[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43264-43267]
[FR Doc No: 2017-19478]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81556; File No. SR-NASDAQ-2017-061]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Amendment No. 1 and Order Granting Accelerated
Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To
Amend Rules 4702 and 4754 Relating to the Nasdaq Closing Cross and To
Make Other Related Changes

September 8, 2017.

I. Introduction

    On July 13, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Exchange Rules 4702 and 4754 relating to
the Nasdaq Closing Cross and to make other related changes. The
proposed rule change was published for comment in the Federal Register
on July 27, 2017.\3\ On August 22, 2017, the Exchange filed Amendment
No. 1 to the proposed rule change.\4\ The Commission received no
comment letters on the proposed rule change. The Commission is
publishing this notice to solicit comments on Amendment No. 1 from
interested persons, and is approving the proposed rule change, as
modified by Amendment No. 1, on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 81188 (July 21,
2017), 82 FR 35014 (``Notice'').
    \4\ In Amendment No. 1, the Exchange proposes to remove a
reference to Retail Order from Exchange Rule 4702(b)(12)(B) and to
remove a reference to Retail Orders and RPI Orders from Exchange
Rule 4703(l), as these two order types are no longer available on
the Exchange. The Exchange also provides an example to illustrate
its assertion that permitting members to submit Limit On Close
(``LOC'') Orders until immediately prior to 3:55 p.m. would
facilitate price discovery in the Nasdaq Closing Cross. Amendment
No. 1 is available at https://www.sec.gov/comments/sr-nasdaq-2017-061/nasdaq2017061.htm.
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II. Description of the Proposed Rule Change, as Modified by Amendment
No. 1 5
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    \5\ For a more detailed description of the proposal, see Notice,
supra note 3 and Amendment No. 1, supra note 4.
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    As described in more detail below, the Exchange proposes to enhance
the operation of the Nasdaq Closing Cross by extending the time period
during which members may submit LOC Orders,\6\ and to make other
changes relating to the Nasdaq Closing Cross and the Nasdaq Opening
Cross.
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    \6\ See Exchange Rule 4702(b)(12) (defining LOC Order).
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A. Acceptance of LOC Orders and Related Changes

    Currently, Exchange Rule 4702(b)(12)(A) provides that LOC Orders
may be entered between 4:00 a.m. ET and immediately prior to 3:50 p.m.
ET. The Exchange proposes to amend this rule to permit LOC orders to be
entered between 3:50 p.m. ET and immediately prior to 3:55 p.m. ET,
provided that there is a First Reference Price.\7\ The Exchange
proposes to define the First Reference Price to mean the

Current Reference Price \8\ in the first Order Imbalance Indicator \9\
disseminated at or after 3:50 p.m. ET.\10\ As proposed, a LOC Order
entered between 3:50 p.m. ET and immediately prior to 3:55 p.m. ET
would be accepted at its limit price, unless the limit price is higher
(lower) than the First Reference Price for a LOC order to buy (sell),
in which case the LOC order would be re-priced to the First Reference
Price.\11\ If the First Reference Price is not at a permissible minimum
increment of $0.01 or $0.0001, as applicable, the First Reference Price
would be rounded (i) to the nearest permitted minimum increment (with
midpoint prices being rounded up) if there is no imbalance, (ii) up if
there is a buy imbalance, or (iii) down if there is a sell
imbalance.\12\
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    \7\ The Exchange proposes a related change to Exchange Rule
4702(b)(12)(B) to provide that LOC Orders and Closing Cross/Extended
Hours Orders entered at or after 3:55 p.m. ET would be rejected.
    \8\ See Exchange Rule 4754(a)(7)(A) (defining Current Reference
Price for the Nasdaq Closing Cross).
    \9\ See Exchange Rule 4754(a)(7) (defining Order Imbalance
Indicator for the Nasdaq Closing Cross).
    \10\ See proposed Exchange Rule 4754(a)(9). According to the
Exchange, if there is no First Reference Price, a value of zero will
be disseminated in the first Order Imbalance Indicator, and a non-
zero value indicates that there is a First Reference Price. See
Notice, supra note 3, at 35015 n.16. The Exchange also states that
the presence of a First Reference Price indicates that there is
matched buy and sell interest that is eligible to participate in the
Nasdaq Closing Cross. See id., at 35015.
    \11\ See proposed changes to Exchange Rule 4702(b)(12)(A).
    \12\ See id.
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    The Exchange also proposes to amend its rules relating to the LULD
Closing Cross \13\ and the Primary Contingency Procedures to reflect
that LOC Orders can be entered until immediately prior to 3:55 p.m.
Specifically, the Exchange proposes to amend Exchange Rule
4754(b)(6)(C)(i) to permit Market On Close (``MOC''), LOC, and
Imbalance Only (``IO'') Orders intended for the Nasdaq Closing Cross
that are entered into the system and placed on the book prior to a
Trading Pause to remain on the book to participate in the LULD Closing
Cross.\14\ As a result, if the Exchange conducts an LULD Closing Cross,
LOC Orders would be eligible to be entered until the earlier of the
Trading Pause or immediately prior to 3:55 p.m.\15\ Similarly, the
Exchange proposes to amend Exchange Rule 4754(b)(7)(B) to permit LOC
Orders entered prior to 3:55 p.m. to participate in the Contingency
Closing Cross.\16\
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    \13\ The Exchange currently uses the LULD Closing Cross when a
Trading Pause pursuant to Exchange Rule 4120(a)(12) is triggered at
or after 3:50 p.m. and before 4:00 p.m. See Exchange Rule
4754(b)(6). The Commission recently approved a proposed rule change
that provided that the LULD Closing Cross would be used when a
Trading Pause exists at or after 3:50 p.m. and before 4:00 p.m. See
Securities Exchange Act Release No. 79876 (January 25, 2017), 82 FR
8888 (January 31, 2017) (SR-NASDAQ-2016-131). The Exchange
represents that the recently approved change is not yet operative,
and the discussion in this proposed rule change is based on
currently implemented functionality. See Notice, supra note 3, at
35015. n.19.
    \14\ The Exchange also proposes a conforming change to Exchange
Rule 4754(b)(6)(C)(iii).
    \15\ See Notice, supra note 3, at 35015. This change would also
correct the rule to reflect that, consistent with current
functionality, IO Orders entered prior to a Trading Pause would
participate in the LULD Closing Cross, instead of only those IO
Orders entered prior to 3:50 p.m. See id. MOC Orders entered after
3:50 p.m. would continue to be rejected, and therefore would not be
eligible for the LULD Closing Cross. See id., at 35015 n.21.
    \16\ The Exchange also proposes to correct a typographical error
in Exchange Rule 4754(b)(7)(E). In addition, the Exchange proposes
to amend Exchange Rule 4754(b)(5), related to auxiliary procedures
for the Closing Cross, to correct an erroneous subparagraph cross-
reference from (c)(2)(D) to (b)(2)(E).
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B. Closing Cross/Extended Hours Orders

    Currently, Exchange Rule 4702(b)(12)(B) states that, following the
Nasdaq Closing Cross, a Closing Cross/Extended Hours Order \17\ may not
operate as a Post-Only Order, Midpoint Peg Post-Only Order,
Supplemental Order, Retail Order, or RPI Order. The Exchange proposes
to amend this rule to provide that Post-Only Orders, Midpoint Peg Post-
Only Orders, and Supplemental Orders may not operate as Closing Cross/
Extended Hours Orders. According to the Exchange, these order types are
eligible to participate in the Nasdaq Closing Cross as part of the
continuous book, but cannot be entered with a flag designating an on-
close instruction, and therefore cannot be Closing Cross/Extended Hours
Orders.\18\ The Exchange also proposes that Market Maker Peg Orders
would no longer be eligible to be entered with a flag designating an
on-close instruction, and therefore would no longer be able to operate
as Closing Cross/Extended Hours Orders.\19\ In addition, the Exchange
proposes to delete the reference to Retail Order and RPI Order from
Exchange Rule 4702(b)(12)(B), because these order types are no longer
offered on the Exchange.\20\
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    \17\ See Exchange Rule 4702(b)(12)(B) (defining Closing Cross/
Extended Hours Order).
    \18\ See Notice, supra note 3, at 35016.
    \19\ See proposed changes to Exchange Rule 4702(b)(12)(B) and
Notice, supra note 3, at 35016.
    \20\ See Amendment No. 1, supra note 4. See also proposed
changes to Exchange Rule 4703(l) (deleting a reference to Retail
Orders and RPI Orders).
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    Finally, Exchange Rule 4702(b)(12)(B) currently provides that
certain Closing Cross/Extended Hours Orders entered between 3:50 p.m.
and the time of the Nasdaq Closing Cross are treated as IO Orders. The
Exchange proposes to remove this functionality.

C. Order Imbalance Indicator

    Currently, Exchange Rule 4752(a)(2) provides that the Order
Imbalance Indicator for the Nasdaq Opening Cross includes, among other
things, the Current Reference Price, the Imbalance, and the number of
paired shares. The definitions of Imbalance,\21\ Current Reference
Price,\22\ and the number of paired shares \23\ currently include Open
Eligible Interest.\24\ The Exchange proposes to delete references to
Open Eligible Interest from these definitions.\25\ According to the
Exchange, in practice, Open Eligible Interest is not included in the
Imbalance, the Current Reference Price, or the number of paired
shares.\26\
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    \21\ See Exchange Rule 4752(a)(1) (defining Imbalance for the
Nasdaq Opening Cross).
    \22\ See Exchange Rule 4752(a)(2)(A) (defining Current Reference
Price for the Nasdaq Opening Cross).
    \23\ See Exchange Rule 4752(a)(2)(B) (describing the calculation
of the number of paired shares for the Nasdaq Opening Cross).
    \24\ See Exchange Rule 4752(a)(8) (defining Open Eligible
Interest).
    \25\ See proposed changes to Exchange Rules 4752(a)(1),
4752(a)(2)(A)(i), and 4752(a)(2)(B).
    \26\ See Notice, supra note 3, at 35016-17.
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    Similarly, Exchange Rule 4754(a)(7) provides that the Order
Imbalance Indicator for the Nasdaq Closing Cross includes, among other
things, the Current Reference Price, the Imbalance, and the number of
paired shares. The definitions of Imbalance,\27\ Current Reference
Price,\28\ and the number of paired shares \29\ currently include Close
Eligible Interest.\30\ The Exchange proposes to delete references to
Close Eligible Interest from these definitions.\31\ According to the
Exchange, in practice, Close Eligible Interest is not included in the
Imbalance, the Current Reference Price, or the number of paired
shares.\32\
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    \27\ See Exchange Rule 4754(a)(2) (defining Imbalance for the
Nasdaq Closing Cross).
    \28\ See Exchange Rule 4754(a)(7)(A)(i) (defining Current
Reference Price for the Nasdaq Closing Cross).
    \29\ See Exchange Rule 4754(a)(7)(B) (describing the calculation
of the number of paired shares for the Nasdaq Closing Cross).
    \30\ See Exchange Rule 4754(a)(1) (defining Close Eligible
Interest).
    \31\ See proposed changes to Exchange Rules 4754(a)(2),
4754(a)(7)(A)(i), and 4754(a)(7)(B).
    \32\ See Notice, supra note 3, at 35016-17.
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D. Implementation

    The Exchange proposes to implement the functionality described in
the proposal in a symbol-by-symbol rollout in either Q3 or Q4 2017.\33\
The Exchange

will announce the implementation date and the symbol rollout in an
Equity Trader Alert issued to members prior to the implementation
date.\34\
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    \33\ See id., at 35017.
    \34\ See id.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 1, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\35\ In particular, the
Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act,\36\ which requires, among other things,
that the rules of a national securities exchange be 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 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.
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    \35\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \36\ 15 U.S.C. 78f(b)(5).
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    As discussed above, the Exchange proposes to permit members to
submit LOC Orders between 3:50 p.m. and immediately prior to 3:55 p.m.
if there is a First Reference Price. The Exchange also proposes to re-
price LOC Orders entered during this time period to the First Reference
Price if their limit price is more aggressive than the First Reference
Price. The Commission believes that these changes could encourage
additional participation in the Nasdaq Closing Cross, reduce
imbalances, and promote price discovery, without creating a significant
impact on the price of the Nasdaq Closing Cross. In addition, as
discussed above, the Exchange proposes to permit MOC, LOC, and IO
Orders intended for the Closing Cross that are entered into the system
and placed on the book prior to the Trading Pause to remain on the book
and participate in an LULD Closing Cross. Similarly, the Exchange
proposes to permit LOC Orders entered prior to 3:55 p.m. to participate
in a Contingency Closing Cross. The Commission believes that these
changes are consistent with the proposal to permit members to submit
LOC Orders between 3:50 p.m. and immediately prior to 3:55 p.m., and
would allow these LOC Orders to participate in an LULD Closing Cross or
Contingency Closing Cross.\37\
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    \37\ The Commission also notes that the proposal to correct a
typographical error in Exchange Rule 4754(b)(7)(E) and to change a
cross-reference in Exchange Rule 4754(b)(5) are technical
corrections to the rules.
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    As discussed above, the Exchange proposes to amend Exchange Rule
4702(b)(12)(B) to identify the order types that are currently not
eligible to operate as Closing Cross/Extended Hours Orders, provide
that Market Maker Peg Orders cannot operate as Closing Cross/Extended
Hours Orders, and delete a reference to Retail Order and RPI Order. The
Commission believes that these proposed changes are reasonable. The
Commission notes that, according to the Exchange, Market Maker Peg
Orders are designed to assist Nasdaq members in meeting their quoting
obligations, and not to submit interest flagged with an on-close
instruction.\38\ The Commission also notes that Retail Orders and RPI
Orders are no longer available on the Exchange.\39\
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    \38\ See Notice, supra note 3, at 35018. The exchange also notes
that the proposed changes to Closing Cross/Extended Hours Orders
would align its on-close order handling with the characteristics of
various order types. See id., at 35014.
    \39\ See Amendment No. 1, supra note 4.
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    Moreover, as discussed above, the Exchange proposes to amend
Exchange Rule 4702(b)(12)(B) to eliminate provisions that would treat
certain Closing Cross/Extended Hours Orders entered between 3:50 p.m.
and the time of the Nasdaq Closing Cross as IO Orders. The Commission
notes that the proposal would allow Closing Cross/Extended Hours Orders
entered between 3:50 p.m. and immediately prior to 3:55 p.m. to operate
as LOC Orders,\40\ rather than converting to IO Orders, which, unlike
LOC Orders, do not trade if there is no Imbalance and do not maintain
price priority as a result being continuously re-priced to the best bid
or offer.\41\ The Commission also notes that Nasdaq members may
continue to enter IO Orders until the time of execution of the Nasdaq
Closing Cross, and may continue to enter other Close Eligible Interest
on the continuous book up until the time of the Nasdaq Closing
Cross.\42\
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    \40\ As noted above, LOC Orders and Closing Cross/Extended Hours
Orders entered after 3:55 p.m. would be rejected.
    \41\ See Notice, supra note 3, at 35018.
    \42\ See id., at 35014.
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    Finally, as discussed above, the Exchange proposes to exclude Open
Eligible Interest and Close Eligible Interest from certain information
disseminated in the Order Imbalance Indicator for the Nasdaq Opening
Cross and the Nasdaq Closing Cross. The Commission notes that, as
proposed, the Imbalance, Current Reference Price, and paired shares
calculations would not include types of orders that may be executed in
the continuous market before the Opening Cross or the Closing
Cross.\43\ The Commission also notes that these changes would enhance
transparency because they would reflect the information that is
currently disseminated in the Order Imbalance Indicator.
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    \43\ See id., at 35018.
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IV. Solicitation of Comments on Amendment No. 1 to the Proposed Rule
Change

    Interested persons are invited to submit written data, views, and
arguments concerning whether Amendment No. 1 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2017-061 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-061. This
file number should be included on the subject line if email 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, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the 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-
NASDAQ-2017-061, and should be submitted on or before October 5, 2017.

V. Accelerated Approval of the Proposed Rule Change, as Modified by
Amendment No. 1

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment No. 1, prior to the thirtieth day
after the date of publication of Amendment No. 1 in the Federal
Register. In Amendment No. 1, the Exchange proposes to remove outdated
references to Retail Orders and RPI Orders, which are no longer offered
on the Exchange. The Commission believes that deleting these outdated
references would help to bring clarity and accuracy to the Exchange
rules. The Commission also believes that these changes are of a
technical nature and do not materially or substantively alter the
proposed rule change. In addition, in Amendment No. 1, the Exchange
provides an example to illustrate and support its assertion that
extending the time period for the entry of LOC orders until immediately
prior to 3:55 p.m. should facilitate the price discovery mechanism of
the Nasdaq Closing Cross. Accordingly, the Commission finds good cause,
pursuant to Section 19(b)(2) of the Act,\44\ to approve the proposed
rule change, as modified by Amendment No. 1, on an accelerated basis.
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    \44\ 15 U.S.C. 78s(b)(2).
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VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\45\ that the proposed rule change (SR-NASDAQ-2017-061), as
modified by Amendment No. 1, be, and hereby is, approved on an
accelerated basis.
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    \45\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\46\
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    \46\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-19478 Filed 9-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]
[Page 61501-61502]
[DOCID:fr05oc10-111]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0496]

Cooperative Agreement To Support Capacity Building Activities
Through the World Health Organization Global Foodborne Infections
Network

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to accept and consider a single source application to award a
cooperative agreement to the World Health Organization (WHO) Advisory
Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR)
and in support of the WHO Global Foodborne Infections Network (GFN) and
to provide guidance to the WHO on a framework for the development of an
international network to promote and enhance collaboration on
harmonization and data sharing among countries with Antimicrobial
Resistance (AMR) surveillance programs.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    Program Contact: Patrick McDermott, Division of Animal and Food
Microbiology, Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Mod II, rm. 1505, Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Management Contact: Katherine C. Bond, Office of International
Programs, Office of the Commissioner, FDA, White Oak Bldg. 32, rm.
3300, 10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>    Grants Contact: Kimberly Pendleton, Division of Acquisition and
Grants, FDA, 5630 Fishers Lane (HFA-500), rm. 2104, Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact Kimberly Pendleton.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

[RFA-FD-10-006]
[Catalog of Federal Domestic Assistance Number(s): 93.103 https://
www.cfda.gov]

A. Background

    The Food and Drug Administration (FDA) is announcing its intention
to accept and consider a single source application for a cooperative
agreement to the WHO GFN. This project represents a collaborative
agreement between the WHO and FDA aimed at capacity building in
laboratory based surveillance of foodborne pathogens and disease in
developing regions to support AGISAR and GFN to enable FDA to realize
its goal of developing an international database for human and animal
isolates of foodborne pathogens and their susceptibility profiles.

B. Research Objectives

     Support WHO capacity building activities with member
countries for AMR monitoring (development of AMR training modules for
GFN training courses, and hosting of visiting scientist from developing
countries).
     Develop harmonized schemes for monitoring antimicrobial
resistance in zoonotic and enteric bacteria to include appropriate
sampling.
     Promote information sharing on AMR (development of a
global AMR databank).
     Provide expert advice to WHO, and promote WHO and FDA
collaborative work to advise WHO Member States on containment of AMR
with a particular focus to Human Critically Important Antimicrobials.
AGISAR should be the core advisory group to review criteria for ranking
human and animal antimicrobials to be reviewed by WHO; and FDA's
resources could be used in support of AGISAR's participation.
     Support and advise WHO on selection of sentinel sites to
be strategically identified around the globe and designing pilot
projects to conduct integrated surveillance of antimicrobial
resistance.
     Promote development of standardized methods for monitoring
antimicrobial use and work with member states for the implementation of
these methods at the country-level.
     Promote the development of published articles on the
emergence of AMR threats and challenges, and the

need for AMR surveillance with a forward-look toward sustainable
solutions through global collaboration and evidence-based approaches.

C. Eligibility Information

    The following organizations/institutions are eligible to apply: The
World Health Organization

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing one award of $847,500 (total costs
including indirect costs) in fiscal year (FY) 2010 in support of this
project. Subject to the availability of funds and successful
performance, 2 additional years of support up to $565,000 per year will
be available.

B. Length of Support

    The support will be 1 year with the possibility of an additional 2
years of noncompetitive support. Continuation beyond the first year
will be based on satisfactory performance during the preceding year,
receipt of a non-competing continuation application and available
Federal FY appropriations.

    Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24903 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45416-45417]
[FR Doc No: 2023-15083]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2023-0349; FRL-11156-01-OGC]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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SUMMARY: In accordance with the Clean Air Act, as amended (CAA or the
Act), notice is given of a proposed consent decree in Sierra Club v.
U.S. EPA, et al., No. 3:23-cv-00780-TLT. On February 22, 2023,
Plaintiff Sierra Club filed a complaint in the United States District
Court for the Northern District of California Oakland Division,
alleging that the Environmental Protection Agency (EPA or the Agency)
failed to perform certain non-discretionary duties in accordance with
the Act to promulgate a Federal implementation plan (FIP) within two
years of finding that Texas failed to submit a state implementation
plan (SIP) for the Rusk/Panola 2010 SO2 National Ambient Air
Quality Standard (SO2 NAAQS) nonattainment area. EPA is
providing notice of this proposed consent decree, which would resolve
all claims in the case by establishing a deadline for EPA to take final
action as specified in the decree.

DATES: Written comments on the proposed consent decree must be received
by August 16, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OGC-2023-0349, online at https://www.regulations.gov (EPA's preferred
method). Follow the online instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
number for this action. Comments received may be posted without change
to https://www.regulations.gov, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Additional Information
about Commenting on the Proposed Consent Decree'' heading under the
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Hali Kerr, Air and Radiation Law
Office, Office of General Counsel, U.S. Environmental Protection
Agency; telephone<PHONE_NUMBER>; email address [email protected].

SUPPLEMENTARY INFORMATION:

I. Obtaining a Copy of the Proposed Consent Decree

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2023-0349) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER> and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    The electronic version of the public docket for this action
contains a copy of the proposed consent decree and is available through
https://www.regulations.gov. You may use https://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and access those documents in
the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number then select
``search.''

II. Additional Information About the Proposed Consent Decree

    On December 13, 2016, the EPA designated portions of Rusk and
Panola Counties, Texas as a ``nonattainment'' area for the 2010
SO2 NAAQS (effective January 12, 2017). 81 FR 89870. The CAA
required the State of Texas to submit a SIP within 18 months of the
effective date of the designation that would provide pollution
reductions necessary for the Rusk-Panola nonattainment area to attain
the SO2 NAAQS. Texas did not submit a SIP by the 18-month
deadline. On August 10, 2020, the EPA issued a statutorily required
Finding of Failure to Submit a SIP for the nonattainment area; this
created a duty for the EPA to promulgate a FIP for the nonattainment
area unless EPA takes final action approving a corrective SIP from the
State within two years of the effective date of the Finding of Failure
to Submit (by September 9, 2022). Texas did not obtain approval of a
corrective SIP by September 9, 2022.
    On February 22, 2023, Plaintiff Sierra Club filed a complaint in
the United States District Court for the Northern District of
California Oakland Division, alleging that the EPA failed to promulgate
a FIP within two years of finding that Texas failed to submit a SIP for
the Rusk/Panola 2010 SO2 NAAQS nonattainment area.\1\
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    \1\ On February 28, 2022, the State of Texas submitted a SIP for
the nonattainment area; this SIP is currently being reviewed by the
EPA.
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    The proposed consent decree would establish a deadline of December
13, 2024 for EPA to take final action promulgating a FIP for the
nonattainment area unless the EPA approves a corrective SIP for the
area satisfying the requirements of CAA section 172(c), 42 U.S.C.
7502(c), before that deadline.
    In accordance with section 113(g) of the CAA, for a period of
thirty (30) days following the date of publication of this document,
the Agency will accept written comments relating to the proposed
consent decree. EPA or the Department of Justice may withdraw or
withhold consent to the proposed consent decree if the comments
disclose

facts or considerations that indicate that such consent is
inappropriate, improper, inadequate, or inconsistent with the
requirements of the Act.

III. Additional Information About Commenting on the Proposed Consent
Decree

    Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-
0349, via https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from this docket. EPA may publish any comment
received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information
identified as CBI, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section of this document. Note that written
comments containing CBI and submitted by mail may be delayed and
deliveries or couriers will be received by scheduled appointment only.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment. This ensures that you
can be identified as the submitter of the comment and allows EPA to
contact you in case EPA cannot read your comment due to technical
difficulties or needs further information on the substance of your
comment. Any identifying or contact information provided in the body of
a comment will be included as part of the comment that is placed in the
official public docket and made available in EPA's electronic public
docket. 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.
    Use of the https://www.regulations.gov website to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
    Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.

Gautam Srinivasan,
Associate General Counsel.
[FR Doc. 2023-15083 Filed 7-14-23; 8:45 am]
BILLING CODE 6560-50-P


INCIDENT REPORT February 2, 2004 Jonathan Chen, Ph. D. U. S. Environmental Protection Agency Office of Pesticide Programs Antimicrobials Division TABLE OF CONTENTS INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF CCA EXPOSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.1 OPP's Incident Data System ( IDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.2 Poison Control Center ( PCC) Data  1993 through 1996 . . . . . . . . . . . . . . . 5 1.3 California Data  1982 through 1996 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1.4 Incident Reports Published in Scientific Literature. . . . . . . . . . . . . . . . . . . . 7 2.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Page 3 of 9 INTRODUCTION The purpose of this chapter is to review the evidence of health effects in humans resulting from exposure to chromated copper arsenate ( CCA). In particular, the acute and chronic toxicity, teratogenic/ reproductive effects, and carcinogenicity are discussed.

A critical evaluation of the health effects of CCA is made difficult by the fact that few studies have been conducted wherein the specific exposure of interest was the mixture of chromated copper arsenate . For a substance that has been widely used for many years by a large number of people in many geographical areas, it is reasonable to expect that much information would be written about the substance. Indeed, ample information is available on physical and chemical properties and on usage of materials treated with CCA. However, there is a true paucity of structured studies with credible exposure assessments and appropriate controls available for review. A few reports are available on populations exposed to multiple wood preservatives, including CCA. In contrast, a large body of literature exists on the health effects ( acute and chronic) in humans of exposure to the components in CCA, most particularly arsenic and to a lesser degree, chromium and copper. Nevertheless, considerable attention was given to presenting the information collected during the review in as logical a format as possible. In this section the potential acute health effects of CCA in humans, reported as incident reports from different sources, are summarized.

1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF CCA EXPOSURE There are many incident report data associated with the individual components of CCA. However, in view of evaluating the health effects of CCA exposure, in this section, only incidents associated with direct CCA or CCA treated wood exposure are evaluated. The following data bases have been consulted:

1. OPP Incident Data System ( IDS)  The Incident Data System of The Office of Pesticide Programs ( OPP) of the Environmental Protection Agency ( EPA) contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies, and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, sometimes with enough cases and/ or enough documentation risk mitigation measures may be suggested.

2. Poison Control Centers  as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1996 for all pesticides. Most of the national Poison Control Centers ( PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System which obtains data from about 65 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings involving drugs, household products, pesticides, etc. Page 4 of 9 3. California Department of Pesticide Regulation  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure ( worker activity), type of illness ( systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

4. Literature Published Incident Reports  Some incident reports associated with CCA related human health hazard are published in the scientific literature.

1.1 OPP's Incident Data System ( IDS)

Please note that the following cases from the IDS do not have documentation confirming exposure or health effects. . Registrants are not required to report incidents involving exposure to previously treated wood, only direct exposure to CCA itself. Therefore, it is possible that serious adverse effects involving exposures to treated wood have been missed by this review. Legal claims of severe damage to eyes and skin including infections requiring amputation have been reported but only in a cursory way and without enough documentation to be included in this review.

Incident # I001618 001 In an incident report received 8/ 1/ 91, a Florida man handling arsenic treated lumber, which was not properly marked with warnings, reported severe injury. He experienced itching, burning rashes, neurological symptoms, and breathing problems.

Incident # I002606 001 In an incident report received 9/ 10/ 95, a woman and her child were exposed to treated wood in their condominium stairs. The child developed a film on their teeth and the woman developed dermatitis. Reported as a potential source of inhalation and dermal exposure was sap draining from the wood.

Incident # I003604 010 In Virginia, multiple chlorine and wood preservative spills result in high numbers of fish kills reported 4/ 15/ 92.

Incident# I006508 001 In a report dated 1/ 1/ 94, a construction supervisor reported " ruined" nerves in feet and legs. Believes saw dust and fumes from cutting and routing much CCA treated lumber are responsible. Page 5 of 9 Incident # I007587 033 Washington State Department of Health 1997 annual report includes 219 incidents involving CCA that were investigated by the Washington Department of Agriculture and the Washington State Departments of Labor and Health in 1996.

Incident# I002365 001 On 01/ 01/ 91 an incident was reported in which pressurized timber was used as a wall around a vegetable garden. Persons who ate the vegetables became ill. Arsenic was detected in soil and potato samples.

Incident I007824 001 In an incident report dated 01/ 01/ 95, pressure treated wood caused a chronic rash that persisted for three years. The rash was subsiding when, in 9/ 98, the person cut some pieces of CCA treated wood and the rash returned.

Incident I008468 001 On 5/ 16/ 95 a person received a splinter from CCA treated wood which then developed into a severe infection requiring surgery. Dorsal cellulitis, ascending limphangitis, and acute tenosynovitis were reported.

1.2 Poison Control Center ( PCC) Data  1993 through 1996 No information available.

1.3 California Data  1982 through 1996 Detailed descriptions of nine cases submitted to the California Pesticide Illness Surveillance Program ( 1982 1996) were reviewed. A brief summary of each of these reported incidences are listed below. Table 4 1 presents the types of illnesses reported by year. The first four number of the incident Case ID is the year the incident was happened.

Incident # 1987 866. Sawdust from CCA treated wood blew into a clerk's eye. The eye became swollen and irritated. The report indicated that the clerk had previously been sawing the wood and had worn safety goggles.

Incident# 1987 1009. Two workers were exposed while working with CCA treated wood. Dust masks were worn. Symptoms reported included headache, nausea, shakiness, and thirst.

Incident # 1987 1576 A worker not wearing protective gloves was handling CCA treated wood and wiped his eye with his contaminated hand. Eye swelling and redness was reported. Page 6 of 9 Incident# 1989 1496 A lumber yard worker scraped his back on a pile of wood. It was unknown if the wood was treated with CCA. He was wearing proper clothing but developed a large rash around the initial scratch. Diagnosis of contact dermatitis was made.

Incident# 1991 3071 A worker developed a rash on both forearms after handling CCA treated lumber. No gloves or arm protection was worn.

Incident# 1992 1484 A lumber yard worker developed contact dermatitis on both palms and fingers after handling CCA treated wood.

Incident# 1995 1057 A lumber mill worker reported nausea and headache radiating down to shoulders after boring holes in wood to check penetration of CCA treatment.

Incident# 1996 301 A wood treatment facility worker experienced eye irritation after CCA from freshly treated lumber splashed into his eye.

Table 4 1. Cases Due to CCA Exposure in California Reported by Type of Illness and Year, 1982 1996 Year Illness Type Systemica Eye Skin Total 1987 2 2  4 1989   1 1 1991   1 1 1992 96 1 1 1 3 Total 4 3 3 9 a Category includes cases where skin, eye, or respiratory effects were also reported. Page 7 of 9 1.4 Incident Reports Published in Scientific Literature.

As reported by Hay, et al ( 2000), a 33 year old man attempted suicide by ingesting an unknown liquid, later identified as a CCA preservative, 75 minutes before his arrival in the emergency department. He was in severe respiratory distress, drooling, tachycardia, and hypotensive. There was an orange color on the palms of both hands. Severe green colored burns of the buccal mucosa were observed. The larynx was edematous. Blood tests revealed partially compensated metabolic acidosis. The patient deteriorated rapidly; the systolic blood pressure dropped to 70 mmHg, and he passed bloody diarrhea. The patient died 2.5 hours after his arrival to the hospital.

According to Geschke, et al. ( 1996) a middle age man, his wife, and his father experienced severe abdominal pain, vomiting, and diarrhea one to two hours after a barbeque. A dog present at the barbeque also seemed unwell. The man's vomiting and diarrhea subsided after two days but was followed by tingling of the fingers, facial numbness, and cramps down the left side of his torso. Within the same week he experienced exfoliation of the skin on both hands. The fuel for the barbeque was timber offcuts from a nearby construction site. 3 days following the incident urinary arsenic levels was 4.9 µ mol/ L. Food poisoning was ruled out.

All eight members of a rural Wisconsin family experienced a three year period of sensory hyperesthesias, muscle cramps, recurrent pruitic conjunctivitis, earaches, and otis media, sinusitus, bronchitis, pneumonia, nose bleeds, easy bruising, and seasonal alopecia ranging from thinning hair to complete baldness. A four week old neonate with recurring viral pneumonia and respiratory exacerbations was treated with a permanent tracheotomy. All children exhibited recurrent " measle like" rashes. The children who went barefoot experienced reddened, thickened skin on the soles of the feet and babies who crawled on the floor showed rashes on the legs, arms, and diaper and stomach area which later became desquamated. The youngest child developed a thrombosed penile artery. All family members experienced malaise, easy fatigue, and lack of sensation in the arms, hands, feet, and legs. Severe muscle cramps were reported in the evening hours. Frequent headaches developed and the two parents reported " black outs" sometimes lasting for two hours in duration. The two youngest children had multiple grand mal seizures from birth to one year of age. One child was diagnosed by a physician as having idopathic thrombocytopenic pupua. The mother's fifth pregnancy resulted in a premature birth with placenta previa or abruptio placenta. It was determined that the cause of the disorders was due to the use of CCA treated marine wood and plywood scraps in a wood stove used inside the home for heating in winter months. Reported exposure occurred through ingestion, inhalation, and direct contact with ashes, vapors, and unburned wood ( Peters, et al., 1984).

In 1993, a 36 year old construction worker with a history of peptic ulcer disease was admitted to a hospital for severe abdominal pain localized to the epigastric region, lower left quadrant, or sometimes everywhere. The pain was accompanied with nausea but no vomiting. An extensive laboratory work up was negative for ulcers upon admission. Additionally, the patient had a negative colonoscopy, nerve conduction test, and electromylegram. The man received Demerol, Dilaudid, Darvocet, Percocet, and a low dose morphine pump but the abdominal pain was still severe. A urinalysis performed showed urinary arsenic levels of 865 mcg/ L ( normal less than 100 mcg/ L) and the patient was treated for arsenic toxicity. The patient indicated a definite exposure Page 8 of 9 to CCA treated wood for the past several years in his occupation ( Nakawatase and Nakatsuka, 1993).

In 1976 Aitken reported on a 35 year old self employed carpenter who was admitted to a Health Center with reports of the skin of his whole body feeling cold. He had been working with CCAtreated wood and for the past four months had been using scraps of the wood as fuel for cooking food. A urinalysis showed arsenic levels of 230 mcg/ L ( normal less than 100 mcg/ L). He was treated for arsenic exposure.

In 1998, seven cows out of a herd of 37 became ill with diarrhea, weakness, stumbling, and prostration. Four of the seven cows died within 48 hours of onset of symptoms. All cows in the herd were in otherwise good health and feed and water was negative for any causative agent. A burnsite in the pasture was found to contain ashes and incompletely burned CCA treated fence posts with an arsenic concentration of 1850 ppm. Upon autopsy the four deceased cows had multifocal abomasal hemorrhage, severe hyperemia of the small intestine, and arsenic concentrations in the liver, abomasal contents, and rumen contents of 4.2, 42, and 105 ppm, respectively ( Hullinger, et al. 1998).

Reported in 1980, seven Californian construction workers developed symptoms of arsenic poisoning while building a pier using woods treated with a combination of ammonium, copper and arsenic ( ACA). Workers urinary arsenic levels were elevated. This incident led to a study conducted at 3 Californian wood treatment plants with varying levels of worker exposure. A study of the urinary arsenic levels of workers illustrates a dose response relationship with high exposure resulting in high urinary arsenic levels ( Rosenburg, et al. 1980). Page 9 of 9 2.0 REFERENCES Aitken, I. Arsenic Poisoning Associated with the Burning of Arsenic Treated Timber. Papua New Guinea Medical Journal 1976 June; 19( 2): 103 104.

Geschecke, A., Lynch, V., Rouch, G., and Golec, R. Arsenic Poisoning After a Barbeque. MJA 1996 Sep; 165: 296.

Hay, E., Derazon, H., Eisenberg, Y. and Natalia, B. ( 2000) Suicide by Ingestion of CCA Wood Preservative. Journal of Emergency Medicine, 19 ( 2) 159 163.

Hullinger, G., Sangster, L, Colvin, B., and Frazier, K. Bovine Arsenic Toxicosis From Ingestion of Ashed Copper Chrome Arsenate Treated Timber. Vet Hum Toxicol 1998 Jun; 40( 3): 147 8.

Nakawatase, T. and Nakatsuka, C. Arsenic Toxicity in Hawaii: A Case Report and Review. Hawaii Medical Journal 1993 Oct; 52( 10): 258 260.

Rosenberg, M., Landrigan, P, and Crowley, S. Low Level Arsenic Exposure in Wood Processing Plants. Am J Ind Med 1980; 1( 1): 99 107.

Peters, H., Croft, W., Woolson, E., Darcey, B., and Olson, M. Seasonal Arsenic Exposure From Burning Chromium Copper Arsenate Treated Wood. JAMA 1984 May; 215( 18): 2393 2396.


[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Page 53392]
[FR Doc No: 2020-19044]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0489]

National Offshore Safety Advisory Committee

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee video teleconference
meeting.

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SUMMARY: The National Offshore Safety Advisory Committee teleconference
meeting scheduled for August 26, 2020 and announced in the Federal
Register on July 28, 2020 has been rescheduled.

DATES: The meeting announced at 85 FR 45436 has been rescheduled to
September 30, 2020, from 10 a.m. to 2:30 p.m. Eastern Daylight Time.

FOR FURTHER INFORMATION CONTACT: Commander Stephen West, Designated
Federal Officer of the National Offshore Safety Advisory Committee,
2703 Martin Luther King Jr. Ave. SE, Stop 7509, Washington, DC, 20593-
7509, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>or Mr. Patrick Clark, telephone<PHONE_NUMBER>,
or email<EMAIL_ADDRESS>
    Dated: August 25, 2020.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2020-19044 Filed 8-26-20; 8:45 am]
BILLING CODE 9110-04-P


September 4, 2015

Via Electronic Transmission<EMAIL_ADDRESS>Mr. Gregory Helms
Project Manager, Corrosivity Standard
Office of Resource Conservation and Recovery
U.S. Environmental Protection Agency (5304 P)
1200 Pennsylvania Ave., NW
Washington, DC 20460

Dear Mr. Helms:

Waste Management (WM) is pleased to offer the following comments and information regarding the recently signed settlement agreement between the U.S. Environmental Protection Agency (EPA) and the Public Employees for Environmental Responsibility (PEER).  EPA has agreed to decide by March 31, 2016 whether to grant the PEER petition for rulemaking to propose to revise the corrosivity characteristic to (i) lower the alkaline limit from a pH of 12.5 to 11.5, and (ii) extend the characteristic to physically solid wastes.  WM believes that the operational and cost implications of granting the PEER petition for rulemaking would be very significant for our hazardous waste management operations, our municipal solid waste landfill operations, the management and recycling of construction and demolition (C&D) debris and would impose significant new costs on our customers.

WM is the leading provider of comprehensive waste and environmental services in North America.  Headquartered in Houston, WM serves over 20 million municipal, commercial, industrial and residential customers in 48 states and most Canadian provinces, providing waste collection, transfer, treatment, disposal, and recycling services.  We operate 262 Subtitle D MSW landfills and 5 Subtitle C hazardous waste landfills.  We also recycle over 800,000 tons of C&D wastes each year for beneficial reuse.

Based on a review of our operations, we believe that a change to the alkaline limit and its application to non-aqueous, solid wastes would result in a very significant increase in new hazardous waste volumes.  In fact, the increased volume of newly characterized hazardous waste would be so great, that it would quickly overwhelm the existing Subtitle C infrastructure needed to manage it.  The petitioners note that the reason for their recommended rulemaking is to prevent chemical burns and respiratory consequences from exposures to alkaline corrosive materials.  However, the listing of these wastes as hazardous will neither prevent exposures from alkaline corrosive dust nor protect workers, response personnel or the public during demolitions, implosions or explosions of concrete buildings or structures.  RCRA hazardous waste management requirements for manifesting, transporting, treating and disposing of wastes would require risk evaluation and control during waste generation, storage, treatment and disposal.  Waste Management's health and safety program requires consideration of worker exposure risks for all Special Wastes (non-MSW).  We are concerned that reducing the alkaline pH limit, would not provide a substantial increase in worker protection, but would require the management of a large quantity of liquid and solid waste as hazardous waste, including treatment residues from metals stabilization using alkaline reagents as discussed below.

Implications for Hazardous Waste Operations

WM owns and operates five hazardous waste Subtitle C landfills.  Together they accept and manage (when operating at full capacity) about one million tons of hazardous wastes per year.  About 60 percent or approximately 600,000 tons would have a known pH level of greater than 11.5 or if stabilized would have a resulting pH level of greater than 11.5.

All five of our hazardous waste landfills are permitted to accept a variety of materials that must be stabilized in accordance with the RCRA Land Disposal Requirements.  Examples of these materials include wastewater treatment sludge, solids and soils containing heavy metals from remediation of industrial facilities, sand blast grit, incinerator ash, incinerator slag, and emissions control dust and residuals.

Solids with no free liquids having an "as is" pH of greater than or equal to 11.5 are directly disposed in the Subtitle C landfills.  Solids requiring treatment for metals undergo alkaline stabilization, which is the primary EPA and industry accepted treatment method for hazardous waste metals and inorganics.  Reagents commonly used in stabilization include fly ash, bed ash, Portland cement, lime and cement kiln dust.  Approximately 95 percent of stabilized, post-treatment wastes will have a pH greater than 11.5.  Liquid waste may also be treated to the DEACT standard with alkaline solidification/stabilization reagents to facilitate removal of the hazardous waste characteristic by converting a liquid to a solid.  These wastes would likely have a pH above 11.5 as well.

If the Agency were to apply the D002 characteristic to physically solid wastes, stabilization of RCRA metal and inorganic containing wastes in accordance with LDRs would create a new characteristic "alkaline" waste during treatment of metals.  Attempts to reduce the pH would require the use of acidic materials that could cause the stabilized waste to fail the TCLP for metals.  Neutralization treatment (e.g. using an acid to neutralize sodium hydroxide, lime or other alkaline solids) would result in potentially violent heat-producing reactions that would pose safety concerns for our employees.  We are not aware of any Agency or industry-accepted stabilization technology for RCRA metals that does not involve alkaline reagents.  Furthermore, low pH solids could present compatibility issues with the predominantly basic or alkaline nature of a Subtitle C landfill.

If EPA were to apply the D002 definition to solid matrices, this would also affect the treatment of debris to the alternate debris standards.  Our Subtitle C landfills manage debris wastes using macro encapsulation or microencapsulation.  Microencapsulation uses high alkaline materials as reagents to render the contaminants in the debris less able to leach into the environment.  In the case of macroencapsulation, removal of the hazardous characteristic would have to be performed prior to the placement of the debris in the HDPE MACRO vault.  It would be extremely difficult to lower the pH of the solid matrix below 11.5 and it would be difficult to sample treated debris to confirm a lowered pH.

Implications for Subtitle D MSW Landfills

WM's Subtitle D landfills receive close to 100 million tons of non-hazardous wastes each year.  A portion of this volume is non-hazardous solid wastes that will likely have a pH greater than 11.5.  These materials may include remediation soils, filter cake and caustic scrubber solids, cooling tower solids, caustic catalysts, concrete and cement, tank cleanout residues, sandblast media, soda ash, drilling muds containing bentonite and furnace or incinerator ash meeting LDR treatment standards.  Because these solids are not required to report a pH level, we were unable to develop a definitive inventory of alkaline waste volumes received.  Nonetheless, by querying our internal databases for materials most likely to have a pH above 11.5, we developed an estimated annual volume of 1.5 million tons received.  We believe this volume significantly underestimates the actual amount of non-hazardous solid materials we receive that could be classified as hazardous if the alkaline pH limit were lowered to 11.5 and applied to solid materials.

More than a quarter of our MSW landfills (approximately 70) perform solidification of solid wastes prior to disposal.  Over half of those landfills use reagents such as lime, fly ash and cement kiln dust in the solidification process.  The reagents received for direct disposal, the reagent materials used in solidification and the post-treatment waste would likely become hazardous if the D002 definition were to apply a lower pH limit to solids.  Using internal records we identified the landfills that perform solidification and estimated the volume of material solidified.

Of the nearly 100 million tons of solid waste received at our Subtitle D landfills, we estimate over one percent undergoes solidification (approximately 1.07 million tons) with alkaline reagents.  This would result in newly characterized hazardous wastes in an amount 50 percent greater than the annual amount of hazardous waste received by all five of WM's Subtitle C landfills.

These wastes would need to be handled and disposed as hazardous wastes, which will greatly increase their management costs.  WM's hazardous waste management professionals estimated that the increased costs per ton would range from $181 up to $395.  This would be the incremental cost addition as compared to the current practice of landfilling de-characterized solids at a Subtitle D landfill.

Implications for Management of Construction & Demolition (C&D) Debris

We understand that the Agency is also evaluating the application of the D002 standard to C&D wastes.  WM's waste acceptance managers suggested that the portion of C&D wastes most likely to trigger a pH above 11.5 would be Portland cement and concrete.  According to EPA's June 2015, Advancing Sustainable Materials Management: 2013 Fact Sheet -- Assessing Trends in Material Generation, Recycling and Disposal in the United States, EPA530-R-15-003, 67 percent of the total volume of C&D debris generated comprises Portland cement and concrete.  In 2013, the amount of Portland cement and concrete debris generated was 353 million tons.  Much of that material is beneficially reused rather than disposed.  Waste Management alone recycled over 500,000 tons of cement and concrete in 2013.  If these materials were classified as hazardous waste due to a lowered pH standard applied to solid materials, beneficial reuse in roadbed or new construction would likely halt, and the materials would need to be landfilled in Subtitle C facilities.

This raises a very troubling implementation issue should EPA revise the corrosivity characteristic  -  there will not be sufficient disposal capacity for the significantly augmented amount of hazardous waste generated by the regulatory change.  In addition, what would be the Land Disposal Restriction (LDR) standard for concrete?  Adjusting the pH of concrete prior to landfill disposal would not be practical.

Insufficient Subtitle C Capacity

EPA cannot assume that if it creates new hazardous waste by regulatory fiat, disposal capacity to handle it will follow.  Our experience is that commercial hazardous waste capacity is extremely difficult to expand.  The process for siting and continuing to renew and expand hazardous waste management capacity is extraordinarily complex, combining the challenges of zoning, hydrogeological compatibility, demands on permit writers and negotiators, and the political will of communities to allow Subtitle C capacity within their midst when it is far easier to assume it can go to another's backyard.  State requirements supplement the federal Subtitle C regulations and often require complex NEPA-like assessments, approvals by local officials, extensive public outreach and consideration of need.  WM recently received an expansion permit for one of our Subtitle C landfills that took over half a dozen years to be approved.  A second landfill seeking an expansion permit underwent an engineering review by the state for over eight years.  When EPA proposed the Coal Combustion Residuals Rule (75 Fed. Reg. 35158), it acknowledged that Subtitle C landfill capacity was wholly inadequate to handle CCR residuals that might constitute 100 million tons each year.  The volume of materials that would become hazardous wastes should EPA decide to grant the PEER rulemaking petition would dwarf that amount.

WM appreciates the opportunity to provide comments and information to assist the Agency in making its regulatory determination in response to the PEER petition for rulemaking.  We strongly recommend that EPA maintain the current corrosivity standard that defines an alkaline or basic hazardous waste as an aqueous waste with a pH greater than or equal to 12.5.  The PEER proposal would not have the intended effect of protecting  first responders or the public from inhalation exposures or chemical burns.  WM's hazardous waste professionals are convinced that attempts to treat stabilized alkaline wastes to lower their pH would be contrary to the requirement to stabilize the waste to immobilize the toxic metals.  These materials have been managed safely in Subtitle D landfills for over 35 years.  Application of the corrosivity standard to solid materials and C&D debris will so significantly increase the volume of hazardous waste produced each year, that sufficient Subtitle C disposal capacity will not be available to accommodate them.

Should you have any questions about the information provided, please feel free to contact me at<PHONE_NUMBER> or<EMAIL_ADDRESS> We look forward to continuing to work with you as you develop your response to the petition.

All the best,

Kerry Kelly, Senior Director Federal Affairs

Cc:	Schatzi Fitz-James<EMAIL_ADDRESS>


[Federal Register: April 29, 2008 (Volume 73, Number 83)]
[Rules and Regulations]
[Page 23111-23114]
[DOCID:fr29ap08-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2004-WI-0002; FRL-8557-4]

Redesignation of the Forest County Potawatomi Community
Reservation to a PSD Class I Area; Dispute Resolution With the State of
Wisconsin

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of dispute resolution.

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SUMMARY: The purpose of this notice is to announce the resolution of an
intergovernmental dispute over a request by the Forest County
Potawatomi Community (FCP Community) to redesignate portions of the FCP
Community reservation as a non-Federal Class I area under the Clean Air
Act (CAA or Act) program for prevention of significant deterioration of
air quality. On June 8, 1995, the Governors of Wisconsin and Michigan
raised concerns about EPA's proposal to approve the request of the FCP
Community to redesignate portions of its reservation as a non-Federal
Class I area and asked EPA to initiate the intergovernmental dispute
resolution process provided for in the CAA. The State of Wisconsin and
the FCP Community were able to reach an agreement concerning the
redesignation. After considering the final agreement signed by the FCP
Community and the State of Wisconsin, EPA finds that this

agreement resolves the dispute and no further action is required by
EPA. In a separate rulemaking published in this Federal Register, EPA
is finalizing its proposed decision to redesignate the FCP Community as
a non-Federal Class I area. The Class I designation will result in
lowering the allowable increases in ambient concentrations of
particulate matter, sulfur dioxide, and nitrogen oxide within the
reservation.

DATES: This action is effective on May 29, 2008.

FOR FURTHER INFORMATION CONTACT: Constantine Blathras, Air Permits
Section, Air Programs Branch (AR-18J), Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604-3507;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. General Information

A. Does This Action Apply to Me?

    This action will apply to applicants to the Prevention of
Significant Deterioration (PSD) construction permit program on Class I
trust lands of the Forest County Potawatomi Community.

B. How Can I Get Copies of This Document and Related Information?

    1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-R05-OAR-2004-WI-0002. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Air Docket, in the EPA Headquarters Library, Room
Number 3334 in the EPA West Building, located at 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation will be 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST),
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the Air Docket is<PHONE_NUMBER>. The docket is also available
during normal business hours for public inspection and copying at the
Air Programs Branch, Region 5, EPA (AR-18J), 77 West Jackson Boulevard,
Chicago, Illinois 60604.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at: http://www.epa.gov/fedrgstr/. In addition to being
available in the docket and on the EPA Federal Register Internet Web
site, an electronic copy of this notice is also available on the EPA's
New Source Review (NSR) Web site, under Regulations & Standards, at
http://www.epa.gov/nsr/actions.html.

C. How Is This Notice Organized?

    The information in this notice is organized as follows:

I. General Information
    A. Does This Action Apply to Me?
    B. How Can I Get Copies of This Document and Related
Information?
    C. How Is this Notice Organized?
II. This Notice
    A. Area Proposed for Redesignation
    B. Authority for Invoking Dispute Resolution Procedures
    C. Agency Action

II. This Notice

A. Area Proposed for Redesignation

    On February 14, 1995, the FCP Community submitted a request to the
EPA to approve the redesignation of the air quality status of selected
parcels of the FCP Community's Reservation from ``Class II'' to ``Class
I'' under the CAA's PSD regulations. The area of FCP Community
reservation lands that has been proposed for redesignation to Class I
comprises 10,818 acres, all of which is located in Forest County,
Wisconsin.

B. Authority for Invoking Dispute Resolution Procedures

    Section 164(e) of the CAA and 40 CFR 52.21(t) provide the current
statutory and regulatory framework for resolving disputes between
states and Tribes over redesignation of an area or for permits for new
major emitting facilities that may cause or contribute to a cumulative
change in air quality under the PSD program. Section 164(e) of the CAA
provides that if the Governor of an affected state or the appropriate
Indian Governing Body of an affected Tribe disagrees with a request for
redesignation by either party, then the governor or Indian ruling body
may request that EPA negotiate with the parties to resolve the dispute.
Pursuant to the statute and implementing regulations, EPA is not a
party to the dispute. The Administrator of EPA is, by statute,
designated as the final arbitrator of the dispute. The statute provides
that either party can ask the Administrator for a recommendation to
resolve the dispute, and if the parties fail to reach an agreement
during the negotiations, ``the Administrator shall resolve the dispute
and his determination, or the results of the agreements reached through
other means, shall become part of the applicable plan and shall be
enforceable as part of such plan.'' Section 164(e), 42 U.S.C. 7474(e).
    Similarly, if a permit is proposed to be issued for any new major
emitting facility proposed for construction in any state, which the
Governor of an affected state or the governing body of an affected
Indian Tribe determines will cause or contribute to a cumulative change
in air quality in excess of that allowed within the affected state or
reservation, the Governor or Tribal ruling body may invoke the same
dispute resolution mechanism. States or Tribes with Class I areas,
however, cannot ``veto'' permits that may adversely affect those areas.
    While EPA has authority to resolve disputes, this authority is
exercised only if the parties in dispute do not reach an agreement
during the dispute resolution process. A discussion of EPA's
authorities to resolve disputes is found in EPA's notice resolving the
dispute between the State of Michigan and the FCP Community, published
in this Federal Register. Where, as here, in the case of Wisconsin and
the FCP Community, the parties reached their own resolution of their
issues, EPA believes that the agreement becomes part of the
``applicable plan'' and the dispute is ended. 42 U.S.C. 7474(e).

C. Agency Action

1. Background on Redesignation Request
    Pursuant to section 164(c), 42 U.S.C. 7474(c), the FCP Community
Tribal Council formally submitted a proposal to redesignate certain FCP
Community reservation lands from Class II to Class I to the EPA on
February 24, 1995. A Class I air quality designation provides greater
protection for air resources by decreasing the increases allowed in the
ambient concentrations of particulate matter, sulfur dioxide, and
nitrogen oxides from any new major stationary sources or major
modifications to existing sources in the vicinity. The types of
facilities whose emissions could impact these lower limits are
generally new or expanding large industrial sources such as electric
utilities and pulp and paper mills. No new operating permits or
additional controls would be required for existing sources solely as a
result of a Class I designation.
    Along with reducing allowable concentrations of key pollutants,
Class I areas may also include air quality related values (AQRV) which
are intended to further protect air quality. In the case of the FCP
Community redesignation, the Tribe has proposed acidic and mercury
deposition as the

AQRVs they are seeking to protect. Because state officials were
concerned about AQRVs and other issues, an intergovernmental dispute
eventually developed and the parties ultimately sought dispute
resolution under section 164(e).
    By statute, the Agency must approve or disapprove a request for
redesignation. Accordingly, on June 29, 1995, EPA published a notice in
the Federal Register (FR) proposing to approve the redesignation
request by the FCP Community to Class I area status. The notice
provided for a 60-day public comment period. However, on June 8, 1995,
the Governors of Wisconsin and Michigan sent a letter to EPA objecting
to EPA's proposal to grant the FCP Community request for redesignation
and requesting dispute resolution. The June 8 letter focused on two
concerns, first, the states' perception that EPA lacked rules to handle
such redesignation requests and the implementation of non-federal Class
I areas, and second, that a non-federal class I area would
``significantly infringe upon the ability of our state governments to
manage the natural resources of our states.''\1\
---------------------------------------------------------------------------

    \1\ Letter from Governor Tommy G. Thompson and Governor John
Engler to Carol Browner, June 8, 1995.
---------------------------------------------------------------------------

    To address their concerns, the Agency published a FR notice (60 FR
40139) on August 7, 1995, postponing the scheduled August 2, 1995
public hearing and extending at the states' request the public comment
period indefinitely, while the Agency attempted to negotiate with the
states and respond to the issues they had raised.
    As already noted, section 164(e) of the Act allows either the
Governor of a state or the Indian ruling body to request to the
Administrator to enter into negotiations with the parties involved to
resolve such a dispute. In response to the Governors' letter, EPA
contracted with a professional mediation service (RESOLVE, Inc.) to
provide mediation services. RESOLVE discussed the case with EPA and the
parties, and circulated resumes and a list of potential mediators for
comment by the parties.
    In the meantime, EPA had formed a senior EPA workgroup to
cooperatively develop options for consideration by the states and
Tribes regarding roles and responsibilities of non-Federal class I area
managers. To gather public comment on different proposals, EPA
published an advanced notice of proposed rulemaking (ANPR) on May 16,
1997. 62 FR 27158. EPA held public workshops in Chicago and Phoenix on
the ANPR, and gathered testimony on the options for proposed
rulemaking. 62 FR 33786 (June 23, 1997). The ANPR was not finalized
however, and no new regulations were established.
    In further follow-up to the Wisconsin and Michigan Governor's
letters invoking dispute resolution, EPA engaged in an extended
correspondence with Wisconsin and Michigan regarding the relationship
of the proposed redesignation to proposed rulemaking, which can be
found in the record for this notice. Following nearly 2 years of
discussions, however, the states and the Tribe had not reached a
resolution of the issues that had been raised by the states, nor had
EPA completed the public notice process on the proposed redesignation.
Therefore, on July 10, 1997, EPA published notice for two informational
meetings and public hearings on the FCP Community's redesignation
request and established a close for the public comment period of
September 15, 1997. 62 FR 37007 (July 10, 1997). EPA held two public
hearings on the proposed redesignation on August 12, 1997, in Carter,
Wisconsin, and August 13, 1997, in Rhinelander, Wisconsin,
respectively. By the close of the public comment period, EPA had
received more than 120 comments on the proposed redesignation.
    On April 21, 1998 \2\, Wisconsin requested that EPA reinitiate the
dispute resolution process under section 164(e). In response, EPA sent
letters to the State of Wisconsin, the State of Michigan, and the FCP
Community requesting a meeting to begin the negotiations to resolve the
dispute. EPA requested that the parties each identify their chief
negotiator, and that each party submit a written list of issues that
they wished to resolve through the dispute resolution process. EPA, in
consultation with the parties, requested RESOLVE to select a mediator,
and Triangle Associates, Inc., Seattle, Washington, was chosen to
mediate the discussions.
---------------------------------------------------------------------------

    \2\ Letter from Governor Tommy Thompson to Richard Wilson,
Acting Assistant Administrator for Air and Radiation, April 21,
1998.
---------------------------------------------------------------------------

    Once a mutually acceptable mediator had been agreed upon, EPA
requested that the mediator establish a formal process for conducting
compilation of issues, organizing and structuring meetings, and
communication among the parties.\3\ This included interviews with each
of the parties, discussions of the issues lists submitted by each
party, and structuring a series of meetings. Following an initial
interview, the Agency requested a meeting of all parties to agree upon
a protocol, establish a list of issues appropriate for discussion under
section 164(e), and plan a series of further meetings aimed at
resolving the dispute.
---------------------------------------------------------------------------

    \3\ The public docket for this rulemaking contains documents
relating to the dispute resolution process except those that are
covered by privilege, such as the federal Alternative Dispute
Resolution Act. Privileged documents are listed in the index, though
have not been made available to the public.
---------------------------------------------------------------------------

    The first dispute resolution meeting occurred on September 2, 1998,
at the Region 5 offices in Chicago, Illinois. Both the States of
Wisconsin and Michigan participated in this meeting, and states and
Tribe each identified issues of concern and attempted to find areas of
overlap that could potentially lead to resolution.
    Following this first meeting, the parties requested that EPA
examine the twenty-one issues submitted for dispute resolution to
determine which would be appropriate for discussion and resolution
under section 164(e) of the CAA. EPA Region 5, in consultation with
EPA's headquarters offices (Office of Air and Radiation, Office of
General Counsel, and Office of Air Quality Planning and Standards), by
letter of November 6, 1998, ultimately submitted to the parties a list
of six suitable topics for further discussion and resolution. These
issues included: ``(1) Whether the lands proposed for redesignation are
of sufficient size to allow for effective air quality management; (2)
the extent to which the lands proposed for redesignation have
sufficient size to have air quality related values; (3) the off-
reservation impacts of redesignation as discussed in the [FCP
Community's] Technical Support Document; (4) the Tribe's choice of
mercury deposition as an AQRV; (5) the Tribe's choice of AQRVs; and (6)
the roles and responsibilities of the respective parties in the dispute
resolution discussion on September 2, 1998.'' \4\ The Agency also
informed the parties that the remaining issues were either unsuitable
for discussion under the CAA section 164(e), or where wholly within
EPA's purview as decision maker under CAA section 164(b) and 164(e).
---------------------------------------------------------------------------

    \4\ Letter from Stephen Rothblatt, Acting Director, Air and
Radiation Division, Region 5, to George E. Meyer, Secretary WDNR,
and Joseph Young, attorney for FCP, November 6, 1998 (cc to Denis
Drake, MDEQ).
---------------------------------------------------------------------------

    On November 16, 1998, the parties held a second dispute resolution
meeting in Green Bay, Wisconsin. However, the State of Michigan elected
not to participate in this meeting.\5\

During the second meeting, the parties discussed each of the six
issues, with each party having the opportunity to raise their specific
concerns. The State of Wisconsin and FCP Community exchanged ideas for
achieving a mutually acceptable resolution, which addressed both
parties' concerns. The parties scheduled another negotiating session
for December.
---------------------------------------------------------------------------

    \5\ The State of Michigan did not participate in any subsequent
dispute resolution meetings between Wisconsin and the FCP. The
Administrator's resolution of the dispute between the State of
Michigan and the FCP Community is concurrently published in a
separate FR notice.
---------------------------------------------------------------------------

    On December 22, 1998, the parties met in Milwaukee, Wisconsin. As a
result of further discussions which took place at this meeting, the
parties developed a draft negotiation concept paper. The parties, as
well as EPA, agreed to seek concurrence from their respective boards
and governing bodies. The parties agreed that sufficient progress had
been made towards resolving the dispute to warrant another meeting in
February 1999.
    The parties held another dispute resolution meeting on the FCP
Community reservation in Carter, Wisconsin on February 3, 1999. During
this meeting, the parties developed specific language that they wished
to include in a draft agreement in principle. After review by both
parties, as well as by EPA, the lead negotiators for the State of
Wisconsin, the FCP Community, and EPA signed the agreement, signifying
their good faith intent to seek concurrence from their respective
authorities and management. EPA was not a party to the dispute, and its
role was to acknowledge the parties' agreement.
    Following the development of the agreement in principle document, a
drafting team comprised of representatives of the parties and from EPA
began developing the detailed terms of the final agreement. On April 8,
1999, the parties held a meeting to work out the language of the final
agreement. After each of the parties, as well as EPA, had an
opportunity to review and comment on the draft of the final agreement,
the parties agreed that another drafting session would be necessary.
The parties, together with EPA, held a final conference call to
complete the draft final agreement on June 7, 1999.
2. The FCP Community and the State of Wisconsin Memorandum of Agreement
    The 1999 Memorandum of Agreement between the FCP Community and the
State of Wisconsin (FCP Community-Wisconsin MOA) fully resolves the
dispute between the state and the Tribe concerning the FCP Community's
request for Class I redesignation of its reservation lands. The Class I
Final Agreement provides a framework for establishing how the state and
FCP Community will implement the Class I area under their respective
authorities. The provisions of this agreement become effective upon
EPA's final action to approve the FCP Community's request for Class I
redesignation, as published in a separate final rule in the Federal
Register. While EPA also was a signatory to this agreement, EPA's role
in the process was to acknowledge the agreement entered into by the
parties on their own respective authorities.
3. Effect of the FCP Community and State of Wisconsin Memorandum of
Agreement on the Wisconsin State Implementation Plan (SIP)
    CAA section 164(e) provides that ``the results of the agreements
reached through other means, shall become part of the applicable plan
and shall be enforceable as part of such plan.'' CAA section 164(e), 42
U.S.C. 7474(e). The PSD program is implemented in Wisconsin under an
EPA approved State Implementation Plan (SIP) which excludes all of
Indian country within the state. The terms of the FCP Community-
Wisconsin MOA do not apply to the effects of the Class I redesignation
on the redesignated area, and thus are not appropriate for inclusion in
the Federal Implementation Plan (FIP) EPA is issuing in a concurrent
rulemaking, located in this Federal Register publication. Rather, the
agreement establishes certain special provisions regarding the effects
of the Class I redesignation on potential sources outside the
redesignated area. These provisions will need to be implemented by
revising the Wisconsin SIP and have been summarized by EPA as follows
in the December 18, 2006, Federal Register proposal:

    [T]he agreement between the FCP Community and Wisconsin subjects
all major sources in Wisconsin located within a ten (10) mile radius
of any redesignated Tribal land to performing an increment analysis
and to meeting consumption requirements applicable to a Class I
area. Major sources located outside of ten (10) miles are subject to
increment analysis and consumption requirements applicable to any
redesignated Tribal land as if it were a Class II area. Also under
the agreement, all major sources within sixty-two (62) miles are
subject to an analysis of their impact on AQRVs of the redesignated
Tribal lands to determine if they will have an adverse impact on
these AQRVs.

71 FR 75696. As these special provisions differ from Wisconsin's
currently approved SIP for the PSD program, for this portion of the FCP
Community-Wisconsin MOA to become enforceable will require revision of
the Wisconsin SIP, which otherwise would not recognize a limitation of
the area in which the Class I increment analysis must be conducted.
    EPA takes the position that it generally will not interfere with
the agreements reached between Tribes and states through the CAA's
164(e) dispute resolution process. However, to the extent that the
agreement reached under the terms of the MOA allows for restricting the
requirements normally associated with Class I areas, as these apply to
sources located outside a 10-mile radius of the redesignated
reservation lands, EPA takes the position that a revision of the
Wisconsin SIP will be necessary to implement this provision to
potential sources located outside boundaries of the redesignated
parcels. In the absence of such modification to the Wisconsin SIP, the
current PSD rules codified at 40 CFR Part 52 will apply to the FCP
Community's Class I area as approved in EPA's final action published in
this Federal Register.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and record keeping requirements, Sulfur dioxides,
Volatile organic compounds.

    Dated: April 18, 2008.
Stephen L. Johnson,
Administrator.
 [FR Doc. E8-8970 Filed 4-28-08; 8:45 am]

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[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Pages 59804-59805]
[FR Doc No: 2020-20968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1640]

Draft Guidance for Cannabidiol; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry, entitled
``Draft Guidance for Cannabidiol.'' The draft guidance, when finalized,
will provide product-specific recommendations on, among other things,
the information and data needed to demonstrate bioequivalence (BE) to
support abbreviated new drug applications (ANDAs) for cannabidiol oral
solution.

DATES: Submit either electronic or written comments on the draft
guidance by November 23, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1640 for ``Draft Guidance for Cannabidiol.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' will be publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002,
301-796-0683.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a draft guidance on a generic
cannabidiol oral solution.
    FDA initially approved new drug application 210365 for EPIDIOLEX
(cannabidiol) in September 2018. We are now issuing draft guidance for
industry on BE recommendations for generic cannabidiol oral solution
(``Draft Guidance for Cannabidiol'').
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
information and data to demonstrate BE to support ANDAs for cannabidiol
oral solution. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20968 Filed 9-22-20; 8:45 am]
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