[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Rules and Regulations]
[Pages 58493-58499]
[FR Doc No: 2012-23352]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0593; FRL-9358-3]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective September 21, 2012. Objections and
requests for hearings must be received on or before November 20, 2012,
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-2011-0593, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, 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: Bethany Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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.
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 site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0593 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 20, 2012. 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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0593, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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.htm.
    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 August 26, 2011, 76 FR 53374 (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7886)
by Valent U.S.A. Corporation, 1600 Riviera Ave., Suite 200, Walnut
Creek, CA 94596. The petition requested that 40 CFR 180.568 be amended
by establishing tolerances for residues of the herbicide, flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on Pea and bean,
dried shelled (except soybean), crop subgroup 6C at 0.1 parts per
million (ppm); Rapeseed, crop subgroup 20A at 0.35 ppm for seed, 0.04
ppm for meal, and 0.02 ppm for refined oil; Sunflower, crop subgroup
20B at 0.5 ppm for seed, 0.03 for meal, 0.02 ppm for refined oil; and
Wheat at 0.35 ppm for grain, 5.0 ppm for straw, 0.02 ppm for forage,
0.02 ppm for hay, 0.35 ppm for bran, 0.05 ppm for flour, 0.35 ppm for
germ, 0.08 ppm for middlings, 0.11 ppm for shorts, 110 ppm for
aspirated grain fractions. In addition, the petition requested
revocation of the existing tolerance for residues of flumioxazin in or
on beans, dry seed, if a tolerance for Crop subgroup 6C (which includes
this commodity) is set as requested. That notice referenced a summary
of the petition prepared by Valent U.S.A. Corporation, the registrant,
which is available in the docket, EPA-HQ-OPP-2011-0593 at 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 and use of
the OECD tolerance calculation procedures, EPA has determined that a
single tolerance to cover all of the commodities within each of the
crop subgroups is appropriate versus individual tolerances for each of
the commodities within the crop subgroups. In addition, EPA has
determined that several of the proposed tolerances for wheat
commodities, including wheat bran, flour, germ, middlings, and shorts,
are not required. The reason 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 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 flumioxazin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flumioxazin 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. A summary of the toxicological findings are as follows:
    Flumioxazin has mild or low acute toxicity when administered
orally, dermally, or by inhalation. It is not an eye or skin irritant,
or a dermal sensitizer. In general, the subchronic and chronic toxicity
studies demonstrated that toxic effects associated with flumioxazin
include anemia as well as effects on the liver and the cardiovascular
system. Developmental effects were observed in developmental rat
studies but not in developmental rabbit studies. Hematologic
(hematopoietic) effects of anemia were noted in rats, consisting of
alterations in hemoglobin parameters. Increased renal toxicity in male
rats was also reported following chronic exposure. There is no evidence
of neurotoxicity or immunotoxicity in the recently submitted guideline
studies. Increased quantitative susceptibility was seen in the rat
developmental toxicity studies. Fetal effects were observed in the
absence of maternal toxicity. In addition, both increased qualitative
and quantitative susceptibility were observed in the rat reproduction
study. Severe fetal effects were observed at lower doses than milder
parental effects. In most of the available mutagenicity studies,
flumioxazin was negative for mutagenicity; however, aberrations were
seen in a chromosomal aberration assay (CHO cells). Based on the lack
of evidence of carcinogenicity in mice and rats, flumioxazin is
classified as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level

(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at http://www.regulations.gov in the
document, Flumioxazin. Human Health Risk Assessment for the Proposed
Uses on Wheat, Sunflower, Safflower, Flax, Lentils and Field Peas on
page 20 in docket ID number EPA-HQ-OPP-2011-0593.

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 (U/SF) 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 flumioxazin used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Flumioxazin 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 (Females 13-50       NOAEL = 3 mg/kg/day   Acute RfD = aPAD =   Oral Developmental and
 years of age).                     UFA = 10x.            0.03 mg/kg/day.      Supplemental Pre-natal Studies
                                   UFH = 10x...........                        (Rat) LOAEL = 10 mg/kg/day, based
                                   FQPA SF = 1x........                        on cardiovascular effects in
                                                                               fetuses.
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Acute dietary (General population  No appropriate toxicological effects attributable to a single exposure (dose)
 including infants and children).   were observed in oral toxicity studies including maternal effects in
                                    developmental studies in rats and rabbits. Therefore, a dose and endpoint
                                    were not identified for this risk assessment.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.0 mg/kg/day  Chronic RfD= cPAD =  2-Year Chronic/Carcinogenicity
                                   UFA = 10x...........   0.02 mg/kg/day.      Study (Rat) LOAEL = 18 mg/kg/day,
                                   UFH = 10x...........                        based on increased chronic
                                   FQPA SF = 1x........                        nephropathy in males and
                                                                               decreased hematological
                                                                               parameters in females.
Incidental oral short-term (1 to   NOAEL= 6.3 mg/kg/day  LOC for MOE = 100..  2-Generation Reproduction Study
 30 days) and intermediate-term    UFA = 10x...........                        (Rat) LOAEL = 12.7 mg/kg/day,
 (1 to 6 months).                  UFH = 10x...........                        based on decreased pup body
                                   FQPA SF = 1x........                        weight and testicular atrophy in
                                                                               F1 males.
Dermal-Children short-term (1 to   NOAEL = 6.3 mg/kg/    LOC for MOE = 100..  2-Generation Reproduction Study
 30 days) and intermediate-term     day (dermal                                (Rat) LOAEL = 12.7 mg/kg/day,
 (1 to 6 months).                   absorption factor =                        based on decreased pup body
                                    8%).                                       weight and testicular atrophy in
                                   UFA = 10x...........                        F1 males.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Dermal-Adults All Durations......  NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  Dermal Developmental Study (Rat)
                                   UFA = 10x...........                        LOAEL = 100 mg/kg/day, based on
                                   UFH = 10x...........                        cardiovascular effects in
                                   FQPA SF = 1x........                        fetuses.
Inhalation short-term (1 to 30     oral study NOAEL= 3   LOC for MOE = 1000.  Oral Developmental Study (Rat)
 days) and Intermediate term (1     mg/kg/day                                  LOAEL = 10 mg/kg/day, based on
 to 6 months).                      (inhalation                                cardiovascular effects in
                                    absorption rate =                          fetuses.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 10x.......
                                   UFDB................
Inhalation Long-term (> 6 months)  NOAEL = 2 mg/kg/day   LOC for MOE = 1000.  2-Year Chronic/Carcinogenicity
                                    (inhalation                                Study (Rat) LOAEL = 18 mg/kg/day,
                                    absorption rate =                          based on increased chronic
                                    100%).                                     nephropathy in males and
                                   UFA = 10x...........                        decreased hematological
                                   UFH = 10x...........                        parameters in females.
                                   FQPA SF = 10x.......
                                   UFDB................
                                  ------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)  ``Not likely to be a carcinogenic to humans,'' based on the lack of
                                    carcinogenicity in a 2-year rat study, an 18-month mouse study, and a
                                    battery of mutagenic studies.
----------------------------------------------------------------------------------------------------------------
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). UFDB = to account for the absence of data or other
  data deficiency. 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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR
180.568. EPA assessed dietary exposures from flumioxazin 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 flumioxazin. 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 assumed residues are present in all commodities at
the tolerance level and that 100% of commodities with tolerances are
treated with flumioxazin. In addition, EPA used default concentration
factors to estimate residues of flumioxazin in processed commodities.
Acute dietary exposure was only estimated for females 13-49 years old
based on cardiovascular effects in fetuses observed in the oral
developmental and supplemental pre-natal rat studies. An endpoint of
concern was not established for acute dietary assessment of the general
population.
    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 assumed residues are
present in all commodities at the tolerance level and that 100% of
commodities with tolerances are treated with flumioxazin. In addition,
EPA used default concentration factors to estimate residues of
flumioxazin in processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flumioxazin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk was not conducted.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flumioxazin. 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.
    Modeled estimates of drinking water concentrations, based on the
estimated environmental concentrations (EECs) for flumioxazin and its
major degradates (482-HA and APF) under the use as an aquatic
herbicide, were directly entered into the dietary exposure model. For
acute dietary risk assessment, the water concentration value of 400
parts per billion (ppb) was used to assess the contribution to drinking
water. For chronic dietary risk assessment, the water concentration of
value 142 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). Flumioxazin is
currently registered for the following uses that could result in
residential exposures: Aquatic areas, ornamental gardens, ornamental
trees, and turf in residential lawns, athletic fields, parks, and golf
courses. EPA assessed residential exposure with the assumption that
homeowner handlers wear shorts, short-sleeved shirts, socks, and shoes,
and that they complete all tasks associated with the use of a pesticide
product including mixing/loading, if needed, as well as the
application. Residential handler exposure scenarios for both dermal and
inhalation are considered to be short-term only, due to the infrequent
use patterns associated with homeowner products. EPA uses the term
``post-application'' to describe exposure to individuals that occur as
a result of being in an environment that has been previously treated
with a pesticide. Flumioxazin can be used in many areas that can be
frequented by the general population including residential areas, golf
courses, lakes, and ponds. As a result, individuals can be exposed by
entering these areas if they have been previously treated. Therefore,
short-term and intermediate dermal post-application exposures and risks
were assessed for adults and children. In addition, oral post-
application exposures and risks were assessed for children to be
protective of possible hand-to-mouth, object-to-mouth, and soil
ingestion activities that may occur on treated turf areas. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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
flumioxazin to share a common mechanism of toxicity with any other
substances, and flumioxazin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that flumioxazin 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://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 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. Evidence of increased
susceptibility to fetuses was observed in the oral and dermal
developmental rat studies [i.e. cardiovascular anomalies (ventricular
septal defect)] that occurred in the absence of maternal toxicity.
Additionally, the rat reproduction study demonstrated evidence of
qualitative and quantitative post-natal susceptibility because
reproductive effects in offspring were observed at doses lower than
those that caused parental/systemic toxicity, and because the
reproductive effects in offspring were considered to be more severe
than the parental/systemic effects.
    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 for oral and dermal exposures, but be
retained at 10X for inhalation exposures. That decision is based on the
following findings:
    i. The toxicity database for flumioxazin is largely complete with
the exception of an inhalation developmental study, which was recently
determined necessary, in order to better assess route-specific
inhalation risks. In the absence of this study, a 10x FQPA safety
factor to account for database uncertainty is needed to protect the
safety of infants and children to assess risks for all inhalation
exposure scenarios. The toxicity profile can be characterized for all
effects, including potential developmental and reproductive toxicity,
immunotoxicity and neurotoxicity with the current database.
    ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although increased susceptibility was seen in the rat
developmental and reproductive studies, EPA's concern for these effects
is low, and there are no residual uncertainties for pre- and/or
postnatal toxicity because: The developmental toxicity NOAELs/LOAELs
are well characterized after oral and dermal exposure; the offspring
toxicity NOAEL and LOAEL are well characterized in the reproduction
study and; the Points of Departure (POD) for assessing risk to
developing fetuses, infants, and children have been selected either
from the developmental and reproductive toxicity studies from the
chronic study which established a lower POD for chronic effects than
the studies in pre- and postnatal animals. Thus, the regulatory
endpoints for flumioxazin are protective of the increased
susceptibility seen in the developmental and reproduction studies, and
there are no residual concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure
databases. Because the acute and chronic dietary exposure estimates
were based on several conservative assumptions (100% of crops treated
with residues present at tolerance levels, default processing factors
and screening level drinking water estimates), EPA is confident that
the dietary exposure assessments do not underestimate risk to the
general U.S. population and various population subgroups. Similarly,
EPA does not believe that the non-dietary residential exposures are
underestimated because they are based on the conservative assumptions
of EPA's Draft Standard Operating Procedures (SOPs) for Residential
Exposure Assessments (December 1997), and updates contained in the
Science Advisory Council Policy 12 (February 2001) as well as the uses
specified in the proposed labels.

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
aPAD and 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. Acute aggregate risk takes into account exposure to
residues in food and drinking water alone. Therefore, acute aggregate
risk is equivalent to the acute dietary risk as discussed in Unit
III.C.1.i. The acute dietary exposure estimate for females 13-49 years
old will utilize 68% of the aPAD, which is below the Agency's LOC (100%
of the aPAD).
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 54% of the cPAD for all
infants (< 1 year 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
flumioxazin is not expected.
    3. Short-term risk. Flumioxazin is currently registered for uses
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
flumioxazin.
    Different methodologies were used for the presentation of short-
term aggregate risk for adults and children. An aggregate risk estimate
(ARI) approach was required to estimate short-term adult aggregate risk
because there are different LOCs for adult dermal and inhalation
exposures, 100 and 1,000, respectively. For short-term child aggregate
risk, the combined MOE approach was used because the endpoint of
concern (decreased pup weight) and the LOC are the same. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate ARI of 1.15 for adults and aggregate MOE
of 150 for children. Because EPA's LOC for flumioxazin is an ARI of 1
or below and a MOE of 100 or below, these aggregate risk estimates 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). Since the short- and intermediate-term toxicological endpoints
for flumioxazin are the same for each route of exposure, only short-
term exposures were assessed.

    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flumioxazin 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 flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method, Valent Method RM30-A-1) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. There are no MRLs
established by Codex, Canada, or Mexico for any of the proposed
commodities in the current registration actions.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the requested tolerances by adjusting the tolerance
values, substituting crop group tolerances for individual tolerances,
and dropping unnecessary tolerances. The tolerance levels were revised
based on analysis of the field trial data using the Organization for
Economic Cooperation and Development (OECD) tolerance calculation
procedures. EPA believes they differ from the petitioner's proposed
tolerances for dried pea, rapeseed subgroup 20A, and wheat grain and
straw due to the petitioner having possibly used the National
Technology Transfer and Advancement Act of 1995 (NAFTA) tolerance
calculation procedures as opposed to the OECD procedure. In addition,
EPA is setting single tolerances for the crop subgroups (6C, 20A and
20B) versus individual tolerances for each commodity within the
subgroups since maximum residues of the commodities within the crop
subgroups differ by less than 5X. The proposed tolerances for wheat
commodities (bran, flour, germ, middlings, and shorts) are also not
necessary since they are covered by the tolerance being set for wheat
grain.

V. Conclusion

    Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H)-dione, including its
metabolites and degradates, in or on the commodities as set forth in
the regulatory text. Compliance with the tolerance levels specified
below is to be determined by measuring only flumioxazin.

VI. Statutory and Executive Order Reviews

    This final rule 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 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 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 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 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 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) (Pub. L. 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 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: September 10, 2012.
Lois Rossi,
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. Section 180.568 is amended by:
0
a. Alphabetically adding the following commodities to the table in
paragraph (a);
0
b. Removing the commodity, ``bean, dry seed'' from the table in
paragraph (a).
    The amendments read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

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

                                * * * * *
Grain, aspirated fractions................................        100

                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C..          0.07

                                * * * * *
Rapeseed subgroup 20A.....................................          0.40

                                * * * * *
Sunflower subgroup 20B....................................          0.50

                                * * * * *
Wheat, forage.............................................          0.02
Wheat, grain..............................................          0.40
Wheat, hay................................................          0.02
Wheat, straw..............................................          6.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-23352 Filed 9-20-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4676-4678]
[FR Doc No: 2022-01699]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94031]

Order Granting Application by The Nasdaq Stock Market LLC for an
Exemption Pursuant to Section 36(a) of the Exchange Act From the Rule
Filing Requirements of Section 19(b) of the Exchange Act With Respect
to Certain Rules Incorporated by Reference

January 24, 2022.
    The Nasdaq Stock Market LLC (``Nasdaq'' or ``Exchange'') has filed
with the Securities and Exchange Commission (``Commission'') an
application for an exemption under Section 36(a)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ from the rule filing
requirements of Section 19(b) of the Exchange Act \2\ with respect to
certain rules of the Financial Industry Regulatory Authority, Inc.
(``FINRA''), Cboe Exchange, Inc. (``Cboe''), and New York Stock
Exchange LLC (``NYSE''), that the Exchange seeks to incorporate by
reference.\3\ Section 36 of the Exchange Act, subject to certain
limitations, authorizes the Commission to conditionally or
unconditionally exempt any person, security, or transaction, or any
class thereof, from any provision of the Exchange Act or rule
thereunder, if necessary or appropriate in the public interest and
consistent with the protection of investors.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78mm(a)(1).
    \2\ 15 U.S.C. 78s(b).
    \3\ See Letter from Angela S. Dunn, Principal Associate General
Counsel, Nasdaq, to J. Matthew DeLesDernier, Assistant Secretary,
Commission, dated January 20, 2022 (``Exemptive Request'').
---------------------------------------------------------------------------

    The Exchange has requested, pursuant to Rule 0-12 under the
Exchange Act,\4\ that the Commission grant the Exchange an exemption
from the rule filing requirements of Section 19(b) of the Exchange Act
for changes to the Exchange's rules that are effected solely by virtue
of a change to a cross-referenced FINRA, Cboe, or NYSE rule.
Specifically, the Exchange requests that it be permitted to incorporate
by reference changes made to the FINRA, Cboe, and NYSE rules that are
cross-referenced in the Exchange's rules identified below, without the
need for the Exchange to file separately similar proposed rule changes
pursuant to Section 19(b) of the Exchange Act: \5\
---------------------------------------------------------------------------

    \4\ 17 CFR 240.0-12.
    \5\ See Exemptive Request, supra note 3, at 5.
---------------------------------------------------------------------------

     General 9, Section 1(b) (Prohibition Against Trading Ahead
of Customer Orders) cross-references FINRA Rule 5320 (except for FINRA
Rule 5320.02(b) and the reference to FINRA Rule 6420 in FINRA Rule
5320).
     General 9, Section 1(c) (Front Running Policy) cross-
references FINRA Rule 5270.
     General 9, Section 1(f) (Confirmation of Callable Common
Stock) cross-references FINRA Rule 2232.
     General 9, Section 1(h) (Interfering With the Transfer of
Customer Accounts in the Context of Employment Disputes) cross-
references FINRA Rule 2140.
     General 9, Section 2 (Customers' Securities or Funds)
cross-references FINRA Rule 2150.
     General 9, Section 3 (Communications with the Public)
cross-references FINRA Rule 2210 (except for FINRA Rule 2210(c)).
     General 9, Section 5 (Telemarketing) cross-references
FINRA Rule 3230.
     General 9, Section 6 (Forwarding of Proxy and Other
Issuer-Related Materials) cross-references FINRA Rule 2251.
     General 9, Section 7 (Disclosure of Financial Condition,
Control Relationship with Issuer and Participation or Interest in
Primary or Secondary Distribution) cross-references FINRA Rules 2261,
2262, and 2269.
     General 9, Section 8 (SIPC Information) cross-references
FINRA Rule 2266.
     General 9, Section 9 (Fairness Opinions) cross-references
FINRA Rule 5150.
     General 9, Section 10(a) (Recommendations to Customers
(Suitability)) cross-references FINRA Rule 2111 (except for the
references to FINRA Rule 2214 in FINRA Rule 2111).
     General 9, Section 10(c) (Know Your Customer) cross-
references FINRA Rule 2090.
     General 9, Section 11 (Best Execution and
Interpositioning) cross-references FINRA Rule 5310 (except for the
references to FINRA Rule 2121 and its supplementary material in FINRA
Rule 5310).
     General 9, Section 12 (Customer Account Statements) cross-
references FINRA Rule 2231.
     General 9, Section 13 (Margin Disclosure Statement) cross-
references FINRA Rule 2264.
     General 9, Section 14 (Approval Procedures for Day-Trading
Accounts) cross-references FINRA Rules 2130 and 2270.
     General 9, Section 15 (Borrowing From or Lending to
Customers) cross-references FINRA Rule 3240.
     General 9, Section 16 (Charges for Services Performed)
cross-references FINRA Rule 2122.

     General 9, Section 17 (Net Transactions with Customers)
cross-references FINRA Rule 2124.
     General 9, Section 19 (Discretionary Accounts) cross-
references FINRA Rule 3260.
     General 9, Section 20 (Supervision) cross-references FINRA
Rules 3110 and 3170.
     General 9, Section 21 (Supervisory Control System, Annual
Certification of Compliance and Supervisory Processes) cross-references
FINRA Rules 3120 and 3130 (except for the references to MSRB rules in
FINRA Rule 3130).
     General 9, Section 23 (Outside Business Activities of an
Associated Person) cross-references FINRA Rule 3270.
     General 9, Section 24 (Private Securities Transactions of
an Associated Person) cross-references FINRA Rule 3280.
     General 9, Section 25 (Transactions for or by Associated
Persons) cross-references FINRA Rule 3210.
     General 9, Section 26 (Influencing or Rewarding Employees
of Others) cross-references FINRA Rule 3220.
     General 9, Section 27 (Reporting Requirements) cross-
references FINRA Rule 4530 (except for FINRA Rule 4530(h)).
     General 9, Section 28 (Disclosure to Associated Persons
When Signing Form U4) cross-references FINRA Rule 2263 (except for
subsection (2) of FINRA Rule 2263).
     General 9, Section 30 (Books and Records) cross-references
FINRA Rule 4511.
     General 9, Section 31 (Use of Information Obtained in
Fiduciary Capacity) cross-references FINRA Rule 2060.
     General 9, Section 33 (Reporting Requirements for Clearing
Firms) cross-references FINRA Rule 4540.
     General 9, Section 34 (Extensions of Time Under Regulation
T and SEC Rule 15c3-3) cross-references FINRA Rule 4230.
     General 9, Section 37 (Anti-Money Laundering Compliance
Program) cross-references FINRA Rule 3310.
     General 9, Section 38(b) (Margin Requirements) cross-
references FINRA Rule 4210.
     General 9, Section 39(b) (Fidelity Bonds) cross-references
FINRA Rule 4360.
     General 9, Section 40 (Capital Compliance) cross-
references FINRA Rule 4110.
     General 9, Section 41 (Regulatory Notification and
Business Curtailment) cross-references FINRA Rule 4120.
     General 9, Section 42 (Audit) cross-references FINRA Rule
4140.
     General 9, Section 43 (General Requirements) cross-
references FINRA Rule 4511.
     General 9, Section 44 (Records of Written Customer
Complaints) cross-references FINRA Rule 4513.
     General 9, Section 45 (Customer Account Information)
cross-references FINRA Rule 4512.
     General 9, Section 46 (Authorization Records for
Negotiable Instruments Drawn From a Customer's Account) cross-
references FINRA Rule 4514.
     General 9, Section 47 (Approval and Documentation of
Changes in Account Name or Designation) cross-references FINRA Rule
4515.
     General 9, Section 48 (Notifications, Questionnaires and
Reports) cross-references FINRA Rule 4521.
     Equity 10, Section 1 (Direct Participation Programs)
cross-references FINRA Rules 2310 and 5110.
     Equity 10, Section 2 (Investment Company Securities)
cross-references FINRA Rule 2341 (except for the reference to FINRA
Rule 2320 in FINRA Rule 2341).
     Equity 11, Rule 11860 (Acceptance and Settlement of COD
Orders) cross-references FINRA Rule 11860.
     Equity 11, Rule 11870 (Customer Account Transfer
Contracts) cross-references FINRA Rule 11870.
     Options 6C, Section 3 (Margin Requirements) cross-
references the initial and maintenance margin requirements of Cboe and
NYSE.
     Options 10, Section 20 (Communications with Public
Customers) cross-references FINRA's Communications with Public
Customers rule.
    The Exchange represents that the FINRA, Cboe, and NYSE rules listed
above are regulatory rules and not trading rules.\6\ The Exchange
represents that, as a condition to the requested exemption from Section
19(b) of the Exchange Act, the Exchange will provide written notice to
its members whenever FINRA, Cboe, or NYSE proposes a change to a cross-
referenced rule.\7\ The Exchange states that such notice will alert its
members and persons associated with a member to the proposed FINRA,
Cboe, or NYSE rule change and give them an opportunity to comment on
the proposal.\8\ The Exchange further represents that it will inform
members in writing when the Commission approves any such proposed rule
changes.\9\
---------------------------------------------------------------------------

    \6\ See id. at 6, n.12. The Exchange also states that it is not
``cherry picking'' because the Exchange would be incorporating
categories of rules. See id.
    \7\ See id. at 6. The Exchange represents that it will provide
such notice via a posting on the same website location where the
Exchange posts its own rule filings pursuant to Rule 19b-4(l) within
the time frame required by such rule. See id. at 6, n.13. The
website posting will include a link to the location on FINRA's,
Cboe's, or NYSE's website where the applicable proposed rule change
is posted. See id.
    \8\ See id. at 6.
    \9\ See id.
---------------------------------------------------------------------------

    According to the Exchange, this exemption is appropriate because it
would result in the Exchange's rulebook being consistent with the
relevant cross-referenced FINRA, Cboe, and NYSE rules at all times,
thus ensuring consistent regulation of joint members of Nasdaq, FINRA,
Cboe, and NYSE.\10\ The Exchange further states that, even if members
are not joint members of Nasdaq, FINRA, Cboe, and NYSE, the exemption
is appropriate because it will permit its rules to remain consistent
with FINRA's, Cboe's, and NYSE's rules and ensure consistent treatment
of industry members with respect to the aforementioned rules.\11\
---------------------------------------------------------------------------

    \10\ See id. at 5.
    \11\ See id. at 5-6.
---------------------------------------------------------------------------

    The Commission has issued exemptions similar to the Exchange's
request.\12\ In granting similar exemptions, the Commission stated that
it would consider similar future exemption requests, provided that:
---------------------------------------------------------------------------

    \12\ See, e.g., Securities Exchange Act Release Nos. 83296 (May
21, 2018), 83 FR 24362 (May 25, 2018) (order granting NYSE National,
Inc.'s exemptive request relating to rules of FINRA incorporated by
reference); 83040 (April 12, 2018), 83 FR 17198 (April 18, 2018)
(order granting MIAX PEARL, LLC's exemptive request relating to
rules of the Miami International Securities Exchange, LLC
incorporated by reference); 76998 (January 29, 2016), 81 FR 6066,
6083-84 (February 4, 2016) (order granting application for
registration as a national securities exchange of ISE Mercury, LLC
and exemptive request relating to rules of certain self-regulatory
organizations (``SROs'') (including FINRA) incorporated by
reference); 61534 (February 18, 2010), 75 FR 8760 (February 25,
2010) (order granting BATS Exchange, Inc.'s exemptive request
relating to rules incorporated by reference by the BATS Exchange
Options Market rules) (``BATS Options Market Order''); 61152
(December 10, 2009), 74 FR 66699, 66709-10 (December 16, 2009)
(order granting application for registration as a national
securities exchange of C2 Options Exchange, Incorporated and
exemptive request relating to rules of the Chicago Board Options
Exchange, Incorporated, incorporated by reference).
---------------------------------------------------------------------------

     An SRO wishing to incorporate rules of another SRO by
reference has submitted a written request for an order exempting it
from the requirement in Section 19(b) of the Exchange Act to file
proposed rule changes relating to the rules incorporated by reference,
has identified the applicable originating SRO(s), together with the
rules it wants to incorporate by reference, and otherwise has complied
with the procedural requirements set forth in the Commission's release
governing procedures for requesting exemptive

orders pursuant to Rule 0-12 under the Exchange Act; \13\
---------------------------------------------------------------------------

    \13\ See 17 CFR 240.0-12 and Securities Exchange Act Release No.
39624 (February 5, 1998), 63 FR 8101 (February 18, 1998) (Commission
Procedures for Filing Applications for Orders for Exemptive Relief
Pursuant to Section 36 of the Exchange Act; Final Rule).
---------------------------------------------------------------------------

     The incorporating SRO has requested incorporation of
categories of rules (rather than individual rules within a category)
that are not trading rules (e.g., the SRO has requested incorporation
of rules such as margin, suitability, or arbitration); and
     The incorporating SRO has reasonable procedures in place
to provide written notice to its members each time a change is proposed
to the incorporated rules of another SRO.\14\
---------------------------------------------------------------------------

    \14\ See BATS Options Market Order, supra note 12 (citing
Securities Exchange Act Release No. 49260 (February 17, 2004), 69 FR
8500 (February 24, 2004) (order granting exemptive request relating
to rules incorporated by reference by several SROs) (``2004
Order'')).
---------------------------------------------------------------------------

    The Commission believes that the Exchange has satisfied each of
these conditions. The Commission also believes that granting the
Exchange an exemption from the rule filing requirements under Section
19(b) of the Exchange Act will promote efficient use of the
Commission's and the Exchange's resources by avoiding duplicative rule
filings based on simultaneous changes to identical rule text sought by
more than one SRO.\15\ The Commission therefore finds it appropriate in
the public interest and consistent with the protection of investors to
exempt the Exchange from the rule filing requirements under Section
19(b) of the Exchange Act with respect to the above-described FINRA,
Cboe, and NYSE rules it has incorporated by reference. This exemption
is conditioned upon the Exchange promptly providing written notice to
its members whenever FINRA, Cboe, or NYSE changes a rule that the
Exchange has incorporated by reference.
---------------------------------------------------------------------------

    \15\ See BATS Options Market Order, supra note 12, 75 FR at
8761; see also 2004 Order, supra note 14, 69 FR at 8502.
---------------------------------------------------------------------------

    Accordingly, it is ordered, pursuant to Section 36 of the Exchange
Act,\16\ that the Exchange is exempt from the rule filing requirements
of Section 19(b) of the Exchange Act solely with respect to changes to
the rules identified in the Exemptive Request, provided that the
Exchange promptly provides written notice to its members whenever
FINRA, Cboe, or NYSE proposes to change a rule that the Exchange has
incorporated by reference.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78mm.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(76).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01699 Filed 1-27-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 12, 2010 (Volume 75, Number 132)]
[Notices]
[Page 39700-39701]
[DOCID:fr12jy10-61]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-0560]

Information Collection Request to Office of Management and
Budget; OMB; Control Number: 1625-New

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) and Analysis to the Office of Management and Budget (OMB)
requesting an approval for the following collection of information:
1625-New, Port Stakeholder Interface Form. Before submitting this ICR
to OMB, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before September 10,
2010.

ADDRESSES: To avoid duplicate submissions to the docket [USCG-2010-
0560], please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: Docket Management Facility (DMF) (M-30), U.S. Department
of Transportation (DOT), West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand deliver: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:

Commandant (CG-611), ATTN Paperwork Reduction Act Manager, US Coast
Guard, 2100 2ND ST SW. STOP 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    The Coast Guard invites comments on whether this ICR should be
granted based on the collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collection; (2) the accuracy of the estimated burden of the collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the collection; and (4) ways to minimize the burden of the
collections on respondents, including the use of automated collection
techniques or other forms of information technology.
    We encourage you to respond to this request by submitting comments
and related materials. We will post all comments received, without
change, to http://www.regulations.gov. They will include any personal
information you provide. We have an agreement with DOT to use their
DMF. Please see the ``Privacy Act'' paragraph below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2010-0560], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit your comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES; but please
submit them by only one means. If you submit them by mail or delivery,
submit them in an unbound format, no larger than 8-\1/2\ by 11 inches,
suitable for copying and electronic filing.
    If you submit them by mail and would like to know that they reached
the Facility, please enclose a stamped, self-addressed postcard or
envelope. We will consider all comments and material received during
the comment period and will address them accordingly.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Click on the ``read comments'' box, which will then become
highlighted in blue. In the ``Keyword'' box insert ``USCG-2010-0560 ''
and click ``Search.'' Click the ``Open Docket Folder'' in the
``Actions'' column. You may also visit the DMF in room W12-140 on the
West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act statement regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

Information Collection Request

    Title: Port Stakeholder Interface Form.
    OMB Control Number: 1625-New.
    Summary: This information is needed to ensure the Coast Guard can
gather critical cargo information from port stakeholders in the event
of a port closure or disruption to the Marine Transportation System.
    Need: Section 202 of Public Law 109-347 authorizes the Secretary
Department of Homeland Security to develop and update, as necessary,
protocols for the resumption of trade in the event of a transportation
disruption/security incident. It further instructs that appropriate
factors be considered for establishing prioritization of vessels and
cargo determined by the President to be critical for response and
recovery, including factors relating to public health, national
security, and economic need.
    Forms: CG-3142.

    Respondents: Owners and operators of port facilities.
    Frequency: On occasion.
    Burden Estimate: This is a new collection with an estimated burden
hours of 12,000 per year.

    Dated: June 18, 2010.
M.B. Lytle,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2010-16858 Filed 7-9-10; 8:45 am]
BILLING CODE 9110-04-P


Screening Level Usage Analysis for ( Mancozeb) 3/ 24/ 05 What is a Screening Level Usage Analysis ( SLUA)?   Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

What does it contain?   Pesticide usage data for a single active ingredient only.   Agricultural use sites ( crops) that the pesticide is reported to be used on   Pesticide usage information on the national level for the United States.   Annual percent of crop treated ( average & maximum) for each agricultural use site.   Average annual pounds of the pesticide applied for each agricultural use site.

What assumptions can I make about the data reported?   Average pounds of active ingredient applied  Values are calculated by merging pesticide usage data sources together; averaging by year, averaging across all years, & then rounding. Note: If the estimated value is less than 500, then that value is labeled < 500. Estimated values between 500 & < 1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)   Average percent of crop treated  Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 1, then the value is labeled < 1.   Maximum percent of crop treated  Value is the single maximum value reported across all data sources, across all years, & rounded up. Note: If the estimated value is less than 2.5, then the value is labeled < 2.5.

What are the data sources used?   USDA NASS ( United States Department of Agriculture's National Agricultural Statistics Service)   pesticide usage data from 1998 to 2003.   NCFAP ( National Center for Food and Agricultural Policy)   pesticide usage data from 1997 & is only used if data is not available from the other sources.   Private pesticide market research   pesticide usage data from 1998 to 2003.

What are the limitations to the data?   Registered/ labeled uses may exist but are not surveyed by the available data sources.   Lack of reported usage data for the pesticide on a crop does not imply zero usage.   Usage data on a particular site may be noted in data sources, but not quantified. In these instances, no usage would be reported in the SLUA for that use site.   Non agricultural use sites ( e. g., turf, post harvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates.

Who do I contact for further information and/ or questions on this SLUA?   ( Jenna Carter, Botanist, BEAD)   (( 703) 308 8370, carter. jenna@ epa. gov) Thursday, March 24, 2005 Screening Level Estimates of Agricultural Uses of Mancozeb Sorted Alphabetically Crop Lbs. A. I. Percent Crop Ttd. Avg. Max. 1 Almonds 7,000 < 1 < 2.5 2 Apples 1,000,000 30 35 3 Asparagus 40,000 20 30 4 Beans, Green 7,000 < 1 5 5 Cabbage 8,000 5 10 6 Cantaloupes 20,000 5 10 7 Carrots 1,000 < 1 < 2.5 8 Cherries 1,000 < 1 < 2.5 9 Corn ( Field) < 500 < 1 < 2.5 10 Cotton 10,000 < 1 < 2.5 11 Cranberries ( NCFAP ' 97) 40,000 30 12 Cucumber 50,000 10 15 13 Eggplant 5,000 20 25 14 Garlic 20,000 10 40 15 Grapes 300,000 15 35 16 Lettuce 2,000 < 1 < 2.5 17 Onions 400,000 50 65 18 Oranges 6,000 < 1 < 2.5 19 Peaches 3,000 < 1 < 2.5 20 Peanuts 8,000 < 1 < 2.5 21 Pears 200,000 40 55 22 Pecans 3,000 < 1 < 2.5 23 Peppers 20,000 5 10 24 Potatoes 2,900,000 54 65 25 Prunes & Plums 2,000 < 1 < 2.5 26 Pumpkins 10,000 5 10 27 Squash 50,000 15 20 28 Strawberries 1,000 < 1 < 2.5 29 Sugar Beets 100,000 5 10 30 Sweet Corn 100,000 10 15 31 Tobacco 60,000 5 10 32 Tomatoes 600,000 25 50 33 Walnuts 4,000 < 1 < 2.5 34 Watermelons 300,000 35 45 35 Wheat 200,000 < 1 < 2.5 ______________________________________

All numbers rounded. '< 500' indicates less than 500 pounds of active ingredient. '< 2.5' indicates less than 2.5 percent of crop is treated.


October 16, 2007

MEMORANDUM

SUBJECT: 	Consultant response to United States Environmental Protection
Agencies (US EPA) Human Studies Review Board (HSRB).

FROM: 	Steve Schofield, PhD.

Senior Advisor - Public Health Entomology,

National Defence, Canada.

TO: 		US EPA HSRB

		c/o Paul Lewis, PhD.

		Executive Director,

		HSRB

		Office of the Science Advisor

		US EPA

BACKGROUND:

The HSRB of the EPA has identified several methodological issues related
to mosquito repellent testing and has requested inputs from independent
consultants1.  Specifically, the HSRB is considering the outcome measure
first confirmed bite (FCB), defined as one bite confirmed by another
within a 30 minute period2, and its correlate, first confirmed landing
with intent to bite.

The following responses are specific, that is they are concerned only
with the questions posed by the HSRB and not with wider issues such as:
the relative merit of using FCB versus other repellent outcome measures
like relative protection; or the applicability of regulatory estimates
of repellent performance to real-world use scenarios.  Further,
responses provided herein represent the opinion of the consultant, and
do not necessarily reflect those of the Canadian Department of National
Defence.

HSRB QUESTIONS/CONSULTANT RESPONSES:

Section 1 – Time intervals between first and second bites.

Q1. What do data show about the variability of the time intervals
between first and subsequent landings in mosquito repellent field
trials?

A1. FCB is not the most common endpoint used in peer-reviewed and
published field studies on repellent efficacy.  Further, even where FCB
is used, non-confirmed bites are not always reported.  Consequently,
there is a relative paucity of data available for critical analyses of
this question.

In our own recent studies3,4, the initial bite on a repellent-treated
subject was usually confirmed by another bite within 30 min.  Is this
representative of what normally would be expected?  To the extent that
bites tend to be temporally aggregated – it likely is. However, the
specifics of such clustering are not expected to be constant, but rather
should vary based on factors such as the interplay between biting
pressure and the relative protection (RP) afforded by the product.  In
our work, because biting pressure was high (e.g., 10+ bites/min) at the
time of the first bite, expectation is for a confirming bite to occur
within 30 min (also see A4). Such may not be the case under a different
set of experimental conditions.

Q2. What is the current scientific understanding of how factors other
than repellent efficacy could affect the likelihood that an initial
event—a mosquito landing or mosquito bite—would be “confirmed”
by another similar event within 30 minutes?  Please address at least
these factors:

Characteristics of mosquito populations

Characteristics of test sites

Characteristics of test subjects

Characteristics of test methods

A2. A variety of factors can influence estimation of repellent efficacy.
 These include, but are not necessarily limited to, characteristics of:
mosquito populations, test sites, test subjects and test methods. A
brief discussion of each of the above-listed factors is presented below.
If required, additional commentary is available in several recent
publications that have tackled this subject area 5,6.

Mosquito populations. Substantial intergeneric, interspecific and
intraspecific variability has been demonstrated in the response of
mosquitoes to repellents. Certain genera (Anopheles)7,8 and species (An.
albimanus9) are less “sensitive” to deet than are others; and
variability between species strains has been demonstrated10,11. Other
mosquito based-factors that might influence outcomes from repellent
tests include nutritional status, endogenous activity cycles, age/parity
status and mosquito population density5,6.

Test sites. Variability between test sites can influence repellent
performance estimates.  For example, differences in mosquito population
density or species make-up (as discussed above) may substantially affect
outcomes. Further, climatic influences such as wind speed, temperature,
humidity and ambient light5,6 might impact mosquito activity and
behaviour and/or the persistence of repellent products on test subjects.

Test subjects. Variability between test subjects can have a profound
impact on estimates of repellent performance3,5,6. In some of our recent
work, despite virtually identical test circumstances, FCB estimates
varied by approximately 40% among subjects3 and moderate-intensity
exercise was associated with an approximately 50% reduction in product
performance4. Although causal relationships remain elusive,
subject-based variability likely involves the interplay of factors such
as: intrinsic variability in the release of cues (e.g., semiochemicals)
that affect mosquito behaviour and/or subject-based differences in
evaporative, absorptive or physical loss of repellent.

Test methods. Potential impacts of test method on repellent performance
estimates are numerous. They include: simultaneous use of the same
subject (or even different subjects12) for biting pressure and repellent
performance estimates5,6, variable performance outcome measures (e.g.,
FCB versus RP), intermittency of exposure, inconsistent data analyses,
varied subject-activity patterns, various emphasis on product versus
subject based variability, different approaches to product dosing or
area treated, etc.

Summary: Evaluation of how (or whether) all of the above-listed factors
would affect estimation of FCB, or more specifically the likelihood of
confirmation within a 30 min period has not been systematically
reviewed. Certainly, field13 and laboratory studies14 have suggested a
relationship between mosquito biting pressure or density and time to
first bite or FCB, respectively.  By extension, similar effects are
expected for the likelihood of a confirmatory bite within any 30 min
period (also see A4). Likewise, Barnard’s15 observation that parity
and age interact to increase the likelihood of biting at the point of
FCB suggests that mosquito based factors might also influence these
probabilities.

Q3 Can the impact of such factors on the likelihood or timing of an
initial and confirming event be predicted?  Can it be quantified?

A3. The impact on the above-listed factors on the likelihood and timing
of a first and confirming bite can be predicted and quantified.  For
example, we can reasonably predict that moderate-level exercise will
attenuate product performance thereby resulting in a (probabilistic)
systematic decrease in the time of the first and subsequent bites.
Similarly, we can design a set of protocols to evaluate the phenomena
and to quantify (a posteriori) the effect for that specific suite of
experimental circumstances.

However, given the lack of standardization between studies, the paucity
of research specifically directly towards evaluation of the
above-mentioned factors and the complexity of the test system,
elaboration of anything more than a very basic general model is not
possible.

Section 2 – Validity of intermittently sampling to determine FCB

At its June 27 - 29, 2007 meeting the Board learned that different
designs with different “length-biased” sampling for mosquito
repellent field studies are in use.  One design exposes subjects to
potential mosquito landings for one minute of every 15 minutes; another
design exposes subjects to potential mosquito landings for five minutes
of every 30 minutes.  The DFO is separately providing a CD containing
the background materials for the June 27 – 29, 2007 HSRB meeting.  The
protocols are loaded on the CD.  These designs have different
“length-biased” sampling.

Q4. What is the methodological rationale for the two different designs?

Periodic exposure to mosquito attack is a procedural norm in
peer-reviewed and published field studies that use RP as an endpoint.
Alternative approaches include continuous exposure to elaborate RP
and/or FCB, or various approaches using survivorship analyses.  To my
knowledge, intermittent exposure of treated subjects to establish FCB
has not been used widely in field studies.

From a guidelines perspective, the recent draft US EPA guideline on
repellent testing would seem to allow for intermittent exposure in the
field even where FCB is the endpoint2. However, previous EPA doctrine as
well as other relevant guidelines17,18 indicate exposure in the field is
to be continuous or suggest RP as the appropriate endpoint19.

I can only speculate on the methodological rationale for use of
intermittent exposure where FCB is the endpoint.  It might provide
logistic advantage where multiple subjects are being screened, or could
reflect an extension from laboratory approaches where intermittent
exposure appears to be more generally accepted2,16,17.

From an analytic perspective, caution is warranted where FCB is
calculated on the basis of non-continuous field exposure because it
reduces biting pressure by a factor equivalent to: 1/(1-proportional
decrease in exposure). The upshot (where RP < 100%) is a decrease in the
probability of receiving a first and confirmatory bite in any 30 min
period. In other words, intermittent exposure should systematically
overestimate FCB compared against continuous exposure.  To illustrate
this point, I have modeled the likelihood of FCB failure during any 30
min period under several scenarios:

continuous exposure of treated subjects to mosquito attack

intermittent exposure for 10 min/30 min (i.e. two 5-min periods)

intermittent exposure for 3 min/30 min (i.e. three 1-min periods)

It is assumed that: biting pressure is at the EPA minimum of one
bite/min2,16 or higher, RP is 75% or 95%; the probability of a given
mosquito biting is 1-RP; 0 mosquitoes have bitten at time 0; and biting
probability is binomially distributed (NOTE: using a Poisson-based
approach yields virtually identical results).

Outcomes are shown in the figure (pg. 10) and demonstrate that, within
the model construct, intermittent exposure can substantially reduce the
probability of seeing a FCB at a given RP. For example, at a RP of 75%
(well below the EPA RP standard of 95%2,16) and a biting pressure of one
bite/min, the probability of a FCB is <20% with intermittent exposure
totaling 3 min over 30 min compared to a probability approaching 100%
for continuous exposure. Similarly, at the higher RP of 95%, the
probability of a FCB can be more than 10 times less during intermittent
compared against continuous exposure.

It should be pointed out that the above model represents a simple
approach to analyzing and representing concerns about FCB and sampling
interval.  While useful conceptually, it has not been validated
(experimentally or statistically) or elaborated (e.g., for periods > 30
min) and hence should not be construed to represent anything more the
simple illustrative model intended.

Q5. Which design is used more widely in the field? Why?

A5. As indicated in Q4, these designs have not been widely used in
peer-reviewed and published field studies evaluating repellent
performance.

Q6. Can potential effects of variation in the pattern of intermittent
exposure on the results of efficacy testing be isolated from the effects
of other variables?  If so, can the direction or magnitude of the
effects be predicted?  How might these influences be analyzed and
accounted for in collecting, reporting and analyzing repellent efficacy
data?

A6. Outside of theoretical probability models, the present peer-reviewed
and published database for repellent testing is not sufficient to allow
for elaboration of general quantitative models describing the impact of
intermittent exposure on the results of efficacy tests. Specific
characterizations, for example by comparing in the same field procedure
the estimates of FCB derived through intermittent versus continuous
exposure, are possible (but, to my knowledge, have not been done).

Given the absence of a robust framework to characterize the impact of
intermittent exposure on FCB-based outcomes, development of specific
advice on how to analyze and account for the impact of intermittent
exposure on estimates of FCB is not possible. General approaches that
might be appropriate include: internal standardization within a given
experiment by benchmarking intermittent FCB results against those
derived from continuous exposure; adjust upwards minimum biting pressure
requirements to offset reduced exposure intervals, and; abandon the
approach and instead evaluate performance based on intermittent or
continuous exposure for RP and/or continuous exposure for FCB.

Section 3 – Alternative endpoints to FCB

Dr. Matt Kramer, a USDA statistician who has served as a consultant, has
suggested that the precision of estimates of Complete Protection Time
(CPT) in repellent testing could be significantly increased by defining
a failure of efficacy as the mean time from treatment to a series of
several landings or bites.  He has stated:

The precision of CPT increases when it is estimated beyond time to
[First Confirmed Bite] FCB or FCLanding.  How well CPT can be estimated
depends on the distribution of so many bites beyond FCB.  The number of
mosquitoes that will bite (n) will determine results of the test.  Each
person in the field should be his/her own control; that way it is
possible to know n per person, and reduce person-to-person variability.

If using the mean time to the first 5 bites, the SE will decrease
proportionally as n increases (n = 5 in this case).  That is equivalent
to an increase in the power of the test of 5 times.  This method allows
for detecting formulation differences near the CPT.

Q7. Does this approach, indeed, increase the precision of estimates of
CPT markedly without requiring additional subjects?

A7. The above proposal is difficult to judge in the absence of a more
detailed description.  Nevertheless, the following comments are
provided:

The proposal is not directly comparable to FCB unless the suggestion is
for an endpoint of 5 versus 2 bites within a 30-min period.  This change
would actually decrease sensitivity for detecting product differences
over at least part of the range of possible biting pressures.

Presuming the intent is to have an endpoint of 5 cumulative bites over x
period, performance might be expressed as: timing of the 5th bite;
arithmetic mean time for all 5 bites; or another measure such as mean
timing of bites based on survivorship analyses. The latter two
approaches likely would improve precision, at least when compared
against a measure solely based on time to first bite. Whether or not
this in turn would yield useful additional statistical power cannot be
determined on the basis on the information provided.

If 5 cumulative bites over x period is the measure of interest, then the
proposed approach seems similar to measuring RP, albeit where outcomes
are censored on the basis of a maximum number of bites.  In this vein,
it is informative that estimates of RP do not appear to be especially
sensitive where detection of product-based differences is the goal.
Admittedly, most evaluations to date have been limited to conventional
statistical analyses. More robust experimental design or analytic
techniques might yield greater sensitivity.

The above discussion begs the question: what level of difference in
protection time is biologically, operationally, or economically
meaningful? We3 have previously argued that substantial advantage might
not be gained by designing experiments to be able to detect small
variations in repellent performance.  Rather, procedures that are
adequately powered to detect rather large differences (e.g., 20% or
greater) in performance might be sufficient, or even preferable.

Q8. If so, would this increased precision justify the incremental risk
to the subjects resulting from their exposure to a greater number of
mosquito landings?

A8. This question is difficult to answer because risks and benefits
change with experimental, epidemiological and societal context.  For
example, exposure to several additional mosquito bites during a
repellent test in North America likely does not appreciably/meaningfully
change the risk that an individual will be infected with an arbovirus.
At the same time, a marginal increase in precision in a repellent trial
or protection time estimate is unlikely to provide
appreciable/meaningful benefit to society.

Q9. Is it practical to test long-lasting repellents to the point of five
landings?

A9. Yes.  Indeed, multiple bites or landings are the norm where RP is
the endpoint.

REFERENCES

HSRB. 2007. Discussion questions for mosquito repellent studies. October
4, 2007.

EPA. 2006. OPPTS 810.3700. Product performance of skin-applied
repellents of insects and other arthropods. Draft Guideline.

Schofield S, Tepper M, Gadawski R. 2007. Field evaluation against
mosquitoes of regular and polymer-based deet formulations in Manitoba,
Canada, with comment on methodological issues. J Med Entomol. 44:457-62.

Schofield S, Tepper M, Gadawski R. In press. Laboratory and field
evaluation of the impact of exercise on the performance of regular and
polymer-based deet repellents. J Med Entomol.

Barnard DR. 2000. Repellents and toxicants for personal protection.
Position paper. World Health Organization – Pesticide Evaluation
Scheme (pgs 26-27).    HYPERLINK
"http://whqlibdoc.who.int/hq/2000/WHO_CDS_WHOPES_GCDPP_2000.5.pdf"
http://whqlibdoc.who.int/hq/2000/WHO_CDS_WHOPES_GCDPP_2000.5.pdf

Insect Repellents. Principles, Methods and Use. 2007. CRC Press, New
York (Chapters 5, 6, 12).

Frances SP, Waterson DG, Beebe NW, Cooper RD.  2004. Field evaluation of
repellent formulations containing deet and picaridin against mosquitoes
in Northern Territory, Australia. J Med Entomol. 41:414-7.

Frances SP, Cooper RD, Popat S, Beebe NW. 2001. Field evaluation of
repellents containing deet and AI3-37220 against Anopheles koliensis in
Papua New Guinea. J Am Mosq Control Assoc. 17:42-4.

Klun JA, Strickman D, Rowton E, Williams J, Kramer M, Roberts D, Debboun
M. 2004. Comparative resistance of Anopheles albimanus and Aedes aegypti
to N,N-diethyl-3-methylbenzamide (Deet) and
2-methylpiperidinyl-3-cyclohexen-1-carboxamide (AI3-37220) in laboratory
human-volunteer repellent assays. J Med Entomol. 41:418-22.

Rutledge LC, Gupta RK, Piper GN, Lowe CA. 1994. Studies on the
inheritance of repellent tolerances in Aedes aegypti. J Am Mosq Control
Assoc. 10:93-100.

Rutledge LC, Moussa MA, Lowe CA and Sofield RK. 1978. Comparative
sensitivity of representative mosquitoes (Diptera: Culicidae) to
repellents. J Med Entomol. 14:536-541.

Moore SJ, Davies CR, Hill N, Cameron MM. 2007. Are mosquitoes diverted
from repellent-using individuals to non-users? Results of a field study
in Bolivia. Trop Med Int Health. 12:532-9.

Granett P. 1940. Studies of mosquito repellents, I. Test procedure and
method of evaluating test data. J Econ Entomol. 33: 563-65

Barnard DR, Posey KH, Smith D, Schreck CE. 1998. Mosquito density,
biting rate and cage size effects on repellent tests. Med Vet Entomol.
12:39-45.

Barnard DR. 1998. Mediation of deet repellency in mosquitoes (Diptera:
Culicidae) by species, age, and parity. J Med Entomol. 35:340-3.

EPA. 1999. OPPTS 810.3700. Product performance test guidelines –
insect repellents for human skin and outdoor premises.

Pest Management Regulatory Agency, Health Canada. 1995.  Draft Efficacy
Assessment Guidelines: Personal repellents. Ottawa.

American Society for Testing and Materials. E 939-94 (Reapproved 2006).
Field testing topical applications of compounds as repellents for
medically important and pest arthropods (including insects, ticks and
mites): 1. Mosquitoes.

WHOPES. 1996. Report of the WHO informal consultation on the evaluation
and testing of insecticides (96.1). Geneva.

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[Federal Register Volume 82, Number 164 (Friday, August 25, 2017)]
[Notices]
[Page 40619]
[FR Doc No: 2017-18002]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: National Air
Tour Safety Standards

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
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information collection. FAA regulations set safety and oversight rules
for a broad variety of sightseeing and commercial air tour flights to
improve the overall safety of commercial air tours by requiring all air
tour.

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ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
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addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
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this information collection, including (a) Whether the proposed
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FOR FURTHER INFORMATION CONTACT: Barbara Hall at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

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was published on June 19, 2017 (82 FR 27951). There were no comments.
FAA regulations set safety and oversight rules for a broad variety of
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    Issued in Washington, DC, on August 21, 2017.
Ronda L. Thompson,
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[FR Doc. 2017-18002 Filed 8-24-17; 8:45 am]
 BILLING CODE 4910-13-P