[Federal Register: July 8, 2008 (Volume 73, Number 131)]
[Notices]
[Page 39049-39050]
[DOCID:fr08jy08-110]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2008-0017]

Electrical Standards for Construction and General Industry;
Extension of the Office of Management and Budget's (OMB) Approval of
the Information Collection (Paperwork) Requirements

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

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits comments concerning its request for an extension
of the information collection requirements contained in the Electrical
Standards for Construction (29 CFR part 1926, subpart K) and for
General Industry (29 CFR part 1910, subpart S). The Standards address
safety procedures for installation and maintenance of electric
utilization equipment that prevent death and serious injuries among
construction and general industry employees in the workplace caused by
electrical hazards.

DATES: Comments must be submitted (postmarked, sent, or received) by
September 8, 2008.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2008-0017,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2008-0017). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available online at http://
www.regulations.gov. For further information on submitting comments see
the ``Public Participation'' heading in the section of this notice
titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the Act or for developing information
regarding the causes and prevention of occupational injuries,
illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires
that OSHA obtain such information with minimum burden upon employers,
especially those operating small businesses, and to reduce to the
maximum extent feasible unnecessary duplication of efforts in obtaining
information (29 U.S.C. 657).
    The information collection requirements specified by the Electrical
Standards for Construction and General Industry alert employees to the
presence and types of electrical hazards in the workplace, thereby
preventing serious injury and death by electrocution. The information
collection requirements in the standards involve the following: The
employer using electrical equipment that is marked with the
manufacturer's name, trademark, or other descriptive markings that
identify the producer of the equipment, and marking the equipment with
the voltage, current, wattage, or other ratings necessary; requiring
each disconnecting means for motors and appliances to be marked legibly
to indicate its purpose, unless located and arranged so the purpose is
evident; requiring the entrances to rooms and other guarded locations
containing exposed live parts to be marked with conspicuous warning
signs forbidding unqualified persons from entering; and, for
construction employers only, establishing and implementing the assured
equipment grounding conductor program instead of using ground-fault
circuit interrupters.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
cost) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is proposing to combine the information collection
requirements contained in the Design Safety Systems for Electrical
Systems (29 CFR 1910.302-.308 and 1910.399 (OMB Control No. 1218-0256)
with the information collection requirements contained in the
Electrical Standards for Construction (29 CFR part 1926, subpart K) and
for General Industry (29 CFR part 1910, subpart S) (OMB Control No.
1218-0130). In doing so, the Agency is proposing to adjust the total
burden hours of these subparts from 92,644 hours to 151,172 hours; a
total increase of 58,528 hours. The burden hours have increased
primarily due to an increase in the total number of jobsites for
construction from 42,750 to 45,000. The

Agency will summarize the comments submitted in response to this
notice, and will include this summary in the request to OMB to extend
the approval of the information collection requirements contained in
the standards.
    Type of Review: Extension of a currently approved collection.
    Title: Electrical Standards for Construction (29 CFR part 1926,
subpart K) and General Industry (29 CFR part 1910, subpart S).
    OMB Number: 1218-0130.
    Affected Public: Business or other for-profit; not-for-profit
institutions; Federal Government; State, local, or tribal governments.
    Number of Respondents: 500,000.
    Frequency of Response: Occasionally.
    Total Responses: 2,331,135.
    Average Time per Response: Varies from three minutes (.08 hour) to
post and construct each sign to four hours to document a hazardous
classified location by a certified electrical engineer.
    Estimated Total Burden Hours: 151,172.
    Estimated Cost (Operation and Maintenance): $7,500.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2008-0017). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available through the website, and for assistance in using the Internet
to locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007 (72 FR
31159).

    Signed at Washington, DC, on July 1, 2008.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E8-15392 Filed 7-7-08; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Notices]
[Page 36849-36850]
[DOCID:fr28jn06-133]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54024; File No. SR-NYSE-2006-44]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Specialist Algorithmic Quoting Messages Permitted Pursuant
to Exchange Rule 104

June 21, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 20, 2006, the New York Stock Exchange LLC (``NYSE'') or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Item I and II
below, which Items have been prepared by the Exchange. NYSE filed the
proposed rule change pursuant to section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(6) thereunder,\4\ which renders the proposed rule change
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    NYSE proposes to amend Exchange Rule 104 (Dealings by Specialists)
with respect to the specialists' ability to establish systems employing
algorithms to send messages via a connection to the Display
Book[supreg] system for the purpose of updating quotations
systematically. The text of the proposed rule change is available on
the Exchange's Web site (http://www.nyse.com), at the Exchange's Office

of the Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Under the NYSE HYBRID MARKET\SM\ initiative \5\, the Exchange
proposed several changes to the manner in which specialists on the
Exchange would be able to establish electronic connections to the
Display Book[supreg] \6\ system (``Display Book'') to provide them with
access to certain information and permit them to make a range of
specified quoting and trading decisions based on that information. The
Exchange proposed amendments to Exchange Rule 104 (Dealings by
Specialists) to provide specialists with the ability to implement
systems that use proprietary algorithms based on predetermined
parameters to electronically participate in the Hybrid Market
(``Specialist Algorithm''). The Specialist Algorithm is designed to
communicate with the Display Book system via an Exchange-owned external
application program interface (``API'').
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 53539 (March 22,
2006), 71 FR 16353 (March 31, 2006).
    \6\ The Display Book system is an order management and execution
facility. It receives and displays orders to the specialist,
contains the orders received by the specialist (the ``Book''), and
provides a mechanism to execute and report transactions to the
Consolidated Tape.
---------------------------------------------------------------------------

    As approved in the Hybrid Market initiative, the Specialist
Algorithm is permitted to send messages to the Display Book via the API
to quote or trade on behalf of the specialist's proprietary interest.
The Specialist Algorithm will generate these quoting or trading
messages in reaction to specific types of information it will have
access to. This information includes specialist dealer position,
existing quotes, publicly available information the specialist chooses
to supply to the algorithm, incoming orders as they are entering
Exchange systems, and information about orders on the display Book such
as limit orders, percentage orders, stop orders, and auction limit and
auction market orders. This latter information stream is known as
``state of the book'' information.
    Since the approval of the Hybrid Market, the Exchange has continued
to discuss Hybrid Market features with its members and advisory
committees. Based on these discussions, the Exchange has decided to
make changes to certain aspects of the Hybrid Market, to produce a
trading venue that best addresses the various needs of its members and
customers.
    As part of the implementation of Phase II of the Hybrid Market, the
Exchange is proposing that it have the ability to permit specialists to
send quoting messages via the API in all securities without the
specialists having access to information about incoming orders as they
are entering Exchange systems. This is similar to the manner in which
specialists are allowed to send quoting messages in exchange traded
funds (``ETFs'') and Trust Issued Receipts today,\7\ before the
effectiveness of the full Hybrid amendments, except that the specialist
systems would have access to state of the book information.
---------------------------------------------------------------------------

    \7\ Exchange Rule 104 was amended for this purpose in 2004. See
Securities Exchange Act Release No. 50412 (September 20, 2004), 69
FR 57741 (September 27, 2004).
---------------------------------------------------------------------------

    Exchange Rule 104 currently allows specialists to send quoting
messages via the API in ETFs and Trust Issued Receipts. These
specialists' algorithms do not have access to the state of the book
information stream. The provision discussed in this filing will be
superseded with the Exchange rule 104 amendments noted above when Phase
II of the Hybrid Market is fully implemented.
    The Exchange believes that use of the API to quote in this fashion
will enable specialists and the Exchange to obtain valuable real time
experience with respect to the use of specialist proprietary
algorithms.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act \8\ in general, and furthers the
objectives of section 6(b)(5) of the Act \9\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
by its terms, become operative for 30 days from the date on which it
was filed, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest, it
has become effective pursuant to section 19(b)(3)(A) of the Act \10\
and Rule 19b-4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay and designate the proposed
rule change immediately operative upon filing. The Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest because it would allow
specialists to quote more efficiently. Accordingly, the Commission
designates the proposal to be effective and operative upon filing with
the Commission.\13\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2006-44 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSE-2006-44. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2006-44 and should be submitted on or before July
19, 2006.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 06-5754 Filed 6-27-06; 8:45 am]

BILLING CODE 8010-01-M


[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Notices]
[Page 54888-54889]
[DOCID:fr09se10-73]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0416]

Determination of Regulatory Review Period for Purposes of Patent
Extension; IXIARO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for IXIARO and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biologic product
IXIARO (Japanese Encephalitis Virus, Vaccine Inactivated, Adsorbed).
IXIARO is indicated for active immunization for the prevention of
disease caused by Japanese encephalitis virus in persons 17 years of
age and older. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for IXIARO (U.S.
Patent No. 6,309,650) from Chiel Jedang Corp. and Walter Reed Army
Institute of Research, and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated February 17, 2010, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of IXIARO
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
IXIARO is 3,461 days. Of this time, 2,994 days occurred during the
testing phase of the regulatory review period, while 467 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 10,
1999. The applicant claims October 9, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 10, 1999,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 20, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
IXIARO (BLA B125280/0) was initially submitted on December 20, 2007.
    3. The date the application was approved: March 30, 2009. FDA has
verified the applicant's claim that BLA B125280/0 was approved on March
30, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,588 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by November 8, 2010. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by March 8, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with

the docket number found in brackets in the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22394 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]
[Page 52427-52428]
[DOCID:fr25au10-130]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0354]

Guidance for Industry: Questions and Answers Regarding the Effect
of Section 4205 of the Patient Protection and Affordable Care Act of
2010 on State and Local Menu and Vending Machine Labeling Laws;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding the Effect of Section 4205 of the Patient
Protection and Affordable Care Act of 2010 on State and Local Menu and
Vending Machine Labeling Laws.'' Section 4205 of the Patient Protection
and Affordable Care Act of 2010 (Affordable Care Act) establishes
requirements for nutrition labeling of standard menu items for chain
retail food establishments and chain vending machine operators. FDA is
issuing this guidance to clarify section 4205's effect on State and
local menu and vending machine labeling laws, and to ensure that
industry and State and local government understand the immediate
effects of the law.

DATES: Submit either electronic or written comments on the guidance at
any time.

ADDRESSES: Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the guidance to the Office of Nutrition, Labeling and Dietary
Supplements, Center for Food Safety and Applied Nutrition (HFS-820),
Food and Drug Administration, 5100 Paint Branch Pkwy., 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 guidance.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled
``Guidance for Industry: Questions and Answers Regarding the Effect of
Section 4205 of the Patient Protection and Affordable Care Act of 2010
on State and Local Menu and Vending Machine Labeling Laws.'' FDA is
issuing this guidance in a Questions and Answers format as an
informational guide to industry and State and local governments
affected by the enactment of section 4205 of the Affordable Care Act
(Public Law 111-148), which became effective on March 23, 2010. Section
4205 of the Affordable Care Act requires restaurants or similar retail
food establishments with 20 or more locations doing business under the
same name and offering for sale substantially the same menu items
(``chain retail food establishments'') to disclose specific nutrition
information about certain food items offered for sale. Section 4205
also requires vending machines operated by persons who own or operate
20 or more vending machines (``chain vending machine operators'') to
disclose calorie information for certain food articles sold in vending
machines. FDA is issuing this guidance to clarify section 4205's effect
on State and local menu and vending machine labeling laws, and to
ensure that industry and State and local government understand the
immediate effects of the law.
    FDA is issuing this guidance as level 1 guidance consistent with
FDA's good guidance practices regulation (Sec.  10.115 (21 CFR
10.115)). Consistent with FDA's good guidance practices regulation, the
agency will accept comment, but is implementing the guidance document
immediately, in accordance with Sec.  10.115(g)(2), because the agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to the
mandates in section 4205 of the Affordable Care Act, which was
effective on March 23, 2010. The guidance represents the agency's
current thinking on section 4205's effective date, and effect on State
and local menu and vending machine labeling laws. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in the Federal Food, Drug, and Cosmetic Act and
established by section 4205 of the Affordable Care Act. 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 section 4205
of the Affordable Care Act have been approved under OMB control no.
0910-0665.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/FoodGuidances.

    Dated: August 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21067 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Proposed Rules]
[Pages 2095-2101]
[FR Doc No: 2022-00028]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0428; FRL-9374-01-R4]

Finding of Failure To Attain the 2010 Sulfur Dioxide Standard;
Tennessee; Sullivan County Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
determine that the Sullivan County, Tennessee sulfur dioxide
(SO2) nonattainment area failed to attain the 2010 1-hour
SO2 primary National Ambient Air Quality Standard (NAAQS or
standard) by the applicable attainment date of October 4, 2018, based
upon a weight of evidence analysis of available quality-assured and
certified SO2 ambient air monitoring data and SO2
emissions data from January 2015 through December 2017. If EPA
finalizes this determination as proposed, the State of Tennessee will
be required to submit revisions to the Tennessee State Implementation
Plan (SIP) that, among other elements, provide for expeditious
attainment of the 2010 SO2 standard.

DATES: Comments must be received on or before February 14, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2021-0428 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Evan Adams, Air Regulatory

Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be
reached by telephone at<PHONE_NUMBER> or via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. The 2010 SO2 NAAQS
    B. Designations, Classifications, and Attainment Dates for the
2010 SO2 NAAQS
II. Proposed Determinations and Consequences
    A. Applicable Statutory and Regulatory Provisions
    B. Monitoring Network Considerations
    C. Sullivan County SO2 Monitoring Network
    D. SO2 Data Considerations and Proposed Determination
    E. Consequences for SO2 Nonattainment Areas Failing
To Attain Standards by Attainment Dates
III. Proposed Action and Request for Public Comment
IV. Statutory and Executive Order Reviews

I. Background

A. The 2010 SO2 NAAQS

    Under section 109 of the Clean Air Act (CAA or ``Act''), EPA has
established primary and secondary NAAQS for certain pervasive air
pollutants (referred to as ``criteria pollutants'') and conducts
periodic reviews of the NAAQS to determine whether they should be
revised or whether new NAAQS should be established. The primary NAAQS
represent ambient air quality standards the attainment and maintenance
of which EPA has determined, including a margin of safety, are
requisite to protect the public health. The secondary NAAQS represent
ambient air quality standards the attainment and maintenance of which
EPA has determined are requisite to protect the public welfare from any
known or anticipated adverse effects associated with the presence of
such air pollutant in the ambient air.
    Under the CAA, EPA must establish a NAAQS for SO2, which
is primarily released to the atmosphere through the burning of fossil
fuels by power plants and other industrial facilities. Short-term
exposure to SO2 can damage the human respiratory system and
increase breathing difficulties. Small children and people with
respiratory conditions, such as asthma, are more sensitive to the
effects of SO2. Sulfur oxides at high concentrations can
also react with compounds to form small particulates that can penetrate
deeply into the lungs and cause health problems.
    EPA first established primary SO2 standards in 1971 at
0.14 parts per million (ppm) over a 24-hour averaging period and 0.3
ppm over an annual averaging period.\1\ In June 2010, EPA revised the
primary NAAQS for SO2 to provide increased protection of
public health, providing for revocation of the 1971 primary annual and
24-hour SO2 standards for most areas of the country
following area designations under the new NAAQS.\2\ The 2010 NAAQS is
75 parts per billion (ppb) (equivalent to 0.075 ppm) over a 1-hour
averaging period.\3\ A violation of the 2010 1-hour SO2
NAAQS occurs when the annual 99th percentile of ambient daily maximum
1-hour average SO2 concentrations, averaged over a 3-year
period, exceeds 75 ppb.\4\
---------------------------------------------------------------------------

    \1\ See 36 FR 8186 (April 30, 1971).
    \2\ 40 CFR 50.4(e).
    \3\ See 75 FR 35520 (June 22, 2010).
    \4\ 40 CFR 50.17.
---------------------------------------------------------------------------

B. Designations, Classifications, and Attainment Dates for the 2010 SO2
NAAQS

    Following promulgation of any new or revised NAAQS, EPA is required
by CAA section 107(d) to designate areas throughout the nation as
attaining or not attaining the NAAQS. On August 5, 2013, EPA finalized
its first round (round 1) of designations for the 2010 primary
SO2 NAAQS.\5\ Specifically, in the 2013 action, EPA
designated 29 areas in 16 states as nonattainment for the 2010
SO2 NAAQS, including a portion of Sullivan County
(hereinafter referred to as ``the Sullivan County Area'' or Area) in
Tennessee. The Sullivan County Area lies within a 3-kilometer (km)
radius circle centered around the B-253 powerhouse at the Eastman
Chemical Company facility in Kingsport, Tennessee (Eastman), which
encompasses an SO2 monitor operating at the time of
designation (Air Quality System (AQS) Site ID: 47-163-0007).\6\ EPA's
round 1 designations for the 2010 SO2 NAAQS, including the
Sullivan County Area, became effective on October 4, 2013. Pursuant to
CAA section 192(a), the attainment date for the Area was no later than
October 4, 2018, which is five years after the effective date of the
final action designating each round 1 area as nonattainment for the
2010 SO2 NAAQS.
---------------------------------------------------------------------------

    \5\ See 78 FR 47191 (August 5, 2013).
    \6\ For exact descriptions of the Sullivan County Area, refer to
40 CFR 81.343.
---------------------------------------------------------------------------

    Under CAA section 179(c) of the CAA, within six months of the
attainment date, the EPA is required to make a determination, based on
the area's air quality as of the attainment date, whether an area
attained by that date. If the EPA determines that an area failed to
attain by the attainment date, EPA is required to publish that
determination in the Federal Register. CAA section 179(c)(2). On June
25, 2021, EPA entered into a consent decree with the Center for
Biological Diversity in the U.S. District Court for the Northern
District of California.\7\ The consent decree requires EPA to finalize,
by January 31, 2022, or March 31, 2022, depending on the nonattainment
area, a determination whether certain round 1 SO2
nonattainment areas (including the Sullivan County Area) attained the
1-hour SO2 standard by the October 4, 2018 attainment date.
For the Sullivan County Area, the consent decree deadline is March 31,
2022.
---------------------------------------------------------------------------

    \7\ See Center for Biological Diversity et al v. EPA; Case No.
3:20-cv-05436-EMC in the docket for this proposed action.
---------------------------------------------------------------------------

II. Proposed Determination and Consequences

A. Applicable Statutory and Regulatory Provisions

    Section 179(c)(1) of the CAA requires EPA to determine whether a
nonattainment area attained an applicable standard by the applicable
attainment date based on the area's air quality as of the applicable
attainment date. A determination of whether an area's air quality meets
applicable standards is generally based upon the most recent three
years of complete, quality-assured data gathered at established state
and local air monitoring stations (SLAMS) in a nonattainment area and
entered into the EPA's Air Quality System (AQS) database.\8\ Data from
ambient air monitors operated by state and local agencies in compliance
with EPA's monitoring requirements must be submitted to AQS.\9\
Monitoring agencies annually certify that these data are accurate to
the best of their knowledge.\10\ EPA uses the certified air monitoring
data to calculate design values that are used to determine the area's
air quality status in accordance with 40 CFR part 50 Appendix T (for
SO2).
---------------------------------------------------------------------------

    \8\ AQS is EPA's repository of ambient air quality data.
    \9\ 40 CFR 58.16.
    \10\ 40 CFR 58.15.
---------------------------------------------------------------------------

    Specifically, under EPA regulations in 40 CFR 50.17 and in
accordance with 40 CFR part 50 Appendix T, the 2010 1-hour annual
SO2 standard is met when the design value is less than or
equal to 75 ppb. Design values are calculated by

computing the three-year average of the annual 99th percentile daily
maximum 1-hour average concentrations.\11\ When calculating 1-hour
primary standard design values, the calculated design values are
rounded to the nearest whole number (i.e., 1 ppb) by convention. An
SO2 1-hour primary standard design value is valid if it
encompasses three consecutive calendar years of complete data. A year
is considered complete when all four quarters are complete, and a
quarter is complete when at least 75 percent of the sampling days are
complete. A sampling day is considered complete if 75 percent of the
hourly concentration values are reported; this includes data affected
by exceptional events that have been approved for exclusion by the EPA
Administrator.\12\
---------------------------------------------------------------------------

    \11\ As defined in 40 CFR part 50, Appendix T, section 1(c),
daily maximum 1-hour values refer to the maximum 1-hour
SO2 concentration values measured from midnight to
midnight that are used in the NAAQS computations.
    \12\ See 40 CFR part 50, Appendix T, sections 1(c), 3(b), 4(c),
and 5(a).
---------------------------------------------------------------------------

    EPA notes that when determining the attainment status of
SO2 nonattainment areas, including when making
determinations of attainment by the attainment date, in addition to
ambient monitoring data, the Agency may also consider air quality
dispersion modeling and/or a demonstration that the control strategy in
the SIP has been fully implemented.\13\ With regard to the use of
monitoring data for such determinations, EPA's 2014 Nonattainment
SO2 Guidance \14\ specifically notes that ``[i]f the EPA
determines that the air quality monitors located in the affected area
are located in the area of maximum concentration, the EPA may be able
to use the data from these monitors to make the determination of
attainment without the use of air quality modeling data.'' \15\ The
modeling analysis of whether monitors are located in the area of
maximum concentration is necessary where EPA is making a determination
that an area attained by its attainment date based solely on that
monitoring information. In the case of the Sullivan County Area, the
SLAMS monitors did not start collecting data until the middle of 2016;
therefore, a valid 2015-2017 design value based on three consecutive
calendar years cannot be calculated.\16\ EPA's proposed determination
that the area did not attain by its attainment date is, therefore,
based on a technical analysis of the weight of available evidence --
including monitoring data and emissions data from the relevant time
period, as described in section II.C and II.D of this notice. As noted,
the determination of whether the monitors are located in the area of
maximum concentration is not needed in this situation, because a
demonstration is not being made that the Area has attained the 2010
SO2 NAAQS by the October 4, 2018, attainment date.
---------------------------------------------------------------------------

    \13\ For the Sullivan County Area, EPA has not yet approved an
attainment demonstration with accompanying emission limits into the
SIP. Thus, EPA cannot analyze compliance with an approved SIP
control strategy.
    \14\ EPA, Guidance for 1-Hour SO2 Nonattainment Area
SIP Submissions (April 2014) (``2014 SO2 Guidance''),
p.49, available at: https://www.epa.gov/sites/default/files/2016-06/documents/20140423guidance_nonattainment_sip.pdf.
    \15\ Id., p.50.
    \16\ The current SO2 monitoring network in the Area,
which is comprised of four SLAMS monitors and represented in
Tennessee's ambient air monitoring network plan, is designed to
measure SO2 air quality in the areas of expected maximum
1-hour SO2 concentration.
---------------------------------------------------------------------------

B. Monitoring Network Considerations

    Section 110(a)(2)(B)(i) of the CAA requires states to establish and
operate air monitoring networks to compile data on ambient air quality
for all criteria pollutants. EPA's monitoring requirements are
specified by regulation in 40 CFR part 58. These requirements are
applicable to the state, and where delegated, to local air monitoring
agencies that operate criteria pollutant monitors. The regulations in
40 CFR part 58 establish specific requirements for operating air
quality surveillance networks to measure ambient concentrations of
SO2, including requirements for measurement methods, network
design, quality assurance procedures, and the minimum number of
monitoring sites designated as SLAMS. In sections 4.4 and 4.5 of
Appendix D to 40 CFR part 58, EPA specifies minimum SLAMS monitoring
requirements for SO2. SLAMS produce data that are eligible
for comparison with the NAAQS, and therefore, the monitor must be an
approved federal reference method (FRM), federal equivalent method
(FEM), or approved regional method (ARM) monitor. Appendix A to 40 CFR
part 58 specifies quality assurance requirements for SLAMS monitors.
The minimum number of required SO2 SLAMS is described in
sections 4.4.2 and 4.4.3 of Appendix D to 40 CFR part 58. According to
section 4.4.2, the minimum number of required SO2 monitoring
sites is determined by the population weighted emissions index for each
state's core based statistical area. Section 4.4.3 describes additional
monitors that may be required by an EPA regional administrator.
    Under 40 CFR 58.10, states are required to submit annual monitoring
network plans (AMNP) for ambient air monitoring networks for approval
by EPA. Each AMNP discusses the status of the air monitoring network as
required under 40 CFR 58.10 and addresses the operation and maintenance
of the air monitoring network, including any proposed modifications to
the network. EPA reviews these AMNPs for compliance with the applicable
monitoring network design requirements in 40 CFR part 58.\17\ EPA also
conducts regular technical systems audits (TSAs) during which EPA
reviews and inspects ambient air monitoring programs to assess
compliance with applicable regulations concerning the collection,
analysis, validation, and reporting of ambient air quality data.\18\
---------------------------------------------------------------------------

    \17\ See, e.g., letter dated September 14, 2020, from Caroline
Y. Freeman, Director, Air and Radiation Division, EPA Region IV, to
Michelle Owenby, Director, Division of Air Pollution Control, TDEC.
Copies of EPA letters responding to Tennessee's AMNPs for 2016-2020
are included in the docket for this proposed action.
    \18\ See 40 CFR part 58, appendix A, section 2.5.
---------------------------------------------------------------------------

    For the Sullivan County Area, the Tennessee Department of
Environment and Conservation (TDEC) is responsible for assuring that
the Area meets air quality monitoring requirements. TDEC submitted an
annual monitoring network plan to EPA that describes the various
monitoring sites operated by TDEC.\19\ EPA approved TDEC's most recent
AMNP on September 30, 2021, and concluded that the air agency's ambient
air monitoring network meets or exceeds the requirements for the
minimum number of SLAMS for all criteria pollutants, including
SO2, in the Sullivan County Area.\20\ For additional
information related to Sullivan County Area's SO2 monitoring
network, including EPA's TSAs and the State's response and air
monitoring data, please refer to EPA's technical support document (TSD)
located in the docket for this proposed action (Sullivan County
TSD).\21\
---------------------------------------------------------------------------

    \19\ See, e.g., Tennessee's current AMNP ``2021 Tennessee Annual
Monitoring Network Plan.'' EPA Region 4 approved the 2021 AMNP on
September 30, 2021. Copies of Tennessee's AMNPs for 2015-2021 are
included in the docket for this proposed action.
    \20\ See letter dated September 30, 2021, from Caroline Y.
Freeman, Director, Air and Radiation Division, EPA Region IV, to
Michelle Owenby, Director, Division of Air Pollution Control, TDEC
in the docket for this proposed action.
    \21\ See Technical Support Document Finding of Failure to Attain
the 2010 1-Hour SO2 NAAQS For the Sullivan County,
Tennessee Nonattainment Area in the docket for this proposed action.
---------------------------------------------------------------------------

C. Sullivan County SO2 Monitoring Network

    During the round 1 SO2 designations in 2013, Eastman
operated an industrial

SO2 monitor near the facility at the Ross N. Robinson site
(AQS ID: 47-163-0007). From 2010 to 2012, Tennessee certified to EPA
that all industry-operated monitoring data in Tennessee, including the
Eastman SO2 monitor, met EPA regulatory requirements,
including quality assurance requirements. EPA used this data as the
basis for an SO2 nonattainment determination on August 13,
2013, based on a 2009-2011 design value of 196 ppb at the Ross N.
Robinson industrial monitor.
    In September 2013 (and subsequently in 2016), after an EPA TSA, EPA
found that Tennessee was unable to provide the required quality
assurance records and documentation for the industry-operated air
monitoring sites in Sullivan County. EPA determined that the Eastman
industrial monitors were not meeting the quality assurance requirements
in 40 CFR part 58 Appendix A and therefore not comparable to the NAAQS.
As a result of EPA's TSA findings, TDEC assigned a NAAQS exclusion flag
to the Ross N. Robinson industrial monitor's data in AQS beginning in
September 2013 to indicate the data did not meet regulatory
requirements. For the 2015-2017 period, no valid SO2
monitoring data were collected in the Area from January 1, 2015, to
July 20, 2016. Consequently, the Area did not have a valid
SO2 design value for the 2015-2017 period. See Sullivan
County TSD for more details on EPA's TSAs.
    To characterize SO2 concentrations in the Sullivan
County Area, Tennessee began operating a SLAMS SO2 monitor
(AQS ID: 47-163-6001) on July 21, 2016, adjacent to the Ross N.
Robinson industrial monitoring site under an EPA-approved quality
assurance project plan, and in accordance with EPA's regulatory
requirements at Appendix D to 40 CFR part 58. The Ross N. Robinson
SLAMS site is located adjacent to Eastman's industrial monitor of the
same name on Wilburn Drive in Kingsport. On September 1, 2016, TDEC
also installed a second monitor (AQS ID: 47-163-6002) at the Skyland
Drive industrial monitoring site to further characterize high elevation
SO2 concentrations in the complex terrain around the
Sullivan County Area. This monitor was sited in accordance with the
normalized air modeling conducted by Tennessee in accordance with 40
CFR part 58 and EPA's SO2 Monitoring Technical Assistance
Document (TAD).\22\ The Skyland Drive SLAMS monitor site is located
with Eastman's industrial SO2 monitor of the same name on
Skyland Drive at Bagwell St. in Kingsport. The primary monitors \23\ at
each of these sites are FEM monitors. Valid hourly SO2 data
for the Area became available for the remainder of the design value
period (i.e., from July 21, 2016, to December 31, 2017) once the Ross
N. Robinson SLAMS site started operating. These monitoring data have
been reported to AQS and certified by TDEC. Eastman stopped reporting
data to AQS in 2016 for their industrial monitors and ceased operating
these monitors in 2019. During the 2015-2017 design value period, the
TDEC SLAMS monitors did not collect data in 2015 or the first half of
2016. Therefore, a valid 2015-2017 design value cannot be calculated
for the nonattainment area.
---------------------------------------------------------------------------

    \22\ See SO2 NAAQS Designations Source-Oriented
Monitoring Technical Assistance Document (TADs), Draft February 2016
in the docket for this proposed action.
    \23\ A primary monitor is a term defined in 40 CFR part 58 that
means the monitor identified by the monitoring organization that
provides concentration data used for comparison to the NAAQS. For
any specific site, only one monitor for each pollutant can be
designated in AQS as primary monitor for a given period of time. The
primary monitor identifies the default data source for creating a
combined site record for purposes of NAAQS comparisons.
---------------------------------------------------------------------------

    In 2017, Tennessee committed to expanding its existing
SO2 ambient air monitoring network within the nonattainment
area.\24\ In 2018, EPA approved the portion of TDEC's AMNP that added
two SLAMS monitors within the Sullivan County Area to characterize the
expected areas of maximum 1-hour SO2 concentrations near the
Eastman facility.\25\ TDEC subsequently began operating the two
additional SLAMS sites at Happy Hill (AQS ID: 47-163-6004) in October
2018 and Andrew Johnson Elementary School (AQS ID: 47-163-6003) in
January 2019 to characterize the areas of expected maximum 1-hour
SO2 concentrations around the facility. These monitors were
sited in accordance with the normalized air modeling conducted by
Tennessee in accordance with 40 CFR part 58 and EPA's SO2
TAD. EPA approved the SO2 portion of TDEC's AMNP in 2016,
2018, 2019, and 2020.\26\
---------------------------------------------------------------------------

    \24\ In 2017, EPA commented on TDEC's SO2 draft
attainment SIP for the Sullivan County Area and recommended that the
State expand the monitoring network within the nonattainment area to
verify that the SO2 emission reduction measures proposed
in the attainment SIP at the time would ensure attainment of the 1-
hour standard. See EPA 2017 comment letter found in the docket for
this proposed action. Tennessee submitted an attainment SIP for the
Sullivan County Area on May 11, 2017. EPA proposed approval of the
attainment SIP on June 29, 2018 (83 FR 30609) but has not finalized
approval as of this action.
    \25\ See letter dated July 24, 2018, from Beverly Banister,
Director, Air, Pesticides and Toxic Management Division, EPA Region
IV, to Michelle Owenby, Director, Division of Air Pollution Control,
TDEC included in the docket for this proposed action.
    \26\ The most recent TDEC AMNP, submitted and approved in 2020,
includes four SO2 SLAMS in the nonattainment area which
will provide NAAQS-comparable monitoring data moving forward.
---------------------------------------------------------------------------

D. SO2 Data Considerations and Proposed Determination

    As discussed in section II.C above, air monitoring data in the area
from January 1, 2015, to July 20, 2016, did not meet the quality
assurance requirements in 40 CFR part 58 Appendix A and therefore are
not comparable to the NAAQS. Therefore, a valid 2015-2017 design value
could not be determined for the nonattainment area. In lieu of a 2015-
2017, 3-year design value, EPA has developed a weight of evidence
assessment based on available air quality monitoring data and source-
specific SO2 emissions in the Area from January 2015 through
December 2017 to support the determination that the Sullivan County
Area did not attain the 1-hour SO2 standard by the October
4, 2018, attainment date based on the area's air quality as of the
attainment date. This section summarizes EPA's weight of evidence
approach and data considerations for the nonattainment area. More
detailed discussions on the air monitoring and SO2 emission
data are provided in EPA's Sullivan County TSD located in the docket
for this proposed action.
1. Sullivan County SO2 Monitoring Data
    As discussed in section I.B above, the applicable attainment date
for the Sullivan County Area, is October 4, 2018. In accordance with
Appendix T to 40 CFR part 50, determinations of SO2 NAAQS
compliance are based on three consecutive calendar years of data. To
determine the air quality as of the attainment date in the
nonattainment area, EPA reviewed the available data collected during
the three calendar years immediately preceding the attainment date for
the Sullivan County Area (i.e., January 1, 2015, through December 31,
2017), as well as SO2 emissions data at Eastman.
    As discussed above, no NAAQS-comparable SO2 monitoring
data is available for the Area for January 1, 2015, to July 20, 2016.
The available SLAMS SO2 data for the Sullivan County Area
from July 21, 2016, through December 31, 2017, have been certified by
TDEC. EPA has also evaluated the completeness of these data in
accordance with the requirements of 40 CFR part 50, Appendix T. The
data collected by TDEC in the three calendar years preceding the
attainment date meet the quarterly completeness criteria

for only 6 out of 12 quarters at the Ross N. Robinson SO2
monitor since the monitor began operation on July 21, 2016, and 5 out
of 12 quarters at the Skyland Drive SO2 monitor since the
monitor began operation on September 1, 2016. The available annual 99th
percentile daily maximum 1-hour average SO2 data at each
monitoring site within the Sullivan County Area for the 2015-2017
period are presented in Table 1.

                       Table 1--2015-2017 SO2 Monitoring Data for the Sullivan County Area
----------------------------------------------------------------------------------------------------------------
                                   Annual 99th percentile daily maximum 1-hour
                                                  average (ppb)
         Site (AQS ID)          ------------------------------------------------       Design value valid?
                                      2015            2016            2017
----------------------------------------------------------------------------------------------------------------
Ross N. Robinson (47-163-6001).         \a\ N/A         \b\ 152              92  No.
Skyland Dr. (47-163-6002)......         \a\ N/A          \b\ 91              78  No.
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ The SLAMS monitors did not collect data in 2015.
\b\ The Ross N. Robinson monitor had only two quarters of complete data in 2016 due to the monitor beginning
  operation on July 21, 2016. The Skyland Drive monitor had only one quarter of complete data in 2016 due to the
  monitor beginning operation on September 1, 2016.
Source: EPA AQS Design Value Report, retrieved September 14, 2021.

    The data in Table 1 indicates that although the two sites in the
Sullivan County Area did not have complete data in 2015 and 2016 to
determine a 3-year design value, both monitors consistently measured
99th percentile daily maximum 1-hour SO2 concentrations
above the 75 ppb level of the 1-hour NAAQS in 2016 and 2017, after
beginning operation in mid-2016. Both monitors have complete 2017
datasets.
    For an area to attain the 2010 SO2 NAAQS by the October
4, 2018, attainment date, the design value based upon monitored air
quality data from 2015-2017 at each eligible monitoring sites must be
equal to or less than 75 ppb for the 1-hour standard. Table 1 above
shows that the annual 99th percentile daily maximum 1-hour average at
each monitoring site exceeds 75 ppb in 2016 and 2017. See also Table 1
in the Sullivan County TSD.
2. Eastman SO2 Emissions Data
    As mentioned above, in round 1 SO2 designations, EPA
designated as nonattainment the portion of Sullivan County within a 3-
km radius circle centered at Eastman's B-253 powerhouse, which at the
time of designations encompassed the one monitor that was violating the
2010 1-hour SO2 NAAQS based on 2009-2011 air quality data.
Table 2 shows that the SO2 emissions, expressed in tons per
year (tpy), from Eastman account for more than 99 percent of the total
SO2 emissions in Sullivan County during the 2015-2017 period
relevant for this proposed determination that the Area failed to attain
the SO2 NAAQS by the applicable attainment date. Prior to
the Sullivan County Area being designated as nonattainment for the 2010
1-hour SO2 NAAQS in 2013, Eastman operated 15 coal-fired
boilers at their facility to generate steam and electricity. As
discussed in more detail in the Sullivan County TSD for this proposed
action, Eastman's annual SO2 emissions have been steadily
decreasing since 2013 due primarily to the changes in operations of the
coal-fired boilers.

    Table 2--2015-2017 SO2 Emission Data for the Sullivan County SO2
                           Nonattainment Area
------------------------------------------------------------------------
                                         Total Sullivan
                                           County SO2       Eastman SO2
             Calendar year               emissions from      emissions
                                           all sources         (tpy)
                                              (tpy)
------------------------------------------------------------------------
2015..................................            17,980          17,978
2016..................................            14,325          14,324
2017..................................            10,792          10,746
------------------------------------------------------------------------

    As shown in Table 2, the total annual SO2 emissions from
Eastman decreased over 7,000 tpy from 17,978 tpy in 2015 to 10,746 tpy
in 2017. During 2015-2017, the annual emissions were highest in 2015,
when no air monitoring data is available, and emissions decreased
significantly in 2016 and 2017. The decrease was primarily because of
the conversion of two large coal-fired boilers, Boilers 27 and 28 in
the B-253 powerhouse, from burning coal to natural gas fuel that was
completed in 2016. These two boiler conversions were part of a larger
SO2 emissions control project beginning in 2014 and ending
in 2018, which converted all five boilers in the B-253 powerhouse from
burning coal to burn natural gas fuel. These conversions had a
significant impact on SO2 emissions: Emissions from the B-
253 powerhouse decreased from 14,171 tpy in 2012 to less than 10 tpy in
2019.\27\ The total annual SO2 emissions from the entire
Eastman facility decreased from 21,246 tpy in 2012 to 4,510 tpy in
2019. See Sullivan County TSD for complete details of the boiler
conversions and resulting emissions changes.
---------------------------------------------------------------------------

    \27\ The conversion of the B-253 boilers from burning coal to
natural gas was completed in October 2018. Thus, the SO2
emissions from the B-253 powerhouse dropped significantly to 10 tpy
in 2019.
---------------------------------------------------------------------------

    It is important to also consider trends in hourly SO2
emissions since the 2010 SO2 NAAQS is a short-term standard
that is evaluated using hourly measurements of ambient SO2
concentrations. EPA's evaluation of Eastman's hourly emissions data
found that their emissions were over 33 percent higher during the
period from January 1, 2015, to June 30, 2016, (when no valid ambient
monitoring data was available), than the July 1, 2016, through December
31, 2017, period (when valid

ambient monitoring data show exceedances of the NAAQS).\28\
---------------------------------------------------------------------------

    \28\ See Figure 5 and Table 3 of the Sullivan County TSD in the
docket for this proposed action.
---------------------------------------------------------------------------

3. Weight of Evidence Analysis Conclusions and Proposed Determination
    To determine the air quality in the Sullivan County Area as of the
applicable attainment date, EPA reviewed the available ambient
monitoring data and annual and hourly SO2 emissions data at
Eastman from January 1, 2015, to December 31, 2017. As shown in Table
1, the available SO2 ambient monitoring data in the Sullivan
County Area indicates that the 99th percentile maximum daily 1-hour
SO2 concentration in both 2016 and 2017 exceeded the 1-hour
SO2 NAAQS level of 75 ppb. The primary SO2
emissions sources in the nonattainment area are the coal-fired boilers
at Eastman. Both the annual SO2 emissions and the hourly
SO2 emissions from the Eastman boilers were significantly
higher from January 1, 2015, to June 30, 2016, when air monitoring data
are not available, than from July 1, 2016, through December 31, 2017,
when air monitoring data are available. Ambient SO2
concentrations are very source-oriented, and in this case, the Eastman
boilers make up virtually the entire emissions inventory for the Area.
Considering that the ambient measured concentrations exceeded the level
of the NAAQS in 2016 and 2017, when emissions from the primary source
of SO2 were lower than they were in 2015, EPA believes it is
reasonable to expect that the 99th percentile maximum daily 1-hour
SO2 concentration in 2015 likely also exceeded the level of
75 ppb. Consequently, the three-year average of: The 99th percentile
value for 2015 (likely exceeded the level of the NAAQS), 2016 (exceeded
the level of the NAAQS), and 2017 (exceeded the level of the NAAQS)
almost certainly would have resulted in a design value that violated
the NAAQS. EPA therefore proposes to find that this analysis of
available ambient concentration data and SO2 emissions data
demonstrates by a weight of evidence that the Sullivan County Area
failed to attain the 1-hour SO2 NAAQS by the required
attainment date of October 4, 2018.

E. Consequences for SO2 Nonattainment Areas Failing To Attain Standards
by Attainment Dates

    The consequences for SO2 nonattainment areas for failing
to attain the standard by the applicable attainment date are set forth
in CAA section 179(d). Under section 179(d), a state must submit a SIP
revision for the area meeting the requirements of CAA sections 110 and
172, the latter of which requires, among other elements, a
demonstration of attainment and reasonable further progress, and
contingency measures. In addition, under CAA section 179(d)(2), the SIP
revision must include such additional measures as EPA may reasonably
prescribe, including all measures that can be feasibly implemented in
the area in light of technological achievability, costs, and any non-
air quality and other air quality-related health and environmental
impacts.
    In this case, the dominant source of SO2 emissions in
the Sullivan County Area is the Eastman facility. EPA expects that
information concerning potential additional control measures would be
collected by TDEC as part of its development of the SIP revision to
address the requirements that would be triggered by a final finding of
failure to attain for the Area. The State is required to submit the SIP
revision within one year after EPA publishes a final action in the
Federal Register determining that the nonattainment area failed to
attain the applicable SO2 standard by the applicable
attainment date. In addition to triggering requirements for a new SIP
submittal, a final determination that a nonattainment area failed to
attain the NAAQS by the applicable attainment date would trigger the
implementation of contingency measures adopted into the SIP under
172(c)(9).
    Under CAA sections 179(d)(3) and 172(a)(2), the new attainment date
for each nonattainment area is the date by which attainment can be
achieved as expeditiously as practicable, but no later than five years
after EPA publishes a final action in the Federal Register determining
that the nonattainment area failed to attain the applicable
SO2 standard by the applicable attainment date.\29\
---------------------------------------------------------------------------

    \29\ Pursuant to CAA sections 172(a)(2)(D) and 192(a), the
attainment date extension provision under section 172(a)(2)(A) does
not apply to the SO2 NAAQS.
---------------------------------------------------------------------------

III. Proposed Action and Request for Public Comment

    Under CAA section 179(c)(1), EPA proposes to determine that the
Sullivan County Area failed to attain the 2010 1-hour SO2
standard by the applicable attainment date of October 4, 2018. This
determination is based upon a weight of evidence analysis of available
quality assured and certified SO2 monitored air quality data
and emissions data from January 2015 through December 2017 in lieu of a
valid 2015-2017 design value. If finalized as proposed, the State of
Tennessee would be required under CAA section 179(d) to submit a
revision to the SIP for the Sullivan County Area. The required SIP
revision for the area must, among other elements, demonstrate
expeditious attainment of the standards within the period prescribed by
CAA section 179(d). If finalized as proposed, the SIP revision required
under CAA section 179(d) would be due for submittal to EPA no later
than one year after the publication date of the final action.
    EPA is soliciting public comments on the issues discussed in this
notice.\30\ The Agency will accept comments from the public on this
proposal for the next 30 days. The deadline and instruction on how to
submit comment can be found in the DATES and ADDRESSES sections of this
notice. EPA will consider these comments before taking final action.
---------------------------------------------------------------------------

    \30\ The scope of this proposed action is limited to whether the
Sullivan County Area attained the 1-hour SO2 standard by
the applicable October 4, 2018, attainment date. Therefore, EPA is
not soliciting further comment on the approvability of the State's
2017 SO2 attainment SIP that the Agency previously
proposed to approve on June 29, 2018. See 83 FR 30609. The comment
period for that proposal closed on July 30, 2018. EPA has not yet
taken final action on that SIP submission.
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review, and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and therefore
was not submitted to the Office of Management and Budget (OMB) for
review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the PRA because it does not contain any information
collection activities.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This
proposed action, if finalized, would require the state to adopt and
submit a SIP revision to satisfy CAA requirements and would

not itself directly regulate any small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate of $100 million
or more, as described in UMRA (2 U.S.C. 1531-1538) and does not
significantly or uniquely affect small governments. This action itself
imposes no enforceable duty on any state, local, or tribal governments,
or the private sector. This action proposes to determine that the
Sullivan County Area failed to attain the NAAQS by the applicable
attainment date. If finalized, this determination would trigger
existing statutory timeframes for the State to submit SIP revisions.
Such a determination in and of itself does not impose any federal
intergovernmental mandate.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. The proposed finding of failure to attain
SO2 NAAQS does not apply to tribal areas, and the proposed
rule would not impose a burden on Indian reservation lands or other
areas where EPA or an Indian tribe has demonstrated that a tribe has
jurisdiction. Thus, this proposed rule does not have tribal
implications and will not impose substantial direct costs on tribal
governments or preempt tribal law as specified by Executive Order
13175.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This proposed action is not subject to Executive
Order 13045 because the effect of this proposed action, if finalized,
would be to trigger additional planning requirements under the CAA.
This proposed action does not establish an environmental standard
intended to mitigate health or safety risks.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211, because
it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA believes that this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The
effect of this proposed action, if finalized, would be to trigger
additional planning requirements under the CAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Pollution, Sulfur
dioxide.

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

    Dated: December 29, 2021.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-00028 Filed 1-12-22; 8:45 am]
BILLING CODE 6560-50-P