[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Notices]
[Pages 8391-8393]
[FR Doc No: 2011-3186]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 63859; File No. SR-BX-2011-007]

Self-Regulatory Organizations; NASDAQ OMX BX LLC; Notice of
Filing of Proposed Rule Change Relating to Permanent Approval of the BX
and NES Inbound Routing Relationship

February 7, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on January 28, 2011, NASDAQ OMX BX LLC (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, pursuant to Section 19(b)(1) of the Act \3\ and Rule
19b-4 thereunder,\4\ proposes request permanent approval of the
Exchange's pilot program to permit the Exchange to accept inbound
orders that Nasdaq Execution Services, LLC (``NES'') routes in its
capacity as a facility of NASDAQ (with the attendant obligations and
conditions).
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    \3\ 15 U.S.C. 78s(b)(1).
    \4\ 17 CFR 240.19b-4.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
Exchange has prepared summaries, set forth in sections A, B, and C
below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to request permanent
approval of the Exchange's pilot program to permit the Exchange to
accept inbound orders that NES routes in its capacity as a facility of
NASDAQ (with the attendant obligations and conditions). Currently, NES
is the approved outbound routing facility of the NASDAQ Stock Market
LLC (``NASDAQ'') for cash equities, providing outbound routing from
NASDAQ to other market centers.\5\ BX also has been previously approved
to receive inbound routes of equities orders by NES in its capacity as
an order routing facility of NASDAQ on a pilot basis.\6\ On January 19,
2011, the Exchange filed a proposal to extend the current pilot program
until June 15, 2011, with further understanding that the Exchange would
file a separate proposal with the Commission seeking permanent approval
of the BX and NES routing relationship.\7\ The Exchange hereby seeks
permanent approval to permit the Exchange to accept inbound orders that
NES routes in its capacity as a facility of NASDAQ (with the attendant
obligations and conditions).
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    \5\ See Securities Exchange Act Release Nos. 50311 (September 3,
2004), 69 FR 54818 (September 10, 2004) (Order Granting Application
for a Temporary Conditional Exemption Pursuant To Section 36(a) of
the Exchange Act by the National Association of Securities Dealers,
Inc. Relating to the Acquisition of an ECN by The Nasdaq Stock
Market, Inc.) and 52902 (December 7, 2005), 70 FR 73810 (December
13, 2005) (SR-NASD-2005-128) (Order Approving a Proposed Rule Change
To Establish Rules Governing the Operation of the INET System). See
also SR-NASDAQ-2011-004 (January 14, 2011); Securities Exchange Act
Release Nos. 63083 (October 13, 2010), 75 FR 64370 (October 19,
2010) (SR-NASDAQ-2010-127); 62736 (August 17, 2010), 75 FR 51861
(August 23, 2010) (SR-NASDAQ-2010-100); 61682 (March 10, 2010), 75
FR 12592 (March 16, 2010) (SR-NASDAQ-2010-030); 61460 (February 1,
2010), 75 FR 6077 (February 5, 2010) (SR-NASDAQ-2010-018); 60039
(June 3, 2009), 74 FR 27365 (June 9, 2009) (SR-NASDAQ-2009-050);
59875 (May 6, 2009), 74 FR 22794 (May 14, 2009) (SR-NASDAQ-2009-
043); 59807 (April 21, 2009), 74 FR 19251 (April 28, 2009) (SR-
NASDAQ-2009-036); 59153 (December 23, 2008), 73 FR 80485 (December
31, 2008) (SR-NASDAQ-2008-098); 58752 (October 8, 2008), 73 FR 61181
(October 15, 2008) (SR-NASDAQ-2008-079); 58135 (July 10, 2008), 73
FR 40898 (July 16, 2008) (SR-NASDAQ-2008-061); 58069 (June 30,
2008), 73 FR 39360 (July 9, 2008) (SR-NASDAQ-2008-054); 56708
(October 26, 2007), 72 FR 61925 (November 1, 2007) (SR-NASDAQ-2007-
078); 56867 (November 29, 2007), 72 FR 69263 (December 7, 2007) (SR-
NASDAQ-2007-065); 55335 (February 23, 2007), 72 FR 9369 (March 1,
2007) (SR-NASDAQ-2007-005); 54613 (October 17, 2006), 71 FR 62325
(October 24, 2006) (SR-NASDAQ 2006-043); 54271 (August 3, 2006), 71
FR 45876 (August 10, 2006) (SR-NASDAQ-2006-027); and 54155 (July 14,
2006), 71 FR 41291 (July 20, 2006) (SR-NASDAQ-2006-001).
    \6\ See Securities Exchange Act Release Nos. 59154 (December 23,
2008), 73 FR 80468 (December 31, 2008) (SR-BX-2008-048); 61271
(December 31, 2009), 75 FR 1102 (January 8, 2010) (SR-BX-2009-085);
61782 (March 25, 2010), 75 FR 16534 (April 1, 2010) (SR-BX-2010-
021); 62528 (July 19, 2010), 75 FR 43210 (July 23, 2010) (SR-BX-
2010-048). See also Securities Exchange Act Release No. 63769
(January 26, 2011)(SR-BX-2011-003).
    \7\ See Securities Exchange Act Release No. 63769 (January 26,
2011)(SR-BX-2011-003).
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    In the initial Order, the Commission granted the BX and NES inbound
routing relationship on a pilot basis. During this pilot period, BX
committed to the following conditions:
    1. The Exchange and FINRA will enter into a regulatory services
agreement (``Regulatory Contract''), as well as an agreement pursuant
to Rule 17d-2 under the Act (``17d-2 Agreement'').\8\ Pursuant to the
Regulatory Contract and the 17d-2 Agreement, FINRA will be allocated
regulatory responsibilities to review NES's compliance with certain
Exchange rules.\9\ Pursuant to the Regulatory Contract, however, BX
retains ultimate responsibility for enforcing its rules with respect to
NES;
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    \8\ 17 CFR 240.17d-2.
    \9\ The Exchange also states that NES is subject to independent
oversight by FINRA, its Designated Examining Authority, for
compliance with financial responsibility requirements. See
Securities Exchange Act Release No. 58927 (November 10, 2008), 73 FR
69685, 69689 (November 19, 2008) (``Notice'').
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    2. FINRA will monitor NES for compliance with the Exchange's
trading rules, and will collect and maintain certain related
information; \10\
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    \10\ Pursuant to the Regulatory Contract, both FINRA and the
Exchange will collect and maintain all alerts, complaints,
investigations and enforcement actions in which NES (in its capacity
as a facility of Nasdaq routing orders to the Exchange) is
identified as a participant that has potentially violated applicable
Commission or Exchange rules. The Exchange and FINRA will retain
these records in an easily accessible manner in order to facilitate
any potential review conducted by the Commission's Office of
Compliance Inspections and Examinations. Id.

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    3. FINRA will provide a report to the Exchange's chief regulatory
officer (``CRO''), on a quarterly basis, that: (i) Quantifies all
alerts (of which FINRA is aware) that identify NES as a participant
that has potentially violated Commission or Exchange rules, and (ii)
lists all investigations that identify NES as a participant that has
potentially violated Commission or Exchange rules; \11\
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    \11\ Id.
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    4. adopt Rule 2140(c), which requires NASDAQ OMX, as the holding
company owning both the Exchange and NES, to establish and maintain
procedures and internal controls reasonably designed to ensure that NES
does not develop or implement changes to its system, based on non-
public information obtained regarding planned changes to the Exchange's
systems as a result of its affiliation with the Exchange, until such
information is available generally to similarly situated Exchange
members, in connection with the provision of inbound order routing to
the Exchange; \12\ and
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    \12\ See Equity Rule 2140(c). See also Notice, supra note 7, 73
FR at 69689-69690.
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    5. That the routing of orders from NES to the Exchange, in NES's
capacity as a facility of Nasdaq, be authorized for a pilot period of
twelve months.\13\
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    \13\ See Amendment No. 2 to Notice, filed December 23, 2008. In
Amendment No. 2, the Exchange clarified that its proposal, as
opposed to Nasdaq's corresponding proposal, be approved on a twelve-
month pilot basis. See also Notice, supra note 7, n.15 and
accompanying text.
     See e-mail from Arlinda J. Clark, Assistant General Counsel,
NASDQ OMX BX, to Jennifer Dodd, Special Counsel, Office of Market
Supervision, Division of Trading and Markets, Commission, dated
February 3, 2011 (requesting corrections to this footnote).
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    The Exchange has met all the above-listed conditions. By meeting
the above-conditions, the Exchange has set up mechanisms that protect
the independence of the Exchange's regulatory responsibility with
respect to NES, as well as demonstrate that NES cannot use any
information advantage it may have because of its affiliation with the
Exchange. Since the Exchange has met all the above-listed conditions,
it now seeks permanent approval of the BX and NES inbound routing
relationship. The Exchange will continue to comply with the conditions
1-4 stated above.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\14\ in general, and with
Section 6(b)(5) of the Act,\15\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Specifically,
the proposed rule change will allow the Exchange to continue receiving
inbound routes of equities orders from NES, acting in its capacity as a
facility of NASDAQ, in a manner consistent with prior approvals and
established protections. The Exchange believes that having met the
commitments established during the pilot program demonstrates that the
Exchange has mechanisms that protect the independence of the Exchange's
regulatory responsibility with respect to NES, as well as demonstrate
that NES cannot use any information advantage it may have because of
its affiliation with the Exchange.
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    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2011-007 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2011-007. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies such filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BX-
2011-007 and should be submitted on or before March 7, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-3186 Filed 2-11-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44885-44887]
[FR Doc No: 2020-16048]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2020-0181; FRL-10011-36-ORD]

Notice of Public Comment Period on Technical Documents for
External Peer Review and the Pool of Candidate Peer Reviewers for a
Report on Physiologically Based Pharmacokinetic (PBPK) Modeling for
Chloroprene and a Supplemental Analysis of Metabolite Clearance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and external peer review.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period on documents

associated with a Report on Physiologically Based Pharmacokinetic
(PBPK) Modeling for Chloroprene and a Supplemental Analysis of
Metabolite Clearance. These documents will undergo independent external
scientific peer review managed by Versar (https://www.versar.com/), an
EPA contractor. Public comments on the documents associated with the
PBPK modeling will be provided to the external peer reviewers. Versar
will convene a virtual meeting of the peer reviewers, which will be
open to the public and include an opportunity to provide oral comments.
In preparation for the external peer review, EPA is also announcing a
30-day public comment period on the pool of candidates to conduct the
external peer review of the documents identified above. Versar will
consider public comments on these candidates and evaluate any conflicts
of interest and/or appearance of lack of impartiality, and will then
select nine independent experts from the pool of 19 candidates.
Information on the external peer review process, including details on
how to provide comments on the proposed pool of candidates, is further
described in this notice. Once complete, the final peer review report
will be used to inform EPA's Reconsideration of a 2017 Request for
Correction related to the Integrated Risk Information System (IRIS)
assessment of chloroprene.

DATES: The 30-day public comment period on the technical documents and
the list of proposed peer review candidates begins July 24, 2020 and
ends August 24, 2020. Comments must be received on or before August 24,
2020.

ADDRESSES: Submit written comments to Docket ID No. EPA-HQ-ORD-2020-
0181 no later than August 24, 2020. Documents associated with this peer
review will be available within the docket.
    Submit comments on the pool of candidate peer reviewers to Versar
no later than August 24, 2020 by one of the following methods:
<EMAIL_ADDRESS>(Subject line: Chloroprene PBPK Peer
Review); or by phone<PHONE_NUMBER> (ask for Tracey Cowen). Please be
advised that public comments are subject to release under the Freedom
of Information Act.

FOR FURTHER INFORMATION CONTACT:
    For information on how to submit comments on the technical
documents contact: The EPA Headquarters Docket Center; telephone: 202-
566-1752; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>    For general information contact: Dahnish Shams, CPHEA; telephone:
202-564-2758; or email<EMAIL_ADDRESS>    For information regarding the peer review contact: Versar at
<EMAIL_ADDRESS>(Subject line: Chloroprene PBPK Peer
Review); or by phone<PHONE_NUMBER> (ask for Tracey Cowen).

SUPPLEMENTARY INFORMATION:

I. Background

    On June 26, 2017, the U.S. EPA received a Request for Correction
(RFC) provided on behalf of Denka Performance Elastomer LLC (DPE). In
the RFC letter, DPE claimed that the Toxicological Review of
Chloroprene (CAS NO. 126-99-8) in Support of Summary Information on the
Integrated Risk Information System (IRIS), disseminated by EPA's Office
of Research and Development (ORD) in 2010, did not reflect the ``best
available science'' or ``sound and objective scientific practices'' and
requested correction. On January 25, 2018, EPA concluded in response
that the underlying information and conclusions presented in the IRIS
chloroprene assessment are consistent with the EPA's Information
Quality Guidelines and that no evidence published since the 2010 IRIS
Assessment would change its conclusions. On July 23, 2018, DPE
submitted a Request for Reconsideration of Denial of Request for
Correction (RFR) with regard to EPA's decision, and entered into
discussions with EPA to address the uncertainties identified by EPA as
documented in the RFC response. Additional information regarding the
chloroprene RFC/RFR can be found at: https://www.epa.gov/quality/epa-information-quality-guidelines-requests-correction-and-requests-reconsideration#17002. Discussions with Denka LLC (DPE) and its
contractor, Ramboll, are summarized on the IRIS website (https://cfpub.epa.gov/ncea/iris2/events.cfm#stakeholderMeetings).
    An updated PBPK model is now available in a report:
``Physiologically Based Pharmacokinetic (PBPK) Modeling for Chloroprene
(Ramboll, 2020)''. This report, and a Supplemental Analysis of
Metabolite Clearance (U.S. EPA, 2020), will undergo external peer
review to help to inform future decisions regarding the RFR.

II. Information About this Peer Review

    Versar is considering a list of candidates from which to select the
independent, external, peer review panel. The List of Candidates (LoC)
document has been posted to the docket at https://www.regulations.gov
(Docket ID No. EPA-HQ-ORD-2020-0181) and is included below. After
review and consideration of public comments, Versar will select from
this pool the final list of nine (9) peer reviewers in a manner
consistent with EPA's Peer Review Handbook 4th Edition, 2015 (EPA/100/
B-15/001). Versar will independently conduct a conflict of interest
(COI) screening of candidates to ensure that the selected experts have
no COI. EPA will announce the peer review panel meeting date, location,
and registration details, along with the final list of peer reviewers
selected by Versar, at least 30 days prior to the peer review meeting,
on the EPA IRIS website (https://www.epa.gov/iris). Teleconference and
webinar information regarding this public meeting will be provided
through the IRIS website (https://www.epa.gov/iris) and via EPA's IRIS
listserv. To register for the IRIS listserv, visit IRIS website at
https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect. Specific questions or comments on the peer
review process should be directed to Versar by email:
<EMAIL_ADDRESS>(Subject line: Chloroprene PBPK Peer
Review); or by phone<PHONE_NUMBER> (ask for Tracey Cowen). Comments or
questions regarding the peer review candidates must be provided to
Versar by August 24, 2020.

1. Guohua An, M.D., Ph.D., Iowa State University
2. Leslie Z. Benet, Ph.D., University of California San Francisco
3. James V. Bruckner, Ph.D., University of Georgia
4. Michael J. Daniels, Ph.D., University of Florida
5. Stephen S. Ferguson, Ph.D., National Institute of Environmental
Health Sciences (NIEHS),
    National Toxicology Program Division (DNTP)
6. Bernard T. Golding, Ph.D., Newcastle University, UK
7. Jeffrey Heys, Ph.D., P.E., Montana State University
8. Nan-Hung Hsieh, Ph.D., Texas A&M University
9. Zhoumeng Lin, BMed, Ph.D., D.A.B.T., Kansas State University
10. Jochem Louisse, Ph.D., Wageningen Food Safety Research (WFSR),
part of Wageningen University and Research, the Netherlands
11. Annie Lumen, Ph.D., Food and Drug Administration (FDA), National
Center for Toxicological Research (NCTR)
12. Kenneth M. Portier, Ph.D., Independent Consultant
13. Dhaval K. Shah, Ph.D., University of Buffalo
14. Kan Shao, Ph.D., Indiana University
15. Jordan Ned Smith, Ph.D., Pacific Northwest National Laboratory
(PNNL)

16. Gong Tang, Ph.D., University of Pittsburgh, Graduate School of
Public Health
17. Raymond S. H. Yang, Ph.D., Colorado State University
18. Qiang Zhang, Ph.D., Emory University
19. Yiliang Zhu, Ph.D., University of New Mexico School of Medicine

III. How to Submit Technical Comments to the Docket

    Please note that questions or comments regarding the peer review
process, including comments on the candidate pool of peer reviewers,
should be directed to<EMAIL_ADDRESS>(Subject line:
Chloroprene PBPK Peer Review); or by phone<PHONE_NUMBER> (ask for
Tracey Cowen). Comments on the technical documents related to the PBPK
modeling should be submitted to Docket ID No. EPA-HQ-ORD-2020-0181, by
one of the following methods:
     Online: https://www.regulations.gov. Follow the online
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>. Due to COVID-
19, there may be a delay in processing comments submitted by mail.

    Note: The EPA Docket Center and Reading Room is currently closed
to public visitors to reduce the risk of transmitting COVID-19.
Docket Center staff will continue to provide remote customer service
via email, phone, and webform. The public can submit comments via
www.Regulations.gov or email. No hand deliveries are currently being
accepted.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2020-0181. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

Wayne E. Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2020-16048 Filed 7-23-20; 8:45 am]
BILLING CODE 6560-50-P


1,354.5 IGNITABLE SPENT SOLVENT AND CO MONOMER FROM LOW DENSITY POLYETHYLENE PRODUCTION: MIXTURE OF MINERAL SPIRITS AND VINYL ACETATE.

28.0 IGNITABLE SPENT SOLVENT AND CO MONOMER FROM LOW DENSITY POLYETHYLENE PRODUCTION: MIXTURE OF MINERAL SPIRITS AND METHYL ACRYLATE.

0.2 IGNITABLE SPENT SOLVENT FROM OPERATIONAL CLEANOUT: MIXTURE OF ALIPHATIC HYDROCARBONS.

0.2 IGNITABLE SPENT SOLVENTS FROM QUALITY CONTROL LABORATORY OPERATIONS: MIXTURE OF SOLVENTS, WITH MAIN COMPONENTS BEING CYCLOHEXANE AND TETRACHLOROETHENE.

1.2 WASTE PAINT MATERIALS AND MIXTURE OF VARIOUS OIL BASED PAINTS.

0.7 IGNITABLE SPENT SOLVENTS FROM QUALITY CONTROL LABORATORY OPERATIONS: MIXTURE OF SOLVENTS, WITH MAIN COMPONENTS BEING CYCLOHEXANE AND TETRACHLOROETHENE.

TXD008090011 2,212.8 2,212.0 BY PRODUCT ORGANICS FROM MERCAPTAN MANUFACTURING. TOWER BOT 0.8 WASTE PAINT THINNER AND PAINT COLLECTED IN 55 GALLON DRUMS TXR000025809 2,670.4 0.4 PAINT THINNER OR PETROLEUM DISTILLATES Already a distillation byproduct 26.6 POLYETHYLENE AND POLYVINYLACETATE WAX IN VINYL ACETATE FRO 2,319.1 RECOVERED ORGANICS  SPENT CONTAMINATED LUBRICATING OILS, MI 11.8 SPENT PARTS WASHER SOLVENT 29.5 HEAVY AROMATIC HYDROCARBONS ( ETHYLENE TARS)

15.2 POLYETHYLENE ADDITIVE SLURRY ( AMINES, ANTIOXIDENTS & AMIDE 4.4 WASTE PAINT RELATED RESIDUES, EXCESS PAINT AND APPLICATOR Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 9 17.7 SPENT CYCLOHEXANE WASH SOLUTION 197.0 SPENT METHANOL USED IN CLEANING PROCESS VESSELS 21.9 RECOVERED, SPENT ORGANIC PEROXIDE IN MINERAL SPIRITS 2.5 OLD/ CONTAMINATED FUEL 0.2 USED N PROPANOL PUMP SEAL FLUIDS 24.2 SPENT LABORATORY SOLVENT WITH ANALYTICAL RESIDUES MOD985791995 2,158.5 1,437.9 IGNITABLE SPENT SOLVENT FROM PHARMACEUTICAL MFG PROCESS  MI XTURE OF METHANOL AND TOLUENE 485.6 SPENT SOLVENT FROM PHARMACEUTICAL MFG PROCESS SOLUTION OF ME THYLENE CHLORIDE AND WATER WITH ACETONE 234.9 IGNITABLE SPENT SOLVENT FROM PHARMACEUTICAL MFG. PROCESS TOL UENE KYD082390394 2,002.0 459.5 IGNITABLE, BARIUM, CHROMIUM, LEAD 1,542.5 IGNITABLE, LEAD, BARIUM, MEK, TOLUENE MAD980912323 2,947.1 1,111.0 TOXIC IGNITABLE SOLVENT ( ACETONE, TOLUENE, BUTANOL, XYLENE) GENERATED FROM ORGANIC CHEMICAL FILTERING PROCESSING AND EQUIPMENT CLEANING.

3.6 DISTILLATION STILLBOTTOMS AND SPENT SOLVENT. CONTAINS METHYLENE CHLORIDE AND ANILINE. Already a distillation byproduct 566.1 TOXIC IGNITABLE AQUEOUS SOLUTION CONTAINS ( ACETONE, TOLUENE, BUTANOL,

METHANOL, CHLOROBENZENE) GENERATED FROM SITE AIR ABATEMENT EQUIPMENT,

WASTEWATER CONTROL EQUIPMENT, PRODUCT FILTERING AND EQUIPMENT CLEANOUTS.

783.5 TOXIC IGNITABLE AQUEOUS SOLUTION CONTAINS ( ACETONE, TOLUENE, BUTANOL,

METHYLENE CHLORIDE, METHANOL) GENERATED FROM SITE AIR ABATEMENT EQUIPMENT,

WASTEWATER CONTROL EQUIPMENT, PRODUCT FILTERING AND EQUIPMENT CLEANOUTS.

48.9 IGNITABLE SOLVENT SOLUTION, BUTANOL CONTAMINATED WITH ETHYL ACETATE.

150.1 IGNITABLE AQUEOUS SOLUTION, CONTAINS ISOPROPANOL GENERATED FROM PRODUCT FILTERING.

20.0 WASTE SOLVENTS FROM DRYER CONDENSATE AND CAPTURED VENT OVERHEADS.( BUTANOL,

ACETONE, ISOPROPANOL, CYCLOHEXANE) GENERATED FROM ORGANIC CHEMICAL DRYING.

8.7 SPENT INPROCESS SOLVENT WASTE, ( METHANOL, TOLUENE, XYLENE, ISOPROPANOL, ETHYL Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 10 ACETATE) GENERATED FROM ORGANIC CHEMICAL MANUFACTURE.

0.5 WASTE METHYLENE CHLORIDE AND ISOPROPANOL. GENERATED FROM ORGANIC CHEMICAL MANUFACTURING.

0.8 LABORATORY SOLVENT WASTE. GENERATED IN QUALITY AND RESEARCH LABORTORIES.

9.4 WASTE SOLVENTS FROM CONTAMINATED REACTION. ( BUTANOL, ETHYL ACETATE)

GENERATED WHEN INPROCESS REACTION BECAME CONTAMINATED WITH ETHYL ACETATE.

0.8 SPENT IGNITABLE, CORROSIVE SOLVENT USED IN VESSEL CLEANING ( ACETONE,

HYDROCHLORIC ACID) GENERATED FROM PROCESS VESSEL CLEANING. Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 11 0.3 IGNITABLE, TOXIC AND CORROSIVE CLEANOUT SOLUTION, ( ACETONE, METHYLENE CHLORIDE,

HYDROCHLORIC ACID). GENERATED FROM VESSEL CLEANING.

18.6 SPENT TOXIC SOLVENT, ( METHYLENE CHLORIDE). SENT OFFSITE FOR RECOVERY. GENERATED FROM ORGANIC CHEMICAL MANUFACTURE.

42.5 DISTILLATION STILLBOTTOMS AND SPENT SOLVENT. CONTAINS ISOPROPANOL OR CYCLOHEXANE. GENERATED FROM ONSITE SOLVENT RECOVERY. Already a distillation byproduct 2.4 IGNITABLE WASTE OIL, CONTAMINATED WITH CYCLOHEXANE. GENERATED FROM OIL CHANGES ON VACCUM PUMPS.

1.0 INPROCESS SOLVENT SAMPLE STREAMS CONTAINING, METHANOL, TOLUENE, ACETONE OR ACETIC ACID. GENERATED FROM SAMPLING ORGANIC CHEMICAL REACTIONS.

6.0 SPENT SOLVENTS GENERATED FROM PROCESS CLEANOUTS. ( METHANOL, ISOPROPANOL,

BUTANOL)

99.7 DISTILLATION STILLBOTTOMS AND SPENT SOLVENT. CONTAINS METHYLENE CHLORIDE AND PYRIDINE. Already a distillation byproduct 2.7 SPENT PROCESS SOLVENT ( PROPIONIC ACID) GENERATED IN ORGANIC CHEMICAL MANUFACTURE.

0.2 SPENT PROCESS SOLVENT, ( PROPIONIC ACID, M CRESOL) GENERATED IN ORGANIC CHEMICAL MANUFACTURE.

13.1 SPENT IGNITABLE, CORROSIVE, TOXIC LIQUID GENERATED FROM DISTILLATION OF SOLVENTS FROM ORGANIC CHEMICAL MANUFACTURING. CONTAINS CHLOROBENZENE AND HYDROCHLORIC ACID. Already a distillation byproduct 57.5 SPENT IGNITABLE, TOXIC, CORROSIVE LIQUID. GENERATED FROM THE DISTILLATION OF SOLVENTS IN ORGANIC CHEMICAL MANUFACTURING. CONTAINS CHLOROBENZENE, METHANOL AND HYDROCHLORIC ACID. Already a distillation byproduct PAD042259374 1,842.2 1,841.9 WASTE FLAMMABLE LIQUID, HEPTANE/ TOLUENE SOLUTION SEPARATED F ROM CAUSTIC WASH 0.2 WASTE COMBUSTIBLE LIQUID, PETROLEUM NAPHTHA USED AS A PARTS CLEANER IN MAINTENANCE SHOP TXD980867345 1,804.0 7.1 RESIN WASTE  OFF GRADE NON SALABLE RESIN USED IN FUEL SUPPL 61.5 MIXED SOLVENTS FROM PROCESS AID OF REACTIONS  10,000 GAL. T Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 12 1,735.4 AQUEOUS/ SOLVENT SOLUTION  CHEMICALS/ WASTEWATER FROM REACTIO PAD003008943 1,741.4 9.3 INKS, DYES, ALCOHOLS AND ADHESIVES FROM CONSUMER HEALTHCARE PRODUCTS AND PHARMAUCEUTICALS PACKAGING OPERATIONS 0.8 MIXTURE CONTAINING PETROLEUM NAPHTHA USED IN MACHINERY PARTS WASHER 1,695.0 OFF SPEC PRODUCTION WASTE CONTAINING FLAMABLE LIQUIDS 33.5 ALCOHOLS MIXTURES USED IN THE PRODUCTION OF CONSUMER HEALTHC ARE PRODUCTS AND PHARMACEUTICALS 2.9 OUT DATED OR EXPIRED FLAVORINGS USED IN THE PRODUCTION OF CO NSUMER HEALTHCARE PRODUCTS PRD090346909 1,618.1 IGNITABLE SPENT SOLVENT FROM THE PRODUCTION OF PHARMACEUTICA LS PRODUCT.

LAD003913183 1,491.5 WASTE FLAMMABLE LIQUIDS ( ETHANOL/ PROPANOL)

OHD004282976 1,558.9 1,153.9 WASTE FLAMMABLE LIQUID  SPENT SOLVENT 136.3 WASTE GELLED ALKYD RESIN CONTAINING NAPHTHA 268.8 WASTE OFF SPECIFICATION SOLVENT BORNE PAINT TXD096037932 1,596.0 956.0 MIXED ORGANIC LIQUIDS WITH 140 F.

637.6 WASTE ISOBUTANOL AND DIOL 0.6 FURFURAL WASTE 1.8 ISOBUTYRALDEHYDE WASTE TXD980625966 1,510.0 1,494.8 RED OIL AND RED OIL POLYMER WITH HAN 15.1 METHANOL/ PROPANOL MIXTURE 0.1 DIMETHYL SULFIDE GAD075876623 1,569.7 0.0 SPENT SOLVENT FROM QUALITY CONTROL TESTING ( CONTAINS PYRIDIN E AND DICHLOROMETHANE), IGNITABLE AND TOXIC 6.1 ORGANIC DEFECTIVE PAINT, IGNITABLE, TOXIC FOR METALS AND MEK 388.7 DEFECTIVE SOLVENT BASED PAINT AND SPENT SOLVENT ( IGNITABLE A ND TOXIC CONTAINS METALS AND SOLVENT)

1.6 EPOXY PRIMER, IGNITABLE Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 13 1,173.3 SPENT SOLVENT FROM CLEANING PAINT PRODUCTION EQUIPMENT, IGNI TABLE AND TOXIC TXD008088833 1,574.2 0.7 MIXED LIQUID LABORATORY WASTE FROMTECHNICAL LABORATORY ACTIV 37.9 POLYMER BLOWDOWN CONAINING SOLVENT. INITIAL GENERATION 1996 1,497.1 SPENT NON HALOGENATED SOLVENT FROM LOW DENSITY POLYETHYLENE 0.2 HALOGENATED LABORATORY SOLVENT FROM QUALITY CONTROL LABORATO 0.4 QUALITY CONTROL LABORATORY WASTE. FIRST GENERATED 1980.

1.7 PILOT PLANT WASTE SOLVENT GENERATED DURING POLYETHYLENE 5.0 PLANT DEGREASER, HAZARDOUS LIQUID. MAINTENANCE PARTS WASHER 1.3 PAINT THINNER, CHLOROBENZENE.

0.5 SP SOLVENT/ MONOMER/ AND ADDITIVES 29.4 SPECIALTY POLYMER WASTE INACTIVE CATALYST. GENERATED DURING 0.1 POLYARD, HAZARDOUS, LIQUID, RESIDUE FROM LOW DENSITY POLYETH TXD008088247 1,550.6 31.2 BCHLOR WASH WATER 18.7 DIOL WASTE FROM THE MANUFACTURE AND PURIFICATION OF DIOL PRO 919.2 DBE REACTOR BOTTOMS / MANUFACTURE OF DIBASIC ESTERS 562.4 REACTOR WASH SOLUTION / PROCESS EQUIPMENT CLEANING / FEB. 19 0.2 OTHER ORGANIC LIQUIDS 0.2 LIQUID WASTE FROM THE MANUFACTURE OF SIMA.

0.7 BENZYL CHLORIDE WASTES Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 14 18.0 AQUEOUS REACTOR WASH SOLUTION CAD070635669 1,266.5 FLAMMABLE SPENT SOLVENT FROM THE MANUFACTURING OF BULK PHARMACEUTICALS WHICH INCLUDE A MIXTURE OF TOLUENE, METHANOL ISOPROPYL ALCOHOL, ETHYL ACETATE AND ETHANOL LAD098168206 1,259.0 HEAVY ENDS/ OFF SPEC PRODUCT FROM PRODUCTION OF ETHYLENE DICH LORIDE BY " DIRECT CHLORINATION" PROCESS, EDC, 1,1,2 TRICHLOR OETHYLENE, BIS 2 CHLOROETHYL ETHER TXD065096273 1,677.9 24.6 OFF SPECIFICATION BUTYL ACRYLATE 0.1 LIGHT ENDS FROM BUTYL METHACRYLATE/ ISO BUTYL METHACRYLATE PR 1.9 IMMERSION SOLVENT USED IN SAFETY KLEEN PARTS WASHERS 3.0 PAINT/ THINNER MIXTURES. GENERATED FROM PAINTING AND MAINTEN 865.5 81R RESIDUE. MANUFACTURING WASTE FROM THE PRODUCTION OF 81R 49.0 METHYL METHACRYLATE, OFF SPEC PRODUCT.

455.5 B 3 LIGHT ENDS. MANUFACTURING BYPRODUCT OF MMA AND MAA PROD 11.7 OFF SPEC METHACRYLIC ACID PRODUCT 17.1 METHYL METHACRYLATE TANK WASHINGS AND DISCHARGES. FROM CRUD 0.0 SAFETY KLEEN SOLVENT, USED IN DEGREASING OPERATIONS AND PART 226.0 BMA BLEED STRIPPER BOTTOMS. MANUFACTURING WASTE FROM THE PR 23.3 ACETIC ACID, COPRODUCT OF ACRYLIC ACID PRODUCTION. DISCARDE WVD005005483 1,823.8 385.3 IGNITABLE MATERIAL FROM UNIT PRODUCTION ( PVA/ IPA STREAM)

0.2 DISCARDED RAW MATERIAL CYCLOHEXANONE.

440.6 IGNITABLE RESIDUES CONTAINING CHROMIUM FROM UNIT PRODUCTION ( CBM RESIDUES).

1.8 MISCELLANEOUS IGNITABLE ORGANIC MATERIALS FROM PLANT LABORAT ORY. Organic Liquids Generating Facilities Reviewed for Potential to be Solvent Recovery Residuals X 15 6.2 PAINT WASTE CONTAINING VARIOUS SOLVENTS.

368.9 IGNITABLE MATERIAL FROM PRODUCTION ( PVA RESIDUES).

2.1 MISCELLANEOUS IGNITABLE OUT OF DATE PRODUCTS.

49.1 IGNITABLE RESIDUES FROM PRODUCTION OF DIENE 299 CONTAINING A LCOHOLS.

414.1 IGNITABLE RESIDUES CONTAINING BENZENE FROM UNIT PRODUCTION ( MVA RESIDUES).

18.4 IGNITABLE MATERIAL FROM UNIT PRODUCTION ( PVA LA 1 WASTE).

42.6 IGNITABLE RESIDUES CONTAINING BENZENE AND METHYL ETHYL KETO NE FROM UNIT PRODUCTION ( ACETONE RECOVERY).

55.0 FLAMMABLE WASTE FROM OVERHEAD STRIP; MIXTURE CONTAINS ISOPRO PANOL AND VINYL ETHYL ETHER.

39.6 IGNITABLE RESIDUES CONTAINING BENZENE AND METHYL ETHYL KETON E FROM UNIT PRODUCTION ( MVA RESIDUES).


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Page 20072]
[FR Doc No: C1-2018-09317]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9977-57-Region 10]

Re-issuance of a General NPDES Permit (GP) for Small Suction
Dredges in Idaho

Correction

    In notice document 2018-09317 appearing on page 19281 in the issue
of Wednesday, May 2, 2018, make the following correction:
    In the third column, under the DATES heading, in the fifth line
``May 2, 2018'' should read ``June 1, 2018''.
[FR Doc. C1-2018-09317 Filed 5-4-18; 8:45 am]
 BILLING CODE 1301-00-D


"King, Heidi R."<EMAIL_ADDRESS> 09/30/2008 11:59 AM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Brian Heninger/DC/USEPA/US@EPA, Charlotte Bertrand/DC/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Kathy Kaufman/RTP/USEPA/US@EPA, "Clark, Michael C." <EMAIL_ADDRESS>Nathalie Simon/DC/USEPA/US@EPA, Al McGartland/DC/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, "Fraas, Arthur G."<EMAIL_ADDRESS>"Lee, Amanda I." <EMAIL_ADDRESS>"Mancini, Dominic J." <EMAIL_ADDRESS> Subject

RE: counties not in attainment for Pb NAAQS RIA

Thank you Ron.

--   It sounds as if the Regulator Impact Analysis should include

estimates of the cost of further large scale remediation projects at

Superfund-like sites.  A quick web search suggests that remediation

should have been complete in 1995 in Carbon, PA, for example.

--  It also sounds as if we now have reason to believe there will be

non-attainment areas outside the known TSP monitoring network.  The

circular a-4 requires that we make best effort at estimating the full

cost and bene of the regulation.  Until now, we have no information

suggesting the locations and magnitude of likely non-attainment areas

outside the current limited monitor network.  Have we already put

together a list of superfund sites in which lead is a contaminant?

--  As for metal processors, haven't we included in the analysis an

estimate of the cost (and air qual improvement) associated with applying

controls to identified metal processors?  They seemed to be well

represented in the data.

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, September 29, 2008 5:26 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>Clark, Michael C.;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>Fraas, Arthur G.; Lee, Amanda I.; Mancini, Dominic

J.

Subject: counties not in attainment for Pb NAAQS RIA

Heidi, this morning Kathy offered to share information about what we

know about the sources in the 9 counties which do not attain a 0.15

microgram/m3 standard with identified controls.  The data is shown in

the attached.  In summary:

o     Every county has a metal processing facility, these are largely

small facilities.   Some of which have existing controls (like a

baghouse).  Others do not have control information in the NEI.

o     4 of the counties have known land contamination, 3 of which have

Superfund sites.

We will be happy to discuss these once you have had a chance to review

the enclosed.  Have a good evening.

Ron

(See attached file: Pb sources at monitors over 0.15 ron.doc)


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80307-80310]
[FR Doc No: 2023-25367]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3926]

Request for Nominations for Voting Members on Public Advisory
Panels or Committees; Device Good Manufacturing Practice Advisory
Committee and the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) and the Medical
Devices Advisory Committee (MDAC) device panels in the Center for
Devices and Radiological Health. This annual notice is also in
accordance with the 21st Century Cures Act, which requires the
Secretary of Health and Human Services (the Secretary) to provide an
annual opportunity for patients, representatives of patients, and
sponsors of medical devices that may be specifically the subject of a
review by a classification panel to provide recommendations for
individuals with appropriate expertise to fill voting member positions
on classification panels. FDA seeks to include the views of women and
men, members of all racial and ethnic groups, and individuals with and
without disabilities on its advisory committees, and therefore,
encourages nominations of appropriately qualified candidates from these
groups.

DATES: Nominations received on or before January 16, 2024, will be
given first consideration for membership on the DGMPAC and Panels of
the MDAC. Nominations received after January 16, 2024, will be
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:

                   Table 1--Primary Contact and Panel
------------------------------------------------------------------------
         Primary contact person                 Committee or panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the       Medical Devices Dispute
 Center Director, Center for Devices      Resolution Panel.
 and Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5561, Silver
 Spring, MD 20993,<PHONE_NUMBER>,
 [email protected].
James P. Swink, Office of Management,    Circulatory System Devices
 Center for Devices and Radiological      Panel, Ophthalmic Devices
 Health, Food and Drug Administration,    Panel.
 10903 New Hampshire Ave., Bldg. 66,
 Rm. 5211, Silver Spring, MD 20993, 301-
 796-6313, [email protected].
Akinola Awojope, Office of Management,   Dental Products Panel,
 Center for Devices and Radiological      Neurological Devices Panel,
 Health, Food and Drug Administration,    Obstetrics and Gynecology
 10903 New Hampshire Ave., Bldg. 66,      Devices Panel, Orthopaedic and
 Rm. 5216, Silver Spring, MD 20993, 301-  Rehabilitation Devices Panel.
 636-0512, [email protected].

Jarrod Collier, Office of Management,    DGMPAC, General Hospital and
 Center for Devices and Radiological      Personal Use Devices Panel,
 Health, Food and Drug Administration,    Hematology and Pathology
 10903 New Hampshire Ave., Bldg. 66,      Devices Panel, Molecular and
 Rm. 5216, Silver Spring, MD 20993, 240-  Clinical Genetics Panel.
 672-5763, [email protected].
Candace Nalls, Office of Management,     Anesthesiology and Respiratory
 Center for Devices and Radiological      Therapy Devices Panel; Ear,
 Health, Food and Drug Administration,    Nose, and Throat Devices
 10903 New Hampshire Ave., Bldg. 66,      Panel; Gastroenterology and
 Rm. 5214, Silver Spring, MD 20993, 301-  Urology Devices Panel.
 636-0510, [email protected].
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:

                        Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
               Expertise needed                   Vacancies                 Approximate date needed
----------------------------------------------------------------------------------------------------------------
Device Good Manufacturing Practice Advisory                 1  Immediately.
 Committee--Experts in medical device quality               2  June 1, 2024.
 management system requirements/current good
 manufacturing practices, with experience in
 both part 820 (21 CFR part 820) and
 International Organization for
 Standardization (ISO) 13485, are needed to
 provide cross-cutting scientific or clinical
 expertise concerning the particular issue in
 dispute. Vacancies include representatives
 of the interests of the general public and
 government.
Anesthesiology and Respiratory Therapy                      1  December 1, 2024.
 Devices Panel of the Medical Devices
 Advisory Committee--Anesthesiologists,
 pulmonary medicine specialists, or other
 experts who have specialized interests in
 ventilator support, sleep medicine,
 pharmacology, physiology, or the effects and
 complications of anesthesia. FDA is also
 seeking applicants with pediatric expertise
 in these areas.
Circulatory System Devices Panel of the                     3  July 1, 2024.
 Medical Devices Advisory Committee--
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.
Dental Products Panel of the Medical Devices                7  Immediately.
 Advisory Committee--Dentists, engineers and
 scientists who have expertise in the areas
 of dental implants, dental materials, oral
 and maxillofacial surgery, endodontics,
 periodontology, tissue engineering, snoring/
 sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the                  7  Immediately.
 Medical Devices Advisory Committee--
 Otologists, neurotologists, and audiologists.
Gastroenterology and Urology Devices Panel of               2  January 1, 2024.
 the Medical Devices Advisory Committee--
 Gastroenterologists, urologists, and
 nephrologists.
General Hospital and Personal Use Devices                   1  Immediately.
 Panel of the Medical Devices Advisory                      2  January 1, 2024.
 Committee--Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, human factors experts, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel of the               4  Immediately.
 Medical Devices Advisory Committee--
 Hematologists (benign and/or malignant
 hematology), hematopathologists (general and
 special hematology, coagulation and
 hemostasis, and hematological oncology),
 gynecologists with special interests in
 gynecological oncology, cytopathologists,
 and molecular pathologists with special
 interests in development of predictive and
 prognostic biomarkers, molecular oncology,
 cancer screening, cancer risk, digital
 pathology, whole slide imaging; devices
 utilizing artificial intelligence/machine
 learning.
Medical Devices Dispute Resolution Panel of                 1  Immediately.
 the Medical Devices Advisory Committee--                   1  October 1, 2024.
 Experts with cross-cutting scientific,
 clinical, analytical or mediation skills.
Molecular and Clinical Genetics Panel of the                2  Immediately.
 Medical Devices Advisory Committee--Experts
 in human genetics, molecular diagnostics,
 and in the clinical management of patients
 with genetic disorders, and (e.g.,
 pediatricians, obstetricians,
 neonatologists). Individuals with training
 in inborn errors of metabolism, biochemical
 and/or molecular genetics, population
 genetics, epidemiology and related
 statistical training, bioinformatics,
 computational genetics/genomics, variant
 classification, cancer genetics/genomics,
 molecular oncology, radiation biology, and
 clinical molecular genetics testing, (e.g.,
 sequencing, whole exome sequencing, whole
 genome sequencing, non-invasive prenatal
 testing, cancer screening, circulating cell
 free/circulating tumor nucleic acid testing,
 digital polymerase chain reaction,
 genotyping, array comparative genomic
 hybridization, etc.). Individuals with
 experience in genetics counseling, medical
 ethics are also desired, and individuals
 with experience in ancillary fields of study
 will be considered.
Neurological Devices Panel of the Medical                   2  Immediately.
 Devices Advisory Committee--Neurosurgeons                  2  December 1, 2023.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians.

Obstetrics and Gynecology Devices Panel of                  2  February 1, 2024.
 the Medical Devices Advisory Committee--
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted
 reproductive technologies, contraception,
 postoperative adhesions, and cervical cancer
 and colposcopy; biostatisticians and
 engineers with experience in obstetrics/
 gynecology devices; urogynecologists;
 experts in breast care; experts in
 gynecology in the older patient; experts in
 diagnostic (optical) spectroscopy; experts
 in midwifery; labor and delivery nursing.
Ophthalmic Devices Panel of the Medical                     3  November 1, 2024.
 Devices Advisory Committee--Ophthalmologists
 with expertise in corneal-external disease,
 vitreo-retinal surgery, glaucoma, ocular
 immunology, ocular pathology; optometrists;
 vision scientists; and ophthalmic
 professionals with expertise in clinical
 trial design, quality of life assessment,
 electrophysiology, low vision
 rehabilitation, and biostatistics.
Orthopaedic and Rehabilitation Devices Panel                1  Immediately.
 of the Medical Devices Advisory Committee--                2  September 1, 2024.
 Orthopaedic surgeons (joint, spine, trauma,
 reconstruction, sports medicine, hand, foot
 and ankle, and pediatric orthopaedic
 surgeons); rheumatologists; engineers
 (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, and musculoskeletal engineering;
 radiologists specializing in musculoskeletal
 imaging and analyses and biostatisticians.
----------------------------------------------------------------------------------------------------------------

I. General Description of the Committees Duties

A. DGMPAC

    The DGMPAC reviews regulations proposed for promulgation regarding
good manufacturing practices governing the methods used in, and the
facilities and controls used for, the manufacture, packing, storage and
installation of devices, and makes recommendations to the Commissioner
of Food and Drugs (the Commissioner) regarding the feasibility and
reasonableness of those proposed regulations. The DGMPAC also advises
the Commissioner on any petition submitted by a manufacturer for an
exemption or variance from good manufacturing practice regulations that
is referred to the committee.

B. Panels of MDAC

    The MDAC reviews and evaluates data on the safety and effectiveness
of marketed and investigational devices and makes recommendations for
their regulation. The panels engage in many activities to fulfill the
functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions
for device advisory panels. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
performs the following duties: (1) advises the Commissioner regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the FD&C Act, (7) advises on the necessity
to ban a device, and (8) responds to requests from the Agency to review
and make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Voting Members

A. DGMPAC

    The DGMPAC consists of a core of nine members including the Chair.
Members and the Chair are selected by the Secretary. Persons nominated
for membership as a health professional or officer or employee of any
Federal, State, or local government should have knowledge of or
expertise in any one or more of the following areas: quality assurance
concerning the design, manufacture, and use of medical devices in
accordance with part 820 and/or ISO 13485. To be eligible for selection
as a representative of the general public, nominees should possess
appropriate qualifications to understand and contribute to the DGMPAC's
work. Three of the members shall be officers or employees of any State
or local government or of the Federal Government; two shall be
representative of the interests of the device manufacturing industry;
two shall be representatives of the interests of physicians and other
health professionals; and two shall be representatives of the interests
of the general public. FDA is publishing a separate document announcing
the Request for Nominations Notification for Non-Voting Representatives
of the interests of the device manufacturing industry. Almost all non-
Federal members of this committee serve as Special Government
Employees. Members are invited to serve for overlapping terms of 4
years. The current needs for the DGMPAC are listed in table 2.

B. Panels of the MDAC

    The MDAC with its 18 panels shall consist of a maximum of 159
standing members. Members are selected by the Commissioner or designee
from among authorities in clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. Almost all non-Federal members of this committee serve as
Special Government

Employees. A maximum of 122 members shall be standing voting members
and 37 shall be nonvoting members who serve as representatives of
consumer interests and of industry interests. FDA is publishing
separate documents announcing the Request for Nominations Notification
for Nonvoting Representatives on certain panels of the MDAC. Persons
nominated for membership on the panels should have adequately
diversified experience appropriate to the work of the panel in such
fields as clinical and administrative medicine, engineering, biological
and physical sciences, statistics, and other related professions. The
nature of specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment may include experience in
medical practice, teaching, and/or research relevant to the field of
activity of the panel. The current needs for each panel are listed in
table 2. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels or
advisory committees. Self-nominations are also accepted. Nominations
must include a current, complete r[eacute]sum[eacute] or curriculum
vitae for each nominee, including current business address, telephone
number, and email address if available and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES). Nominations must also specify the
advisory committees or panel(s) for which the nominee is recommended.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters related to
financial holdings, employment, and research grants and/or contracts to
permit evaluation of possible sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25367 Filed 11-16-23; 8:45 am]
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[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60318-60319]
[FR Doc No: 2012-24337]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2010-0026]
RIN 2105-AE14

Procedures for Transportation Workplace Drug and Alcohol Testing
Programs: 6-acetylmorphine (6-AM) Testing

AGENCY: Office of the Secretary, U.S. Department of Transportation
(DOT).

ACTION: Final rule.

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SUMMARY: This rule adopts as final, without change, a May 4, 2012,
interim final rule (IFR) which no longer requires laboratories and
Medical Review Officers (MRO) to consult with one another regarding the
testing for the presence of morphine when the laboratory confirms the
presence of 6-acetylmorphine (6-AM). Also, laboratories and MROs will
no longer need to report 6-AM results to the Office of Drug and Alcohol
Policy and Compliance (ODAPC). This rule also responds to comments on
the IFR.

DATES: The rule is effective October 3, 2012.

FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, U.S. Department of
Transportation, Office of Drug and Alcohol Policy and Compliance, 1200
New Jersey Avenue SE., Washington, DC 20590;<PHONE_NUMBER> (voice), 202-
366-3897 (fax), or<EMAIL_ADDRESS>(email).

SUPPLEMENTARY INFORMATION:

Background and Purpose

    On August 16, 2010, [75 FR 49850] the Department published its
final rule to harmonize with many aspects of the revised Department of
Health and Human Services (HHS) Mandatory Guidelines [73 FR 71858]. One
item with which the DOT harmonized was the laboratory testing for 6-
acetylmorphine (6-AM) without a morphine marker. 6-AM is a unique
metabolite produced when a person uses the illicit drug heroin. Prior
to the October 1, 2010, rulemaking, both the HHS and Department of
Transportation (DOT) regulations required the laboratory to first test
for morphine, and if it detected morphine at the HHS/DOT cutoff of
2000ng/mL, the lab would then test for 6-AM.
    For the reasons discussed in the DOT final rule [75 FR 49850], we
decided that, until more experience was gained with the new testing
procedures for 6-AM, we would place additional requirements on
laboratories and MROs. Specifically, when there was a 6-AM positive
result and morphine was not detected by a laboratory at the 2000ng/mL
cutoff, we added a requirement for the laboratory and MRO to determine
whether morphine was detected at the laboratory's level of detection
(LOD). If morphine was not detected at the laboratory's LOD, the
laboratory and MRO were to report that result to DOT's Office of Drug
and Alcohol Policy and Compliance (ODAPC). After consulting with ODAPC,
the MRO would make a verified result determination, keeping in mind
that there is no legitimate explanation for 6-AM in the employee's
specimen [see Sec.  40.151(g)]. The Department would track these
results and discuss them with HHS.
    On May 4, 2012, the Department issued an IFR [77 FR 26471] and
effective July 3, 2012, related to 6-AM testing. For reasons stated in
that IFR, we removed the requirement for laboratories and MROs to
consult with one another regarding the testing for the presence of 6-
AM. The IFR also streamlined the laboratory analysis and MRO reporting
of 6-AM results by not having either the laboratory or MRO report the
6-AM information to ODAPC. The IFR also sought comments to the IFR
which were to be submitted by June 4, 2012. There were two such
comments.

Discussion of Comments to the Docket

    There were two comments to the docket representing three
organizations. One comment was submitted by a large organization which
represents physicians who are MROs. The other comment was submitted by
a large medical review officer service and consortium which provide
drug and alcohol testing services primarily to the pipeline industry.
    Each of the commentors fully supported the Department's position on
amending the requirements for testing and reporting 6-AM test results.
Their support of the IFR further reinforces that there are no
legitimate medical explanations for the confirmation of 6-AM on a DOT
drug test and that the MRO must make positive results determinations in
these cases.
    One commenter asked whether we had noted a spike followed by a
decline in the 6-AM results during the first year of testing, as they
did. They wondered whether our commissioned study was designed to shed
light on their observation.
    We would note that over time, the Department has indeed seen an
increase of laboratory-reported 6-AM test results. However, we found
that the largest semi-annual period rise of 6-AM results, by number and
percentage increase, came even before the October 2010 effective date
of the new rules. This larger rise was noted when we compared the July-
December 2009 period with the January-June 2010 period. Also, it is
important to note that the number of total drug tests reported by
laboratories has risen during each 6-month period, starting with the
July-December 2009 period, and the number of 6-AM positive results has
steadily risen each period since July-December 2008.
    The following table displays the laboratory data for 6-AM before,
during transition, and after full implementation of the new testing
protocols:

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                                                                                2010 \*\  July-
      Semi-Annual period        2008  July-Dec    2009  Jan-June    2009  July-Dec    2010  Jan-June         Dec         2011  Jan-June   2011  July-Dec
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Laboratory Test Results  2.85 million....  2.59 million....  2.57 million....  2.69 million....  2.77 million...  2.82 million...  2.87 million
6-AM Laboratory Positives....  121.............  158.............  173.............  281.............  298............  371............  429
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\ The new requirement for 6-AM testing was in effect for the last 3 months of the period.

    Our commissioned study was not designed to evaluate the pattern of
6-AM test results over time. Its scope was ``* * * to verify the
atypical results obtained by the laboratories, to determine if other
drug or metabolites present in the specimens could explain the absence
of morphine, and to determine if something other than heroin use could
explain the presence of 6-AM.'' [77 FR 26472] The study's findings were
presented and discussed in the IFR. [77 FR 26472] We would note that
the rise in 6-AM positives was predicted, and a rise seems to have
become the trend over time.
    For the reasons discussed above and outlined in the IFR, we are
adopting the rule text in the IFR as final.

Regulatory Analyses and Notices

Authority

    The statutory authority for this rule derives from the Omnibus
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322,
5331, 20140, 31306, and 54101 et seq.) and the Department of
Transportation Act (49 U.S.C. 322).

Executive Order 12866 and Regulatory Flexibility Act

    This Final Rule is not significant for purposes of Executive Order
12866 or the DOT's regulatory policies and procedures. It finalizes
modifications, already in effect, to our procedures that do not
increase costs on regulated parties. The rule will impose no new
burdens on any parties, and will actually decrease the burden upon the
laboratories and the MROs. I hereby certify, under the Regulatory
Flexibility Act, that this rule does not have a significant economic
impact on a substantial number of small entities.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.

    Accordingly, the Interim Final Rule amending 49 CFR Part 40 which
was published at 77 FR 26471 on May 4, 2012 is adopted as a final rule
without change.

    Issued on September 20th, 2012, at Washington DC
Ray LaHood,
Secretary of Transportation.
[FR Doc. 2012-24337 Filed 10-2-12; 8:45 am]
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