[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]
[Page 26662-26668]
[DOCID:fr12my10-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0032; FRL-8824-5]

Fluazinam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluazinam in or on bushberry subgroup 13-07B; onion, bulb, subgroup 3-
07A; lettuce, head; and lettuce, leaf. This regulation additionally
removes several established individual commodities and bushberry
subgroup 13B, as they will be superseded by inclusion in bushberry
subgroup 13-07B. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and
requests for hearings must be received on or before July 12, 2010, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0032. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. 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 Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, 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 those
engaged in the following activities:
     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 to
provide 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. 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 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 cite at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those

objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2009-0032 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 July
12, 2010. 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 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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0032, 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 Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7506) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.574 be amended by
establishing tolerances for residues of the fungicide fluazinam, (3-
chloro- N -[3-chloro-2,6-dinitro-4-(trifluoromethyl) phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on lettuce, head at 0.02 parts
per million (ppm); lettuce, leaf at 2.0 ppm; onion, bulb, subgroup 3-
07A at 0.15 ppm; and bushberry subgroup 13-07B at 4.5 ppm. The petition
additionally requested to remove the established tolerances in or on
aronia berry, buffalo currant, Chilean guava, European barberry,
highbush cranberry, edible honeysuckle, jostaberry, Juneberry,
lingonberry, native currant, salal, sea buckthorn, and bushberry
subgroup 13B at 7.0 ppm. The published notice of the petition
referenced a summary of the petition prepared on behalf of IR-4 by ISK
Biosciences, 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
revised the proposed tolerances for bushberry subgroup 13-07B and
onion, bulb, subgroup 3-07A. EPA has also revised the tolerance
expression for all established commodities to be consistent with
current Agency policy. The reasons for these changes are 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 fluazinam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluazinam
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Following subchronic and chronic exposure to fluazinam, the liver
appeared to be a primary target organ in rats, dogs, and mice. Signs of
liver toxicity included changes in clinical chemistry (increased serum
alkaline phosphatase and aspartate aminotransferase), increased
absolute and/or relative liver weights, increased incidences of gross
lesions (pale, enlarged, pitted, mottled, accentuated markings), and a
variety of histopathological lesions. Treatment-related effects were
also observed in other organs following subchronic and chronic exposure
to fluazinam, but these effects were not consistently noted in all
three species or in all studies in a given species.
    In a developmental toxicity study in rats, fetal effects included
decreases in body and placental weights, increased incidences of
facial/palate clefts, diaphragmatic hernias, delayed ossification in
several bone types, increases in late resorptions, as well as evidence
of a greenish amniotic fluid and postimplantation loss. Maternal
effects, including decreases in body weight gain/food consumption and
increases in water consumption and urogenital staining, were observed
at the same dose level. In the rat developmental neurotoxicity (DNT)
study, effects in pups (including decreases in body weight/body weight
gain and delayed preputial separation) were noted in the absence of
maternal toxicity.
    In an acute neurotoxicity study in rats, effects included decreases
in motor activity and soft stools; these effects were considered to be
due to systemic toxicity and not a result of frank neurotoxicity. No
signs of neurotoxicity were observed in two subchronic neurotoxicity
studies in rat up to the highest dose tested (HDT). A neurotoxic lesion
described as vacuolation of the white matter of the central nervous
system was observed in subchronic and chronic studies in mice and dogs;
however, this lesion was found to be reversible and is attributed to an
impurity (impurity 5). Based on the level of this impurity in technical
grade fluazinam, the risk assessment for the

parent compound is considered protective of the effects noted.
    In a rat carcinogenicity study, there was some evidence that
fluazinam induced an increase in thyroid gland follicular cell tumors
in male rats. In one mouse carcinogenicity study, clear evidence of a
treatment-related increase of hepatocellular tumors was observed in
male mice; in another mouse carcinogenicity study, there was equivocal
evidence that fluazinam may have induced an increase in hepatocellular
tumors in male mice. There was no evidence of statistically-significant
tumor increases in female mice or rats in any study and no evidence of
mutagenic activity in the submitted mutagenicity studies for fluazinam.
EPA has classified fluazinam as having suggestive evidence of
carcinogenicity.
    Specific information on the studies received and the nature of the
adverse effects caused by fluazinam 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 document ``Fluazinam. Human Health Risk
Assessment for the Proposed Uses on Apples, Carrots, Lettuce, and the
Bulb Onion Subgroup (3-07A), and a Request for a Reduced Tolerance on
the Bushberry Subgroup (13-07B),'' pp. 60-65 in docket ID number EPA-
HQ-OPP-2009-0032.

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://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluazinam used for
human risk assessment is shown in the table of this unit.

       Table--Summary of Toxicological Doses and Endpoints for fluazinam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 7milligrams/     Acute RfD = 0.07 mg/kg/  Developmental Toxicity
(Females 13-49 years of age).........   kilogram/day (mg/kg/     day                      Study-Rabbits
                                        day)                    aPAD = 0.07 mg/kg/day..  LOAEL = 12 mg/kg/day
                                       UFA = 10x..............                            based on increased
                                       UFH = 10x..............                            incidence of total
                                       FQPA SF = 1x...........                            litter resorptions and
                                                                                possible increased
                                                                                incidence of fetal
                                                                                skeletal
                                                                                abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 50 mg/kg/day     Acute RfD = 0.5 mg/kg/   Acute Neurotoxicity-
(General population including infants  UFA = 10x..............   day                      Rats
 and children).                        UFH = 10x..............  aPAD = 0.5 mg/kg/day...  LOAEL = 1,000 mg/kg/day
                                       FQPA SF =1x............                            based on decreased
                                                                                motor activity and
                                                                                soft stools on day of
                                                                                dosing.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 1.1 mg/kg/day    Chronic RfD = 0.011 mg/  Carcinogenicity-Mice
(All populations)....................  UFA = 10x..............   kg/day                   LOAEL = 10.7 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.011 mg/kg/day.   based on liver
                                       FQPA SF = 1x...........                            histopathology and
                                                                                increased liver
                                                                                weight.
----------------------------------------------------------------------------------------------------------------
Cancer                                    Classification: Suggestive Evidence of Carcinogenicity. The cRfD is
(Oral, dermal, inhalation)...........                         protective of cancer effects.
----------------------------------------------------------------------------------------------------------------
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. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazinam, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluazinam tolerances in 40 CFR
180.574. EPA assessed dietary exposures from fluazinam 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 fluazinam. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
utilized tolerance-level residues and assumed 100 percent crop treated
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA utilized tolerance-
level residues for all commodities except apple (for which the average
field trial residue value was used) and assumed 100 PCT for all
commodities.

    iii. Cancer. Fluazinam has been classified as having suggestive
evidence of carcinogenicity. This determination is based on weight of
evidence considerations where a concern for potential carcinogenic
effects in humans is raised, but the animal data are judged not
sufficient for a stronger conclusion.
    Carcinogenicity studies were conducted in rats and mice. In rats,
increased incidences of thyroid gland follicular cell tumors were seen
in males but not in females. In mice, there were conflicting results
with regard to hepatocarcinogenicity. In one study, benign and
malignant liver tumors were seen in males; no liver tumors were seen in
females. In the second study, carcinogenic response was equivocal and
tumors did not occur in a dose-related manner. In males, the dose that
induced liver tumors in the first study failed to induce liver tumors
in the same strain of mice in the second study. In the second study, in
females, liver tumors were seen only at an excessive toxic dose. There
was no evidence of mutagenicity either in in vivo or in vitro assays.
No chemicals structurally related to fluazinam were identified as
carcinogens.
    Since the evidence for carcinogenicity is not sufficient to
indicate anything greater than a suggestion of a carcinogenic
potential, EPA concludes that quantification of cancer risk would not
be scientifically appropriate, as it attaches greater significance to
the positive cancer findings than the entire dataset warrants. Further,
due to the equivocal and inconsistent nature of the cancer response in
the rat and mouse studies (in rats, effects seen only in males; in
mice, one study showed effects only in males but even these effects
were not reproducible), EPA finds that when judged qualitatively the
data indicate no greater than a negligible risk of cancer. The Agency
has determined that the POD (1.1 mg/kg/day) selected for deriving the
cRfD is protective of all chronic effects, including the equivocal
cancer effects; therefore, the chronic dietary exposure assessment was
relied upon for assessing cancer risk.
    iv. Anticipated residue 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 section 408(f)(1) of
FFDCA 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 section 408(b)(2)(E) of
FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water for risk assessment are parent fluazinam and its
degradates, including DCPA, CAPA, DAPA, and HYPA. The Agency used
screening level water exposure models in the dietary exposure analysis
and risk assessment for fluazinam and its degradates in drinking water.
These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of fluazinam and its
degradates. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://
www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluazinam and its
degradates for surface water are estimated to be 117 parts per billion
(ppb) for acute exposures and 19.8 ppb for chronic exposures. For
ground water, the EDWCs are estimated to be 0.216 ppb for both acute
and chronic exposures.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The water concentration values
of 117 ppb and 19.8 ppb were used to assess the contribution to
drinking water in the acute and chronic dietary risk assessments,
respectively.
    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). Fluazinam 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 fluazinam to share a common mechanism of toxicity
with any other substances, and fluazinam does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluazinam does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (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. The prenatal and postnatal
toxicology database for fluazinam includes rat and rabbit prenatal
developmental toxicity studies, a 2-generation reproductive toxicity
study in rats, and a DNT study in rats. There was no evidence of
increased quantitative or qualitative susceptibility in the rabbit
developmental toxicity study or the rat 2-generation reproductive
toxicity study; however, evidence of increased qualitative
susceptibility of fetuses was observed in the rat developmental
toxicity study and evidence of increased quantitative susceptibility of
fetuses was observed in the rat DNT study.
    In the developmental toxicity study in rats, fetal effects
(increased incidences of facial/palate clefts and other rare
deformities in the fetuses) were observed in the presence of minimal
maternal toxicity (decreased body weight gain and food consumption, and
increased water consumption and urogenital staining). In the rat DNT
study, decreases in body weight/body weight gain and a delay in
completion of balano-preputial separation were observed in pups in the
absence of maternal effects, suggesting increased quantitative
susceptibility of the offspring.

    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 fluazinam is complete, except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (Harmonized Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. The available data for
fluazinam show no evidence of treatment-related effects on the immune
system, and the Agency does not believe that conducting an
immunotoxicity study will result in a lower POD than that currently
selected for overall risk assessment. Therefore, an additional database
uncertainty factor to account for potential immunotoxicity does not
need to be applied.
    ii. A DNT study in rat is available and shows evidence of increased
quantitative susceptibility of offspring. Although the NOAEL for this
study (2 mg/kg/day) is lower than that used for the aRfD for females
13-49 (7 mg/kg/day), the effects noted in the DNT study are considered
to be postnatal effects attributable to multiple doses; therefore, the
study endpoint is not appropriate for acute dietary exposures. The cRfD
(0.011 mg/kg/day) is based on a lower NOAEL (1.1 mg/kg/day), and is
considered to be protective of potential developmental effects.
Therefore, the degree of concern is low for the observed effects and
there are no residual uncertainties with regard to prenatal and/or
postnatal neurotoxicity.
    iii. Although there is qualitative evidence of increased
susceptibility following in utero exposure to fluazinam in the rat
developmental toxicity study, the degree of concern for the observed
effects is low. Fetal effects were observed only at the HDT and in the
presence of maternal toxicity, and there is a clear NOAEL for the fetal
effects seen. Additionally, the NOAEL (50 mg/kg/day) identified in the
developmental toxicity study in rats is significantly higher than the
NOAEL used (7 mg/kg/day) to establish the aRfD for females 13-49.
Therefore, the aRfD is protective of any potential developmental
effects and there are no residual uncertainties for prenatal and/or
postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments were
performed based on 100 PCT for all commodities. Additionally, the acute
assessment is based on tolerance level residues for all commodities,
and the chronic assessment is based on tolerance level residues for all
commodities except apple (for which the average field trial value was
used). These assumptions result in high-end estimates of dietary
exposure. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluazinam in
drinking water. Fluazinam is not registered for any specific use
patterns that would result in residential exposure. These assessments
will not underestimate the exposure and risks posed by fluazinam.

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 fluazinam will occupy 20% of the aPAD for females 13-49 years old
and 20% 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
fluazinam from food and water will utilize 40% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for fluazinam.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures takes into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, fluazinam
is not registered for any use patterns that would result in short- or
intermediate-term residential exposures. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposures plus chronic dietary exposure. Because there are no short- or
intermediate-term residential exposures and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short-term
risk), no further assessment of short- or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and intermediate-term risk for fluazinam.
    4. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA has concluded that the cPAD is
protective of possible cancer effects. Because chronic exposure is 20%
of the cPAD for the most highly exposed population subgroups, cancer
risk resulting from exposure to fluazinam is not of concern.
    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 fluazinam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology, gas chromatography with
electron capture detection (GC/ECD), is available to enforce the
tolerance expression for crop matrices. A high performance liquid
chromatography with ultraviolet detection (HPLC/UV) enforcement method
is also available to enforce the tolerance expression for wine grapes,
which includes residues of the metabolite AMGT. These methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail 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 U.N. 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.
    There are currently no Codex or Mexican MRLs established for
residues of fluazinam in or on the commodities associated with this
petition. However, Canada has an approved MRL for the use of fluazinam
on bushberry subgroup 13B at 7.0 ppm, which is based on an earlier
joint review effort between the Canadian Pesticide Management
Regulatory Agency (PMRA) and EPA.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the data supporting the petition, EPA has
revised the proposed tolerance for onion, bulb, subgroup 3-07A from
0.15 ppm to 0.20 ppm. EPA revised this tolerance level based on
analysis of the residue field trial data using the Agency's Tolerance
Spreadsheet in accordance with the Agency's Guidance for Setting
Pesticide Tolerances Based on Field Trial Data. EPA has also revised
the tolerance expression to clarify:
    1. That, as provided in section 408(a)(3) of FFDCA, the tolerance
covers metabolites and degradates of fluazinam not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
    Additionally, the Agency has revised the proposed tolerance for
bushberry subgroup 13-07B from 4.5 ppm to 7.0 ppm. Permanent tolerances
exist for residues of fluazinam in or on bushberry subgroup 13B and
several individual bushberry commodities (aronia berry, buffalo
currant, Chilean guava, European barberry, highbush cranberry, edible
honeysuckle, jostaberry, juneberry, lingonberry, native currant, salal,
and sea buckthorn) at 7.0 ppm. IR-4 petitioned the Agency to establish
a tolerance for the revised bushberry subgroup 13-07B at 4.5 ppm, which
would supersede the tolerances for both bushberry subgroup 13B and the
individual bushberry tolerances. After reevaluating the existing data
in support of the bushberry subgroup 13-07B tolerance in accordance
with the Agency's Guidance for Setting Pesticide Tolerances Based on
Field Trial Data, EPA has determined that the probability plot for the
residue data are lognormally distributed and that the bushberry
subgroup 13-07B tolerance should be established at 7.0 ppm. The revised
tolerance for bushberry subgroup 13-07B at 7.0 ppm is equivalent to the
existing tolerances for the individual bushberry commodities and
bushberry subgroup 13B. Further, the 7.0 ppm tolerance on bushberry
harmonizes with a MRL established in Canada, as discussed in Unit IV.B.

V. Conclusion

    Therefore, tolerances are established for residues of fluazinam,
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on bushberry subgroup 13-07B
at 7.0 ppm; lettuce, head at 0.02 ppm; lettuce, leaf at 2.0 ppm; and
onion, bulb, subgroup 3-07A at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule 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 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., 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
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 this final rule in the Federal
Register. This final 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: May 4, 2010.
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. Section 180.574 is amended as follows:
0
i. Revise the introductory text of paragraph (a)(1);

0
ii. Remove the entries for ``Aronia berry''; ``Buffalo currant'';
``Bushberry subgroup 13B''; ``Chilean guava''; ``European barberry'';
``Highbush cranberry''; ``Honeysuckle, edible''; ``Jostaberry'';
``Juneberry''; ``Lingonberry''; ``Native currant''; ``Salal''; and
``Sea buckthorn'' from the table in paragraph (a)(1);
0
iii. Alphabetically add commodities to the table in paragraph (a)(1);
and
0
iv. Revise the introductory text of paragraph (a)(2).
    The amendments read as follows:

Sec.  180.574  Fluazinam; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of fluazinam
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified below is to be determined by
measuring only fluazinam.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Bushberry subgroup 13-07B............................                7.0
                                * * * * *
Lettuce, head........................................               0.02
Lettuce, leaf........................................                2.0
Onion, bulb, subgroup 3-07A..........................               0.20
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluazinam, including
its metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only fluazinam and its metabolite AMGT (3-[[4-
amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-nitro-6-
(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) propionic
acid).
* * * * *

[FR Doc. 2010-11302 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: August 19, 2010 (Volume 75, Number 160)]
[Rules and Regulations]
[Page 51175-51176]
[DOCID:fr19au10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0403; Airspace Docket No. 10-ACE-4]

Establishment of Class E Airspace; Perryville, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Perryville, MO to
accommodate Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAPs) at Perryville Municipal Airport, Perryville, MO. The
FAA is taking this action to enhance the safety and management of
Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On May 4, 2010, the FAA published in the Federal Register a notice
of proposed rulemaking to amend Class E airspace for Perryville, MO,
creating additional controlled airspace at Perryville Municipal Airport
(75 FR 23636) Docket No. FAA-2010-0403. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9T
signed August 27, 2009, and effective September 15, 2009, which is
incorporated by reference in 14 CFR Part 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by adding additional Class E airspace extending upward from 700
feet above the surface to accommodate SIAPs at Perryville Municipal
Airport, Perryville, MO. This action is necessary for the safety and
management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it

is certified that this rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Perryville Municipal Airport,
Perryville, MO.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ACE MO E5 Perryville, MO [Amended]

Perryville Municipal Airport, MO
    (Lat. 37[deg]52'07'' N., long. 89[deg]51'44'' W.)
Farmington VORTAC, MO
    (Lat. 37[deg]40'24'' N., long. 90[deg]14'03'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Perryville Municipal Airport and within
1.8 miles each side of the 057[deg] radial of the Farmington VORTAC
extending from the 6.6-mile radius to 8.2 miles southwest of the
airport, and within 3.9 miles each side of the 197[deg] bearing from
the airport extending from the 6.6-mile radius to 11 miles south of
the airport.

    Issued in Fort Worth, Texas, on August 6, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-20396 Filed 8-18-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6571-6572]
[FR Doc No: 2022-02390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0082]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
regulatory issues. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document.

DATES: The meeting will be held on February 15, 2022, from 8:30 a.m. to
5 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. The online
web conference meeting will be available at the following link on the
day of the meeting: https://youtu.be/nGRNfZ8ZHN8.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0082. The docket will close on February
14, 2022. Submit either electronic or written comments on this public
meeting by February 14, 2022. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of February 14, 2022. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
    Comments received on or before February 10, 2022, will be provided
to the committee. Comments received after February 10, 2022, and by
February 14, 2022, will be taken into consideration by FDA. In the
event that the meeting is cancelled, FDA will continue to evaluate any
relevant applications or information, and consider any comments
submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0082 for ``Vaccines and Related Biological Products Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Eastern Time, Monday through Friday,<PHONE_NUMBER>.
     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.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya or Christina Vert,
Center for Biologics Evaluation and

Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected];
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION: Consistent with FDA's regulations, this
notice is being published with less than 15 days prior to the date of
the meeting based on a determination that convening a meeting of the
Vaccines and Related Biological Products Advisory Committee as soon as
possible is warranted. This Federal Register notice could not be
published 15 days prior to the date of the meeting due to a recent
request to amend the Emergency Use Authorization (EUA) of the Pfizer-
BioNTech COVID-19 mRNA vaccine for administration to children 6 months
through 4 years of age, and the need for prompt discussion of this
request given the COVID-19 pandemic.
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On February
15, 2022, the committee will meet in open session to discuss a request
to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech
COVID-19 mRNA vaccine for administration to children 6 months through 4
years of age.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: On February 15, 2022, from 8:30 a.m. to 5 p.m. Eastern
Time the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. All electronic and written submissions submitted
to the Docket (see ADDRESSES) on or before February 10, 2022, will be
provided to the committee. Comments received after February 10, 2022,
and by February 14, 2022, will be taken into consideration by FDA. Oral
presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m. Eastern Time. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before February 8, 2022. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by February 9, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Prabhakara Atreya or Christina Vert (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02390 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Page 15357]
[FR Doc No: 2017-06067]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL17-52-000]

Republic Transmission, LLC; Notice of Petition for Declaratory
Order

    Take notice that on March 15, 2017, pursuant to section 219 of the
Federal Power Act, 16 U.S.C. 824s (2012), and Rule 207 of the Federal
Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure, 18 CFR 385.207 (2015), Republic Transmission, LLC (Republic)
filed a petition for declaratory order authorizing Republic to use
specific limited transmission rate incentives and treatments for
Republic's development of the Duff-Coleman EHV 345 kV Competitive
Transmission Project, all as more fully explained in the petition.
    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. 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.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 proceeding are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on April 14, 2017.

    Dated: March 22, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06067 Filed 3-27-17; 8:45 am]
 BILLING CODE 6717-01-P


REVIEW OF PESTICIDE REGISTRATIONS PURSUANT TO FIFRA § 3( g)

DISCUSSION DRAFT Prepared for PPDC Work Group on Registration Review Program Introduction FIFRA section 3( g) states, " The registrations of pesticides are to be periodically reviewed. The Administrator shall by regulation establish a procedure for the periodic review of registrations. The goal of these regulations shall be a review of a pesticide's registration every 15 years."

Based on the statutory provision, some members of the PPDC RRWG recommended using 15 years from the date of the last major regulatory action on a pesticide registration as the initial selection criterion, with further refinement based on additional criteria.

Several other RRWG members suggesting using risk considerations as the primary criterion for assigning priority within the group of pesticide registrations scheduled to be reviewed within a 15 year period. The universe for this initial group would be all post 1984 active ingredient registrations. Tiers, based on criteria related to risk, would be used to assign review priority. Other members suggested a hybrid approach.

Following is a proposal for defining the scope of registration review. Cindy Baker volunteered to draft this proposal for the work group to review before presenting it to the full PPDC. This draft takes into consideration what the statute says, EPA resources and existing programs that already address registration, reregistration or other activities. This proposal only deals with scope not process questions like " early off ramp", tiering the process, priorities, etc. those should be addressed when a process is discussed.

Draft Proposal I. Identify review candidates   EPA should inventory all pesticide registrations and add a field to their database where they can identify the date of the last registration action on that registration. All pesticide registrations should be reviewed to ensure they meet the requirements for registration. Congress' language refers specifically to the singular pesticide. This means the review of an individual pesticide. Registration Review does not include inerts as they are not pesticide registrations. While it may be helpful for the Agency to group by active ingredient or common mechanism, they should start with a list of pesticide registrations. II. Registration Review Requirements   the " registration review" of a pesticide registration very simply should be evaluating the pesticide registration to ensure it meets the requirements of registration at the time the registration review is conducted. Registration review includes all Section 3 and Section 24 © registrations. Registration Review is not tolerance reassessment. Special Review and Reregistration already has and will continue to have authority and jurisdiction to conduct their reviews that work should not be duplicated in a registration review process. EPA should have a formally adopted set of registration requirements that are clearly articulated in FIFRA. The registration review process will be to see if the pesticide registration meets those requirements. It is not a vehicle for significant additional generic data requirements to be proposed those should be addressed through updates to Part 158. Once EPA has reviewed a pesticide registration they send a letter to the registrant( s) that states any one or combination of the following: 1) the product has been reviewed and is eligible to remain registered. 2) Registration review indicates the need for additional data to address deficiencies in the database. 3) There are modifications that must be made to the label for it to remain. At the conclusion of any of these actions the 15 year clock is restarted.