[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Page 45673]
[FR Doc No: 2015-18806]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0013; OMB No. 1660-0008]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Elevation Certificate/Floodproofing
Certificate

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before August 31, 2015.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Janice Waller,
Acting Director, Records Management Division, 500 C Street SW.,
Washington, DC 20472-3100, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This information collection previously
published in the Federal Register on May 26, 2015 at 80 FRN 30091 with
a 60 day public comment period. FEMA received six comments.
    The purpose of this notice is to notify the public that FEMA will
submit the information collection abstracted below to the Office of
Management and Budget for review and clearance.

Collection of Information

    Title: Elevation Certificate/Floodproofing Certificate.
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0008.
    Form Titles and Numbers: FEMA Form 086-0-33, Elevation Certificate;
FEMA Form 086-0-34, Floodproofing Certificate for Non-Residential
Structures.
    Abstract: The Elevation Certificate and Floodproofing Certificate
are used in conjunction with the flood insurance application to rate
Post-FIRM budilings in Special Flood Hazard Areas. Post-FIRM buildings
are buildings contructed after the puslication of the initial Flood
Insurance Rate Map (FIRM) for the community.
    Affected Public: Individuals or households; Businesses or other
for-profits; Not-for-profit institutions; Farms; State, Local or Tribal
Governments.
    Estimated Number of Respondents: 9,322.
    Estimated Total Annual Burden Hours: 34,950.
    Estimated Cost: The estimated annual cost to respondents operations
and maintenance costs for technical services is $3,262,700. There are
no annual start-up or capital costs.

    Dated: July 28, 2015.
Janice Waller,
Acting Director, Records Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2015-18806 Filed 7-30-15; 8:45 am]
 BILLING CODE 9110-11-P


[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Notices]
[Page 18073]
[FR Doc No: 2021-07133]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2019-0008]

Ballard Marine Construction; Withdrawal of Application for
Variance and Revocation of Interim Order

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the revocation of the Interim
Order granted to the applicant, Ballard Marine Construction (Ballard),
from provisions of OSHA's standard for work in compressed air
environments, and further announces the applicant's withdrawal of the
application for a permanent variance.

DATES: The revocation of the interim order specified by this notice
becomes effective on April 7, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of Withdrawal of Application for Permanent Variance and
Revocation of Interim Order

    On January 19, 2021, OSHA granted Ballard an Interim Order (86 FR
5253), which permitted the employer to comply with alternative
conditions instead of complying with the requirements of the OSHA's
compressed air standard, 29 CFR 1926.803. Further, the Interim Order
stated that it was to remain in effect through the duration of the
Suffolk County Outfall Tunnel Project. Ballard notified OSHA by letter
dated February 17, 2021 (OSHA-2019-0008-0012) that its portion of the
Suffolk County Outfall Tunnel Project was complete, and that for this
reason, the applicant was withdrawing their application for a permanent
variance.
    OSHA hereby revokes the Interim Order granted to Ballard on January
19, 2021 (86 FR 5253).

II. Authority and Signature

    James S. Frederick, Principal Deputy Assistant Secretary of Labor
for Occupational Safety and Health, 200 Constitution Avenue NW,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the agency is issuing this notice pursuant to Section 29
U.S.C. 655(6)(d), Secretary of Labor's Order No. 8-2020 (85 FR 58393;
Sept. 18, 2020), and 29 CFR 1905.11.

    Signed at Washington, DC, on March 31, 2021.
James S. Frederick,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2021-07133 Filed 4-6-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Rules and Regulations]
[Pages 76676-76679]
[FR Doc No: 2023-24230]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2023-0272; FRL-11237-02-R8]

Air Plan Approval and Disapproval; Colorado; Serious Attainment
Plan Elements and Related Revisions for the 2008 8-Hour Ozone Standard
for the Denver Metro/North Front Range Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions and disapproving portions of a state implementation plan (SIP)
revision submitted by the State of Colorado to meet Clean Air Act (CAA)
requirements for the 2008 8-hour ozone national ambient air quality
standards (NAAQS) in the Denver Metro/North Front Range nonattainment
area (DMNFR Area). Specifically, the EPA is approving the submitted
enhanced monitoring SIP element as meeting applicable Serious area
requirements for the 2008 8-hour ozone NAAQS, and is disapproving the
contingency measure element of the SIP submittal. The EPA is taking
this action pursuant to the CAA.

DATES: This rule is effective December 7, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2023-0272. All documents in the dockets are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., 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 through https://www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Abby Fulton, Air and Radiation
Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver,
Colorado, 80202-1129, telephone number:<PHONE_NUMBER>, email address:
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' means the EPA.

I. Background

    The background and rationale for this action are discussed in
detail in our August 14, 2023 proposed rule and our Response to
Comments document for this action.\1\ In the proposed rule, we proposed
to approve the enhanced monitoring element and to disapprove the
contingency measures element of the March 22, 2021 8-hour ozone
attainment plan SIP submission from the State of Colorado for the DMNFR

Area. Additionally, we proposed to disapprove certain provisions
submitted by the State to meet reasonably available control technology
(RACT) requirements in SIP submissions from March 22, 2021 and May 20,
2022. Specifically, we proposed disapproval of the categorical RACT
rules for refinery fueled process heaters as well as landfill or biogas
fired reciprocating internal combustion engines and the State's RACT
determination for the Golden Aluminum facility. This action does not
take final action on the RACT portion of the proposal. EPA will take
final action on the RACT portion of the August 14, 2023 proposal via a
separate action.
---------------------------------------------------------------------------

    \1\ Proposed rule, Air Plan Approval and Disapproval; Colorado;
Serious Attainment Plan Elements and Related Revisions for the 2008
8-Hour Ozone Standard for the Denver Metro/North Front Range
Nonattainment Area, 88 FR 54975; the response to comments document
is in the docket.
---------------------------------------------------------------------------

II. Comments

    We received comments on the August 14, 2023 proposal from several
commenters: the Center for Biological Diversity, the Air Pollution
Control Division of the Colorado Department of Public Health and
Environment, William Weese Pepple & Ferguson on behalf of Suncor Energy
Inc., and one citizen. All comments received are in the docket for this
action. The comments included views concerning the timing, process, and
approach for EPA to act on Colorado's SIP submittals; supportive and
adverse comments related to our proposed action on the contingency
measures element; and adverse comments related to our proposed action
on certain RACT elements. A summary of the comments that are relevant
to this final action and the EPA's responses are provided in the
Response to Comments document, which is in the docket for this action.
Comments related to RACT will be addressed in a separate action.

III. Final Action

    The EPA is approving the enhanced monitoring portion of Colorado's
ozone attainment plan submitted on March 22, 2021 because we find that
it satisfies the requirements under CAA section 182(c)(1) for the DMNFR
Area with respect to the 2008 ozone NAAQS. We are disapproving the
contingency measures portion of Colorado's ozone attainment plan
submitted on March 22, 2021 because we find that it does not satisfy
the requirements under CAA sections 172(c)(9) or 182(c)(9) for the
DMNFR Area with respect to the 2008 ozone NAAQS. We will be finalizing
action on the RACT requirements in SIP submissions from March 22, 2021
and May 20, 2022 in a separate action. EPA has previously acted on all
other parts of these submittals.\2\
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    \2\ Final rule, Air Plan Approval, Conditional Approval, Limited
Approval and Limited Disapproval; Colorado; Serious Attainment Plan
Elements and Related Revisions for the 2008 8-Hour Ozone Standard
for the Denver Metro/North Front Range Nonattainment Area, 88 FR
29827 (May 9, 2023).
---------------------------------------------------------------------------

    Section 110(c)(1) of the CAA requires the Administrator to
promulgate a Federal implementation plan (FIP) at any time within two
years after the Administrator finds that a state has failed to make a
required SIP submission, finds a SIP submission to be incomplete, or
disapproves a SIP submission, unless the state corrects the deficiency,
and the Administrator approves the SIP revision, before the
Administrator promulgates a FIP. Therefore, EPA will be obligated under
CAA section 110(c)(1) to promulgate a FIP within two years after the
effective date of this disapproval, unless the state submits, and the
EPA approves, SIP revisions to correct the identified deficiencies
before EPA promulgates the FIP.
    In addition, this final disapproval will trigger mandatory
sanctions in accordance with the timelines and provisions of CAA
section 179 and 40 CFR 52.31 unless the state submits, and EPA
approves, SIP revisions that correct the identified deficiencies within
18 months of the effective date of the final disapproval action.

IV. Environmental Justice Considerations

    The EPA reviewed demographic data, which provides an assessment of
individual demographic groups of populations living within the DMNFR
Area. The EPA then compared the data to the national averages for each
of the demographic groups. The results of this analysis are being
provided for informational and transparency purposes. The results of
the demographic analysis indicate that for populations within the DMNFR
Area, there are census block groups with the percent of people of color
(persons who reported their race as a category other than White alone
and/or Hispanic or Latino) is greater than the national average (39%)
and above the 80th percentile.\3\ There are also census block groups
within the DMNFR Area that are below the national average (33%) poverty
level and above the 80th percentile.\4\
---------------------------------------------------------------------------

    \3\ See ``EJSCREEN Maps'' pdf, available within the docket.
    \4\ Id.
---------------------------------------------------------------------------

    This final SIP action identifies deficiencies in the contingency
measure element of the March 22, 2021 SIP submittal for the DMNFR Area
under the 2008 8-hour ozone NAAQS. The EPA's disapproval of these
contingency measures, if finalized, would require that Colorado submit
plans for the DMNFR Area containing contingency measures consistent
with the requirements of the CAA as explained in Sierra Club v. EPA,
985 F.3d 1055 (D.C. Cir. 2021). Such measures would help to improve air
quality in the entire affected nonattainment area through ongoing
reductions of ozone precursor emissions should the measures be
triggered.
    The CAA requires this action, and the EPA recognizes the adverse
impacts of ozone. Information on ozone and its relationship to negative
health impacts can be found in the National Ambient Air Quality
Standards for Ozone.\5\ We expect that this action and resulting
emission reductions will generally be neutral or contribute to reduced
environmental and health impacts on all populations in the DMNFR Area,
including people of color and low income populations. At a minimum,
this action would not worsen any existing air quality and is expected
to ensure the area is meeting requirements to attain and/or maintain
air quality standards. Further, there is no information in the record
indicating that this action is expected to have disproportionately high
or adverse human health or environmental effects on a particular group
of people.
---------------------------------------------------------------------------

    \5\ Final rule, 73 FR 16436 (March 12, 2008).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);

     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
Feb. 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The Colorado Air Quality Control Division did not evaluate
environmental justice considerations as part of its SIP submittal; the
CAA and applicable implementing regulations neither prohibit nor
require such an evaluation. EPA performed an environmental justice
analysis, as is described above in the section titled, ``Environmental
Justice Considerations.'' The analysis was done for the purpose of
providing additional context and information about this rulemaking to
the public, not as a basis of the action. Due to the nature of the
action being taken here, this action is expected to have a neutral to
positive impact on the air quality of the affected area. In addition,
there is no information in the record upon which this decision is based
inconsistent with the stated goal of E.O. 12898 of achieving
environmental justice for people of color, low-income populations, and
Indigenous peoples.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by January 8, 2024. Filing a petition for
reconsideration by the Administrator of this final rule will not affect
the finality of this action for the purposes of judicial review, nor
will it extend the time within which a petition for judicial review may
be filed or postpone the effectiveness of this rule. This action may
not be challenged later in proceedings to enforce its requirements (see
section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

    Dated: October 26, 2023.
KC Becker,
Regional Administrator, Region 8.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. In Sec.  52.320, the table in paragraph (e) is amended by revising
the entry ``2008 Ozone Serious Area Attainment Plan'' to read as
follows:

Sec.  52.320  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                    State effective   EPA effective   Final rule citation/
               Title                      date             date               date                Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                    Maintenance and Attainment Plan Elements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                            Denver Metropolitan Area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
2008 Ozone Serious Area Attainment       2/14/2020        12/7/2023   [insert Federal       Disapproval of
 Plan.                                                                 Register citation],   contingency
                                                                       11/7/2023.            measures. RACM and
                                                                                attainment
                                                                                demonstration
                                                                                withdrawn.

                                                  * * * * * * *
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[FR Doc. 2023-24230 Filed 11-6-23; 8:45 am]
BILLING CODE 6560-50-P


DIDECYL DIMETHYL AMMONIUM CHLORIDE

DIETARY RISK ASSESSMENT

(OPPTS 248.5000)

 Prepared by:

First Draft Versar, Inc.

6850 Versar Center

Springfield, VA 22151

For US EPA/OPP/AD

Amended  and Finalized by:

US EPA/AD/RMBII

MEMORANDUM								Jan 20, 2006

Subject: 	Dietary Risk  Assessment for  Didecyl Dimethyl Ammonium
Chloride (DDAC) for Reregistration Eligibility Decision (RED)

From:			A. Najm Shamim, Ph.D, Chemist and Risk Assessor for DDAC

			Regulatory Management Branch II

			Antimicrobials Division (7510P)

To:			Tracy Lantz, CRM for DDAC RED

			Regulatory Management Branch I

			Antimicrobials Division (7510P)

Thru:			Diane Isbell, Team Leader

			Regulatory Management Branch II

			Antimicrobials Division (7510P)

					And

			Mark Hartman, Chief

			Regulatory Management Branch II

			Antimicrobials Division (7510C)

Executive Summary

Didecyl Dimethyl Ammonium Chloride (DDAC) can be used as a disinfectant
or sanitizer on counter tops, utensils, appliances, tables,
refrigerators, on animal premises and/or farms, and in mushroom
premises.  The use of antimicrobials on food or feed contact surfaces,
agricultural commodities, in animal premises and poultry premises
including hatcheries and application to food-grade eggs may result in
pesticide residues in human food.  Residues from treated surfaces, such
as utensils, countertops, equipment, and appliances can migrate to food
coming into contact with the treated and rinsed surfaces and can be
ingested by humans.

	In the absence of data for residues of  DDAC on treated food contact
surfaces, the Agency estimated residue levels that may occur in food
from the application rates on food contact surfaces.  Dietary exposures
from general agricultural premise use, poultry hatcheries, mushroom
houses and hydroponic uses are expected to be much lower than the
dietary exposures resulting from the surface disinfectant and sanitizing
uses; therefore, these uses were not assessed.

	To estimate the Estimated Daily Intake (EDI) to treated food contact
surfaces and food utensils, an FDA (FDA, 2003) model was used in lieu of
residue data.  The maximum application rate for DDAC in food handling
establishments from the various labeled ready-to-use products is 0.0043
a..i. pounds per gallon of treatment solution.  The EDI calculations
presented in this assessment assume that food can contact 2,000 cm2 or
4,000 cm2 (50% and 100% of the FDA worst case scenario) of treated
surfaces, and that 10% of the pesticide migrate to food, based on the
Agency Residential SOPs. The use of the 10% transfer rate, instead of
the use of a 100% transfer rate that is used in the FDA Sanitizer
Solution Guidelines, requires the submission of confirmatory data to
establish the reliability of the use of the10% transfer rate.  These
daily estimates were conservatively used to assess both acute and
chronic dietary risks.  None of the calculated % aPad or % cPad values
exceeded 100%.

The maximum application rate for DDAC for bottling/packing of food is
0.0020 lbs a.i per gallons of treatment solution.  EDI values were
calculated for these scenarios.  Exposure was assumed to occur through
the ingestion of three food products that might be packaged with treated
material: milk, egg products, and beverages (alcoholic and
non-alcoholic).  None of the calculated % aPad or % cPad values exceeded
100%.

Dietary Toxicity

The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
presented in Table 1.   The aPAD and cPAD were both 0.1 mg/kg/day
(Versar, 2006).

Table 1: DDAC Dietary Toxicity

Exposure

Scenario	Dose Used in Risk Assessment

(mg/kg/day)	Target MOE/UF,

Special FQPA SF

for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(Females 13-50)	NOAEL (developmental) = 10 mg/kg/day	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)
Prenatal Developmental Toxicity - Rat

MRID 41886701

LOAEL = 20 mg/kg/day based on increased incidence of skeletal
variations.

	aPAD = 0.1 mg/kg/day (for Females age 13-50)

Chronic Dietary

(general population)	NOAEL = 10

mg/kg/day	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation
Chronic Toxicity Study - Dog

MRID 41970401

LOAEL = 20 mg/kg/day based on increased incidence  of clinical sign in
males and females and  decreased total cholesterol levels in females.

	cPAD = 0.1 mg/kg/day

a.	cPAD or aPAD= the RfD/FQPA SF (acute RFD and FQPA for aPAD and
chronic RFD and FQPA SF for the cPAD)

Use Information

Seven DDAC products were identified that have uses that could lead to
incidental ingestion.  These uses/products are presented in Table 2.
The labels with the maximum-listed application rate for each use are
presented in bold.

Table 2: Use Site Categories and Application Rates

Use Site	Product Label (Registration No.)	Method of Application	Range of
Application Rates (lb a.i./gal)

Egg handling equipment: Incubator and hatchers 	10324-80

1839-173

10324-81

10324-108

10324-117 	Fogger	0.0223-0.0563

Hatchery: hatchery, settlers, trays, racks, carts, sexing tables,
delivery trucks, and other hard surfaces	10324-80

1839-173

10324-81

10324-108

10324-117	Mop, cloth, sponge, hand pump trigger sprayer, or low pressure
coarse sprayer	0.0014-0.0043

Egg handling rooms: hatcheries	10324-80

1839-173

10324-81

10324-108

10324-117

10324-134	Fogger	0.0007-0.2193

Egg packing plants: food grade eggs	1839-173

10324-81

10324-117	Immersion, low pressure coarse sprayer, or swabs	0.0007-0.0020

Food handling establishments: utensils and equipment 	1839-173

10324-81

10324-117

	Immersion, low pressure coarse sprayer, or swabs	0.0020

Food handling establishments: countertops, appliances, and tables
10324-81

10324-108

10324-117

1839-173

10324-80	Mop, cloth, sponge, hand pump trigger sprayer, or low pressure
coarse sprayer	0.0023-0.0043

Food processing plants: (poultry, meat, fish, tobacco etc.): hard
surfaces and

equipment, including utensils, dishes, silverware, glasses, sink tops,
countertops, refrigerated storage, display equipment, storage shelves,
appliances, conveyers (fruits/vegetables or meat/poultry) etc.	10324-81

10324-108

10324-117

10324-80

1839-173

10324-134

	Mop, cloth, sponge, hand pump trigger sprayer, or low pressure coarse
sprayer, feeding equipment 	0.0020-0.0043

Bottling/packaging sanitizer: food contact surface sanitizer (i.e.
bottle sanitizing, beer storage tanks, and beverage dispensing unit)
1839-173

10324-81

10324-117	Towel, circulation, liquid pour - mechanical or automated
systems	0.0020

Mushroom facilities	10324-80

10324-81

10324-108

10324-117	Mop, cloth, sponge, hand trigger sprayer, or coarse spray
device	0.0023-0.0086

Farm (poultry, swine, dairy) premises, feed storage areas, and cows
(uters, flanks, and teats)	1839-173

10324-81

10324-80

10324-108

10324-117	Towel, mop, cloth, sponge, hand trigger sprayer, or coarse
spray device	0.0007-0.0043

3. Quantitative Dietary assessment

3.1 Egg handling equipment, Agricultural Premise Use, and Poultry
Hatcheries

	DDAC products may be used on egg shells in both poultry hatcheries and
food grade-eggs.   Although it is possible that some of
sanitizer/disinfectant chemicals may penetrate the egg shells, at this
time the Agency believes that the amount of the chemical transferred
into food is likely to be minimal.  Dietary exposures from general
agricultural premise use, poultry hatcheries, mushroom houses and
hydroponic uses are expected to be much lower than the dietary exposures
resulting from the surface disinfectant and sanitizing uses; therefore,
these uses were not assessed.

3.2 Food Handling Establishments and Food Processing Plants

To calculate the EDI associated with use of a DDAC product as a food
utensil sanitizer in food handling establishments, a number of
assumptions have been made based on the FDA guidelines (FDA, 2003).

When a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface (Residual Solution).  The FDA
recommended worst-case concentration for this quantity is 1 mg of
solution per square centimeter of treated surface area.  In the absence
of any other data, this value has been used.

The FDA suggests that, as a worst-case scenario, all food that an
individual consumes will come into contact with 4,000 cm2 of sanitized
non-porous food-contact surfaces.  This contact area represents all the
surface area from silverware, china, and glass used by a person who
regularly eats three meals per day at an institutional or public
facility.

It is assumed that 10% of the active material present on food contact
surfaces will migrate.

The body weights used for this assessment are: adult man = 70 kg; adult
woman = 60 kg, and 3-yr old toddler = 15 kg (USEPA, 1997).

For use of a DDAC product as a counter top disinfectant in food handling
establishments, the same assumptions as listed above were used, and one
additional assumption was added:

The amount of counter top surface area that comes in contact with food
should be much smaller than the amount of food utensil area that comes
into contact with food.  As a conservative estimate, it is assumed that
50% of the FDA value, or 2,000 cm2 of treated counter top surface area,
comes into contact with an individual’s food per day.

The above assumptions and the following equations were used to calculate
EDI and Dietary Daily Dose (DDD):

EDI (mg/p/day) = AR x RS x SA x F x 10-6	 			(1)

DDD (mg/kg/day) = AR x RS x SA x F x 10-6/BW 			(2)

Where:

AR 	=  	Application rate (ppm)

RS	=	Residual solution (mg/cm2)

SA	=	Surface area of the treated surface which comes into contact with
food (cm2)

F 	= 	Fraction of the pesticide transferred or migrated to food
(unitless)

BW 	= 	Body weight (kg)

The input parameters listed in Table 4 and equations 1 and 2 were used
to calculate the output parameters listed in Table 5.

Table 4: Input Parameters for Food Handling Establishments and Food
Processing Plants Hard Surface Sanitizer

Parameter	Value

Rationale

	Food Utensil	Countertop

	Residual Solution on Surface	1 mg/cm2	FDA worst-case assumption

Area of Treated Surface	4,000 cm2	2,000 cm2	100% and 50% of FDA
worst-case assumption for food utensils

DDAC concentration in diluted Solutiona	0.0020 lb a.i./gal    or
                240 ppm        	0.0043 lb a.i./gal   or
      515 ppm                   	Diluted Solution concentration, based
on maximum concentration.

Fraction Transferred	10%	EPA Assumption

Body Weight (kg)

Adult man =

Adult woman =

Child =

70

60

      15	EPA, 1997

a.	Maximum application rates for food utensils were from product labels
1839-173, 10324-81, and 10324-117 for Utensils and product label
10324-80 for counter-tops.

Table 5: Calculated EDIs, aPAD, and cPAD for Utensils and Countertops

Exposure Group	Utensils	Countertops	Aggregate

	EDI (mg/p/d)	DDD (mg/kg/d)	% PADa	EDI (mg/p/d)	DDD (mg/kg/d)	% PADa	EDI
(mg/p/d)	DDD (mg/kg/d)	% PADa (mg/kg/d)

Adult males	0.0959	0.00137	1.37	0.103	0.00147	1.47	0.199	0.00284	2.84

Adult females	0.0959	0.00160	1.60	0.103	0.00172	1.72	0.199	0.00332	3.32

Children	0.0959	0.00639	6.39	0.103	0.00687	6.87	0.199	0.0133	13.3

a.	% PAD = exposure (DDD) /(aPAD or cPAD) x 100. The acute and chronic
population average dose is the same; therefore the % PADs are the same.

For DDAC treatments of food processing plants, the application rates are
similar to food handling establishments presented above, and hence the
exposure, EDIs, DDDs, and % aPAD and cPADs are also similar.

Food Bottling/Packaging

DDAC may also be used as a sanitizer or disinfectant in processing
equipments, utensils in dairies, breweries, canning operations, meat and
vegetable processing plants.  In assessing this use, the following
assumptions were made, based on USEPA (2005):

The DDAC concentration in the treatment solution is 0.0020 lb a.i./gal,
or 240 ppm (0.00024 wt/wt)

When a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface (Residual Solution).  The FDA
recommended worst-case concentration for this quantity is 1 mg of
solution per square centimeter of treated surface area.  In the absence
of any other data, this value has been used.

For the fraction of pesticide that migrates from the residue to the food
(F in equations 3 and 4), a transfer rate of 100% was used instead of
10% because the food is in contact with the treated surfaces for
potentially very long periods of time.

For a given person, the grams of food per surface area of container were
as follows (g/cm2):

Milk (dairy): 				6.6

Egg/mayonnaise:			64.0

Beer, beverages:			150

The daily intake rates for an adult (g/person/day) were as follows:

Beverages, alcoholic/beer:		182

Beverages, non-alcoholic:		240

Egg products:				9.0

Milk:					124

A child will consume a smaller quantity of calories in a given day.  To
account for differences between intake values among children and adults
a calorie intake modification factor of 0.64 was applied to the EDI for
a child.  Recommended energy allowances measured in kilocalories per
body weight for different age groups and genders were taken from the
National Research Counsil’s Recommended Energy Allowances.  The values
are based on the resting energy expenditure and the energy required for
light to moderate levels of activity, as determined by the World Health
Organization (USAID, 2005).  The calculation of the factor is presented
in Table 6 below.

The above assumptions and the following equations were used to calculate
EDI and Dietary Daily Dose (DDD):

EDI (mg/p/day) = AR x RS x DIR x MSA-1 x F x 10-6 x CMF	 		(3)

DDD (mg/kg/day) = AR x RS x DIR x MSA-1 x F x 10-6 x CMF/BW 		(4)

Where:

AR 	=  	Application rate (ppm)

RS	=	Residual solution (mg/cm2)

MSA	=	Mass-surface area ratio (the treated surface that comes into
contact with food) (g/cm2)

DIR	=	Daily intake rate of food in a given day (g/p/day)

F 	= 	Fraction of the pesticide transferred or migrated to food
(unitless)

BW 	= 	Body weight (kg)

CMF	=	Calorie intake modification factor (100% adults; 64.4% Children)

Assumptions 1-4, inputs from Table 6 and 7, and equations 3 and 4 were
used to calculate the dietary rates and doses presented in Table 8.

Table 6: Toddler (3-yr old) and Adult Calorie Intake Comparison

Group (Age)	Body Weight (kg)	Kilocalories per kga	Kilocaloriesb

Child (1-3)	15.0	102	1,530

Female (25-50)	60.0	36.0	2,160

Male (25-50)	70.0	37.0	2,590

Output

Child Modification Factor (CMF)c 	0.644

USAID, 2005

Kilocalories = Kcal/Kg x BW

CMF = Kcal-child ÷ [(Kcal-female + Kcal-male)/2]

Table 7: Input Parameters for Food Bottling/Packaging Hard Surface
Sanitizer

Parameter	Input	Rational

Food mass/surface (g/cm2)

             	Milk 	6.6	USEPA, 2005

	Egg/Mayonnaise	64

Beer, beverages	150

	Intake rates (g/p/d)

         	Milk 	124	USEPA, 2005

	Egg products	9

Beer, beverages	182

Beverages/ nonalcoholic	240

	Fraction Transferred 	100%	FDA worst case assumption

Residual Solution on Surface	1 mg/cm2	FDA worst case Assumption

Quantity DDAC 	0.0020 lb ai  or 240 ppm	Diluted solution concentration,
based on maximum concentration.

Body Weight (kg)

Adult man =

Adult woman =

Child =

70

60

15

USEPA, 1997

a.	Maximum application rates for food utensils were from product labels
1839-173, 10324-81, and 10324-117.

Table 8:  Calculated EDIs, aPAD, and cPAD for Representative Dairy and
Beverage Consumption

Food Type	Exposure Group	EDI (mg/p/d)	DDD (mg/kg/d)	% PAD

Milk 	Adult Male	0.00451	6.44x10-5	0.0644

	Adult Female

7.52x10-5	0.0752

	Childa	0.00290	1.94x10-4	0.194

Egg product	Adult Male	0.000034	4.8x10-7	4.8x10-4

	Adult Female

5.6x10-7	5.6x10-4

	Child a	0.000022	1.44x10-6	1.48x10-3

Beverages, non-alcoholic	Adult Male	0.00038	3.29x10-4	0.0055

	Adult Female

5.6x10-6	0.384

	Childa	0.00056	1.60x10-5	0.0064

Beverages, alcoholic, beer	Adult Male	2.91x10-4	4.16x10-6	0.00416

	Adult Female

4.85x10-6	0.00485

a.	Child EDI values are multiplied by a modification factor of 0.64	4.0
References

FDA. 2003.  “Sanitizing Solutions:	Chemistry Guidelines for Food
Additive Petitions.”

  GOTOBUTTON BM_1_ http://www.cfsan.fda.gov/~dms/opa-cg3a.html.   Last
accessed June 9, 2003.

USAID. 2005. “ANNEX III: Recommended Energy Allowance Tables.”
November 2005.   HYPERLINK
"http://www.usaid.gov/our_work/humanitarian_assistance/ffp/crg/annex-3.h
tm"
http://www.usaid.gov/our_work/humanitarian_assistance/ffp/crg/annex-3.ht
m .  Last viewed January 23, 2006.

USEPA.  1997.  Exposure Factors Handbook. Volume I-II.  Office of
Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa. August
1997.

USEPA. 2005. Dietary Assessment of Chlorine Dioxide, Sodium Chlorite
From Their Use As Indirect Food Contact Sanitizers/Disinfectants (Hard
Surface Sanitizers). Memorandum from Najm Shamim, USEPA to Melba Morrow
and Jennifer Slotnick, USEPA. Dates August 15, 2005.

Versar. 2006. DDAC Occupational and Residential Exposure Assessment.
Memorandum from Adria Diaz/Karie Riley/Kelly McAloon, Versar, Inc., to
Laura Bailey, USEPA dated January 20, 2006.

 PAGE

Page   PAGE  12  of   NUMPAGES  12


[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Notices]
[Pages 1923-1926]
[FR Doc No: 2013-00225]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0350]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemption from the diabetes mellitus
requirement; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 16 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before February 8, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2012-0350 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.,
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., Monday through Friday,
except Federal holidays. The Federal Docket Management System (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 December 29, 2010 (75 FR 82132) at http://www.gpo.gov/fdsys/pkg/FR-2010-12-29/pdf/2010-32876.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 16 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by the
statutes.

Qualifications of Applicants

Shawn J. Ball

    Mr. Ball, 38, has had ITDM since 2012. His endocrinologist examined
him in 2012 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Ball understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Ball meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2012 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from Idaho.

Buck H. Bowers

    Mr. Bowers, 39, has had ITDM since 2008. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bowers understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bowers meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2012 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Ohio.

Jeffrey S. Bublitz

    Mr. Bublitz, 57, has had ITDM since 1990. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bublitz understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bublitz meets the
vision requirements of 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2012 and certified that he has stable nonproliferative
diabetic retinopathy. He holds a Class D operator's license from
Wisconsin.

Ira Scott Chamberlin

    Mr. Chamberlin, 58, has had ITDM since 1991. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Chamberlin understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Chamberlin meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2012 and certified that he does not have diabetic retinopathy.
He holds a Class B CDL from Maine.

Victor W. Dannenbrink

    Mr. Dannenbrink, 64, has had ITDM since 2005. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Dannenbrink understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dannenbrink meets the
vision requirements of 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2012 and certified that he has stable nonproliferative
diabetic retinopathy. He holds a Class B CDL from Iowa.

James K. Dowden

    Mr. Dowden, 55, has had ITDM since 2007. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Dowden understands diabetes
management and monitoring, has stable control of his diabetes using

insulin, and is able to drive a CMV safely. Mr. Dowden meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2012 and certified that he does not have diabetic retinopathy. He holds
a Class A CDL from Minnesota.

Myron P. Egbert

    Mr. Egbert, 54, has had ITDM since 2000. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Egbert understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Egbert meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2012 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Utah.

Michael T. Evans

    Mr. Evans, 30, has had ITDM since 2012. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Evans understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Evans meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2012 and certified that he does not have diabetic retinopathy. He holds
a Class A CDL from Ohio.

Stephen P. Honen

    Mr. Honen, 50, has had ITDM since 2009. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Honen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Honen meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2012 and certified that he does not have diabetic retinopathy. He
holds a Class B CDL from Ohio.

Charles E. Johnston

    Mr. Johnston, 49, has had ITDM since 2011. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Johnston understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Johnston meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2012 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Mississippi.

Steve A. Rau

    Mr. Rau, 56, has had ITDM since 2006. His endocrinologist examined
him in 2012 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Rau understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Rau meets the vision requirements of
49 CFR 391.41(b)(10). His optometrist examined him in 2012 and
certified that he does not have diabetic retinopathy. He holds a Class
D operator's license from North Dakota.

Jack M. Sipich

    Mr. Sipich, 34, has had ITDM since 2012. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sipich understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Sipich meets the vision requirements of 49 CFR 391.41(b)(10).
His optometrist examined him in 2012 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Illinois.

Roger N. Stauffer

    Mr. Stauffer, 33, has had ITDM since 2009. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stauffer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stauffer meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2012 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Michigan.

Tyrone Taylor

    Mr. Taylor, 54, has had ITDM since 2012. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Taylor understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Taylor meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2012 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from North Carolina.

Michael E. Westley

    Mr. Westley, 56, has had ITDM since 2010. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Westley understands

diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Westley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2012 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Florida.

Travis M. Whitt

    Mr. Whitt, 36, has had ITDM since 2011. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Whitt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Whitt meets the vision requirements of 49 CFR 391.41(b)(10).
His optometrist examined him in 2012 and certified that he does not
have diabetic retinopathy. He holds a Class C operator's license from
California.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\ The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

    Issued on: December 28, 2012.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-00225 Filed 1-8-13; 8:45 am]
BILLING CODE P


[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Proposed Rules]
[Page 22550]
[FR Doc No: 2012-8922]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2008-0599; A-1-FRL-9659-4]

Approval and Promulgation of Air Quality Implementation Plans;
New Hampshire; Regional Haze; Reopening of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of comment period.

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

SUMMARY: EPA is reopening the public comment period for a proposal
published in the Federal Register on February 28, 2012. In that action
EPA proposed to approve a revision to the New Hampshire State
Implementation Plan (SIP) submitted by the New Hampshire Department of
Environmental Services (NHDES) on January 29, 2010, with supplemental
submittals on January 14, 2011, and August 26, 2011, that addresses
regional haze for the first planning period from 2008 through 2018. Two
commentors requested an extension of the comment period for this
proposed rulemaking. EPA is now reopening the public comment period.

DATES: The comment period for the proposed rule published on February
28, 2012 (77 FR 11809) is reopened. Comments must be received on or
before April 27, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2008-0599 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2008-0599 Anne
Arnold, U.S. Environmental Protection Agency, EPA New England Regional
Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5
Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, U.S. Environmental Protection
Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
(mail code OEP05-2), Boston, MA 02109-3912. Such deliveries are only
accepted during the Regional Office's normal hours of operation. The
Regional Office's official hours of business are Monday through Friday,
8:30 to 4:30, excluding legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2008-0599. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov, or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or
in hard copy at Office of Ecosystem Protection, U.S. Environmental
Protection Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
Boston, MA. EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30, excluding legal
holidays.
    In addition, copies of the State submittal are also available for
public inspection during normal business hours, by appointment at the
Air Resources Division, Department of Environmental Services, 6 Hazen
Drive, P.O. Box 95, Concord, NH 03302-0095.

FOR FURTHER INFORMATION CONTACT: Anne McWilliams, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail Code OEP05-02), Boston, MA
02109-3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 28, 2012. In that action EPA
proposed to approve a revision to the New Hampshire State
Implementation Plan (SIP) submitted by the New Hampshire Department of
Environmental Services (NHDES) on January 29, 2010, with supplemental
submittals on January 14, 2011, and August 26, 2011, that addresses
regional haze for the first planning period from 2008 through 2018.
Written comments on the proposed rule were to be submitted to EPA on or
before March 29, 2012. Two commentors requested an extension of the
comment period for this proposed rulemaking. EPA is now reopening the
public comment period for the February 28, 2012, New Hampshire Regional
Haze proposed rulemaking until April 27, 2012.

    Dated: April 5, 2012.
H. Curtis Spalding,
Regional Administrator, EPA Region 1.
[FR Doc. 2012-8922 Filed 4-13-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]
[Page 4061]
[DOCID:fr26ja10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-6223-000]

Favinger, Thomas; Notice of Filing

January 19, 2010.
    Take notice that on January 15, 2010, Mr. Thomas G. Favinger filed
an application for authority to hold interlocking positions, pursuant
to section 305(b) of the Federal Power Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 5, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-1396 Filed 1-25-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51235-51237]
[FR Doc No: 2013-20201]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70197; File No. SR-BATS-2013-044]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of BATS Exchange, Inc.

August 14, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 7, 2013, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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 the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BATS Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
will be effective upon filing.
---------------------------------------------------------------------------

    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify pricing applicable to the
Exchange's options platform (``BATS Options'') with respect to orders
routed away by the Exchange and executed at a new options exchange--an
affiliate of the International Securities Exchange, LLC (``ISE'') that
will be called ``ISE Gemini.'' \6\ ISE Gemini commenced trading on
August 5, 2013.
---------------------------------------------------------------------------

    \6\ The Commission notes that the entity referred to herein as
``ISE Gemini'' is Topaz Exchange, LLC d/b/a ISE Gemini.
---------------------------------------------------------------------------

    BATS Options currently charges certain flat rates for routing to
other options exchanges that have been placed into groups based on the
approximate cost of routing to such venues. The grouping of away
options exchanges is based on the cost of transaction fees assessed by
each venue as well as costs to the Exchange for routing (i.e., clearing
fees, connectivity and other infrastructure costs, membership fees,
etc.) (collectively, ``Routing Costs''). The Exchange did not have
sufficient information to know what Routing Costs the Exchange would
incur in connection with routing to ISE Gemini prior to its launch.
Accordingly, the Exchange originally imposed the same pricing for all
executions at ISE Gemini as are charged by the Exchange for orders
routed to and executed at the NASDAQ Options Market (``NOM'') and NYSE
Arca, Inc. (``ARCA'') in non-Penny Pilot Securities,\7\ which is the

most expensive routing category based on Routing Costs.
---------------------------------------------------------------------------

    \7\ The Exchange currently charges different fees and provides
different rebates depending on whether an options class is an
options class that qualifies as a Penny Pilot Security pursuant to
Exchange Rule 21.5, Interpretation and Policy .01 or is a non-penny
options class. Certain other options exchanges also have different
pricing for Penny Pilot Securities and non-Penny Pilot Securities.
Accordingly, the Exchange's routing fees also vary with respect to
the fees for orders executed at such exchanges.
---------------------------------------------------------------------------

    Based on applicable Routing Costs, the Exchange currently charges
$0.90 per contract for Customer \8\ orders and $0.95 per contract for
Professional,\9\ Firm, and Market Maker \10\ orders executed at NOM and
ARCA in non-Penny Pilot Securities, and thus, since August 5, 2013, has
charged these rates for orders routed to and executed at ISE Gemini in
all securities. Based on the pricing released by ISE Gemini immediately
prior to its launch, the Exchange believes that this pricing continues
to be appropriate for non-Penny Pilot Securities executed on ISE
Gemini. Accordingly, the Exchange proposes to continue to charge the
same for executions at ISE Gemini as it does at NOM and ARCA with
respect to non-Penny Pilot Securities. Thus, the Exchange proposes to
continue to charge $0.90 per contract for Customer orders and $0.95 per
contract for Professional, Firm, and Market Maker orders in non-Penny
Pilot Securities executed at ISE Gemini. The Exchange also proposes to
continue to charge $0.95 per contract for all executions of Directed
ISOs routed to ISE Gemini in non-Penny Pilot Securities. However, as
described below, the Exchange proposes to modify pricing for all
executions, including executions of Directed ISOs, of orders routed by
the Exchange to ISE Gemini in Penny Pilot Securities.
---------------------------------------------------------------------------

    \8\ As defined on the Exchange's fee schedule, a ``Customer''
order is any transaction identified by a Member for clearing in the
Customer range at the Options Clearing Corporation (``OCC''), except
for those designated as ``Professional''.
    \9\ The term ``Professional'' is defined in Exchange Rule 16.1
to mean any person or entity that (A) is not a broker or dealer in
securities, and (B) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s).
    \10\ As defined on the Exchange's fee schedule, the terms
``Firm'' and ``Market Maker'' apply to any transaction identified by
a member for clearing in the Firm or Market Maker range,
respectively, at the Options Clearing Corporation (``OCC'').
---------------------------------------------------------------------------

    Based on the pricing released by ISE Gemini, the Exchange believes
it most appropriate to charge the same pricing for orders in Penny
Pilot Securities routed to and executed at ISE Gemini as it does for
NOM and Arca in Penny Pilot Securities. The Exchange currently charges
$0.52 per contract for Customer orders and $0.57 per contract for
Professional, Firm, and Market Maker orders executed at NOM and ARCA in
Penny Pilot Securities. In order to cover the cost of removing
liquidity, including Routing Costs, in Penny Pilot Securities at ISE
Gemini, the Exchange proposes to charge the same rates, specifically
$0.52 per contract for Customer orders and $0.57 per contract for
Professional, Firm, and Market Maker orders executed at ISE Gemini.
    Also based on the pricing released by ISE Gemini, the Exchange
believes it most appropriate charge $0.60 per contract for Directed
ISOs in Penny Pilot Securities routed to and executed at ISE Gemini,
which is the same pricing that the Exchange charges for certain other
Directed ISOs executed at away destinations, as further described
below.
    The Exchange currently charges $0.60 per contract for Directed ISOs
routed and executed at away destinations, with the exception of: (i)
Directed ISOs in Mini Options, for which the Exchange charges $0.15 per
contract; and (ii) in the following situations, for which the Exchange
charges $0.95 per contract: (1) orders in non-Penny Pilot Securities
executed at NOM and ARCA; (2) Professional, Firm and Market Maker
orders executed at BX Options in non-Penny Pilot Securities; (3)
Professional, Firm and Market Maker orders executed at C2; and (4) all
orders executed at ISE Gemini. In order to approximate the Routing
Costs for such orders, the Exchange proposes to charge the standard fee
of $0.60 for Directed ISOs in Penny Pilot Securities routed to and
executed at ISE Gemini instead of the $0.95 that it currently charges.
As described above, the Exchange will continue to charge $0.95 per
contract for Directed ISOs in non-Penny Pilot Securities routed to and
executed at ISE Gemini.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\11\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\12\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues or providers of routing services
if they deem fee levels to be excessive.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    As explained above, the Exchange generally attempts to approximate
the cost of routing to other options exchanges, including other
applicable costs to the Exchange for routing. The Exchange believes
that a pricing model based on approximate Routing Costs is a
reasonable, fair and equitable approach to pricing. Specifically, the
Exchange believes that its proposal to modify fees to ISE Gemini is
fair, equitable and reasonable because the fees are generally an
approximation of the cost to the Exchange for routing orders to such
exchange. The Exchange believes that its flat fee structure for orders
routed to various venues is a fair and equitable approach to pricing,
as it provides certainty with respect to execution fees at groups of
away options exchanges. Under its flat fee structure, taking all costs
to the Exchange into account, the Exchange may operate at a slight gain
or slight loss for orders routed to and executed at ISE Gemini. As a
general matter, the Exchange believes that the proposed fees will allow
it to recoup and cover its costs of providing routing services to ISE
Gemini. The Exchange also believes that the proposed fee structure for
orders routed to and executed at this away options exchange is fair and
equitable and not unreasonably discriminatory in that it applies
equally to all Members.
    As explained above, the Exchange has also proposed to decrease fees
for Directed ISOs in Penny Pilot Securities to ISE Gemini. The Exchange
believes that the proposed fee structure for Directed ISOs routed to
and executed at ISE Gemini is fair, equitable and reasonable because
the fees are an approximation of the cost to the Exchange for routing
such orders and will allow the Exchange to recoup and cover the costs
of providing routing services to ISE Gemini. The Exchange also believes
that the proposed fee structure for Directed ISOs routed to and
executed at ISE Gemini is fair and equitable and not unreasonably
discriminatory in that it applies equally to all Members.
    The Exchange reiterates that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels to be excessive or providers
of routing services if they deem fee levels to be excessive. Finally,
the Exchange notes that it constantly evaluates its routing fees,
including profit and loss attributable to routing, as applicable, in
connection with the operation of a flat fee routing service, and would
consider future adjustments to the proposed pricing structure to the
extent it was recouping a significant profit from routing to ISE
Gemini.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes will
assist the Exchange in recouping costs for routing orders to another
options exchange on behalf of its participants in a manner that is a
better approximation of actual costs than is currently in place. The
Exchange also notes that Members may choose to mark their orders as
ineligible for routing to avoid incurring routing fees.\13\ As stated
above, the Exchange notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels to be excessive or providers
of routing services if they deem fee levels to be excessive.
---------------------------------------------------------------------------

    \13\ See BATS Rule 21.1(d)(8) (describing ``BATS Only'' orders
for BATS Options) and BATS Rule 21.9(a)(1) (describing the BATS
Options routing process, which requires orders to be designated as
available for routing).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \14\ and paragraph (f) of Rule 19b-4
thereunder.\15\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-BATS-2013-044 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2013-044. 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 Web site (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 Web site 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 the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2013-044 and should be
submitted on or before September 10, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-20201 Filed 8-19-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5548-5549]
[FR Doc No: 2019-02952]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0213; FMCSA-2015-0323]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 12
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2014-0213; FMCSA-2015-0323, in the
keyword box, and click ``Search.'' Next, click the ``Open Docket
Folder'' button and choose the document to review. If you do not have
access to the internet, you may view the docket online by visiting the
Docket Management Facility in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On November 20, 2018, FMCSA published a notice announcing its
decision to renew exemptions for 12 individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (83 FR
56683). The public comment period ended on December 20, 2018, and no
comments were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to, or greater
than, the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 12 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315, the following
groups of drivers received renewed exemptions in the month of September
and are discussed below. As of September 9, 2018, and in accordance
with 49 U.S.C. 31136(e) and 31315, the following eight individuals have
satisfied the renewal conditions for obtaining an exemption from the
epilepsy and seizure disorders prohibition in the FMCSRs for interstate
CMV drivers (83 FR 58683):

Mark D. Anderson (NC)
Jeremy N. Bradford (AL)
Jeffrey B. Green (CA)
Stephen M. Harmon (WV)
Donald A. Horst (MD)
Kyle P. Loney (WA)
Leigh P. Mallory (VT)
Raymond VanDeMark (NJ)

    The drivers were included in docket number FMCSA-2015-0323. Their
exemptions are applicable as of September 9, 2018, and will expire on
September 9, 2020.
    As of September 16, 2018, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (83 FR
58683):

Lee H. Anderson (MA)
Gary A. Combs, Jr. (KY)
Roland K. Mezger (PA)
Robert Thomas, Jr. (NC)

    The drivers were included in docket number FMCSA-2014-0213. Their
exemptions are applicable as of September 16, 2018, and will expire on
September 16, 2020.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than

was maintained prior to being granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136 and 31315.

    Issued on: February 13, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-02952 Filed 2-20-19; 8:45 am]
 BILLING CODE 4910-EX-P