[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Rules and Regulations]
[Pages 31722-31728]
[FR Doc No: 2017-14085]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0595; FRL-9962-06]

Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
buprofezin in or on rice grain. Nichino America, Inc. requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2017. Objections and
requests for hearings must be received on or before September 8, 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-2016-0595, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>,

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

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0595 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
September 8, 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-2016-0595, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 9, 2016 (81 FR 89036) (FRL-
9953-69), 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
6E8494) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE, 19808. The petition requested that 40 CFR 180.511 be
amended by establishing a tolerance for residues of the insecticide
buprofezin in or on rice at 0.3 parts per million (ppm). That document
referenced a summary of the petition prepared by Nichino America, Inc.,
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established. The
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin 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 primary organs of buprofezin toxicity are the liver and the
thyroid. In subchronic toxicity studies in rats increased microscopic
lesions in liver and thyroid, increased liver weights, and increased
thyroid weight in males were seen. In chronic studies in the rat, an
increased incidence of follicular cell hyperplasia and hypertrophy in
the thyroid of males were reported. In chronic studies in the dog,
increased relative liver weights were reported in females. Effects
observed in a 24-day dermal toxicity study in rats included
inflammatory infiltrate of the liver and an increase in acanthosis and
hyperkeratosis of the skin in females.
    The developmental toxicity study in the rat showed reduced
ossification and reduced pup weight at maternally toxic doses (death,
decreased pregnancy rates,

increased resorption rates). No developmental toxicity was observed in
the rabbit at or below maternally toxic dose levels. The reproductive
toxicity study showed decreased pup body weights at dose levels where
liver effects (increased relative and/or absolute liver weights) and
decreased body weight gains were observed in the parental generations.
However, in a comparative thyroid toxicity assay, pup toxicity
(decreased pup body weight during early lactation and increased TSH
levels) occurred at a dose that was not maternally toxic. Maternal
toxicity resulted in increased serum TSH concentration, decreased serum
T4 levels in pregnant rats and histopathological findings in the
thyroid (increased follicular cell height and follicular cell
hypertrophy). In this same study, fetal and maternal toxicity occurred
at the same dose. Fetal toxicity was expressed as increased thyroid
weight in males and increased TSH levels in males and females. No
neurotoxic effects were observed in a subchronic neurotoxicity study in
rats at the highest dietary dose tested of 5,000 ppm. There was no
evidence of neurotoxicity or immunotoxicity in the submitted studies.
    EPA has classified buprofezin into the category of ``Suggestive
Evidence of Carcinogenicity, but not sufficient to assess human
carcinogenic potential'' based on liver tumors in female mice only.
Buprofezin was negative in in vitro and in vivo genotoxicity assays.
The Agency noted findings from the published literature indicate that
buprofezin causes cell transformation and induces micronuclei in vitro,
but determined that, in the absence of a positive response in an in
vivo micronucleus assay, buprofezin may have aneugenic potential which
is not expressed in vivo. The Agency has determined that the cPAD is
protective for carcinogenic effects.
    Specific information on the studies received and the nature of the
adverse effects caused by buprofezin 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 ``Buprofezin: Human Health
Risk Assessment for Proposed New Tolerance with No U.S. Registration
in/on Imported Rice Grain'' on page 29 in docket ID number EPA-HQ-OPP-
2016-0595.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for buprofezin used for
human risk assessment is shown in Table 1 of this unit.

                 Table 1--Summary of Toxicological Doses and Endpoints for Buprofezin for Use in
                                          Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  An acute RfD for the general population or any population subgroups (other
 including infants and children).   than females 13-50 years of age) was not selected because no effect
                                    attributable to a single (or few) day(s) oral exposure was observed in
                                    animal studies.
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Acute dietary (Females 13-50       NOAEL = 200 mg/kg/    Acute RfD = 2.0 mg/  Developmental Toxicity Study--Rat.
 years of age).                     day.                  kg/day.             Developmental LOAEL = 800 mg/kg/
                                   UFA = 10x...........  aPAD = 2.0 mg/kg/     day based on reduced ossification
                                   UFH = 10x...........   day.                 & decreased body weight in
                                   FQPA SF = 1x........                        offspring.
                                                                              Maternal LOAEL = 800 mg/kg/day
                                                                               based on mortality, decreased
                                                                               food consumption, weight loss,
                                                                               clinical signs, decreased
                                                                               pregnancy rates and increased
                                                                               resorption rates.
Chronic dietary (All populations)  LOAEL= 10 mg/kg/day.  Chronic RfD = 0.033  Comparative Thyroid Toxicity Study-
                                   UFA = 3x............   mg/kg/day.           rats.
                                   UFH = 10x...........  cPAD = 0.033 mg/kg/  Offspring LOAEL = 10.0 mg/kg/day
                                   UFL = 10x...........   day.                 based on significantly decreased
                                   FQPA SF = 1x........                        pup body weight ([darr]8-13% in
                                                                               males during LD 4-10 and [darr]8-
                                                                               9% in females during LD 4-7)
                                                                               compared to controls and
                                                                               increased TSH levels on LD 4 and
                                                                               LD 21 ([uarr]23-34% in males).
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Cancer (Oral, dermal, inhalation)  Possible human carcinogen. (No Q1*). The cRfD is considered protective of the
                                    cancer effects.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to buprofezin, EPA considered exposure under the petitioned-
for tolerances as well as all existing buprofezin tolerances in 40 CFR
180.511. EPA assessed dietary exposures from buprofezin 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 buprofezin.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA
assumed 100 percent crop treated (PCT) for all commodities. Total
residues of concern in crop commodities (i.e., buprofezin and the BF4
Conjugate which is not detectable by data collection methods but which
may be estimated from metabolism data) were based on tolerance level
residues of buprofezin and available metabolism/magnitude of the data
to estimate other residues of concern. Given the potential for BF9 and
BF12 to concentrate to a greater degree than buprofezin in processed
commodities, Dietary Exposure Evaluation Model (DEEM) default
processing factors were retained for all commodities, except for tomato
paste and puree, which were reduced based on empirical data. Based on
the submitted lemon metabolism data, which indicated that residues of
concern are primarily found in/on the peel, the maximum theoretical
concentration factor for peel was used to estimate residues of concern
in citrus peel. Total residues of concern in meat (i.e., buprofezin and
BF2) and milk (i.e., buprofezin and BF23) were based on the feeding
study data which were used to establish meat and milk tolerances. Based
on the submitted data, which indicated a 5x concentration of residues
into milk cream and fat and a Log Kow of 4.31, a default 25x
concentration factor was applied for milk fat.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). A partially refined chronic dietary analysis was
conducted using the same residue estimates used for the acute dietary
analysis and average percent crop treated estimates when available.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to buprofezin. Cancer risk was assessed using
the same exposure estimates as discussed in Unit III.C.1.ii., chronic
exposure.
    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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    The acute dietary exposure analyses assumed 100 PCT. Average PCT
was used for the following crops for refinement of the chronic
analyses: almond 1%, apple 2.5%, apricot 10%, broccoli 5%, Brussels
sprout 2.5%, cabbage 5%, cantaloupe 5%, cauliflower 10%, cherry 2.5%,
cotton 1%, grapefruit 5%, grape 5%, lemon 2.5%, lettuce 10%, nectarine
5%, olive 2.5%, orange 2.5%, peach 5%, pear 10%, pepper 2.5%, pistachio
10%, plum/prune 5%, pomegranate 15%, pumpkin 1%, spinach 1%, squash 1%,
strawberry 15%, tomato 1%, walnut 1%, and watermelon 2.5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis.
    Average percent of crop treated--Values are calculated by merging
data sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5. Note: If the estimated value is
less than 2.5, then the value is labeled <2.5. If the estimated value
is less than 1, then the value is labeled <1.
    Maximum percent of crop treated--Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5. Note: If the estimated value is less than 2.5,
then the value is labeled <2.5.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for buprofezin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of buprofezin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model version 5 and Variable
Volume Water Model (PRZM5/VVWM) and Pesticide Root Zone Model Ground
Water (PRZM GW) model, the estimated drinking water concentrations
(EDWCs) of buprofezin for acute exposures are estimated to be 78.8
parts per billion (ppb) for surface water and for chronic

exposures are estimated to be 19 ppb for surface water. There was no
breakthrough of buprofezin into ground water during a 100-year
simulation using the PRZM-GW model. Buprofezin, therefore, is not
expected to be detected in shallow ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 78.8 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 19 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Buprofezin is not
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.''
    EPA has not found buprofezin to share a common mechanism of
toxicity with any other substances, and buprofezin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
buprofezin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity
studies in rats and rabbits and the reproduction studies in rats
provided no indication of increased susceptibility of rats or rabbits
following in utero exposure or of rats following pre/postnatal exposure
to buprofezin. However, the comparative thyroid toxicity study
demonstrated offspring susceptibility, but not fetal susceptibility to
buprofezin oral (gavage) administration. The point of departure (POD)
for risk assessment is derived from this study and is based on the most
sensitive endpoint of concern. Previous risk assessments imposed a
database uncertainty factor of 10X for a lack of a comparative thyroid
toxicity study. With the submission of an acceptable comparative
thyroid study, and lack of susceptibility in the developmental and
reproduction studies, the FQPA factor is now reduced to 1x.
    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 buprofezin is complete.
    ii. Thyroid toxicity was seen following subchronic and chronic
exposures to rats as well as chronic exposures to dogs characterized by
decreases in serum thyroxine levels and increased thyroid weights in
dogs and histopathological lesions in in rats. Disruption of thyroid
homeostasis is the initial, critical effect that may lead to adverse
effects on the developing nervous system.
    Normally, if a neurodevelopmental concern is raised by existing
data on a pesticide, a rat developmental neurotoxicity (DNT) study is
requested. However, a DNT study is not required for buprofezin since
this study would not address thyroid toxicity concerns. Thus, in lieu
of the rat DNT study, a special study evaluating the hormonal responses
associated with the developing fetal nervous system was required and
has since been conducted and submitted to the Agency. This study
demonstrated offspring susceptibility, but not fetal susceptibility to
buprofezin oral (gavage) administration.
    Based on the lack of any neurotoxic effects in a subchronic
neurotoxicity study at doses as high as 5,000 ppm and the absence of
neurotoxicity in subchronic and chronic tests, an acute neurotoxicity
study was waived.
    iii. Developmental toxicity studies in rats and rabbits and the
reproduction studies in rats provided no indication of increased
susceptibility of rats or rabbits following in utero exposure or of
rats following pre/postnatal exposure to buprofezin. However, the
comparative thyroid toxicity study demonstrated offspring
susceptibility, but not fetal susceptibility to buprofezin oral
(gavage) administration. The chronic point of departure (POD) for risk
assessment is derived from this study and is based on the most
sensitive endpoint of concern.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment uses conservative
assumptions which result in protective estimates of dietary exposure.
The dietary drinking water assessment uses values generated by model
and associated modeling parameters which are designed to provide
protective, high-end estimates of water concentrations. These
assessments will not underestimate the exposure and risks posed by
buprofezin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
buprofezin will occupy 4.8% of the aPAD for females 13-49 years old,
the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
buprofezin from food and water will utilize 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for buprofezin.

    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, buprofezin
is not 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- or intermediate-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 buprofezin.
    4. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to buprofezin. Therefore, based on the results of the chronic
risk assessment discussed in Unit III.E.2., buprofezin 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 buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available in PAM I and PAM II for
enforcement of buprofezin tolerances, including GC methods with
nitrogen phosphorus detection (GC/NPD), and a GC/mass spectrometry (MS)
method for confirmation of buprofezin residues in plant commodities.

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 a MRL for buprofezin in or on rice
grain.

C. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance in/on rice, grain has been revised
from 0.3 ppm to 1.5 ppm. The proposed tolerance level (0.3 ppm) is
actually for the processed rice commodity, hulled rice grain (i.e.,
brown rice), and not for the recognized rice raw agricultural commodity
(RAC), unhulled/whole rice grain. The recommended tolerance (1.5 ppm)
in/on rice, grain (i.e., unhulled/whole rice grain) will cover residues
in/on hulled rice grain (i.e., brown rice) treated at the maximum
proposed use rate.

V. Conclusion

    Therefore, a tolerance is established for residues of buprofezin in
or on rice, grain at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 18, 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.  180.511, add alphabetically the commodity ``Rice, grain''
to the table in paragraph (a); redesignate footnote 1 to the table as
footnote 2; and add a new footnote 1 to the table to read as follows:

Sec.  180.511  Buprofezin; tolerances for residues.

    (a) * * *

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

                                * * * * *
Rice, grain \1\............................................          1.5

                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 10, 2017 for use on rice.

* * * * *
[FR Doc. 2017-14085 Filed 7-7-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]
[Page 45411-45415]
[DOCID:fr09au06-20]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0251; FRL-8082-2]

Inert Ingredient; Revocation of the Tetrahydrofurfuryl Alcohol
(THFA) Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic
Act (FFDCA) section 408(e)(1), the existing exemption from the
requirement of a tolerance for residues of the inert ingredient
``Tetrahydrofurfuryl alcohol'' (THFA) under 40 CFR 180.910, and
establishes a limited tolerance for THFA under 40 CFR 180.1263. The
regulatory action contributes toward the Agency's tolerance
reassessment requirements under FFDCA section 408(q), as amended by the
Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by
August 2006 to reassess the tolerances that were in existence on August
2, 1996. This regulatory action counts as a tolerance reassessment
toward the August 2006 review deadline.

DATES: This rule is effective February 9, 2008.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0251. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ''Federal Register'' document

electronically through the EPA Internet under the ''Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0251 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 10, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0251, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P),

Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    On April 12, 2006, EPA published in the Federal Register (71 FR
18689; FRL-7771-3) proposed actions for the inert ingredient
tetrahydrofurfuryl alcohol (THFA). This final rule revokes the
exemption from the requirement of a tolerance for THFA under 40 CFR
180.910 and establishes a limited tolerance exemption for THFA under 40
CFR 180.1263. In evaluating THFA, EPA determined that dietary risks of
concern may result from the use of THFA under the current tolerance
exemption in 40 CFR 180.910, which allows an unlimited amount of THFA
to be applied to growing crops and raw agricultural commodities after
harvest. The hazard characterization of THFA shows effects of concern,
including significant developmental and reproductive effects from
repeated oral exposures. The available data show there is evidence of
increased susceptibility (both quantitative and qualitative) of the
offspring after in utero exposure to THFA, including decreased fetal
body weights. The Agency concluded that THFA's unlimited tolerance
exemption under 40 CFR 180.910 does not meet the safety requirements of
FFDCA section 408(b)(2), and proposed the revocation of the tolerance
exemption 18 months after the publication of the final rule in the
Federal Register. In the same document, EPA proposed to establish a new
exemption under 40 CFR 180.1263 for applications to cotton, use with
herbicides with one application to wheat and barley prior to the pre-
boot stage, for use as a seed treatment, and applications at the time
of planting.
    EPA's responses to comments received on the proposed rule are given
in Unit II.B. EPA maintains its conclusion that THFA's tolerance
exemption under 40 CFR 180.910 does not meet the safety standard of
FFDCA section 408(b)(2), therefore, this tolerance exemption is revoked
in this final rule. The revocation will take effect 18 months after the
publication date of this final rule in the Federal Register.
     EPA has evaluated the scope of the new limited THFA tolerance
exemption under 40 CFR 180.1263 and has added limited uses on canola,
soybeans, and field corn, and has clarified that applications will now
be permitted prior to planting. EPA finds that exempting THFA with the
limitations in 40 CFR 180.1263 will be safe for the general population
including infants and children.

B. EPA's Responses to Comments

    1. Applications at the time of planting. Several commentors
requested the proposed use of THFA ``at-plant'' be expanded to include
all applications prior to planting. EPA agrees. The proposed limitation
``For application at the time of planting.'' under 40 CFR 180.1263 is
replaced with ``For applications prior to planting and at the time of
planting.'' This includes uses such as applications made in preparation
for the planting of the crop, in the furrow during planting of seeds
and transplants, and to the soil surface at the time of planting. This
small expansion of the proposed limitation is in keeping with the uses
of currently registered pesticide products containing THFA. Considering
THFA's physical-chemical properties and biodegradation potential in the
environment, the new limitation does not change EPA's safety finding
for the new 40 CFR 180.1263.
    2. Requests to expand uses, and establish application rates and
pre-harvest intervals. One commentor stated that EPA does not have to
restrict the crops that THFA can be applied to if the Agency would set
either a maximum THFA percentage limit in pesticide concentrates, or a
maximum THFA percentage limit for dilute product rates applied to food
crops. In addition, several commentors suggested the establishment of
pre-harvest intervals as a way to limit or eliminate the potential for
residues of THFA on harvested commodities.
    In determining whether uses of THFA could be maintained, the Agency
evaluated the uses of all currently registered pesticide products that
contained THFA. The products were registered for applications to a very
large number of crops and most permitted multiple applications (e.g.,
six) including on the day of harvest. For many pesticide products, the
quantity of THFA in formulation was unusually high, with more than half
containing 75 - 98 % THFA. The Agency discussed its toxicity concerns
for THFA with the registrants of these pesticide products, and the
large majority elected to reformulate their products with another
solvent. Of the pesticide products that continued to contain THFA, EPA
determined that the safety finding could be made for their uses and
crafted the limitations of the new tolerance exemption under 40 CFR
180.1263 to include only those uses. The available reliable information
on THFA's physical-chemical properties and biodegradation potential in
soil was considered in making the safety finding for the uses described
in the new exemption. The uses in the new exemption significantly
reduce the number of times that THFA may be applied per season - often
to one application only -- and, therefore, reduce the potential for
dietary exposures below the Agency's level of concern.
    EPA believes that defining the scope of a tolerance exemption for
THFA requires a cautious approach considering the significant toxicity
concerns. THFA's toxicity profile is more similar to pesticide active
ingredients or safeners than to minimal risk inert ingredients.
Therefore, certain supporting data typically required for active
ingredients and safeners may also be necessary for petitions requesting
applications of THFA to most growing food crops (especially
applications to edible parts). Considering THFA's significant
reproductive and developmental toxicity and lack of neurotoxicity data
(a sub-chronic study reported whole body spasms), EPA does not believe
it can pick a safe maximum application rate or pre-harvest interval in
the absence of the appropriate acceptable guideline studies (such as
crop residue data) normally used by EPA to set these use limitations.
Unfortunately, the Agency does not have acceptable, reliable crop
residue data that could assist in setting THFA application rates and
pre-harvest intervals.
    Several commentors requested that 40 CFR 180.1263 permit the
application of THFA to many crops, such as all cereal grains in crop
group 15. Considering the chemical's toxicity profile, EPA does not
believe it has the necessary data to broadly grant more uses of THFA
now without knowing exact application scenarios. EPA needs to evaluate
the uses of a pesticide product in order to estimate the potential for
residues of THFA and determine whether residue data may be necessary.
In the future, 40 CFR 180.1263 will be amended if the Agency receives a
petition that is supported by data and information

sufficient for the request, and the Agency determines that the safety
finding can be made for these new and/or expanded uses. EPA suggests
that parties interested in petitioning for new and/or expanded uses of
THFA first consult with the Agency to determine data needs.
    Several commentors requested 40 CFR 180.1263 include two early
season (pre-bloom) applications in herbicides on soybeans, canola, and
field corn. The Agency evaluated the requested application scenarios
for these crops and determined that the FQPA safety finding could be
made for these limited early season uses.
    3. Availability of acceptable crop residue data for THFA. All
commenters asserted that a residue study (MRID 56444) provides
sufficient data to demonstrate the rapid rate of decline of THFA
residues from treated crops, and that the results of this study support
the use of THFA on all crops. EPA disagrees that any reliable data have
been submitted to the Agency concerning residues on food resulting from
applications of pesticide products containing THFA. The study
identified by the commentors, MRID 56444, was developed by Chemagro in
1972 and submitted to EPA in 1973 by Quaker Oats Company. The three
crops used (alfalfa, Roma variety tomato, and soybeans in pod) do not
represent the broad range of crops requested by the commentors. It is
not an acceptable study for a number of reasons. MRID 56444 is an
unpublished summary of data (one page per crop) that lacks
documentation about how the study was conducted or method validation,
and does not include a discussion of the study results. The data are
considered to be of low reliability because of the low rates of
recoveries. It appears that sampling was done at 0, 4, and 24 hours
after application of THFA. The results on Roma variety tomato between
the 4 and 24 hour sampling times were contradictory and no discussion
was provided. No results for the 24th hour sample were included in the
comments submitted by Penn Specialty Chemicals, Inc. The study MRID
56444 is considered unacceptable and cannot be used to support a
tolerance or tolerance exemption for THFA.
    The Agency disagrees with the commentors who asserted that THFA is
naturally occurring, and is sufficiently volatile that it will not be
available for uptake into plants and treated crops. An acceptable plant
metabolism study that would describe the potential for plant uptake of
THFA is not available to the Agency. In addition, EPA cannot locate any
reliable information that THFA is a naturally occurring substance and
is ubiquitous in the environment, as the commentor inferred. On the
contrary, Quaker Oats stated that THFA is produced commercially by
catalytic hydrogenation of furfural or furfuryl alcohol.
    4. Use of DEEM in the THFA assessment. All commentors objected to
Agency's use of the inert ingredient screening level DEEM as a basis
for its decision to limit the uses of THFA, and they proposed
refinements that support their THFA use proposals. The Agency's
regulatory decision that the current unlimited THFA tolerance exemption
under 40 CFR 180.910 does not meet the safety requirements of FFDCA
section 408(b)(2) was based on a consideration of the significant
hazard profile of THFA rather than the result of the inert ingredient
screening level DEEM. The results of the screening level DEEM was
provided in the Public Docket for informational purposes in order to
provide some information regarding the potential for exposure from the
use of THFA on food crops under the unlimited 40 CFR 180.910 tolerance
exemption. It should be noted that while the inert ingredient DEEM
screening model is designed to be conservative, it is not conservative
enough to cover the registered uses of THFA under the 40 CFR 180.910
tolerance exemption because the quantity of THFA in the formulations of
many pesticide products was quite high, with more than half containing
75 - 98 % THFA.
    EPA disagrees with the commentors who asserted that the Agency must
refine the inert ingredient DEEM with the dissipation and decline data
they calculated from MRID 56444. The inert ingredient DEEM is used as a
screening level model only, and refinements to the screening model are
inappropriate and do not meet the standards of sound science. Residue
decline data are used in refined exposure modeling and assessments,
which were not performed for THFA because the remaining supported
registered uses included in 40 CFR 180.1263 did not need a refined
exposure assessment. Also, EPA will not consider the results of MRID
56444 in any future refined exposure modeling because the study is
unacceptable (see above).

C. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate commerce (21 U.S.C. 331(a)).
For a food-use pesticide to be sold and distributed, the pesticide must
not only have appropriate tolerances under FFDCA, but also must be
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not
registered in the United States must have tolerances in order for
commodities treated with those pesticides to be imported into the
United States.

D. When do These Actions Become Effective?

    The revocation of the tolerance exemption for THFA under 40 CFR
180.910 becomes effective 18 months after the publication date of this
final rule in the Federal Register. Any commodities listed in the
regulatory text of this document that are treated with the pesticide
chemical subject to this final rule, and that are in the channels of
trade following the tolerance exemption revocations, shall be subject
to FFDCA section 408(1)(5), as established by the FQPA. Under this
section, any residue of the pesticide chemical in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide chemical at a time and in a manner that was lawful under
FIFRA, and
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under an
exemption from tolerance. Evidence to show that food was lawfully
treated may include records that verify the dates that the pesticide
chemical was applied to such food.
    The establishment of the new tolerance exemption for THFA under 40
CFR 180.1263 becomes effective on the publication date of this final
rule in the Federal Register.

E. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances
and exemptions from tolerances that were in

existence on August 2, 1996. This document revokes one inert ingredient
tolerance exemption which is counted as a tolerance reassessment toward
the August 2006, review deadline under FFDCA section 408(q), as amended
by FQPA in 1996.

VI. Statutory and Executive Order Reviews

    In this final rule, EPA is establishing and revoking specific
tolerance exemptions established under section 408(d) of FFDCA. The
Office of Management and Budget (OMB) has exempted this type of action
from review under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this final rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether revocations of tolerances
might significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
This analysis was published on December 17, 1997 (62 FR 66020), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration. Taking into account this analysis, and available
information concerning the pesticide listed in this rule, the Agency
hereby certifies that this final action will not have a significant
economic impact on a substantial number of small entities.
Specifically, as per the 1997 notice, EPA has reviewed its available
data on imports and foreign pesticide usage and concludes that there is
a reasonable international supply of food not treated with pesticides
containing the ingredients being revoked in this notice. Furthermore,
for the pesticide named in this final rule, the Agency knows of no
extraordinary circumstances that exist as to the present revocations
that would change the EPA's previous analysis. In addition, the Agency
has determined that this action will not have a substantial direct
effect on States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive
Order 13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this final rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This final rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this final rule.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
''major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: Juky 26, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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.  180.910, the table is amended by revising the entry for
Tetrahydrofurfuryl alcohol to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
            Inert ingredients                               Limits                              Uses
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Tetrahydrofurfuryl alcohol (THFA) (CAS                    Expires February 9, 2008             Solvent/cosolvent
 Reg. No 97-99-4)
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. Section 180.1263 is added to subpart D to read as follows:

Sec.  180.1263  Tetrahydrofurfuryl alcohol; exemption from the
requirement of a tolerance.

    Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt
from the requirement of a tolerance in or on all raw agricultural
commodities when used in accordance with good agricultural practices as
an inert ingredient applied only:
    (a) For use as a seed treatment.
    (b) For applications prior to planting and at the time of planting.
    (c) For use on cotton.
    (d) For use in herbicides with one application to wheat and barley
prior to the pre-boot stage, and two applications to canola and
soybeans pre-bloom.
    (e) For use in herbicides with two applications to field corn up to
24 inches tall (V 5 stage).
[FR Doc. E6-12591 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Page 58071]
[FR Doc No: 2021-22841]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ22-1-000]

Oncor Electric Delivery Company LLC; Notice of Filing

    Take notice that on October 12, 2021, Oncor Electric Delivery
Company LLC submitted its tariff filing: Oncor TFO Tariff Rate Changes,
to be effective September 20, 2021.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    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 may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on November 2, 2021.

    Dated: October 14, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-22841 Filed 10-19-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Rules and Regulations]
[Pages 67543-67545]
[FR Doc No: 2022-24311]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0982; Project Identifier MCAI-2021-00787-T;
Amendment 39-22202; AD 2022-21-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-
1A11 airplanes. This AD was prompted by reports that the engine feed
pressure switches were installed with no secondary locking mechanism
and can become loose and cause a fuel leak. This AD requires initial
and repetitive inspections at the engine feed pressure switch locations
and installation of a flange adaptor with lockwire to terminate the
repetitive inspections, as specified in a Transport Canada Civil
Aviation (TCCA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective December 14, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 14,
2022.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0982; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building, Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
TCCA, Transport Canada National Aircraft Certification, 159 Cleopatra
Drive, Nepean, Ontario K1A 0N5, Canada; telephone<PHONE_NUMBER>; email
[email protected]; website tc.canada.ca/en/aviation.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2022-0982.

FOR FURTHER INFORMATION CONTACT: Joseph Catanzaro, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus Canada
Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The
NPRM published in the Federal Register on July 29, 2022 (87 FR 45712).
The NPRM was prompted by AD CF-2021-50, dated December 21, 2021, issued
by TCCA, which is the aviation authority for Canada (referred to after
this as the MCAI). The MCAI states that certain fuel system pressure
switches have been installed on the left-hand and right-hand wings
without a secondary locking feature (lockwire). This condition may
allow the fuel pressure switches to become loose and allow fuel to leak
in the affected areas, creating a fire hazard.
    In the NPRM, the FAA proposed to require initial and repetitive
inspections at the engine feed pressure switch locations and
installation of a flange adaptor with lockwire to terminate the
repetitive inspections, as specified in TCCA AD CF-2021-50. The FAA is
issuing this AD to address the unsafe condition on these products.

    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-0982.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    TCCA AD CF-2021-50 specifies procedures for repetitive general
visual inspections of the torque identification stripes, torquing of
the fuel pressure switches, and installation of lockwire at the two
alternating current (AC) boost pump cartridges; repetitive general
visual inspections of the torque identification stripes and torquing of
the fuel pressure switches at the two engine feed pressure switches;
and installation of a new flange adaptor and lockwire, which terminates
the repetitive inspections. This material is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 60 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
                Labor cost                    Parts cost              Cost per  product              operators
----------------------------------------------------------------------------------------------------------------
Up to 27 work-hours x $85 per hour =                  $811  Up to $2,295........................        $137,700
 $2,295.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
14 work-hours x $85 per hour = $1,190.              $0           $1,190
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2022-21-03 Airbus Canada Limited Partnership (Type Certificate
Previously Held by C Series Aircraft Limited Partnership (CSALP);
Bombardier, Inc.): Amendment 39-22202; Docket No. FAA-2022-0982;
Project Identifier MCAI-2021-00787-T.

(a) Effective Date

    This airworthiness directive (AD) is effective December 14,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership Model BD-
500-1A10 and BD-500-1A11 airplanes, certificated in any category, as
identified in Transport Canada Civil Aviation (TCCA) AD CF-2021-50,
dated December 21, 2021 (TCCA AD CF-2021-50).

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports that the engine feed pressure
switches were installed with no secondary locking mechanism and can
become loose and cause a fuel leak. The FAA is issuing this AD to
address the absence of a secondary locking feature (lockwire) on the
fuel pressure switches, which may allow them to become loose and
allow fuel to leak in the affected areas, creating a fire hazard.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, TCCA AD CF-2021-50.

(h) Exception to TCCA AD CF-2021-50

    (1) Where TCCA AD CF-2021-50 refers to hours air time, this AD
requires using flight hours.
    (2) Where TCCA AD CF-2021-50 refers to its effective date, or 14
July 2021, the effective date of TCCA AD CF-2021-21, this AD
requires using the effective date of this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or TCCA; or Airbus Canada Limited Partnership's TCCA
Design Approval Organization (DAO). If approved by the DAO, the
approval must include the DAO-authorized signature.

(j) Additional Information

    For more information about this AD, contact Joseph Catanzaro,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Transport Canada Civil Aviation (TCCA) AD CF-2021-50, dated
December 21, 2021.
    (ii) [Reserved]
    (3) For TCCA AD CF-2021-50, contact TCCA, Transport Canada
National Aircraft Certification, 159 Cleopatra Drive, Nepean,
Ontario K1A 0N5, Canada; telephone<PHONE_NUMBER>; email [email protected]; website tc.canada.ca/en/aviation.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 28, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-24311 Filed 11-8-22; 8:45 am]
BILLING CODE 4910-13-P


species. orig stage year impinged. est entrained. est notes tidewater. silverside age01 1979 68 na Table 4 10 of Document 29706 Intake tidewater. silverside pysl 1979 na 50514 Table 4 10 of Document 29706 Intake comments QC J. Hazen 7/ 19/ 2005 reassigned to laJ. Hazen 7/ 19/ 2005 Impingement and entrainment losses data for the Gould Street Station, Baltimore Harbor, M For the project Intake Richard Streeter 7/ 19/ 05 plant operates 0800 to 2400 only and was not operated at all ( no flow) during low demand p impingement values were estimated for approx. one month intervals Aug 1978 to Jul 1979 entrainment values were estimated for 15 intervals over the period Aug 1978 to Jul 1979 J. Hazen QC. No targeted species. r, Maryland ( Ph2 facility) assigned number 29706 Intake d periods 9 species. orig stage year impinged. est entrained. est junk junk  999  999  999 american. eel age01 1979 35 na american. eel juvenile 1979 na 65,179 blueback. herring age01 1979 14 na atlantic. menhaden age01 1979 2,982 na gizzard. shad age01 1979 3,786 na gizzard. shad postlarvae 1979 na 4,197 bay. anchovy age01 1979 318 na bay. anchovy pysl 1979 na 79,960 spottail. shiner age01 1979 34 na tidewater. silverside age01 1979 68 na tidewater. silverside postlarvae 1979 na 50,514 atlantic. silverside age01 1979 223 na atlantic. silverside postlarvae 1979 na 8,152 atlantic. silverside egg 1979 na 2,038 atlantic. silverside juvenile 1979 na 6,235 silverside. spp age01 1979 10 na white. perch age01 1979 287 na striped. bass age01 1979 117 na pumpkinseed age01 1979 28 na weakfish age01 1979 52 na spot age01 1979 745 na atlantic. croaker age01 1979 9,402 na winter. flounder age01 1979 10 na blue. crab. hard age01 1979 5,750 na blue. crab. soft age01 1979 578 na blue. crab. peeler age01 1979 20 na mud. crab age01 1979 396 na yellow. perch postlarvae 1979 na 2,495 naked. goby postlarvae 1979 na 910,567 unidentifiable postlarvae 1979 na 44,936 notes comments QC junk junk junk Table 4 10 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 4 10 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 5 3 of Document 29706 Intake Table 4 10: Estimated Total Impingement Aug 1978 to Jul 1979 Estimation Period American Eel Blueback Herring Atlantic Menhaden Gizzard Shad Bay Anchovy Spottail Shiner 10 Aug  6 Sep 0 0 379 0 0 0 7 Sep  4 Oct 0 0 111 0 0 0 5 Oct  5 Nov 0 14 336 0 28 0 6 Nov  29 Dec 0 0 31 0 0 0 30 Nov  26 Dec 0 0 13 0 0 0 27 Dec  24 Jan 18 0 18 246 35 0 25 Jan  23 February 17 0 102 3,420 255 34 24 February  22 Mar 0 0 0 105 0 0 23 Mar  18 Apr 0 0 34 0 0 0 19 Apr  17 May 0 0 1,209 15 0 0 18 May  13 Jun 0 0 133 0 0 0 14 Jun  12 Jul 0 0 46 0 0 0 13 Jul  31 Jul 0 0 570 0 0 0 Total ( study) 35 14 2,982 3,786 318 34 Calculated Total rs 35 14 2,982 3,786 318 34 Tidewater Silverside Atlantic Silverside Silverside spp. White Perch Striped Bass Pumpkinseed Weakfish Spot Atlantic Croaker Winter Flounder 0 0 0 30 0 0 0 258 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 56 0 0 0 70 0 0 0 0 0 0 0 10 0 0 0 0 0 13 0 0 0 0 52 0 0 0 0 0 0 0 18 18 0 35 2,018 0 68 170 0 51 51 0 0 0 7,384 0 0 31 10 126 0 0 0 0 0 10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 15 0 0 0 0 0 0 0 0 13 0 0 0 0 0 0 0 9 0 0 0 0 0 9 0 0 0 0 0 11 33 0 0 373 0 0 68 223 10 287 117 28 52 745 9,402 10 68 223 10 287 117 28 52 745 9,402 10 Blue Crab ( hard) Blue Crab ( soft) Blue Crab ( peeler) Mud Crab Total Number ( study) calculated total  rs Total Weight ( kg)

1,364 227 0 167 2,425 2,425 41.0 126 95 0 16 348 348 5.2 56 0 0 42 602 602 13.6 0 0 0 20 61 61 1.1 0 0 0 78 78 0.5 0 0 0 0 2,406 2,406 8.0 0 0 0 0 11,552 11,552 67.8 0 0 0 0 282 282 5.9 0 0 0 22 56 56 0.4 45 0 0 91 1,375 1,375 22.9 27 40 0 27 240 240 4.5 724 19 20 0 835 827 2.3 3,408 197 0 11 4,603 4,603 43.1 5,750 578 20 396 24,863 24,855 216.3 5,750 578 20 396 24,863 24,855 216.3 Table 5 3: Estimated total Entrainment Aug 1978 to Jul 1979 Estimation Period Juvenile American Eel Postlarvae Gizzard Shad Postlarvae Bay Anchovy Juvenile Atlantic Silverside Postlarvae Atlantic Silverside Egg Atlantic Silverside 1 Aug  6 Sep 0 0 79,960 0 0 0 7 Sep  3 Oct 0 0 0 0 0 0 4 Oct  5 Nov 0 0 0 0 0 0 6 Nov  20 Dec 0 0 0 0 0 0 21 Dec  22 Feb 0 0 0 0 0 0 23 Feb  11 Mar 3,775 0 0 0 0 0 12 Mar  25 Mar 0 0 0 0 0 0 26 Mar  7 Apr 3,491 0 0 0 0 0 8 Apr  21 Apr 14,970 0 0 0 0 0 22 Apr  6 May 7,369 0 0 0 0 0 7 May  19 May 31,377 0 0 0 0 0 20 May  2 Jun 0 0 0 0 0 0 3 Jun  16 Jun 4,197 4,197 0 4,197 0 0 17 Jun  1 Jul 0 0 0 2,038 8,152 2,038 2 Jul  30 Jul 0 0 0 0 0 0 Total ( study) 65,179 4,197 79,960 6,235 8,152 2,038 calculated total  rs 65,179 4,197 79,960 6,235 8,152 2,038 Postlarvae Yellow Perch Postlarvae Naked Goby Postlarvae Tidewater Silverside Postlarvae Unidentifiable Total calculated total  rs 0 879,566 0 0 959,526 959,526 0 14,597 0 0 14,597 14,597 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3,775 3,775 0 0 0 0 0 0 0 0 0 0 3,491 3,491 2,495 0 0 0 17,465 17,465 0 0 0 0 7,369 7,369 0 0 0 0 31,377 31,377 0 0 30,134 0 30,134 30,134 0 0 0 0 12,591 12,591 0 2,038 20,380 30,570 65,216 65,216 0 14,366 0 14,366 28,732 28,732 2,495 910,567 50,514 44,936 1,174,273 1,174,273 2,495 910,567 50,514 44,936 1,174,273 1,174,273


[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Notices]
[Page 67811]
[FR Doc No: 2020-23534]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0998; Notice of Availability Docket No. 20-ASO-26]

Notice of Availability of the Final Environmental Assessment
(Final EA)/Finding of No Significant Impact (FONSI) and the Record of
Decision (ROD) for the South-Central Florida Metroplex Project

AGENCY: Federal Aviation Administration, (FAA), Department of
Transportation.

ACTION: Notice of availability.

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

SUMMARY: The FAA, Eastern Service Center, is issuing this notice to
advise the public of the availability of the Final Environmental
Assessment (Final EA)/Finding of No Significant Impact (FONSI) and the
Record of Decision (ROD) for the South-Central Florida Metroplex
Project.

FOR FURTHER INFORMATION CONTACT: Lisa Favors, Federal Aviation
Administration, Operations Support Group, Eastern Service Center, 1701
Columbia Avenue, College Park, Georgia 30337,<PHONE_NUMBER>.
Additional information about the FAA's actions and environmental review
of this project is available at the following website: http://www.metroplexenvironmental.com/fl_metroplex/fl_introduction.html.

SUPPLEMENTARY INFORMATION: The FAA prepared a Final Environmental
Assessment (EA), dated October 15, 2020, to assess the potential
environmental impacts of the South-Central Florida Metroplex project in
compliance with the National Environmental Policy Act of 1969, 42
U.S.C. 4321 et seq. Council on Environmental Quality regulation, 40 CFR
parts 1500-1508, the requirements of Section 106 of the National
Historic Preservation Act, and all other applicable special purpose
laws. The Final EA responds to agency and public comments received by
the FAA and it updates the Draft EA issued on May 11, 2020. This notice
announces that based on the information and analysis contained in the
Final EA, and after reviewing comments received on the Draft EA, the
FAA is issuing a Finding of No Significant Impact and Record of
Decision (FONSI/ROD) for the South-Central Florida Metroplex Project.
The FONSI/ROD documents the FAA's determination that the South-Central
Florida Metroplex Project would not significantly affect the quality of
the human environment and that an Environmental Impact Statement (EIS)
is therefore not necessary. The FONSI/ROD also documents the FAA's
decision to proceed with the proposed action detailed in the Final EA.
The South-Central Florida Metroplex Project will improve the
operational efficiency of the national airspace system in the South-
Central Florida area by optimizing aircraft arrival and departure
procedures at a number of airports.
    Availability: The Final EA and FONSI/ROD is available at the
following locations:
    (1) Online at http://metroplexenvironmental.com.
    (2) Electronic Versions of the documentation have been sent to 117
libraries in the General Study Area with a request to make the digital
document available to patrons. A complete list of these libraries with
electronic copies of the documentation is available online at the
website above. The FAA recognizes that libraries may be closed due to
the COVID-19 public health emergency and, therefore, availability
through these libraries may be impacted.
    (3) If you are unable to access the documentation through one of
these means, by contacting Lisa Favors at<PHONE_NUMBER>.

Lisa Favors,
EPS Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2020-23534 Filed 10-23-20; 8:45 am]
BILLING CODE 4910-13-P