[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Proposed Rules]
[Page 65360]
[FR Doc No: 2014-26212]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 121 and 145

[AC 120-66C]

Advisory Circular for Aviation Safety Action Program (ASAP)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability of proposed revision to Advisory
Circular for Aviation Safety Action Program (ASAP); Extension of
comment period.

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SUMMARY: This action extends the comment period for the Notice of
availability of proposed revision to Advisory Circular for Aviation
Safety Action Program (ASAP) that was published on September 5, 2014.
In that document, the FAA proposed to clarify FAA policy, facilitate
achievement of an ASAP's safety goals, and encourage wider
participation in the program. Multiple industry groups have requested
that the FAA extend the comment period closing date to allow time to
prepare comments.

DATES: The comment period for the Notice of availability of proposed
revision to Advisory Circular for Aviation Safety Action Program (ASAP)
published on September 5, 2014, was scheduled to close on November 4,
2014, and is extended until January 5, 2015.

ADDRESSES: You may send comments identified by AC 120-66C using any of
the following methods:
     Aviation Safety Draft Document Open for Comment Web site:
Go to http://www.faa.gov/aircraft/draft_docs/afs_ac/ and follow the
online instructions for sending your comments electronically.
     Mail: Send comments to 1625 K Street NW., Suite 300,
Washington, DC 20006.
     Fax: Fax comments to<PHONE_NUMBER>. Attn: Laura L. Miller.
     Hand Delivery: Bring comments to 1625 K Street NW., Suite
300, Washington, DC between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Randy McDonald, Air Transportation
Division, Flight Standards Service, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-
8166; facsimile:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Background

    On September 5, 2014, the Federal Aviation Administration (FAA)
published a notice in the Federal Register (79 FR 53008) announcing the
availability of proposed Advisory Circular (AC) 120-66C. AC 120-66C
provides guidance for establishing an air transportation Aviation
Safety Action Program (ASAP). The comment period for that notice was to
have closed November 4, 2014.
    The FAA has reviewed the requests made by multiple industry groups
for extension of the comment period to Notice of availability of
proposed revision to Advisory Circular for Aviation Safety Action
Program (ASAP). These petitioners have shown a substantive interest in
the contents of the Notice and good cause for the extension. The FAA
has determined that extension of the comment period is consistent with
the public interest, and that good cause exists for taking this action.
    Accordingly, the comment period for Notice of availability of
proposed revision to Advisory Circular for Aviation Safety Action
Program (ASAP) is extended until January 5, 2015.

John S. Duncan,
Director, Flight Standards Service.
[FR Doc. 2014-26212 Filed 11-3-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20647-20649]
[FR Doc No: 2016-08075]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0519]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How To Submit Information in
Electronic Format to the Center for Veterinary Medicine Using the Food
and Drug Administration Electronic Submission Gateway

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on extending Office of Management
and Budget (OMB) approval on the existing reporting requirements
relating to how one may submit information electronically to the Center
for Veterinary Medicine (CVM) using the FDA Electronic Submissions
Gateway (ESG).

DATES: Submit either electronic or written comments on the collection
of information by June 7, 2016.

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-2013-N-0519 for ``Guidance for Industry on How To Submit
Information in Electronic Format to the Center for Veterinary Medicine
Using the Food and Drug Administration Electronic Submission Gateway.''
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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on How To Submit Information in Electronic Format
to the Center for Veterinary Medicine Using the Food and Drug
Administration Electronic Submission Gateway--21 CFR 11.2 OMB Control
Number 0910-0454--Extension

    We accept certain types of submissions electronically with no
requirement for a paper copy. These types of documents are listed in
public docket 97S-0251 as required by 21 CFR 11.2. Our ability to
receive and process information submitted electronically is limited by
our current information technology capabilities and the requirements of
the Electronic Records; Electronic Signatures final regulation. Our
guidance entitled ``Guidance for Industry #108: How to Submit
Information in Electronic Format to CVM Using the FDA Electronic
Submission Gateway'' outlines general standards to be used for the
submission of any electronic information to CVM using the FDA ESG. The
likely respondents are sponsors for new animal drug applications.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
              21 CFR section                 FDA form No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
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11.2......................................            3538              29             1.3              38  .08 (5 minutes).............             3.0
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our experience with the submission of
electronic information to us using the FDA ESG and the number of
electronic registration or change requests received between January 1,
2014, and December 31, 2014.

    Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08075 Filed 4-7-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Proposed Rules]
[Pages 71369-71373]
[FR Doc No: 2014-28390]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2012-0352; FRL-9919-97-OAR]

Approval and Promulgation of Air Quality Implementation Plans;
State of Montana Second 10-Year Carbon Monoxide Maintenance Plan for
Billings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing approval of a State Implementation Plan (SIP)
revision submitted by the State of Montana. On July 13, 2011, the
Governor of Montana's designee submitted to EPA a second 10-year
maintenance plan for the Billings area for the carbon monoxide (CO)
National Ambient Air Quality Standard (NAAQS). This maintenance plan
addresses maintenance of the CO NAAQS for a second 10-year period
beyond the original redesignation. EPA is also proposing approval of an
alternative monitoring strategy for the Billings CO maintenance area,
which was submitted by the Governor's designee on June 22, 2012.

DATES: Comments must be received on or before January 2, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2012-0352, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Director, Air Program, Environmental Protection
Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver,
Colorado 80202-1129.
     Hand Delivery: Director, Air Program, EPA, Region 8, Mail
Code 8P-AR, 1595 Wynkoop, Denver, Colorado

80202-1129. Such deliveries are only accepted Monday through Friday,
8:00 a.m. to 4:30 p.m., excluding federal holidays. Special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2012-0352. 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 email. 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 email comment directly to EPA, without
going through http://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. For additional instructions on submitting
comments, go to Section I. General Information of the SUPPLEMENTARY
INFORMATION section of this document.
    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, 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 at the Air Program, EPA,
Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129.
EPA requests that if at all possible, you contact the individual listed
in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of
the docket. You may view the hard copy of the docket Monday through
Friday, 8:00 a.m. to 4:00 p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Adam Clark, Air Program, EPA, Region
8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303)
312-7104<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The initials ADT mean or refer to Average Daily Traffic.
    (iii) The initials CO mean or refer to carbon monoxide.
    (iv) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (v) The initials LMP mean or refer to Limited Maintenance Plan.
    (vi) The initials MDEQ mean or refer to Montana Department of
Environmental Quality.
    (vii) The initials MVEB mean or refer to Motor Vehicle Emissions
Budget.
    (viii) The initials NAAQS mean or refer to the National Ambient Air
Quality Standards.
    (ix) The initials ppm mean or refer to parts per million.
    (x) The initials RTP mean or refer to Regional Transportation Plan.
    (xi) The initials SIP mean or refer to State Implementation Plan.
    (xii) The initials TIP mean or refer to Transportation Improvement
Plan.
    (xiii) The words Montana and State mean or refer to the State of
Montana.

I. General Information

What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit CBI to EPA through http://www.regulations.gov or email. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information on a disk or CD ROM that you mail to EPA, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is claimed as
CBI. In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register, date, and
page number);
     Follow directions and organize your comments;
     Explain why you agree or disagree;
     Suggest alternatives and substitute language for your
requested changes;
     Describe any assumptions and provide any technical
information and/or data that you used;
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced;
     Provide specific examples to illustrate your concerns and
suggest alternatives;
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats; and
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. Billings CO Maintenance Plan

    Under the Clean Air Act (CAA) Amendments of 1990, the Billings area
was designated as nonattainment and classified as a ``not classified''
CO area. This was because the area had been designated as nonattainment
before November 15, 1990, but had not violated the CO NAAQS in 1988 and
1989 (56 FR 56694, November 6, 1991). On February 9, 2001, the Governor
of Montana submitted to us a request to redesignate the Billings CO
nonattainment area to attainment for the CO NAAQS. Along with this
request, the Governor submitted a CAA section 175A(a) maintenance plan
which demonstrated that the area would maintain the CO NAAQS for the
first 10 years following our approval of the redesignation request. We
approved the State's redesignation request and 10-year maintenance plan
on February 21, 2002 (67 FR 7966).

    Eight years after an area is redesignated to attainment, CAA
section 175A(b) requires the state to submit a subsequent maintenance
plan to EPA, covering a second 10-year period.\1\ This second 10-year
maintenance plan must demonstrate continued compliance with the NAAQS
during this second 10-year period. To fulfill this requirement of the
CAA, the Governor of Montana's designee submitted the second 10-year
update of the Billings CO maintenance plan (hereafter; ``revised
Billings Maintenance Plan'') to us on July 13, 2011. With this action,
we are proposing approval of the revised Billings Maintenance Plan.
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    \1\ In this case, the initial maintenance period extended
through 2012. Thus, the second 10-year period extends through 2022.
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    The 8-hour CO NAAQS--9.0 parts per million (ppm)--is attained when
such value is not exceeded more than once a year. 40 CFR 50.8(a)(1).
The Billings area has attained the 8-hour CO NAAQS from 1988 to the
present. In October 1995, EPA issued guidance that provided
nonclassifiable CO nonattainment areas the option of using a less
rigorous ``limited maintenance plan'' (LMP) option to demonstrate
continued attainment and maintenance of the CO NAAQS.\2\ According to
this guidance, areas that can demonstrate design values (2nd highest
max) at or below 7.65 ppm (85% of exceedance levels of the 8-hour CO
NAAQS) for eight consecutive quarters qualify to use an LMP. The area
qualified for and used EPA's LMP option for the first 10-year Billings
CO maintenance plan (67 FR 7966, February 21, 2002). For the revised
Billings Maintenance Plan the State again used the LMP option to
demonstrate continued maintenance of the CO NAAQS in the Billings area.
We have determined that the Billings area continues to qualify for the
LMP option because the maximum design value for the most recent eight
consecutive quarters with certified data at the time the State adopted
the plan (years 2008 and 2009) was 2 ppm.\3\
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    \2\ Memorandum ``Limited Maintenance Plan Option for
Nonclassifiable CO Nonattainment Areas'' from Joseph W. Paisie,
Group Leader, EPA Integrated Policy and Strategies Group, to Air
Branch Chiefs, October 6, 1995.
    \3\ See Table 2 below. Additionally, according to the LMP
guidance, an area using the LMP option must continue to have a
design value ``at or below 7.65 ppm until the time of final EPA
action on the redesignation.'' Table 2, below, demonstrates that the
area meets this requirement.
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B. Alternative CO Monitoring Strategy

    Along with the revised Billings Maintenance Plan, the State
submitted a CO maintenance plan for the Great Falls, Montana
maintenance area, and an alternative strategy for monitoring continued
attainment of the CO NAAQS in all of the State's CO maintenance areas
on July 13, 2011.\4\ The State submitted the alternative monitoring
strategy to conserve resources by discontinuing the gaseous CO ambient
monitors in both the Billings and Great Falls CO maintenance areas. In
place of the gaseous ambient monitors, the State's alternative method
relies on rolling 3-year Average Daily Traffic (ADT) vehicle counts
collected from permanent automatic traffic recorders in each
maintenance area. We commented on the State's ``Alternative Monitoring
Strategy,'' and the State submitted to us a revised version of the
strategy which incorporated our comments on June 22, 2012. The State's
June 22, 2012 Alternative Monitoring Strategy replaced the version
submitted on July 13, 2011.
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    \4\ In addition to Billings and Great Falls, the Missoula, MT CO
maintenance area was included in the July 13, 2011Alternative
Monitoring Strategy.
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III. EPA's Evaluation of Montana's Alternative Monitoring Strategy in
Billings

    Since 2002, no Billings CO monitor has registered a design value
greater than 4.4 ppm, which is roughly half of the NAAQS. Further,
since 2006, no Billings monitor has registered a design value greater
than 2.2 ppm, roughly 25% of the NAAQS.\5\ Citing these consistently
low monitor values, and expressing a desire to conserve monitoring
resources, the State has requested to discontinue CO monitoring in
Billings and instead use an alternative strategy for monitoring
maintenance of the CO NAAQS.
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    \5\ See Table 2 below. Design values were derived from the EPA
AirData (http://www.epa.gov/airdata/) Web site.
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    The State's Alternative Monitoring Strategy utilizes ADT vehicle
counts collected from permanent automatic traffic recorders in the
Billings CO maintenance area to determine average monthly traffic
during the traditional high CO concentration season of November through
February. The State will compare the latest rolling 3-years of monthly
ADT volumes to the 2008-2010 baseline ADT volumes (see Table 1) that
correlate to the low CO monitored values during that period (see Table
2). Because mobile sources are the biggest driver of CO pollution, the
Montana Department of Environmental Quality (MDEQ) reasoned that any
significant increase in CO emissions would have to be accompanied by a
significant increase in ADT.\6\ EPA agrees with the State's reasoning.
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    \6\ See ``Review of National Ambient Air Quality Standards for
Carbon Monoxide,'' 76 FR 54294, August 31, 2011.

             Table 1--Traffic Volumes for Billings, Montana
------------------------------------------------------------------------
              Rolling 2008-2010 ADT:  November to February
-------------------------------------------------------------------------
                                                          Billings  (#A-
                       Month-Year                              050)
------------------------------------------------------------------------
January 2008............................................          32,778
February 2008...........................................          35,463
November 2008...........................................          35,832
December 2008...........................................          32,042
January 2009............................................          33,256
February 2009...........................................          35,695
November 2009...........................................          37,121
December 2009...........................................          33,905
January 2010............................................          32,340
February 2010...........................................          34,317
November 2010...........................................          33,885
December 2010...........................................          34,317
                                                         ---------------
    Average.............................................          34,246
------------------------------------------------------------------------

         Table 2--8-Hour CO Design Values for Billings, Montana
------------------------------------------------------------------------
                 Design Value (ppm) \7\                        Year
------------------------------------------------------------------------
4.3.....................................................            2002
4.4.....................................................            2003
3.7.....................................................            2004
3.5.....................................................            2005
2.......................................................            2006
2.2.....................................................            2007
2.......................................................            2008
1.8.....................................................            2009
1.9.....................................................            2010
1.3.....................................................            2011
------------------------------------------------------------------------

    If the rolling 3-year ADT value is 25% higher than the average
value from the 2008-2010 baseline period of 34,246, the State will
reestablish CO ambient monitoring in Billings the following high season
(November-February). If the CO design value in that season has not
increased from the baseline mean by an equal or greater rate at which
ADT has increased, and the monitor values remain at or below 50% of the
CO NAAQS (2nd max concentration <= 4.5 ppm), the monitor may again be
removed and the ADT counts will continue to be relied upon to determine
compliance with the NAAQS. This process will be repeated each time the
rolling 3-year ADT increases by a factor of 25% (e.g. 50%, 75%) above
the baseline 2008-2010 period, and the same analysis will be conducted
to determine if the monitors can again be removed.
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    \7\ Design values were derived from the EPA AirData (http://www.epa.gov/airdata/) Web site.

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    40 CFR 58.14(c) allows approval of requests to discontinue ambient
monitors ``on a case-by-case basis if discontinuance does not
compromise data collection needed for implementation of a NAAQS and if
the requirements of appendix D to 40 CFR part 58, if any, continue to
be met.'' EPA finds that the Alternative Monitoring Strategy meets the
criteria of 40 CFR 58.14(c) for the Billings CO maintenance area. Given
the long history of low CO concentrations in the Billings area, and the
adequacy of the Alternative Monitoring Strategy at ensuring continued
attainment of the CO NAAQS, EPA finds it appropriate to approve the
State's request to discontinue the Billings monitor and use the
Alternative Monitoring Strategy in its place.

IV. EPA's Evaluation of the Billings Second 10-Year CO Maintenance Plan

    The following are the key elements of a LMP for CO: Emission
Inventory, Maintenance Demonstration, Monitoring Network/Verification
of Continued Attainment, Contingency Plan, and Conformity
Determinations. Below, we describe our evaluation of each of these
elements as it pertains to the revised Billings Maintenance Plan.

A. Emission Inventory

    The revised Billings Maintenance Plan contains an emissions
inventory for the base year 2009. The emission inventory is a list, by
source, of the air contaminants directly emitted into the Billings CO
maintenance area on a typical winter day in 2009.\8\ The mobile sources
data in the emission inventory in the July 13, 2011 submittal were
developed using emissions modeling methods that EPA did not consider
up-to-date. After consultation with EPA, the State then provided EPA
with technical information to clarify and supplement the emissions
inventory from the July 13, 2011 submittal.\9\ This supplemental
technical information utilized EPA recommended mobile sources emissions
modeling methods (MOVES2010b) .\10\ The Billings LMP and supplementary
technical information contain detailed emission inventory information
that was prepared in accordance with EPA guidance and is acceptable to
EPA.\11\
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    \8\ Violations of the CO NAAQS are most likely to occur on
winter weekdays.
    \9\ The supplemental technical information was sent to EPA on
July 23, 2014, and is available in the docket for this action.
    \10\ Motor Vehicle Emissions Simulator (MOVES) model; version
2010b.
    \11\ ``Procedures for Processing Requests to Redesignate Areas
to Attainment,'' from John Calcagni, September 4, 1992.
---------------------------------------------------------------------------

B. Maintenance Demonstration

    We consider the maintenance demonstration requirement to be
satisfied for areas that qualify for and use the LMP option. As
mentioned above, a maintenance area is qualified to use the LMP option
if that area's maximum 8-hour CO design value for eight consecutive
quarters does not exceed 7.65 ppm (85% of the CO NAAQS). EPA maintains
that if an area begins the maintenance period with a design value no
greater than 7.65 ppm, the applicability of prevention of significant
deterioration requirements, the control measures already in the SIP,
and federal measures should provide adequate assurance of maintenance
over the 10-year maintenance period. Therefore, EPA does not require
areas using the LMP option to project emissions over the maintenance
period. Because CO design values in the Billings area are consistently
well below the LMP threshold (See Table 2), the State has adequately
demonstrated that the Billings area will maintain the CO NAAQS into the
future.

C. Monitoring Network/Verification of Continued Attainment

    In the revised Billings Maintenance Plan, the State commits to
``continue to monitor CO using an instrumental method or a functionally
equivalent monitoring methodology as approved by EPA.'' As noted, EPA
is proposing to approve the State's Alternative Monitoring Strategy for
the Billings CO maintenance area as part of this action. Based on final
approval of the Alternative Monitoring Strategy, we will have concluded
that the strategy is adequate to verify continued attainment of the CO
NAAQS in Billings.

D. Contingency Plan

    Section 175A(d) of the CAA requires that a maintenance plan include
contingency provisions to promptly correct any violation of the NAAQS
that occurs after redesignation of an area. To meet this requirement,
the State has identified appropriate contingency measures along with a
schedule for the development and implementation of such measures.
    The Billings Maintenance Plan stated in section <IP_ADDRESS> that the
State will use an exceedance of the CO NAAQS as the trigger for
adopting specific contingency measures for the Billings area. As noted,
the Alternative Monitoring Strategy requires reinstitution of a CO
monitor in Billings if traffic levels increase from the 2008-2010
baseline by a factor of 25%. Therefore, EPA finds that CO emissions in
Billings are very unlikely to increase to the point of an exceedance
without that exceedance being observed by a gaseous monitor.
    The State indicates that notification of an exceedance to EPA and
other affected governments will occur within 60 days. Upon notification
of a CO NAAQS exceedance, MDEQ and Riverstone Health will convene to
recommend an appropriate contingency measure or measures that would be
necessary to avoid a violation of the CO NAAQS. The necessary
contingency measure(s) will then be proposed for local adoption.
Finalization of the necessary contingency measures for local adoption
will be completed within three months of the exceedance notification.
Full implementation of the locally adopted contingency measure(s) will
be achieved within one year after the recording of a CO NAAQS
violation.
    The potential contingency measures, identified in section
<IP_ADDRESS>.C of the Billings Maintenance Plan, include implementation of
a mandatory oxygenated fuels program with local regulations in the
Billings or Yellowstone County area for the winter months of November,
December, and January, and establishing an episodic woodburning
curtailment program. A more complete description of the triggering
mechanism and these contingency measures can be found in section
<IP_ADDRESS> of the Billings Maintenance Plan.
    We find that the contingency measures provided in the State's
maintenance plan for Billings are sufficient and meet the requirements
of section 175A(d) of the CAA.

E. Transportation Conformity

    Transportation conformity is required by section 176(c) of the CAA.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS (CAA 176(c)(1)(B)). EPA's
conformity rule at 40 CFR part 93, subpart A requires that
transportation plans, programs and projects conform to SIPs and
establish the criteria and procedures for determining whether or not
they conform. To effectuate its purpose, the conformity rule requires a
demonstration that emissions from the Regional Transportation Plan
(RTP) and the Transportation Improvement

Program (TIP) are consistent with the motor vehicle emission budget
(MVEB) contained in the control strategy SIP revision or maintenance
plan (40 CFR 93.101, 93.118, and 93.124). A MVEB is defined as the
level of mobile source emissions of a pollutant relied upon in the
attainment or maintenance demonstration to attain or maintain
compliance with the NAAQS in the nonattainment or maintenance area.\12\
---------------------------------------------------------------------------

    \12\ Further information concerning EPA's interpretations
regarding MVEBs can be found in the preamble to EPA's November 24,
1993, transportation conformity rule (see 58 FR 62193--62196).
---------------------------------------------------------------------------

    Under the LMP policy, emissions budgets are treated as essentially
not constraining for the length of the maintenance period. While EPA's
LMP guidance does not exempt an area from the need to affirm
conformity, it explains that the area may demonstrate conformity
without submitting a MVEB. This is because it is unreasonable to expect
that an LMP area will experience so much growth in that period that a
violation of the CO NAAQS would result.\13\ Therefore, for the Billings
CO maintenance area, all actions that require conformity determinations
for CO under our conformity rule provisions are considered to have
already satisfied the regional emissions analysis and ``budget test''
requirements in 40 CFR 93.118.
---------------------------------------------------------------------------

    \13\ Limited Maintenance Plan Guidance at 4. October 6, 1995.
---------------------------------------------------------------------------

    Since LMP areas are still maintenance areas, certain aspects of
transportation conformity determinations still will be required for
transportation plans, programs and projects. Specifically, for such
determinations, RTPs, TIPs and projects must still demonstrate that
they are fiscally constrained (40 CFR 93.108) and meet the criteria for
consultation and Transportation Control Measure implementation in the
conformity rule provisions (40 CFR 93.112 and 40 CFR 93.113,
respectively). In addition, projects in LMP areas still will be
required to meet the applicable criteria for CO hot spot analyses to
satisfy ``project level'' conformity determinations (40 CFR 93.116 and
40 CFR 93.123), which must also incorporate the latest planning
assumptions and models available (40 CFR 93.110 and 40 CFR 93.111,
respectively).
    In view of the CO LMP policy, the effect of this proposed approval
will be to affirm our adequacy finding such that no regional emissions
analyses for future transportation CO conformity determinations are
required for the CO LMP period and beyond (as per EPA's CO LMP policy
and 40 CFR 93.109(e)).

V. Proposed Action

    EPA is proposing to approve the revised Billings Maintenance Plan
submitted on July 13, 2011. This maintenance plan meets the applicable
CAA requirements and EPA has determined it is sufficient to provide for
maintenance of the CO NAAQS over the course of the second 10-year
maintenance period out to 2022.
    EPA is also proposing to approve the State's Alternative Monitoring
Strategy for the Billings CO maintenance area. We do not propose to
approve application of the Alternative Monitoring Strategy in other
areas of Montana with this action, as the Alternative Monitoring
Strategy must be considered on a case-by-case basis specific to the
circumstances of each particular CO maintenance area rather than
broadly.

VI. Statutory and Executive Orders Review

    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, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve 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 (Public Law 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

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

    Dated: November 10, 2014.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2014-28390 Filed 12-1-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Rules and Regulations]
[Pages 14176-14178]
[FR Doc No: 2014-05387]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0683; FRL-9905-26-Region 9]

Revisions to the California State Implementation Plan; South
Coast Air Quality Management District and El Dorado County Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing
approval of revisions to the South Coast Air Quality Management
District and El Dorado County Air Quality Management District portions
of the California State Implementation Plan (SIP). The South Coast
action was proposed in the Federal Register on September 13, 2013 and
concerns carbon monoxide emissions from cement kilns. The El Dorado
County action was proposed in the Federal Register on October 25, 2013
and concerns the District's demonstration that its rules met reasonably
available control technology (RACT) requirements under the 1997 8-hour
ozone National Ambient Air Quality Standards (NAAQS). We are approving
these documents under the Clean Air Act (CAA or the Act).

DATES: This rule will be effective on April 14, 2014.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2013-0683 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-
3901. While all documents in the docket are listed at http://www.regulations.gov, some information may be publicly available only at
the hard copy location (e.g., copyrighted material, large maps,

multi-volume reports), and some may not be available in either location
(e.g., confidential business information (CBI)). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, (415)
947-4122<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action.
II. Public Comments and EPA Responses.
III. EPA Action.
IV. Statutory and Executive Order Reviews.

I. Proposed Action

    On September 13, 2013 (78 FR 56639) under Docket EPA-R09-
OAR-2013-0596, EPA proposed to approve the following rule into the
California SIP.

----------------------------------------------------------------------------------------------------------------
          Local agency             Rule            Rule title              Amended         Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD..........................          1112.1   Emissions of Particulate            12/4/09         07/20/10
                                                    Matter and Carbon Monoxide
                                                    from Cement Kilns.
----------------------------------------------------------------------------------------------------------------

    On October 25, 2013 (78 FR 63934) under Docket EPA-R09-
OAR-2013-0683, EPA proposed to approve the following document into the
California SIP.

------------------------------------------------------------------------
     Local agency          Document         Adopted         Submitted
------------------------------------------------------------------------
EDAQMD...............  EDAQMD                 02/06/07         07/11/07
                        Reasonably
                        Available
                        Control
                        Technology
                        (RACT) State
                        Implementation
                        Plan (SIP)
                        Update
                        Analysis Staff
                        Report (``2006
                        RACT SIP'').
------------------------------------------------------------------------

    Our technical support document for the proposed approval of
EDAQMD's 2006 RACT SIP included a suggestion that EDAQMD submit
negative declarations for the metal parts and products, solvent metal
cleaning, and graphic arts Control Technique Guidelines categories.
These negative declarations were submitted to EPA on September 30,
2013, and we are taking separate action on them.
    We proposed to approve SCAQMD Rule 1112.1 and EDAQMD's 2006 RACT
SIP because we determined that they complied with the relevant CAA
requirements. Our proposed action contains more information on the
submitted documents and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed actions provided a 30-day public comment period. The
docket for South Coast Rule 1112.1 ``Emissions of Particulate Matter
and Carbon Monoxide from Cement Kilns'' received one comment. The
comment was not germane to the proposed action and requested
clarification on the geographic boundary to which the Santa Barbara
County Air Pollution Control District's outer continental shelf
applied. EPA provided a separate reply to the commenter. We received no
comments on the proposed approval of El Dorado County's 2006 RACT SIP.

III. EPA Action

    No comments were submitted that change our assessment of the
submitted documents as described in our proposed actions. Therefore, as
authorized in section 110(k)(3) of the Act, EPA is fully approving
these documents into the California SIP.

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 disproportionate human health or environmental effects with
practical, appropriate, 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 [insert date 60 days from
date of publication of this document in the Federal Register]. 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. 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,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: December 16, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations 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 F--California

0
2. Section 52.220, is amended by adding paragraphs (c)(381) (i)(K) and
(382)(ii) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (381) * * *
    (i) * * *
    (K) South Coast Air Quality Management District.
    (1) Rule 1112.1, ``Emissions of Particulate Matter and Carbon
Monoxide from Cement Kilns,'' amended on December 4, 2009.
* * * * *
    (382) * * *
    (i) * * *
    (ii) Additional Material
    (A) El Dorado County Air Quality Management District.
    (1) El Dorado County Air Quality Management District Reasonably
Available Control Technology (RACT) State Implementation Plan (SIP)
Update Analysis Staff Report (``2006 RACT SIP'') adopted on February 6,
2007.
* * * * *
[FR Doc. 2014-05387 Filed 3-12-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]
[Page 7945-7947]
[DOCID:fr15fe06-55]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0258; FRL-7761-8]

Triadimefon Risk Assessments; Notice of Availability and Risk
Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's risk
assessments, and related documents for the triazole fungicide
triadimefon and for its free triazole metabolites, and opens a public
comment period on these documents. The triazole fungicides, which
include triadimefon, triadimenol, and propiconazole, and others, share
the common metabolites 1,2,4-triazole, triazole alanine, and triazole
acetic acid (also known as free triazoles). EPA has conducted an
aggregate risk assessment for the free triazole metabolites to ensure
that aggregate exposure and risk from these common metabolites meet the
current safety standards. The public is encouraged to suggest risk
management ideas or proposals to address the risks identified. EPA is
developing a Reregistration Eligibility Decision (RED) for triadimefon
through a modified, 4-Phase public participation process that the
Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.

DATES: Comments must be received on or before April 17, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0258; by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2005-0258. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA --HQ-
OPP-2005-0258. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
on-line 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
regulations.gov or e-mail. The regulations.gov website 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 regulations.gov, your e-mail address will be captured
automatically 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage athttp://www.epa.gov/epahome/docket.htm/.

    Docket: All documents in the docket are listed in the
regulation.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, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal

holidays. The telephone number for the docket facility is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v.If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and
environmental fate and effects risk assessments and related documents
for triadimefon, a triazole fungicide, and an aggregate risk assessment
for the free triazole metabolites, and encouraging the public to
suggest risk management ideas or proposals. Triadimefon is a systemic
fungicide used to control rust and mildew on apples, grapes, pears,
pineapple, and raspberries. Non-food uses include pine seedlings,
Christmas trees, residential and commercial turf, ornamentals, and
landscapes. EPA developed the risk assessments and risk
characterization for triadimefon through a modified version of its
public process for making pesticide reregistration eligibility and
tolerance reassessment decisions. Through these programs, EPA is
ensuring that pesticides meet current standards under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
    Triadimefon is a triazole fungicide. It is used as a preharvest
foliar treatment on apples, pears, grapes, raspberries, Christmas
trees, and pine seedlings as well as a pre-/post-harvest treatment for
pineapple and a pre-plant soak/treatment for pine seeds. Triadimefon
products are marketed for homeowner use on residential lawns, landscape
ornamentals, trees, fruit trees, and grapes. Triadimefon-containing
products are also marketed for use by professional applicators on
residential turf, golf courses, other turf such as recreational/
commercial areas, and on ornamental plantings. In addition, other
triazole fungicides, which may metabolize to triazole conjugates, are
formulated into pharmaceutical products which are approved for use by
the Food and Drug Administration (FDA).
    EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for triadimefon and for the free triazole metabolites
1,2,4-triazole, triazole alanine, and triazole acetic acid. Such
comments and input could address, for example, the availability of
additional data to further refine the risk assessments, such as the
need for a Developmental Neurotoxicity (DNT) study, information on
potential exposure to triazole conjugates from pharmaceutical products,
data on actual use patterns including rates, timing, and the kinds of
tasks that are required to produce agricultural commodities and other
products, as well as triadimefon-specific turf transferrable residue or
dislodgeable foliar residue data to help refine exposure and risk
estimates, or could address the Agency's risk assessment methodologies
and assumptions as applied to this specific pesticide.
    Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for triadimefon. Risks of concern associated
with the use of triadimefon include acute and chronic dietary risks,
ecological, residential and worker risks associated with the use on
turf, post-application risk to adults (mowing and gardening) and
youths/toddlers following application to turf, and worker risk due to
inhalation exposure for pine seed treatment. In targeting these risks
of concern, the Agency solicits information on effective and practical
risk reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to triadimefon or its free
triazole metabolites, compared to the general population.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and

Reregistration; Public Participation Process, published in the Federal
Register on May 14, 2004 (69 FR 26819) (FRL-7357-9), explains that in
conducting these programs, the Agency is tailoring its public
participation process to be commensurate with the level of risk, extent
of use, complexity of the issues, and degree of public concern
associated with each pesticide. For triadimefon, a modified, 4-Phase
process with one comment period and ample opportunity for public
consultation seems appropriate in view of its refined risk assessments
and other factors. However, if as a result of comments received during
this comment period EPA finds that additional issues warranting further
discussion are raised, the Agency may lengthen the process and include
a second comment period, as needed.. The decisions presented in the RED
may be supplemented by further risk mitigation measures when EPA
considers whether a cumulative assessment is necessary for the triazole
group of pesticides.
    All comments should be submitted using the methods in ADDRESSES and
must be received by EPA on or before the closing date. Comments will
become part of the Agency Docket for Triadimefon. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory
action.''
    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Triadimefon; Triazole Fungicides,
Pesticides and pests.

    Dated: February 8, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2151 Filed 2-14-06; 8:45 am]

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[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26528-26530]
[FR Doc No: 2021-10180]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0341]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Safety; Federal-State Food Regulatory Program
Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of

certain information by the Agency. Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
associated with FDA's Federal-State Food Regulatory Program Standards.

DATES: Submit either electronic or written comments on the collection
of information by July 13, 2021.

ADDRESSES: 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 July 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 13, 2021. 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-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State Food
Regulatory Program Standards.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Food Safety; Federal-State Food Regulatory Program Standards

OMB Control Number 0910-0760--Revision

    This information collection supports implementation of FDA's
Federal-State Regulatory Program Standards, part of our National
Integrated Food Safety System (IFSS) Programs and Initiatives. For more
information we invite you to

visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. In the United States, Federal and State
governments work cooperatively to ensure the safety of food intended
for both human and animal consumption. Part of this effort includes
developing and maintaining uniform review criteria by which to assess
food safety. FDA has established and maintains a number of program
standards aimed at improving the safety evaluation for certain food
products including manufactured foods and animal feed. Similarly, we
are establishing regulatory program standards for eggs and have
developed the ``Eggs Regulatory Program Standards'' (ERPS). The ERPS is
intended for use by State and local regulatory officials and identifies
ten elements we believe are essential to the effective regulatory
assessment of egg safety. States are encouraged to build systems that
are sustainable and implement plans corresponding to the IFSS.
    In the course of their normal duties, State, local, Territorial,
and Tribal governments collect information pertaining to compliance
with the respective State, local, Territorial, and tribal food safety
requirements within their jurisdictions. Although content and format of
the information collected may vary, these activities are a usual and
customary part of routine regulatory oversight. Respondents to the
information collection are State, local, Territorial, Tribal, and
Federal regulatory agencies participating in FDA's Voluntary National
Retail Food Regulatory Program Standards (information collection
currently approved under OMB control number 0910-0621). Consistent with
the ERPS, respondents will submit the following information to FDA: (1)
Program self-assessment; (2) risk factor study of the regulated
industry; and (3) independent outside audit (verification audit).
    The ERPS offers forms, worksheets, and templates to help
respondents assess and meet the program elements identified and
discussed. Respondents are not required to use the sample collection
instruments included in the ERPS, however all data elements should be
submitted to FDA and supporting documentation retained. The ERPS is not
intended to address any performance appraisal processes that any State,
local, Territorial, or tribal agency may use to evaluate its employees'
performance. Funding opportunities are available to respondents who
choose to implement the ERPS, however these opportunities are limited
and contingent upon the availability of funds, and to those respondents
who currently have an egg inspection contract with FDA and thus subject
to auditing. A copy of the ERPS has been posted to FDA-2021-N-0341 and
is available at https://www.regulations.gov.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
            Respondents; information collection activity                Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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State, Local, Territorial, and/or Tribal Governments; submission of              10               10              100              500          500,000
 data elements to FDA consistent with ERPS.........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our experience with similar information collection, we
estimate an initial 10 respondents will participate in the ERPS, and
assume an average of 500 hours is necessary for the attendant
recordkeeping and submission of data elements to FDA. We expect
participation in the ERPS to increase.

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10180 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P