sum of block counts within radius)
2010 Census3 SF1
Census block
Total population (sum of block group counts, used for demographic percentages)
ACS4 Table B03002 (e1)
Census block group

Race/ethnicity categories (percentages):

 White (non-hispanic):
 People of Color (non-white + hispanic)
 African American (non-hispanic):
 Native American (non-hispanic):
 Other & Mixed race (non-hispanic):
 Hispanic (all races):
ACS Table B03002, Hispanic or Latino Origin by Race (Tiger table X03):
 e3/e1
 (e1-e3)/e1
 e4/e1
 e5/e1
 (e6+e7+e8+e9)/e1
 e12/e1
Census block group
Age groups
ACS Table B01001, Sex by Age (Tiger table X01)
Census block group
Level of education  -  percentage of adults 25 years and older without a high school diploma
ACS Table B15002, Sex by Educational Attainment (Tiger table X15)
Census block group
Individuals living in households earning below the poverty level (percentage of individuals)
ACS Table C17002, Ratio of Income to Poverty Level (Tiger table X17): (e2+e3)/e1
Census block group
Individuals living in linguistically isolated households (percentage of households)
ACS Table C16002, Household Language by Household (Tiger table X16): (e4+e7+e10+e13)/e1
Census block group
      The statistics for race/ethnicity, age groups, educational attainment, poverty, and linguistic isolation are consistent with the demographic statistics used in EPA's EJSCREEN tool for Environmental Justice analysis. We derive our demographic statistics from the ACS, which is the source of data for EJSCREEN's statistics. For the current analysis, however, we provide the impact on different racial and ethnic groups in more detail, as Table 1 illustrates.
 Calculation Methods
	The Proximity Tool uses the census block and census block group identification codes to link each block to the appropriate ACS block group demographic statistics. This allows us to estimate the number of people in different demographic categories for each census block in a specified radius around each facility. As noted in Section 2, demographic data is available at the census block group level. To estimate more detailed block level demographic percentages for the purposes of this analysis, the demographic characteristics of a given block group  -  that is, the percentage of people in different races/ethnicities, the percentage in different age groups, the percentage without a high school diploma, the percentage that are below the poverty level, and the percentage that are linguistically isolated  -  are presumed to also describe each census block located within that block group.

	For comparison, the nationwide demographic percentages are computed from the Census' ACS 5-year averages for 2015-2019 ("2019 ACS"). The denominator for these percentages uses the total nationwide population, which is likewise computed from the 2019 ACS and determined by summing the total population of all census block groups. We also provide the total population based on the 2010 Decennial Census for comparison, because the census block populations are based on 2010 Decennial Census data, as noted in Section 2.

	Sections 3.1 through 3.4 describe calculation methods for racial, ethnic, age, education status, poverty status, and linguistic isolation demographic categories. Section 3.5 describes the gap-filling approach used when block group statistics are not available for a given block, based on computing default averages for the missing demographic(s) at the tract or county level.
    Race, Ethnicity and Age Categories

	Table B03002 (Hispanic or Latino origin by race) of the ACS data provides race/ethnicity statistics for each census block group nationwide. Table B01001 provides age statistics for the population by ranges (in years) for each census block group nationwide. For each census block in this analysis, the race/ethnicity (White, African American, Native American, Multiracial/Other, and Hispanic or Latino) and age range (0-17, 18-64 and >=65 years) for that block is estimated based on the demographic information provided at the block group level, as follows:

		N(s,b/bg) =  N(t,b/bg) x P(s,bg) ∕ 100
where:

	N(s,b/bg) =	number of people in racial/ethnic or age subgroup "s", in block "b" of block group "bg"
	N(t,b/bg) =	total number of people in block "b" of block group "bg"
	P(s,bg) =	percentage of people in racial/ethnic or age subgroup "s", in a block group "bg"

The number of people in each racial/ethnic and age category is calculated using the above equation, summed over all blocks that fall within the specified radius of each facility.
    Level of Education

	Table B15002 (educational attainment) of the ACS provides education attainment statistics for each census block group nationwide. For each census block in this analysis, the number of people 25-years and older without a high school diploma is estimated based on the demographic information provided at the block group level, as follows:

		N(nhs,b/bg) =  N(t,b/bg) x P(nhs,bg) ∕ 100
where:

	N(nhs,b/bg) =	number of people 25-years and older without a high school diploma "nhs", in block "b" of block group "bg"
	N(t,b/bg) =	number of people 25-years and older in block "b" of block group "bg"
	P(nhs,bg) =	percentage of people 25-years and older without a high school diploma "nhs", in a block group "bg"

The number of people 25-years and older without a high school diploma is calculated using the above equation, summed over all blocks that fall within the specified radius of each facility.
3.3	Poverty Level

	Table C17002 (poverty) of the ACS estimates the numbers of individuals within a Census block group who live in households where the household income is below the poverty line, and below various multiples of the poverty line. For this analysis, we calculate the fraction of individuals living in households earning incomes below the poverty level. For each census block in this analysis, the block's household income level is estimated based on the demographic information provided at the block group level, as follows:

	N(hi,b/bg) =  N(t,b/bg) x P(hi,bg) ∕ 100

where "hi" indicates household income below the poverty level, and:

	N(hi,b/bg) = 	number of people living in households "hi" below the poverty level, in block "b" of block group "bg"
	N(t,b/bg) =	total number of people in block "b" of block group "bg"
	P(hi,bg) =	percentage of people living in households "hi" below the poverty level, among the population for which poverty status is known, in block group "bg"

The number of people living in households earning below the poverty level is calculated using the above equation, summed over all blocks that fall within the specified radius of each facility.
3.4	Linguistic Isolation

      Linguistic Isolation is defined by in the ACS as "a household in which all members age 14 years and over speak a non-English language and also speak English less than "very well" (have difficulty with English)." Table C16002 (Tiger table X16_language_spoken_at_home) of the ACS provides the number of households in linguistic isolation in each block group. For each census block in this analysis, the number of people living in linguistic isolation is estimated based on the demographic information provided at the block group level, as follows:

		N(li,b/bg) =  N(t,b/bg) x P(li,bg) ∕ 100
where:

	N(li,b/bg) =	number of people living in linguistic isolation "li", in block "b" of block group "bg"
	N(t,b/bg) =	total number of people in block "b" of block group "bg"
	P(li,bg) =	percentage of linguistically isolated households "li", in block group "bg"

The number of people living in linguistic isolation is calculated using the above equation, summed over all blocks that fall within the specified radius of each facility.
 	Defaults

      Block and block group designations used in the Census may be modified to accommodate population growth in some regions. As a result, certain blocks which are based on the last Decennial Census, may not map to the block group designations used in the latest 5-year ACS survey. In addition, some statistics may not be reported in the ACS for every block group. Race, ethnicity, and age statistics are generally reported for all block groups. However, poverty, linguistic isolation, and educational attainment statistics are not available for some block groups.

      In these cases, we compute default estimates for the missing demographic statistics based on the average statistics for the tract in which the block is located. If no tract-level data are available, demographic statistics are estimated based on the overall demography of the county in which the unmatched block is located. This gap-filling exercise is performed separately for each type of demographic data. That is, in the case where some categories of data are available (for instance, race, age and ethnicity) and others are not available (educational attainment, poverty, or linguistic isolation) we only compute defaults for the categories of data that are missing.

      The tract level defaults are computed using weighted averages based on all of the other block groups in the tract for which data are available. Defaults are calculated as follows for race, ethnicity, and age subgroups:

		P(s,T) =  { ∑ P(s,bg/T) x N(t,bg) } ∕ {∑ N(t,bg)}
where:
	P(s,T) =	percentage of people in race, ethnicity, or age subgroup "s", in tract "T"
	∑	refers to the summation over all block groups in tract "T" for which data are available
	P(s,bg/T) =	percentage of people in race, ethnicity, or age subgroup "s", in a block group "bg" of tract "T"
	N(t,bg) =	total number of people in block group "bg"

Defaults for educational attainment, poverty, and linguistic isolation are calculated in a similar fashion, except that the population weighting term N is replaced by the population over age 25, the population for which poverty status is known, and the number of households, respectively. County level defaults are also calculated in a similar way, except that data are summed over the county instead of the tract.

      Results
	The proximity results describe the demographics of the population surrounding these EAF Steel Plants. Table 2 presents the demographic composition of the population located within a close proximity of 5 km and within 50 km of these 88 facilities as a whole (source category). For context, Table 2 also provides the nationwide percentages of these various demographic groups. The detailed facility-specific results underpinning these source category-wide results are noted in the Appendix.

	The proximity results presented in Table 2 indicate that the population percentages for certain demographic groups within 5 km of the EAF Steel Plants are greater than the corresponding nationwide percentages for those same demographics. The demographic percentage for populations residing within 5 km of facility operations is 5 percentage points greater than its corresponding nationwide percentage for the African American population (17% within 5 km of the facilities compared to 12% nationwide), 4 percentage points greater than its corresponding nationwide percentage for the population below the poverty level (17% within 5 km of the facilities compared to 13% nationwide), and 3 percentage points greater than its corresponding nationwide percentage for the population aged 18 to 64 years (65% within 5 km of the facilities compared to 62% nationwide). The remaining demographic groups within 5 km of facility operations are less than or within 1 percentage point of the corresponding nationwide percentages.

      In addition, the proximity results presented in Table 2 indicate that the population percentage for one demographic group within 50 km of the EAF Steel Plants is greater than the corresponding nationwide percentages for that same demographic. The demographic percentage for populations residing within 50 km of facility operations is 3 percentage points greater than its corresponding nationwide percentage for the African American population (15% within 50 km of the facilities compared to 12% nationwide). The remaining demographic groups within 50 km of facility operations are less than or within 1 percentage point of the corresponding nationwide percentages.

Table 2.  Summary of Demographic Assessment for Steel Plants using Electric Arc Furnaces: Proximity Statistics

                               Population Basis
                             Demographic Group[1]

                                     Total
                              People of Color[2]
                               African
American
                               Native
American
                             Other and
Multiracial
                             Hispanic
or Latino[3]
                                 Ages 0
to 17
                                Ages 18
to 64
                                Ages 65
and up
                         Over 25 Without a HS Diploma
                            Below the Poverty Level

                            Linguistic Isolation[4]
Nationwide Demographics    (2015-2019 ACS)
                                 328,016,242
                                      40%
                                      12%
                                     0.7%
                                      8%
                                      19%
                                      22%
                                      62%
                                      16%
                                      12%
                                      13%
                                      5%
Nationwide Block Counts
(2010 Decennial Census)[5]
                                  312,459,649

                                 Proximity[6]
                   Population Surrounding the 88 Facilities
                                 Steel Plants
                                     50 km
                                  71,578,468
                                      38%
                                      15%
                                     0.3%
                                      8%
                                      15%
                                      22%
                                      62%
                                      16%
                                      11%
                                      13%
                                      5%
                                 Steel Plants
                                     5 km
                                   2,781,665
                                      37%
                                      17%
                                     0.3%
                                      7%
                                      14%
                                      20%
                                      65%
                                      15%
                                      11%
                                      17%
                                      4%
Notes:
[1] The demographic percentages are based on the Census' 2015-2019 American Community Survey five-year averages, at the block group level, and include the 50 states, the District of Columbia, and Puerto Rico. Demographic percentages based on different averages may differ. The total population of each facility and of the entire run group are based on block level data from the 2010 Decennial Census. Populations by demographic group for each facility and for the run group are determined by multiplying each 2010 Decennial block population within the indicated radius by the ACS demographic percentages describing the block group containing each block, and then summing over the appropriate area (facility-specific or run group-wide).
[2] The People of Color population is the total population minus the white population.
3 To avoid double counting, the "Hispanic or Latino" category is treated as a distinct demographic category for these analyses. A person is identified as one of five racial/ethnic categories above: White, African American, Native American, Other and Multiracial, or Hispanic/Latino. A person who identifies as Hispanic or Latino is counted as Hispanic/Latino for this analysis, regardless of what race this person may have also identified as in the Census.
[4] The linguistically isolated population is estimated at the block group level by taking the product of the block group population and the fraction of linguistically isolated households in the block group, assuming that the number of individuals per household is the same for linguistically isolated households as for the general population, and summed over all block groups.
[5] The nationwide 2010 Decennial Census population of 312,459,649 is the summation of all Census block populations within the 50 states, the District of Columbia, and Puerto Rico. Block level population used by the Proximity Tool will be updated based on the 2020 Decennial Census, once processed and quality-assured for these analyses.
6 The population tally and demographic analysis of the total population surrounding all facilities as a whole takes into account neighboring facilities with overlapping study areas and ensures populations in common are counted only once.

 Uncertainty Discussion

	Our analysis of the distribution of population across various demographic groups is subject to the typical uncertainties associated with census data (e.g., errors in filling out and transcribing census forms), which are generally thought to be small, as well as the additional uncertainties associated with the extrapolation of census block group data down to the census block level.

	The methodology for our demographic analyses applies demographic data from the Census American Community Survey (ACS). While this is our best attempt to provide useful information now, our thinking is continuously advancing. The EPA has developed technical guidance for environmental justice analyses. We present these analyses, with their associated uncertainties, to EPA decision makers and the public as additional analyses to inform Risk and Technology Review decisions.

Appendix: Analyzed Facilities

A workbook of spreadsheets containing the detailed facility-specific results underpinning the source category-wide results are provided in the file entitled "Steel EAF Facility-Specific Demographic Results 2023-06-21.xlsx". The size of the dataset covering these 88 facilities at both 5 km and 50 km makes the data more amenable to Excel(R) spreadsheets, than a Word(R) document.