[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Page 43144]
[FR Doc No: 2019-17876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]

Implementing the Food and Drug Administration's Predictive
Toxicology Roadmap: An Update of the Food and Drug Administration's
Activities; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Implementing FDA's
Predictive Toxicology Roadmap: An Update of FDA's Activities.'' The
purpose of the public workshop is to highlight the work FDA has been
doing to support and implement FDA's Predictive Toxicology Roadmap.

DATES: The public workshop will be held on September 18, 2019, from 8
a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Laurie-Anne Sayles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4355, Silver Spring, MD 20993, 301-796-
0621 x4353<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In December 2017, FDA launched its Predictive Toxicology Roadmap, a
six-part framework for integrating predictive toxicology methods into
safety and risk assessments. Among other recommendations, the Roadmap
calls for FDA research to identify data gaps and to support intramural
and extramural research to ensure that the most promising technologies
are developed, validated, and integrated into regulatory review, if
applicable.
    FDA held its initial public hearing on the Roadmap, sponsored by
FDA's cross-agency Toxicology Working Group, on September 12, 2018.
More information about the Roadmap as well as the initial public
hearing can be found on the following website: https://www.fda.gov/predictivetoxroadmap.

II. Topics for Discussion at the Public Workshop

    On Wednesday, September 18, 2019, FDA will highlight the work it
has been doing to support and implement FDA's Predictive Toxicology
Roadmap.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website: https://www.fda.gov/predictivetoxroadmap.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by Monday, September 16, 2019, 5 p.m. Eastern
Time. Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
    If you need special accommodations due to a disability, please
contact Laurie-Anne Sayles (see FOR FURTHER INFORMATION CONTACT) no
later than September 11, 2019, 5 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. To register for the webcast, please visit the
following website: https://www.fda.gov/predictivetoxroadmap.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.fda.gov/predictivetoxroadmap.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17876 Filed 8-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Rules and Regulations]
[Pages 47899-47902]
[FR Doc No: 2019-19499]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R06-OAR-2019-0306; FRL-9998-59-Region 6]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; New Mexico and Albuquerque-Bernalillo
County; Municipal Solid Waste Landfills

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving revisions to the
section 111(d) Plan submitted by the New Mexico Environment Department
(NMED) on May 25, 2017, to regulate landfill gas and its components,
including methane, from existing municipal solid waste (MSW) landfills.
The Plan provides for the implementation and enforcement of the
Emissions Guidelines (EG) for existing landfills in New Mexico, except
Albuquerque-Bernalillo County. We are also approving revisions to the
section 111(d) Plan submitted by the New

Mexico Environment Department (NMED) on behalf of the Albuquerque-
Bernalillo County Air Quality Control Board on May 24, 2017, to
implement and enforce the EG for existing MSW landfills in Albuquerque
and Bernalillo County. The EG requires States to develop plans to
reduce air emissions from all affected MSW landfills within their
jurisdiction.

DATES: This rule is effective on October 11, 2019. The incorporation by
reference of certain material listed in the rule is approved by the
Director of the Federal Register October 11, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2019-0306. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information 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 through https://www.regulations.gov or
in hard copy at the EPA Region 6 Office, 1201 Elm Street, Dallas, Texas
75270.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar, EPA Region 6 Office,
State Planning Implementation Branch, 1201 Elm Street, Dallas, TX
75270,<PHONE_NUMBER><EMAIL_ADDRESS>To inspect the hard copy
materials, please schedule an appointment with Alan Shar at 214-665-
6691.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our June
21, 2019 (84 FR 29138) proposal. In that document, we proposed to
approve revisions to the section 111(d) Plan submitted by the NMED on
May 25, 2017, to regulate landfill gas and its components, including
methane, from existing MSW landfills. We also proposed to approve
revisions to the section 111(d) Plan for the Albuquerque-Bernalillo
County (ABC) Air Quality Control Board submitted on May 24, 2017, to
implement and enforce the EG for existing MSW landfills in Albuquerque
and Bernalillo County. For more information, see the technical support
document \1\ prepared in conjunction with the June 21, 2019 proposal.
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    \1\ EPA Document ID No. EPA-R06-OAR-2019-0306-0002 available at
www.regulations.gov.
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    We received one comment \2\ on the proposal during the public
comment period that closed on July 22, 2019.
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    \2\ EPA Document ID No. EPA-R06-OAR-2019-0306-0005 available at
www.regulations.gov.
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II. Response to Comments

    Comment: The commenter supports our proposed approval action. The
commenter also urges the EPA to fully comply with the remainder of the
terms of the court's order in California et al. v. EPA, 2019 WL
19995769 (N.D. Cal. 2019), with respect to other jurisdictions.
    Response: The EPA appreciates the commenter's support. The June 21,
2019 proposal concerned revisions to section 111(d) Plans for the State
of New Mexico and Albuquerque-Bernalillo County only. The EPA Region 6
is responsible for rulemaking actions within its jurisdictional area.
With this final action, the EPA Region 6 has met its obligations in the
court's order referenced by the commenter. Actions on Plans outside of
the EPA Region 6's geographical jurisdiction are beyond the scope of
this particular rulemaking action.
    This concludes our response to the comment received. No changes
have been made to the proposal (84 FR 29138, June 21, 2019) as a result
of this comment.

III. Final Action

    The EPA is finalizing revisions to the CAA section 111(d) Plan
submitted by the NMED on May 25, 2017, to regulate landfill gas and its
components, including methane, from existing MSW landfills in New
Mexico, except for Albuquerque and Bernalillo County. We are also
finalizing revisions to the CAA section 111(d) Plan submitted by the
NMED on behalf of the Albuquerque-Bernalillo County Air Quality Control
Board on May 24, 2017, for existing MSW landfills in Albuquerque and
Bernalillo County. Both Plans implement and enforce the EG for existing
MSW landfills. See 40 CFR part 60, subpart Cf. The scope of the
approval of the section 111(d) Plans is limited to the provisions of 40
CFR parts 60 and 62 for existing MSW landfills, as referenced in the
emission guidelines, 40 CFR part 60, subpart Cf.

IV. Incorporation by Reference

    In accordance with the requirements of 1 CFR 51.5, we are
finalizing regulatory text that includes the incorporation by reference
of 20.2.64 NMAC (effective May 31, 2017) and 20.11.71 NMAC (effective
May 13, 2017) which are part of the CAA section 111(d) Plans applicable
to existing MSW landfills in New Mexico and Albuquerque-Bernalillo
County, respectively. The regulatory provisions of 20.2.64 NMAC and
20.11.71 NMAC incorporate by reference the Emissions Guidelines (EG)
for existing MSW landfills promulgated by the EPA at 40 CFR part 60,
subpart Cf, and establish emission standards and compliance times for
the control of methane and other organic compounds from certain MSW
landfills that commenced construction, modification, or reconstruction
on or before July 17, 2014. The emissions standards and compliance
times of the two standards contain the same substantive requirements
but apply to MSW landfills in different jurisdictions. The regulatory
provisions of 20.2.64 NMAC apply to MSW landfills located in the State
of New Mexico, except for MSW landfills located in Albuquerque and
Bernalillo County, which are subject to the regulatory provisions of
20.11.71 NMAC. The EPA has made, and will continue to make, 20.2.64
NMAC and 20.11.71 NMAC (as well as the entire New Mexico and
Albuquerque-Bernalillo County 111(d) Plans for MSW landfills) generally
available electronically through www.regulations.gov, Docket No. EPA-
R06-OAR-2019-0306 and in hard copy at the EPA Region 6 office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information). This incorporation by
reference has been approved by the Office of the Federal Register and
the Plans are federally enforceable under the CAA as of the effective
date of this final rulemaking.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve
section 111(d) state plan submissions that comply with the provisions
of the Act and applicable Federal regulations. 42 U.S.C. 7411(d); 40
CFR part 60, subparts B and Cf; and 40 CFR part 62, subpart A. Thus, in
reviewing CAA section 111(d) state plan submissions, the EPA's role is
to approve state choices, provided that they meet the criteria of the
Act and implementing regulations. Accordingly, this action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because this action is not significant under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the CAA section 111(d) Plans are not approved to apply
in Indian country, as defined at 18 U.S.C. 1151, located in the state.
As such, this rule does not have tribal implications, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), and it will not
impose substantial direct costs on tribal governments or preempt tribal
law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 12, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Methane, Municipal solid waste landfill, Reporting and
recordkeeping requirements.

    Dated: September 3, 2019.
Kenley McQueen,
Regional Administrator, Region 6.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 62 as follows:

PART 62--[AMENDED]

0
1. The authority citation for part 62 continues to read as follows:

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

Subpart GG--New Mexico

0
2. Section 62.7855 is revised to read as follows:

Sec.  62.7855  New Mexico Environment Department.

    (a) Identification of plan. Section 111(d) plan for municipal solid
waste landfills and the associated 20.2.64 NMAC, as submitted on May
25, 2017. The plan includes the regulatory provisions cited in
paragraph (d) of this section, which EPA incorporates by reference.
    (b) Identification of sources. The plan applies to all existing
municipal solid waste landfills under the jurisdiction of the New
Mexico Environment Department for which construction, reconstruction,
or modification was commenced on or before July 17, 2014, and are
subject to the requirements of 40 CFR part 60, subpart Cf.
    (c) Effective date. The effective date of the plan for municipal
solid waste landfills is October 11, 2019.
    (d) Incorporation by reference. (1) The material incorporated by
reference in this section was approved by the Director of the Federal
Register Office in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies of the material may be inspected or obtained from the EPA Region
6 office, 1201 Elm Street, Suite 500, Dallas, Texas 75270,<PHONE_NUMBER>
or electronically through www.regulations.gov, Docket No. EPA-R6-OAR-
2019-0306. Copies may be inspected at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email<EMAIL_ADDRESS>or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html.
    (2) State of New Mexico, New Mexico Environment Department, New
Mexico Administrative Code, http://<IP_ADDRESS>/nmac/.
    (i) 20.2.64 NMAC, Chapter 20--Environmental Protection, Chapter 2--
Air Quality (Statewide), Part 64--Municipal Solid Waste Landfills, New
Mexico Administrative Code, effective May 31, 2017.
    (ii) [Reserved]

0
3. Section 62.7856 is revised to read as follows:

Sec.  62.7856  Albuquerque-Bernalillo County Air Quality Control Board.

    (a) Identification of plan. Section 111(d) plan for municipal solid
waste landfills and the associated 20.11.71 NMAC, as submitted on May
24, 2017. The plan includes the regulatory provisions referenced in
paragraph (d) of this section, which EPA incorporates by reference.
    (b) Identification of sources. The plan applies to all existing
municipal solid waste landfills under the jurisdiction of the
Albuquerque-Bernalillo County Air Quality Control Board for which
construction, reconstruction, or modification was commenced on or
before July 17, 2014, and are subject to the requirements of 40 CFR
part 60, subpart Cf.
    (c) Effective date. The effective date of the plan for municipal
solid waste landfills is October 11, 2019.
    (d) Incorporation by reference. (1) The material incorporated by
reference in this section was approved by the Director of the Federal
Register Office in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies of the material may

be inspected or obtained from the EPA Region 6 office, 1201 Elm Street,
Suite 500, Dallas, Texas 75270,<PHONE_NUMBER> or electronically through
www.regulations.gov, Docket No. EPA-R06-OAR-2019-0306. Copies may be
inspected at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
    (2) State of New Mexico, Albuquerque-Bernalillo County Air Quality
Control Board, New Mexico Administrative Code, http://<IP_ADDRESS>/nmac/.
    (i) 20.11.71 NMAC, Title 20--Environmental Protection, Chapter 11--
Albuquerque-Bernalillo-County Air Quality Control Board, Part 71--
Municipal Solid Waste Landfills, New Mexico Administrative Code,
effective May 13, 2017.
    (ii) [Reserved]

[FR Doc. 2019-19499 Filed 9-10-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: February 8, 2007 (Volume 72, Number 26)]
[Notices]
[Page 6002-6008]
[DOCID:fr08fe07-78]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[V-06-1]

Gibraltar Chimney International, LLC, Hoffmann, Inc., and Kiewit
Industrial Co.; Application for Permanent Variance and Interim Order,
Grant of Interim Order, and Request for Comments

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

ACTION: Notice of an application for a permanent variance and interim
order; grant of interim order; and request for comments.

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SUMMARY: Gibraltar Chimney International, LLC, Hoffmann Inc., and
Kiewit Industrial Co. (``the applicants'') have applied for a permanent
variance from the provisions of the OSHA standards that regulate
boatswains' chairs and hoist towers, specifically paragraph (o)(3) of
Sec.  1926.452 and paragraphs (c)(1) through (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16) of Sec.  1926.552. In addition, the applicants
have requested an interim order based on the alternative conditions
specified by the variance application. Since these conditions are the
same as the conditions specified in other permanent variances granted
recently by the Agency for these boatswains'-chair and hoist-tower
provisions, OSHA is granting the applicants' request for an interim
order.

DATES: Comments and requests for a hearing must be submitted
(postmarked, sent, or received) by March 12, 2007. The interim order
specified by this notice becomes effective on February 8, 2007.

ADDRESSES: Electronic. Comments and requests for a hearing may be
submitted electronically at http://www.regulations.gov, which is the

Federal eRulemaking Portal. Follow the instructions online for
submitting comments.
    Facsimile. OSHA allows facsimile transmission of comments that are
10 pages or fewer in length (including attachments), as well as hearing
requests. Send these comments and requests to the OSHA Docket Office at
(202) 693-1648; hard copies of these comments are not required. Instead
of transmitting facsimile copies of attachments that supplement their
comments (e.g., studies and journal articles), commenters may submit
these attachments, in triplicate hard copy, to the OSHA Docket Office,
Technical Data Center, Room N-2625, OSHA, U.S. Department of Labor, 200
Constitution Ave., NW., Washington, DC 20210. These attachments must
clearly identify the sender's name, date, subject, and docket number
(i.e., V-06-1) so that the Agency can attach them to the appropriate
comments.
    Regular mail, express delivery, hand (courier) delivery, and
messenger service. Submit three copies of comments and any additional
material (e.g., studies and journal articles), as well as hearing
requests, to the OSHA Docket Office, Docket No. V-06-1, Technical Data
Center, Room N-2625, OSHA, U.S. Department of Labor, 200 Constitution
Ave., NW., Washington, DC 20210; telephone:<PHONE_NUMBER>. Please
contact the OSHA Docket Office at<PHONE_NUMBER> for information about
security procedures concerning the delivery of materials by express
delivery, hand delivery, and messenger service. The hours of operation
for the OSHA Docket Office and Department of Labor are 8:15 a.m. to
4:45 p.m., e.t.
    Instructions. All submissions must include the Agency name and the
OSHA docket number (i.e., OSHA Docket No. V-06-1). Comments and other
material, including any personal information, are placed in the public
docket without revision, and will be available online at http://www.regulations.gov.
 Therefore, the Agency cautions commenters about

submitting statements they do not want made available to the public, or
submitting comments that contain personal information (either about
themselves or others) such as social security numbers, birth dates, and
medical data.
    Docket. To read or download comments or other material in the
docket, go to http://www.regulations.gov or to the OSHA Docket Office at the address above. Documents in the docket are listed in the http://

http://www.regulations.gov index; however, some information (e.g., copyrighted

material) is not publicly available to read or download through this
Web site. However, all submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT: For information about this notice
contact MaryAnn S. Garrahan, Director, Office of Technical Programs and
Coordination Activities, Room N-3655, OSHA, U.S. Department of Labor,
200 Constitution Ave. NW., Washington, DC 20210; telephone: (202) 693-
2110; fax:<PHONE_NUMBER>. For additional copies of this Federal
Register notice, contact the Office of Publications, Room N-3103, OSHA,
U.S. Department of Labor, 200 Constitution Ave., NW., Washington, DC
20210 (telephone:<PHONE_NUMBER>). Electronic copies of this Federal
Register notice, as well as news releases and other relevant documents,
are available at OSHA's Web site on the Internet at http://www.osha.gov/.
 Contact the OSHA Docket Office for information about

docket materials not available through the OSHA Web site, and for
assistance in using the website to locate docket submissions.
    Additional information about this variance application also is
available from the following OSHA Regional Offices:
     U.S. Department of Labor, OSHA, JFK Federal Building, Room
E340, Boston, MA 02203; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, 201 Varick St., Room 670,
New York, NY 10014; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, Curtis Building, Suite 740
West, 170 South Independence Mall West, Philadelphia, PA 19106;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, Sam Nunn Atlanta Federal
Center, 61 Forsyth St., SW., Room 6T50, Atlanta, GA 30303; telephone:
(404) 562-2300; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, 230 South Dearborn St.,
Room 3244, Chicago, IL 60604; telephone:<PHONE_NUMBER>; fax: (312)
353-7774.
     U.S. Department of Labor, OSHA, 525 Griffin St., Room 602,
Dallas, TX 75202; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, City Center Square, 1100
Main St., Suite 800, Kansas City, MO 64105; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, 1999 Broadway, Suite 1690,
Denver, CO 80202-5716 (overnight), P.O. Box 46550, Denver, CO 80201-
6550 (mail); telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
     U.S. Department of Labor, OSHA, 71 Stevenson St., Room
420, San Francisco, CA 94105; telephone:<PHONE_NUMBER>; fax: (415)
975-4319.
     U.S. Department of Labor, OSHA, 1111 Third Ave., Suite
715, Seattle, WA 98101-3212; telephone:<PHONE_NUMBER>; fax: (206) 553-
6499.

I. Notice of Application

    Gibraltar Chimney International, LLC, Hoffmann, Inc., and Kiewit
Industrial Co. (hereafter, ``the applicants'') have submitted
applications for a permanent variance under Section 6(d) of the

Occupational Safety and Health Act of 1970 (29 U.S.C. 655) and 29 CFR
1905.11 (``Variances and other relief under section 6(d)'') (see Exs.
4-1 and 4-2).\1\ The applicants seek a permanent variance from Sec.
1926.452(o)(3), which provides the tackle requirements for boatswains'
chairs. The applicants also request a variance from paragraphs (c)(1)
through (c)(4), (c)(8), (c)(13), (c)(14)(i), and (c)(16) of Sec.
1926.552 that regulate hoist towers. These latter paragraphs specify
the following requirements:
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    \1\ The principle address for Hoffman, Inc. is 6001 49th St.
South, Muscatine, IA 52761, and the principal address for Gibraltar
Chimney International, LLC is 92 Cooper Ave., Box 386, Tonawanda, NY
14151-0386.
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     (c)(1)--Construction requirements for hoist towers outside
a structure;
     (c)(2)--Construction requirements for hoist towers inside
a structure;
     (c)(3)--Anchoring a hoist tower to a structure;
     (c)(4)--Hoistway doors or gates;
     (c)(8)--Electrically interlocking entrance doors or gates
to the hoistway and cars;
     (c)(13)--Emergency stop switch located in the car;
     (c)(14)(i)--Using a minimum of two wire ropes for drum
hoisting; and
     (c)(16)--Material and component requirements for
construction of personnel hoists.
    The applicants contend that the permanent variance would provide
their employees with a place of employment that is at least as safe and
healthful as they would obtain under the existing provisions.
    The places of employment affected by this variance application are
the present and future projects where the applicants construct
chimneys, located in states under federal authority, as well as State-
plan states that have safety and health plans approved by OSHA under
Section 18 of the Occupational Safety and Health (OSH) Act (29 U.S.C.
667) and 29 CFR part 1952 (``Approved State Plans for Enforcement of
State Standards''). The applicants certify that they have provided
employee representatives of current employees who would be affected by
the permanent variance with a copy of their variance requests. The
applicants also certify that they notified their employees of the
variance requests by posting a summary of the application and
specifying where they can examine a copy of the application at a
prominent location or locations where they normally post notices to
their employees (or instead of a summary, posting the application
itself); and by other appropriate means. In addition, the applicants
have informed employees and their representatives of their right to
petition the Assistant Secretary of Labor for Occupational Safety and
Health for a hearing on this variance application.

II. Multi-State Variance

    In their variance applications, the employers stated that they
perform chimney work in a number of States and Territories that operate
OSHA-approved safety and health programs under Section 18 of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.).
Twenty-six States and Territories have OSHA-approved safety and health
programs.\2\ As part of this variance process, the Directorate of
Cooperative and State Programs will notify the State-Plan States and
Territories of this variance application and advise them that unless
they object, OSHA will assume the State's position regarding this
application is the same as its position regarding prior identical
variances. Fourteen States have agreed to the terms of the earlier
requests (i.e., Alaska, Arizona, Indiana, Maryland, Minnesota, Nevada,
New Mexico, North Carolina, Oregon, Puerto Rico, Tennessee, Vermont,
Virginia, and Wyoming). Four States have imposed additional
requirements and conditions (i.e., Kentucky, Michigan, South Carolina,
and Utah), and four States have objected to the earlier variance
requests (i.e., California, Hawaii, Iowa, and Washington).
---------------------------------------------------------------------------

    \2\ Three State-Plan States (i.e., Connecticut, New Jersey, and
New York) and one Territory (i.e., Virgin Islands) limit their
occupational safety and health authority to public-sector employees
only. State-Plan States and Territories that have jurisdiction over
both public- and private-sector employers and employees are: Alaska,
Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland,
Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon,
Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia,
Washington, and Wyoming.
---------------------------------------------------------------------------

III. Supplementary Information

A. Overview

    The applicants construct, remodel, repair, maintain, inspect, and
demolish tall chimneys made of reinforced concrete, brick, and steel.
This work, which occurs throughout the United States, requires the
applicants to transport employees and construction material to and from
elevated work platforms and scaffolds located, respectively, inside and
outside tapered chimneys. While tapering contributes to the stability
of a chimney, it requires frequent relocation of, and adjustments to,
the work platforms and scaffolds so that they will fit the decreasing
circumference of the chimney as construction progresses upwards.
    To transport employees to various heights inside and outside a
chimney, the applicants propose to use a hoist system that would lift
and lower personnel-transport devices that include personnel cages,
personnel platforms, or boatswains' chairs. The applicants also would
attach a hopper or concrete bucket to the hoist system to raise or
lower material inside or outside a chimney. The applicants would use
personnel cages, personnel platforms, or boatswains' chairs solely to
transport employees with the tools and materials necessary to do their
work, and not to transport only materials or tools in the absence of
employees.
    The applicants would use a hoist engine, located and controlled
outside the chimney, to power the hoist system. The system also would
consist of a wire rope that: spools off the hoist drum into the
interior of the chimney; passes to a footblock that redirects the rope
from the horizontal to the vertical planes; goes from the footblock
through the overhead sheaves above the elevated platform; and finally
drops to the bottom landing of the chimney where it connects to the
personnel or material transport. The cathead, which is a superstructure
at the top of a derrick, supports the overhead sheaves. The overhead
sheaves (and the vertical span of the hoist system) move upward with
the derrick as chimney construction progresses. Two guide cables,
suspended from the cathead, eliminate swaying and rotation of the load.
If the hoist rope breaks, safety clamps activate and grip the guide
cables to prevent the load from falling. The applicants would use a
headache ball, located on the hoist rope directly above the load, to
counterbalance the rope's weight between the cathead sheaves and the
footblock.
    The applicants would implement additional conditions to improve
employee safety, including:
     Attaching the wire rope to the personnel cage using a
keyed-screwpin shackle or positive-locking link;
     Adding limit switches to the hoist system to prevent
overtravel by the personnel- or material-transport devices;
     Providing the safety factors and other precautions
required for personnel hoists specified by the pertinent provisions of
Sec.  1926.552(c), including canopies and shields to protect employees
located in a personnel cage from material that may fall during hoisting
and other overhead activities;
     Providing falling-object protection for scaffold platforms
as specified by Sec.  1926.451(h)(1);

     Conducting tests and inspections of the hoist system as
required by Sec. Sec.  1926.20(b)(2) and 1926.552(c)(15);
     Establishing an accident-prevention program that conforms
to Sec.  1926.20(b)(3);
     Ensuring that employees who use a personnel platform or
boatswains' chair wear full-body harnesses and lanyards, and that the
lanyards are attached to lifelines during the entire period of vertical
transit; and
     Securing the lifelines (used with a personnel platform or
boatswains' chair) to the rigging at the top of the chimney and to a
weight at the bottom of the chimney to provide maximum stability to the
lifelines.

B. Previous Variances From Sec. Sec.  1926.452(o)(3) and 1926.552(c)

    Since 1973, a number of chimney-construction companies demonstrated
to OSHA that several of the hoist-tower requirements of Sec.
1926.552(c) present access problems that pose a serious danger to their
employees. These companies received permanent variances from these
personnel-hoist and boatswains'-chair requirements, and they used
essentially the same alternate apparatus and procedures that the
applicants are now proposing to use in this variance application. The
Agency published the permanent variances for these companies at 38 FR
8545 (April 3, 1973), 44 FR 51352 (August 31, 1979), 50 FR 20145 (May
14, 1985), 50 FR 40627 (October 4, 1985), 52 FR 22552 (June 12, 1987),
68 FR 52961 (September 8, 2003), 70 FR 72659 (December 6, 2005), and 71
FR 10557 (March 1, 2006).\3\
---------------------------------------------------------------------------

    \3\ Zurn Industries, Inc. received two permanent variances from
OSHA. The first variance, granted on May 14, 1985 (50 FR 20145),
addressed the boatswains'-chair provision (then in paragraph (1)(5)
of Sec.  1926.451), as well as the hoist-platform requirements of
paragraphs (c)(1), (c)(2), (c)(3), and (c)(14)(i) of Sec.  1926.552.
The second variance, granted on June 12, 1987 (52 FR 22552),
included these same paragraphs, as well as paragraphs (c)(4),
(c)(8), (c)(13), and (c)(16) of Sec.  1926.552.
---------------------------------------------------------------------------

    In 1980, the Agency evaluated the alternative conditions specified
in the permanent variances that it had granted to chimney-construction
companies as of that date. In doing so, OSHA observed hoisting
operations conducted by these companies at various construction sites.
These evaluations found that, while the alternative conditions
generally were safe, compliance with the conditions among the companies
was uneven (see Exs. 4-3 and 4-4). Additionally, the National Chimney
Construction Safety and Health Advisory Committee, an industry-
affiliated organization, conducted evaluations of the hoist systems
that provided useful information regarding the safety and efficacy of
the alternative conditions (see Ex. 4-5).
    The permanent variance granted by OSHA to American Boiler and
Chimney Co. and Oak Park Chimney Corp. (see 68 FR 52961, September 8,
2003) updated the permanent variances granted by the Agency in the
1970s and 1980s by clarifying the alternative conditions and citing the
most recent consensus standards and other references. On the basis of
this experience and knowledge, the Agency finds that the applicants'
request for a permanent variance is consistent with the permanent
variances that OSHA has granted previously to other employers in the
chimney-construction industry. Therefore, the Agency believes that the
conditions specified in this variance application will provide the
applicants' employees with at least the same level of safety that they
would receive from Sec.  1926.452(o)(3) and paragraphs (c)(1) through
(c)(4), (c)(8), (c)(13), (c)(14)(i), and (c)(16) of Sec.  1926.552.

C. Requested Variance From Sec.  1926.452(o)(3)

    The applicants state that it is necessary, on occasion, to use a
boatswains' chair to transport employees to and from a bracket scaffold
on the outside of an existing chimney during flue installation or
repair work, or to and from an elevated scaffold located inside a
chimney that has a small or tapering diameter. Paragraph (o)(3) of
Sec.  1926.452, which regulates the tackle used to rig a boatswains'
chair, states that this tackle must ``consist of correct size ball
bearings or bushed blocks containing safety hooks and properly `eye-
spliced' minimum five-eighth (5/8'') inch diameter first-grade manila
rope [or equivalent rope].''
    The primary purpose of this paragraph is to allow an employee to
safely control the ascent, descent, and stopping locations of the
boatswains' chair. However, the applicants note that the required
tackle is difficult or impossible to operate on some chimneys that are
over 200 feet tall because of space limitations. Therefore, as an
alternative to complying with the tackle requirements specified by
Sec.  1926.452(o)(3), the applicants propose to use the hoisting system
described in section III.A (``Overview'') of this notice, both inside
and outside a chimney, to raise or lower employees in a personnel cage
to work locations. The applicants would use a personnel cage for this
purpose to the extent that adequate space is available; they would use
a personnel platform whenever a personnel cage is infeasible because of
limited space. However, when limited space also makes a personnel
platform infeasible, the applicants then would use a boatswains' chair
to lift employees to work locations. The applicants would limit use of
the boatswains' chair to elevations above the highest work location
that the personnel cage and personnel platform can reach; under these
conditions, the applicants would attach the boatswains' chair directly
to the hoisting cable only when the structural arrangement precludes
the safe use of the block and tackle required by Sec.  1926.452(o)(3).

D. Requested Variance From Sec.  1926.552(c)

    Paragraph (c) of Sec.  1926.552 specifies the requirements for
enclosed hoisting systems used to transport personnel from one
elevation to another. This paragraph ensures that employers transport
employees safely to and from elevated work platforms by mechanical
means during the construction, alteration, repair, maintenance, or
demolition of structures such as chimneys. However, this standard does
not provide specific safety requirements for hoisting personnel to and
from elevated work platforms and scaffolds in tapered chimneys; the
tapered design requires frequent relocation of, and adjustment to, the
work platforms and scaffolds. The space in a small-diameter or tapered
chimney is not large enough or configured so that it can accommodate an
enclosed hoist tower. Moreover, using an enclosed hoist tower for
outside operations exposes employees to additional fall hazards because
extra bridging and bracing must be installed to support a walkway
between the hoist tower and the tapered chimney.
    Paragraph (c)(1) of Sec.  1926.552 requires the employer to enclose
hoist towers located outside a chimney on the side or sides used for
entrance to, and exit from, the chimney; these enclosures must extend
the full height of the hoist tower. The applicants assert that it is
impractical and hazardous to locate a hoist tower outside tapered
chimneys because it becomes increasingly difficult, as a chimney rises,
to erect, guy, and brace a hoist tower; under these conditions, access
from the hoist tower to the chimney or to the movable scaffolds used in
constructing the chimney exposes employees to a serious fall hazard.
Additionally, the applicants note that the requirement to extend the
enclosures 10 feet above the outside scaffolds often exposes the
employees

involved in building these extensions to dangerous wind conditions.
    Paragraph (c)(2) of Sec.  1926.552 requires that employers enclose
all four sides of a hoist tower even when the tower is located inside a
chimney; the enclosure must extend the full height of the tower. The
applicants contend that it is hazardous for employees to erect and
brace a hoist tower inside a chimney, especially small-diameter or
tapered chimneys, or chimneys with sublevels, because these structures
have limited space and cannot accommodate hoist towers; space
limitations result from chimney design (e.g., tapering), as well as
reinforced steel projecting into the chimney from formwork that is near
the work location.
    As an alternative to complying with the hoist-tower requirements of
Sec.  1926.552(c)(1) and (c)(2), the applicants propose to use the
rope-guided hoist system described above in section III.A
(``Overview'') of this application to transport employees to and from
work locations inside and outside chimneys. Use of the proposed hoist
system would eliminate the need for the applicants to comply with other
provisions of Sec.  1926.552(c) that specify requirements for hoist
towers. Therefore, the applicants are requesting a permanent variance
from several other closely-related provisions, as follows:
     (c)(3)--Anchoring the hoist tower to a structure;
     (c)(4)--Hoistway doors or gates;
     (c)(8)--Electrically interlocking entrance doors or gates
that prevent hoist movement when the doors or gates are open;
     (c)(13)--Emergency stop switch located in the car;
     (c)(14)(i)--Using a minimum of two wire ropes for drum-
type hoisting; and
     (c)(16)--Construction specifications for personnel hoists,
including materials, assembly, structural integrity, and safety
devices.
    The applicants assert that the proposed hoisting system would
protect its employees at least as effectively as the hoist-tower
requirements of Sec.  1926.552(c).

IV. Grant of Interim Order

    In addition to requesting a permanent variance, the applicants also
requested an interim order that would remain in effect until the Agency
makes a decision on their application for a permanent variance. During
this period, the applicants must comply fully with the conditions of
the interim order as an alternative to complying with the tackle
requirements provided for boatswains' chairs by Sec.  1926.452(o)(3)
and the requirements for hoist towers specified by paragraphs (c)(1)
through (c)(4), (c)(8), (c)(13), (c)(14)(i), and (c)(16) of Sec.
1926.552.
    Based on its previous experience with permanent variances from
these provisions granted to other companies, OSHA believes that an
interim order is justified in this case. As noted above in section
III.B (``Previous Variances * * * ''), the Agency has granted a number
of permanent variances from these provisions since 1973. Over this
period, the affected companies have used effectively the alternative
conditions specified in the variances. Moreover, the conditions of the
interim order requested by the applicants substantially duplicate the
conditions approved recently in the permanent variance granted to
American Boiler and Chimney Co. and Oak Park Chimney Corp. (see 68 FR
52961). In granting this permanent variance to American Boiler and
Chimney Co. and Oak Park Chimney Corp., the Agency stated, ``[W]hen the
employers comply with the conditions of the following order, their
employees will be exposed to working conditions that are at least as
safe and healthful as they would be if the employers complied with
paragraph (o)(3) of Sec.  1926.452, and paragraphs (c)(1) through
(c)(4), (c)(8), (c)(13), (c)(14)(i), and (c)(16) of Sec.  1926.552.''
(See 68 FR 52967.)
    Having determined previously that the alternative conditions
proposed by the applicants will protect employees at least as
effectively as the requirements of paragraph (o)(3) of Sec.  1926.452
and paragraphs (c)(1) through (c)(4), (c)(8), (c)(13), (c)(14)(i), and
(c)(16) of Sec.  1926.552, OSHA has decided to grant an interim order
to the applicants pursuant to the provisions of Sec.  1905.11(c).
Accordingly, in lieu of complying with paragraph (o)(3) of Sec.
1926.452 and paragraphs (c)(1) through (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16) of Sec.  1926.552, the applicants will: (1)
Provide notice of this grant of interim order to the employees affected
by the conditions of the interim order using the same means it used to
inform these employees of their applications for a permanent variance;
and (2) comply with the conditions listed below in section V
(``Specific Conditions of the Interim Order * * * '') of this
application for the period between the date of this Federal Register
notice and the date the Agency publishes its final decision on the
application in the Federal Register; the interim order will remain in
effect during this period unless OSHA modifies or revokes it in
accordance with the requirements of Sec.  1905.13.

V. Specific Conditions of the Interim Order and the Application for a
Permanent Variance

    The following conditions apply to the interim order being granted
by OSHA to Gibraltar Chimney International, LLC, Hoffmann, Inc., and
Kiewit Industrial Co., as part of their applications for a permanent
variance described in this Federal Register notice. In addition, these
conditions specify the alternatives to the requirements of paragraph
(o)(3) of Sec.  1926.452 and paragraphs (c)(1) through (c)(4), (c)(8),
(c)(13), (c)(14)(i), and (c)(16) of Sec.  1926.552 that the applicants
are proposing in their application for a permanent variance. These
conditions include: \4\
---------------------------------------------------------------------------

    \4\ In these conditions, the verb ``must'' applies to the
interim order, while the verb ``would'' pertains to the application
for a permanent variance.
---------------------------------------------------------------------------

1. Scope

    (a) The interim order/permanent variance applies/would apply only
to tapered chimneys when the applicants use a rope-guided hoist system
during inside or outside chimney construction to raise or lower their
employees between the bottom landing of a chimney and an elevated work
location on the inside or outside surface of the chimney.
    (b) When using a rope-guided hoist system as specified in this
permanent variance, the applicants must/would:
    (i) Use the personnel cages, personnel platforms, or boatswains'
chairs raised and lowered by the rope-guided hoist system solely to
transport employees with the tools and materials necessary to do their
work; and
    (ii) Attach a hopper or concrete bucket to the rope-guided hoist
system to raise and lower all other materials and tools inside or
outside a chimney.
    (c) Except for the requirements specified by 29 CFR 1926.452(o)(3)
and 1926.552(c)(1) through (c)(4), (c)(8), (c)(13), (c)(14)(i), and
(c)(16), the applicants must/would comply fully with all other
applicable provisions of 29 CFR parts 1910 and 1926.

2. Replacing a Personnel Cage With a Personnel Platform or a
Boatswains' Chair

    (a) Personnel platform. When the applicants demonstrate that
available space makes a personnel cage for transporting employees
infeasible, they may replace the personnel cage with a personnel
platform when they limit use of the personnel platform to elevations
above the last work location that the personnel cage can reach.
    (b) Boatswains' chair. The applicants must/would:

    (i) Before using a boatswains' chair, demonstrate that available
space makes it infeasible to use a personnel platform for transporting
employees;
    (ii) Limit use of a boatswains' chair to elevations above the last
work location that the personnel platform can reach; and
    (iii) Use a boatswains' chair in accordance with block-and-tackle
requirements specified by 29 CFR 1926.452(o)(3), unless they can
demonstrate that the structural arrangement of the chimney precludes
such use.

3. Qualified Competent Person

    (a) The applicants must/would:
    (i) Provide a qualified competent person, as specified in
paragraphs (f) and (m) of 29 CFR 1926.32, who is responsible for
ensuring that the design, maintenance, and inspection of the hoist
system comply with the conditions of this grant and with the
appropriate requirements of 29 CFR part 1926 (``Safety and Health
Regulations for Construction''); and
    (ii) Ensure that the qualified competent person is present at
ground level to assist in an emergency whenever the hoist system is
raising or lowering employees.
    (b) The applicants must/would use a qualified competent person to
design and maintain the cathead described under Condition 8 (``Cathead
and Sheave'') below.

4. Hoist Machine

    (a) Type of hoist. The applicants must/would designate the hoist
machine as a portable personnel hoist.
    (b) Raising or lowering a transport. The applicants must/would
ensure that:
    (i) The hoist machine includes a base-mounted drum hoist designed
to control line speed; and
    (ii) Whenever they raise or lower a personnel or material hoist
(e.g., a personnel cage, personnel platform, boatswains' chair, hopper,
concrete bucket) using the hoist system:
    (A) The drive components are engaged continuously when an empty or
occupied transport is being lowered (i.e., no ``freewheeling'');
    (B) The drive system is interconnected, on a continuous basis,
through a torque converter, mechanical coupling, or an equivalent
coupling (e.g., electronic controller, fluid clutches, hydraulic
drives).
    (C) The braking mechanism is applied automatically when the
transmission is in the neutral position and a forward-reverse coupling
or shifting transmission is being used; and
    (D) No belts are used between the power source and the winding
drum.
    (c) Power source. The applicants must/would power the hoist machine
by an air, electric, hydraulic, or internal-combustion drive mechanism.
    (d) Constant-pressure control switch. The applicants must/would:
    (i) Equip the hoist machine with a hand- or foot-operated constant-
pressure control switch (i.e., a ``deadman control switch'') that stops
the hoist immediately upon release; and
    (ii) Protect the control switch to prevent it from activating if
the hoist machine is struck by a falling or moving object.
    (e) Line-speed indicator. The applicants must/would:
    (i) Equip the hoist machine with an operating line-speed indicator
maintained in good working order; and
    (ii) Ensure that the line-speed indicator is in clear view of the
hoist operator during hoisting operations.
    (f) Braking systems. The applicants must/would equip the hoist
machine with two (2) independent braking systems (i.e., one automatic
and one manual) located on the winding side of the clutch or couplings,
with each braking system being capable of stopping and holding 150
percent of the maximum rated load.
    (g) Slack-rope switch. The applicants must/would equip the hoist
machine with a slack-rope switch to prevent rotation of the winding
drum under slack-rope conditions.
    (h) Frame. The applicants must/would ensure that the frame of the
hoist machine is a self-supporting, rigid, welded-steel structure, and
that holding brackets for anchor lines and legs for anchor bolts are
integral components of the frame.
    (i) Stability. The applicants must/would secure hoist machines in
position to prevent movement, shifting, or dislodgement.
    (j) Location. The applicants must/would:
    (i) Locate the hoist machine far enough from the footblock to
obtain the correct fleet angle for proper spooling of the cable on the
drum; and
    (ii) Ensure that the fleet angle remains between one-half degree
(\1/2\[deg]) and one and one-half degrees (1-\1/2\[deg]) for smooth
drums, and between one-half degree (\1/2\[deg]) and two degrees
(2[deg]) for grooved drums, with the lead sheave centered on the
drum.\5\
---------------------------------------------------------------------------

    \5\ This provision adopts the definition of, and specifications
for, fleet angle from Cranes and Derricks, H. I. Shapiro, et al.
(eds.); New York: McGraw-Hill; 3rd ed., 1999, page 592. Accordingly,
the fleet angle is ``[t]he angle the rope leading onto a [winding]
drum makes with the line perpendicular to the drum rotating axis
when the lead rope is making a wrap against the flange.''
---------------------------------------------------------------------------

    (k) Drum and flange diameter. The applicants must/would:
    (i) Provide a winding drum for the hoist that is at least 30 times
the diameter of the rope used for hoisting; and
    (ii) Ensure that the winding drum has a flange diameter that is at
least one and one-half (1-\1/2\) times the winding-drum diameter.
    (l) Spooling of the rope. The applicants must/would never spool the
rope closer than two (2) inches (5.1 cm) from the outer edge of the
winding-drum flange.
    (m) Electrical system. The applicants must/would ensure that all
electrical equipment is weatherproof.
    (n) Limit switches. The applicants must/would equip the hoist
system with limit switches and related equipment that automatically
prevent overtravel of a personnel cage, personnel platform, boatswains'
chair, or material-transport device at the top of the supporting
structure and at the bottom of the hoistway or lowest landing level.

5. Methods of Operation

    (a) Employee qualifications and training. The applicants must/
would:
    (i) Ensure that only trained and experienced employees, who are
knowledgeable of hoist-system operations, control the hoist machine;
and
    (ii) Provide instruction, periodically and as necessary, on how to
operate the hoist system to each employee who uses a personnel cage,
personnel platform, or boatswains' chair for transportation.
    (b) Speed limitations. The applicants must/would not operate the
hoist at a speed in excess of:
    (i) Two hundred and fifty (250) feet (76.9 m) per minute when a
personnel cage is being used to transport employees;
    (ii) One hundred (100) feet (30.5 m) per minute when a personnel
platform or boatswains' chair is being used to transport employees; or
    (iii) A line speed that is consistent with the design limitations
of the system when only material is being hoisted (i.e., using a
dedicated material-transport device such as a hopper or concrete
bucket).
    (c) Communication. The applicants must/would:
    (i) Use an electronic voice-communication system \6\ to maintain
communication between the hoist operator and the employees located in

or on a moving personnel cage, personnel platform, or boatswains'
chair;
---------------------------------------------------------------------------

    \6\ OSHA is revising the phrase ``a voice-mediated
intercommunication system'' used in previous variances to ``an
electronic voice-communication systems'' to clarify the requirement.
---------------------------------------------------------------------------

    (ii) Stop hoisting if, for any reason, the communication system
fails to operate effectively; and
    (iii) Resume hoisting only when the site superintendent determines
that it is safe to do so.

6. Hoist Rope

    (a) Grade. The applicants must/would use a wire rope for the hoist
system (i.e., ``hoist rope'') that consists of extra-improved plow
steel, an equivalent grade of non-rotating rope, or a regular lay rope
with a suitable swivel mechanism.
    (b) Safety factor. The applicants must/would maintain a safety
factor of at least eight (8) times the safe workload throughout the
entire length of hoist rope.
    (c) Size. The applicants must/would use a hoist rope that is at
least one-half (1/2) inch (1.3 cm) in diameter.
    (d) Inspection, removal, and replacement. The applicants must/
would:
    (i) Thoroughly inspect the hoist rope before the start of each job
and on completing a new setup;
    (ii) Maintain the proper diameter-to-diameter ratios between the
hoist rope and the footblock and the sheave by inspecting the wire rope
regularly (see Conditions 7(c) and 8(d) below); and
    (iii) Remove and replace the wire rope with new wire rope when any
condition specified by 29 CFR 1926.552(a)(3) occurs.
    (e) Attachments. The applicants must/would attach the rope to a
personnel cage, personnel platform, or boatswains' chair with a keyed-
screwpin shackle or positive-locking link.
    (f) Wire-rope fastenings. When the applicants use clip fastenings
(e.g., U-bolt wire-rope clips) with wire ropes, they must/would:
    (i) Use Table H-20 of 29 CFR 1926.251 to determine the number and
spacing of clips;
    (ii) Use at least three (3) drop-forged clips at each fastening;
    (iii) Install the clips with the ``U'' of the clips on the dead end
of the rope; and
    (iv) Space the clips so that the distance between them is six (6)
times the diameter of the rope.

7. Footblock

    (a) Type of block. The applicants must/would use a footblock:
    (i) Consisting of construction-type blocks of solid single-piece
bail with a safety factor that is at least four (4) times the safe
workload, or an equivalent block with roller bearings;
    (ii) Designed for the applied loading, size, and type of wire rope
used for hoisting;
    (iii) Designed with a guard that contains the wire rope within the
sheave groove;
    (iv) Bolted rigidly to the base; and
    (v) Designed and installed so that it turns the moving wire rope to
and from the horizontal or vertical direction as required by the
direction of rope travel.
    (b) Directional change. The applicants must/would ensure that the
angle of change in the hoist rope from the horizontal to the vertical
direction at the footblock is approximately 90[deg].
    (c) Diameter. The applicants must/would ensure that the line
diameter of the footblock is at least 24 times the diameter of the
hoist rope.

8. Cathead and Sheave

    (a) Support. The applicants must/would use a cathead (i.e.,
``overhead support'') that consists of a wide-flange beam, or two (2)
steel-channel sections securely bolted back-to-back to prevent
spreading.
    (b) Installation. The applicants must/would ensure that:
    (i) All sheaves revolve on shafts that rotate on bearings; and
    (ii) The bearings are mounted securely to maintain the proper
bearing position at all times.
    (c) Rope guides. The applicants must/would provide each sheave with
appropriate rope guides to prevent the hoist rope from leaving the
sheave grooves when the rope vibrates or swings abnormally.
    (d) Diameter. The applicants must/would use a sheave with a
diameter that is at least 24 times the diameter of the hoist rope.

9. Guide Ropes

    (a) Number and construction. The applicants must/would affix two
(2) guide ropes by swivels to the cathead. The applicants must/would
ensure that the guide ropes:
    (i) Consist of steel safety cables not less than one-half (\1/2\)
inch (1.3 cm) in diameter; and
    (ii) Be free of damage or defect at all times.
    (b) Guide rope fastening and alignment tension. The applicants
must/would fasten one end of each guide rope securely to the overhead
support, with appropriate tension applied at the foundation.
    (c) Height. The applicants must/would rig the guide ropes along the
entire height of the hoist-machine structure.

10. Personnel Cage

    (a) Construction. The applicants must/would ensure that the
personnel cage is of steel-frame construction and capable of supporting
a load that is four (4) times its maximum rated load capacity. The
applicants also must/would ensure that the personnel cage has:
    (i) A top and sides that are permanently enclosed (except for the
entrance and exit);
    (ii) A floor securely fastened in place;
    (iii) Walls that consist of 14-gauge, one-half (\1/2\) inch (1.3
cm) expanded metal mesh, or an equivalent material;
    (iv) Walls that cover the full height of the personnel cage between
the floor and the overhead covering;
    (v) A sloped roof constructed of one-eighth (\1/8\) inch (0.3 cm)
aluminum, or an equivalent material; and
    (vi) Safe handholds (e.g., rope grips--but not rails or hard
protrusions \7\) that accommodate each occupant.
---------------------------------------------------------------------------

    \7\ To reduce impact hazards should employees lose their balance
because of cage movement.
---------------------------------------------------------------------------

    (b) Overhead weight. The applicants must/would ensure that the
personnel cage has an overhead weight (e.g., a headache ball of
appropriate weight) to compensate for the weight of the hoist rope
between the cathead and footblock. In addition, the applicants must/
would:
    (i) Ensure that the overhead weight is capable of preventing line
run; and
    (ii) Use a means to restrain the movement of the overhead weight so
that the weight does not interfere with safe personnel hoisting.
    (c) Gate. The applicants must/would ensure that the personnel cage
has a gate that:
    (i) Guards the full height of the entrance opening; and
    (ii) Has a functioning mechanical lock that prevents accidental
opening.
    (d) Operating procedures. The applicants must/would post the
procedures for operating the personnel cage conspicuously at the hoist
operator's station.
    (e) Capacity. The applicants must/would:
    (i) Hoist no more than four (4) occupants in the cage at any one
time; and
    (ii) Ensure that the rated load capacity of the cage is at least
250 pounds (113.4 kg) for each occupant so hoisted.
    (f) Employee notification. The applicants must/would post a sign in
each personnel cage notifying employees of the following conditions:
    (i) The standard rated load, as determined by the initial static
drop test specified by Condition 10(g) (``Static drop tests'') below;
and

    (ii) The reduced rated load for the specific job.
    (g) Static drop tests. The applicants must/would:
    (i) Conduct static drop tests of each personnel cage that comply
with the definition of ``static drop test'' specified by section 3
(``Definitions'') and the static drop-test procedures provided in
section 13 (``Inspections and Tests'') of American National Standards
Institute (ANSI) standard A10.22-1990 (R1998) (``American National
Standard for Rope-Guided and Nonguided Worker's Hoists--Safety
Requirements'');
    (ii) Perform the initial static drop test at 125 percent of the
maximum rated load of the personnel cage, and subsequent drop tests at
no less than 100 percent of its maximum rated load; and
    (iii) Use a personnel cage for raising or lowering employees only
when no damage occurred to the components of the cage as a result of
the static drop tests.

11. Safety Clamps

    (a) Fit to the guide ropes. The applicants must/would:
    (i) Fit appropriately designed and constructed safety clamps to the
guide ropes; and
    (ii) Ensure that the safety clamps do not damage the guide ropes
when in use.
    (b) Attach to the personnel cage. The applicants must/would attach
safety clamps to each personnel cage for gripping the guide ropes.
    (c) Operation. The applicants must/would ensure that the safety
clamps attached to the personnel cage:
    (i) Operate on the ``broken rope principle'' defined in section 3
(``Definitions'') of ANSI standard A10.22-1990 (R1998);
    (ii) Be capable of stopping and holding a personnel cage that is
carrying 100 percent of its maximum rated load and traveling at its
maximum allowable speed if the hoist rope breaks at the footblock; and
    (iii) Use a pre-determined and pre-set clamping force (i.e., the
``spring compression force'') for each hoist system.
    (d) Maintenance. The applicants must/would keep the safety-clamp
assemblies clean and functional at all times.

12. Overhead Protection

    (a) The applicants must/would install a canopy or shield over the
top of the personnel cage that is made of steel plate at least three-
sixteenth (\3/16\) of an inch (4.763 mm) thick, or material of
equivalent strength and impact resistance, to protect employees (i.e.,
both inside and outside the chimney) from material and debris that may
fall from above.
    (b) The applicants must/would ensure that the canopy or shield
slopes to the outside of the personnel cage.\8\
---------------------------------------------------------------------------

    \8\ Paragraphs (a) and (b) were adapted from OSHA's Underground
Construction Standard (29 CFR 1926.800(t)(4)(iv)).
---------------------------------------------------------------------------

13. Emergency-Escape Device

    (a) Location. The applicants must/would provide an emergency-escape
device in at least one of the following locations:
    (i) In the personnel cage, provided that the device is long enough
to reach the bottom landing from the highest possible escape point; or
    (ii) At the bottom landing, provided that a means is available in
the personnel cage for the occupants to raise the device to the highest
possible escape point.
    (b) Operating instructions. The applicants must/would ensure that
written instructions for operating the emergency-escape device are
attached to the device.
    (c) Training. The applicants must/would instruct each employee who
uses a personnel cage for transportation on how to operate the
emergency-escape device:
    (i) Before the employee uses a personnel cage for transportation;
and
    (ii) Periodically, and as necessary, thereafter.

14. Personnel Platforms and Fall-Protection Equipment

    (a) Personnel platforms. When the applicants elect to replace the
personnel cage with a personnel platform in accordance with Condition
2(a) above, they must/would:
    (i) Ensure that an enclosure surrounds the platform, and that this
enclosure is at least 42 inches (106.7 cm) above the platform's floor;
    (ii) Provide overhead protection when an overhead hazard is, or
could be, present; and
    (iii) Comply with the applicable scaffolding strength requirements
specified by 29 CFR 1926.451(a)(1).
    (b) Fall-protection equipment. Before employees use work platforms
or boatswains' chairs, the applicants must/would:
    (i) Equip the employees with, and ensure that they use, full-body
harnesses, lanyards, and lifelines as specified by 29 CFR 1926.104 and
the applicable requirements of 29 CFR 1926.502(d); and
    (ii) Ensure that employees secure the lifelines to the top of the
chimney and to a weight at the bottom of the chimney, and that the
employees' lanyards are attached to the lifeline during the entire
period of vertical transit.

15. Inspections, Tests, and Accident Prevention

    (a) The applicants must/would:
    (i) Conduct inspections of the hoist system as required by 29 CFR
1926.20(b)(2);
    (ii) Ensure that a competent person conducts daily visual
inspections of the hoist system; and
    (iii) Inspect and test the hoist system as specified by 29 CFR
1926.552(c)(15).
    (b) The applicants must/would comply with the accident-prevention
requirements of 29 CFR 1926.20(b)(3).

16. Welding

    (a) The applicants must/would ensure that only qualified welders
weld components of the hoisting system.
    (b) The applicants must/would ensure that the qualified welders:
    (i) Are familiar with the weld grades, types, and materials
specified in the design of the system; and
    (ii) Perform the welding tasks in accordance with 29 CFR part 1926,
subpart J (``Welding and Cutting'').

VII. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, 200 Constitution Ave.,
NW., Washington, DC directed the preparation of this notice. This
notice is issued under the authority specified by Section 6(d) of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 655), Secretary
of Labor's Order No. 5-2002 (67 FR 65008), and 29 CFR part 1905.

    Signed at Washington, DC, on February 2, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor.
 [FR Doc. E7-2046 Filed 2-7-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49314-49316]
[FR Doc No: 2019-20327]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3277]

Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of Zika Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Luminex Corp., for the xMAP MultiFLEX Zika RNA Assay. FDA
revoked this Authorization on July 3, 2019, under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as requested by Luminex Corp. by a
letter dated June 18, 2019. The revocation, which includes an
explanation of the reasons for revocation, is reprinted in this
document.

DATES: The Authorization is revoked as of July 3, 2019.

ADDRESSES: Submit written requests for single copies of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276), and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On August 4, 2016, FDA issued an
EUA to Luminex Corp. for the xMAP MultiFLEX Zika RNA Assay, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on October 28, 2016
(81 FR 75092), as required by section 564(h)(1) of the FD&C Act. In
response to requests from Luminex Corp., the EUA was amended on January
7, 2017, and May 19, 2017. Under section 564(g)(2) of the FD&C Act, the
Secretary of HHS may revoke an EUA if, among other things, the criteria
for issuance are no longer met or other circumstances make such
revocation appropriate to protect the public health or safety.

II. EUA Revocation Request for an In Vitro Diagnostic Device for
Detection of the Zika Virus

    On June 18, 2019, Luminex Corp. requested, and on July 3, 2019, FDA
revoked, the EUA for the xMAP MultiFLEX Zika RNA Assay because the
product will no longer be marketed, and these circumstances make
revocation appropriate to protect the public health or safety.

III. Electronic Access

    An electronic version of this document and the full text of the
revocation are available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for Luminex Corp.'s xMAP MultiFLEX Zika RNA Assay. The
revocation in its entirety follows and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.

[GRAPHIC] [TIFF OMITTED] TN19SE19.019

    Dated: September 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20327 Filed 9-18-19; 8:45 am]
 BILLING CODE 4164-01-P