[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47177-47178]
[FR Doc No: 2018-20214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-7022]

Post-Marketing Pediatric-Focused Product Safety Reviews;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) has established a
public docket to collect comments related to the post-marketing,
pediatric-focused safety reviews of products posted between April 2,
2018, and September 14, 2018, on FDA's website but not presented at the
September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These
reviews are intended to be available for review and comment by members
of the PAC, interested parties (such as academic researchers, regulated
industries, consortia, and patient groups), and the general public.

DATES: Submit either electronic or written comments by September 28,
2018.

ADDRESSES: FDA has established a docket for public comment on this
document. The docket number is FDA-2017-N-7022. The docket will close
on September 28, 2018. Submit either electronic or written comments by
that date. Please note that late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before
September 28, 2018. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
September 28, 2018. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-7022 for ``Post-Marketing Pediatric-Focused Product Safety
Reviews; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9

a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenneth Quinto, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5145, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA also has
responsibility for regulating the manufacturing, marketing, and
distribution of tobacco products to protect the public health and to
reduce tobacco use by minors.
    FDA has established a public docket, Docket No. FDA-2017-N-7022, to
receive input on post-marketing pediatric-focused safety reviews of
products posted between April 2, 2018, and September 14, 2018,
available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but
not presented at the September 20, 2018, PAC meeting. FDA welcomes
comments by members of the PAC, as mandated by the Best Pharmaceuticals
for Children Act (Pub. L. 107-109) and the Pediatric Research Equity
Act of 2003 (Pub. L. 108-155), interested parties (such as academic
researchers, regulated industries, consortia, and patient groups), and
the general public. The docket number is FDA-2017-N-7022. The docket
will open for comments on September 17, 2018, and remain open until
September 28, 2018. The post-marketing pediatric-focused safety reviews
are for the following products from the following centers at FDA:

Center for Biologics Evaluation and Research

1. BEXSERO (Meningococcal Group B Vaccine)
2. QUADRACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis
Adsorbed and Inactivated Poliovirus Vaccine)

Center for Drug Evaluation and Research

1. ADZENYS XR-ODT (amphetamine tablet) and DYANAVEL XR (amphetamine
suspension)
2. ANTHIM (obiltoxaximab)
3. APTENSIO XR (methylphenidate hydrochloride) and QUILLICHEW ER
(methylphenidate hydrochloride)
4. BANZEL (rufinamide)
5. CINQAIR (reslizumab)
6. CUTIVATE (fluticasone propionate)
7. DESCOVY (emtricitabine and tenofovir alafenamide)
8. ENTOCORT EC (budesonide)
9. EPIVIR (lamivudine)
10. EPZICOM (abacavir sulfate and lamivudine) and ZIAGEN (abacavir
sulfate)
11. KALETRA (lopinavir and ritonavir)
12. KOVANAZE (tetracaine hydrochloride and oxymetazoline hydrochloride)
13. LAMICTAL (lamotrigine)
14. NATROBA (spinosad)
15. NOXAFIL (posaconazole)
16. ORALTAG (iohexol)
17. ORAVERSE (phentolamine mesylate)
18. OTOVEL (ciprofloxacin and fluocinolone acetonide)
19. PANCREAZE (pancrelipase) and PERTZYE (pancrelipase)
20. PRILOSEC (omeprazole)
21. PROAIR RESPICLICK (abuterol sulfate)
22. PROCYSBI (cysteamine bitartrate)
23. RENVELA (sevelamer carbonate)
24. SPIRIVA (tiotropium bromide)
25. TEFLARO (ceftaroline fosamil)
26. TETRACAINE HYDROCHLORIDE Ophthalmic Solution (tetracaine
hydrochloride)
27. XOPENEX (levalbuterol)
28. ZOMIG Nasal Spray (zolmitriptan)

Center for Devices and Radiological Health

1. CONTEGRA PULMONARY VALVED CONDUIT (Humanitarian Device Exemption
(HDE))
2. ELANA SURGICAL KIT (HDE)
3. ENTERRA THERAPY SYSTEM (HDE)
4. LIPOSORBER LA-15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
6. PLEXIMMUNE (HDE)
7. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20214 Filed 9-17-18; 8:45 a.m.]
BILLING CODE 4164-01-P


[Federal Register: January 19, 2007 (Volume 72, Number 12)]
[Notices]
[Page 2506-2507]
[DOCID:fr19ja07-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

January 11, 2007.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC06-140-000; EL06-86-000.
    Applicants: E.ON U.S. LLC.
    Description: E.ON US LLC's formal notice that seeks to join and be
included in the Spare Transformer Sharing Agreement.
    Filed Date: 12/21/2006.
    Accession Number: 20070109-0076.
    Comment Date: 5 p.m. Eastern Time on Thursday, January 11, 2007.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER98-2782-011.
    Applicants: AG-Energy, LP.
    Description: Power City Partners, LP notifies FERC of a change in
facts regarding its upstream ownership.
    Filed Date: 01/09/2007.
    Accession Number: 20070110-0140.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 30, 2007.

    Docket Numbers: ER99-1435-013.
    Applicants: Avista Corporation.
    Description: Avista Corp submits its report on activities in the
ancillary services markets conducted pursuant to FERC Electric Tariff,
Volume No. 9.
    Filed Date: 01/09/2007.
    Accession Number: 20070110-0142.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 30, 2007.

    Docket Numbers: ER06-120-002.
    Applicants: Duke Power Company LLC.
    Description: Duke Energy Carolinas, LLC submits Explanatory
Statement in support of Offer of Settlement re Duke Energy Corporation.
    Filed Date: 01/08/2007.
    Accession Number: 20070109-0079.
    Comment Date: 5 p.m. Eastern Time on Monday, January 29, 2007.

    Docket Numbers: ER07-109-003.
    Applicants: BTEC Southaven LLC.
    Description: BTEC Southaven, LLC submits its Third Substitute
Original Sheet No. 2 to its FERC Electric Tariff.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0377.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-148-002.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas and Electric Co submits an errata to the
12/19/06 submittal of the revised Service Agreement 18 to FERC Electric
Tariff, Second Revised Volume No. 11 correcting typographic errors.
    Filed Date: 01/08/2007.
    Accession Number: 20070109-0078.
    Comment Date: 5 p.m. Eastern Time on Monday, January 29, 2007.

    Docket Numbers: ER07-174-003.
    Applicants: Osceola Windpower, LLC.
    Description: Osceola Windpower, LLC submits an amendment to its
market-based rate tariff to remove the duplicative provision on the
reassignment of transmission capacity inadvertently included in the 12/
8/06 filing.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0255.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-410-001.
    Applicants: Oklahoma Gas and Electric Company.
    Description: Oklahoma Gas and Electric Company submits a cover
sheet canceling Rate Schedule FERC No. 147.
    Filed Date: 01/09/2007.
    Accession Number: 20070110-0141.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 30, 2007.

    Docket Numbers: ER07-412-000.
    Applicants: ECP Energy I, LLC.
    Description: ECP Energy I, LLC submits an application for Order

accepting Initial Tariff, Waiving Regulations and Granting Blanket
Approvals.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0252.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-413-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Second Revised Sheet No. 6
to FERC Electric Tariff, Original Volume No. 6, to be effective 1/2/07.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0253.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-414-000.
    Applicants: Caledonia Power I, L.L.C.
    Description: Caledonia Power I, LLC submits notice of cancellation
of its market-based rate tariff, FERC Electric Tariff, First Revised
Volume No. 1.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0258.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-415-000.
    Applicants: DTE Pontiac North, LLC.
    Description: DTE Pontiac North, LLC submits an application for
order authorizing Market-Based Rates, Certain Waivers and Blanket
Authorizations.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0254.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-416-000.
    Applicants: Geneva Roth Holding, LLC.
    Description: Geneva Roth Holding, LLC submits its FERC Electric
Tariff, Original Volume No. 1.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0376.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.

    Docket Numbers: ER07-417-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc submits
supplements to FERC Rate Schedule filing of Jurisdictional Agreements
Part 1 of 4.
    Filed Date: 01/08/2007.
    Accession Number: 20070109-0135.
    Comment Date: 5 p.m. Eastern Time on Monday, January 29, 2007.

    Docket Numbers: ER07-418-000.
    Applicants: Western Systems Power Pool, Inc.
    Description: Western Systems Power Pool, Inc submits its request to
amend the WSPP Agreement to include Alcoa Power Marketing, LLC et al as
members.
    Filed Date: 01/08/2007.
    Accession Number: 20070109-0098.
    Comment Date: 5 p.m. Eastern Time on Monday, January 29, 2007.

    Docket Numbers: ER07-419-000.
    Applicants: PPL Electric Utilities Corporation.
    Description: Metropolitan Edison Co submits a revised
Interconnection Agreement with PPL Electric Utilities Corp.
    Filed Date: 01/08/2007.
    Accession Number: 20070109-0099.
    Comment Date: 5 p.m. Eastern Time on Monday, January 29, 2007.

    Docket Numbers: ER07-420-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corporation as agent
for Kentucky Power Co submits an interconnection agreement with East
Kentucky Power Cooperative.
    Filed Date: 01/09/2007.
    Accession Number: 20070110-0143.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 30, 2007.

    Docket Numbers: ER07-421-000.
    Applicants: Wisconsin Power and Light Company.
    Description: Wisconsin Power and Light Co submits the First Revised
Power Supply Agreement with Wisconsin Public Power Inc.
    Filed Date: 01/05/2007.
    Accession Number: 20070108-0256.
    Comment Date: 5 p.m. Eastern Time on Friday, January 26, 2007.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern Time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-667 Filed 1-18-07; 8:45 am]

BILLING CODE 6717-01-P


From: Bean, Greg<EMAIL_ADDRESS> Sent: Friday, May 04, 2012 5:05 PM

To<EMAIL_ADDRESS> Cc: PPSURVEY<EMAIL_ADDRESS><EMAIL_ADDRESS>Woock, Steve; Crapo, Ann; Wood, Brian; Wood, Mike; Johnson, Ken; Haynes, Tim

Subject: Attention Docket ID No. EPA-HQ-OAR 2007 0544

The attached files are being submitted for corrections to Subpart S data & Facility-Wide Risk Modeling Results for  Weyerhaeuser NR Company, Longview, WA.

An explanation of the corrections is included in the attached cover letter (scanned pdf copy of the signed letter, plus a clean pdf copy without the signature).  Two NCASI guidance documents are also included for reference. The corrected data is in the attached Excel spreadsheet.

Gregory R. Bean

Sr. Environmental Engineer

Weyerhaeuser NR Company

<EMAIL_ADDRESS> (360)578-4445


[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Proposed Rules]
[Pages 79338-79340]
[FR Doc No: 2013-31188]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-1067; Directorate Identifier 2013-NM-164-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. 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
certain Bombardier, Inc. Model DHC-8-400 series airplanes. This
proposed AD was prompted by reports of missing clamps that are required
to provide positive separation between the alternating current (AC)
feeder cables and the hydraulic line of the landing gear alternate
extension. This proposed AD would require inspecting for missing
clamps, and related investigative and corrective actions if necessary.
We are proposing this AD to detect and correct chafing of the AC feeder
cable. A chafed and arcing AC feeder cable could puncture the adjacent
hydraulic line, which, in combination with the use of the alternate
extension system, could result in an in-flight fire.

DATES: We must receive comments on this proposed AD by February 13,
2014.

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
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this 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 Management Facility
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: Assata Dessaline, Aerospace Engineer,
Avionics and Service Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; 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-2013-1067; Directorate Identifier 2013-NM-164-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2013-16, dated June 14, 2013 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for the specified products. The MCAI states:

    During production checks, it was found that the appropriate
clamps required to provide positive separation between the AC feeder
cables and the hydraulic line of the landing gear alternate
extension were omitted. The AC feeder cable could sag and be in
direct contact with the swage fitting of the landing gear alternate
extension hydraulic line, resulting in chafing of the AC feeder
cable. The chafed and arcing AC feeder cable could puncture the
adjacent hydraulic line. In combination with the use of the
alternate extension system, this could result in an in-flight fire.
    This [TCCA] AD mandates the [general visual] inspection [for
missing clamps], and rectification [related investigative and
corrective actions] as necessary, for proper clamp installation.

The related investigative action is a general visual inspection of the
AC power feeder cables and the hydraulic line for damage due to
chafing. The corrective actions include repair of chafed parts, and
replacement of missing clamps. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating it in Docket No. FAA-2013-1067.

Relevant Service Information

    Bombardier, Inc. has issued Bombardier Service Bulletin 84-24-53,
Revision A, dated May 16, 2013. 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.

Costs of Compliance

    We estimate that this proposed AD affects 78 airplanes of U.S.
registry.
    We also estimate that it would take about 2 work-hours 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 this proposed AD on U.S. operators to be $13,260, or $170
per product.
    In addition, we estimate that any necessary follow-on actions would
take about 2 work-hours and require parts costing $11, for a cost of
$181 per product. We have received no definitive data that would enable
us to provide cost estimates for the on-condition repair of the AC
power feeder cables and hydraulic lines specified in this proposed AD.
We have no way of determining the number of aircraft that might need
these actions.

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 proposed 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.

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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2013-1067; Directorate Identifier
2013-NM-164-AD.

(a) Comments Due Date

    We must receive comments by February 13, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -
402 airplanes, certificated in any category, serial numbers 4001
through 4347 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
power.

(e) Reason

    This AD was prompted by reports of missing clamps that are
required to provide positive separation between the alternating
current (AC) feeder cables and the hydraulic line of the landing
gear alternate extension.

We are issuing this AD to detect and correct chafing of the AC
feeder cable. A chafed and arcing AC feeder cable could puncture the
adjacent hydraulic line, which, in combination with the use of the
alternate extension system, could result in an in-flight fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Clamp Inspection, Related Investigative Actions, and Corrective
Actions

    Within 6,000 flight hours or 36 months after the effective date
of this AD, whichever occurs earlier: Do a general visual inspection
for installation of clamps between the AC feeder cables and
hydraulic line; and do all applicable related investigative and
corrective actions; in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 84-24-53, Revision A,
dated May 16, 2013. Do all applicable related investigative and
corrective actions before further flight.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 84-24-53, dated
May 11, 2012.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
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, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval). For a repair method to be approved,
the repair approval must specifically refer to this AD. You are
required to ensure the product is airworthy before it is returned to
service.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2013-16, dated June 14,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2013-1067.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may view this 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 December 20, 2013.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-31188 Filed 12-27-13; 8:45 am]
BILLING CODE 4910-13-P


Although listed in the index, some
information is not publicly available,
i.e., confidential business information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically at
www.regulations.gov
or in hard copy
during normal business hours at the Air
Protection Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. Copies of the State submittal are
available at the Virginia Department of
Environmental Quality, 629 East Main
Street, Richmond, Virginia, 23219.
FOR FURTHER INFORMATION CONTACT:
Marilyn Powers, (215) 814–2308 or by e-
<a<EMAIL_ADDRESS>at
<a href="http://mailto:powers.marilyn<EMAIL_ADDRESS>VerDate Aug<31>2005
23:53 Dec 27, 2007
Jkt 214001
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
E:\FR\FM\28DER1.SGM
28DER1


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Page 47222]
[FR Doc No: 2011-19763]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4007-DR; Docket ID FEMA-2011-0001]

Wyoming; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for State of Wyoming (FEMA-4007-DR), dated July 22, 2011, and related
determinations.

DATES: Effective Date: July 25, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Mark H. Landry,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of Mark H. Armstrong as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-19763 Filed 8-3-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]
[Page 54492]
[DOCID:fr08se10-5]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2010-N-0002]

Oral Dosage Form New Animal Drugs; Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Novartis Animal Health US, Inc. The
supplemental NADA provides for use of an increased strength of tiamulin
concentrate solution in the drinking water of swine for the treatment
of certain bacterial respiratory and enteric diseases.

DATES: This rule is effective September 8, 2010.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to
NADA 140-916 for DENAGARD (tiamulin) Liquid Concentrate administered in
drinking water for the treatment of certain bacterial respiratory and
enteric diseases in swine. The supplemental NADA provides for use of a
12.5 percent tiamulin concentrate solution. The supplemental NADA is
approved as of June 14, 2010, and 21 CFR 520.2455 is amended to reflect
the approval.
    Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33 that this action is of
a 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.2455, revise paragraphs (a) and (b) to read as follows:

Sec.  520.2455  Tiamulin.

    (a) Specifications. (1) Each gram of soluble powder contains 450
milligrams (mg) tiamulin hydrogen fumarate.
    (2) Each milliliter (mL) of solution contains 125 mg (12.5 percent)
tiamulin hydrogen fumarate.
    (3) Each mL of solution contains 123 mg (12.3 percent) tiamulin
hydrogen fumarate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this
chapter for use as in paragraph (d) of this section.
    (1) No. 058198 for products described in paragraphs (a)(1) and
(a)(2) of this section.
    (2) No. 059130 for products described in paragraphs (a)(1) and
(a)(3) of this section.
* * * * *

    Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22277 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 192 (Wednesday, October 5, 2022)]
[Notices]
[Pages 60430-60432]
[FR Doc No: 2022-21693]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Submission Deadline for Schedule Information for
Chicago O'Hare International Airport, John F. Kennedy International
Airport, Los Angeles International Airport, Newark Liberty
International Airport, and San Francisco International Airport for the
Summer 2023 Scheduling Season

AGENCY: Department of Transportation, Federal Aviation Administration
(FAA).

ACTION: Notice of submission deadline.

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

SUMMARY: Under this notice, the FAA announces the submission deadline
of October 6, 2022, for Summer 2023 flight schedules at Chicago O'Hare
International Airport (ORD), John F. Kennedy International Airport
(JFK), Los Angeles International Airport (LAX), Newark Liberty
International Airport (EWR), and San Francisco International Airport
(SFO).

DATES: Schedules should be submitted by October 6, 2022.

ADDRESSES: Schedules may be submitted to the Slot Administration Office
by email to: [email protected].

FOR FURTHER INFORMATION CONTACT: Al Meilus, Manager, Slot
Administration and Capacity Analysis, FAA ATO System Operations
Services, AJR-G, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION: This document provides routine notice to

carriers serving capacity-constrained airports in the United States,
including ORD, JFK, LAX, EWR, and SFO. In particular, this notice
announces the deadline for carriers to submit schedules for the Summer
2023 scheduling season. The FAA deadline coincides with the schedule
submission deadline established in the Calendar of Coordination
Activities as published by the International Air Transport Association
(IATA).\1\
---------------------------------------------------------------------------

    \1\ www.iata.org/contentassets/4ede2aabfcc14a55919e468054d714fe/calendar-coordination-activities.pdf.
---------------------------------------------------------------------------

General Information for All Airports

    The FAA has designated JFK as an IATA Level 3 airport consistent
with the Worldwide Slot Guidelines (WSG).\2\ The FAA currently limits
scheduled operations at JFK by order that expires on October 29,
2022.\3\ The FAA intends to extend the JFK Order as well as a similar
order that applies to LGA.\4\
---------------------------------------------------------------------------

    \2\ The FAA generally applies the WSG to the extent there is no
conflict with U.S. law or regulation. The FAA recognizes the WSG has
been replaced by the Worldwide Airports Slot Guidelines (WASG)
edition 1, effective June 1, 2020, and subsequently WASG edition 2,
effective July 1, 2022. The WASG is published jointly by Airports
Council International-World, IATA, and the Worldwide Airport
Coordinators Group (WWACG). While the FAA is considering whether to
implement certain changes to the Guidelines in the United States, it
will continue to apply WSG edition 9.
    \3\ Operating Limitations at John F. Kennedy International
Airport, 73 FR 3510 (Jan. 18, 2008), as most recently extended 85 FR
58258 (Sept. 18, 2020). The slot coordination parameters for JFK are
set forth in this Order.
    \4\ Operating Limitations at New York LaGuardia Airport, 71 FR
77854 (Dec. 27, 2006), as most recently extended 85 FR 38255, (Sep.
18, 2020). LGA is the equivalent of an IATA Level 3, coordinated
airport. Schedule submissions at LGA are not required for the Summer
2023 scheduling season as slots at LGA are allocated and managed by
the FAA under separate rules and processes.
---------------------------------------------------------------------------

    The FAA has designated EWR, LAX, ORD, and SFO as Level 2 airports
\5\ subject to a schedule review process premised upon voluntary
cooperation. The Summer 2023 scheduling season is from March 26, 2023,
through October 28, 2023, in recognition of the IATA summer scheduling
period.
---------------------------------------------------------------------------

    \5\ These designations remain effective until the FAA announces
a change in the Federal Register.
---------------------------------------------------------------------------

    The FAA is primarily concerned about scheduled and other regularly
conducted commercial operations during designated hours, but carriers
may submit schedule plans for the entire day. The designated hours for
the Summer 2023 scheduling season are: at EWR and JFK, from 0600 to
2300 Eastern Time (1000 to 0300 UTC); at LAX and SFO, from 0600 to 2300
Pacific Time (1300 to 0600 UTC); and at ORD, from 0600 to 2100 Central
Time (1100 to 0200 UTC). These hours are unchanged from previous
scheduling seasons.
    Carriers should submit schedule information in sufficient detail
including, at minimum, the marketing or operating carrier, flight
number, scheduled time of operation, frequency, aircraft equipment, and
effective dates. IATA standard schedule information format and data
elements for communications at Level 2 and Level 3 airports in the IATA
Standard Schedules Information Manual (SSIM) Chapter 6 may be used. The
WSG provides additional information on schedule submissions at Level 2
and Level 3 airports. Some carriers at JFK manage and track slots
through FAA-assigned Slot ID numbers corresponding to an arrival or
departure slot in a particular half-hour on a particular day of week
and date. The FAA has a similar voluntary process for tracking
schedules at EWR with Reference IDs, and certain carriers are managing
their schedules accordingly. The primary users of IDs are United States
and Canadian carriers that have the highest frequencies and
considerable schedule changes throughout the season and can benefit
from a simplified exchange of information not dependent on full flight
details. Carriers are encouraged to submit schedule requests at those
airports using Slot or Reference IDs.
    As stated in the WSG, schedule facilitation at a Level 2 airport is
based on the following: (1) schedule adjustments are mutually agreed
upon between the carriers and the facilitator; (2) the intent to avoid
exceeding the airport's coordination parameters; (3) the concepts of
historic precedence and series of slots do not apply at Level 2
airports (although WSG recommends giving priority to approved services
that plan to operate unchanged from the previous equivalent season at
Level 2 airports); and (4) the facilitator should adjust the smallest
number of flights by the least amount of time necessary to avoid
exceeding the airport's coordination parameters. Consistent with the
WSG, the success of Level 2 in the United States depends on the
voluntary cooperation of carriers.
    The FAA considers several factors and priorities that are
consistent with the WSG as it reviews schedule and slot requests at
Level 2 and Level 3 airports, including (1) historic slots or services
from the previous equivalent season over new demand for the same
timings; (2) services that are unchanged over services that plan to
change time or other capacity relevant parameters; (3) introduction of
year-round services; (4) effective period of operation; (5) regularly
planned operations over ad hoc operations; and (6) other operational
factors that may limit a carrier's timing flexibility.
    The FAA seeks to maintain close communications with carriers and
terminal schedule facilitators on potential runway schedule issues or
terminal and gate issues that may affect the runway times. In addition
to applying these priorities from the WSG, the U.S. Government has
adopted a number of measures and procedures to promote competition and
new entry at U.S. slot-controlled and schedule-facilitated airports.
    Consistent with the limited, conditional extension of COVID-19
related relief for the Summer 2022 scheduling season,\6\ slots or
schedules operated as approved on a non-historic or an ad hoc basis in
Summer 2022 will be given priority over new requests for the same
timings in Summer 2023, subject to capacity availability and consistent
with established rules and policies in effect in the United States.
This priority applies to slot or schedule requests for Summer 2023,
which are comparable in timing, frequency, and duration to the ad hoc
approvals made by the FAA for Summer 2022 and operated by the carrier
as approved. This priority does not affect the historic precedence or
priority of slot holders and carriers with schedule approvals,
respectively, which met the conditions of the waiver during Summer 2022
and which seek to resume operating in Summer 2023. The FAA may consider
this priority in the event that slots with the potential for historic
precedence become available for permanent allocation by the FAA.
Foreign air carriers seeking priority under this provision will be
required to represent that their home jurisdiction will provide
reciprocal priority to U.S. carrier requests of this nature.
---------------------------------------------------------------------------

    \6\ See FAA Notice of Limited, Conditional Extension of COVID-19
Related Relief for International Operations only for the Summer 2022
Scheduling Season, 87 FR 18057 (Mar. 29, 2022).
---------------------------------------------------------------------------

    Slot management in the United States differs in some respects from
procedures in other countries. In the United States, the FAA is
responsible for facilitation and coordination of runway access for
takeoffs and landings at Level 2 and Level 3 airports; however, the
airport authority or its designee is responsible for facilitation and
coordination of terminal/gate/airport facility access. The process with
the individual airports for terminal access and other airport services
is separate from, and in addition to, the FAA schedule review based on
runway capacity.

    Generally, the FAA uses average hourly runway capacity throughput
for airports and performance metrics in conducting its schedule review
at Level 2 airports and determining the scheduling limits at Level 3
airports included in FAA rules or orders.\7\ The FAA also considers
other factors that can affect operations, such as capacity changes due
to runway, taxiway, or other airport construction, air traffic control
procedural changes, airport surface operations, and historical or
projected flight delays and congestion.
---------------------------------------------------------------------------

    \7\ The FAA typically determines an airport's average adjusted
runway capacity or typical throughput for Level 2 airports by
reviewing hourly data on the arrival and departure rates that air
traffic control indicates could be accepted for that hour, commonly
known as ``called'' rates. The FAA also reviews the actual number of
arrivals and departures that operated in the same hour. Generally,
the FAA uses the higher of the two numbers, called or actual, for
identifying trends and schedule review purposes. Some dates are
excluded from analysis, such as during periods when extended airport
closures or construction could affect capacity.
---------------------------------------------------------------------------

    Finally, the FAA notes that the schedule information submitted by
carriers to the FAA may be subject to disclosure under the Freedom of
Information Act (FOIA). The WSG also provides for release of
information at certain stages of slot coordination and schedule
facilitation. In general, once it acts on a schedule submission or slot
request, the FAA may release information on slot allocation or similar
slot transactions, or schedule information reviewed as part of the
schedule facilitation process. The FAA does not expect that practice to
change, and most slot and schedule information would not be exempt from
release under FOIA. The FAA recognizes that some carriers may submit
information on schedule plans that is both customarily and actually
treated as private. Carriers that submit such confidential schedule
information should clearly mark the information, or any relevant
portions thereof, as proprietary information (``PROPIN''). The FAA will
take the necessary steps to protect properly designated information to
the extent allowable by law.

EWR General Information

    Consistent with the WSG, carriers are asked for their voluntary
cooperation to adjust schedules to meet the targeted scheduling limits
in order to minimize potential congestion and delay. For the Summer
2023 scheduling season, the voluntary, targeted hourly scheduling
limits remains at 79 operations and 43 operations per half-hour.\8\ To
help with a balance between arrivals and departures, the targeted
maximum number of scheduled arrivals or departures, respectively, is 43
in an hour and 24 in a half-hour. These targets are expected to allow
some higher levels of operations in certain periods (not to exceed the
hourly limits) and some recovery from lower demand in adjacent periods.
Consistent with general established practice at EWR, the FAA will
accept flights above the limits if the flights were operated as
approved, or treated as operated, by the same carrier on a regular
basis in the previous corresponding season (i.e., Summer 2022) and
consistent with the recent DOT reassignment of 16 peak-hour runway
timings.\9\
---------------------------------------------------------------------------

    \8\ 83 FR 21335 (May 9, 2018).
    \9\ See Department of Transportation Order 2022-7-1, Docket DOT-
OST-2021-0103, served July 5, 2022, ``Reassignment of Schedules at
Newark-Liberty International Airport''.
---------------------------------------------------------------------------

    The FAA is aware that some carriers have recently operated flights
without approved runway times, which is inconsistent with Level 2
airport principles. Carriers are reminded FAA approval for runway times
is separate from the approval process for gates or other airport
infrastructure and both are essential for the success of Level 2 at
EWR. Schedule facilitation at Level 2 airports is designed to engender
collaboration and gain mutual agreement between the carriers and the
FAA regarding schedules and potential adjustments to stay within the
performance goals and capacity limits of the airport and to mitigate
delays and congestion that would result in the need for Level 3 slot
controls.\10\ As we emerge from the pandemic, the FAA expects that all
carriers operating at EWR will respect the targeted hourly and half-
hourly scheduling limits and continue to work cooperatively with the
FAA in order to avoid unacceptable delays and other adverse operational
impacts at the airport. The Level 2 process at EWR does not provide
priority consideration for flights that were scheduled or operated
without approved runway times.\11\
---------------------------------------------------------------------------

    \10\ See FAA Slot Administration website ``Slot Administration--
U.S. Level 2 Airports'' available at: https://www.faa.gov/about/office_org/headquarters_offices/ato/service_units/systemops/perf_analysis/slot_administration/slot_administration_schedule_facilitation/level-2-airports.
    \11\ Change of Newark Liberty International Airport (EWR)
Designation, 81 FR 19861 at 19862 (April, 6, 2016). Note: The WSG
recognizes that some carriers might operate at times without
approval from the airports schedule facilitator. Further, the Change
of EWR Designation notice provides ``consistent with the WSG
carriers would not receive historic status for such flights if the
airport level changes from Level 2 to Level 3.''

    Issued in Washington, DC, on September 30, 2022.
Alyce Hood-Fleming,
Acting Vice President, System Operations Services.
[FR Doc. 2022-21693 Filed 10-3-22; 11:15 am]
BILLING CODE 4910-13-P


                    Summary of EPA Meeting with C12 Energy
                                 May 10, 2012

On Thursday, May 10, 2012, representatives of EPA met with Mr. Barclay Rogers of C12 Energy to discuss the status of the August 8, 2011 proposed rule.  Topics included the nature of C12 Energy's business and interest in the proposed regulation, the comments that C12 Energy had submitted to EPA in response to the proposed rule, and the status of the pending final rule.  Mr. Rogers did not submit any written materials at this meeting.
Attendees:
Ross Elliott, EPA/ORCR
Melissa Kaps, EPA/ORCR
Bruce Kobelski, EPA/ OGWDW
Barclay Rogers, C12 Energy


[Federal Register: October 19, 2010 (Volume 75, Number 201)]
[Proposed Rules]
[Page 64216-64221]
[DOCID:fr19oc10-17]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0032]

29 CFR Parts 1910 and 1926

Interpretation of OSHA's Provisions for Feasible Administrative
or Engineering Controls of Occupational Noise

AGENCY: Occupational Safety and Health Administration (OSHA)

ACTION: Proposed interpretation.

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

SUMMARY: This document constitutes OSHA's official interpretation of
the term feasible administrative or engineering controls as used in the
applicable sections of OSHA's General Industry and Construction
Occupational Noise Exposure standards. Under the standard, employers
must use administrative or engineering controls rather than personal
protective equipment (PPE) to reduce noise exposures that are above
acceptable levels when such controls are feasible. OSHA proposes to
clarify that feasible as used in the standard has its ordinary meaning
of capable of being done. The Agency intends to revise its current
enforcement policy to reflect this interpretation. The Agency solicits
comments from interested parties on this interpretation.

DATES: Submit comments on or before December 20, 2010.

ADDRESSES: You may submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the instructions online for making electronic
submissions;
    Fax: You may fax submissions not longer than 10 pages, including
attachments, to the OSHA Docket Office at<PHONE_NUMBER>.
    Mail, hand delivery, express mail, messenger and courier service:
If you use this option, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2010-0032,
U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, NW.,
Washington, DC 20210. Deliveries (hand, express mail, messenger and
courier service) are accepted from 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All submissions must include the agency name and the
OSHA docket number for this interpretation (OSHA-2010-0032).
Submissions are placed in the public docket without change and may be
accessed online http://www.regulations.gov. Be careful about submitting
personal information such as social security numbers and birth dates.
    Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http:/
/www.regulations.gov index; some information (e.g., copyrighted
material), however, can not be read or downloaded at the website. All
submissions, including copyrighted material, can be examined or copied
at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT:  General information or press
inquiries: MaryAnn Garrahan, Acting Director, Office of Communications,
Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone<PHONE_NUMBER>.
    For Technical Inquiries: Audrey Profitt, Senior Industrial
Hygienist, Directorate of Enforcement Programs, Room N-3119, OSHA, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone:<PHONE_NUMBER>, or fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This Federal Register document sets out
OSHA's proposed interpretation of feasible administrative or
engineering controls in 29 CFR 1910.95(b)(1) and 1926.52(b) for the
purpose of enforcing compliance with these standards. This document
does not address feasibility in any other context. Sections
1910.95(b)(1) and 1926.52(b), which are substantively identical,
require that when employees are exposed to sound exceeding the
permissible level, feasible administrative or engineering controls must
be utilized to reduce the sound to within that level, and if such
controls are ineffective, personal protective equipment must be
provided and used. Feasibility encompasses both economic and
technological considerations, but this document addresses only economic
feasibility. Under OSHA's current enforcement policy, the agency issues
citations for failure to use engineering and administrative controls
only when hearing protectors are ineffective or the costs of such
controls are less than the cost of an effective hearing conservation
program.
    As discussed below, this policy is contrary to the plain meaning of
the standard and thwarts the safety and health purposes of the OSH Act
by rarely requiring administrative and engineering controls even though
these

controls are affordable and generally more effective than hearing
protectors in reducing noise exposure. Accordingly, OSHA now proposes
to consider administrative or engineering controls economically
feasible when the cost of implementing such controls will not threaten
the employer's ability to remain in business, or if such a threat to
viability results from the employer's failure to meet industry safety
and health standards.

I. Regulatory Background

    Section 6(a) of the OSH Act required the Secretary, during the two-
year period following the Act's effective date, to promulgate as an
OSHA standard any national consensus standard and established Federal
standard unless she determined that the promulgation of such a standard
would not result in improved safety or health. 29 U.S.C. 655(a).
Pursuant to section 6(a), OSHA promulgated the general industry noise
standard as an ``established federal standard'' in 1971. 36 FR 10466,
10518, May 29, 1971 (codified as Sec.  1910.95). Section 1910.95(b)(1)
is derived from 41 CFR 50-204.10, an occupational noise exposure
standard promulgated under the Walsh-Healey Government Contracts Act,
41 U.S.C. 35-45, which requires that federal government contracts for
materials over $10,000 must provide that the work be done under
sanitary and safe working conditions, 41 U.S.C. 35(d). The requirements
of the Walsh-Healey Act noise standard are the same as those of the OSH
Act noise standard. Compare 41 CFR 50-204.10(b) with 29 CFR
1910.95(b)(1).
    Section 1910.95(b)(1) states as follows:

    When employees are subjected to sound exceeding those listed in
Table G-16, feasible administrative or engineering controls shall be
utilized. If such controls fail to reduce sound levels within the
levels of Table G-16, personal protective equipment shall be
provided and used to reduce sound levels within the levels of the
table.

Sec.  1910.95(b)(1).

    OSHA also promulgated the construction noise standard, originally
codified at 29 CFR 1518.52, as an ``established federal standard'' in
1971. 36 FR 10466, 10469, May 29, 1971. Before being adopted unchanged
as an OSH Act standard, section 1518.52(b) was issued under the
Construction Safety Act, 40 U.S.C. 333 (1969), which requires that
federal construction contracts for over $100,000 must provide that the
work be done under sanitary and safe working conditions. 40 U.S.C.
3704(a)(1) (formerly cited as 40 U.S.C. 333(a)(1)); 36 FR 7340, 7348,
April 17, 1971. At the end of 1971, Sec.  1518.52(b) was redesignated
as Sec.  1926.52(b), 36 FR 25232, Dec. 30, 1971, its current
codification.
    Section 1926.52(b) is almost verbatim identical to Sec.
1910.95(b)(1) and provides:

    When employees are subjected to sound exceeding those listed in
Table D-2 of this section, feasible administrative or engineering
controls shall be utilized. If such controls fail to reduce sound
levels within the levels of the table, personal protective equipment
as required in subpart E, shall be provided and used to reduce sound
levels within the levels of the table.

Sec.  1926.52(b).\1\
---------------------------------------------------------------------------

    \1\ Table D-2 of Sec.  1926.52(b) is identical to Table G-16 of
Sec.  1910.95(b)(1).

    Engineering controls involve modifications to plant, equipment,
processes or materials that reduce the sound intensity at the source,
by substituting quieter machines and processes, or by isolating the
machine or its operator. See Forging Indus. Ass'n v. Secretary of
Labor, 773 F.2d 1436, 1440 n.3 (4th Cir. 1985) (en banc); Donovan v.
Castle & Cooke Foods, 692 F.2d 641, 643 n.2 (9th Cir. 1982).
Administrative controls involve modifications of work assignments to
reduce employees' exposure to noise, such as rotating employees so that
they work in noisy areas for a short time. Forging Indus., 773 F.2d at
1440 n.3. Personal protective equipment (PPE) includes hearing
protectors such as ear plugs and ear muffs fitted to individual
employees. Castle & Cooke, 692 F.2d at 643 n.2.

II. Interpretive History of Economically Feasible Administrative or
Engineering Controls

 A. Current Enforcement Policy

    OSHA's early interpretive guidance on 29 CFR 1910.95(b)(1)
indicated that feasible engineering or administrative controls must be
used to reduce noise to acceptable levels and that PPE must be used as
a supplement when such controls are not completely effective in
achieving this objective. Letter from Barry J. White, OSHA Assistant
Secretary for Regional Programs, to Leslie Anderson (March 19, 1975).
In the following decade, OSHA issued citations to employers for failure
to use affordable engineering and administrative controls to reduce
noise levels. The Occupational Safety and Health Review Commission
issued a series of decisions swinging back and forth between a cost-
benefit interpretation of economically feasible controls and a broader,
plain-meaning definition of the term as ``capable of being done.'' The
Commission ultimately settled on the cost-benefit interpretation.\2\
Although OSHA has not changed its interpretation of the standard, its
enforcement policy since 1983 has allowed employers to rely on a
hearing conservation program based on PPE if such a program reduces
noise exposures to acceptable levels and is less costly than
administrative and engineering controls. The development of the case
law in this area is described below.\3\
---------------------------------------------------------------------------

    \2\ To an economist, cost-benefit analysis contemplates an
actual quantitative comparison of costs and benefits, typically
through the conversion of all benefits and costs to monetary values.
In the Castle & Cooke Foods case, discussed below, the Commission
found that the health benefits of engineering controls did not
justify their costs without monetizing the benefits and without
explaining its valuation method. Although this approach would not
constitute cost-benefit analysis in the sense used by economists,
this document will refer to it as a cost-benefit test because that
is the terminology used by the Commission.
    \3\ OSHA has not interpreted, and the Commission has not
construed, the virtually identical language of Sec.  1926.52(b).
---------------------------------------------------------------------------

B. Commission and Court of Appeals Interpretations of Feasible

    The Commission first addressed section 1910.95(b)(1) in Continental
Can Co., 4 BNA OSHC 1541, 1547 (Nos. 3973, 4397, 4501, 4853, 5327,
7122, 7910 & 7920, 1976). There, the Commission rejected the
Secretary's argument that the costs of noise-reducing engineering
controls are not relevant unless they would seriously jeopardize the
financial health of the company. The Commission held that, in
determining whether controls are economically feasible, all the
relevant costs and benefit factors must be weighed. Ibid. The
Commission refined this cost-benefit interpretation in Castle & Cooke
Foods, 5 BNA OSHC 1435, 1438 (No. 10925, 1977), aff'd, 692 F.2d 641
(9th Cir. 1982), holding that engineering controls are economically
feasible only if the health benefits to employees from noise reduction
justify the cost to the employer. Applying this test, the Commission
found that, although engineering controls would reduce ambient noise in
Castle & Cooke's plants to within the limits of Table G-16, the hearing
loss avoided by such a reduction would not be life-threatening or, in
most cases, seriously debilitating. Id. at 1440. Rejecting the
Secretary's position that engineering controls were affordable, that
the health benefits of such controls would be significant, and that
hearing protectors were less effective, the Commission concluded that
the health benefits did not justify the cost of implementing
engineering controls. Ibid. The Secretary

appealed Castle & Cooke to the Ninth Circuit, and while that case was
pending, the Supreme Court decided American Textile Mfgs. Institute,
Inc. v. Donovan (ATM), 452 U.S. 490, 508-11 (1981). In ATMI, the Court
held that feasible in section 6(b)(5) of the OSH Act, which requires
that the Secretary promulgate standards for toxic substances at the
most protective level, ``to the extent feasible,'' means ``capable of
being done,'' and therefore rules out balancing costs and benefits.
ATMI, 452 U.S. at 508-09. The Ninth Circuit rejected the Secretary's
argument that the Supreme Court's interpretation of feasible in section
6(b)(5) was controlling as to the meaning of the same term in Sec.
1910.95(b)(1). Believing itself bound to defer to the Commission's
expertise in interpreting the standard, the Ninth Circuit distinguished
ATMI on the ground that the Court's holding was limited to section
6(b)(5) standards and left open whether the general requirement in
section 3(8) of the Act that OSHA standards be ``reasonably necessary''
might support cost-benefit analysis for standards issued under
provisions other than section 6(b)(5).\4\ Donovan v. Castle & Cooke
Foods, 692 F.2d 641, 648-49 (9th Cir. 1982). On this basis, the Ninth
Circuit concluded that the Commission was ``free to exercise its
authority to interpret the [standard]'' and the Commission's cost-
benefit interpretation was neither unreasonable nor arbitrary. Id. at
649
---------------------------------------------------------------------------

    \4\ Section 3(8) of the Act defines an occupational safety and
health standard as one ``which requires conditions, or the adoption
or use of one or more practices, means, methods, operations or
processes reasonably necessary or appropriate to provide safe or
healthful employment and places of employment.'' 29 U.S.C. 652(8).
---------------------------------------------------------------------------

    In December 1982, a month after the Ninth Circuit affirmed Castle &
Cooke, the Commission reinterpreted the word feasible in section
1910.95(b)(1) in light of ATMI. Sun Ship, Inc., 11 BNA OSHC 1028 (No.
16118, 1982). Rejecting the Ninth Circuit's analysis as ``divergent,''
two Commissioners agreed that the Supreme Court's interpretation of
feasible in section 6(b)(5) controls the meaning of the same term in
the noise standard, and precludes balancing the health benefits of
engineering controls against their costs. Sun Ship, 11 BNA OSHC at
1031-32. Administrative and engineering controls are economically
feasible, the Commission held, if their cost does not threaten the
cited employer's long-term profitability and competitiveness, or if the
employer's inability to afford these controls results from having
lagged behind the industry in providing safety or health protection for
employees. Id. at 1033. Chairman Rowland dissented, arguing that the
fact that the Commission had previously been unable to agree on the
meaning of feasible, indicated that Sec.  1910.95(b)(1) lacked
ascertainable criteria for its enforcement and was therefore
unenforceable as written. Id. at 1037-43.
    In 1984, the Commission overruled Sun Ship in a split decision in
which the two majority commissioners presented different rationales.
Sherwin-Williams Co., 11 BNA OSHC 2105, 2110-11 (No. 14131, 1984). In
the majority opinion, Commissioner Buckley resurrected the Ninth
Circuit's Castle & Cooke analysis that the majority in Sun Ship had
expressly rejected. Citing the Ninth Circuit's holding that the
Commission was not required by ATMI to abandon cost-benefit analysis
under Sec.  1910.95(b)(1), and the fact that the Secretary had revised
her enforcement policy in 1983 to accept a cost-benefit approach,
Commissioner Buckley concluded that Sun Ship should be reexamined.
Sherwin-Williams Co., 11 BNA OSHC at 2108-09. He also found that it was
reasonable to believe that the government contractors bidding on Walsh-
Healey Act contracts would have understood ``feasible administrative
and engineering controls'' to mean those controls that were practical
and cost-effective. Id. at 2110. For these reasons, Commissioner
Buckley concluded that cost-benefit analysis was incorporated into the
noise standard upon its adoption under section 6(a) of the OSH Act.
Ibid. Under this approach, if the employer produces evidence of the
cost of controls, the Secretary must prove that ``the benefit of the
proposed engineering controls justifies their relative cost in
comparison to other abatement methods.'' Ibid.
    Chairman Rowland concurred in overruling Sun Ship, but for a
different reason. Chairman Rowland restated the position he had taken
in his dissent in Sun Ship that Sec.  1910.95(b)(1) was unenforceable
as written because it provided no ascertainable criteria for
determining what administrative and engineering controls were
``feasible'' and impermissibly delegated authority to the Commission to
decide what the standard meant. Sherwin-Williams, 11 BNA OSHC at 2111
(Rowland, Ch., concurring). Chairman Rowland noted, however, that
absent agreement by two commissioners on the standard's interpretation,
the parties and administrative law judges would have no clear guidance
on what principles to apply. Ibid. He concluded that ``as between the
test set forth in Sun Ship and the cost-benefit approach adopted by
Commissioner Buckley, I believe the later test represents the more
reasoned result.'' Ibid. Thus Chairman Rowland joined in adopting
Commissioner Buckley's cost-benefit test for determining the
feasibility of engineering controls. Id. at 2112.
    Commissioner Cleary dissented, finding no grounds to overrule Sun
Ship. Sherwin-Williams, 11 BNA OSHC at 2112-14 (Cleary, C.,
dissenting). He argued that the Court in ATMI determined that the plain
meaning of feasible is ``capable of being done,'' and that the term
therefore cannot be understood to incorporate a cost-benefit analysis.
Id. at 2112. The fact that ATMI dealt with section 6(b)(5), rather than
section 6(a), of the OSH Act was unimportant, in Commissioner Cleary's
view, because there is nothing in the Act to support giving the term
feasible in the noise standard anything other than its plain, ordinary
meaning. Id. at 2112-13. He also noted that acceptance of the
majority's cost-benefit approach would virtually eliminate engineering
controls from the noise standard since earplugs or earmuffs will almost
always cost less than effective engineering controls. Id. at 2113-14.
In Commissioner Cleary's view, the majority's adoption of a cost-
benefit test amounted to an unauthorized amendment of the standard. Id.
at 2114.
    In response to the Ninth Circuit's Castle & Cooke decision, OSHA
adopted enforcement guidelines allowing employers to use PPE and a
hearing conservation program, rather than engineering or administrative
controls, when hearing protectors are less costly than such controls,
unless noise levels are especially elevated CPL 2-2.35A, Sec.  G (Dec.
19, 1983). A hearing conservation program is one that meets the
standard's requirements for protecting employees from the harmful
effects of noise at or above 85 decibels. See Sec.  1910.95(c)-(o);
Forging Indus., 773 F.2d at 1440. Such a program includes monitoring,
periodic audiometric testing, provision of hearing protectors, training
and other elements. Forging Indus., 773 F.2d at 1440-41.
    OSHA's enforcement policy as set forth in the Field Operations
Manual (FOM) authorizes citing employers for failing to use engineering
and/or administrative controls only when (1) noise levels are so high--
said to border on 100 dBA when the most effective hearing protectors
are used--that hearing protectors alone will not reliably reduce noise
to acceptable levels; or (2) the costs of such controls are less than
the cost of an effective hearing conservation program. FOM, CPL 02-00-
148, Chapt. 4 Sec.  XI.B.1 (Nov.

9, 2009). Since effective engineering and administrative controls
almost always cost more than a hearing conservation program based on
hearing protectors, citations are rarely issued for failure to use such
controls under OSHA's current policy.

III. OSHA's Interpretation of Economic Feasibility in 29 CFR
1910.95(b)(1) and 1926.52(b)

    The legal landscape concerning the interpretation of Sec.
1910.95(b)(1) (and therefore of the substantively identical Sec.
1926.52(b)) has dramatically changed since the Ninth Circuit's Castle &
Cooke, and the Commission's Sherwin-Williams decisions. In Martin v.
OSHRC (CF & I), 499 U.S. 144, 150-55 (1991), the Supreme Court
established that the Secretary is the administrative actor responsible
for issuing authoritative interpretations of OSHA standards, while the
Commission's role, as neutral arbiter, is to determine whether the
Secretary's interpretation is reasonable. The Commission is not, as the
Ninth Circuit believed, free to exercise de novo authority to interpret
a standard, and a court of appeals is to defer to the Secretary's
interpretation if reasonable, not the Commission's. Although OSHA has
for some time acquiesced as a matter of enforcement policy in the
Commission's cost-benefit test for determining the economic feasibility
of administrative and engineering controls under the noise standards,
the agency has decided that this approach is inconsistent with the
standards. For the reasons stated below, OSHA has concluded that
engaging in cost-benefit analysis under Sec. Sec.  1910.95(b)(1) and
1926.52(b) is contrary to the plain meaning of feasibility and thwarts
the safety and health purposes of the OSH Act and the standard.
Therefore, OSHA proposes to consider administrative or engineering
controls economically feasible under the noise standards when the cost
of these controls will not threaten the cited employer's ability to
stay in business or when the threat to viability results from the
employer's having lagged behind the industry in providing safety and
health protection for employees.
    The language of the noise standards frames the analysis. The
Supreme Court has held that the word feasible has the plain meaning of
``capable of being done'' and does not permit cost-benefit analysis.
The noise standards require that ``feasible administrative or
engineering controls'' be utilized when noise is excessive. In ATMI,
the Supreme Court considered the meaning of the word feasible in the
context of section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b)(5), which
requires that the Secretary set standards for toxic substances at the
level which most adequately assures, ``to the extent feasible,'' that
no employee will suffer material impairment of health. The Court found
that the plain meaning of feasible is ``capable of being done;''
``[t]hus, Sec.  6(b)(5) directs the Secretary to issue the standard
that `most adequately assures * * * that no employee will suffer
material impairment of health,' limited only by the extent to which
this is `capable of being done.' '' ATMI, 452 U.S. at 508-09. The Court
further concluded that Congress's use of the word feasible in section
6(b)(5) ``defined the basic relationship between costs and benefits, by
placing the `benefit' of worker health above all other considerations
save those making attainment of this `benefit' unachievable.'' Id. at
509. Thus, the feasibility analysis required by section 6(b)(5)
necessarily rules out a balancing of costs and benefits. ``[C]ost-
benefit analysis by OSHA is not required by the statute because
feasibility analysis is.'' Ibid.
    The Court's analysis in ATMI governs the interpretation of
Sec. Sec.  1910.95(b)(1) and 1926.52(b). By requiring feasible
administrative or engineering controls to be utilized when noise levels
exceed those specified in Table G-16, the standard directs employers to
use those controls capable of reducing exposures. The cost of such
controls is relevant only to the extent that it is so high as to
threaten the employer's ability to stay in business. This construction
is supported not only by the plain meaning of feasible, but also by the
canon of construction that regulatory language should be given the same
meaning as the same language appearing in the statute. See Sun Ship, 11
BNA OSHC at 1032.
    The 1984 Sherwin-Williams decision adopting a cost-benefit
requirement for the general industry noise standard despite ATMI is
plainly wrong and cannot stand. The Commission was unable to agree on a
rationale for overruling Sun Ship, in which the majority had held that
the Supreme Court's interpretation of feasible in section 6(b)(5)
controlled the meaning of same term in Sec.  1910.95(b)(1). Moreover,
neither Commissioner Buckley's majority opinion nor Chairman Rowland's
separate concurrence is persuasive.
    Commissioner Buckley identified two factors which he believed
supported rejecting the plain meaning of ``feasible'' in favor of a
cost-benefit approach. The first factor, taken from the Ninth Circuit's
Castle & Cooke decision, is that ATMI did not address whether section
3(8) of the OSH Act, which defines an occupational safety or health
standard, in part, as one requiring ``reasonably necessary'' measures,
requires a cost-benefit analysis for standards issued under provisions
other than section 6(b)(5). The Ninth Circuit inferred from the Court's
failure to address this issue that ATMI did not require the Commission
to abandon a cost-benefit approach to a noise standard issued under
section 6(a). Donovan v. Castle & Cooke Foods, 692 F.2d at 649. The
Ninth Circuit's reasoning, however, is seriously flawed.
    As a threshold matter, the Secretary has rejected the notion that
section 3(8)'s ``reasonably necessary'' language imposes a requirement
for cost-benefit analysis even for standards not subject to section
6(b)(5)'s feasibility constraint. In response to litigation arising
under the lockout/tagout standard, the Secretary concluded that section
3(8) does not require a formal cost-benefit analysis--in which all the
costs and benefits of a particular action are identified, quantified
and compared--for safety standards, which are issued under section 6(b)
but are not subject to section 6(b)(5). 58 FR 16612, 16622, Mar. 30,
1993 (Supplemental Statement of Reasons); International Union, United
Automobile, Aerospace & Agricultural Implement Workers of America, UAW
v. OSHA, 37 F.3d 665, 669-70 (D.C. Cir. 1994). The Secretary's
interpretation of section 3(8), as published in her Federal Register
supplemental statement, is entitled to deference as long as it is
reasonable. United States v. Mead Corp., 553 U.S. 218, 226-27 (2001).
    Moreover, cost-benefit analysis is inconsistent with the text of
Sec.  1910.95(b)(1). Section 6(a) required the Secretary to promulgate
the existing Walsh-Healey noise standard as an OSHA standard unless it
would not result in improved safety or health. OSH Act, 29 U.S.C.
655(a). The statutorily mandated standard requires feasible controls to
be used to reduce exposure. To read section 3(8) as imposing a
requirement that controls be used only if the benefits justify the cost
would eviscerate the feasible controls requirement that section 6(a)
required the Secretary to promulgate. The standard makes administrative
and engineering controls the primary means of compliance; only if such
controls are infeasible, i.e., so costly as to imperil the employer's
long-term viability, may employers use hearing protectors. Section
1910.95(b)(1); Forging Indus., 773 F.2d at 1440.
    Yet the Commission's cost-benefit approach completely reverses this

priority; hearing protectors may be used unless they cost more than the
engineering controls necessary to achieve an equivalent noise
reduction. Castle & Cooke, 5 BNA OSHC at 1441. Under the Commission's
interpretation, hearing protectors are presumptively appropriate, even
if administrative and engineering controls are affordable and
effective. Just as Congress could not have intended the general
language of section 3(8) to countermand the specific feasibility
requirement of section 6(b)(5), ATMI, 452 U.S. at 513, Congress could
not have understood that section 3(8) would eviscerate the specific
requirements of the existing federal standards that the Secretary was
required by section 6(a) to adopt during the two-year period following
the OSH Act's effective date. For Sec.  1910.95(b)(1), no less than
standards promulgated under section 6(b)(5), the term ``feasible''
defines ``the basic relationship between costs and benefits by placing
the `benefit' of worker health above all other considerations save
those making attainment of this `benefit' unachievable * * *. Thus,
cost-benefit analysis * * * is not required by the statute because
feasibility analysis is.'' ATMI, 452 U.S. at 509.
    The second factor identified by Commissioner Buckley for departing
from the plain meaning of ``feasible'' in Sec.  1910.95(b)(1) is even
less persuasive. Although the Commissioner found no regulatory or
adjudicative history indicating how the standard was interpreted under
the Walsh-Healey Act, he assumed that government contractors bidding on
Walsh-Healey Act contracts would not have construed the term
``feasible'' in accordance with the dictionary definition, but rather
would have understood the term to allow for cost-benefit analysis.
Sherwin-Williams, 11 BNA OSHC at 2109-10.
    Commissioner Buckley's assumptions about the competitive bidding
process under the Walsh-Healey Act are both irrelevant and unfounded.
They are irrelevant because Sec.  1910.95(b)(1), was promulgated under
Sec.  6(a) of the OSH Act as an ``occupational safety and health
standard.'' 29 U.S.C. 655(a). The Secretary is responsible for issuing
authoritative interpretations of OSHA standards, and she is not bound
by the perspective of a hypothetical government contractor bidding on a
Walsh-Healey contract. CF & I, 499 U.S. at 150-55. The Secretary's
interpretation of Sec.  1910.95(b)(1) must be given effect if it is
reasonable, ``that is, so long as the interpretation sensibly conforms
to the purpose and wording of the regulations.'' Id. at 150-51.
Construing the standard to require that administrative or engineering
controls be used as long as they do not threaten the employer's ability
to stay in business is consistent with the standard's plain meaning and
its purpose of protecting employee health by achieving reductions in
noise exposure. It is the Secretary's reasonable construction of the
standard, which constitutes an exercise of delegated law-making
authority when embodied in an OSHA citation, that is entitled to
deference, not the Commission's interpretation. Id. at 150-55.
Speculation about how government contractors might have interpreted the
standard in bidding on a Walsh-Healey contract is wholly irrelevant.
    In any event, Commissioner Buckley's assumption as to how the
``feasible'' controls requirement would have been interpreted in the
federal procurement context is entirely unfounded. First, as the
commissioner himself admitted, there is nothing in the regulatory or
adjudicatory history of the Walsh-Healey noise standard to support an
assumption that feasible was not understood by government contractors
to have its plain, ordinary meaning. Commissioner Buckley's
interpretation thus violated the fundamental canon of construction that
words are to be interpreted in accordance with their normal meaning
unless there is specific evidence to the contrary. Furthermore, the
notion that prospective contractors would have understood that they
should include the costs of engineering controls only if they
determined that the benefits outweighed the costs is completely
contrary to basic principles of government procurement. Sherwin-
Williams, 11 BNA OSHC at 2109-10. The competitive process requires that
all prospective contractors bid on the same requirements; the process
cannot possibly permit some bidders to decide for themselves whether
engineering controls are required, or not required. Thus, feasible
controls must have been understood--by both the government and its
contractors--in accordance with its plain meaning.
    OSHA's current enforcement policy on Sec.  1910.95(b)(1) closely
tracks the Commission's cost-benefit approach. Where PPE and a hearing
conservation program are cheaper, the current enforcement policy allows
employers to rely on them, rather than administrative or engineering
controls, unless noise levels are so high that PPE will not reduce
noise exposure to acceptable levels.\5\ FOM, CPL 02-00-148, Sec.  XI.B.
The policy provides, moreover, that PPE may be used up to 100 dBA.
Ibid. As discussed above, this policy is inconsistent with the noise
standards' explicit requirement that feasible administrative and
engineering controls be used to reduce noise exposures to the level set
by the standard and that PPE be used if administrative and engineering
controls are unable to reduce noise to permitted levels. The standards'
reliance on feasible engineering and administrative controls as the
primary means of reducing noise exposures is consistent with OSHA's
traditional adherence to a hierarchy of preferred controls, and is
supported by good industrial hygiene practice and OSHA's experience in
assuring that workers have a healthy workplace. See, e.g., OSHA, 29 CFR
parts 1915, 1917-18 & 1926, ``Occupational Exposure to Hexavalent
Chromium,'' Final Rule, 71 FR 10100, 10345, Feb. 28, 2006 (discussing
methods of compliance for reducing exposures to hexavalent chromium).
Hearing protectors are less reliable than administrative and
engineering controls in reducing noise levels and maintaining such
reductions over time. OSHA's current enforcement policy virtually
eliminates the requirement to use administrative or engineering
controls since such controls almost always cost more than hearing
protectors. Furthermore, the current policy thwarts the safety and
health purposes of the OSH Act by rarely requiring administrative and
engineering controls even though these controls are generally more
effective than hearing protectors in reducing noise exposure.
---------------------------------------------------------------------------

    \5\ In the terminology economists normally employ, the current
enforcement policy would be better characterized as a least-cost,
rather than a benefit-cost, approach.
---------------------------------------------------------------------------

    Accordingly, OSHA now proposes to interpret Sec. Sec.
1910.95(b)(1) and 1926.52(b) in conformity with the plain meaning of
these provisions and with the safety and health purposes of the OSH
Act. OSHA proposes to interpret the term feasible in these provisions
as having the same meaning that the term has in section 6(b)(5) of the
Act, i.e., ``capable of being done,'' or ``achievable.'' OSHA also
proposes to consider administrative or engineering controls
economically feasible if they will not threaten the employer's ability
to remain in business or if the threat to viability results from the
employer's having failed to keep up with industry safety and health
standards. OSHA further intends to change its enforcement policy to
authorize the issuance of citations requiring the use of administrative
or engineering controls when these controls are feasible in

accordance with this interpretation. OSHA welcomes comments from
---------------------------------------------------------------------------
interested parties on this proposed interpretation.

    Authority: 29 U.S.C. 655; 29 CFR 1910.95(b)(1) & 1926.52(b);
Secretary's Order 5-200, 72 FR 31160, June 5, 2007.

    Signed at Washington, DC, October 12, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-26135 Filed 10-18-10; 8:45 am]
BILLING CODE 4510-29-P