[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28270-28276]
[FR Doc No: 2012-11602]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0421; FRL-9346-7]

Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

DATES: This regulation is effective May 14, 2012. Objections and
requests for hearings must be received on or before July 13, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0421. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Olga Odiott, 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. To access the
OCSPP test guidelines referenced in this document electronically,
please go http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

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-2010-0421 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 13, 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-2010-0421, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 23, 2010 (75 FR 35803) (FRL-8831-
3), 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 0F7709)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-
3528. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide fluxapyroxad, 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, in or on multiple commodities. That notice
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing. Based on EPA's review of the data supporting the
petition, BASF Company revised their petition (PP 0F7709) by:
    1. Proposing tolerances for corn, pop, grain; corn, sweet kernels
plus cobs with husks removed; and wheat, grain;
    2. Decreasing or increasing the proposed tolerances for various
commodities;
    3. Deleting the proposed tolerance for vegetable, root, subgroup 1A
and proposing a tolerance for beet, sugar; and
    4. Proposing a tolerance for oilseeds, group 20.
    The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with 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 fluxapyroxad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluxapyroxad 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.
    Fluxapyroxad is of low acute toxicity by the oral, dermal and
inhalation routes, is not irritating to the eyes and skin, and is not a
dermal sensitizer. The primary target organ for fluxapyroxad exposure
via the oral route is the liver with secondary toxicity in the thyroid
for rats only. Liver toxicity was observed in rats, mice, and dogs,
with rats as the most sensitive species for all durations of exposure.
In rats, adaptive effects of hepatocellular hypertrophy and increased
liver weights and changes in liver enzyme activities were first
observed. As the dose or duration of exposure to fluxapyroxad
increased, clinical chemistry changes related to liver function also
occurred, followed by hepatocellular necrosis, neoplastic changes in
the liver, and tumors. Thyroid effects were observed only in rats.
These effects were secondary to changes in liver enzyme regulation,
which increased metabolism of thyroid hormone, resulting changes in
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were not observed in species other than
rats or in organs other than the liver and thyroid.
    In accordance with the EPA's Final Guidelines for Carcinogen Risk
Assessment (March, 2005), fluxapyroxad is classified as ``Not likely to
be Carcinogenic to Humans'' based on convincing evidence that
carcinogenic effects are not likely below a defined dose range:
     No treatment-related tumors were seen in male or female
mice when tested at doses that were adequate to assess carcinogenicity
(including the Limit Dose);
     Treatment-related liver tumors were seen in male rats at
doses >=250 parts per million (ppm) (11 milligrams/kilogram/day (mg/kg/
day)) and in female rats at doses >=1,500 ppm (82 mg/kg/day);
     Treatment-related thyroid follicular cell tumors were seen
in male rats only at doses >=1,500 ppm (68 mg/kg/day);
     There is no mutagenicity concern from in vivo or in vitro
assays;
     The hypothesized mode of action (i.e., a non-genotoxic)
for each tumor type (i.e., the liver and thyroid) was supported by
adequate studies that clearly identified the sequence of key events,
dose-response concordance and temporal relationship to the tumor types.
The mode of action met the criteria established by the Agency.
    The Agency has determined that the chronic population adjusted dose
(cPAD) will adequately account for all chronic effects, including
carcinogenicity, that could result from exposure to fluxapyroxad.
    No evidence of neurotoxicity was observed in response to repeated
administration of fluxapyroxad. An acute neurotoxicity study showed
decreased rearing and motor activity. This occurred on the day of
dosing only and in the absence of histopathological effects or
alterations in brain weights.

This indicated that any neurotoxic effects of fluxapyroxad are likely
to be transient and reversible due to alterations in neuropharmacology
and not from neuronal damage. There were no neurotoxic effects observed
in the subchronic dietary toxicity study. No evidence of reproductive
toxicity was observed. Developmental effects observed in both rats and
mice (thyroid follicular hypertrophy and hyperplasia in rats and
decreased defecation, food consumption, body weight/body weight gain,
and increased litter loss in rabbits) occurred at the same doses as
those that caused adverse effects in maternal animals, indicating no
quantitative susceptibility. Since the maternal toxicities of thyroid
hormone perturbation in rats and systemic toxicity in rabbits likely
contributed to the observed developmental effects there is low concern
for qualitative susceptibility. An immunotoxicity study in mice showed
no evidence of immunotoxic effects from fluxapyroxad.
    Subchronic oral toxicity studies in rats, developmental toxicity
studies in rabbits, and in vitro and in vivo genotoxicity studies were
performed for fluxapyroxad metabolites F700F001, M700F002, and
M700F048. Like fluxapyroxad, no genotoxic effects were observed for any
of these metabolites. All three metabolites displayed lower subchronic
toxicity via the oral route than fluxapyroxad, with evidence of non-
specific toxicity (decreased body weight) observed only for M700F0048
at the limit dose. Only M700F0048 exhibited developmental toxicity at
doses similar to those that caused developmental effects in rabbits
with fluxapyroxad treatment. However, these effects (abortions and
resorptions) were of a different nature than for fluxapyroxad (paw
hyperflexion) and are considered secondary to maternal toxicity. The
Agency considers these studies sufficient for hazard identification and
characterization and concludes that these metabolites do not have
hazards that exceed those of fluxapyroxad in nature, severity, or
potency.
    Specific information on the studies received and the nature of the
adverse effects caused by fluxapyroxad 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 ``Fluxapyroxad: Human Health Risk
Assessment for Use of New Active Ingredient on Cereal Grains, Legume
Vegetables (Succulent and Dry), Oil Seed Crops (Canola and Sunflower),
Peanuts, Pome Fruit, Stone Fruit, Root and Tuber Vegetables (Potatoes
and Sugar Beets), Fruiting Vegetables, and Cotton,'' at page 39 in
docket ID number EPA-HQ-OPP-2010-0421-0005.

B. Toxicological Points of Departure/Levels of Concern

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

  Table--Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 125 mg/kg/    aRfD = 1.25 mg/kg/   Acute neurotoxicity study in rats.
 including infants and children,    day.                  day.                LOAEL = 500 mg/kg/day based on
 and Females 13-49 years of age).  UFA = 10x...........  aPAD = 1.25 mg/kg/    decreased motor activity (both
                                   UFH = 10x...........   day.                 sexes) and decreased rearing
                                   FQPA SF = 1x........                        (males only)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All               NOAEL= 2.1 mg/kg/day  cRfD = 0.021 mg/kg/  Chronic toxicity/carcinogenicity
 populations)..                    UFA = 10x...........   day..                study in rats.
                                   UFH = 10x...........  cPAD = 0.021 mg/kg/  LOAEL = 11 mg/kg/day based on non-
                                   FQPA SF = 1x........   day.                 neoplastic changes in the liver
                                                                               (foci, masses)
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal,              Classification: Not likely to be carcinogenic to humans at doses sufficient
 inhalation)..                      to induce liver and/or thyroid tumors. Quantification of risk using a non-
                                    linear approach (i.e., RfD) will adequately account for all chronic
                                    toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, tolerance level residues adjusted to account for
metabolites of concern, 100 percent crop treated (PCT) assumptions, and
Dietary Exposure Evaluation Model (DEEM) default and empirical
processing factors were used.
    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, a moderately refined
chronic dietary exposure analysis was performed. An assumption of 100
PCT, and DEEM default and empirical processing factors were used for
the chronic dietary analysis. Highest average field trial (HAFT)
residues for parent plus metabolite were used for all plant
commodities. For livestock commodities, tolerance level residues
adjusted to account for metabolites of concern were used.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to fluxapyroxad. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the acute
dietary assessment for fluxapyroxad. Tolerance level residues and 100
PCT information were assumed for all food commodities. For the chronic
dietary assessment tolerance level residues and 100 PCT information
were assumed for livestock commodities. HAFT residues for parent plus
metabolite were used for all plant commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluxapyroxad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluxapyroxad. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and the
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluxapyroxad for
acute exposures are estimated to be 14.1 parts per billion (ppb) for
surface water and 0.087 ppb for ground water. For chronic exposures the
EDWCs are estimated to be 6.7 ppb for surface water and 0.087 ppb for
ground water. Modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model. The EDWCs of 14.1 ppb
for surface water and 0.087 ppb for ground water were used for the
acute and the chronic dietary assessments, respectively.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fluxapyroxad is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluxapyroxad to share a common mechanism of
toxicity with any other substances, and fluxapyroxad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluxapyroxad 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. No evidence of quantitative
susceptibility was observed in a reproductive and developmental
toxicity study in rats or in developmental toxicity studies in rats and
rabbits. Developmental toxicity data in rats showed decreased body
weight and body weight gain in the offspring at the same dose levels
that caused thyroid follicular hypertrophy/hyperplasia in parental
animals. Effects in rabbits were limited to paw hyperflexion, a
malformation that is not considered to result from a single exposure
and that usually reverses as the animal matures. Developmental effects
observed in both rats and rabbits occurred at the same doses as those
that caused adverse effects in maternal animals, indicating

no quantitative susceptibility. The Agency has low concern for
developmental toxicity because the observed effects were of low
severity, were likely secondary to maternal toxicity, and demonstrated
clear NOAELs. Further, the NOAELs for these effects were at dose levels
higher than the points of departure selected for risk assessment for
repeat-exposure scenarios. Therefore, based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to prenatal and/or postnatal toxicity.
    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 fluxapyroxad is complete.
    ii. There is no indication that fluxapyroxad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Neither the acute or
the subchronic neurotoxicity studies indicated specific neurotoxicity
responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid
hormone levels, the Agency considered the potential for fluxapyroxad to
cause developmental neurotoxicity as a result of thyroid hormone
disruption, which is more sensitive endpoint than the endpoints used in
a developmental neurotoxicity study. Based on its evaluation of thyroid
hormone data submitted for fluxapyroxad and the ontogeny of thyroid
hormone metabolism, the Agency has determined that adverse thyroid
hormone disruptions in the young are unlikely to occur at dose levels
as low as the points of departure chosen for risk assessment. The
Agency has low concern for neurotoxic effects of fluxapyroxad at any
life stage.
    iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues or field trial residue data.
The dietary risk assessment is based on reliable data, is conservative
and will not underestimate dietary exposure to fluxapyroxad. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluxapyroxad in drinking water.
These assessments will not underestimate the exposure and risks posed
by fluxapyroxad.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluxapyroxad will occupy 6% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluxapyroxad from food and water will utilize 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fluxapyroxad.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluxapyroxad
is not registered for any use patterns that would result in short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD.
    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). Fluxapyroxad is not registered for any use patterns that would
result in intermediate-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD.
    5. Aggregate cancer risk for U.S. population. In accordance with
the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005),
EPA classified fluxapyroxad as ``Not likely to be Carcinogenic to
Humans'' based on convincing evidence that carcinogenic effects are not
likely below a defined dose range. The Agency has determined that the
quantification of risk using the cPAD for fluxapyroxad will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from exposure to fluxapyroxad. As noted above, chronic exposure
to fluxapyroxad from food and water will utilize 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
    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 fluxapyroxad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/
MS) method is available as an enforcement method. This method uses
reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient
elution, and includes 2 ion transitions to be monitored for the parent
and the metabolites M700F008 and M700F048, so the method also serves as
the confirmatory method.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

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

C. Revisions to Petitioned-For Tolerances

    Based on EPA's review, BASF Company revised their petition (PP
0F7709) by:
    1. Proposing tolerances for corn, pop, grain; corn, sweet kernels
plus cobs with husks removed; and wheat, grain. Tolerances for these
commodities were originally proposed as part of the respective crop
group tolerances, but the Agency determined that separate tolerances
are needed because of differences between the needed tolerances and the
proposed crop group tolerances.
    2. Decreasing or increasing the proposed tolerances for various
commodities.
    3. Deleting the proposed tolerance for vegetable, root, subgroup 1A
and proposing a tolerance for beet, sugar. The submitted data are not
sufficient to support a tolerance for the proposed subgroup 1A, but it
supports a tolerance for beet, sugar.
    4. Deleting tolerances that the Agency determined are not needed
and/or are covered by other proposed tolerances.
    5. Proposing a tolerance for oilseeds, group 20. The registrant had
proposed tolerances for all the representative commodities for crop
group 20 and the submitted data supports establishment of the group
tolerance.
    The Agency concluded that based on the residue data these changes
are required to support the proposed uses. The Agency analyzed the
field trial data for the respective commodities using the Organization
for Economic Cooperation and Development tolerance calculation
procedures to determine the appropriate tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad,
3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, as requested in the revised petition.

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 the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 2, 2012.
Steven Bradbury,
Director, 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. Add Sec.  180.666 to subpart C to read as follows:

Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide fluxapyroxad, including its metabolites and degradates, in or
on the commodities listed in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-
biphenyl]-2-yl)-1H-pyrazole-4-carboxamide in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace..........................................        2.0
Beet, sugar................................................        0.1
Beet, sugar, dried pulp....................................        0.1
Beet, sugar, tops..........................................        7.0
Cattle, fat................................................        0.05
Cattle, meat...............................................        0.01
Cattle, meat byproducts....................................        0.03
Corn, field, grain.........................................        0.01
Corn, oil..................................................        0.03
Corn, pop, grain...........................................        0.01
Corn, sweet, kernels plus cobs with husks removed..........        0.15
Cotton, gin byproducts.....................................        0.01
Cotton, undelinted seed....................................        0.01
Egg........................................................        0.002
Fruit, pome, group 11......................................        0.8
Fruit, stone, group 12.....................................        2.0
Goat, fat..................................................        0.05

Goat, meat.................................................        0.01
Goat, meat byproducts......................................        0.03
Grain, aspirated fractions.................................       20.0
Grain, cereal, group 15, (except corn, field, grain; except        3.0
 corn, pop, grain; except corn, kernels plus cobs with
 husks removed; except wheat)..............................
Grain, cereal, forage, fodder and straw, group 16..........       20
Horse, fat.................................................        0.05
Horse, meat................................................        0.01
Horse, meat byproducts.....................................        0.03
Milk.......................................................        0.005
Oilseeds, group 20.........................................        0.9
Pea and bean, dried shelled except soybean, subgroup 6C....        0.4
Pea and bean, succulent shelled, subgroup 6B...............        0.5
Peanut.....................................................        0.01
Peanut, refined oil........................................        0.02
Plum, prune................................................        3.0
Potato, wet peel...........................................        0.1
Rice, bran.................................................        4.5
Rice, hulls................................................        8.0
Sheep, fat.................................................        0.05
Sheep, meat................................................        0.01
Sheep, meat byproducts.....................................        0.03
Soybean, hulls.............................................        0.3
Soybean, seed..............................................        0.15
Vegetable, foliage of legume, group 7......................       30
Vegetables, fruiting, group 8..............................        0.7
Vegetable, legume, edible podded, subgroup 6A..............        2.0
Vegetable, tuberous and corm, subgroup 1C..................        0.02
Wheat, bran................................................        0.6
Wheat, grain...............................................        0.3
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-11602 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 77 (Tuesday, April 21, 2020)]
[Notices]
[Pages 22197-22200]
[FR Doc No: 2020-08386]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88654; File No. SR-OCC-2020-004]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change To Modify the Sequence for
Processing Options Transactions

April 15, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 6, 2020, the Options Clearing Corporation (``OCC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by OCC. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    This proposed rule change by OCC would amend Interpretations and
Policies .04 to Rule 801 and Interpretations and Policies .04 to Rule
805 to describe a proposed change to the sequence in which options
transactions are processed, as described below. The proposed changes to
OCC's Rules are included in Exhibit 5 of the filing. Material proposed
to be added to OCC's Rules as currently in effect is marked by
underlining and material proposed to be deleted is marked with
strikethrough text. All terms with initial capitalization that are not
otherwise defined herein have the same meaning as set forth in the By-
Laws and Rules.\3\
---------------------------------------------------------------------------

    \3\ OCC's By-Laws and Rules can be found on OCC's public
website: http://optionsclearing.com/about/publications/bylaws.jsp.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(1) Purpose
Background
    OCC currently processes all securities and commodity futures
options transactions in the following order: \4\
---------------------------------------------------------------------------

    \4\ A ``commodity future'' is defined in Article I(c)(24) of By-
Laws as ``a futures contract within the exclusive jurisdiction of
the Commodity Futures Trading Commission that is traded on, through
the facilities of, or subject to the rules of a futures market.''
Options on securities futures currently do not exist.

Options Processing Sequence for All Accounts
    Opening Buys
    Opening Sells
    Closing Buys
    Exercises
    Closing Sells
    Assignments

    Based on discussions with Clearing Members, OCC is proposing to
modify the sequence in which options transactions are processed at OCC
for all account types to provide that all sell transactions are
processed before exercises (i.e., closing sells would be processed
before exercises under the proposed change).\5\ For instance, for

securities options transactions, this proposal would change the order
in which such transactions are processed in ``customers' accounts,''
``firm accounts,'' and ``Market-Maker accounts'' such that all sell
transactions are processed prior to exercises.\6\ OCC is proposing to
amend Interpretations and Policies .04 to Rule 801 and Interpretations
and Policies .04 to Rule 805 to reflect this change in the processing
sequence for options transactions.
---------------------------------------------------------------------------

    \5\ Opening buys increase long positions and closing sells
decrease long positions. Opening sells increase short positions and
closing buys decrease short positions.
    \6\ OCC Clearing Members hold omnibus accounts at OCC for
customer positions (i.e., a ``customers' account'' as defined in
Article I, Section 1.C.(37) of the By-Laws) to the extent they
conduct a customer business. They also hold omnibus accounts at OCC
for non-customer positions (i.e., a ``firm account'' as defined in
Article I, Section 1.F.(6) of the By-Laws) to the extent they
conduct a proprietary business. To the extent they clear for Market-
Makers, they also hold ``Market-Maker accounts'' as defined in
Article I, Section 1.M.(1) of the By-Laws.
---------------------------------------------------------------------------

    This proposed change is made possible by increased proficiency in
Clearing Member position processing and is intended to help Clearing
Members comply with certain exchange requirements that are described
below.\7\ OCC's current processing sequence was adopted at a time when
trade processing was a far different process than it is today. OCC used
to receive a batch file from each exchange at the end of the trading
day showing the trades that had been executed on the exchange that day.
OCC would then process those trades on a batch basis prior to the open
of trading the following business day. Now, OCC receives, and Clearing
Members can see, trades executed on an exchange on a near real-time
basis.\8\ Clearing Members utilize this information as well as certain
tools provided by OCC (described below) to balance exercise notices
against existing long positions during the trading day.
---------------------------------------------------------------------------

    \7\ The proposed rule change also is designed to help facilitate
the ability to run OCC's current clearing system, known as ENCORE,
in parallel with a new clearing system on which OCC is working, as
the proposed processing sequence is the one expected to be used in
the new clearing system. As OCC's core clearing system, ENCORE
processes trades received from OCC's participant exchanges and
settlements among OCC's Clearing Members.
    \8\ This functionality has been available in ENCORE since 2002.
---------------------------------------------------------------------------

Customers' and Firm Account Processing for Securities Options
Transactions
    As noted, OCC's current processing sequence has been in place for
many years and was designed when options transactions were processed on
a batch basis. It originally was designed to protect a Clearing Member
against the risk that an erroneously coded transaction could result in
the Clearing Member not exercising a customer's long position. In
particular, because the vast majority of customer securities options
positions are maintained on a gross basis at OCC, a miscoded sell
transaction of one customer could close out a long position in the same
series of another customer, thereby preventing that customer from
exercising that option.\9\ For example, Customer A and Customer B use
the same Clearing Member. Customer A wants to exercise a long position,
and on the same day Customer B directs the Clearing Member to execute
an opening sell. If the Customer B trade is erroneously marked as a
closing sell, the long position that Customer A seeks to exercise could
be closed out by that closing sell and thus be unavailable for
exercise.
---------------------------------------------------------------------------

    \9\ There are a small subset of customer and firm sub-accounts
that have elected to be held on a net basis. These accounts are
discussed below.
---------------------------------------------------------------------------

    Processing exercises before closing sells ensured that all intended
exercises would be processed irrespective of a mismarked customer
transaction. OCC believes this is no longer necessary due to increased
proficiency in Clearing Member position processing. In particular,
Clearing Members now have the ability to use certain functions provided
by OCC to confirm that submitted exercises have sufficient long
positions. These functions include a screen in OCC's ENCORE clearing
system called the Exercise screen that shows Clearing Members during a
trading day whether they have ``Insufficient Longs'' (i.e.,
insufficient long positions) for the exercise notices they have
received during that trading day.\10\ These functions also include
OCC's On Demand Position file (``ODP'') that allows Clearing Members
during a trading day to balance long positions versus exercises that
are received during that trading day to ensure that the Clearing
Members have sufficient long positions for those exercises. In
addition, they have the ability to correct open/close errors by
entering a position adjustment in ENCORE prior to exercises being
processed. In the example above, where Customer B's trade is
erroneously marked as a closing sell, Customer A's long position could
be closed out by that closing sell and thus be unavailable for
exercise. Position Adjustments allow a firm to correct open/close
errors associated with a trade. This correction functionality can only
be used for non-critical aspects of a trade and cannot be used, for
instance, to change the price, symbol or other critical aspects of a
trade.
---------------------------------------------------------------------------

    \10\ See supra note 7.
---------------------------------------------------------------------------

    Clearing Members have indicated that they believe this change will
help them comply with certain exchange rules that require customers to
only exercise ``outstanding'' net long positions. As an example, BATS
Rule 23.1(a) provides that, ``an outstanding options contract may be
exercised during the time period specified in the Rules of [OCC] by the
tender to [OCC] of an exercise notice in accordance with the Rules of
[OCC].'' \11\ BATS Rule 16.1(a)(43) defines ``outstanding'' as ``an
options contract which has been issued by [OCC] and has neither been
the subject of a closing writing transaction nor has reached its
expiration date.'' Clearing Members have indicated that issues could
arise under the rule in situations where a customer position is subject
to conflicting closing sale and exercise instructions, which could lead
to a position being exercised that was intended to be closed out under
OCC's current processing sequence.
---------------------------------------------------------------------------

    \11\ See also FINRA Rule 2360(b)(23), NYSE American Options Rule
980(a), and NYSE Arca Rule 6.24-O(a).
---------------------------------------------------------------------------

Market Maker and Other Net Account Processing for Securities Options
Transactions
    The processing sequence set forth above for customer and firm
accounts also applies to Market-Maker accounts held by Clearing
Members. Market-Maker accounts, however, are held on a net basis. This
means that at the end of each trading day, OCC nets offsetting
positions in the same options series in each Market-Maker account.\12\
Prior to 2014, this netting occurred at the end of the processing
sequence immediately before assignments.
---------------------------------------------------------------------------

    \12\ A few Clearing Members have established the functionality
to designate sub-accounts within their omnibus customer and firm
accounts held at OCC. These sub-accounts are established for a
specific customer or joint back office account and the account
holders can elect to hold these accounts on a net basis to assist
with the position reconciliation process. When the account holders
elect to hold the accounts in this manner, they are subject to the
same netting process to which Market-Maker accounts are subject. See
Interpretation and Policy .04 to Article VI, Section 3 of OCC's By-
Laws.
---------------------------------------------------------------------------

    In response to operational risk concerns related to the processing
of dividend play transactions by Market-Makers, a modification to OCC's
systems was approved by OCC's Board of Directors to insert a step in
the processing sequence that would limit Market-Maker exercises to net
long positions.\13\ From a systems perspective,

this change was implemented by moving up the netting in the processing
sequence such that it occurred before exercises, as set forth below.
---------------------------------------------------------------------------

    \13\ A dividend play is a trading strategy that historically was
primarily engaged in by Market-Makers and involved buying and
selling an equal number of call options right before a dividend date
on the underlying equity and exercising the long call options with
the goal of capturing the dividend on the underlying equity.

Options Processing Sequence for Market Maker and Other Net Accounts
    Opening Buys
    Opening Sells
    Closing Buys
    Net Positions in Net Accounts (location after 2014 change)
    Exercises
    Closing Sells
    [Net Positions in Net Accounts (location prior to 2014 change)]
    Assignments

    From a Rules perspective, this change was implemented by adopting
Interpretations and Policies .04 to Rule 801 and Interpretations and
Policies .04 to Rule 805.\14\ In relevant part, these provisions
provide that, ``[w]ith respect to any Market-Maker account, the
Corporation shall process sell transactions in respect of option
contracts prior to exercises in respect of such contracts.'' Despite
this rule text, as indicated in the net processing sequence list
immediately above, closing sells continued to be processed after
exercises for Market-Maker and other net accounts after the 2014
change. As described below, the proposed change to the options
processing sequence that is the subject of this rule filing would
modify the sequence for all accounts, including Market-Maker and other
net accounts, such that closing sells would be processed before
exercises.
---------------------------------------------------------------------------

    \14\ See Exchange Act Release No. 73438 (October 27, 2014), 79
FR 64843 (October 31, 2014) (SR-OCC-2014-15).
---------------------------------------------------------------------------

Customer and House Account Processing for Options on Commodity Futures
    While OCC currently uses the same processing sequence for options
on commodity futures, OCC understands that futures customers and
Clearing Members are indifferent to the processing sequence for futures
transactions. Futures firms submit very few trades marked as closing
transactions, and as a result, are accustomed to submitting nightly
adjustments to correct their open interest. This process reduces the
potential of an exercise error since the firms verify their long
positions on a daily basis.
Proposed Change to Processing Sequence
    OCC proposes to modify the processing sequence for all securities
and futures options transactions for all account types to process all
closing sell transactions prior to all exercise transactions. The
proposed processing sequence is set forth below.

Proposed Options Processing Sequence for All Accounts
    Opening Buys
    Opening Sells
    Closing Buys
    Closing Sells
    Exercises
    Assignments

    For Market-Maker and other accounts held on a net basis, OCC
proposes to net offsetting positions after closing sells but before
exercises. Each Market-Maker account is held individually (i.e., on a
Market-Maker by Market-Maker basis) at a Clearing Member on a net
basis, unlike customer accounts. Holding each Market-Maker account in
this manner helps with the position reconciliation process at Market-
Makers and allows them to see a single net position in each options
series for risk management purposes.
    OCC has discussed the proposed change with its Clearing Members at
the OCC Roundtable, which is an OCC-sponsored advisory group comprised
of representatives from OCC's participant exchanges, a cross-section of
OCC Clearing Members, and OCC staff, and during regular monthly
operations update calls with Clearing Members and exchanges.\15\ OCC
also issued Information Memos on its public website to inform Clearing
Members of the proposed change.\16\ Based upon the feedback from these
discussions, OCC believes that its current processing sequence for
options transactions no longer needs to be designed to protect Clearing
Members from errors in customers' accounts that would result in closing
out a position that was intended to be exercised. As noted, Clearing
Members have increased their position processing proficiency and can
now use OCC tools to confirm that submitted exercises have sufficient
long positions. They also have the ability to correct any errors prior
to exercises being processed. Clearing Members also have indicated that
they believe this change will help them comply with certain exchange
rules that require customers to exercise only ``outstanding'' net long
positions. By processing all buys and sells prior to exercises, they
believe that the proposed change would help address situations in which
a customer position is subject to conflicting closing sale and exercise
instructions, which could lead to a position being exercised that was
intended to be closed out under the current processing sequence.
---------------------------------------------------------------------------

    \15\ OCC provided supplemental materials to its Clearing Members
after the August 2019 Monthly Operations Update meeting to help
illustrate the proposed change in the processing sequence. OCC
provided these materials as Exhibit 3A to File No. SR-OCC-2020-004.
    \16\ See OCC Information Memo #45781, dated October 9, 2019, and
Information Memo #46129, dated December 10, 2019. OCC provided these
Information Memos as Exhibits 3B and 3C to File No. SR-OCC-2020-004.
---------------------------------------------------------------------------

(2) Statutory Basis
    Section 17A(b)(3)(F) of the Act \17\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities and derivatives
transactions. OCC believes that the proposed rule change will promote
the prompt and accurate clearance and settlement of securities
transactions. In this regard, the proposed rule change would provide
for the processing of closing sell transactions prior to exercises,
which OCC's Clearing Members have indicated would help promote
compliance with exchange rules noted above that require that only
outstanding options positions be exercised. As indicated above, OCC's
system no longer needs to be designed to protect Clearing Members from
customer transaction marking errors in which a sell transaction is
miscoded as a closing sell transaction. The near real-time processing
of options transactions by OCC and OCC tools have helped Clearing
Members increase their position processing proficiency. The proposed
change to the position processing sequence would result in OCC's system
allowing only net long positions to be exercised in all accounts,
including individual customer accounts. This result is designed to
promote compliance with exchange rules and further the goal of
promoting the prompt and accurate clearance and settlement of
securities transactions.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    In addition, the proposed rule change is not inconsistent with the
existing By-Laws and Rules of OCC, including any rules proposed to be
amended.

(B) Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act \18\ requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the Act. OCC does not believe that the
proposed

rule change would impact or impose any burden on competition. The
proposed rule change would not affect the competitive dynamics between
Clearing Members in that it would apply to all Clearing Members
equally. The proposed rule change also would not inhibit access to
OCC's services or disadvantage or favor any particular user in
relationship to another. In this regard, as described above, the
proposed rule change is designed to further facilitate the prompt and
accurate clearance and settlement of securities transactions. It would
change the processing sequence so that closing sells are processed
before exercises, which would ensure from a systematic perspective that
only net long positions can be exercised.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2020-004 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-OCC-2020-004. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of OCC and on OCC's website at
https://www.theocc.com/about/publications/bylaws.jsp.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly.
    All submissions should refer to File Number SR-OCC-2020-004 and
should be submitted on or before May 12, 2020.
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08386 Filed 4-20-20; 8:45 am]
BILLING CODE 8011-01-P


                             SUPPORTING STATEMENT                                       for                                         Application for Merchant Mariner Credential (MMC), Application for Merchant Mariner Medical Certificate, Application for Merchant Mariner Medical Certificate for Entry Level Ratings, Small Vessel Sea Service Form, DOT/USCG Periodic Drug Testing Form, Disclosure Statement for Narcotics, DWI/DUI, and/or Other Convictions, Merchant Mariner Medical Certificate, Recognition of Foreign Certificate                                                                   OMB CONTROL NO.:  1625-0040                                         COLLECTION INSTRUMENTS:  CG-719B, CG-719K, CG-719K/E, CG-719S, CG-719P, CG-719C.

A.  JUSTIFICATION

1.  Explain the circumstances that make the collection of information necessary.

Title 46, Code of Federal Regulations (CFR), parts 10, 11, 12, 13, and 16, and International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended (STCW Convention) and the STCW Code, including the STCW Final Rule (Docket No. USCG-2004-17914) published on December 24, 2013, mandate that each applicant for a Merchant Mariner Credential (MMC) or Medical Certificate make written application to the Coast Guard (CG-719B); present a completed Coast Guard physical examination report (CG-719K or CG-719K/E) executed by a physician, attesting to the applicant's medical fitness to perform the functions for the credential sought; provide documentary evidence of sea service on vessels (CG-719S); provide evidence of having passed a chemical test for dangerous drugs (CG-719P); and as needed, provide a statement for Narcotics, DWI/DUI, and/or Other Convictions (CG-719C).

The changes to the forms in this collection are not associated with new statutory or regulatory authority, but rather improvements to the flow and quality of content, user functionality, and to aid the Coast Guard in processing applications.

2.  Indicate how, by whom, how frequently, and for what purposes the information is to be used and the consequence to the Federal program or policy activities if the collection of information was not conducted.

The Coast Guard will evaluate the collection of information against applicable statutes, regulations and policies solely for the purposes of determining eligibility for issuance of an MMC and/or Medical Certificate.  This evaluation is performed on occasion, meaning as submitted by the respondent when he or she applies for an MMC or Medical Certificate every year, 2 years, or 5 years, as applicable.  Per the CFR, the Coast Guard requires the information to process applications and issue MMCs or Medical Certificates to applicants who can prove their medically qualified, and whose background, training and certifications can be verified to ensure security and safety related requirements are met.  This information assists the Coast Guard in its effort to help secure U.S. ports, waterways, marine infrastructure, and marine-related commercial activities, including international trade, by protecting the Merchant Mariner Credentialing Program from abuse or fraud.  Additionally, much of the information collected is stored in the Merchant Mariner Licensing and Documentation database, which is used during the evaluation of future MMC and Medical Certificate applications.

3.  Describe whether the collection of information involves the use of automated collection techniques.

The forms under this collection are available in a .pdf-fillable version.  The Coast Guard continues to work towards developing a system that will allow respondents to submit electronically.  The Coast Guard implemented email submission of application packages to Regional Examination Centers (RECs) in January 2010.  The Coast Guard also accepts submissions by fax and mail.

4.  Describe efforts to identify duplication.

As the requirements for a Coast Guard MMC and Medical Certificate are unique and very specific, no duplication of information collected is known.  The forms within this collection are the only instruments available that specifically address the requirements for issuance of a Coast Guard MMC or Medical Certificate. No other Federal, State, or Local agencies collect this information.

5.  If the collection of information impacts small businesses or other small entities describe the methods used to minimize burden.

The information collection does not impact small businesses.

6.  Describe the consequences to the Federal program or policy activities if the collection were not conducted or conducted less frequently.

The Coast Guard is mandated by law to issue MMCs and Medical Certificates to individuals found qualified as to age, character, habits of life, experience, professional qualifications, and physical fitness.  Without the ability to collect this information the Coast Guard would not be able to adhere to statutory and regulatory requirements.

7.  Explain any special circumstances.

No special circumstances exist for this collection of information.

8.  Solicitation of Comments.

A 60-day Notice will be published in the Federal Register to obtain public comment on this collection.

9.  Explain any decision to provide any payment or gift to respondents.

No payments or gifts are provided to respondents.

10.  Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

Confidentiality is provided to respondents via a System of Records, 65 FR 19476-01, dated April 11, 2000.

11.  Provide additional justification for any questions of a sensitive nature.

There is no "sensitive nature" information collected.

12.  Provide estimates of the hour burden of the collection of information.

On average, the Coast Guard receives approximately 56,500 applications (CG-719B) annually.  An application (CG-719B) itself takes approximately 9 minutes to complete, and may be e-mailed, faxed, mailed or hand carried to a Regional Examination Center for processing.  Applications are either accompanied by a CG-719K (18 minutes to complete/ used by ~80% of respondents) or CG-719K/E (10 minutes to complete/used by ~20% of respondents), which provide information for determining an applicant's fitness for duty as a merchant mariner.  In addition, it is estimated that another 12,000 mariners will apply for the Medical Certificate annually by completing the CG-719K (~80%) or CG-719K/E (~20%).  The CG-719P (5 minutes to complete) and CG-719S (15 minutes to complete) are typically submitted with the applicant's application as documentary evidence of having passed a chemical test for dangerous drug and evidence of sea service on vessels.  The CG-719C, which is a new instrument in this collection, can be used when an applicant must disclose use of narcotics, DWI/DUI, and/or other convictions (10 minutes to complete).  The CG-719C was created as an optional form to assist respondents who are legally required to disclose information to the Coast Guard.

The burden associated with the additional 12,000 respondents (CG-719K & CG-719K/E) discussed in the paragraph above was overlooked and not accounted for in the last Supporting Statement, but is accounted for in the table below.

Based on the table below, the total burden hours will be approximately 47,444, an increase of 3,186 from the previously approved Supporting Statement.

The estimate cost of the hour burden is $1,488,508.06 ($22.41 (wage data retrieved using U.S. BLS website) * 1.4 (loaded factor) * 47,444 hours).

CG-719B

Annual applications (CG-719B) completed: 56,500 Time to complete a CG-719B: 9 minutes  Original Burden Hours:  8,475 Notification of Change from previous renewal:   0 Additional Burden Hours: 0 New Total Burden Hours for CG-719B: 8,475 CG-719K

Estimated number of Application for Merchant Mariner Medical Certificate (CG-719K) (45,200 (80% of 56,500) + 9,600 (80% of 12,000/STCW)): 54,800  Time to complete a CG-719K: 18 minutes Original Burden Hours: 13,560 Notification of Change from previous renewal: 2,880 Additional Burden Hours: 2,880 New Total Burden Hours CG-719K: 16,440 CG-719K/E

Estimated number of Application for Merchant Mariner Medical Certificate for Entry Level Ratings (CG-719K/E) (11,300 (20% of 56,500) + 2,400 (20% of 12,000/STCW)): 13,700 Time to complete 1 CG-719K/E: 10 minutes Original Burden Hours: 3,390 Notification of Change from previous renewal: 1,107 Additional Burden Hours: 0 New Total Burden Hours CG-719K/E: 2,283 CG-719S

Estimated number of Small Vessel Sea Service Forms completed (CG-719S): 56,500 Time to complete 1 CG-719S: 15 minutes Original Burden Hours: 14,125  Notification of Change from previous renewal: 0 Additional Burden Hours: 0 New Total Burden Hours for CG-719S: 14,125 CG-719P

Estimated number of DOT/USCG Periodic Drug Testing Forms (CG-719P): 56,500 Time to complete 1 CG-719P: 5 minutes Original Burden Hours: 4,708 Notification of Change from previous renewal: 0 Additional Burden Hours: 0 New Total Burden Hours for CG-719P: 4,708  CG-719C

Estimated number of Disclosure Statement for Narcotics, DWI/DUI, and/or other Convictions (CG-719P) (15% of 56,500): 8,475 Time to complete 1 CG-719C: 10 minutes Original Burden Hours: 0 Notification of Change from previous renewal: 1,413 Additional Burden Hours: 1,413 New Total Burden Hours for CG-719C: 1,413 New Total Burden Hours (CG-719B + CG-719K + CG-719K/E + CG-719S + CG-719P + CG-719C)  47,444

13.  Provide estimates of the total annual cost burden to respondents.

There are no annualized capital and start-up costs.

14.  Provide estimates of annualized cost to the Federal Government.

Expense Type Expense Explanation

Annual Costs (dollars) Direct Costs to the Federal Government Evaluation of forms (point of receipt to approval or rejection of forms) $11,394,464

Merchant Mariner License and Documentation database  $800,000

Shipping costs $14,993

Safety and Suitability databases $31,303

Subtotal, Direct Costs to the Government $12,240,760 Contractor Expenses In-Processing of forms/Production of credential $2,488,896

Subtotal, Contracted Services $2,488,896

TOTAL COST TO THE GOVERNMENT $14,729,656

15.  Explanation for Program Changes or Adjustments.

There is no change in burden.  There is no proposed change to the reporting or recordkeeping requirements of this collection.  The reporting and recordkeeping requirements, and the methodology for calculating burden, remain unchanged.

16.  For collection of information whose results will be published.

There are no current plans to use the information for statistical purposes.

17.  If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that displaying the expiration date would be inappropriate.

The OMB expiration date will be displayed on the CG-719B, CG-719K, CG-719K/E, CG-719S, CG-719P, and CG-719C, however, the CG-4610, CG-4610A, and CG-4610B are static credentials and certificates that are controlled and produced by the Coast Guard on a requested/approved basis.

18.  Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act Submission".

There are no exceptions.

B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS.

This information is not collected through the use of statistical methods.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

11/19/15

MEMORANDUM

SUBJECT: Test Procedure Review with Cummins, Volvo, Navistar, Paccar,
Daimler Eaton and Allison

FROM: James Sanchez

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards
for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents communication on November 19, 2015 between
representatives of Cummins, Volvo, Navistar, Paccar, Eaton, Allison,
Daimler and EPA to discuss heavy-duty test procedures proposed in the
Phase 2 greenhouse gas and fuel efficiency standards for heavy-duty
vehicles notice of proposed rulemaking.  The draft presentations are
enclosed.

EPA presented results from testing conducted at EPA’s National Vehicle
and Fuel Emissions Laboratory.  The results showed the performance of a
few numerical schemes to interpolate and extrapolate data from the
alternative engine mapping procedure.

Participants:

Cummins – Jackie Yeager, Manik Narula

Eaton – Erik Dykes

EPA – Houshun Zhang, James Sanchez

Navistar – Cortney Guzlas, Dave Gardner

PACCAR – Dan Kieffer, Erin Luke, Mark Malowicki

Allison – Mike Howenstein

Volvo – Tony Greszler, Marc Miller

Daimler – Anirban Sett

Discussion and follow-up items (with owner's name in bold):

Cycle average map procedure – All

Reviewed updated draft of 1036.540

Default transmission gear ratios represent two different 6 speed
automatics – question about applicability across all the vehicle
categories; so far N13 testing has not shown issue

EMTC recommending to prescribe test order for more repeatable results

Procedure currently assumes use of Part 1065 regression analysis
criteria for cycle validation

Frequency of zero/span/check has not been set in procedure yet but
testing has used 40 minutes

How is SEA or confirmatory test run?

Send the latest draft procedure to the group – James

Engine testing at EPA – James

Reviewed results from Volvo D13 500 and 400 hp engine tests

Evaluating various regression models: linear with cross terms, fuel mass
and bsfc, engine speed (N) and torque (T) instead of N/V and cycle work

Does % error have same meaning whether fuel mass or bsfc?

Share slides presented today – James

Topics for future calls:

(12/3) Cycle average map procedure (continued) – All

(12/3) Half-hill cycle results – Erik

(12/3) SwRI testing update – Houshun

(TBD) ISB child results on 55/65 cycles – Houshun

(Tentative) PACCAR results on use of fuel mass vs. bsfc in powertrain
map – Costi/Mark


[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4806-4807]
[FR Doc No: 2014-01691]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0081]

Qualification of Drivers; Application for Exemption; Implantable
Cardioverter Defibrillator

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

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA has received applications from three individuals with
implantable cardioverter defibrillators (ICDs) for an exemption from
the cardiovascular disease standard in the Federal Motor Carrier Safety
Regulations (FMCSRs). The Agency's current advisory criteria for the
applicable FMCSR recommends that CMV drivers with ICDs should not be
qualified due to the likelihood of causing a loss of ability to operate
a commercial motor vehicle (CMV) safely. If granted, an exemption would
allow these individuals with ICDs to operate a CMV in interstate
commerce.

DATES: Comments must be received on or before February 28, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2012-0081 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Charles Horan, Director, Office of
Carrier, Driver, and Vehicle Safety Standards<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-(306), 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

    FMCSA has the authority to grant exemptions from the FMCSRs;
pursuant to 49 U.S.C. 31315 and 31136(e) as amended by Section 4007 of
the Transportation Equity Act for the 21st Century (TEA- 21) [Pub. L.
105-178, June 9, 1998, 112 Stat. 107, 401]. On August 20, 2004, FMCSA
published a final rule implementing the changes made by section 4007
(69 FR 51589). The current regulations require FMCSA to publish a
notice of each exemption request in the Federal Register. The Agency
must provide the public with an opportunity to inspect the information
relevant to the application, including any safety analyses that have
been conducted. The Agency must also provide an opportunity for public
comment on the request (49 CFR 381.315(a)).
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)). If the Agency denies the request, it must state the reason
for doing so. If the Agency decision is to grant the exemption, the
notice must specify the person or class of persons receiving the
exemption and the regulatory provision or provisions from which an
exemption is granted. The notice must also specify the effective period
of the exemption (up to 2 years) and explain the terms and conditions
of the exemption. If granted, the exemption may be renewed (49 CFR
381.315(c) and 381.300(b)).
    The three individuals included in this notice have each requested
an exemption from the provisions of 49 CFR 391.41(b)(4), which applies
to drivers who operate CMVs in interstate commerce, as defined in 49
CFR 390.5. Section 391.41(b)(4) states that:

``. . . a person is physically qualified to drive a commercial motor
vehicle if that person has no current clinical diagnosis of
myocardial infarction, angina pectoris, coronary insufficiency,
thrombosis, or any other cardiovascular disease of a variety known
to be accompanied by syncope (temporary loss of consciousness due to
a sudden decline in blood flow to the brain), dyspnea (shortness of
breath), collapse, or congestive cardiac failure.''

    The FMCSA provides medical advisory criteria as recommendations for
use by medical examiners in determining whether drivers with certain
medical conditions, procedures, and/or treatments should be certified
to operate CMVs in interstate commerce in accordance with the various
physical qualification standards in 49 CFR part 391, subpart E. The
advisory criteria are currently set out as part of the medical
examination report published with 49 CFR 391.43. The advisory criteria
for section 391.41(b)(4) provide that:

    The term ``has no current clinical diagnosis of'' is
specifically designed to encompass: ``a clinical diagnosis of'' (1)
a current cardiovascular condition, or (2) a cardiovascular
condition which has not fully stabilized regardless of the time
limit. The term ``known to be accompanied by'' is designed to
include a clinical diagnosis of a cardiovascular disease (1) which
is accompanied by symptoms of syncope, dyspnea, collapse or
congestive cardiac failure; and/or (2) which is likely to cause
syncope, dyspnea, collapse, or congestive cardiac failure. It is the
intent of the FMCSRs to render unqualified, a driver who has a
current cardiovascular disease which is accompanied by and/or likely
to cause symptoms of syncope, dyspnea, collapse, or

congestive cardiac failure. However, the subjective decision of
whether the nature and severity of an individual's condition will
likely cause symptoms of cardiovascular insufficiency is on an
individual basis and qualification rests with the medical examiner
and the motor carrier.

    In the case of persons with ICDs, the underlying condition for
which the ICD was implanted may place the driver at risk for syncope (a
transient loss of consciousness) or other gradual or sudden
incapacitation that may result in loss of ability to safely control a
CMV. When an ICD deploys, the driver experiences a loss of ability to
safely control a CMV. See the conference report on Cardiovascular
Advisory Panel Guidelines for Medical Examination of Commercial Motor
vehicle Drivers at 94-95 (2002).\1\
---------------------------------------------------------------------------

    \1\ Now available at http://www.fmcsa.dot.gov/documents/cardio.pdf (retrieved July 22, 2013).
---------------------------------------------------------------------------

Individual Applications for Exemption--Qualifications

James Dean

    Mr. Dean is a 53 year old CMV driver who holds a class A and a
class D commercial driver's license (CDL) from the State of Wisconsin.
He has driven a CMV for over 29 years. Mr. Dean had an ICD placed due
to ventricular tachycardia and a low ejection fraction which improved.
The device deployed in 2011. Mr. Dean would like to continue to drive a
truck in interstate commerce.

Mark Steiner

    Mr. Steiner is a 64 year old CMV driver who holds a class A CDL
from the state of Ohio. He has driven a CMV for 38 years. Mr. Steiner
had angioplasty and stent placement after he had a heart attack while
driving (first cardiac event in his life) in January 2012. The ICD was
placed preventively in November 2012 after he completed cardiac
rehabilitation. The device has not deployed. Mr. Steiner would like to
continue to drive a truck in interstate commerce.

Craig Bohms

    Mr. Bohms is a 57 year old owner operator of a CMV who holds a
class A commercial driver's license (CDL) from the State of Illinois.
According to Mr. Bohms, following a heart attack in April 2013 he was
implanted with an ICD. In an August 2013 letter that was submitted by
Mr. Bohms electrophysiologist (EP) physician, he stated ``Mr. Bohms was
implanted with an ICD as a preventative measure to protect him from
possible ventricular tachycardia . . . from an EP standpoint, Mr. Bohms
is able to drive and return to work without restrictions''. Mr. Bohms
would like to continue to drive a truck in interstate commerce.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA may grant an
exemption if it makes a finding that the exemption ``would likely
achieve a level of safety that is equivalent to or greater than that
would be achieved absent such an exemption.'' FMCSA requests public
comment from all interested persons on the exemption application
described in this notice. In accordance with 49 U.S.C. 31315(b)(4), and
49 CFR 381.315(b) and (d), the safety analysis or assessment, and other
supporting information is available for examination and review. The
Agency will consider all comments received before the close of business
February 28, 2014. Comments will be available for examination in the
docket at the location listed under the ADDRESSES section of this
notice. The Agency will file comments received after the comment
closing date in the public docket, and will consider them to the extent
practicable. In addition to late comments, FMCSA will also continue to
file, in the public docket, relevant information that becomes available
after the comment closing date. Interested persons should monitor the
public docket for new material.

    Issued on: January 10, 2014.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2014-01691 Filed 1-28-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67457-67458]
[FR Doc No: 2021-25850]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-423-000]

Columbia Utilities Power Business LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Columbia Utilities Power Business LLC's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 9, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link.

Enter the docket number excluding the last three digits in the docket
number field to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact the Federal Energy Regulatory Commission
at [email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.

    Dated: November 19, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-25850 Filed 11-24-21; 8:45 am]
BILLING CODE 6717-01-P