[Federal Register Volume 77, Number 207 (Thursday, October 25, 2012)]
[Proposed Rules]
[Pages 65146-65148]
[FR Doc No: 2012-26264]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1106; Directorate Identifier 2012-NM-084-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and
Model A340-200, -300, -500, and -600 series airplanes. This proposed AD
was prompted by a report that erroneous height indication by one radio
altimeter with engaged flare and retard mode, in case of go-around,
might lead to a temporary loss of airplane longitudinal control. This
proposed AD would require revising the airplane flight manual. We are
proposing this AD to ensure that the flightcrew applies the appropriate
operational procedures in the event of an erroneous indication of the
radio altimeter, which could result in temporary loss of airplane
longitudinal control.

DATES: We must receive comments on this proposed AD by December 10,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA 1601
Lind Avenue SW., Renton, Washington 98057-3356; telephone (425) 227-
1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-1106;
Directorate Identifier 2012-NM-084-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0069, dated April 24, 2012 (referred to
after this as ``the MCAI''), to correct an unsafe

condition for the specified products. The MCAI states:

    Airbus performed tests to investigate the consequences of one
radio altimeter providing an erroneous indication.
    These tests concluded that with engaged flare and retard mode,
in case of go-around, the situation may lead to a temporary loss of
aeroplane longitudinal control.
    To address this condition, Airbus issued a new Airplane Flight
Manual (AFM) operational procedure.
    For the reasons described above, this [EASA] AD requires
amendment of the applicable AFM to ensure that the flight crew
applies the appropriate operational procedures.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Temporary Revision TR37, Issue 1.0, dated June
15, 2010; and Temporary Revision TR38, Issue 1.0, dated June 15, 2010;
to the Airbus A330/A340 AFM. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    While the compliance time for doing the actions specified in EASA
AD 2012-0069, dated April 24, 2012, is within 14 days after the
effective date of EASA AD 2012-0069, dated April 24, 2012, this
proposed AD has a required compliance time of within 30 days after the
effective date of this AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 64 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $5,440, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-1106; Directorate Identifier 2012-NM-
084-AD.

(a) Comments Due Date

    We must receive comments by December 10, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-223F and -243F airplanes;
Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -
322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212,
-213, -311, -312, -313, -541, and -642 airplanes; certificated in
any category; all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by a report that erroneous height
indication by one radio altimeter with engaged flare and retard
mode, in case of go-around, might lead to a temporary loss of
airplane longitudinal control. We are issuing this AD to ensure that
the flightcrew applies the appropriate operational procedures in the
event of an erroneous indication of the radio altimeter, which could
result in temporary loss of airplane longitudinal control.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Airplane Flight Manual (AFM) Revision

    (1) Within 30 days after the effective date of this AD, revise
the applicable section of the Airbus A330/A340 AFM to include the
information in Airbus Temporary Revision TR37, Issue 1.0, dated June
15, 2010; or Airbus Temporary Revision TR38, Issue 1.0, dated June
15, 2010; to the Airbus A330/A340 AFM. This may be done by inserting
a copy of this AD, or Airbus Temporary Revision TR37, Issue 1.0,
dated June 15, 2010, and Airbus Temporary Revision TR38, Issue 1.0,
dated June 15, 2010; in the AFM.
    Note 1 to paragraph (g)(1) of this AD: When the information in
Airbus Temporary Revision TR37, Issue 1.0, dated June 15, 2010; or
Airbus Temporary Revision TR38, Issue 1.0, dated June 15, 2010, to
the Airbus A3330/A340 AFM, has been included in the applicable
section of the general revisions of the AFM, the general revisions
may be inserted into the AFM, and the copy of this AD may be removed
from the AFM, provided

the relevant information in the general revisions is identical to
that in Airbus Temporary Revision TR37, Issue 1.0, dated June 15,
2010; or Airbus Temporary Revision TR38, Issue 1.0, dated June 15,
2010.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(i) Related Information

    (1) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2012-0069, dated April 24, 2012, and the service
information specified in paragraphs (i)(1)(i) and (i)(1)(ii) of this
AD, for related information.
    (i) Airbus Temporary Revision TR37, Issue 1.0, dated June 15,
2010.
    (ii) Airbus Temporary Revision TR38, Issue 1.0, dated June 15,
2010.
    (2) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on October 14, 2012.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26264 Filed 10-24-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Notices]
[Page 55431-55432]
[DOCID:fr21se05-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 35-28029]

Filings Under the Public Utility Holding Company Act of 1935, as
Amended (``Act'')

September 14, 2005.
    Notice is hereby given that the following filing(s) has/have been
made with the Commission pursuant to provisions of the Act and rules
promulgated under the Act. All interested persons are referred to the
application(s) and/or declaration(s) for complete statements of the
proposed transaction(s) summarized below. The application(s) and/or
declaration(s) and any amendment(s) is/are available for public
inspection through the Commission's Branch of Public Reference.
    Interested persons wishing to comment or request a hearing on the
application(s) and/or declaration(s) should submit their views in
writing by October 6, 2005, to the Secretary, Securities and Exchange
Commission, Washington, DC 20549-0609, and serve a copy on the relevant
applicant(s) and/or declarant(s) at the address(es) specified below.
Proof of service (by affidavit or, in the case of an attorney at law,
by certificate) should be filed with the request. Any request for
hearing should identify specifically the issues of facts or law that
are disputed. A person who so requests will be notified of any hearing,
if ordered, and will receive a copy of any notice or order issued in
the matter. After October 6, 2005, the application(s) and/or
declaration(s), as filed or as amended, may be granted and/or permitted
to become effective.

Black Hills Corporation, et al. (70-10237)

    Black Hills Corporation (``Black Hills''), a registered public-
utility holding company, Black Hills Power, Inc. (``Black Hills
Power''), an electric-utility subsidiary of Black Hills, both located
at 625 Ninth Street, Rapid City, SD 57701, and Cheyenne Light, Fuel and
Power Company, also an electric-utility subsidiary of Black Hills,
located at 108 West 18th, Cheyenne, WY 82001, Black Hills Energy, Inc.
(``Black Hills Energy''), a nonutility subsidiary of Black Hills, and
all of Black Hills other subsidiaries (collectively, ``Subsidiaries''),
located at 625 Ninth Street, Rapid City, SD 57701 (collectively,
``Applicants''), have filed with the Commission a post-effective
amendment to their previously filed application-declaration
(``Application'') under sections 6(a), 7, 9(a), 10, 11, 12(b) and (c),
13(b), 32, 33 and 34 of the Act and rules 42, 43, 45, 52, 53, 54, 58
and 88 through 92.
    Black Hills requests certain extensions of time.

I. Background

    Black Hills is an integrated public-utility holding company.\1\ On
December 28, 2004, the Commission authorized Black Hills and its
Subsidiaries to engage in various financing and other transactions
(``Financing Order'').\2\ In connection with the Financing Order, Black
Hills committed to establish a limited liability subsidiary, Black
Hills Service Company, LLC (``Black Hills Service''), to provide
centralized services (such as accounting, financial, human resources,
information technology and legal services) to the companies in the
Black Hills system \3\ and to submit certain filings to the Commission
and to implement certain processes and methodologies by December 28,
2005.\4\
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    \1\ Black Hills is engaged in two lines of business: (1) The
generation, transmission, distribution and sale of electricity to
retail and wholesale customers; and (2) through Black Hills Energy
and its subsidiaries, the development, ownership and operation of
exempt wholesale generators, as defined in section 32 of the Act,
qualifying facilities as defined in the Public Utility Regulatory
Policies Act of 1978, as amended, and the production, transportation
and marketing of natural gas, oil, coal and other energy
commodities, power marketing and other energy-related activities.
Applicants previously engaged in certain exempt telecommunications
activities and these businesses have recently been sold.
    \2\ Black Hills Corporation, et al., Holding Company Act Release
No. 27931. Black Hills registered as a public-utility holding
company under the Act earlier this year, in 2005. By the Financing
Order, Black Hills, then a public-utility holding company exempt
from registration under section 3(a)(1) of the Act by rule 2, Black
Hills Power, its subsidiary electric-utility company, and all other
direct and indirect subsidiaries, were authorized to engage in
financing and investment activities, intrasystem services and other
related activities and transactions, through December 31, 2007,
following Black Hills' registration as a public-utility holding
company. A recent, related notice was issued on July 26, 2005,
addressing certain administrative money pool matters. See Black
Hills Corporation, et al., Holding Co. Act Release No. 28003. No
hearing has been requested.
    \3\ Black Hills states that it explained, in its application for
the Financing Order, that the Black Hills system companies will
engage in a variety of affiliate transactions for goods, services
and construction, in accordance with rules 87, 88, 90 and 91, unless
otherwise authorized by Commission order or rule. Black Hills states
it also committed to file accounting and cost allocation procedures
with the Commission by October 1, 2005; to form Black Hills Service
within sixty days of issuance of the Financing Order, but sought
authority to delay (for not longer than twelve months) the full
implementation of Black Hills Service and the required accounting
systems and cost allocation methodologies; and finally, to complete
conversion of non-exempt market-based rate affiliate transactions to
cost-based transactions (not later than twelve months following
issuance of the Financing Order). In the Financing Order, the
Commission acknowledged Black Hills' plans for these procedures,
Black Hills Service and the affiliate arrangements.
    \4\ Black Hills states that it established Black Hills Service
and has taken significant steps to implement it. Black Hills states
further that, in this implementation, it has already expended
significant resources in extensive planning and organizational
initiatives to identify employees and functions to be transferred to
Black Hills Service, defining extensive new organizational,
management and personnel structures to be put in place at Black
Hills Service and associate companies and formulating required
changes to human resources systems and pension and benefit plans.
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    The Act was repealed on August 8, 2005, and the Public Utility
Holding Company Act of 2005 (``PUHCA 2005'') was enacted on that date
by the Energy Policy Act of 2005 (``Energy Policy Act 2005''). The
repeal of the Act ends the Commission's authority over Black Hills and
the Black Hills system under this statute as of February 8, 2006 and
subjects Black Hills and the Black Hills system to new, but in certain
respects similar, regulation by the Federal Energy Regulatory
Commission (``FERC'') under PUHCA 2005.
    FERC is required to issue certain PUHCA 2005 regulations by
December 8, 2005. Black Hills states that the new FERC regulations may
affect some of the processes and methodologies relating to allocation
of costs, among other things, that were addressed in the Financing
Order.

II. Requested Authority

    Black Hills, therefore, requests the Commission to permit it:
    1. To extend Black Hills' time for certain filings with the
Commission, from October 1, 2005, through February 8, 2006, the
effective date of the Act's repeal (describing accounting systems and
cost allocation methodologies);
    2. To extend the time for Black Hills' full implementation of Black
Hills Service, from December 28, 2005, through February 8, 2006, the
effective date of the Act's repeal (accounting systems and cost
allocation methodologies); and
    3. To extend the time for Black Hills' conversions of non-exempt
market-based rate affiliate transactions to cost-based transactions
from December 28, 2005, through February 8, 2006, the effective date of
the Act's repeal.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-18817 Filed 9-20-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Page 33020]
[FR Doc No: 2022-11714]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2022-0379]

Safety Zones; Recurring Events in Captain of the Port Duluth--
City of Bayfield 4th of July Fireworks Display

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the City of
Bayfield Fireworks in Bayfield, WI. This action is necessary to protect
participants and spectators during the City of Bayfield Fireworks.
During the enforcement period, entry into, transiting, or anchoring
within the safety zone is prohibited unless authorized by the Captain
of the Port Duluth or designated on-scene representative.

DATES: The regulations in 33 CFR 165.943(b) will be enforced from 9
p.m. through 10:30 p.m. on July 4, 2022, for the City of Bayfield
Fireworks safety zone, Sec.  165.943.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LTJG Joe McGinnis, telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual City of Bayfield 4th of July Fireworks Display in 33 CFR
165.943 from 9 p.m. through 10:30 p.m. on July 4, 2022. All waters of
the Lake Superior North Channel in Bayfield, WI within the arc of a
circle with a radius of no more than 1,120 feet from the launch site at
position 46[deg]48'40'' N, 090[deg]48'32'' W.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or their
designated on-scene representative. The Captain of the Port's
designated on-scene representative may be contacted via VHF Channel 16.
    This document is issued under authority of 33 CFR 165.943 and 5
U.S.C. 552 (a). In addition to this publication in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of the enforcement of this safety zone via
Broadcast Notice to Mariners.

    Dated: May 17, 2022.
F.M. Smith,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2022-11714 Filed 5-31-22; 8:45 am]
BILLING CODE 9110-04-P


-----Original Message-----
From: Chris Hessler<EMAIL_ADDRESS>Sent: Friday, October 17, 2014 5:05 PM
To: Harvey, Reid
Cc: Hoffman, Howard; Robinson, Debra; Ted Michaels
Subject: RE: Follow up

Reid,
Thanks for getting back to me.

Debra, Would something on the afternoon of the 28th work?  If not, please let us know what might work the week of the 27th.

Howard, Please let me know what might work for you next week.  Tuesday 10/21 and Wednesday 10/22 are the most flexible on my end.
Chris

-----Original Message-----
From: Harvey, Reid<EMAIL_ADDRESS>Sent: Friday, October 17, 2014 9:12 AM
To: Chris Hessler
Cc: Hoffman, Howard; Robinson, Debra
Subject: RE: Follow up

Hi Chris - I'm traveling in Denver all next week so I'd suggest you first connect with Howard to line up logistics for a call or meeting with him on your legal questions.   He's at<PHONE_NUMBER>.  I assume that would involve just the two of you, and I'm not needed for that.

I'm back in town the week of the 27th.  You can contact my scheduler, Debra Robinson, if you want to set something up that week.  The week of 11/3 I'm in Canada later in the week.  Assuming the topic of that second meeting is getting into the details on the M&V for performance contract projects, then Debra should also invite Joe Bryson, Niko Dietsch, Chris Sherry, Denise Mulholland, and Julie Rosenberg.

Thanks,
Reid

Director, Clean Air Markets Division
Office of Atmospheric Programs/OAR
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW (6204J)
Washington, DC  20460

202-343-9429

www.epa.gov/airmarkets

-----Original Message-----
From: Chris Hessler<EMAIL_ADDRESS>Sent: Friday, October 17, 2014 8:50 AM
To: Harvey, Reid
Cc: Hoffman, Howard
Subject: Re: Follow up

Reid,
Any thoughts on when a meeting might work?
Chris

> On Oct 14, 2014, at 12:56 PM, "Harvey, Reid"<EMAIL_ADDRESS>wrote:
>
> Chris - I recall we had discussed perhaps starting with a discussion with Howard on some of the legal issues?  Does that make sense?
>
> Best,
> Reid
>
>
> -----Original Message-----
> From: Goffman, Joseph
> Sent: Tuesday, October 14, 2014 11:31 AM
> To: Chris Hessler
> Cc: Harvey, Reid; Hoffman, Howard
> Subject: Re: Follow up
>
> + Reid and Howard to take it from here.
>
> - Joseph  Goffman
> Sent from my iPhone
>
>> On Oct 14, 2014, at 10:59 AM, "Chris Hessler"<EMAIL_ADDRESS>wrote:
>>
>> Joe,
>> I wanted to touch base with you about scheduling follow up meetings on our 111(d) discussion. You had suggested that two separate follow up meetings might be warranted. With whom should I be working to schedule those meetings?
>> Chris


[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Rules and Regulations]
[Page 23947-23953]
[DOCID:fr01my08-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2006-P-0405] (formerly Docket No. 2006P-0069)

Food Labeling: Health Claims; Soluble Fiber from Certain Foods
and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulation authorizing a health claim on the relationship between
soluble fiber from certain foods and risk of coronary heart disease
(CHD). The amendment exempts certain foods from the nutrient content
requirement of ``low fat.'' The exemption will apply if the food
exceeds the ``low fat'' requirement due to fat content derived from
whole oat sources. The amendment expands the use of this health claim
to some whole oat products that are currently ineligible for the health
claim. FDA is taking this

action in response to a petition submitted by the Quaker Oats Co.

DATES: This final rule is effective May 1, 2008.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 6, 2007 (72 FR 5367), FDA
published a proposed rule to amend the regulation authorizing a health
claim on the relationship between soluble fiber from certain foods and
risk of CHD. FDA proposed to amend the CHD health claim at Sec.  101.81
(21 CFR 101.81) so that foods that exceed the nutrient content
requirement in Sec.  101.62 for ``low fat'' due to fat content derived
from whole oat sources (i.e., oat bran, rolled oats, whole oat flour,
and oatrim) listed in Sec.  101.81(c)(2)(ii)(A) would be eligible to
bear the health claim. Specifically, FDA proposed to amend Sec.
101.81(c)(2)(iii)(C) by removing the phrase, ``low fat'' food and
creating a new Sec.  101.81(c)(2)(iii)(D) to specify that the food
shall meet the ``low fat'' food requirement, unless the food exceeds
this requirement due to fat content derived from whole oat sources
listed in Sec.  101.81(c)(2)(ii)(A). FDA issued this proposed rule in
response to a health claim petition submitted by the Quaker Oats Co.
(the petitioner) on November 7, 2005, under section 403(r)(4) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)).
Section 403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B)(i)) states
that the Secretary of Health and Human Services (the Secretary) (and,
by delegation, FDA) shall issue regulations for health claims if the
Secretary determines, based on the totality of publicly available
scientific evidence, that there is significant scientific agreement
that the claim is supported by such evidence (see also 21 CFR
101.14(c)). Section 403(r)(4) of the act sets out the procedures that
FDA is to follow upon receiving a health claim petition. FDA filed the
petition for comprehensive review in accordance with section 403(r)(4)
of the act on February 15, 2006.
    In regulations authorizing CHD-related health claims, FDA has
required, with a few exceptions, that foods bearing such claims meet
the ``low fat`` criterion defined by Sec.  101.62(b)(2),\1\ the ``low
saturated fat'' criterion defined by Sec.  101.62(c)(2), and the ``low
cholesterol'' criterion defined by Sec.  101.62(d)(2) (see authorized
claims in 21 CFR 101.75, 101.77, 101.81, 101.82, and 101.83) rather
than applying the total fat, saturated fat, and cholesterol content
disqualifying levels specified in the general requirement for health
claims (Sec.  101.14(a)(4)). The ``low fat'' criterion is currently
applied to the soluble fiber from certain foods and CHD health claim in
Sec.  101.81(c)(2)(iii)(C).
---------------------------------------------------------------------------

    \1\ ``Low fat'' food is defined in Sec.  101.62(b)(2) as
follows: (1) A food that has a RACC greater than 30 g or greater
than 2 tablespoons and contains 3 g or less of fat per RACC; or (2)
a food that has a RACC of 30 g or less or 2 tablespoons or less and
contains 3 g or less of fat per reference amount customarily
consumed (RACC) and per 50 g of food.
    Further, under Sec.  101.62(b)(3), meal products and main dish
products (as defined in Sec.  101.13(l) and Sec.  101.13(m)
respectively) are ``low fat'' if they contain 3 g or less of total
fat per 100 g and not more than 30 percent of calories from fat.
---------------------------------------------------------------------------

    Prior to the publication of this final rule, foods such as Quaker
Oats Co.'s flavored reduced sugar instant oatmeal products were
ineligible for the soluble fiber from certain foods and CHD health
claim because these products did not meet the ``low fat'' criterion,
whereas its flavored, unmodified instant oatmeal product containing the
same amount of rolled oats and fat, but 12 grams (g) more sugar, per
packet does meet the criterion. The removal of sugar from the flavored
unmodified instant oatmeal product resulted in more whole oats (and
thus fat from whole oats) per RACC. Thus, these food products were not
eligible to bear the soluble fiber from certain foods and CHD health
claim because these foods exceed the ``low fat'' criterion due to the
fat contained in the whole oat source.
    In the proposed rule, FDA stated that a food product that contains
any fat from ingredients other than whole oat sources would not be
exempt from the ``low fat'' requirement. However, FDA asked for comment
on whether whole oat food products that contain sources of fat other
than whole oat sources should be exempt from the ``low fat''
requirement and, if so, how much and what types(s) of fat contributed
by these sources would be acceptable (72 FR 5367 at 5370).
    FDA solicited comments on the proposed rule. The comment period
closed on April 23, 2007. The agency received eight responses, each
containing one or more comments, to the proposed rule. The comments
were from trade associations, industry, a health professional
organization, a foreign government, and consumers. Most of the comments
supported the proposed amendment. One comment raised issues that were
outside the scope of this rulemaking and will not be discussed in this
document. The remaining comments and the agency's responses are
discussed below.
    (Comment 1) One comment opposed FDA exempting whole oat food
products from the ``low fat'' requirement, but did not provide any
specific information or data in support of its position.
    (Response) The agency disagrees with this comment. FDA believes
that the consumption of foods containing whole oat products is helpful
in reducing the risk of CHD, and the amount by which the fat content
derived solely from whole oat sources may exceed the low fat criterion
would not be very significant and is not likely to be a health concern.
Moreover, the exemption does not cover a food product that contains any
fat from ingredients other than whole oat sources and granting this
exemption will provide consumers more choices of whole oat products (72
FR 5367 at 5370). The comment did not provide any information or data
in support of its position.
    (Comment 2) One comment opposing the proposed rule argued that
granting the exemption would be the same as saying that full fat whole
oatmeal cookies could reduce the risk of heart disease.
    (Response) The agency disagrees with the comment. As discussed in
the proposed rule, only a limited number of products would be newly
eligible to bear the claim (72 FR 5367 at 5372). Under the new
exemption, a food must meet the ``low fat'' requirement ``unless the
food exceeds this requirement due to fat content derived from whole oat
sources'' (Sec.  101.81(c)(2)(iii)(D)). The products eligible to bear
the claim would not contain any fat from sources other than the fat
inherent in the whole oat sources. Food products that are typically
made with other fat sources, such as cookies, would likely be
ineligible for the claim.
    (Comment 3) One comment opposing the proposed rule was concerned
that the exemption allowing an exception to a marketing claim for a
single food product that has been modified would confuse consumers.
    (Response) FDA disagrees with the comment. Consumers will not be
confused by this exemption because it does not apply only to a single
food product. The final rule merely expands the use of this health
claim to cover any whole oat product that was previously ineligible for
the claim due to the fat derived from the whole oat source. The food
product described in the petition only serves as an example of a
consequence that was not intended

(reduction of sugar leading to ineligibility for the claim) in the
authorization of the original health claim. The agency wishes to
eliminate this unintended consequence and allow consumers access to
information about the health benefits of whole oat sources.
    (Comment 4) One comment stated that any health claim related to CHD
should meet requirements of ``low soluble fibre, low saturated fat, and
low cholesterol.'' The comment did not provide any specific information
or data in support of its position.
    (Response) Foods eligible for CHD-related health claims are
currently required to meet the definition of ``low fat,'' ``low
saturated fat,'' and ``low cholesterol,'' unless specifically exempted
(see 21 CFR 101.75 (dietary saturated fat and cholesterol and CHD)), 21
CFR 101.77 (fruits, vegetables, and grain products containing fiber and
CHD), Sec.  101.81 (soluble fiber and CHD), 21 CFR 101.82 (soy protein
and CHD), and 21 CFR 101.83 (plant sterol/stanol esters and CHD)). This
final rule does not change the nutrient content requirements for ``low
saturated fat,'' ``low fat,''or ``low cholesterol'' found in these CHD-
related health claims. The agency notes that the soy protein and CHD
health claim also contains an exemption for the ``low fat''
requirement. Specifically, the soy protein and CHD health claim
requires the food to meet the nutrient content requirement for ``low
fat'' found in Sec.  101.62 ``unless it consists of or is derived from
whole soybeans and contains no fat in addition to the fat inherently
present in the whole soybeans it contains or from which it is derived''
(Sec.  101.82(c)(2)(iii)(C)).
    Contrary to what the comment infers, foods are not required to meet
any soluble fiber requirements to bear a CHD-related health claim
except in the specific case where fiber has been declared as the
substance that is the subject of the claim (i.e., the fruits,
vegetables, and grain products containing fiber and CHD-related health
claim found at Sec.  101.77 and the health claim discussed in this
rule). Even in these cases, the fiber requirement is to meet certain
fiber levels, not to keep the fiber (soluble or otherwise) ``low.'' The
agency has determined in these CHD-related health claims that diets
that are low in saturated fat and cholesterol and that include soluble
fiber from certain foods may reduce the risk of CHD (see Sec. Sec.
101.77(a) and 101.81(a) for explanations of the relationship between
diets low in saturated fat and cholesterol that contain fiber).
Therefore for these CHD-related health claims, the goal is to encourage
the consumption of fiber-rich foods, and not to limit the amount of
fiber in the food as the comment suggests.
    (Comment 5) Two comments requested that FDA extend the exemption
from the ``low fat'' requirement to other beta-glucan-containing food
products, specifically whole grain barley, dry milled barley, and other
barley products.
    (Response) FDA is not now exempting other beta-glucan-containing
food products from the ``low fat'' nutrient content requirement. As
discussed in the proposed rule, it is possible that a product could
exceed the maximum total fat permitted under the ``low fat''
requirement solely due to fat from whole oat sources. The total fat
content of whole oat sources can be as high as 7.0 g per 100 g, whereas
other cereal grain products are lower in fat. ``Whole oats contain a
higher amount of total fat than barley (2.3 g per 100 g) or other
cereal grains such as whole wheat (1.9 g per 100 g whole wheat flour),
rice (2.9 g per 100 g brown rice) or corn (1.2 g per 100 g dry corn
grits)'' (72 FR 5367 at 5369). As a result of these nutrient
compositions, it is likely that additional cereal grain food products
on the market consisting of other cereal grains (and not including
other sources of fat) would already meet the ``low fat'' requirement
for the soluble fiber claim and would not require any exemption to this
requirement. The agency is aware, however, that advances in food
technology (such as the reduction of sugar in oatmeal products) can
lead to consequences unintended by the original health claim, and in
those cases, the agency can be petitioned under section 403(r)(4) of
the act to address the issue in rulemaking.
    (Comment 6) Two comments requested that FDA eliminate the ``low
fat'' requirement for this health claim based on the latest 2005
Dietary Guidelines for Americans science and dietary recommendations.
The comments recommended that a ``moderate'' level of fat should be the
requirement that foods eligible for the claim should have to meet. This
change, the comments noted, could allow food products eligible to bear
the claim to contain as much as 13 g total fat (the total fat
disqualifying level). In support of their position, the comments
pointed out that the 2005 Dietary Guidelines for Americans do not
require that diets be low in fat.
    (Response) FDA is not revising the rule as requested by the
comment. Section 101.81(c)(2)(iii)(C) states that a food eligible to
bear a soluble fiber and CHD health claim must meet the nutrient
content requirements in Sec.  101.62 for a ``low saturated fat,'' ``low
cholesterol,'' and ``low fat'' food. ``Low saturated fat,'' ``low
cholesterol,'' and ``low fat'' are nutrient content claims defined by
regulation (Sec.  101.62). ``Moderate fat'' is not defined by
regulation nor was defining this term foreshadowed in the proposal.
However, any interested person can petition the agency to define and
authorize a new nutrient content claim for ``moderate fat'' under
section 403(r)(4) of the act.
    (Comment 7) One comment requested that FDA exempt fat from
fortificants (e.g., vitamin A palmitate) from the ``low fat''
requirement because the amount of fat from fortificants would likely be
``inconsequential.''
    (Response) FDA is not granting the requested exemption. The agency
asked for comment in the proposed rule about whether to exempt whole
oat products that contain sources of fat other than whole oat sources
and, if so, how much and what type(s) of fat contributed by these
sources would be acceptable. However, FDA did not receive, nor does it
have, sufficient data regarding fortificants, such as vitamin A
palmitate, to determine if whole oat foods that contain sources of fat
from fortificants should be exempted from the ``low fat'' requirement.
    Although FDA is not now revising the rule to include fat from
fortificants as a source of fat eligible for the exemption from the
``low fat'' requirement, any interested person can petition the agency
for such an exemption under section 403(r)(4) of the act.
    (Comment 8) One comment requested that FDA confirm the nutrient
composition values for total fat because the USDA National Nutrient
Database has been updated since the proposal was published in February
2007.
    (Response) The agency has confirmed that the values for fat
composition of the grains cited in the proposed rule (i.e., about 6.9 g
per 100 g for whole oats (same as whole oat flour), 6.3 g per 100 g for
rolled oats, and 7.0 g per 100 g for oat bran) have remained unchanged
in the newest release of the USDA National Nutrient Database for
Standard Reference, Release 20 (Ref. 1).
    (Comment 9) One comment suggested that FDA also provide exemptions
to the per 50 g provision of the ``low fat'' requirement for foods with
small serving sizes. The comment stated that products should not need
to meet the ``low fat'' criteria on a per 50 g basis in addition to a
per RACC and labeled serving size basis since products with small
serving sizes (e.g., ready-to-eat cereals) would not be eligible for
the health claim.

    (Response) FDA advises that the exemption to the ``low fat''
requirement is not restricted by this final rule to food products with
typical serving sizes. If a whole oat food product with a small serving
size of 30 g or less or 2 tablespoons or less exceeds the ``low fat''
requirement on a 50 g basis due to fat derived solely from the whole
oat source, it is exempted from the ``low fat'' requirement as well.
    Given the information discussed in the preamble to the proposed
rule and the absence of contrary information in the comments, FDA is
adopting as a final rule, without change, the proposed amendment to
Sec.  101.81 to exempt certain foods from the nutrient content
requirement of ``low fat'' if the food exceeds this requirement due to
fat content derived from whole oat sources.

II. Analysis of Economic Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency does not
believe that this final rule is an economically significant regulatory
action as defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule allows new voluntary
behavior and imposes no additional restrictions on current practices,
the agency certifies that this final rule will not have a significant
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before finalizing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

A. The Need for Regulation

    Current 21 CFR 101.81 authorizes a health claim on foods for the
relationship between soluble fiber from certain foods and reduced risk
of CHD. One of the requirements for the claim is the nutrient content
requirement for ``low fat.'' In order to bear the claim, foods must
contain no more than 3 g of fat per RACC. The RACC for plain oatmeal is
40 g dry weight and the RACC for flavored, sweetened oatmeal is 55 g
dry weight, assuming that 15 g of sugar is added. The amount of fat in
40 g of rolled oats is just below 3 g, mostly polyunsaturated fatty
acids and monounsaturated fatty acids. A recently introduced flavored
reduced-sugar oatmeal does not meet the criterion of 3 g or less of fat
per 55 g dry weight. Because the amount of added sugar in this reduced-
sugar oatmeal is less than 15 g, the proportional amount of fat,
essentially all from whole oats, is slightly more than 3 g of fat per
55 g of the product compared to the sweetened oatmeal, even though the
total amount of fat in both the sweetened and reduced-sugar oatmeal
products is the same.
    The ineligibility of reduced-sugar oatmeal for this health claim
due to less added sugar is an unintended consequence of the regulation.
The current regulation, without amendment, causes a distortion in the
market, where products are essentially penalized for adding less sugar
or filler. In certain instances where two products are identical at the
package level, except for the amount of sugar added, only the product
with more sugar is able to carry the CHD health claim because the
product with less sugar has more oats per RACC and exceeds the ``low
fat'' requirement. The final rule is needed to remove this unintended
consequence.

B. Regulatory Options Considered

    The final rule amends the regulation authorizing a health claim on
the relationship between soluble fiber from certain foods and risk of
CHD. The amendment exempts certain foods from the nutrient content
requirement of ``low fat''. The exemption applies if the food exceeds
this requirement due to fat content derived from certain oat sources.
    In drafting this rule, FDA considered two regulatory alternatives
in addition to the final rule. The agency considered the following
alternatives: (1) No additional regulatory action and (2) general
relaxation of the total fat requirement, while keeping in place
restrictions on saturated fat and cholesterol. This final rule will not
be an economically significant regulatory action. FDA is not
quantitatively estimating the benefits and costs of the regulatory
alternatives to the final rule. In what follows, FDA qualitatively
compares the costs and benefits of the regulatory options to the costs
and benefits of the final rule.
    1. Option one. The first option considered is no action. As stated
earlier, the current rule as it stands causes an unintended distortion
in the market. Consumers have a higher than necessary search cost to
find products that are both reduced in sugar and that have similar
attributes of those currently carrying the CHD claim. Furthermore,
taking no action stifles the innovation of new products that have all
of the attributes of those with the CHD claim and that are reduced in
sugar.
    2. Option two. A second alternative to the final rule is a general
relaxation of the total fat requirement from all fat sources for all
products covered by the rule, while keeping in place restrictions on
saturated fat and cholesterol. Relaxing the restriction for total fat
from whole oat sources will not dampen the signal of the CHD claim
(i.e. it will not reduce the clarity of the message that products
bearing that claim in their labeling may reduce the risk of CHD),
whereas a general relaxation of total fat from all fat sources in such
products may have a deleterious effect in that the fat content may be
excessive and increase the risk of CHD and negate the health benefits
from the beta-glucan soluble fiber sources. The total fat content is
about 6.9 g per 100 g for whole oats (same as whole oat flour) (Ref.
1), 6.3 g per 100 g for rolled oats (Ref. 1), 7.0 g per 100 g for oat
bran (Ref. 1), and 2.1 g per 100 g for oatrim (Ref. 2). Whole oats
contain a higher amount of total fat than barley (2.3 g per 100 g) or
other cereal grains such as whole wheat (1.9 g per 100 g whole wheat
flour), rice (2.9 g per 100 g brown rice) or corn (1.2 g per 100 g dry
corn grits) (Ref. 1). However, most whole oat products that are
essentially all whole oats meet the ``low fat'' requirement unless fat
from other sources are added. For some products that do not meet the
``low fat'' requirement due to fat from whole oat sources, the amount
of fat exceeding the ``low fat'' requirement may be small. For example,
if a flavored sweetened oatmeal product were made almost entirely of
whole oats, the total fat content of this product would not exceed 4 g
per 55 g of RACC.
    Further, whole oats contain 1.2 g saturated fatty acids, 2.2 g
monounsaturated fatty acids, and 2.5 g

polyunsaturated fatty acids per 100 g (Ref. 1), and thus,
polyunsaturated and monounsaturated fatty acids are the predominant
types of fat in whole oats. Whole oats do not contain cholesterol. The
2005 Dietary Guidelines for Americans (Ref. 3) recommends total fat
intake be kept between 20 to 35 percent of calories, with most fats
coming from sources of polyunsaturated and monounsaturated fatty acids,
and less than 10 percent of calories from saturated fatty acids, and
cholesterol intake be kept at less than 300 mg/day. Thus, the fat
profile of whole oats is consistent with the 2005 Dietary Guidelines
for Americans recommendation of a moderate amount of total fat with
most sources coming from polyunsaturated and monounsaturated fatty
acids, and limiting intake of saturated fatty acids and cholesterol.
Relaxing the total fat requirement for fat from whole oats will not
have a negative health effect, and will allow the CHD claim to retain
clarity when directing consumers to products consistent with a diet
that is low in saturated fat and cholesterol, and high in soluble
fiber.
    Relaxing the total fat requirement for fat from all fat sources in
whole oat products may weaken the CHD claim signal that products
bearing that claim in their labeling may reduce the risk of CHD. Under
this scenario, products carrying the CHD claim could contain up to 13 g
of fat per 55 g serving (i.e., the total fat disqualifying level for an
individual food). The total fat disqualifying level is the level of
total fat in a food above which the food will be disqualified from
making a health claim (Sec.  101.14(a)(4)). Unlike whole oat sources,
other products may have significantly more than the 3 g of fat per RACC
that is the current total fat allowance for products carrying the CHD
claim, and some may even approach the 13 g per RACC. Consumers using
these products could easily increase their fat intake to levels above
those recommended by the 2005 Dietary Guidelines for Americans (Ref.
3). Furthermore, under current regulation that only stipulates
disqualifying levels for saturated fat, cholesterol, and total fat,
some of the increased fat intake could include trans fat.
    The potential health benefits would therefore be lower and the
costs higher under this option than under the final rule.

C. The Final Rule

    This section details the costs and benefits of the final rule. The
baseline in this case is the current rule, option one listed above, so
the benefits of the final rule are derived from an increase in the
number of products consumers have to choose from that carry the CHD
claim. The costs of the final rule are the health effects associated
with the potential net increase in fat intake and the new labeling
costs if a manufacturer decides to voluntarily use the health claim.\2\
---------------------------------------------------------------------------

    \2\ As discussed in detail in section C.3 of this regulatory
impact analysis, a firm will not choose to label its product with
the CHD claim if the firm can not make up the cost in higher margins
for its product, increased volume of sales, or a combination of the
two. Further, consumers will not pay the higher margin, or CHD claim
premium, if they do not value the product relatively more than other
products not carrying the claim. This increase in consumer
willingness to pay for the CHD claim, though not to be confused with
health benefits, will offset the private cost of the new labels.
---------------------------------------------------------------------------

1. Coverage of the rule
    Because much of the information required to assess whether a
product will qualify for the CHD claim is not required on the Nutrition
Facts label, FDA does not know with certainty how many products
currently marketed will be affected by the final rule.\3\ Furthermore,
FDA cannot predict how many new products will be introduced because of
the final rule.
---------------------------------------------------------------------------

    \3\ For example, the source of the fat content is not required
on the Nutrition Facts label.
---------------------------------------------------------------------------

    In estimating the baseline number of products, FDA identified five
products in the 2001 Food Label and Package Survey (FLAPS) (Ref. 4)
that use the fiber related CHD claim. Of these products, three are hot
cereals, one is a cold cereal, and one is wheat germ. Wheat germ
products will not be affected by the final rule. Other types of
products containing whole oats, such as cereal and snack bars, muffins,
and cookies, will also not likely be affected by the final rule, as
these products typically contain fat from sources other than whole oat
sources, and would not be eligible to carry the CHD claim.
    FLAPS is only a sample of all of the products available on the
market. The five hot cereal products sampled made up 90 percent of all
hot cereal sales in 2001. Therefore, it is possible that one or two
products on the market that carry the CHD claim in 2001 were missed by
the survey. The 6 cold cereals sampled made up only 18 percent of all
cold cereal sales in 2001. Assuming the sample is representative
implies that six or more products carrying the CHD claim were not
included in the survey. Since 2001, new products carrying the claim may
have entered the market and some products may have dropped out.
    Through a search of the web and local grocery stores, FDA
identified a single ``lower sugar`` hot cereal product that does not
currently qualify for the CHD claim, but might under the final rule.
The company that produces this product also produces two other ``lower
sugar`` hot cereal products that qualify for the claim under the
current rule. Beyond this single product, it is difficult to accurately
predict how many products will be developed that would qualify for the
claim under the final rule. Other ``lower sugar'' flavors might be
developed. Furthermore, ``no sugar added'' products could be developed
that could qualify for the CHD claim. Based on the current, limited
information, FDA estimates that between one and ten current and future
products will be affected by this final rule.
2. Benefits
    The principal benefits of the final rule are derived from an
increase in the number of products consumers have to choose from that
carry the CHD claim. Society benefits from the increased number of CHD
claim products in two ways: (1) Increased consumer information and (2)
a potential health benefit.
    a. Increased consumer information. Consumers place a premium on
products bearing a reduced CHD risk claim. That is, they value these
products more than similar products not carrying the CHD claim. Part of
this premium is due to a perceived health benefit. Part of it is also
due to the fact that the CHD claim on the label, if consistent,\4\ This
is where you want the beginning of your text to appear instantly gives
the consumer a lot of information about the product and therefore
reduces search costs. The final rule, for example, will greatly
increase the efficiency of a consumer's search for a product that is
lower in sugar and also has all the qualities of a product carrying the
CHD claim.
---------------------------------------------------------------------------

    \4\ In section B.2 of this regulatory impact analysis, we assert
that the relaxation of the total fat requirement for products made
primarily of whole oats does not decrease the consistency or
strength of the signal given by the CHD claim.
---------------------------------------------------------------------------

    b. Potential health benefit. If consumers substitute the new CHD
claim products for less healthy alternatives, the final rule will have
a positive health effect. If a consumer is currently eating a product
daily that is ``lower in sugar'' but happens to be relatively high in
saturated fat and cholesterol, that consumer could potentially enjoy
better health by switching to the new ``lower in sugar'' product that
also carries the CHD claim. For example, some evidence suggests that
the risk of CHD may be decreased by more than 2 percent for every 1 g
of

oat bran consumed daily (Ref. 5). Without data allowing a prediction of
consumer response, FDA cannot quantify this effect. Because the number
of new products is likely to be small and the total dietary intake of
consumers across the population is not likely to change drastically due
to substitution between breakfast cereals, the health benefit is
expected to be small.
3. Costs
    The principal costs of the final rule are the new labeling costs if
a manufacturer decides to voluntarily use the health claim, and the
possible negative health effect due to a potential increase in fat
intake.
    a. Labeling costs. Although voluntary labeling costs are
necessarily less than the consumer premium placed on the products, it
is useful to estimate the costs. Doing so gives a better idea of the
costs generated and provides a lower bound to the total consumer
utility gained from such products.
    FDA used the 2004 Labeling Cost Model (Ref. 6) to calculate the
potential new labeling costs produced by the final rule. The model
calculates the cost of a new label based on the product type, label
type, type of analytical and market tests necessary to develop the new
label, compliance time, and inflation. Since the label is voluntary,
firms can choose when to add the CHD label to their packaging and
therefore can control the cost of the new label. If the firm chooses to
immediately add the new label to the packaging, the full cost of
redoing the label can be attributed to the CHD claim. Costs in this
case will fall between $4,900 and $10,600 (mean = $6,800) per unique
product. Firms typically update their label about every 3 years. If
firms add the CHD claim when they would normally update their label,
the cost of adding the new information on the package approaches zero.
    New products that are developed because of the final rule will not
incur new labeling costs due to the CHD claim label. They will simply
work the claim into their initial label development. Since FDA only
identified one current existing product that may qualify for the CHD
claim because of the relaxation of the total fat requirement in the
final rule, the one time new labeling costs are estimated to be between
zero and $10,600.
    b. Potential increase in fat intake. One other potential cost
arises if total fat intake increases as a result of this claim. Total
fat intake could either increase or decrease due to the final rule.
Under the final rule, products carrying the CHD claim will on average
contain more total fat than under the current rule. If there is no
substitution between CHD claim products and other products, then the
total intake of mostly polyunsaturated and monounsaturated fats would
increase slightly in the population currently consuming CHD claim
products. There is no evidence that a small increase in unsaturated
fatty acids due to increased consumption of whole oat sources, even for
a person eating multiple servings daily, would cause a negative health
effect. In fact, a person with such a diet would still easily fall
within the recommended fat intake (Ref. 3). If there is substitution
between other products and CHD claims products (for example, between
CHD claims cereal and other cereals that are higher in fat), it is
possible that new CHD claims products might actually cause a decrease
in total fat consumption.
    Due to the small number of products likely to make the CHD claim in
the future, the health effect is likely to be small, but because some
substitution from higher fat products is likely to occur, the health
effect of the final rule with respect to fat intake will probably be
positive.
4. Summary of Benefits and Costs
    Benefits and costs of the final rule are likely to be small because
few products will be affected. Voluntary labeling costs for those
manufacturers who choose to use the health claim are small (less than a
one-time cost of $11,000) and necessarily less than the consumer
premium placed on the products. Furthermore, it is likely that, with
more product choices available bearing the CHD claim, there will be a
net shift towards these products carrying the claim and away from other
products. Although the size of this shift cannot be estimated with
available data, it would result in a public health benefit.

III. Environmental Impact

    FDA has determined under 21 CFR 25.32(p) that this action is of the
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    FDA concludes that labeling provisions of this rule are not subject
to review by the Office of Management and Budget because they do not
constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food labeling
health claim on beta-glucan soluble fiber and CHD risk is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public.'' (see 5
CFR 1320.3(c)(2)).

V. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive Order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act provides
that: ``* * * no State or political subdivision of a State may directly
or indirectly establish under any authority or continue in effect as to
any food in interstate commerce-- * * * (5) any requirement respecting
any claim of the type described in section 403(r)(1) made in the label
or labeling of food that is not identical to the requirement of section
403(r). * * *''
    This final rule amends existing food labeling regulations to
provide an exemption for certain foods from the nutrient content
requirement of ``low fat.'' Although this rule has a preemptive effect,
in that it would preclude States from issuing any health claim labeling
requirements for soluble fiber from certain foods and a reduced risk of
CHD that are not identical to those required by this final rule, this
preemptive effect is consistent with what Congress set forth in section
403A of the act. Section 403A(a)(5) of the act displaces both state
legislative requirements and state common law duties. (Riegel v.
Medtronic, 128 S. Ct. 999 (2008)).
    FDA believes that the preemptive effect of this final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
Order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' On
February 5, 2007, FDA's Division of Federal and State Relations
provided notice by fax and e-mail transmission to State health
commissioners, State agriculture commissioners, food program directors,
and drug program directors as well as

FDA field personnel, of FDA's publication of the proposed amendment to
the health claim regulation authorizing the health claim for soluble
fiber from certain foods and CHD (Sec.  101.81).
    In addition, the agency sought input from all stakeholders through
publication of the proposed rule (72 FR 5367). FDA received no comments
from any states on the proposed rulemaking.
    In conclusion, the agency believes that it has complied with all of
the applicable requirements under the Executive Order and has
determined that the preemptive effects of this final rule are
consistent with Executive Order 13132.

VI. References

    The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852 and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday. (FDA has verified all Web site addresses,
but FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
    1. U.S. Department of Agriculture, Agricultural Research
Service. 2007. USDA National Nutrient Database for Standard
Reference, Release 20. Nutrient Data Laboratory Home Page, http://
www.ars.usda.gov/ba/bhnrc/ndl.
     2. The Quaker Oats Co. and Rhodia, Inc., ``Oatrim [Beta
Trim\TM\] Health Petition,'' HCN1, vol. 1, Docket No. 01A-0313,
April 12, 2001.
    3. U.S. Department of Health and Human Services and U.S.
Department of Agriculture, Dietary Guidelines for Americans, 2005,
6\th\ Edition, Washington, DC: U.S. Government Printing Office,
(http://www.health.gov/dietaryguidelines/dga2005/document/), January
2005.
    4. U.S. Food and Drug Administration, CFSAN/Office of
Nutritional Products, Labeling, and Dietary Supplements, Food Label
and Package Survey 2000-2001, (http://www.cfsan.fda.gov/~dms/lab-
flap.html), May 2006.
    5. Institute of Medicine of the National Academies, Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids, the National Academies Press,
Washington, DC, 2005, pp. 367-368.
    6. RTI International, FDA Labeling Cost Model, Final Report,
(http://www.foodrisk.org/exclusives/FDA--LCM/), October 2004.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.81 is amended by revising paragraph (c)(2)(iii)(C) and
by adding new paragraph (c)(2)(iii)(D) to read as follows:

Sec.  101.81  Health claims: Soluble fiber from certain foods and risk
of coronary heart disease (CHD).

* * * * *
    (c) * * *
    (2) * * *
    (iii) * * *
    (C) The food shall meet the nutrient content requirement in Sec.
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (D) The food shall meet the nutrient content requirement in Sec.
101.62(b)(2) for a ``low fat'' food, unless the food exceeds this
requirement due to fat content derived from whole oat sources listed in
paragraph (c)(2)(ii)(A) of this section.
* * * * *

    Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9590 Filed 4-30-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Proposed Rules]
[Pages 66366-66368]
[FR Doc No: 2019-26146]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2019-0636: FRL-10002-84-Region 10]

Air Plan Approval; WA; Updates to Source-Category Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Washington State Implementation Plan (SIP)
that were submitted by the Department of Ecology (Ecology). In 1991,
Ecology established source-category regulations for kraft pulp mills,
sulfite pulping mills, and primary aluminum plants. These source-
category regulations contain requirements specific to these types of
facilities. However, the source-category regulations also rely upon
cross-references to the general air quality regulations to implement
program

elements such as new source review permitting. Since 1991, many of the
cross-references to the general regulations for air pollution sources
have changed. In this action, the EPA is proposing to revise the SIP to
update the cross-references and other miscellaneous changes.

DATES: Written comments must be received on or before January 3, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2019-0636 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The 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. The 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://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, EPA Region 10, 1200 Sixth
Avenue--Suite 155, Seattle, WA 98101, at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

I. Background

    In 1991, Washington established rules for kraft pulp mills, sulfite
pulp mills, and primary aluminum plants and submitted the rules to the
EPA for approval into the Washington SIP. The EPA approved Chapters
173-405 Kraft Pulping Mills, 173-410 Sulfite Pulping Mills, and 173-415
Primary Aluminum Plants Washington Administrative Code (WAC) on January
15, 1993 (58 FR 4578). These regulations established source-category
specific requirements with cross-references to Chapter 173-400 WAC
General Regulations for Air Pollution Sources to meet general
requirements. Since the EPA's last approval in 1993, many of the cross-
references contained in Chapters 173-405, 173-410, and 173-415 WAC have
changed. On November 5, 2019, Ecology submitted updated portions of
Chapters 173-405, 173-410, and 173-415 WAC for approval into the SIP.

II. Analysis of Rule Updates

    Washington's SIP submission consists primarily of minor changes to
the rules, with a few more substantive changes described below. The
relatively minor changes to Chapters 173-405, 173-410, and 173-415 WAC
include updating cross-references to the requirements in Chapter 173-
400 WAC and making clarifying changes to definitions and supporting
rule language. Redline/strikeout analyses of Ecology's 2019 rule
revisions proposed for approval are included in the docket for this
action. The more significant changes include revising WAC 173-405-072
Monitoring Requirements and 173-410-062 Monitoring Requirements to
extend the timeframe for submission of source testing reports from
fifteen days to sixty days for kraft and sulfite pulping mills.
Ecology's SIP submission explains that the change was made to provide a
more realistic timeframe to complete and submit a quality-assured
performance test report. The sixty-day timeframe is the same as the
federal performance report submission timeline established for the pulp
and paper industry in 40 CFR part 63, subpart S. See 40 CFR.
63.455(h)(2). Similarly, Ecology revised WAC 173-415-060 Monitoring
Requirements to extend the time allowed for submission of source
testing reports from thirty to sixty days for primary aluminum plants.
This sixty-day timeframe is the same as the federal performance report
submission timeline for primary aluminum plants in 40 CFR pat 63,
subpart LL. See 40 CFR 63.850(b) for primary aluminum plants.
    In addition to the 2019 regulatory changes described above,
effective September 23, 2005, Ecology revised Chapter 173-415 WAC,
which was not submitted for SIP revision at that time. Specifically,
Ecology revised WAC 173-415-020 Definitions and WAC 173-415-060
Monitoring and Reporting to better align with the federal definitions
and requirements in 40 CFR part 63, subpart LL. Ecology also added WAC
173-415-015 Applicability that clarified the general provisions of
Chapter 173-400 WAC apply to all emission sources, including all
primary aluminum reduction plants. This revision allowed Ecology to
repeal the redundant provisions of WAC 173-415-045 Creditable Stack
Height & Dispersion Techniques, WAC 173-415-050 New Source Review
(NSR), 173-415-051 Prevention of Significant Deterioration (PSD), and
173-415-080 Emission Inventory, which cited to older, subsequently
revised provisions of Chapter 173-400 WAC. A copy of the 2005 changes
(WSR 05-17-169) is included in the docket for this action. We are
proposing to approve these changes. We also note, as described below,
that Ecology's 2005 revisions related to the regulation of fluorides
are outside the scope of Clean Air Act (CAA) section 110 requirements
for SIPs.
    Consistent with our January 15, 1993 approval, Ecology did not
submit requirements related to total reduced sulfur, fluorides, or
cross-references to toxic air pollutants regulated under Chapter 173-
460 WAC, because they are outside the scope of CAA section 110
requirements for SIPs. Similarly, Chapters 173-405, 173-410, and 173-
415 WAC cross-reference Chapter 173-400 WAC; however, not all
provisions of Chapter 173-400 WAC are contained in the SIP.\1\ Lastly,
Ecology did not submit all revisions to Chapters 173-405, 173-410, and
173-415 WAC as part of the current SIP update. Please see Appendix A of
Ecology's November 5, 2019, SIP revision request for a full listing of
updates submitted for approval.
---------------------------------------------------------------------------

    \1\ See 40 CFR 52.2470(c), Table 2--Additional Regulations
Approved for Washington Department of Ecology (Ecology) Direct
Jurisdiction.
---------------------------------------------------------------------------

III. Proposed Action

    We are proposing to approve and incorporate by reference the
revisions to the Washington SIP shown in the table below. We are also
proposing to remove from the SIP the outdated and subsequent repealed
provisions of WAC 173-415-045, 173-415-050, 173-415-051, and 173-415-
080.

------------------------------------------------------------------------
                                          State
   State citation      Title/subject    effective       Explanations
                                           date
------------------------------------------------------------------------
  Washington Administrative Code, Chapter 173-405--Kraft Pulping Mills
------------------------------------------------------------------------
173-405-021.........  Definitions....      5/24/19  ....................
173-405-072.........  Monitoring           5/24/19  Except 173-405-
                       Requirements.                 072(2).
173-405-086.........  New Source           5/24/19  Except provisions
                       Review (NSR).                 related to WAC 173-
                                                     400-114 and
                                                     provisions excluded
                                                     from our approval
                                                     of WAC 173-400-110
                                                     through 173-400-
                                                     113.
173-405-087.........  Prevention of        5/24/19  Except 173-400-
                       Significant                   720(4)(a)(i through
                       Deterioration                 iv), 173-400-
                       (PSD).                        720(4)(b)(iii)(C),
                                                     and 173-400-750(2)
                                                     second sentence.
------------------------------------------------------------------------
 Washington Administrative Code, Chapter 173-410--Sulfite Pulping Mills
------------------------------------------------------------------------
173-410-021.........  Definitions....      5/24/19  ....................
173-410-062.........  Monitoring           5/24/19  ....................
                       Requirements.
173-410-086.........  New Source           5/24/19  Except provisions
                       Review (NSR).                 related to WAC 173-
                                                     400-114 and
                                                     provisions excluded
                                                     from our approval
                                                     of WAC 173-400-110
                                                     through 173-400-
                                                     113.
173-410-087.........  Prevention of        5/24/19  Except 173-400-
                       Significant                   720(4)(a)(i through
                       Deterioration                 iv), 173-400-
                       (PSD).                        720(4)(b)(iii)(C),
                                                     and 173-400-750(2)
                                                     second sentence.
------------------------------------------------------------------------
Washington Administrative Code, Chapter 173-415--Primary Aluminum Plants
------------------------------------------------------------------------
173-415-015.........  Applicability..      5/24/19  Except 173-415-
                                                     015(3).
173-415-020.........  Definitions....      5/24/19  Except 173-415-
                                                     020(6).
173-415-060.........  Monitoring and       5/24/19  Except 173-415-
                       Reporting.                    060(1)(b).
------------------------------------------------------------------------

IV. Incorporation by Reference

    In this rule, the EPA is proposing to include, in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the regulatory changes described in section III above. The
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov.

V. Statutory and Executive Orders Review

    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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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 this action does not involve technical standards; and
     Does not provide the 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).
    The SIP is not approved to apply on any Indian reservation land in
Washington except as specifically noted below and is also not approved
to apply in any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Washington's SIP is approved to apply on non-trust land within the
exterior boundaries of the Puyallup Indian Reservation, also known as
the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement
Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and
local agencies in Washington authority over activities on non-trust
lands within the 1873 Survey Area. Consistent with EPA policy, the EPA
provided a consultation opportunity to the Puyallup Tribe in a letter
dated May 16, 2019.

List of Subjects in 40 CFR Part 52

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

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

    Dated: November 22, 2019.
Chris Hladick,
Regional Administrator, Region 10.
[FR Doc. 2019-26146 Filed 12-3-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Page 57741]
[FR Doc No: 2022-20375]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95789; File No. SR-MRX-2022-09]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of
Withdrawal of Proposed Rule Change To Amend Options 7, Section 6 to Add
Port Fees

September 15, 2022.
    On July 1, 2022, Nasdaq MRX, LLC (``MRX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to assess port fees. The
proposed rule change was published for comment in the Federal Register
on July 18, 2022.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 95262 (July 12,
2022), 87 FR 42780.
---------------------------------------------------------------------------

    On August 25, 2022, MRX withdrew the proposed rule change (SR-MRX-
2022-09).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-20375 Filed 9-20-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Page 1960]
[FR Doc No: 2021-00249]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0619; FRL-10016-62-OMS]

Agency Information Collection Activities; Renewal Request
Submitted to OMB for Review and Approval; Comment Request; Pesticide
Program Public Sector Collections (FIFRA Sections 18 & 24(c)) (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted the
following information collection request (ICR), Pesticide Program
Public Sector Collections (FIFRA Sections 18 & 24(c)) (EPA ICR Number
2311.04 and OMB Control Number 2070-0182), to the Office of Management
and Budget (OMB) for review and approval in accordance with the
Paperwork Reduction Act. This is a proposed extension of ICR, which is
currently approved through February 28, 2021. Public comments were
previously requested via the Federal Register on August 17, 2020 during
a 60-day comment period. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be received on or before February 10, 2021.

ADDRESSES: Submit your comments to EPA, referencing docket
identification (ID) number EPA- HQ-OPP-2017-0619, online using http://www.regulations.gov.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Mission Support Division
(7101M), Office of Program Support, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 347-0159; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave., NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This ICR covers the paperwork burden under the PRA that
is associated with two types of pesticide registration requests made by
States, U.S. Territories, or Federal agencies. Specifically, this ICR
covers emergency exemption requests, which allow for an unregistered
use of a pesticide, and State registrations of a pesticide use to meet
a special local need (SLN). FIFRA section 18 authorizes EPA to grant
emergency exemptions to States, U.S. Territories, and Federal agencies
to allow an unregistered use of a pesticide for a limited time if EPA
determines that emergency conditions exist. FIFRA Section 18 requests
include unregistered pesticide use exemptions for specific
agricultural, public health, quarantine and crisis purposes. FIFRA
Section 24(c) authorizes any particular State to register additional
uses of a federally registered pesticide for distribution and use
within that state to meet a SLN.
    Form Numbers: 8570-25 & 8570-4.
    Respondents/Affected Entities: States and Federal government
agencies and pesticide, fertilizer, and other agricultural chemical
manufacturing.
    Respondent's obligation to respond: Mandatory under FIFRA Sections
3 and 11.
    Frequency of response: On Occasion.
    Estimated total number of potential respondents: 283.
    Estimated total burden: 25,753 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Estimated total costs: $ 1,829,103 (per year), includes no
annualized capital investment or maintenance and operational costs.
    Changes in the estimates: There is no change in the number of hours
in the total estimated respondent burden compared with that identified
in the ICR currently approved by OMB.

    Dated: December 11, 2020.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-00249 Filed 1-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 3, 2007 (Volume 72, Number 63)]
[Notices]
[Page 15879-15880]
[DOCID:fr03ap07-55]

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ENVIRONMENTAL PROTECTION AGENCY

[OH-165-1; FRL-8294-7]

Adequacy Status of the Parkersburg, Steubenville-Weirton, Lima,
Wheeling, and Canton, OH, Submitted 8-Hour Ozone Redesignation and
Maintenance Plans for Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this action, EPA is notifying the public that EPA has found
that the motor vehicle emissions budgets (MVEBs) for 8-hour ozone for
five areas in the State of Ohio, submitted as part of the redesignation
and maintenance plans for these areas, are adequate for conformity
purposes. As a result of our finding, the Parkersburg (Washington
County), Steubenville-Weirton (Jefferson County), Lima (Allen County),
Wheeling (Belmont County), and Canton (Stark County) areas must use the
MVEBs from the submitted 8-hour ozone redesignation and maintenance
plans for future conformity determinations.

DATES: This finding is effective April 18, 2007.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Life Scientist,
Criteria Pollutant Section (AR-18J), Air Programs Branch, Air and
Radiation Division, United States Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312)
353-8777<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we'',
``us'' or ``our'' is used, we mean EPA.

Background

    Today's action is simply an announcement of findings that we have
already made. On December 28, 2006,

EPA Region 5 sent a letter to the Ohio Environmental Protection Agency
(OEPA) stating that the 2009 and 2018 MVEBs in the Steubenville-Weirton
area are adequate. EPA Region 5 sent letters to OEPA on January 22,
2007, stating that the 2009 and 2018 MVEBs in the Parkersburg, Lima,
Wheeling, and Canton areas are adequate. Ohio submitted the budgets as
part of the 8-hour ozone redesignation requests and maintenance plans
for these areas. The submittals were announced on EPA's conformity
website, and received no comments: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm
, (once there, click on ``What SIP

submissions are currently under EPA adequacy review?'').
    The 2009 and 2018 MVEBs, in tons per day, for volatile organic
compounds (VOC) for these areas are as follows:

------------------------------------------------------------------------
                         Area                             2009     2018
------------------------------------------------------------------------
Parkersburg...........................................     2.59     1.67
Steubenville-Weirton..................................     2.63     1.37
Lima..................................................     5.08     2.89
Wheeling..............................................     2.60     1.52
Canton................................................    10.02     5.37
------------------------------------------------------------------------

    The 2009 and 2018 MVEBs, in tons per day, for oxides of nitrogen
(NOX) for these areas are as follows:

------------------------------------------------------------------------
                         Area                             2009     2018
------------------------------------------------------------------------
Parkersburg...........................................     3.58     1.76
Steubenville-Weirton..................................     4.10     1.67
Lima..................................................     8.28     3.47
Wheeling..............................................     4.69     1.91
Canton................................................    18.03     7.08
------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule requires that transportation
plans, programs, and projects conform to state air quality
implementation plans and establishes the criteria and procedures for
determining whether or not they do. Conformity to a State
Implementation Plan (SIP) means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the national ambient air quality standards.
    The criteria by which we determine whether a SIP's motor vehicle
emission budgets are adequate for conformity purposes are outlined in
40 CFR 93.118(e)(4). We have described our process for determining the
adequacy of submitted SIP budgets in our July 1, 2004, preamble
starting at 69 FR 40038, and we used the information in these resources
while making our adequacy determination. Please note that an adequacy
review is separate from EPA's completeness review, and it also should
not be used to prejudge EPA's ultimate approval of the SIP. Even if we
find a budget adequate, the SIP could later be disapproved.
    The finding and the response to comments are available at EPA's
conformity Web site: heep://http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm
.

    Authority: 42 U.S.C. 7401-7671 q.

    Dated: March 21, 2007.
Gary Gulezian,
Acting Regional Administrator, Region 5.
 [FR Doc. E7-6150 Filed 4-2-07; 8:45 am]

BILLING CODE 6560-50-P