[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Pages 8877-8879]
[FR Doc No: 2020-03159]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0259]

Patient-Focused Drug Development for Stimulant Use Disorder;
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Patient-Focused Drug
Development for Stimulant Use Disorder.'' The purpose of the public
meeting is to allow FDA to obtain stakeholder perspectives on the
impact of stimulant use disorder and views on treatment approaches for
stimulant use disorder.

DATES: The public meeting will be held on March 10, 2020, from 12:30
p.m. to 5 p.m. Submit either electronic or written comments on this
public meeting by May 11, 2020. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at the Silver Spring Civic
Building, 1 Veterans Pl., Silver Spring, MD 20910. The building is
located at Veterans Plaza in downtown Silver Spring and is accessible
via the Silver Spring Metro Station on the Red Line. Paid public
parking is also available at the Town Square Garage (Garage 61), 801
Ellsworth Dr., Silver Spring, MD 20910, and the Wayne-Ellsworth Garage
(Garage 60), 921 Wayne Ave., Silver Spring, MD 20910. For more
information regarding parking, Metro access, and the meeting location,
please refer to https://www.montgomerycountymd.gov/cupf/info-reservation/SSCB.html.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 11, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of May 11, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2020-N-0259 for ``Patient-Focused Drug Development for Stimulant
Use Disorder; Public Meeting; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lyna Merzoug, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-6001<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    This meeting will provide FDA the opportunity to obtain input from
individuals with stimulant use disorder and other related stakeholders
on the impact of stimulant use disorder and views on treatment goals
and approaches. FDA is interested in stakeholders' perspectives on: (1)
The health effects and daily impacts of their condition; (2) the impact
(if any) of opioid and polysubstance use on their condition; (3)
treatment goals; and (4) decision factors considered when seeking out
or selecting a treatment.
    Stimulant use disorder describes a range of problems associated
with the use of illicit stimulant drugs, including methamphetamine and
cocaine, and prescription stimulants (e.g., ADDERALL, RITALIN), but not
including caffeine or nicotine. A diagnosis of stimulant use disorder
is made when a clinician identifies a pattern of use of amphetamine-
type substance, cocaine, or other stimulant that leads to clinically
significant impairment or distress, including an inability to reduce or
control consumption, cravings to use a stimulant, continued use of a
stimulant despite it causing negative consequences, and the need to use
increased amounts of a stimulant to achieve the desired effect. There
are no FDA-approved medications for stimulant use disorder.
    The questions that will be asked of individuals with stimulant use
disorder and other stakeholders at the meeting are listed in the
following section and organized by topic. For each topic, a brief
initial panel discussion will begin the dialogue. This will be followed
by a facilitated discussion inviting comments from other audience
participants. In addition to input generated through this public
meeting, FDA is interested in receiving stakeholder input addressing
these questions through written comments, which can be submitted to the
public docket (see ADDRESSES). As noted above, when submitting
comments, if you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' When submitting comments, if you are
commenting on behalf of a stimulant user, please indicate that you are
doing so and answer the following questions as much as possible from
the stimulant user's perspective, but please refrain from providing
information that would identify third parties, including minor
children.
    FDA will post the agenda and other meeting materials approximately
5 days before the meeting at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-stimulant-use-disorder-03102020-03102020.

II. Discussion Questions at the Public Meeting

A. Topic 1: Health Effects and Daily Impacts

    1. How would you describe your experience with stimulant use
disorder?
    a. Which stimulant(s) did you start using first?
    b. What stimulant(s) are you using now?
    c. Did you use any other illicit or prescription drugs before you
started using the stimulant that you are currently using?
    d. How are you using stimulants? How has your stimulant(s) use
changed over time? Are you using more frequently or at higher doses?
    e. Do you use stimulants in combination with other drug(s)? If so,
what other drugs do you use and why?
    f. Have you used a stimulant(s) as treatment for opioid withdrawal
and/or overdose?
    2. Of all the ways that stimulant use disorder impacts your health
and well-being, which effects have the most significant impact on your
daily life and the daily life of your family and/or friends? Examples
may include physical and mental effects of using stimulants (effects on
your body and thinking), effects of stimulant withdrawal, effects of
cravings, impacts on your ability to function in personal or
professional life, or emotional or social effects.
    a. What drives your use of stimulants?
    b. Are there certain activities that you can only do if you take a
stimulant? If so, what are those activities?
    c. Are there specific activities that are important to you but that
you cannot do at all or as fully as you would like because of your
stimulant use? Examples of activities may include daily hygiene;
meeting school, work, or family responsibilities; participation in
social activities.
    d. How does your stimulant use affect daily life on your best days?
On your worst days?
    3. What worries you most about your condition?

B. Topic 2: Current Approaches to Management

    1. Have you considered seeking treatment? Why or why not?

    2. What are you currently doing to help manage your stimulant use?
    a. How well have these management approaches worked for you?
    b. How well have they helped address the effects of stimulant use
that are most troubling to you?
    c. What are the biggest problems you have faced in using these
approaches? Examples may include bothersome side effects, challenges or
barriers to access, concern about stigma.
    3. What are the biggest factors that you consider when making
decisions about seeking out or engaging in treatment for stimulant use
disorder?
    4. What specific things would you look for in an ideal treatment
for stimulant use disorder?
    5. If you had the opportunity to participate in a clinical study to
test an experimental treatment for stimulant use disorder, what factors
would you consider when deciding whether you would participate?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://stimulantusedisorder-pfdd.eventbrite.com/. Contact information provided
during registration will remain confidential and only be used to send
meeting updates to participants.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by March 3, 2020, 11:59 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. If time
and space permit, onsite registration on the day of the public meeting
will be provided beginning at 11:30 a.m.
    If you need special accommodations due to a disability, please
contact Lyna Merzoug (SEE FURTHER INFORMATION CONTACT) no later than
March 3, 2020.
    Panelist Selection: Stakeholders, particularly people suffering
from stimulant use disorder, who are interested in presenting comments
as part of the initial panel discussions will be asked to indicate in
their registration which topic(s) they wish to address. These
stakeholders also will be asked to send<EMAIL_ADDRESS>a
brief summary of responses to the discussion questions listed above by
February 26, 2020. Panelists will be notified of their selection
approximately 7 days before the public meeting. We will try to
accommodate all stakeholders who wish to speak, either through the
panel discussion or audience participation; however, the duration of
comments may be limited by time constraints.
    Open Public Comment: There will be time allotted during the meeting
for open public comment. Signup for this session will be on a first-
come, first-serve basis on the day of the workshop. Individuals and
organizations with common interests are urged to consolidate or
coordinate and request time for a joint presentation. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
    Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the public meeting: FDA will also stream a
live audio recording of this public meeting with the presentation
slides. The audio recording and presentation slides, along with a
meeting transcript and summary report, will also be made publicly
available after the meeting. Because of the sensitive nature of the
meeting topic, and the importance of gathering candid, meaningful input
from individuals who have come forward to speak about living with
stimulant use disorder, no other audio recording, video recording, and/
or photography will be allowed at this Patient-Focused Drug Development
meeting. FDA is asking for your cooperation and strongly requests that
you respect the privacy of all attendees. You will be asked to indicate
in your registration whether you plan to attend in person or via the
webcast. To register for the webcast, please visit https://stimulantusedisorder-pfdd.eventbrite.com/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings.

    Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03159 Filed 2-14-20; 8:45 a.m.]
BILLING CODE 4164-01-P


[Federal Register: October 19, 2010 (Volume 75, Number 201)]
[Rules and Regulations]
[Page 64162-64165]
[DOCID:fr19oc10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[Docket EPA-R10-OAR-2010-0433; FRL-9214-7]

Determination of Attainment for PM10: Eagle River PM10
Nonattainment Area, AK

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA has determined that the Eagle River nonattainment area in
Alaska attained the National Ambient Air Quality Standard (NAAQS) for
particulate matter with an aerodynamic diameter of less than or equal
to a nominal ten micrometers (PM10) as of December 31, 1994.

DATES: This rule is effective on December 20, 2010, without further
notice, unless EPA receives adverse comment by November 18, 2010. If
EPA receives adverse comment, we will publish a timely withdrawal in
the Federal Register informing the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2010-0433, by any of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: Claudia Vergnani Vaupel, EPA Region 10, Office of
Air, Waste and Toxics, AWT-107, 1200 Sixth Avenue, Suite 900, Seattle,
WA 98101.
     Hand Delivery/Courier: EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle, WA 98101. Attention: Claudia Vergnani Vaupel,
Office of Air, Waste and Toxics, AWT-107. Such deliveries are only
accepted during normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2010-0433. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://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 e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail 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 docket are listed in the http://
www.regulations.gov index. 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. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue,
Seattle, WA 98101.

FOR FURTHER INFORMATION CONTACT: Claudia Vergnani Vaupel at telephone
number:<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>or the
above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',
``us'' or ``our'' are used, we mean EPA. Information is organized as
follows:

Table of Comments

I. Background
    A. PM\10\ Standard
    B. The Eagle River PM10 Nonattainment Area
    C. Attainment Date for the Eagle River PM\10\ Nonattainment Area
    D. PM\10\ Planning in the Eagle River PM10
Nonattainment Area
II. Attainment Determination
    A. What are the requirements for attainment determinations?
    B. What do the air quality data show as of the December 31, 1994
attainment date?
    C. What do more recent air quality data show?
III. EPA's Final Action
IV. Statutory and Executive Order Reviews

I. Background

A. PM10 Standard

    The NAAQS are levels for certain ambient air pollutants set by EPA
to protect public health and welfare. PM10, or particulate
matter with an aerodynamic diameter less than or equal to a nominal 10
micrometers, is among the ambient air pollutants for which EPA has
established health-based standards. On July 1, 1987 (52 FR 24634), EPA
promulgated two primary standards for PM10: A 24-hour
standard of 150 micrograms per cubic meter ([mu]g/m\3\) and an annual
PM10 standard of 50 [mu]g/m\3\. EPA also promulgated
secondary PM10 standards that were identical to the primary
standards.
    Effective December 18, 2006, EPA revoked the annual PM10
standard but retained the 24-hour PM10 standard. 71 FR 61144
(October 17, 2006). The 24-hour PM10 standard is attained
when the expected number of days per calendar year with a 24-hour
concentration above 154 [mu]g/m\3\, as determined in accordance with 40
CFR part 50, appendix K, is equal to or less than one.\1\ 40 CFR 50.6
and 40 CFR part 50, appendix K.
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    \1\ An exceedance is defined as a daily value that is above the
level of the 24-hour standard (150 [mu]g/m\3\) after rounding to the
nearest 10 [mu]g/m\3\ (i.e. values ending in 5 or greater are to be
rounded up). Thus, a recorded value of 154 [mu]g/m\3\ would not be
an exceedance since it would be rounded to 150[mu]/m\3\ whereas a
recorded value of 155 [mu]g/m\3\ would be an exceedance since it
would be rounded to 160 [mu]/m\3\. See 40 CFR part 50, appendix K,
section 1.0.

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B. The Eagle River PM10 Nonattainment Area

    On August 7, 1987 (52 FR 29383), EPA identified a number of areas
across the country as PM10 ``Group I'' areas of concern,
that is, areas with a 95% or greater likelihood of violating the
PM10 NAAQS and requiring substantial planning efforts. The
Eagle River PM10 nonattainment area was identified as a
Group I area of concern.
    Areas meeting the requirements of section 107(d)(4)(B) were
designated nonattainment for PM10 by operation of law and
classified ``moderate'' upon enactment of the 1990 Clean Air Act
Amendments. See generally 42 U.S.C. 7407(d)(4)(B). These areas included
all former Group I PM10 planning areas identified in 52 FR
29383 (August 7, 1987), and further clarified in 55 FR 45799 (October
31, 1990), and any other areas violating the NAAQS for PM10
prior to January 1, 1989. A Federal Register notice announcing the
areas designated nonattainment for PM10 upon enactment of
the 1990 Clean Air Act Amendments, known as ``initial'' PM10
nonattainment areas, was published on March 15, 1991 (56 FR 11101). The
Eagle River PM10 nonattainment area was one of these initial
moderate PM10 nonattainment areas.

C. Attainment Date for the Eagle River PM10 Nonattainment Area

    All initial moderate PM10 nonattainment areas had the
same applicable attainment date of December 31, 1994. States containing
initial moderate PM10 nonattainment areas were required to
develop and submit to EPA by November 15, 1991, a state implementation
plan (SIP) revision providing implementation of reasonably available
control measures (RACM), including reasonably available control
technology (RACT), and a demonstration of whether attainment of the
PM10 NAAQS by the December 31, 1994, attainment date was
practicable. See section 189(a).

D. PM10 Planning in the Eagle River PM10 Nonattainment Area

    After the Eagle River PM10 nonattainment area was
designated nonattainment for PM10, the Alaska Department of
Environmental Conservation (ADEC) began in the early 1990s to prepare
the technical elements needed to bring the area into attainment and
meet the planning requirements of title I of the CAA. Based on these
technical products ADEC, developed and implemented control measures on
PM10 sources in the Eagle River PM10
nonattainment area. The State submitted these control measures to EPA
on October 15, 1991, as a moderate PM10 nonattainment SIP
revision under section 189(a) of the Act. The control strategy focused
on implementing road surfacing and paving projects to reduce fugitive
dust from paved and unpaved streets and windblown dust. EPA took final
action to approve the State's moderate PM10 SIP on August
13, 1993. See 58 FR 43084.

II. Attainment Determination

A. What are the requirements for attainment determinations?

    Generally, EPA determines whether an area's air quality is meeting
the PM10 NAAQS based upon complete, quality-assured data
gathered at established state and local air monitoring stations (SLAMS)
and national air monitoring stations (NAMS) in the nonattainment areas
and entered into the EPA Air Quality System (AQS). Data from air
monitors operated by state/local/tribal agencies in compliance with EPA
monitoring requirements must be submitted to AQS. EPA relies primarily
on data in AQS when determining the attainment status of an area. See
40 CFR 50.6; 40 CFR part 50, appendix J; 40 CFR part 53; 40 CFR part
58, appendix A. EPA will also consider air quality data from other air
monitoring stations in the nonattainment area provided that the
stations meet the Federal monitoring requirements for SLAMS, including
the quality assurance and quality control criteria in 40 CFR part 58,
appendix A. 40 CFR 58.14 (2006) and 58.20 (2007); \2\ 71 FR 61236,
61242 (October 17, 2006). All valid data are reviewed to determine the
area's air quality status in accordance with 40 CFR part 50, appendix
K.
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    \2\ EPA promulgated amendments to the ambient air monitoring
regulations in 40 CFR parts 53 and 58 on October 17, 2006. See 71 FR
61236. The requirements for Special Purpose Monitors were revised
and moved from 40 CFR 58.14 to 40 CFR 58.20.
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    Attainment of the 24-hour PM10 standard is determined by
calculating the expected number of exceedances of the standard in a
year. The 24-hour standard is attained when the expected number of days
per calendar year with a 24-hour concentration above 154 [mu]g/m\3\, as
determined in accordance with 40 CFR part 50, appendix K, is less than
or equal to one. Generally, three consecutive years of air quality data
are required to show attainment of the 24-hour PM10
standard. See 40 CFR part 50 and appendix K.

B. What do the air quality data show as of the December 31, 1994
attainment date?

    Because the Eagle River PM10 nonattainment area has a
December 31, 1994, attainment date, our determination of whether or not
the area attained the standard is based on 1992, 1993 and 1994 complete
quality-assured data for the area. During that period, the State of
Alaska operated two PM10 SLAMS monitoring sites within the
Eagle River nonattainment area: the Parkgate site and the Baronoff
site. Both monitoring sites met EPA SLAMS network design and siting
requirements set forth at 40 CFR part 58, appendices D and E. The
Parkgate site began operation in 1985 and continues to operate. The
Baronoff site began operating in May of 1992 and ceased operation in
1996.
Parkgate Site
    Our review of complete quality-assured air quality data from the
Parkgate site for the period from January 1, 1992 through December 31,
1994, shows that one 24-hour PM10 value, reported on
September 16, 1992, exceeded the level of the 24-hour standard.\3\ This
24-hour value was flagged by ADEC in AQS as a special event due to a
volcanic eruption. Under EPA's 1994 guidance,\4\ data may be excluded
from regulatory determinations related to exceedances or violations of
the NAAQS if it is adequately demonstrated that a special event caused
the exceedance or violation. EPA concurred on this exceedance as a
special event in a letter to ADEC on May 24, 1995. Consequently, this
value is excluded from expected exceedance calculations. Because there
was no other recorded exceedance of the 24-hour PM10
standard during calendar years 1992-1994, the expected PM10
exceedance rate for the 1992-1994 period at the Parkgate site is 0.0.
Therefore, the Parkgate site has demonstrated attainment for the 24-
hour PM10

NAAQS as of the attainment date of December 31, 1994.
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    \3\ To meet data completeness criteria, missing data in the
first quarter of 1994 was substituted according to EPA guidance. See
``PM10 SIP Development Guideline'' (EPA-450/2-86-001,
June 1987), ``Guideline on Exceptions to Data Requirements for
Determining Attainment of Particulate Matter Standards'' (EPA-450 4-
87-005, April 1987), and the data completeness discussion in the
Memorandum from Chris Hall entitled ``Eagle River PM10
Attainment Determination,'' (October 5, 2010).
    \4\``Guideline on the Identification and Handling of Ambient Air
Quality Data Affected by Special Events or Special Conditions''
(EPA-454/D-94-001, September, 1994).
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    Additionally, we evaluated expected exceedances for the three-year
period prior to and after the attainment date. Because other than the
September 1992 special event, no other exceedance was recorded during
calendar years 1991 through 1997, the Parkgate site has also
demonstrated attainment of the 24-hour PM10 NAAQS for
calendar years 1991-1993, 1993-1995, 1994-1996, and 1995-1997.
 Baronoff Monitoring Site
    EPA also reviewed the data from the Baronoff site, the other SLAMS
site in the Eagle River PM10 nonattainment area that was
operating during the 1992-1994 period. Because this monitor began
operating on May 27, 1992, and did not operate for one full quarter
during the 1992-1994 period, the data from this monitor cannot be used
for making a determination of attainment for the 1992-1994 period.\5\
Even so, we can evaluate whether the data from this monitor show that
the Eagle River PM10 nonattainment area failed to attain for
the 1992-1994 period. Although the Baronoff site recorded three
exceedances of the 24-hour PM10 NAAQS in the 1992-1994
period (all in 1992), these values were flagged by ADEC as special
events due to a volcanic eruption. EPA concurred on the flagged
exceedances in a May 24, 1995, letter to ADEC and thus these values are
excluded from the expected exceedance calculations. Outside of these
flagged exceedances there has been no other exceedance of the 24-hour
PM10 standard at the Baronoff site from May 27, 1992 through
December 31, 1994 (nor through October 1, 1996, when the monitor ceased
operation). We therefore conclude that data from the Baronoff site does
not show the Eagle River PM10 nonattainment area failed to
attain the PM10 standard by the December 31, 1994,
attainment date.\6\
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    \5\ Because data for the 1st quarter 1992 was less than 50%
complete, the substitution guidance used for the Parkgate site was
not used for this site.
    \6\ Based on the available data, the site does not show a
violation of the 24-hour PM10 NAAQS. See 40 CFR part 50,
appendix K, section 2.3(c).
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C. What does more recent air quality data show?

    Although the attainment date for the Eagle River PM10
nonattainment area is December 31, 1994, and the air quality data used
to determine attainment by that date includes all data collected in
calendar years 1992, 1993, and 1994, EPA has also reviewed the air
quality data collected at the State monitoring sites from January 1992
through the most recent available data in AQS. The Parkgate site
recorded one exceedance of the standard in each of the years 2007 and
2009. These exceedances were timely flagged by ADEC as exceptional
events due to high winds and will be evaluated by EPA under the
Exceptional Events Rule and addressed in a separate action.\7\ Under
the Exceptional Events Rule, EPA may exclude data from regulatory
determinations related to exceedances or violations of the NAAQS if it
is adequately demonstrated that an exceptional event caused the
exceedance or violation. 40 CFR 50.1, 50.14. If in the future EPA
determines, after notice-and-comment rulemaking, that the area is no
longer attaining the PM10 NAAQS, EPA will publish such
determination in the Federal Register.
---------------------------------------------------------------------------

    \7\ Note that ADEC has recently advised EPA of an exceedance in
September 2010 that they also intend to flag as a high wind
exceptional event.
---------------------------------------------------------------------------

III. EPA's Final Action

    EPA is determining that the Eagle River area has attained the
PM10 standard based on the three years of complete, quality-
assured data as of the attainment date of December 31, 1994. For the
period from 1992-1994, the expected exceedance rate of 0.0 for the
Parkgate site is equal to or less than the expected exceedance rate of
1.0 that is allowed under the PM10 NAAQS. Because complete
quality-assured data for this period show an expected exceedance rate
equal to or below the PM10 standard, EPA concludes that the
area has met the standard. EPA therefore determines that the Eagle
River nonattainment area has attained the 24-hour PM10 NAAQS
as of the December 31, 1994, attainment date.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
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 Order
12866 (58 FR 51735, October 4, 1993);
     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, as 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 Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

    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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 20, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. 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 81

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: October 7, 2010.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2010-26258 Filed 10-18-10; 8:45 am]
BILLING CODE 6560-50-P


10/ 02 Miscellaneous Sources 13.2.1 1 13.2.1 Paved Roads <IP_ADDRESS> General Particulate emissions occur whenever vehicles travel over a paved surface such as a road or parking lot. Particulate emissions from paved roads are due to direct emissions from vehicles in the form of exhaust, brake wear and tire wear emissions and resuspension of loose material on the road surface. In general terms, resuspended particulate emissions from paved roads originate from, and result in the depletion of, the loose material present on the surface ( i. e., the surface loading). In turn, that surface loading is continuously replenished by other sources. At industrial sites, surface loading is replenished by spillage of material and trackout from unpaved roads and staging areas. Figure 13.2.1 1 illustrates several transfer processes occurring on public streets.

Various field studies have found that public streets and highways, as well as roadways at industrial facilities, can be major sources of the atmospheric particulate matter within an area. 1 9 Of particular interest in many parts of the United States are the increased levels of emissions from public paved roads when the equilibrium between deposition and removal processes is upset. This situation can occur for various reasons, including application of granular materials for snow and ice control, mud/ dirt carryout from construction activities in the area, and deposition from wind and/ or water erosion of surrounding unstabilized areas. In the absence of continuous addition of fresh material ( through localized trackout or application of antiskid material), paved road surface loading should reach an equilibrium value in which the amount of material resuspended matches the amount replenished. The equilibrium surface loading value depends upon numerous factors. It is believed that the most important factors are: mean speed of vehicles traveling the road; the average daily traffic ( ADT); the number of lanes and ADT per lane; the fraction of heavy vehicles ( buses and trucks); and the presence/ absence of curbs, storm sewers and parking lanes. 10 EPA's Office of Transportation and Air Quality plans to release the MOBILE6.1 model soon. This model will calculate particulate emissions from on road mobile sources from the engine exhaust, brake wear and tire wear. The emission factors in this section of AP 42 implicitly include the emissions of exhaust, brake wear, and tire wear that occurred in the field testing that produced the data used to develop the emission factor equation, in addition to resuspended particulate matter from the road surface. Therefore, adding the emission factors in this section to those calculated by MOBILE6.1 poses the problem of double counting. The double counting problem is of most concern when estimating the emissions on high traffic volume roads with low surface silt loadings. The following modifications should be made if double counting is a substantial issue for a particular application of this section. Where MOBILE6.1 predicts higher emissions of particulate matter than the equations in this section for a given combination of road and traffic variables, then only the MOBILE6.1 results should be used and resuspended particulate matter should be considered negligible. Where MOBILE6.1 predictions are less than the emissions that would be predicted from the equation in this section, then the emissions calculated with the equation in this section can be taken as a reasonable representation of total particulate emissions. If in such a case it is desired to separate emissions into resuspended particulate matter versus exhaust, brake and tire wear matter, then the MOBILE6.1 estimates can be subtracted from the estimates made using the equation in this section with the remainder taken as the resuspended portion of the emissions. 13.2.1 2 EMISSION FACTORS 10/ 02 <IP_ADDRESS> Emissions And Correction Parameters Dust emissions from paved roads have been found to vary with what is termed the " silt loading" present on the road surface as well as the average weight of vehicles traveling the road. The term silt loading ( sL) refers to the mass of silt size material ( equal to or less than 75 micrometers [ : m] in physical diameter) per unit area of the travel surface. The total road surface dust loading consists of loose material that can be collected by broom sweeping and vacuuming of the traveled portion of the paved road. The silt fraction is determined by measuring the proportion of the loose dry surface dust that passes through a 200 mesh screen, using the ASTM C 136 method. Silt loading is the product of the silt fraction and the total loading, and is abbreviated " sL". Additional details on the sampling and analysis of such material are provided in AP 42 Appendices C. 1 and C. 2.

The surface sL provides a reasonable means of characterizing seasonal variability in a paved road emission inventory. In many areas of the country, road surface loadings 11 21 are heaviest during the late winter and early spring months when the residual loading from snow/ ice controls is greatest. As noted earlier, once replenishment of fresh material is eliminated, the road surface loading can be expected to reach an equilibrium value, which is substantially lower than the late winter/ early spring values. 10/ 02 Miscellaneous Sources 13.2.1 3 Figure 13.2.1 1. Deposition and removal processes. 13.2.1 4 EMISSION FACTORS 10/ 02 Table 13.2 1.1. PARTICLE SIZE MULTIPLIERS FOR PAVED ROAD EQUATION Size rangea Particle Size Multiplier kb g/ VKT g/ VMT lb/ VMT PM 2.5c 1.1 1.8 0.0040 PM 10 4.6 7.3 0.016 PM 15 5.5 9.0 0.020 PM 30d 24 38 0.082 a Refers to airborne particulate matter ( PM x) with an aerodynamic diameter equal to or less than x micrometers.

b Units shown are grams per vehicle kilometer traveled ( g/ VKT), grams per vehicle mile traveled ( g/ VMT), and pounds per vehicle mile traveled ( lb/ VMT). The multiplier k includes unit conversions to produce emission factors in the units shown for the indicated size range from the mixed units required in Equation 1.

c Ratio of PM 2.5 to PM 10 taken from Reference 22.

d PM 30 is sometimes termed " suspendable particulate" ( SP) and is often used as a surrogate for TSP. <IP_ADDRESS> Predictive Emission Factor Equations10 The quantity of particulate emissions from vehicle traffic on a dry paved road may be estimated using the following empirical expression: E= k ( sL/ 2) 0.65 ( W/ 3 ) 1.5 ( 1) where: E = particulate emission factor ( having units matching the units of k) k = particle size multiplier for particle size range and units of interest ( see below) sL = road surface silt loading ( grams per square meter) ( g/ m2) W = average weight ( tons) of the vehicles traveling the road It is important to note that Equation 1 calls for the average weight of all vehicles traveling the road. For example, if 99 percent of traffic on the road are 2 ton cars/ trucks while the remaining 1 percent consists of 20 ton trucks, then the mean weight " W" is 2.2 tons. More specifically, Equation 1 is not intended to be used to calculate a separate emission factor for each vehicle weight class. Instead, only one emission factor should be calculated to represent the " fleet" average weight of all vehicles traveling the road.

The particle size multiplier ( k) above varies with aerodynamic size range as shown in Table 13.2.1 1. To determine particulate emissions for a specific particle size range, use the appropriate value of k shown in Table 13.2.1 1.

The above equation is based on a regression analysis of numerous emission tests, including 65 tests for PM 10.10 Sources tested include public paved roads, as well as controlled and uncontrolled industrial paved roads. All sources tested were of freely flowing vehicles traveling at constant speed on relatively level roads . No tests of " stop and go" traffic or vehicles under load were available for inclusion in the data base. The equations retain the quality rating of A ( B for PM 2.5), if applied within the range of source conditions that were tested in developing the equation as follows: 10/ 02 Miscellaneous Sources 13.2.1 5 Silt loading: 0.02  400 g/ m2 0.03  570 grains/ square foot ( ft2) Mean vehicle weight: 1.8  38 megagrams ( Mg) 2.0  42 tons Mean vehicle speed: 16  88 kilometers per hour ( kph) 10  55 miles per hour ( mph)

To retain the quality rating for the emission factor equation when it is applied to a specific paved road, it is necessary that reliable correction parameter values for the specific road in question be determined. With the exception of limited access roadways, which are difficult to sample, the collection and use of site specific silt loading ( sL) data for public paved road emission inventories are strongly recommended. The field and laboratory procedures for determining surface material silt content and surface dust loading are summarized in Appendices C. 1 and C. 2. In the event that site specific values cannot be obtained, an appropriate value for a paved public road may be selected from the values given in Table 13.2.1 2, but the quality rating of the equation should be reduced by 2 levels. Also, recall that Equation 1 refers to emissions due to freely flowing ( not stop and go) traffic at constant speed on level roads.

Equation 1 may be extrapolated to average uncontrolled conditions ( but including natural mitigation) under the simplifying assumption that annual ( or other long term) average emissions are inversely proportional to the frequency of measurable (> 0.254 mm [ 0.01 inch]) precipitation by application of a precipitation correction term. The precipitation correction term can be applied on a daily or an hourly basis. For the daily basis, equation 1 becomes:

Eext = k ( sL/ 2) 0.65 ( W/ 3 ) 1.5 ( 1 P/ 4N) ( 2)

where k, sL, and W are as defined in Equation 1 and Eext = annual or other long term average emission factor in the same units as k P = number of " wet" days with at least 0.254 mm ( 0.01 in) of precipitation during the averaging period N = number of days in the averaging period ( e. g., 365 for annual, 91 for seasonal, 30 for monthly)

Note that the assumption leading to Equation 2 is based on analogy with the approach used to develop long term average unpaved road emission factors in Section 13.2.2. However, Equation 2 above incorporates an additional factor of " 4" in the denominator to account for the fact that paved roads dry more quickly than unpaved roads and that the precipitation may not occur over the complete 24 hour day.

For the hourly basis, equation 1 becomes:

Eext = k ( sL/ 2) 0.65 ( W/ 3 ) 1.5 ( 1 1.2P/ N) ( 3)

where k, sL, and W are as defined in Equation 1 and Eext = annual or other long term average emission factor in the same units as k P = number of hours with at least 0.254 mm ( 0.01 in) of precipitation during the averaging period N = number of hours in the averaging period ( e. g., 8760 for annual, 2124 for seasonal, 720 for monthly) 13.2.1 6 EMISSION FACTORS 10/ 02 Note: In the hourly moisture correction term ( 1 1.2P/ N) for equation 3, the 1.2 multiplier is applied to account for the residual mitigative effect of moisture. For most applications, this equation will produce satisfactory results. However, if the time interval for which the equation is applied is short, e. g., for one hour or one day, the application of this multiplier makes it possible for the moisture correction term to become negative. This will result in calculated negative emissions which is not realistic. Users should expand the time interval to include sufficient " dry" hours such that negative emissions are not calculated. For the special case where this equation is used to calculate emissions on an hour by hour basis, such as would be done in some emissions modeling situations, the moisture correction term should be modified so that the moisture correction " credit" is applied to the first hours following cessation of precipitation. In this special case, it is suggested that this 20% " credit" be applied on a basis of one hour credit for each hour of precipitation up to a maximum of 12 hours.

Note that the assumption leading to Equation 3 is based on analogy with the approach used to develop long term average unpaved road emission factors in Section 13.2.2.

Figure 13.2.1 2 presents the geographical distribution of " wet" days on an annual basis for the United States. Maps showing this information on a monthly basis are available in the Climatic Atlas of the United States23 . Alternative sources include other Department of Commerce publications ( such as local climatological data summaries). The National Climatic Data Center ( NCDC) offers several products that provide hourly precipitation data. In particular, NCDC offers Solar and Meteorological Surface Observation Network 1961 1990 ( SAMSON) CD ROM, which contains 30 years worth of hourly meteorological data for first order National Weather Service locations. Whatever meteorological data are used, the source of that data and the averaging period should be clearly specified.

It is emphasized that the simple assumption underlying Equations 2 and 3 has not been verified in any rigorous manner. For that reason, the quality ratings for Equations 2 and 3 should be downgraded one letter from the rating that would be applied to Equation 1.

During the preparation of the background document ( Reference 10), public road silt loading values from 1992 and earlier were assembled into a data base. This data base is available in the file named " r13s03 1b. zip" located at the Internet URL " http:// www. epa. gov/ ttn/ chief/ ap42/ ch13/ related/ c13s02 1. html" on the World Wide Web. Although hundreds of public paved road silt loading measurements had been collected, there was no uniformity in sampling equipment and analysis techniques, in roadway classification schemes, and in the types of data reported. Not surprisingly, the data set did not yield a coherent relationship between silt loading and road class, average daily traffic ( ADT), etc., even though an inverse relationship between silt loading and ADT has been found for a subclass of curbed paved roads in urban areas. Further complicating the analysis is the fact that, in many parts of the country, paved road silt loading varies greatly over the course of the year, probably because of cyclic variations in mud/ dirt carryout and in use of anti skid materials. Although there were strong reasons to suspect that the assembled data base was skewed towards high values, independent data were not available to confirm the suspicions. 10/ 02 Miscellaneous Sources 13.2.1 7 Figure 13.2.1 2. Mean number of days with 0.01 inch or more of precipitation in the United States. 13.2.1 8 EMISSION FACTORS 10/ 02 Table 13.2.1 2 ( Metric Units). RECOMMENDED DEFAULT SILT LOADING ( g/ m2) VALUES FOR PUBLIC PAVED ROADSa High ADT roadsb Low ADT roads Normal conditions 0.1 0.4 Worst case conditionsc 0.5 3 a Excluding limited access roads. See discussion in text. 1 g/ m2 is equal to 1.43 grains/ ft2 b High ADT refers to roads with at least 5,000 vehicles per day. c For conditions such as post winter storm or areas with substantial mud/ dirt carryout. Since the time that the background document was prepared, new field sampling programs have shown that the assembled silt loading data set is biased high for " normal" situations. 24 Just as importantly, however, the newer programs confirm that substantially higher than " normal" silt loadings can occur on public paved roads. As a result, two sets of default values are provided in Table 13.2.1 2, one for " normal" conditions and another for worst case conditions ( such as after winter storm seasons or in areas with substantial mud/ dirt trackout). The " normal" silt loading data base is available in the file " r13s03 1a. zip" located at the Internet URL " http:// www. epa. gov/ ttn/ chief/ ap42/ ch13/ related/ c13s02 1. html" on the World Wide Web.

The range of silt loading values in the data base for normal conditions is 0.01 to 1.0 for high ADT roads and 0.054 to 6.8 for low ADT roads. Consequently the use of a default value from Table 13.2.1 2 should be expected to yield only an order of magnitude estimate of the emission factor. Public paved road silt loadings are dependent upon: traffic characteristics ( speed, ADT, and fraction of heavy vehicles); road characteristics ( curbs, number of lanes, parking lanes); local land use ( agriculture, new residential construction) and regional/ seasonal factors ( snow/ ice controls, wind blown dust). As a result, the collection and use of site specific silt loading data is highly recommended. In the event that default silt loading values are used, the quality ratings for the equation should be downgraded 2 levels.

Limited access roadways pose severe logistical difficulties in terms of surface sampling, and few silt loading data are available for such roads. Nevertheless, the available data do not suggest great variation in silt loading for limited access roadways from one part of the country to another. For annual conditions, a default value of 0.015 g/ m2 is recommended for limited access roadways. 9,22 Even fewer of the available data correspond to worst case situations, and elevated loadings are observed to be quickly depleted because of high traffic speeds and high ADT rates. A default value of 0.2 g/ m2 is recommended for short periods of time following application of snow/ ice controls to limited access roads. 22 The limited data on silt loading values for industrial roads have shown as much variability as public roads. Because of the variations of traffic conditions and the use of preventive mitigative controls, the data probably do not reflect the full extent of the potential variation in silt loading on industrial roads. However, the collection of site specific silt loading data from industrial roads is easier and safer than for public roads. Therefore, the collection and use of site specific silt loading data is preferred and is highly recommended. In the event that site specific values cannot be obtained, an appropriate value for an industrial road may be selected from the mean values given in Table 13.2.1 3, but the quality rating of the equation should be reduced by 2 levels. 10/ 02 Miscellaneous Sources 13.2.1 9 Table 13.2.1 3 ( Metric And English Units). TYPICAL SILT CONTENT AND LOADING VALUES FOR PAVED ROADS AT INDUSTRIAL FACILITIESa Industry No. Of Sites No. Of Sample s Silt Content (%) No. Of Travel Lanes Total Loading x 10 ! 3 Silt Loading ( g/ m2)

Range Mean Range Mean Unitsb Range Mean Copper smelting 1 3 15.4 21.7 19.0 2 12.9 19.5 45.8 69.2 15.9 55.4 kg/ km lb/ mi 188 400 292 Iron and steel production 9 48 1.1 35.7 12.5 2 0.006 4.77 0.020 16.9 0.495 1.75 kg/ km lb/ mi 0.09 79 9.7 Asphalt batching 1 3 2.6 4.6 3.3 1 12.1 18.0 43.0 64.0 14.9 52.8 kg/ km lb/ mi 76 193 120 Concrete batching 1 3 5.2 6.0 5.5 2 1.4 1.8 5.0 6.4 1.7 5.9 kg/ km lb/ mi 11 12 12 Sand and gravel processing 1 3 6.4 7.9 7.1 1 2.8 5.5 9.9 19.4 3.8 13.3 kg/ km lb/ mi 53 95 70 Municipal solid waste landfill 2 7     2       1.1 32.0 7.4 Quarry 1 6     2       2.4 14 8.2 a References 1 2,5 6,11 13. Values represent samples collected from industrial roads. Public road silt loading values are presented in Table 13.2.1 2. Dashes indicate information not available.

b Multiply entries by 1000 to obtain stated units; kilograms per kilometer ( kg/ km) and pounds per mile ( lb/ mi). 13.2.1 10 EMISSION FACTORS 10/ 02 <IP_ADDRESS> Controls6,25 Because of the importance of the silt loading, control techniques for paved roads attempt either to prevent material from being deposited onto the surface ( preventive controls) or to remove from the travel lanes any material that has been deposited ( mitigative controls). Covering of loads in trucks, and the paving of access areas to unpaved lots or construction sites, are examples of preventive measures. Examples of mitigative controls include vacuum sweeping, water flushing, and broom sweeping and flushing. Actual control efficiencies for any of these techniques can be highly variable. Locally measured silt loadings before and after the application of controls is the preferred method to evaluate controls. It is particularly important to note that street sweeping of gutters and curb areas may actually increase the silt loading on the traveled portion of the road. Redistribution of loose material onto the travel lanes will actually produce a short term increase in the emissions.

In general, preventive controls are usually more cost effective than mitigative controls. The costeffectiveness of mitigative controls falls off dramatically as the size of an area to be treated increases. The cost effectiveness of mitigative measures is also unfavorable if only a short period of time is required for the road to return to equilibrium silt loading condition. That is to say, the number and length of public roads within most areas of interest preclude any widespread and routine use of mitigative controls. On the other hand, because of the more limited scope of roads at an industrial site, mitigative measures may be used quite successfully ( especially in situations where truck spillage occurs). Note, however, that public agencies could make effective use of mitigative controls to remove sand/ salt from roads after the winter ends.

Because available controls will affect the silt loading, controlled emission factors may be obtained by substituting controlled silt loading values into the equation. ( Emission factors from controlled industrial roads were used in the development of the equation.) The collection of surface loading samples from treated, as well as baseline ( untreated), roads provides a means to track effectiveness of the controls over time.

<IP_ADDRESS> Changes since Fifth Edition The following changes were made since the publication of the Fifth Edition of AP 42:

1) The particle size multiplier was reduced by approximately 55% as a result of emission testing specifically to evaluate the PM 2.5 component of the emissions.

2) Default silt loading values were included in Table 13.2.1 2 replacing the Tables and Figures containing silt loading statistical information.

3) Editorial changes within the text were made indicating the possible causes of variations in the silt loading between roads within and among different locations. The uncertainty of using the default silt loading value was discussed.

4) Section <IP_ADDRESS> was revised to clarify the role of dust loading in resuspension. Additional minor text changes were made.

5) Equations 2 and 3, Figure 13.2.1 2, and text were added to incorporate natural mitigation into annual or other long term average emission factors.

6) Discussion was added to the text on the application of the MOBILE6.1 model and this section of AP 42. 10/ 02 Miscellaneous Sources 13.2.1 11 7) References were rearranged and renumbered.

References For Section 13.2.1 1. D. R. Dunbar, Resuspension Of Particulate Matter, EPA 450/ 2 76 031, U. S. Environmental Protection Agency, Research Triangle Park, NC, March 1976.

2. R. Bohn, et al., Fugitive Emissions From Integrated Iron And Steel Plants, EPA 600/ 2 78 050, U. S. Environmental Protection Agency, Cincinnati, OH, March 1978.

3. C. Cowherd, Jr., et al., Iron And Steel Plant Open Dust Source Fugitive Emission Evaluation, EPA 600/ 2 79 103, U. S. Environmental Protection Agency, Cincinnati, OH, May 1979.

4. C. Cowherd, Jr., et al., Quantification Of Dust Entrainment From Paved Roadways, EPA 450/ 3 77 027, U. S. Environmental Protection Agency, Research Triangle Park, NC, July 1977.

5. Size Specific Particulate Emission Factors For Uncontrolled Industrial And Rural Roads, EPA Contract No. 68 02 3158, Midwest Research Institute, Kansas City, MO, September 1983.

6. T. Cuscino, Jr., et al., Iron And Steel Plant Open Source Fugitive Emission Control Evaluation, EPA 600/ 2 83 110, U. S. Environmental Protection Agency, Cincinnati, OH, October 1983.

7. J. P. Reider, Size specific Particulate Emission Factors For Uncontrolled Industrial And Rural Roads, EPA Contract 68 02 3158, Midwest Research Institute, Kansas City, MO, September 1983.

8. C. Cowherd, Jr., and P. J. Englehart, Paved Road Particulate Emissions, EPA 600/ 7 84 077, U. S. Environmental Protection Agency, Cincinnati, OH, July 1984.

9. C. Cowherd, Jr., and P. J. Englehart, Size Specific Particulate Emission Factors For Industrial And Rural Roads, EPA 600/ 7 85 038, U. S. Environmental Protection Agency, Cincinnati, OH, September 1985.

10. Emission Factor Documentation For AP 42, Sections 11.2.5 and 11.2.6   Paved Roads, EPA Contract No. 68 D0 0123, Midwest Research Institute, Kansas City, MO, March 1993.

11. Evaluation Of Open Dust Sources In The Vicinity Of Buffalo, New York, EPA Contract No. 68 02 2545, Midwest Research Institute, Kansas City, MO, March 1979.

12. PM 10 Emission Inventory Of Landfills In The Lake Calumet Area, EPA Contract No. 68 02 3891, Midwest Research Institute, Kansas City, MO, September 1987.

13. Chicago Area Particulate Matter Emission Inventory   Sampling And Analysis, Contract No. 68 02 4395, Midwest Research Institute, Kansas City, MO, May 1988.

14. Montana Street Sampling Data, Montana Department Of Health And Environmental Sciences, Helena, MT, July 1992.

15. Street Sanding Emissions And Control Study, PEI Associates, Inc., Cincinnati, OH, October 1989. 13.2.1 12 EMISSION FACTORS 10/ 02 16. Evaluation Of PM 10 Emission Factors For Paved Streets, Harding Lawson Associates, Denver, CO, October 1991.

17. Street Sanding Emissions And Control Study, RTP Environmental Associates, Inc., Denver, CO, July 1990.

18. Post storm Measurement Results   Salt Lake County Road Dust Silt Loading Winter 1991/ 92 Measurement Program, Aerovironment, Inc., Monrovia, CA, June 1992.

19. Written communication from Harold Glasser, Department of Health, Clark County ( NV).

20. PM 10 Emissions Inventory Data For The Maricopa And Pima Planning Areas, EPA Contract No. 68 02 3888, Engineering Science, Pasadena, CA, January 1987.

21. Characterization Of PM 10 Emissions From Antiskid Materials Applied To Ice And Snow Covered Roadways, EPA Contract No. 68 D0 0137, Midwest Research Institute, Kansas City, MO, October 1992.

22. Fugitive Particulate Matter Emissions, EPA Contract No. 68 D2 0159, Work Assignment No. 4 06, Midwest Research Institute, Kansas City, MO, April 1997.

23. Climatic Atlas Of The United States, U. S. Department of Commerce, Washington, D. C., June 1968.

24. Written communication from G. Muleski, Midwest Research Institute, Kansas City, MO, to R. Myers, U. S. Environmental Protection Agency, Research Triangle Park, NC, September 30, 1997.

25. C. Cowherd, Jr., et al., Control Of Open Fugitive Dust Sources, EPA 450/ 3 88 008, U. S. Environmental Protection Agency, Research Triangle Park, NC, September 1988.


[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Page 45658]
[FR Doc No: 2017-20898]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

RTCA Federal Advisory Committee

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA charter renewal.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
renewal of the RTCA Charter (FAA Order 1110.77X) for 6 months,
effective September 29, 2017. The Federal Aviation Administration (FAA)
is authorized to establish the RTCA advisory committee in accordance
with the provisions of the Federal Advisory Committee Act (FACA). The
current charter agreement requires that the RTCA manage various Federal
subcommittees on behalf of the agency.
    The objective of the advisory committee is to seek resolution of
issues and challenges involving air transportation concepts,
requirements, operational capabilities, the associated use of
technology, and related considerations to aeronautical operations that
affect the future of the Air Traffic Management System and the
integration of new technologies.

FOR FURTHER INFORMATION CONTACT: Andy Cebula at<EMAIL_ADDRESS>or
(202) 330-0652, or the RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: The Federal Advisory Committee meetings are
open to the public and announced in the Federal Register, except as
authorized by Section 10(d) of the Federal Advisory Committee Act.

    Issued in Washington, DC, on September 26, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-20898 Filed 9-28-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Proposed Rules]
[Pages 84516-84517]
[FR Doc No: 2016-27949]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-3401]

Scientific Evaluation of the Evidence on the Beneficial
Physiological Effects of Isolated or Synthetic Non-Digestible
Carbohydrates Submitted as a Citizen Petition; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance entitled ``Scientific Evaluation of
the Evidence on the Beneficial Physiological Effects of Isolated or
Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition
(21 CFR 10.30).'' The draft guidance, when finalized, will describe our
views on the scientific evidence needed and the approach to evaluating
the scientific evidence on the physiological effects of isolated or
synthetic non-digestible carbohydrates that are added to foods that are
beneficial to human health.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on the
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on this document
by January 23, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-3401 for ``Scientific Evaluation of the Evidence on the
Beneficial Physiological Effects of Isolated or Synthetic Non-
digestible Carbohydrates Submitted as a Citizen Petition (21 CFR
10.30).'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Scientific Evaluation of the Evidence on the Beneficial
Physiological Effects of Isolated or Synthetic Non-digestible
Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' We are
issuing the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent the current thinking of FDA on this topic. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
    In the Federal Register of May 27, 2016 (81 FR 33741), we published
a final rule amending our Nutrition and Supplement Facts label
regulations. The final rule provides a definition of dietary fiber as
non-digestible soluble and insoluble carbohydrates (with 3 or more
monomeric units), and lignin that are intrinsic and intact in plants;
isolated or synthetic non-digestible carbohydrates (with 3 or more
monomeric units) determined by FDA to have physiological effects that
are beneficial to human health Sec.  101.9(c)(6)(i)) (21 CFR 101.9
(c)(6)(i)). One mechanism by which a manufacturer could request an
amendment to the dietary fiber definition is by using the citizen
petition process in Sec.  10.30. If an isolated or synthetic
nondigestible carbohydrate meets the dietary fiber definition, then it
would be added to the list of dietary fibers in the definition in Sec.
101.9(c)(6)(i)).
    The draft guidance document represents our current thinking
regarding the type of scientific evidence on which we will rely and the
scientific evaluation process we plan to use in determining the
strength of the evidence for the relationship between an isolated or
synthetic non-digestible carbohydrate that is added to food and a
physiological effect that is beneficial to human health.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec.  101.9 have been approved under OMB
control number 0910-0813.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27949 Filed 11-22-16; 8:45 am]
BILLING CODE 4164-01-P