[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Rules and Regulations]
[Pages 65552-65557]
[FR Doc No: 2016-22976]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0226; FRL-9951-68]

Flupyradifurone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective September 23, 2016. Objections and
requests for hearings must be received on or before November 22, 2016,
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-2013-0226, 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-2013-0226 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 22, 2016. 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-2013-0226, 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 March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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
5F8404) by Bayer CropScience LP, 2 T.W. Alexander

Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the insecticide, flupyradifurone, in or on abiu at 0.6
parts per million (ppm); akee apple at 0.6 ppm; avocado at 0.6 ppm;
bacury at 0.6 ppm; banana at 0.6 ppm; binjai at 0.6 ppm; caneberry,
subgroup 13-07A at 5 ppm; canistel at 0.6 ppm; cilantro, fresh leaves
at 30 ppm; cupuac[uacute] at 0.6 ppm; etambe at 0.6 ppm; jatob[aacute]
at 0.6 ppm; kava, fresh leaves at 40 ppm; kava, roots at 0.9 ppm; kei
apple at 0.6 ppm; langstat at 0.6 ppm; lanjut at 0.6 ppm; lucuma at 0.6
ppm; mabolo at 0.6 ppm; mango at 0.6 ppm; mangosteen at 0.6 ppm; paho
at 0.6 ppm; papaya at 0.6 ppm; pawpaw, common at 0.6 ppm; pelipisan at
0.6 ppm; pequi at 0.6 ppm; pequia at 0.6 ppm; persimmon, american at
0.6 ppm; plantain at 0.6 ppm; pomegranate at 0.6 ppm; poshte at 0.6
ppm; quandong at 0.6 ppm; quinoa at 3 ppm; sapote at 0.6 ppm; sataw at
0.6 ppm; screw-pine at 0.6 ppm; star apple at 0.6 ppm; stone fruit,
stone group 12-12 at 1.5 ppm; tamarind-of-the-Indies at 0.6 ppm; and
wild loquat at 0.6 ppm. That document referenced a summary of the
petition prepared by Bayer CropScience LP, the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified some of the commodity definitions that were proposed. The
reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flupyradifurone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flupyradifurone
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 most sensitive effects seen in the flupyradifurone database
were skeletal muscle atrophy/degeneration in dogs. With repeated
dosing, reductions in body weight and food consumption were commonly
seen in various studies and in all species of test animals (rats, mice,
dogs, and rabbits). The liver and thyroid were shown to be the common
findings of flupyradifurone toxicity. The database appears to suggest
that dogs are more sensitive to the effects of flupyradifurone;
however, with body weight adjustments (based on a \3/4\ scaling
factor), the dog and rat are almost equally as sensitive in response to
flupyradifurone toxicity. The skeletal muscle atrophy/degeneration seen
in the 90-day and 1-year dog studies formed the basis for chronic
dietary exposure toxicity endpoints.
    The developmental toxicity study in rats demonstrated no evidence
of susceptibility in developing animals. In the rabbit developmental
toxicity study, there was an increase in the incidence of fetal death
at 80 milligram/kilogram/day (mg/kg/day) (the highest dose tested), a
dose that did not produce adverse effects in the maternal animals.
    Therefore, a quantitative increase in susceptibility was
demonstrated in the rabbit developmental toxicity study. In the 2-
generation reproduction study in rats, decreased parental body weights
(>=10%) were seen at the lowest-observed-adverse-effect-level (LOAEL)
of 137 mg/kg/day (parental no-observed-adverse-effect-level (NOAEL) =
37.8 mg/kg/day). In contrast, body weight decreases that were
considered adverse were seen in F2 pups at 37.8 mg/kg/day (the parental
NOAEL and the offspring LOAEL; offspring NOAEL = 7.7 mg/kg/day). These
findings suggest quantitative susceptibility for developing young
animals.
    The acute neurotoxicity study (dosing by gavage) showed that at the
time of peak-effect, flupyradifurone caused increases in the incidence
of piloerection and dilated pupils at 50 mg/kg. At the next higher dose
level (200 mg/kg) and above, it produced a large host of clinical
signs, which were related to neurotoxicity. The clinical signs included
dilated pupils, lower muscle tone, low arousal, tremors, myoclonic
jerks, chewing, repetitive licking of lips, gait incoordination,
flattened or hunched posture, and impaired righting reflex. In the 90-
day neurotoxicity study, no neurotoxicity or other adverse effects were
seen at dose levels as high as 174 mg/kg/day. The developmental
neurotoxicity study at 102 mg/kg/day yielded an increased incidence of
increased amplitude in startle response.
    Flupyradifurone is classified as ``not likely to be carcinogenic to
humans.'' Carcinogenicity studies in rats and mice did not yield a
compound-related increase in tumor incidence, and the genotoxicity
battery did not show flupyradifurone to produce any genotoxicity.
Flupyradifurone did not demonstrate any immunotoxic effects.
    Specific information on the studies received and the nature of the
adverse effects caused by flupyradifurone as well as the NOAEL and the
LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Flupyradifurone (122304)
Human Health Risk Assessment in Support of Proposed Uses on Kava,
Cilantro, Stone Fruit, Group 12-12, Caneberry, Subgroup 13-07A, Quinoa,
and Tropical Fruits; Amended Use Requests for Soil Applications to
Leafy Vegetables, Group 4 and Brassica (Cole) Leafy Vegetables, Group
5; Use on Greenhouse Grown Tomato, Pepper, Cucumber, and Lettuce; Label
Amendment to Add Commodities of Tree Nuts, Group 14-12 to label; and
Label Amendment to Add Use Directions for Clover Grown for Forage,
Fodder, Seed, Straw, and Hay'' on page 49 in docket ID number EPA-HQ-
OPP-2013-0226.

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

     Table 1--Summary of Toxicological Doses and Endpoints for Flupyradifurone 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 (All populations)..  NOAEL = 35 mg/kg/day  Acute RfD = 0.35 mg/ Acute neurotoxicity study--rat
                                   UFA = 10 x..........   kg/day.             LOAEL = 50 mg/kg/day based on
                                   UFH = 10 x..........  aPAD = 0.35 mg/kg/    increased incidences of
                                   FQPA SF = 1 x.......   day.                 piloerection in both sexes and
                                                                               pupil dilation in females on Day
                                                                               1. At the next higher dose level
                                                                               (200 mg/kg) or above, lower
                                                                               muscle tone, rapid respiration,
                                                                               low arousal, tremors, myoclonic
                                                                               jerks, chewing, repetitive
                                                                               licking of lips, gait
                                                                               incoordination, flattened or
                                                                               hunched posture, dilated pupils,
                                                                               impaired (uncoordinated or slow)
                                                                               righting reflex, impaired flexor
                                                                               and tail pinch responses and
                                                                               reduced rectal temperature.
                                                                               Automated measures of motor
                                                                               activity were also reduced in
                                                                               both sexes, compared to controls.
Chronic dietary (All populations)  NOAEL= 7.8 mg/kg/day  Chronic RfD = 0.078  Oral toxicity study--dog (1-year)
                                   UFA = 10 x..........   mg/kg/day.          LOAEL = 28 mg/kg/day based on
                                   UFH = 10 x..........  cPAD = 0.078 mg/kg/   minimal to slight, focal to
                                   FQPA SF = 1 x.......   day.                 multifocal areas of skeletal
                                                                               muscle degeneration in
                                                                               gastrocnemius and/or biceps
                                                                               femoris muscle.
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  Oral toxicity study--dog (90-day)
                                    study NOAEL = 12 mg/                      LOAEL = 33 mg/kg/day based
                                    kg/day (dermal                             skeletal muscle atrophy/
                                    absorption rate =                          degeneration.
                                    7.42%.                                    2-Generation reproduction study--
                                   UFA = 10 x..........                        rat (co-critical study)
                                   UFH = 10 x..........                       NOAEL = 7.7 mg/kg/day.
                                   FQPA SF = 1 x.......                       Offspring LOAEL = 38.7 mg/kg/day
                                                                               based on pup body weight
                                                                               decrease.
Inhalation short-term (1 to 30     Oral study NOAEL =    LOC for MOE = 100..  Oral toxicity study--dog (90-day)
 days).                             12 mg/kg/day                              LOAEL = 33 mg/kg/day based on
                                    (inhalation                                skeletal muscle atrophy/
                                    absorption rate =                          degeneration.
                                    100%).                                    2-Generation reproduction study--
                                   UFA = 10 x..........                        rat (co-critical study)
                                   UFH = 10 x..........                       NOAEL = 7.7 mg/kg/day.
                                   FQPA SF = 1 x.......                       Offspring LOAEL = 38.7 mg/kg/day
                                                                               based on pup body weight
                                                                               decrease.
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Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans--based on data
                                    showing no treatment-related increase in tumors incidence in rat and mouse
                                    carcinogenicity studies. No mutagenic concern was reported in the
                                    genotoxicity studies.
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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).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flupyradifurone, EPA considered exposure under the
petitioned-for tolerances as well as all existing flupyradifurone
tolerances in 40 CFR 180.679. EPA assessed dietary exposures from
flupyradifurone 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 flupyradifurone. In estimating
acute dietary exposure, EPA used food consumption data from the United
States Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA;
2003-2008). As to residue levels in food, EPA assumed 100% crop treated
(PCT), tolerance level residues and Dietary Exposure Evaluation Model
(DEEM) (ver. 7.81) default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment

EPA used the food consumption data from the USDA's NHANES/WWEIA; 2003-
2008. As to residue levels in food, EPA assumed 100 PCT, tolerance
level residues and DEEM (ver. 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flupyradifurone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
flupyradifurone. Tolerance level residues and 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flupyradifurone in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of flupyradifurone. 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/Exposure Analysis Modeling
System (PRZM/EXAMS), Tier 1 Rice Model and Pesticide Root Zone Model
Ground Water (PRZM GW) model, the estimated drinking water
concentrations (EDWCs) of flupyradifurone for acute exposures are
estimated to be 112 parts per billion (ppb) for surface water and 352
ppb for ground water, and for chronic exposures are estimated to be 112
ppb for surface water and 307 ppb for 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 352 ppb was used to assess
the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 307 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).
    Currently there are no registered uses for flupyradifurone that
could result in residential exposures. However, there is a proposal to
register uses that could result in residential exposures for
application to ornamental plants (gardens, trees, shrubs, flowers).
Therefore, the EPA considered the proposed residential uses and
assessed residential exposure using the following assumptions: For
residential handlers, short-term dermal and inhalation exposures were
assessed for adults mixing, loading and applying liquids and ready to
use formulations to gardens and trees using a variety of application
equipment. For post-application exposure, short-term dermal exposures
to adults and children (6 to <11 years old) to gardens, trees, and
retail plants and indoor plants was evaluated. Only short-term
residential exposures are expected. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flupyradifurone to share a common mechanism of
toxicity with any other substances, and flupyradifurone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flupyradifurone 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. There is no evidence that
flupyradifurone produces increased susceptibility in in the rat
developmental study. There is quantitative increase in susceptibility
in the rabbit developmental and rat reproduction studies. In the rabbit
developmental study, no maternal effect was seen at the highest tested
dose (80 mg/kg/day), while there was an increase in fetal death and
decrease fetal body weight at the same dose level. In the rat
reproduction study, maternal effect, decrease in body weight, was seen
at 137 mg/kg/day, whereas decreases in pup body weight was seen at the
next lower dose, 38.7 mg/kg/day or above. However, the PODs selected
for risk assessment are protective of the quantitative susceptibility
seen in the rabbit fetuses and rat pups.
    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 flupyradifurone is complete.
    ii. Although there is evidence that flupyradifurone has neurotoxic
effects, EPA has a complete set of neurotoxicity studies (acute,
subchronic, and developmental). The effects of those studies are well-
characterized and indicate neurotoxic effects that occur at levels
above the chronic POD that was selected for risk assessment. The NOAEL
for the acute neurotoxicity study is being used for the acute POD.
Therefore, there is no need to retain the 10X FQPA SF to account for
any uncertainty concerning these effects.
    iii. There is no evidence that flupyradifurone results in increased
susceptibility in in utero rats. There is quantitative increase in
susceptibility in the rabbit developmental and rat reproduction
studies. However, the PODs selected for risk assessment are protective
of the quantitative susceptibility seen in the rabbit fetuses and rat
pups.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to

flupyradifurone in drinking water. EPA used similarly conservative
assumptions to assess the proposed residential post-application
exposure of children. These assessments will not underestimate the
exposure and risks posed by flupyradifurone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flupyradifurone will occupy 37% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flupyradifurone from food and water will utilize 86% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flupyradifurone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). For
flupyradifurone there are uses pending which the Agency has included in
this action that could result in short-term residential exposure, and
the Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to flupyradifurone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and proposed residential exposures result in aggregate MOEs of 170 for
adults and 190 for children (6 to <11 years old). Because EPA's level
of concern for flupyradifurone is a MOE of 100 or below, these MOEs are
not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
flupyradifurone is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for flupyradifurone.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flupyradifurone is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flupyradifurone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method (Method RV-001-P10-03) which uses
high-performance liquid chromatography with tandem mass spectrometry
(HPLC/MS/MS) to quantitate residues of flupyradifurone and
difluoroacetic acid (DFA) in various crops is available for
enforcement.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for flupyradifurone.

C. Response to Comments

    EPA received two comments to the Notice of Filing. The first
stated, in part, that EPA should deny this petition because it is a
harmful and toxic chemical. The Agency understands the commenter's
concerns and recognizes that some individuals believe that pesticides
should be banned on agricultural crops. However, the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. EPA has
assessed the effects of this chemical on human health and determined
that aggregate exposure to it will be safe. This citizen's comment
appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.
    The second comment was from Interregional Research Project Number 4
(IR-4) and was in support of the petition.

D. Revisions to Petitioned-For Tolerances

    Bayer CropScience LP petitioned for tolerances on abiu, akee apple,
avocado, bacury, banana, binjai, canistel, cupuac[uacute], etambe,
jatob[aacute], kei apple, langstat, lanjut, lucuma, mabolo, mango,
mangosteen, paho, papaya, common pawpaw, pelipisan, pequi, pequia,
American persimmon, plantain, pomegranate, poshte, quandong, sapote,
sataw, screw-pine, star apple, tamarind-of-the-Indies, and wild loquat.
These commodities are all listed in the newly established crop subgroup
24B for tropical and subtropical, medium to large fruit, with a smooth,
inedible peel. Subgroup 24B further breaks out the different types of
avocado (to include Guatemalan, Mexican, and West Indian avocado),
mango (to include horse and Saipan mango), and sapote (to include

black, green, and white sapote). Although the petitioner did not
specify any particular kind of avocado, mango, and sapote, the Agency
considers the request for avocado, mango, and sapote to be general in
nature and include all varieties of those commodities. As a result, the
requested commodities align with the commodities contained in the new
subgroup 24B.
    In the Federal Register of May 3, 2016 (81 FR 26471) (FRL-9944-87)
establishing that crop group, EPA indicated that, for existing
petitions for which a Notice of Filing had been published, the Agency
would attempt to conform these petitions to the rule. Therefore,
consistent with this rule, EPA is establishing tolerances on crop
subgroup 24B, the tropical and subtropical, medium to large fruit,
smooth, inedible peel subgroup, rather than all the commodities
individually. EPA's dietary and aggregate risk assessments are based on
data from the required representative commodities and account for
flupyradifurone exposure from all of the subgroup 24B commodities.

V. Conclusion

    Therefore, tolerances are established for residues of
flupyradifurone, including its metabolites and degradates, in or on
caneberry subgroup 13-07A at 5.0 ppm; cilantro, fresh leaves at 30 ppm;
fruit, stone, group 12-12 at 1.5 ppm; kava, fresh leaves at 40 ppm;
kava, roots at 0.90 ppm; quinoa, grain at 3.0 ppm; and the tropical and
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B
at 0.60 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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: September 14, 2016.
Daniel J. Rosenblatt,
Acting 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.  180.679, add alphabetically the commodities ``Caneberry
subgroup 13-07A''; ``Cilantro, fresh leaves''; ``Fruit, stone, group
12-12''; ``Kava, fresh leaves''; ``Kava, roots''; ``Quinoa, grain'';
and ``Tropical and subtropical, medium to large fruit, smooth, inedible
peel subgroup 24B'' to the table in paragraph (a) to read as follows:

Sec.  180.679  Flupyradifurone; tolerances for residues.

    (a) * * *

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

                                * * * * *
Caneberry subgroup 13-07A...............................             5.0

                                * * * * *
Cilantro, fresh leaves..................................              30

                                * * * * *
Fruit, stone, group 12-12...............................             1.5

                                * * * * *
Kava, fresh leaves......................................              40
Kava, roots.............................................            0.90

                                * * * * *
Quinoa, grain...........................................             3.0

                                * * * * *
Tropical and subtropical, medium to large fruit, smooth,            0.60
 inedible peel subgroup 24B.............................

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

* * * * *
[FR Doc. 2016-22976 Filed 9-22-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12609-12610]
[FR Doc No: 2012-4895]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4042-DR; Docket ID FEMA-2012-0002]

Virginia; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4,
2011, and related determinations.

DATES: Effective Date: February 7, 2012.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Daniel T.
Alexander, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Donald L. Keldsen as
Federal Coordinating Officer for this disaster.

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

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-4895 Filed 2-29-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Page 80886]
[FR Doc No: 2010-32237]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Ninth Meeting--RTCA Special Committee 220: Automatic Flight
Guidance and Control

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 220: Automatic Flight Guidance
and Control meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 220: Automatic Flight Guidance and
Control.

DATES: The meeting will be held February 15th-17th, 2011. February 15th
and 16th, from 9 a.m. to 5 p.m. and February 17th from 9 a.m. to 2 p.m.

ADDRESSES: The meeting will be held at the Hilton, Clearwater Beach,
400 Mandalay Ave., Clearwater Beach, FL 33767, USA. telephone (727)
298-3222, Fax<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street,
NW., Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 220: Automatic Flight Guidance
and Control meeting. The agenda will include:
     Welcome/Agenda Overview.
     Presentation of progress WG2.
     Presentation of progress WG3.
     Continue Development of Installation Guidance White
Papers.
     Wrap-up and Review of Action Items.
     Establish Dates, Location, Agenda for Next Meeting.
     Other Business.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on December 15, 2010.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2010-32237 Filed 12-22-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 1, 2006 (Volume 71, Number 40)]
[Notices]
[Page 10497-10498]
[DOCID:fr01mr06-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Applications for Non-Project Use of Project Lands and
Amendment of Shoreline Management Plan and Soliciting Comments, Motions
to Intervene, and Protests

February 22, 2005.
    Take notice that the following applications have been filed with
the Commission and are available for public inspection:
    a. Application Types: Non-project use of Project Lands and
Amendment of Shoreline Management Plan.
    b. Project No: 2232-510 & 511.
    c. Date Filed: January 26, 2006.
    d. Applicant: Duke Power, a division of Duke Energy Corporation.
    e. Name of Project: Catawba-Wateree Project.

    f. Location: The project is located on Lake Norman, in Catawba
County, North Carolina. This project does not occupy any Tribal or
federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a) 825(r)
and sections 799 and 801.
    h. Applicant Contact: Joe Hall, Lake Management Representative,
Duke Energy Corporation, P.O. Box 1006, Charlotte, NC 28201-1006, (704)
382-8576.
    i. FERC Contact: Any questions on this notice should be addressed
to Mr. Jon E. Cofrancesco at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: March 22, 2006.
    All documents (original and eight copies) should be filed with: Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington DC 20426. Please include the project
numbers (P-2232-510 & 511) on any comments or motions filed. Comments,
protests, and interventions may be filed electronically via the
internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site at http://www.ferc.gov under

the e-Filing( link. The Commission strongly encourages e-filings.
    k. Description of Request: Duke Power is seeking authorization to
lease to Davidson Development, LLC 0.22 acre of Project land on Lake
Norman for a Commercial/ Residential Marina, which would consist of a
dock with seven boat slips. The dock would be constructed off-site and
floated into place during low lake recreation usage. These slips would
serve the residents of Cove Key Townhomes at Westview. Further, Duke
Power is seeking authorization to change the designated shoreline
classification for the site, as shown in the project's approved
shoreline management plan. Specifically, Duke Power requests the
approved shoreline classification map (Catawba-Wateree Project-Cowans
Ford Development, Sheet 3 of 10) for the site's approximately 700 feet
of shoreline be changed from a Future Residential designation to a
Future Commercial/Residential designation.
    l. Location of the Applications: This filing is available for
review at the Commission in the Public Reference Room 888 First Street,
NE., Room 2A, Washington, DC 20426 or may be viewed on the Commission's
Web site at http://www.ferc.gov using the ``e-library'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, call toll-free 1-866-208-
3676 or e-mail<EMAIL_ADDRESS>For TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described applications. Copies of the
applications may be obtained by agencies directly from the Applicant.
If an agency does not file comments within the time specified for
filing comments, it will be presumed to have no comments. One copy of
an agency's comments must also be sent to the Applicant's
representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E6-2866 Filed 2-28-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Page 13283]
[FR Doc No: 2019-06592]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1461-000]

Greenlight Energy Inc.; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Greenlight
Energy Inc.'s application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 18, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected]. or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 29, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-06592 Filed 4-3-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71508-71510]
[FR Doc No: 2016-25041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0601]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Medicated Feeds

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Submit either electronic or written comments on the collection
of information by December 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0601 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice Regulations for Medicated Feeds.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more

information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Current Good Manufacturing Practice Regulations for Medicated Feeds--21
CFR Part 225

OMB Control Number 0910-0152--Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue
current good manufacturing practice (cGMP) regulations for drugs,
including medicated feeds. Medicated feeds are administered to animals
for the prevention, cure, mitigation, or treatment of disease, or
growth promotion and feed efficiency. Statutory requirements for cGMPs
have been codified under part 225 (21 CFR part 225). Medicated feeds
that are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the FD&C Act.
Under part 225, a manufacturer is required to establish, maintain, and
retain records for a medicated feed, including records to document
procedures required during the manufacturing process to assure that
proper quality control is maintained. Such records would, for example,
contain information concerning receipt and inventory of drug
components, batch production, laboratory assay results (i.e. batch and
stability testing), labels, and product distribution.
    This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
cGMP criteria in part 225 to determine whether or not the systems and
procedures used by manufacturers of medicated feeds are adequate to
assure that their feeds meet the requirements of the FD&C Act as to
safety, and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
    A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required and the recordkeeping requirements are less demanding for
those medicated feeds for which FDA has determined that the drugs used
in their manufacture need less control. Respondents to this collection
of information are commercial feed mills and mixer-feeders.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Recordkeeping Burden
                                                     [Registered licensed commercial feed mills] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR Section                     Number of      records per    Total annual        Average burden per recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)...................             877             260         228,020  1.......................................         228,020
225.28(c) and (d).............................             877              45          39,465  0.50 (30 minutes).......................        19,732.5
225.80(b)(2)..................................             877           1,600       1,403,200  0.12 (7 minutes)........................         168,384
225.102(b)(1).................................             877           7,800       6,840,600  0.08 (5 minutes)........................         547,248
225.110(b)(1) and (b)(2)......................             877           7,800       6,840,600  0.02 (1 minute).........................         136,812
225.115(b)(1) and (b)(2)......................             877               5           4,385  0.12 (7 minutes)........................           526.2
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................     1,100,722.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 2--Estimated Annual Recordkeeping Burden
                                                         [Registered licensed mixer-feeders] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR Section                     Number of      records per    Total annual        Average burden per recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b) through (b)(8)......................             100             260          26,000  0.15 (9 minutes)........................           3,900
225.58(c) through (d).........................             100              36           3,600  0.50 (30 minutes).......................           1,800
225.80(b) (2).................................             100              48           4,800  0.12 (7 minutes)........................             576
225.102(b)(1) through (b)(5)..................             100             260          26,000  0.40 (24 minutes).......................          10,400
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................          16,676
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 3--Estimated Annual Recordkeeping Burden
                                                  [Nonregistered unlicensed commercial feed mills] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR Section                     Number of      records per    Total annual        Average burden per recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142.......................................           4,186               4          16,744  1.......................................          16,744
225.158.......................................           4,186               1           4,186  4.......................................          16,744
225.180.......................................           4,186              96         401,856  0.12 (7 minutes)........................          48,223
225.202.......................................           4,186             260       1,088,360  0.65 (39 minutes).......................         707,434
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         789,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 4--Estimated Annual Recordkeeping Burden
                                                      [Nonregistered unlicensed mixer-feeders] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR Section                     Number of      records per    Total annual        Average burden per recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142.......................................           3,400               4          13,600  1.......................................          13,600
225.158.......................................           3,400               1           3,400  4.......................................          13,600
225.180.......................................           3,400              32         108,800  0.12 (7 minutes)........................          13,056
225.202.......................................           3,400             260         884,000  0.33 (20 minutes).......................         291,720
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         331,976
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of time required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from Agency records and experience.

    Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25041 Filed 10-14-16; 8:45 am]
BILLING CODE 4164-01-P