[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49301-49302]
[FR Doc No: 2015-20187]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0373]

Qualification of Drivers; Exemption Applications; Narcolepsy

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denial of exemption applications.

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SUMMARY: FMCSA announces its decision to deny applications from three
individuals seeking exemptions from the prohibitions against operating
a commercial motor vehicle (CMV) in interstate commerce by persons
with: (1) Either a clinical diagnosis of epilepsy or any other
condition that is likely to cause a loss of consciousness or any loss
of ability to operate a CMV safely, or (2) a mental, nervous, organic,
or functional disease or psychiatric disorder likely to interfere with
his/her ability to drive a commercial motor vehicle safely. FMCSA has
statutory authority to exempt individuals from certain parts of the
Federal Motor Carrier Safety Regulations, if the exemptions granted
will not compromise safety. The Agency must conclude that granting
these exemptions provides a level of safety that will be equivalent to
or greater than the level of safety maintained without the exemptions
for these CMV drivers. Based on a review of the applications and
following an opportunity for public comment, FMCSA has concluded that
the individuals did not demonstrate that they could achieve a level of
safety that is equivalent to, or greater than, the level of safety that
would be obtained by complying with the regulation.

DATES: This decision is effective July 24, 2015.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan III, Director, Office
of Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>, or via
email at<EMAIL_ADDRESS>or by letter FMCSA, Room W64-224,
Department of Transportation, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' FMCSA can renew exemptions at the end of each
2-year period. The three individuals listed in this notice have each
requested such an exemption from the physical qualification
requirements in 49 CFR 391.41(b)(8) and (b)(9), which applies to
drivers of CMVs in interstate commerce. Accordingly, the Agency
evaluates the qualifications of each applicant to determine whether
granting an exemption will achieve the required level of safety
mandated by statute.
    Narcolepsy is a chronic neurological disorder caused by autoimmune
destruction of hypocretin-producing neurons inhibiting the brain's
ability to regulate sleep-wake cycles normally. Persons with narcolepsy
experience frequent excessive daytime sleepiness, comparable to how
non-narcoleptics feel after 24 to 48 hours of sleep deprivation, as
well as disturbed nocturnal sleep, which often is confused with
insomnia. See NIH Narcolepsy Fact Sheet at www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm.
    The Agency considered the topic of narcolepsy and the potential
impact on commercial drivers in a 2009 Evidence Report. The Evidence
Report ``Narcolepsy (with and without cataplexy) and Commercial Motor
Vehicle Driver Safety'' addressed several key questions.\1\
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    \1\ Evidence Report: Narcolepsy (with and without cataplexy) and
Commercial Motor Vehicle Driver Safety; October 6, 2009.
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    Key Question 1: Are individuals with narcolepsy (with and without
cataplexy) at an increased risk for a motor vehicle crash when compared
to comparable individuals without the disorder?
    Key Question 2: Do currently recommended treatments for narcolepsy
reduce the risk for a motor vehicle crash?
    Key question 2 was further divided into several questions
concerning the impact of various medication therapies for narcolepsy on
driver safety. The complete report is included in the docket FMCSA
2014-0373.
    The evidence report reviewed studies from the available literature
and evaluated outcomes on measures of Excessive Daytime Sleepiness
(EDS), cataplexy, event rate, measures of cognitive and psychomotor
function, and driving performance. For key question 1, the currently
available evidence (both direct and indirect) supports the contention
that drivers with narcolepsy are at an increased risk for a motor
vehicle crash when compared to otherwise similar individuals who do not
have the disorder. The strength of the evidence was rated as strong.
The direct evidence (from three crash studies) (study quality rating of
``Low'') conducted with non-CMV drivers showed that individuals with
narcolepsy are at an increased risk for a crash compared to individuals
who do not have narcolepsy. The indirect evidence (studies of driving
tests and driving simulation, quality rating ``moderate''), examined
factors associated with simulated driving outcomes, (driving
performance, tracking error, fewer correct responses and more instances
of going out of bounds compared to healthy controls). In summary, while
there are limitations in the quality of the studies that examined
direct crash risk in the evidence base, all study results showed a
strong effect size and statistical significance. Indirect evidence of
crash provides strong support for the direct crash study findings.
Based upon available information, there is strong evidence that non-
commercial drivers with narcolepsy are at an increased risk of crash.
    Concerning key question 2 and its sub-questions, the American
Academy of Sleep Medicine (AASM) and the European Federation of
Neurological Societies recommend modafinil as the first-line of
treatment and

methylphenidate as the second-line of treatment. The AASM also
recommends amphetamine, methamphetamine, or dextroamphetamine as
alternative second-line treatments. No studies that directly examined
the impact of treatment with modafinil, armodafinil, sodium oxybate
(used with narcolepsy with cataplexy), or anti-depressants on crash
risk or driving performance were identified during the literature
searches. Evidence-based conclusions pertaining to treatment with these
medications on crash risk and driving performance could not be drawn.
    Currently available evidence suggests that amphetamines and/or
methylphenidate are effective in improving symptoms of EDS in
individuals with narcolepsy (quality of studies range from ``moderate
to low''). However, these improvements do not result in levels of
daytime sleepiness that can be considered to be normal in the vast
majority of individuals. Evidence-based conclusions pertaining to the
impact of treatment with amphetamines, methylphenidate, or other
related stimulant drugs on cognitive and psychomotor function among
individuals with narcolepsy cannot be drawn at this time.
    In January 2010, the FMCSA's Medical Review Board (MRB) recommended
that individuals with narcolepsy be ineligible for a commercial
driver's license, even with treatment.\2\
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    \2\ Medical Review Board Meeting; January 6, 2010; http://www.mrb.fmcsa.dot.gov/documents/Final_Jan_6_2010_MRB_Meeting_Summary.pdf.
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Discussion of Public Comments

    The FMCSA published the names of three individuals seeking
exemption in a Federal Register Notice, on April 17, 2015, and
requested public comment. The public comment period closed on May 18,
2015. A total of 17 commenters responded. The majority of commenters
were in favor of the applicants continuing to drive CMV's with
Narcolepsy. Fourteen commenters consisting mainly of private citizens
stated that the individual drivers listed in the notice were
responsible drivers, were stable and compliant with their medication
therapy, had safe driving histories, and believed that the individuals
would continue to be safe drivers while on medication The State of New
York's medical consultants reviewed the docket and suggested that
drivers with narcolepsy be allowed to operate commercially only if they
have been treated medically and have been event-free for at least one
year. Three commenters did not support exemption for drivers with
narcolepsy. One anonymous commenter encouraged the FMCSA not to grant
exemptions to these individuals due to concerns of the high risk of the
underlying medical condition in combination with operating a large CMV.

FMCSA Response

    To evaluate the effects of these exemption requests on safety,
FMCSA reviewed and considered the content of each request individually
and all comments received.
    FMCSA acknowledges comments received attesting that individual
applicants are responsible drivers currently on a stable therapeutic
regimen which includes medication therapy. The Agency considered
available medical and scientific data concerning medication therapy for
narcolepsy. As discussed in the background section of this notice,
evidence-based conclusions pertaining to treatment with medications on
crash risk and driving performance could not be drawn.
    Concerning ATAs comments recommending granting fewer exemptions and
revising the current medical standards, FMCSA acknowledges ATA's
concerns. The FMCSA has statutory authority (49 U.S.C. 31136(e) and
31315), to consider granting exemptions from the Federal Motor Carrier
Safety Regulations for a 2-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to or greater
than the level that would be achieved absent such exemption.'' The
FMCSA reviews its medical standards through the use of evidence
reports, various medical expert panels and the Agency's Medical Review
Board and proposes evidence-based revisions to the medical standards
through the rulemaking process which takes a considerable length of
time.
    The exemption process is the Agency's most viable alternative in
the short term to consider whether drivers with disqualifying medical
conditions and who are found to meet an equivalent level of safety,
should be permitted to operate in interstate commerce.

Conclusion

    FMCSA evaluated the three individual exemption requests on their
merits and available data from FMCSA's Evidence Reports, the Medical
Review Board recommendations and public comments received. The Agency
has determined that the available medical and scientific literature and
research provides insufficient data to enable the Agency to conclude
that granting the exemptions would achieve a level of safety equivalent
to or greater than the level of safety maintained without the
exemption. Each applicant has, prior to this notice, received a letter
of final disposition on his/her exemption request. Those decision
letters outlined fully the basis for the denial and constitute final
Agency action. The list published today summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4).
    The following three applicants are denied exemptions from the
physical qualification standards in [49 CFR 391.41(b)(8)] and [49 CFR
391.41(b)(9)]: Thomas Skagen, Charles Larry Peterson, and Stanley
Jandreau.

    Issued on: August 3, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-20187 Filed 8-14-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Rules and Regulations]
[Pages 20100-20105]
[FR Doc No: 2014-07820]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0576; FRL-9907-46]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluoxastrobin in or on wheat, grain; and revises tolerances for milk;
and milk, fat. Arysta LifeScience, North America, LLC, requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 11, 2014. Objections and
requests for hearings must be received on or before June 10, 2014, 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-2012-0576, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://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-2012-0576 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
June 10, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0576, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.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 February 27, 2013 (78 FR 13296) (FRL-
9380-2), EPA issued a document pursuant to

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of
a pesticide petition (PP 2F8130) by Arysta LifeScience, North America,
LLC, 15401 Weston Pkwy., Suite 150, Cary, NC 27513. The petition
requested that 40 CFR 180.609 be amended by establishing tolerances for
residues of the fungicide, fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its Z-isomer, (1Z)-[2-[[6-
(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, in or on wheat, grain at 0.15
parts per million (ppm). The petition also requested that 40 CFR
180.609 be amended by revising tolerances for milk from 0.02 ppm to
0.03 ppm; and milk, fat from 0.50 ppm to 0.75 ppm. That document
referenced a summary of the petition prepared by Arysta LifeScience,
North America LLC, the registrant, which is available in the docket,
http://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.

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 fluoxastrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluoxastrobin
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 repeated exposure, fluoxastrobin has mild or low toxicity
in all tested species except for the dog. Repeated oral administration
to dogs resulted in adverse liver toxicity at considerably lower doses
than those noted in other species. Based on species sensitivity, the
effects observed in the dog were used as endpoints for risk assessment.
In both the 90-day and one-year oral feeding studies in dogs, the liver
appeared to be the target organ. In dogs, mice, and rats, the kidney
was another target organ. There was no indication of an adverse effect
attributable to a single dose. Based on developmental toxicity studies
(rat and rabbit) and a two-generation reproduction study (rat), there
was neither increased susceptibility of pre-/postnatal exposure to
fluoxastrobin, nor adverse effects on reproduction. Furthermore, acute
neurotoxic effects were not seen in an acute neurotoxicity study in
rats up to the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day).
In a subchronic neurotoxicity study in rats, fluoxastrobin did not
elicit any neurotoxic effects. Repeated dose studies of fluoxastrobin
in the database did not show immunotoxic effects in rats. Results of
genotoxicity testing were negative and there were no treatment-related
carcinogenicity findings in adequately performed carcinogenicity
studies in rats and mice. Therefore, fluoxastrobin 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
fluoxastrobin 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,
``Fluoxastrobin. Aggregate Human Health Risk Assessment for the
Proposed New Uses on Melon Subgroup 9A and Sorghum, Along with
Establishment of Permanent Tolerances on Wheat, and Amendments to
Established Tolerances on Milk and Milk Fat'' on pages 26-31 in docket
ID number EPA-HQ-OPP-2012-0576.

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 the NOAEL and the LOAEL are identified.
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 fluoxastrobin used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary, Non-Occupational,
                                  and Occupational Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population    None: There is no indication of an adverse effect attributable to a single
 including infants and children)                         dose. An aRfD was not established.
 and Females 13-49 years of age.
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Chronic dietary (All populations)  NOAEL = 1.5 mg/kg/    Chronic RfD = 0.015  Chronic toxicity dog LOAEL = M/F
                                    day.                  mg/kg/day.           8.1/7.7 mg/kg/day based on body
                                   UFA = 10x...........  cPAD = 0.015 mg/kg/   weight reductions and
                                   UFH = 10x...........   day..                hepatocytomegaly and cytoplasmic
                                   FQPA SF = 1x........                        changes associated with increased
                                                                               serum liver alkaline phosphatase
                                                                               indicative of cholestasis.
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Incidental oral short-term (1 to   NOAEL = 3.0 mg/kg/    LOC for MOE = 100..  90-day subchronic dog LOAEL = M/F
 30 days) and Intermediate-term     day.                                       24.8/24.2 mg/kg/day based on dose-
 (1-6 months).                     UFA = 10x...........                        related reductions in net body
                                   UFH = 10x...........                        weight gain and food efficiency
                                   FQPA SF = 1x........                        in addition to toxicity findings
                                                                               in the liver (cholestasis) in
                                                                               both sexes, and kidneys
                                                                               (increased relative weights in
                                                                               females and degeneration of the
                                                                               proximal tubular epithelium in
                                                                               males).
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Dermal short-term (1 to 30 days).  None: There were no systemic or dermal toxicity findings in a 28-day dermal
                                    toxicity study in the rat up to the limit dose (1,000 mg/kg/day) and there
                                    were no developmental or neurotoxicity concerns raised in other studies.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6   NOAEL = 3.0 mg/kg/    Residential LOC for  90-day subchronic dog LOAEL = M/F
 months).                           day.                  MOE = 100.           24.8/24.2 mg/kg/day based on dose-
                                   dermal absorption     Occupational LOC      related reductions in net body
                                    factor = 2.3%..       for MOE = 100..      weight gain and food efficiency
                                                                               in addition to toxicity findings
                                                                               in the liver (cholestasis) in
                                                                               both sexes, and kidneys
                                                                               (increased relative weights in
                                                                               females and degeneration of the
                                                                               proximal tubular epithelium in
                                                                               males).
----------------------------------------------------------------------------------------------------------------
Inhalation \b\ Short-Term (1-30    NOAEL = 3.0 mg/kg/    Residential LOC for  90-day subchronic dog LOAEL = M/F
 days) and Intermediate-Term (1-6   day.                  MOE = 100.           24.8/24.2 mg/kg/day based on dose-
 months).                                                Occupational LOC      related reductions in net body
                                                          for MOE = 100..      weight gain and food efficiency
                                                                               in addition to toxicity findings
                                                                               in the liver (cholestasis) in
                                                                               both sexes, and kidneys
                                                                               (increased relative weights in
                                                                               females and degeneration of the
                                                                               proximal tubular epithelium in
                                                                               males).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
\a\ ``Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response
  data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures.'' NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern.
\b\ Toxicity by the oral route is assumed to be equivalent to the inhalation route. A subchronic inhalation
  toxicity study is not required for fluoxastrobin at this time. Although no subchronic inhalation data is
  available EPA has waived the data requirement. In determining the need for a subchronic inhalation study,
  EPA's weight of evidence decision process included both hazard and exposure considerations as well as
  incorporation of a presumed 10X Database Uncertainty Factor (UFdb) for the lack of this study. Specifically,
  with regard to exposure considerations, the Agency's Level of Concern in the evaluating the need for the
  subchronic inhalation study is a Margin of Exposure (MOE) of 1,000 for inhalation exposure, which includes the
  10X inter-species extrapolation factor, 10X intra-species variation factor, and the 10X UFdb. For
  fluoxystrobin, residential inhalation exposures resulted in MOEs higher than the LOC of 1,000 when using an
  oral Point of Departure (POD). This indicates that the lack of an inhalation study does not reduce the overall
  confidence in the risk assessment or result in an uncertainty (i.e., the study will not provide a POD
  sufficiently low to result in a risk of concern). Because EPA's decision to waive the subchronic inhalation
  study essentially incorporates an additional 10X UFdb (i.e. the study was only waived because risks were at
  least 10X lower than required by use of the inter- and intraspecies safety factors), a second additional 10X
  FQPA safety factor is not being retained for the protection of infants and children due to the absence of this
  study.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin 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. No such effects were
identified in the toxicological studies for fluoxastrobin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. A slightly refined chronic dietary exposure
assessment was performed for fluoxastrobin using tolerance-level
residues, average field trial residues, and 100 percent crop treated
(PCT). This risk assessment was conducted using

the DEEM-FCID Version 3.16. This model uses 2003-2008 food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluoxastrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fluoxastrobin. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluoxastrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluoxastrobin. 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. In
addition to evaluating the EDWCs from the proposed uses, EDWCs were
reevaluated for all existing uses with Pesticide Root Zone Model Ground
Water (PRZM-GW), which models continued use of fluoxastrobin over many
years. For the chronic dietary assessment, the most conservative EDWC
(137 [mu]g/L) was based on an existing turf use modeled with a 100 year
simulation of 100 years of repeated applications, using the highest
single maximum application rate and the highest yearly application
rate.
    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). Fluoxastrobin is
currently registered for the following uses that could result in
residential exposures: Spot treatment and/or broadcast control of
diseases on turf, including lawns and golf courses. EPA assessed
residential exposure using the following assumptions: Residential
handler exposure for adults is expected to be short-term only.
Intermediate-term and chronic exposures are not likely because of the
intermittent nature of applications by homeowners. Since there are no
toxicity findings for the short-term dermal route of exposure up to the
limit dose, the residential handler assessment only includes the
inhalation route of exposure. There is also potential for homeowners
and their families (of varying ages) to be exposed as a result of
entering areas that have previously been treated with fluoxastrobin.
Exposure might occur on areas such as lawns used by children or
recreational areas such as golf courses used by adults and youths.
Potential routes of exposure include dermal (adults and children) and
incidental oral ingestion (children). Since no acute hazard has been
identified, an assessment of episodic granular ingestion was not
conducted. Further information regarding EPA standard assumptions and
generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin 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. The available studies used
to evaluate pre- and postnatal exposure susceptibility do not indicate
increased susceptibility of rats or rabbits to fluoxastrobin. These
studies include the following:
    i. Developmental toxicity studies in rats.
    ii. Developmental toxicity studies in rabbits.
    iii. A 2-generation reproduction study in rats.
    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 fluoxastrobin is complete. EPA waived
the requirement for a subchronic inhalation data based on, among other
things, its conclusion that even if an additional 10X safety factor was
applied, inhalation exposure would not raise a risk of concern.
    ii. There is no indication that fluoxastrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The rat developmental study was tested up to the limit dose
(1,000 mg/kg/day), and the rabbit developmental study was tested up to
400 mg/kg/day (highest dose tested). At the highest dose tested, there
were decreases in food consumption and body weight in the maternal
animals, but there were no developmental effects. Furthermore, in the
rat reproduction study, there was no sensitivity in the offspring of
the pups relative to the parental animals.
    iv. The exposure databases are estimated based on data that
reasonably account for potential exposures. The chronic dietary food
exposure assessment was conservatively based on 100 PCT assumptions,
tolerance-level residues, and conservative ground and surface drinking
water modeling estimates. New 2012 Residential Standard Operating
Procedures (SOPs) were used to assess post-application exposure to
children including incidental oral exposure. The residential post-
application assessment assumes maximum application rates and
conservative day zero hand-to-mouth

activities. Although EPA has required additional data on transferable
residues from treated turf for fluoxastrobin, EPA is confident that it
has not underestimated turf exposure due to the conservativeness of the
default turf transfer value and conservative assumptions in the short-
term turf assessment procedures (e.g., assuming residues do not degrade
over the thirty day assessment period and assuming high-end activities
on turf for every day of the assessment period). All of the exposure
estimates for fluoxastrobin are based on conservative high-end
assumptions and are not likely to result in underestimated risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluoxastrobin from food and water will utilize 30% of the cPAD for the
general population, and 66% of the cPAD for all infants <1 year old,
the population subgroup with the highest estimated chronic dietary
exposure to fluoxastrobin. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
    Fluoxastrobin 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 fluoxastrobin. Because all
short- and intermediate-term quantitative hazard assessments (via the
dermal and incidental oral routes) for fluoxastrobin are based on the
same endpoint, a screening-level, conservative aggregate risk
assessment was conducted that combined the short-term incidental oral
and intermediate-term exposure estimates (i.e., the highest exposure
estimates) in the risk assessments for adults. The Agency believes that
most residential exposure will be short-term, based on the use pattern.
    There is potential short- and intermediate-term exposure to
fluoxastrobin via the dietary (which is considered background exposure)
and residential (which is considered primary) pathways. For adults,
these pathways lead to exposure via the oral (background), and dermal
and inhalation (primary) routes. For children, these pathways lead to
exposure via the oral (background), and incidental oral and dermal
(primary) routes.
    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 MOEs of 610 for adults
and 170 for children (1-2 years old). Because EPA's level of concern
for fluoxastrobin is a MOE of 100 or below, these MOEs are not of
concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. Method No. 00604 is available for plant commodities and
Method No. 00691 is available for animal commodities. 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 Codex MRLs established for fluoxastrobin. However,
there are Canadian MRLs established on sorghum and milk at 0.02 ppm,
milk fat at 0.15 ppm, wheat bran at 0.15 ppm, and wheat grain at 0.1
ppm. Furthermore, the Canadian tolerance expression is not harmonized
with the US tolerance expression. For plants and livestock, the
Canadian tolerance expression does not include the Z-isomer.

C. Response to Comments

    Two comments were received to the docket from members of the
public. Both comments were the same. The commenters objected to the
proposed tolerance on the ground that it would result in fluoride being
added to treated crops. The commenters offered no basis for this claim.
    The Agency reviewed all plant, livestock, and environmental
degradation data and determined that the fluorine will not be released
into the environment when applied to crops or non-agricultural areas.
Neither free fluorine nor de-fluorinated fluoxastrobin was observed in
food or water in any of the metabolism, degradation, and magnitude of
residue studies.

V. Conclusion

    Therefore, tolerances are established for residues of
fluoxastrobin, in or on wheat, grain at 0.15 ppm; and tolerances are
revised for milk and milk, fat at 0.03 ppm and 0.75 ppm respectively.
Additionally, the established tolerance for wheat bran at 0.15 ppm is
no longer needed and should be revoked because the recommended
tolerance of 0.15 ppm for wheat, grain will cover expected residues in
wheat bran.

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) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: March 28, 2014.
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. In Sec.  180.609:
0
a. Remove ``Wheat, bran'' from the table in paragraph (a)(1).
0
b. Add ``Wheat, grain'' in alphabetical order to the table in paragraph
(a)(1).
0
c. Revise ``Milk'' and ``Milk, fat'' in the table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

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

                                * * * * *
Wheat, grain............................................            0.15

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

    (2) * * *

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

                                * * * * *
Milk....................................................            0.03
Milk, fat...............................................            0.75

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

* * * * *
[FR Doc. 2014-07820 Filed 4-10-14; 8:45 am]
BILLING CODE 6560-50-P