[Federal Register Volume 76, Number 44 (Monday, March 7, 2011)]
[Rules and Regulations]
[Pages 12283-12292]
[FR Doc No: 2011-4911]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R06-RCRA-2010-0587.; FRL-9274-4]

Texas: Final Authorization of State-initiated Changes and
Incorporation by Reference of State Hazardous Waste Management Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: During a review of Texas' regulations, the EPA identified a
variety of State-initiated changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA). We have determined
that these changes are minor and satisfy all requirements needed to
qualify for Final authorization and are authorizing the State-initiated
changes through this Direct Final action.
    The Solid Waste Disposal Act, as amended, commonly referred to as
the Resource Conservation and Recovery Act (RCRA), allows the
Environmental Protection Agency (EPA) to authorize States to operate
their hazardous waste management programs in lieu of the Federal
program. The EPA uses the regulations entitled ``Approved State
Hazardous Waste Management Programs'' to provide notice of the
authorization status of State programs and to incorporate by reference
those provisions of the State statutes and regulations that will be
subject to the EPA's inspection and enforcement. The rule codifies in
the regulations the prior approval of Texas' hazardous waste management
program and incorporates by reference authorized provisions of the
State's statutes and regulations.

DATES: This regulation is effective May 6, 2011, unless the EPA
receives adverse written comment on the codification of the Texas
authorized RCRA program by the close of business April 6, 2011. If the
EPA receives such comments, it will publish a timely withdrawal of this
direct final rule in the Federal Register informing the public that
this rule will not take effect. The incorporation by reference of
authorized provisions in the Texas statutes and regulations contained
in this rule is approved by the Director of the Federal Register as of
May 6, 2011

in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-
RCRA-2010-0587 by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2 E-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    3. Mail: Alima Patterson, Region 6, Regional Authorization
Coordinator, or Julia Banks, Codification Coordinator, State/Tribal
Oversight Section (6PD-O), Multimedia Planning and Permitting Division,
EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.
    4. Hand Delivery or Courier: Deliver your comments to Alima
Patterson, Region 6, Regional Authorization Coordinator, or Julia
Banks, Codification Coordinator, State/Tribal Oversight Section (6PD-
O), Multimedia Planning and Permitting Division, EPA Region 6, 1445
Ross Avenue, Dallas, Texas 75202-2733.
    Instructions: Do not submit information that you consider to be CBI
or otherwise protected through http://www.regulations.gov, or e-mail.
The Federal http://www.regulations.gov Web site is an ``anonymous
access'' system, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an e-mail comment directly to the EPA without going through
http://www.regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses. You can view and copy the documents
that form the basis for this authorization and codification and
associated publicly available materials from 8:30 a.m. to 4 p.m. Monday
through Friday at the following location: EPA, Region 6, 1445 Ross
Avenue, Dallas, Texas 75202-2733, phone number<PHONE_NUMBER>.
Interested persons wanting to examine these documents should make an
appointment with the office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6 Regional
Authorization Coordinator, and Julia Banks Codification Coordinator,
State/Tribal Oversight Section (6PD-O), Multimedia Planning and
Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas
75202-2733, Phone numbers:<PHONE_NUMBER>, and<PHONE_NUMBER>, E-mail
address<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Authorization of State-Initiated Changes

A. Why are revisions to State programs necessary?

    States which have received Final authorization from the EPA under
RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous
waste program that is equivalent to, consistent with, and no less
stringent than the Federal hazardous waste program. As the Federal
program changes, the States must change their programs and ask the EPA
to authorize the changes. Changes to State hazardous waste programs may
be necessary when Federal or State statutory or regulatory authority is
modified or when certain other changes occur. Most commonly, States
must change their programs because of changes to the EPA's regulations
in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268,
270, 273 and 279. States can also initiate their own changes to their
hazardous waste program and these changes must then be authorized.

B. What decisions have we made in this rule?

    We conclude that Texas' revisions to its authorized program meet
all of the statutory and regulatory requirements established by RCRA.
We found that the State-initiated changes make Texas' rules more clear
or conform more closely to the Federal equivalents and are so minor in
nature that a formal application is unnecessary. Therefore, we grant
Texas final authorization to operate its hazardous waste program with
the changes described in the table at Section G below. Texas has
responsibility for permitting Treatment, Storage, and Disposal
Facilities (TSDFs) within its borders (except in Indian Country) and
for carrying out all authorized aspects of the RCRA program, subject to
the limitations of the Hazardous and Solid Waste Amendments of 1984
(HSWA). New Federal requirements and prohibitions imposed by Federal
regulations that EPA promulgates under the authority of HSWA take
effect in authorized States before they are authorized for the
requirements. Thus, the EPA will implement those requirements and
prohibitions in Texas, including issuing permits, until the State is
granted authorization to do so.

C. What is the effect of this authorization decision?

    The effect of this decision is that a facility in Texas subject to
RCRA will now have to comply with the authorized State requirements
instead of the equivalent Federal requirements in order to comply with
RCRA. Texas has enforcement responsibilities under its State hazardous
waste program for violations of such program, but the EPA retains its
authority under RCRA sections 3007, 3008, 3013, and 7003, which
include, among others, authority to:
     Do inspections, and require monitoring, tests, analyses,
or reports;
     Enforce RCRA requirements and suspend or revoke permits;
and
     Take enforcement actions regardless of whether the State
has taken its own actions.
    This action does not impose additional requirements on the
regulated community because the statutes and regulations for which
Texas is being authorized by this direct action are already effective
and are not changed by this action.

D. Why wasn't there a proposed rule before this rule?

    The EPA did not publish a proposal before this rule because we view
this as a routine program change and do not expect comments that oppose
this approval. We are providing an opportunity for public comment now.
In addition to this rule, in the Proposed Rules section of this Federal
Register, we are publishing a separate document that proposes to
authorize the State program changes.

E. What happens if EPA receives comments that oppose this action?

    If the EPA receives comments that oppose this authorization or the
incorporation-by-reference of the State program, we will withdraw this
rule by publishing a timely document in the Federal Register before the
rule becomes effective. The EPA will base any further decision on the
authorization of the State program changes, or the incorporation-by-
reference, on the proposal mentioned in the previous paragraph. We will
then address all public comments in a later

final rule. If you want to comment on this authorization and
incorporation-by-reference, you must do so at this time. If we receive
comments that oppose only the authorization of a particular change to
the State hazardous waste program or the incorporation-by-reference of
the State program, we may withdraw only that part of this rule, but the
authorization of the program changes or the incorporation-by-reference
of the State program that the comments do not oppose will become
effective on the date specified above. The Federal Register withdrawal
document will specify which part of the authorization or incorporation-
by-reference of the State program will become effective and which part
is being withdrawn.

F. For what has Texas previously been authorized?

    The State of Texas initially received final authorization on
December 26, 1984 (49 FR 48300), to implement its Base Hazardous Waste
Management Program. This authorization was clarified in a notice
published March 26, 1985 (50 FR 11858). Texas received authorization
for revisions to its program, effective October 4, 1985 (51 FR 3952),
February 17, 1987 (51 FR 45320), March 15, 1990 (55 FR 7318), July 23,
1990 (55 FR 21383), October 21, 1991 (56 FR 41626), December 4, 1992
(57 FR 45719), June 27, 1994 (59 FR 16987), June 27, 1994 (59 FR
17273), November 26, 1997 (62 FR 47947), December 3, 1997 (62 FR
49163), October 18, 1999 (64 FR 44836), November 15, 1999 (64 FR
49673), September 11, 2000 (65 FR 43246), June 14, 2005 (70 FR 34371),
December 29, 2008, (73 FR 64252), and July 13, 2009 (74 FR 22469).

G. What changes are we authorizing with this action?

    The State has made amendments to the provisions listed in the table
which follows. These amendments clarify the State's regulations and
make the State's regulations more internally consistent. The State's
laws and regulations, as amended by these provisions, provide authority
which remains equivalent to and no less stringent than the Federal laws
and regulations. These State-initiated changes satisfy the requirements
of 40 CFR 271.21(a). We are granting Texas final authorization to carry
out the following provisions of the State's program in lieu of the
Federal program. These provisions are analogous to the indicated RCRA
statutory provisions or RCRA regulations found at 40 CFR as of July 1,
2005. The Texas provisions are from the Texas Administrative Code
(TAC), Title 30, effective December 31, 2007.

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           State requirement              Analogous Federal requirement
------------------------------------------------------------------------
30 TAC 3.2(25) ``Person''..............  40 CFR 260.10 ``Person''; 40
                                          CFR 270.2 ``Person''.
30 TAC 281.21(d).......................  40 CFR 124.6 related; no direct
                                          Federal analog.
30 TAC 305.2(20) ``licensed              40 CFR 260.10 related; no
 professional geoscientist''.             direct Federal analog.
30 TAC 305.45(a)(8) intro.--(a)(8)(B)..  40 CFR 270.13(l) related.
30 TAC 305.50(a)(6)....................  40 CFR 270.17(b)(1), 270.20(b),
                                          270.21(b)(1)(i).
30 TAC 324.2(8) and (9)................  40 CFR 279.1 related.
30 TAC 324.4...........................  40 CFR 279.12.
30 TAC 324.7...........................  40 CFR 279.30-279.32 (Subpart
                                          D).
30 TAC 324.16..........................  40 CFR 279.10(i).
30 TAC 324.21..........................  40 CFR 271.16 related; no
                                          direct Federal analog.
30 TAC 335.1(87) ``Licensed              40 CFR 260.10 related; no
 professional geoscientist''.             direct Federal analog.
30 TAC 335.116, except (g).............  40 CFR 265.90, except (f).
30 TAC 335.123.........................  40 CFR 265.280.
30 TAC 335.156(b)(3)-(b)(5)............  40 CFR 264.90(b)(3)-(b)(5).
30 TAC 335.172.........................  40 CFR 264.280.
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H. Who handles permits after the authorization takes effect?

    This authorization does not affect the status of State permits and
those permits issued by the EPA because no new substantive requirements
are a part of these revisions.

I. How does this action affect Indian Country (18 U.S.C. 1151) in
Texas?

    Texas is not authorized to carry out its Hazardous Waste Program in
Indian Country within the State. This authority remains with EPA.
Therefore, this action has no effect in Indian Country.

II. Incorporation-by-Reference

A. What is codification?

    Codification is the process of placing a State's statutes and
regulations that comprise the State's authorized hazardous waste
management program into the Code of Federal Regulations (CFR). Section
3006(b) of RCRA, as amended, allows the Environmental Protection Agency
(EPA) to authorize State hazardous waste management programs to operate
in lieu of the Federal hazardous waste management regulatory program.
The EPA codifies its authorization of State programs in 40 CFR part 272
and incorporates by reference State statutes and regulations that the
EPA will enforce under sections 3007 and 3008 of RCRA and any other
applicable statutory provisions.
    The incorporation by reference of State authorized programs in the
CFR should substantially enhance the public's ability to discern the
current status of the authorized State program and State requirements
that can be Federally enforced. This effort provides clear notice to
the public of the scope of the authorized program in each State.

B. What is the history of the codification of Texas' hazardous waste
management program?

    The EPA incorporated by reference Texas' then authorized hazardous
waste program effective December 3, 1997 (62 FR 49163), November 15,
1999 (64 FR 49673), and December 29, 2008 (73 FR 64252). In this
action, EPA is revising Subpart SS of 40 CFR part 272 to include the
recent authorization revision actions effective July 13, 2009 (74 FR
22469).

C. What codification decisions have we made in this rule?

    The purpose of this Federal Register document is to codify Texas'
base hazardous waste management program and its revisions to that
program. The EPA provided notices and opportunity for comments on the
Agency's decisions to authorize the Texas program, and the EPA is not
now reopening the decisions, nor requesting comments, on the Texas

authorizations as published in the Federal Register notices specified
in Section F of this document.
    This document incorporates by reference Texas' hazardous waste
statutes and regulations and clarifies which of these provisions are
included in the authorized and Federally enforceable program. By
codifying Texas' authorized program and by amending the Code of Federal
Regulations, the public will be more easily able to discern the status
of Federally approved requirements of the Texas hazardous waste
management program.
    The EPA is incorporating by reference the Texas authorized
hazardous waste program in subpart SS of 40 CFR part 272. Section
272.2201 incorporates by reference Texas' authorized hazardous waste
statutes and regulations. Section 272.2201 also references the
statutory provisions (including procedural and enforcement provisions)
which provide the legal basis for the State's implementation of the
hazardous waste management program, the Memorandum of Agreement, the
Attorney General's Statements and the Program Description, which are
approved as part of the hazardous waste management program under
Subtitle C of RCRA.

D. What is the effect of Texas' codification on enforcement?

    The EPA retains its authority under statutory provisions, including
but not limited to, RCRA sections 3007, 3008, 3013, and 7003, and other
applicable statutory and regulatory provisions to undertake inspections
and enforcement actions and to issue orders in authorized States. With
respect to these actions, the EPA will rely on Federal sanctions,
Federal inspection authorities, and Federal procedures rather than any
authorized State analogues to these provisions. Therefore, the EPA is
not incorporating by reference such particular, approved Texas
procedural and enforcement authorities. Section 272.2201(c)(2) of 40
CFR lists the statutory and regulatory provisions which provide the
legal basis for the State's implementation of the hazardous waste
management program, as well as those procedural and enforcement
authorities that are part of the State's approved program, but these
are not incorporated by reference.

E. What State provisions are not part of the codification?

    The public needs to be aware that some provisions of Texas'
hazardous waste management program are not part of the Federally
authorized State program. These non-authorized provisions include:
    (1) Provisions that are not part of the RCRA subtitle C program
because they are ``broader in scope'' than RCRA subtitle C (see 40 CFR
271.1(i));
    (2) Federal rules for which Texas is not authorized, but which have
been incorporated into the State regulations because of the way the
State adopted Federal regulations by reference;
    (3) Unauthorized amendments to authorized State provisions; and
    (4) New unauthorized State requirements.
    State provisions that are ``broader in scope'' than the Federal
program are not part of the RCRA authorized program and the EPA will
not enforce them. Therefore, they are not incorporated by reference in
40 CFR part 272. For reference and clarity, 40 CFR 272.2201(c)(3) lists
the Texas regulatory provisions which are ``broader in scope'' than the
Federal program and which are not part of the authorized program being
incorporated by reference. ``Broader in scope'' provisions cannot be
enforced by the EPA; the State, however, may enforce such provisions
under State law.
    Texas has adopted but is not authorized for the following Federal
rules published in the Federal Register on April 12, 1996 (61 FR
16290); December 5, 1997 (62 FR 64504); October 22, 1998 (63 FR 56710);
June 8, 2000 (65 FR 36365); March 4, 2005 (70 FR 10776), as amended
June 16, 2005 (70 FR 35034). Therefore, these Federal amendments
included in Texas' adoption by reference at 30 Texas Administrative
Code (TAC) sections: 335.112(a)(1) and (a)(4), 335.152(a)(1) and
(a)(4), and 335.431(c)(1), are not part of the State's authorized
program and are not part of the incorporation by reference addressed by
this Federal Register document.
    Additionally, Texas' hazardous waste regulations include amendments
which have not been authorized by the EPA. Since the EPA cannot enforce
a State's requirements which have not been reviewed and authorized in
accordance with RCRA section 3006 and 40 CFR part 271, it is important
to be precise in delineating the scope of a State's authorized
hazardous waste program. Regulatory provisions that have not been
authorized by the EPA include amendments to previously authorized State
regulations as well as new State requirements.
    In those instances where Texas has made unauthorized amendments to
previously authorized sections of State code, the EPA is identifying in
40 CFR 272.2201(c)(4) any regulations which, while adopted by the State
and incorporated by reference, include language not authorized by the
EPA. Those unauthorized portions of the State regulations are not
Federally enforceable. Thus, notwithstanding the language in Texas
hazardous waste regulations incorporated by reference at 40 CFR
272.2201(c)(1), the EPA will only enforce those portions of the State
regulations that are actually authorized by the EPA. For the
convenience of the regulated community, the actual State regulatory
text authorized by the EPA for the citations listed at 272.2201(c)(4)
(i.e., without the unauthorized amendments) is compiled as a separate
document, Addendum to the EPA Approved Texas Regulatory Requirements
Applicable to the Hazardous Waste Management Program, July 2009. This
document is available from EPA Region 6, EPA Region 6, 1445 Ross
Avenue, Dallas, Texas 75202-2733, Phone number:<PHONE_NUMBER>.
    State regulations that are not incorporated by reference in this
rule at 40 CFR 272.2201(c)(1), or that are not listed in 40 CFR
272.2201(c)(3) (``broader in scope'') or 40 CFR 272.2201(c)(4)
(``unauthorized amendments to authorized State provisions''), are
considered new unauthorized State requirements. These requirements are
not Federally enforceable.
    With respect to any requirement pursuant to the Hazardous and Solid
Waste Amendments of 1984 (HSWA) for which the State has not yet been
authorized, the EPA will continue to enforce the Federal HSWA standards
until the State is authorized for these provisions.

F. What will be the effect of Federal HSWA requirements on the
codification?

    The EPA is not amending 40 CFR part 272 to include HSWA
requirements and prohibitions that are implemented by EPA. Section
3006(g) of RCRA provides that any HSWA requirement or prohibition
(including implementing regulations) takes effect in authorized and not
authorized States at the same time. A HSWA requirement or prohibition
supersedes any less stringent or inconsistent State provision which may
have been previously authorized by the EPA (50 FR 28702, July 15,
1985). The EPA has the authority to implement HSWA requirements in all
States, including authorized States, until the States become authorized
for such requirement or prohibition. Authorized States are required to
revise their programs to

adopt the HSWA requirements and prohibitions, and then to seek
authorization for those revisions pursuant to 40 CFR part 271.
    Instead of amending the 40 CFR part 272 every time a new HSWA
provision takes effect under the authority of RCRA section 3006(g), the
EPA will wait until the State receives authorization for its analog to
the new HSWA provision before amending the State's 40 CFR part 272
incorporation by reference. Until then, persons wanting to know whether
a HSWA requirement or prohibition is in effect should refer to 40 CFR
271.1(j), as amended, which lists each such provision.
    Some existing State requirements may be similar to the HSWA
requirement implemented by the EPA. However, until the EPA authorizes
those State requirements, the EPA can only enforce the HSWA
requirements and not the State analogs. The EPA will not codify those
State requirements until the State receives authorization for those
requirements.
Statutory and Executive Order Reviews
    The Office of Management and Budget has exempted this action from
the requirements of Executive Order 12866 (58 FR 51735, October 4,
1993), and therefore, this action is not subject to review by OMB. This
rule incorporated by reference Texas' authorized hazardous waste
management regulations, and imposes no additional requirements beyond
those imposed by State law. This final rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Incorporation by
reference will not impose any new burdens on small entities.
Accordingly, I certify that this action will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule
merely incorporates by reference certain existing State hazardous waste
management program requirements which the EPA already approves under 40
CFR part 271, and does not impose any additional enforceable duty
beyond that required by State law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999), because it merely incorporates by reference
existing State hazardous waste management program requirements without
altering the relationship or the distribution of power and
responsibilities established by RCRA. This action also does not have
Tribal implications within the meaning of Executive Order 13175 (65 FR
67249, November 6, 2000).
    This action also is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because it is not economically significant and
it does not make decisions based on environmental health or safety
risks. This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply
Distribution or Use'' (66 FR 28344, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.
    Under RCRA 3006(b), the EPA grants a State's application for
incorporation by reference as long as the State meets the criteria
required by RCRA. It would thus be inconsistent with applicable law for
the EPA, when it reviews a State incorporation by reference
application, to require the use of any particular voluntary consensus
standard in place of another standard that otherwise satisfies the
requirements of RCRA. Thus, the requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272) do not apply. The final rule does not include environmental
justice issues that require consideration under Executive Order 12898
(59 FR 7629, February 16, 1994). The EPA has complied with Executive
Order 12630 (53 FR 8859, March 15, 1988) by examining the takings
implications of the rule in accordance with the ``Attorney General's
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings'' issued under the executive order. As required
by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996),
in issuing this rule, the EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States prior to publication in the Federal Register. A major
rule cannot take effect until 60 days after it is published in the
Federal Register. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Parts 271 and 272

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Incorporation by reference, Indian lands,
Intergovernmental relations, Penalties, Reporting and recordkeeping
requirements.

    Authority: This rule is issued under the authority of Sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as amended
42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: January 24, 2011.
Al Armendariz,
Regional Administrator, Region 6.

    For the reasons set forth in the preamble, 40 CFR parts 271 and 272
are amended as follows:

PART 271--REQUIREMENTS FOR AUTHORIZATION OF STATE HAZARDOUS WASTE
PROGRAMS

    EPA is granting final authorization under part 271 to the State of
Texas for revisions to its hazardous waste program under the Resource
Conservation and Recovery Act.

PART 272--APPROVED STATE HAZARDOUS WASTE MANAGEMENT PROGRAMS

0
1. The authority citation for part 272 continues to read as follows:

    Authority: Sections 2002(a), 3006, and 7004(b) of the Solid
Waste Disposal Act, as amended by the Resource Conservation and
Recovery Act of 1976, as amended, 42 U.S.C. 6912(a), 6926, and
6974(b).

Subpart SS--[Amended]

0
2. Subpart SS is amended by revising Sec.  272.2201 to read as follows:

Sec.  272.2201  Texas State-Administered Program: Final Authorization.

    (a) Pursuant to section 3006(b) of RCRA, 42 U.S.C. 6926(b), the EPA
granted Texas final authorization for the following elements as
submitted to EPA in Texas' Base program application for final
authorization which was approved by EPA effective on December 26, 1984.
Subsequent program revision applications were approved effective on
October 4, 1985, February 17, 1987, March 15, 1990, July 23, 1990,
October 21, 1991, December 4, 1992, June 27,

1994, November 26, 1997, December 3, 1997, October 18, 1999, November
15, 1999, September 11, 2000, June 14, 2005, December 29, 2008, July
13, 2009, and May 6, 2011.
    (b) The State of Texas has primary responsibility for enforcing its
hazardous waste management program. However, EPA retains the authority
to exercise its inspection and enforcement authorities in accordance
with sections 3007, 3008, 3013, 7003 of RCRA, 42 U.S.C. 6927, 6928,
6934, 6973, and any other applicable statutory and regulatory
provisions, regardless of whether the State has taken its own actions,
as well as in accordance with other statutory and regulatory
provisions.
    (c) State Statutes and Regulations.
    (1) The Texas statutes and regulations cited in paragraph (c)(1)(i)
of this section are incorporated by reference as part of the hazardous
waste management program under Subtitle C of RCRA, 42 U.S.C. 6921 et
seq. This incorporation by reference is approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies of the Texas regulations that are incorporated by reference in
this paragraph are available from West Group, 610 Opperman Drive,
Eagan, 55123, Attention: Order Entry; Phone: 1-800-328-9352; Web site:
http://west.thomson.com. You may inspect a copy at EPA Region 6
Library, 12th Floor, 1445 Ross Avenue, Dallas, Texas 75202-2733, Phone
number:<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (i) The Binder entitled ``EPA Approved Texas Statutory and
Regulatory Requirements Applicable to the Hazardous Waste Management
Program,'' dated July 2009.
    (ii) [Reserved]
    (2) The following provisions provide the legal basis for the
State's implementation of the hazardous waste management program, but
they are not being incorporated by reference and do not replace Federal
authorities:
    (i) Texas Health and Safety Code (THSC) Annotated, (Vernon, 2001);
Chapter 361, The Texas Solid Waste Disposal Act, sections 361.002,
361.016, 361.017, 361.018, 361.023, 361.024, 361.029, 361.032, 361.033,
361.035, 361.036, 361.037(a), 361.061, 361.063, 361.0635, 361.064,
361.0641, 361.066(b) and (c), 361.067, 361.068, 361.069, 361.079,
361.080(a) and (b), 361.081, 361.083, 361.833, 361.0861(c), 361.0885,
361.090, 361.095(b)-(f), 361.096, 361.097, 361.098, 361.099(a),
361.100, 361.101, 361.102 through 361.109, 361.113, 361.116, 361.272
through 361.275, 361.278, 361.301, 361.321(a) and (b), 361.321(c)
(except the phrase ``Except as provided by Section 361.322(a)''),
361.321(d), 361.321(e) (except the phrase ``Except as provided by
Section 361.322(e)''), 361.451, 361.501 through 361.506, and 361.509(a)
introductory paragraph, (a)(11), (b), (c) introductory paragraph, and
(c)(2); Chapter 371, Texas Oil Collection, Management, and Recycling
Act, sections 371.0025(b) and (c), 371.024(a), 371.024(c) and (d),
371.026(a) and (b), 371.028, and 371.043(b).
    (ii) Texas Health and Safety Code (THSC) Annotated, (Vernon, 2007
Supplement), effective September 1, 2007: Chapter 361, The Texas Solid
Waste Disposal Act, sections 361.0215(b)(2) and (b)(3), 361.0666,
361.078, 361.0791, 361.082 (except 361.082(a) and (f)), 361.084,
361.085, 361.0871(b), 361.088, 361.089, 361.114, and 361.271.
    (iii) Texas Water Code (TWC), Texas Codes Annotated (Vernon, 2000),
effective September 1, 1999, as amended: Chapter 5, sections 5.102
through 5.105, 5.112, and 5.351; Chapter 7, sections 7.032, 7.051(a),
7.052(c) and (d), 7.053 through 7.062, 7.064 through 7.069, 7.075,
7.101, 7.104, 7.105, 7.107, 7.110, 7.162, 7.163, 7.189, 7.190,
7.252(1), 7.351, 7.353; Chapter 26, section 26.011; and Chapter 27,
sections 27.018 and 27.019.
    (iv) Texas Water Code (TWC), Texas Codes Annotated (Vernon, 2002),
effective September 1, 2001, as amended: Chapter 5, section 5.177;
Chapter 7, sections 7.067 and 7.102.
    (v) Texas Water Code (TWC), Texas Codes Annotated (Vernon, 2007),
effective September 1, 2007, as amended: Chapter 5, sections 5.501
through 5.505, 5.509 through 5.512, 5.515, 5.551 through 5.557; Chapter
7, sections 7.031, 7.052(a),7.052(c) and (d), 7.102, 7.176, and 7.187;
Chapter 26, sections 26.001(13), 26.039, 26.341 through 26.367; and
Chapter 27, section 27.003.
    (vi) Texas Government Code (Vernon, 1998), section 311.027,
effective May 11, 1993.
    (vii) Texas Administrative Code (TAC), Title 30, Environmental
Quality, 1994, as amended, effective through January 1, 1994: Chapter
305, sections 305.91 through 305.93, 305.98, and 305.99.
    (viii) Texas Administrative Code (TAC), Title 30, Environmental
Quality, 1997, as amended, effective through January 1, 1997: Chapter
281, sections 281.17(f); Chapter 305, sections 305.29(b) through (d),
305.94 and 305.95, 305.97, 305.100, 305.101 (except 305.101(c)),
305.102, 305.103, and 305.105.
    (ix) Texas Administrative Code (TAC), Title 30, Environmental
Quality, 2008, as amended, effective through December 31, 2007: Chapter
39, sections 39.13 (except (10)), 39.105, 39.107, 39.109, 39.413
(except (10)); Chapter 50, sections 50.13, 50.19, 50.39, 50.113 (except
(d)), 50.119, and 50.139; Chapter 55, sections 55.27 (except (b)),
55.201 (except as applicable to contested case hearings), and 55.211
(except as applicable to contested case hearings); Chapter 70, section
70.10; Chapter 281, sections 281.1 (except the clause ``except as
provided by * * * Prioritization Process)''), 281.2 introductory
paragraph, 281.2(4), 281.3(a) and (b), 281.5 (except the clause
``Except as provided by * * * Discharge Permits)'', the phrase
``radioactive material'', and the phrase ``subsurface area drip
dispersal systems''), 281.17(d) (except the references to radioactive
material licenses), 281.17(e), 281.18(a) (except for the sentence ``For
applications for radioactive * * * within 30 days.'', 281.19(a) (except
the last sentence), 281.19(b) (except the phrase ``Except as provided
in subsection (c) of this section,''), 281.20, 281.21(a) (except the
phrase ``and the Texas Radiation Control Act * * * Chapter 401.'', the
acronym ``TRCA'', and the phrase ``subsurface area drip dispersal
systems''), 281.21(b), 281.21(c) (except the phrase ``radioactive
materials,'' in 281.21(c)(2)), 281.21(d), 281.22(a) (except the phrase
``For applications for radioactive * * * to deny the license.''),
281.22(b) (except the phrase ``or an injection well,'' in the first
sentence and the phrase ``For underground injection wells * * * the
same facility or activity.''), 281.23(a), and 281.24; Chapter 305,
sections 305.64(d) and (f), 305.66(c), 305.66(e) (except for the last
sentence), 305.66(f) through (l), 305.123 (except the phrases ``and 401
* * * regulation)'' and ``and 32''), 305.125(1) and (3), 305.125(20),
305.127(1)(B)(i), 305.127(4)(A) and (C), 305.127(6), 305.401(a),
305.401(b) (except the text ``Sec.  39.3 of this title (relating to
Purpose) * * * Sec.  55.21 of this title (relating to Requests for
Contested Case Hearings, Public Comment''), 305.401(d) through (h); and
Chapter 335, sections 335.2(b), 335.43(b), 335.206, 335.391 through
335.393.
    (3) The following statutory and regulatory provisions are broader
in scope than the Federal program, are not part of the authorized
program, and are not incorporated by reference:

    (i) Texas Health and Safety Code (THSC) Annotated, (Vernon 2001):
Chapter 361, The Texas Solid Waste Disposal Act, sections 361.131
through 140; Chapter 371, Texas Oil Collection, Management, and
Recycling Act, sections 371.021, 371.022, 371.024(e), 371.0245,
371.0246, 371.025, and 371.026(c).
    (ii) Texas Administrative Code (TAC), Title 30, Environmental
Quality, 2008, as amended, effective through December 31, 2007: Chapter
305, sections 305.53 and 305.64(b)(4); Chapter 335, sections 335.321
through 335.332, Appendices I and II, and 335.401 through 412.
    (4) Unauthorized State Amendments and Provisions. (i) The following
authorized provisions of the Texas regulations include amendments
published in the Texas Register that are not approved by EPA. Such
unauthorized amendments are not part of the State's authorized program
and are, therefore, not Federally enforceable. Thus, notwithstanding
the language in the Texas hazardous waste regulations incorporated by
reference at paragraph (c)(1)(i) of this section, EPA will enforce the
State provisions that are actually authorized by EPA. The effective
dates of the State's authorized provisions are listed in the Table
below. The actual State regulatory text authorized by EPA (i.e.,
without the unauthorized amendments) is available as a separate
document, Addendum to the EPA-Approved Texas Regulatory and Statutory
Requirements Applicable to the Hazardous Waste Management Program,
July, 2009. Copies of the document can be obtained from U.S. EPA Region
6, 1445 Ross Avenue, Suite 1200, Dallas, TX 75202.

------------------------------------------------------------------------
                                                 Unauthorized State
  State provision  (December    Effective            amendments
     31, 2007, except as         date of   -----------------------------
          indicated)            authorized   Texas Register   Effective
                                provision      reference         date
------------------------------------------------------------------------
335.2(c).....................      11/7/91  18 TexReg 2799.      5/12/93
                                            18 TexReg 8218.     11/23/93
335.6(a).....................      7/29/92  18 TexReg 2799.      5/12/93
                                            22 TexReg 12060     12/15/97
                                            23 TexReg 10878     10/19/98
335.6(c) introductory              7/29/92  17 TexReg 8010.     11/27/92
 paragraph.                                 20 TexReg 2709.      4/24/95
                                            20 TexReg 3722.      5/30/95
                                            21 TexReg 1425.       3/1/96
                                            21 TexReg 2400.       3/6/96
                                            22 TexReg 12060     12/15/97
                                            23 TexReg 10878     10/19/98
                                            26 TexReg 9135.     11/15/01
335.6(g).....................      7/29/92  18 TexReg 3814.      6/28/93
                                            22 TexReg 12060     12/15/97
                                            23 TexReg 10878     10/19/98
335.10(b)(22) (December 31,        7/27/88  17 TexReg 8010.     11/27/92
 2001).
335.24(b) introductory              3/1/96  21 TexReg 10983     11/20/96
 paragraph.                                 23 TexReg 10878     10/19/98
335.24(c) introductory              3/1/96  21 TexReg 10983     11/20/96
 paragraph.                                 23 TexReg 10878     10/19/98
335.41(c)....................       9/1/86  18 TexReg 8218.     11/23/93
335.45(b)....................       9/1/86  17 TexReg 5017.      7/29/92
335.204(a)(1)................      5/28/86  16 TexReg 6065.      11/7/91
335.204(b)(1)................      5/28/86  16 TexReg 6065.      11/7/91
335.204(b)(6)................      5/28/86  16 TexReg 6065.      11/7/91
335.204(c)(1)................      5/28/86  16 TexReg 6065.      11/7/91
335.204(d)(1)................      5/28/86  16 TexReg 6065.      11/7/91
335.204(e)(6)................      5/28/86  16 TexReg 6065.      11/7/91
------------------------------------------------------------------------

     (ii) Additionally Texas has partially or fully adopted, but is not
authorized to implement, the Federal rules that are listed in the
following table. The EPA will continue to implement the Federal HSWA
requirements for which Texas is not authorized until the State receives
specific authorization for those requirements. The EPA will not enforce
the non-HSWA Federal rules although they may be enforceable under State
law. For those Federal rules that contain both HSWA and non-HSWA
requirements, the EPA will enforce only the HSWA portions of the rules.

----------------------------------------------------------------------------------------------------------------
           Federal requirement             Federal Register reference               Publication date
----------------------------------------------------------------------------------------------------------------
Imports and Exports of Hazardous Waste:   61 FR 16290................  April 12, 1996.
 Implementation of OECD Council Decision
 (HSWA) (Checklist 152)
Clarification of Standards for Hazardous  62 FR 64504................  December 5, 1997.
 Waste LDR Treatment Variances (SWA)
 (Checklist 162).
Post-Closure Permit Requirement and       63 FR 56710................  October 22, 1998.
 Closure Process (HSWA and Non-HSWA)
 (Checklist 174)
Organobromine Production Wastes;          64 FR 36365................  June 8, 2000.
 Petroleum Refining Wastes;
 Identification and Listing of Hazardous
 Waste; Land Disposal Restrictions
 (HSWA) (Checklist 187).
Zinc Fertilizers Made from Recycled       67 FR 48393................  July 24, 2002.
 Hazardous Secondary Materials (HSWA and
 Non-HSWA) (Checklist 200).
Modification of the Hazardous Waste       70 FR 10776................  March 4, 2005.
 Manifest System (HSWA and Non-HSWA)      70 FR 35034................  June 16, 2005.
 (Checklist 207).

Methods Innovation Rule and SW-846        70 FR 34538................  June 14, 2005.
 Update IIIB (HSWA and Non-HSWA)          70 FR 44150................  August 1, 2005.
 (Checklist 208).
Hazardous Waste Management System;        70 FR 45508................  August 5, 2005.
 Modification of the Hazardous Waste
 Program; Mercury Containing Equipment
 (Non-HSWA) (Checklist 209).
----------------------------------------------------------------------------------------------------------------

     (iii) Texas has chosen not to adopt, and is not authorized to
implement, the following optional Federal rules:

----------------------------------------------------------------------------------------------------------------
           Federal requirement             Federal Register reference               Publication date
----------------------------------------------------------------------------------------------------------------
NESHAPS Second Technical Correction,      66 FR 24270................  May 14, 2001.
 Vacatur (Non-HSWA) (Checklist Rule
 188.1).
Storage, Treatment, Transportation and    66 FR 27218................  May 16, 2001.
 Disposal of Mixed Waste (Non-HSWA)
 (Checklist 191).
Inorganic Chemical Manufacturing Waste    67 FR 17119................  April 9, 2002.
 Identification and Listing (HSWA/Non-
 HSWA) (Checklist Rule 195.1).
Hazardous Air Pollutant Standards for     67 FR 6792.................  February 13, 2002.
 Combustors: Interim Standards (HSWA/Non-
 HSWA) (Checklist 197).
Land Disposal Restrictions: National      67 FR 62618................  October 7, 2002.
 Treatment Variance to Designate New
 Treatment Subcategories for
 Radioactively Contaminated Cadmium,
 Mercury-Containing Batteries and Silver-
 Containing Batteries (HSWA) (Checklist
 201).
Hazardous Waste Management System;        68 FR 44659................  July 30, 2003.
 Identification and Listing of Hazardous
 Waste; Recycled Used Oil Management
 Standards (Non-HSWA) (Checklist 203).
National Environmental Performance Track  69 FR 21737................  April 22, 2004.
 Program (Non-HSWA) (Checklist 204).      69 FR 62217................  October 25, 2004.
NESHAP: Surface Coating of Automobiles    69 FR 22601................  April 26, 2004.
 and Light-Duty Trucks (Non-HSWA)
 (Checklist 205).
----------------------------------------------------------------------------------------------------------------

     (5) Memorandum of Agreement. The Memorandum of Agreement between
EPA Region VI and the State of Texas, signed by the Executive Director
of the Texas Natural Resource Conservation Commission (TNRCC) on March
10, 2009, and by the EPA Regional Administrator on April 22, 2009, is
referenced as part of the authorized hazardous waste management program
under subtitle C of RCRA, 42 U.S.C. 6921 et seq.
    (6) Statement of Legal Authority. ``Attorney General's Statement
for Final Authorization'', signed by the Attorney General of Texas on
May 22, 1984 and revisions, supplements, and addenda to that Statement
dated November 21, 1986, July 21, 1988, December 4, 1989, April 11,
1990, July 31, 1991, February 25, 1992, November 30, 1992, March 8,
1993, January 7, 1994, August 9, 1996, October 16, 1996, as amended
February 7, 1997, March 11, 1997, January 5, 1999, November 2, 1999,
March 1, 2002, and July 16, 2008 are referenced as part of the
authorized hazardous waste management program under Subtitle C of RCRA,
42 U.S.C. 6921 et seq.
    (7) Program Description. The Program Description and any other
materials submitted as part of the original application or as
supplements thereto are referenced as part of the authorized hazardous
waste management program under subtitle C of RCRA, 42 U.S.C. 6921 et
seq.

0
3. Appendix A to part 272, State Requirements, is amended by revising
the listing for ``Texas'' to read as follows:

Appendix A to Part 272--State Requirements

* * * * *

Texas

    The statutory provisions include:
    Texas Health and Safety Code (THSC) Annotated, (Vernon 2001):
Chapter 361, The Texas Solid Waste Disposal Act, sections 361.003
(except (3), (4), (19), (27), (35), and (39)), 361.019(a), 361.0235,
361.066(a), 361.087, 361.093, 361.094, 361.095(a), 361.099(b), and
361.110; Chapter 371, The Texas Oil Collection, Management, and
Recycling Act, sections 371.003, 371.024(b), 371.026(d), and
371.041.
    Texas Health and Safety Code (THSC) Annotated, (Vernon 2007
Supplement): Chapter 361, The Texas Solid Waste Disposal Act,
sections 361.082(a) and (f), 361.086, and 361.0871(a).
    Copies of the Texas statutes that are incorporated by reference
are available from West Group, 610 Opperman Drive, Eagan, 55123,
Attention: Order Entry; Phone: 1-800-328-9352; Web site: http://west.thomson.com.
    The regulatory provisions include:
    Texas Administrative Code, (TAC), Title 30, Environmental
Quality, 2008, as amended, effective through December 31, 2007.
Please note that the 2008 TAC, Title 30 is the most recent version
of the Texas authorized hazardous waste regulations. For a few
provisions, the authorized version is found in the TAC, Title 30,
Environmental Quality dated January 1, 1994, January 1, 1997,
December 31, 1999, or December 31, 2001. Texas made subsequent
changes to these provisions but these changes have not been
authorized by EPA. The provisions from earlier sets of regulations
are noted in the table below.
    Chapter 3, Section 3.2(25) ``Person''; Chapter 20, Section
20.15; Chapter 35, Section 35.402(e); Chapter 39, Sections 39.5(g),
39.11, 39.103(a)(2), (b), (d)(4), and (g), 39.405(f)(1), 39.411
(except (b)(4)(B), (b)(10), (11), and (13)), 39.503(d) (except the
reference to 39.405(h) in 39.503(d) introductory paragraph); Chapter
55, Sections 55.25(b)(1) through (3), 55.152(a)(3), 55.152(b),
55.154, and 55.156(b)(1); Chapter 281, Section 281.3(c);
    Chapter 305, Subchapter A--General Provisions, Sections 305.1(a)
(except the reference to Chapter 401, relative to Radioactive
Materials); 305.2 introductory paragraph (except the references to
Chapter 401, relative to Radioactive Materials and the reference to
TWC 32.002); 305.2(1) (except the phrase ``or a post-closure
order''); 305.2(6), (11), (12), (14), (15), (19), (20), (24), (26),
(27), (31) and (40)-(42); 305.3;
    Chapter 305, Subchapter B--Emergency Orders, Temporary Orders,
and Executive Director Authorizations, Sections 305.29(a) (January
1, 1997); 305.30;

    Chapter 305, Subchapter C--Application for Permit, Sections
305.41 (except the reference to Chapter 401, relative to Radioactive
Materials, the reference to TWC Chapter 32, and the last sentence
addressing post-closure orders); 305.42(a) (except the phrase ``or
who requests a post-closure order * * * to obtain a post-closure
order''); 305.42(b) and (d); 305.43(b) (except the two phrases ``or
post-closure orders''); 305.44 (except (d), the phrase ``or post-
closure orders'' in (a)(1), and the phrase ``or a post-closure
order'' in (c)); 305.45(a) (except (a)(7)(I) and (J), and the phrase
``Sec.  305.54 of this title * * * Content of Applications),'' in
305.45(a)(8)(C)); 305.45(b); 305.47 (except the phrases ``or a
recipient of a post-closure order'' and ``or order''); 305.50(a)
introductory paragraph-(a)(3) (except the last two sentences in
305.50(a)(2)); 305.50(a)(4) introductory paragraph and (a)(4)(A);
305.50(4)(B)-(D) (January 1, 1994); 305.50(a)(4)(G);
305.50(a)(5)(8), (13) and (14); 305.51;
    Chapter 305, Subchapter D--Amendments, Modifications, Renewals,
Transfers, Corrections, Revocations, and Suspension of Permits,
Sections 305.61; 305.62(a) (except the phrase in the first sentence
``Sec.  305.70 of this title * * * Solid Waste Class I
Modifications'' and the phrase in the fifth sentence ``If the
permittee requests a modification of a municipal solid waste permit
* * * Sec.  305.70 of this title.''); 305.62(b); 305.62(c) (January
1, 1997); 305.62(d) (except (d)(6)); 305.62(e)-(h); 305.63(a)
introductory paragraph (except first sentence); 305.63(a)(1) and
(2); 305.63(a)(3) (except last sentence); 305.63(a)(4)-(6);
305.64(a); 305.64(b) (except (b)(4) and (b)(5)); 305.64(c);
305.64(e); 305.64(g) (December 31, 1999); 305.66(a) (except (a)(7)-
(a)(9)); 305.66(d); 305.67(a) and (b); 305.69(a)-(h) (January 1,
1997); 305.69(i)-(k) (except (k) A.8-A.10);
    Chapter 305, Subchapter F--Permit Characteristics and
Conditions, Sections 305.121 (except the phrases ``radioactive
material disposal'' and ``subsurface area drip dispersal systems'');
305.122(a)-(c); 305.124; 305.125 introductory paragraph; 305.125(2)
and (4); 305.125(5) (except the last two sentences); 305.125(6)
(January 1, 1997); 305.125 (7) and (8); 305.125(9) (except (9)(C));
305.125(10) (except the phrase ``and 32''); 305.125(11) (except the
phrase ``as otherwise required by Chapter 336 of this title''
relative to Radioactive Substances in (11)(B)); 305.125(12);
305.125(13) (December 31, 2001); 305.125(14)--(19), and (21);
305.127 introductory paragraph; 305.127(1)(B)(iii); 305.127(1)(E)
and (F); 305.127(2); 305.127(3)(A) (except the last two sentences);
305.127(3)(B) and (C); 305.127(4)(B); 305.127(5)(C); 305.128;
    Chapter 305, Subchapter G--Additional Conditions for Hazardous
and Industrial Solid Waste Storage, Processing, or Disposal Permits,
Sections 305.141 through 305.145; 305.146 introductory paragraph and
(1) (January 1, 1997); 305.150;
    Chapter 305, Subchapter I--Hazardous Waste Incinerator Permits,
Sections 305.171 through 305.175;
    Chapter 305, Subchapter J--Permits for Land Treatment
Demonstrations Using Field Tests or Laboratory Analyses, Sections
305.181 through 305.184;
    Chapter 305, Subchapter K--Research, Development and
Demonstration Permits, Sections 305.191 through 305.194;
    Chapter 305, Subchapter L--Groundwater Compliance Plan, Section
305.401(c);
    Chapter 305, Subchapter Q--Permits for Boilers and Industrial
Furnaces Burning Hazardous Waste, Sections 305.571; 305.572 (except
(a)(6)); 305.573;
    Chapter 324--Used Oil, Sections 324.1 through 324.2(6); 324.2
``Secondary containment'' (January 1, 1997); 324.2(8) and (9); 324.3
(except 324.3(5)); 324.4; 324.6; 324.7; 324.11 through 324.14;
324.15 (January 1, 1997); 324.16; 324.21;
    Chapter 335, Subchapter A--Industrial Solid Waste and Municipal
Hazardous Waste in General, Sections 335.1 introductory paragraph
(December 31, 2001); 335.1(1)-(4), (6)-(8), (10)-(12), (16), (17),
(21), (22), (24)-(28), (31); 335.1(32) ``Designated facility''
(December 31, 2001); 335.1(33), (36)-(42), (43) (except for the
phrase ``or is used for neutralizing the pH of non-hazardous
industrial solid waste''), (44)-(46), (48)-(53), (55)-(61), (64)-
(73), (75)-(82), (83)-(86) (except the phrase ``solid waste or'' in
each subsection), (87), (88)-(89) (except the phrase ``solid waste
or'' in both subsections); 335.1(86) ``Manifest'' and (87)
``Manifest document number'' (December 31, 2001); 335.1(92), (93),
(94) (except the phrase ``solid waste or''), (95)-(108); 335.1(110)
(except the phrase ``solid waste or''), (111), (116), (117) (except
the phrase ``solid waste or''), (118)-(121), (123), (125)-(129),
(131), (132), (133)(A)-(G) (except the phrase ``Except for materials
described in subparagraph (H) of this paragraph.'' at (133)(D) and
(G) introductory paragraphs), (133)(I) and (J), (134), (136)-(145)
(except the phrase ``solid waste or'' at (138), (141) and (143)),
(146) (except the phrase ``or industrial solid''), (147), (148),
(149) and (150) (except the phrase ``or industrial solid'' in both
subsections), (152)-(154), (155) (except the phrase ``solid waste
or''), (156)-(161), (162) (except the phrase ``or industrial
solid''), (163), (164) and (165) (except the phrase ``solid waste
or''); 335.2(a) and (c); 335.2(e)-(g); 335.2(i) (except the phrases
``or decontamination'' and ``or obtain an order in lieu of a post-
closure permit * * * of this section''); 335.2(j) and (l); 335.4;
335.5 (except (d)); 335.6(a); 335.6(b) (January 1, 1997); 335.6(c);
335.6(d) (except the last sentence) (January 1, 1994); 335.6(e)
(January 1, 1994); 335.6(f)-(j); 335.7 (December 31, 1999);
335.8(a)(1) and (2); 335.9(a) (except (a)(2) and (3)); 335.9(a)(2)
and (3) (January 1, 1997); 335.9(b) (January 1, 1994); 335.10(a)
introductory paragraph and (a)(1) (except references to ``class 1
wastes'') (January 1, 1994); 335.10(a)(3) (except the phrase ``,
unless the generator is identified in paragraph (2) of this
section'') (December 31, 2001); 335.10(a)(4) (December 31, 2001);
335.10(a)(6); 335.10(b) (except 335.10(b)(5), (8), and (18))
(December 31, 2001); 335.10(b)(5), (8), and (18) (January 1, 1994);
335.10(c) (except the phrase ``the United States customs
official,'') (December 31, 2001); 335.10(d) and (e) (December 31,
2001); 335.10(f); 335.11 (except 11(d)) (December 31, 2001); 335.12
(except 335.12(a)(5) and (d)); 335.13(a) (January 1, 1997);
335.13(c) and (d) (January 1, 1994); 335.13(e) and (f) (January 1,
1997); 335.13(g) (January 1, 1994); 335.14; 335.15 introductory
paragraph (January 1, 1994); 335.15(1); 335.17(a); 335.18(a); 335.19
(except 335.19(d)); 335.20 through 335.22; 335.23 (except (2));
335.23(2) (January 1, 1994); 335.24(a)-(f); 335.24(m) and (n);
335.29; 335.29(2) and (3) (December 31, 2001); 335.30; 335.31;
    Chapter 335, Subchapter B--Hazardous Waste Management General
Provisions, Sections 335.41(a)-(c); 335.41(d) (except (d)(1) and
(d)(5)-(8)); 335.41(d)(1) (December 31, 2001); 335.41(e); 335.41(f)
(except (f)(2)(A)(iii)); 335.41(f)(2)(A)(iii) (December 31, 2001);
335.41(g) and (h); 335.41(j); 335.43 and 335.44 (December 31, 1999);
335.45; 335.47 (except 335.47(b) and the second sentence in (c)(3));
335.47(b) (December 31, 1999);
    Chapter 335, Subchapter C--Standards Applicable to Generators of
Hazardous Waste, Sections 335.61 (except (f)); 335.62; 335.63;
335.65; 335.66; 335.67 and 335.68 (December 31, 2001); 335.69
(except (i) and (m)); 335.70; 335.71 (January 1, 1994); 335.73
through 335.75; 335.76 (except 335.76(d) and (h)); 335.76(d)
(December 31, 2001); 335.77; 335.78 (except (b), (d)(2), (e)
introductory paragraph, (f)(2), and (g)(2)); 335.78(b), (e)
introductory paragraph, (f)(2), and (g)(2) (January 1, 1997);
    Chapter 335, Subchapter D--Standards Applicable to Transporters
of Hazardous Waste, Sections 335.91 (except (e)); 335.92; 335.93
(except (e)); 335.93(e) (December 31, 1999); 335.94 (except the
phrase ``owned or operated by a registered transporter'' in (a)
introductory paragraph);
    Chapter 335, Subchapter E--Interim Standards for Owners and
Operators of Hazardous Waste Storage, Processing, or Disposal
Facilities, Sections 335.111(a)-(c); 335.112(a) (except (a)(4)-(7)
and (a)(17)); 335.112(a)(4)-(6) (December 31, 2001); 335.112(a)(7)
(January 1, 1997); 335.112(b) (except (b)(4)(I) and (J), and
(b)(7)); 335.112(c); 335.113; 335.114 (January 1, 1997); 335.115
introductory paragraph (January 1, 1997); 335.115(1)-(4); 335.116
(except (g) and the phrase ``and (g)'' at (b)); 335.117 (except
(a)(2)(B), (a)(2)(C), and (b)(2)); 335.117(a)(2)(B), (a)(2)(C), and
(b)(2) (January 1, 1997); 335.118(a); 335.118(b) (December 31,
2001); 335.119(a) and (b) (December 31, 2001); 335.120 through
335.127;
    Chapter 335, Subchapter F--Permitting Standards for Owners and
Operators of Hazardous Waste Storage, Processing, or Disposal
Facilities, Sections 335.151(a)-(c); 335.152 (except (a)(4)-(6));
335.152(a)(4) (January 1, 1997); 335.152(a)(5) (December 31, 2001);
335.152(a)(6) (January 1, 1997); 335.152(b); 335.152(c) (except
(c)(5)-(7)); 335.153; 335.154 (January 1, 1997); 335.155
introductory paragraph (January 1, 1997); 335.155(1)-(3); 335.156(a)
introductory paragraph through (2) (except the phrase ``or (3)'' at
(a)(1) and the phrase ``Except as provided * * * subsection,'' at
(a)(2)); 335.156(b) and (c); 335.157 through 335.166; 335.167(a)
(except the phrase ``or post-closure order''); 335.167(b) and (c)
(December 31, 1999); 335.168 through 335.178;

    Chapter 335, Subchapter G--Location Standards for Hazardous
Waste Storage, Processing, or Disposal, Sections 335.201(a) (except
(a)(3)); 335.201(c); 335.202 introductory paragraph; 335.202(2),
(4), (9)-(11), (13), (15)-(18); 335.203; 335.204(a) introductory
paragraph--(a)(5); 335.204(b)(1)-(6); 335.204(c)(1)-(5);
335.204(d)(1)-(5); 335.204(e) introductory paragraph; 335.204(e)(1)
introductory paragraph (except the phrase ``Except as * * * (B) of
this paragraph,'' and the word ``event'' at the end of the
paragraph); 335.204(e)(2)-(7); 335.204(f); 335.205(a) introductory
paragraph-(a)(2) and (e);
    Chapter 335, Subchapter H--Standards for the Management of
Specific Wastes and Specific Types of Facilities, Sections 335.211;
335.212; 335.213 (January 1, 1997); 335.214; 335.221; 335.222
through 335.225; 335.241(except (b)(4) and (d)); 335.241(d) (January
1, 1997); 335.251; 335.261 (except (e)) (December 31, 2001);
335.271; 335.272;
    Chapter 335, Subchapter O--Land Disposal Restrictions, Section
335.431;
    Chapter 335, Subchapter R--Waste Classification, Sections
335.504 introductory paragraph--(3); 335.504(4) (December 31, 1999).
    Copies of the Texas regulations that are incorporated by
reference are available from West Group, 610 Opperman Drive, Eagan,
55123, ATTENTION: Order Entry; Phone: 1-800-328-9352; Web site:
http://west.thomson.com.
* * * * *
[FR Doc. 2011-4911 Filed 3-4-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Notices]
[Pages 12059-12062]
[FR Doc No: 2012-4597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0171]

Using Innovative Technologies and Other Conditions of Safe Use To
Expand Which Drug Products Can Be Considered Nonprescription; Public
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The U.S. Food and Drug Administration (FDA or the Agency) is
announcing a public hearing to obtain input on a new paradigm we are
considering. Under this paradigm, the Agency would approve certain
drugs that would otherwise require a prescription for nonprescription
use (also known as over-the-counter or OTC) under conditions of safe
use. These conditions of safe use would be specific to the drug product
and might require sale in certain pre-defined health care settings,
such as a pharmacy. This public hearing is being held to obtain
information and comments from the public on the feasibility of this
paradigm and its potential benefits and costs.

DATES: Public Hearing: The public hearing will be held on March 22 and
23, 2012, from 9 a.m. to 4 p.m. The meeting may be extended or may end
early depending on the level of public participation.
    Presentations and Comments: Submit either electronic or written
requests for oral presentations and comments by March 9, 2012. (See
section IV of this document for details.) Either electronic or written
comments will be accepted after the hearing until May 7, 2012 (See
section VI of this document for details.)

ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993-
0002.
    Comments and Transcripts: Submit either electronic or written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document. Transcripts of the hearing will be available
for review at the Division of Dockets Management and on the Internet at
http://www.regulations.gov approximately 45 days after the hearing.

FOR FURTHER INFORMATION CONTACT: Lee Lemley, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing a public hearing to obtain
input on a potential new paradigm under which the Agency would approve
certain drugs that would otherwise require a prescription for
nonprescription use under conditions of safe use specific to the drug
product. Some drugs approved in this manner might require sale in
certain pre-defined health care settings, such as a pharmacy.

I. Background

A. Prescription and Nonprescription Drugs

    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA
approves new drugs under section 505 (21 U.S.C. 355) either as
prescription or nonprescription. Under section 503(b)(1)(A) of the FD&C
Act (21 U.S.C. 353(b)(1)(A)), a drug must be dispensed by prescription
if, ``because of its toxicity or other potentiality for harmful effect,
or the method of its use, or the collateral measures necessary to its
use, [it] is not safe for use except under the supervision of a
practitioner licensed by law to administer such drug.'' Under sections
505(d)(1) and (d)(4), FDA has considerable latitude in determining
whether the information submitted as part of a new drug application
(NDA) is sufficient to ensure that a drug is safe for use under its
proposed labeling. FDA also makes a determination under 503(b) as to
whether the product meets the criteria for prescription-only
dispensing.
    Prescription drugs are dispensed upon receipt of a prescription
from a practitioner licensed by law to administer the drug (which may
include health care professionals such as physicians, nurse
practitioners, physician's assistants, and others whom we will refer to
here as practitioners or prescribers). (See 21 U.S.C. 353(b).) In many
instances, under the current regulatory system, a patient has to obtain
at least the initial prescription, and in some cases, prescription
refills, from a practitioner through an in person interaction.
Obtaining a refill for other prescription drugs involves at least a
telephone call or other communication with the practitioner. In
contrast, nonprescription drugs (sometimes referred to as over-the-
counter or OTC products) can be purchased by consumers in pharmacies,
supermarkets, and other retail establishments without the need for a
prescription. Currently, consumers can purchase nonprescription drugs
from a retailer for diseases or conditions that do not meet the
statutory criteria for prescription products and that are safe and
effective for use in self-medication as directed in the labeling. (See
21 U.S.C. 353(b).) Generally, OTC products: (1) Are available to treat
diseases or conditions that can be self-diagnosed without a prior
interaction with a practitioner, (2) are not associated with toxicities
that require an evaluation of the benefits and risks by a practitioner;
and (3) do not require a practitioner's input for use.

B. Undertreatment of Diseases and Other Effects on the Health Care
System

    Undertreatment of many common diseases or conditions in the United
States is a well recognized public health problem. Increasing the
number of people who are able to obtain for the first time and those
who continue on necessary drug therapy could provide improved health
outcomes. The requirement to obtain a prescription for appropriate
medication (and to make one or more visits to a practitioner) may
contribute to undertreatment of certain common medical conditions
including

hyperlipidemia (high cholesterol), hypertension (high blood pressure),
migraine headaches, and asthma. For instance, some consumers do not
seek necessary medical care, which may include prescription drug
therapy, because of the cost and time required to visit a health care
practitioner for an initial diagnosis and an initial prescription. Some
patients who obtain an initial prescription do not continue on
necessary medication because they would need to make additional visits
to a health care practitioner for a prescription refill after any
refills authorized by the initial prescription have been used or the
time during which they can be filled has expired. Some prescription
medications require routine monitoring through the prescribing
practitioner such as blood tests to assist in the diagnosis of a
condition, or to determine whether or how well the medication is
working, or to adjust the dose. FDA believes that some of these visits
could be eliminated by making certain prescription medications
available without a prescription but with certain other conditions of
safe use that would ensure they could be used safely and effectively
without the initial involvement of a health care practitioner. In some
cases, a visit to a practitioner would be required for the initial
prescription, but a certain number of refills could be authorized
beyond those that would normally be authorized without a return visit
under specialized conditions of safe use. This paradigm might be useful
for certain rescue medicines, such as inhalers used to treat asthma or
epinephrine for allergic reactions, that patients need to keep on hand
for use in emergencies. In addition to improved health outcomes for
consumers staying on their medications, the time and attention that
physicians and other health care providers expend on routine tasks
related to prescription refills reduces the time that they are
available to attend to more seriously ill patients. Eliminating or
reducing the number of routine visits could free up prescribers to
spend time with more seriously ill patients, reduce the burdens on the
already overburdened health care system, and reduce health care costs.

II. New Paradigm

    FDA is considering whether medications for certain diseases or
conditions that would otherwise be available only by prescription could
be made available without a prescription with certain conditions of
safe use. For example, some conditions of safe use could be designed to
assist patients in self-selection of an appropriate medication or
provide for followup monitoring during continued use. The conditions of
use could include requiring pharmacist intervention to ensure
appropriate nonprescription use. Additionally, conditions of safe use
could involve the use of innovative technologies, such as diagnostics
approved or cleared by FDA for use in the pharmacy or other setting.
    FDA is aware that industry is developing new technologies that
consumers could use to self-screen for a particular disease or
condition and determine whether a particular medication is appropriate
for them. For example, kiosks or other technological aids in pharmacies
or on the Internet could lead consumers through an algorithm for a
particular drug product. Such an algorithm could consist of a series of
questions that help consumers properly self-diagnose certain medical
conditions, or determine whether specific medication warnings
contraindicate their use of a drug product. In addition, for some drug
products that require an initial prescription, the product could be
made available as a nonprescription product with a condition of safe
use for the purpose of product refills.
    In addition, some drug products that would otherwise require a
prescription could be approved as nonprescription drug products with
some type of pharmacist intervention as their condition of safe use.
For example, some diseases or conditions might require confirmation of
a diagnosis or routine monitoring using a diagnostic test (e.g., a
blood test for cholesterol levels or liver function) that could be
available in a pharmacy. A pharmacist, or consumer, could then use the
results to determine whether use of a certain drug product is
appropriate. Other potential roles for the pharmacist include assessing
whether the consumer has any conditions or other risk factors that
would indicate that the drug should not be used, or assisting the
consumer in choosing between various drug products. For drugs that
require use of a diagnostic test, creating a pathway for
nonprescription use may result in the development by industry of
diagnostics suitable for use by the patient or a pharmacy professional.
    FDA is also considering whether the same drug product could be
simultaneously available as both a prescription and nonprescription
product with conditions of safe use. Dual availability could help
ensure greater access to needed medications by making obtaining them
more flexible. Consumers could choose to continue seeing their health
care practitioner to diagnose diseases or conditions and obtain
prescriptions, and when their local retail establishment is not
equipped to offer the nonprescription product with conditions of safe
use. Other consumers could take advantage of the ability to obtain
nonprescription products with conditions of safe use where they are
available.
    FDA is seeking input on what types of evidence would be needed to
demonstrate that certain drugs could be used safely and effectively in
the nonprescription setting with conditions of safe use. We anticipate
that, depending upon the situation, applications for approval of
nonprescription products with conditions of safe use may need to
include patient studies (e.g., self-selection studies, label
comprehension studies, and actual use studies) to demonstrate that the
drug would be safe and effective under the specified conditions. When a
device, e.g., diagnostic test or computer algorithm, is necessary as a
condition of safe use, evidence may need to be submitted demonstrating
that it will perform its intended function and can be appropriately
administered in the particular setting in which it will be used. We
expect that certain classes of drugs may be appropriate candidates for
nonprescription use under this new paradigm, but FDA would need to
evaluate each NDA, and when applicable, each device, on a case-by-case
basis.

III. Scope of the Public Hearing

    FDA is holding this public hearing to seek input from interested
members of the public including consumers, pharmacists, physicians and
other members of the medical community, regulated industry, insurers,
and managed care organizations on a potential new paradigm to allow
certain drugs that would otherwise require a prescription to be
approved as nonprescription drugs with conditions of safe use. FDA is
interested in obtaining information and public comment on the following
issues:

A. Types of Technology and Conditions of Safe Use

    1. Can you suggest specific medical conditions or diseases for
which consumers may benefit if the treatment drug were available as a
nonprescription product with conditions of safe use?
    2. What types of technologies (e.g., kiosks, computer algorithms)
are currently in development that could assist in allowing drugs to be
used safely and effectively in the nonprescription setting?

    3. What other types of conditions of safe use (e.g., pharmacy
monitoring or counseling) could be used to help ensure the safe and
effective use of certain drug products as nonprescription products?
    4. Are there types of diagnostic aids, such as noninvasive blood
pressure monitors and urinalysis reagent strips, that could be used in
the nonprescription setting after appropriate FDA review, either with
or without the aid of a pharmacist to diagnose or monitor a disease or
condition?
    5. What data or other information exist on the use of conditions of
safe use, including novel technologies, and on their effects on health
care, access to medication, and/or disease and treatment education or
awareness?
    6. Are there data on how expanded access to medication or increased
consumer education or awareness could affect patient or consumer
behavior (e.g., by promoting patient compliance with a medication
dosage regimen) or on health outcomes generally that would be relevant
to the discussion of expanding the availability of nonprescription
medications with conditions of safe use?
    7. What types of studies could be conducted to evaluate the effects
of conditions of safe use on the safety and efficacy of particular
drugs and on behavior and health outcomes?
    8. What types of studies could be conducted to evaluate the safety
and efficacy of any technologies that might be relied upon as
conditions of safe use?

B. Pharmacy, Consumer, and Health Care Provider Issues

    1. Would this new paradigm increase consumer access to necessary
medical care?
    2. Are data available about the number of consumers who require
drug therapy for conditions or diseases but who currently do not take
such medication because of the burdens associated with obtaining a
prescription?
    3. Would a lack of oversight from a practitioner, including
involvement in diagnosing the condition or monitoring for drug
interactions or other drug effects, be a concern? If so, how could
these concerns be addressed?
    4. How might the new paradigm be expected to affect consumers
financially or otherwise affect access to and delivery of health care
generally?
    5. Would expanding what could be considered nonprescription drugs
under the new paradigm, and thus creating greater consumer access to
needed drug products, reduce burden on emergency rooms and on
individual health care providers, or otherwise increase the
availability of these resources for other consumers? Are there other
ways in which the new paradigm might reduce the burden on the health
care system?
    6. How might various types of conditions of safe use on
nonprescription drug products affect pharmacy business operations? What
differences might there be in the operational issues experienced by
pharmacies operated by chains and independently operated retail
outlets?
    7. Would additional specialized training be needed for pharmacists
if this paradigm were adopted?
    8. If availability of a nonprescription product with conditions of
safe use were limited to certain outlets (e.g., a chain pharmacy that
chooses to offer a particular technology or service), would the
situation create confusion or difficulties for consumers seeking to
obtain the drug product? Could such a situation create difficulties for
practitioners in knowing whether a particular consumer could access the
drug with a prescription or would be able to obtain the same product as
a nonprescription drug product at a retail outlet? If so, how could
these issues be overcome?
    9. What experiences have practitioners, pharmacists, and insurers
had with state-authorized arrangements under which access to
prescription drugs has been expanded that might be relevant to and
inform our consideration of this paradigm (e.g., a collaborative
practice agreement between a pharmacist and a practitioner that allows
the pharmacist to dispense a prescription drug to a consumer who meets
certain criteria under a standing or open prescription, when that
consumer did not obtain a prescription directly from a practitioner, or
that allows a pharmacist to refill a prescription after an initial
prescription from a practitioner pursuant to a similar agreement)?
    10. What are the public health and regulatory implications of the
use of in vitro diagnostic tests as conditions of safe use for
nonprescription drug products in a pharmacy setting (e.g., as a
laboratory under the Clinical Laboratory Improvement Act of 1988 (CLIA)
(Public Law 100-578))?

C. Other Related Issues

    1. How would insurance coverage of pharmaceuticals be affected by
approving nonprescription products with conditions of safe use for
widely prescribed prescription drugs under this paradigm?
    2. How would out-of-pocket costs for the insured be affected by
making prescription drugs available as nonprescription products with
conditions of safe use?
    3. Would the new paradigm increase liability concerns for
pharmacists and pharmacies? To what extent would these concerns raise
the cost of the services provided?
    4. What proprietary, technological, economic, or competitive
barriers might impede widespread implementation of this paradigm? To
the extent such impediments exist, are there suggestions for mitigating
or avoiding the impediments specific to this paradigm?
    5. Would overall health care costs decrease if this paradigm were
instituted?

IV. Attendance and/or Participation in the Public Hearing

    The public hearing is free and seating will be on a first-come,
first-served basis. Attendees who do not wish to make an oral
presentation do not need to register.
    If you wish to make an oral presentation during the hearing, you
must register by submitting either an electronic or a written request
by 5 p.m. on March 9, 2012, to Lee Lemley (see FOR FURTHER INFORMATION
CONTACT). You must provide your name, title, business affiliation (if
applicable), address, telephone and fax numbers, email address, and
type of organization you represent (e.g., industry, consumer
organization). You also should submit a brief summary of the
presentation, including the discussion topic(s) that will be addressed
and the approximate time requested for your presentation. We encourage
individuals and organizations with common interests to consolidate or
coordinate their presentations to allow adequate time for each request
for presentation. Persons registered to make an oral presentation
should check in before the hearing.
    Participants should submit a copy of each presentation to Lee
Lemley (see FOR FURTHER INFORMATION CONTACT) no later than March 19,
2012. We will file the hearing schedule, indicating the order of
presentation and the time allotted to each person, with the Division of
Dockets Management (see ADDRESSES). Additional information will also be
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm.
    We will mail, email, or telephone the schedule to each participant
before the hearing. In anticipation of the hearing presentations moving
ahead of schedule, participants are encouraged to arrive early to
ensure their designated order of presentation. Participants who

are not present when called risk forfeiting their scheduled time.
    If you need special accommodations due to a disability, contact Lee
Lemley (see FOR FURTHER INFORMATION CONTACT) at least 7 days in
advance.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the relevant centers.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation
(21 CFR 15.30(e)). Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (part 10 (21 CFR part 10), subpart C) (Sec.
10.203(a)). Under Sec.  10.205, representatives of the electronic media
may be permitted, subject to certain limitations, to videotape, film,
or otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec.  15.30(b). (See section VII of this document for
more details.) To the extent that the conditions for the hearing as
described in this document conflict with any provisions set out in part
15, this document acts as a waiver of those provisions as specified in
Sec.  15.30(h)).

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments for
consideration. Persons who wish to provide additional materials for
consideration should file these materials with the Division of Dockets
Management. You should annotate and organize your comments to identify
the specific questions identified by the topic to which they refer. It
is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

VII. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript also
will be available in either hard copy or on CD-ROM after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Office of
Management Programs, Food and Drug Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4597 Filed 2-27-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35306-35307]
[FR Doc No: 2020-12406]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-462-000]

National Fuel Gas Supply Corporation; Notice of Application

    Take notice that on May 22, 2020, National Fuel Gas Supply
Corporation (National Fuel) 6363 Main Street, Williamsville, New York
14221, filed in Docket No. CP20-462-000 an application pursuant to
section 7(c) of the Natural Gas Act (NGA), and Part 157 of the
Commission's regulations requesting authorization to operate the 12-
inch diameter pipeline installed in the Allegheny River (12-inch
Pipeline), in association with its 2018 construction of its
jurisdictional Allegheny River crossing under CP16-28-000. The 12-inch
Pipeline is located at the crossing of the Allegheny River, in Warren
County, Pennsylvania, all as more fully set forth in the application
which is on file with the Commission and open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to Alice
A. Curtiss, Deputy General Counsel, National Fuel Gas Supply
Corporation, 6363 Main Street, Williamsville, New York 14221, by phone
at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the

Secretary of the Commission. Environmental commenters will be placed on
the Commission's environmental mailing list and will be notified of
meetings associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission and will not have the right to seek court review of the
Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new NGA section 3 or
section 7 proceeding.\1\ Persons desiring to become a party to a
certificate proceeding are to intervene in a timely manner. If seeking
to intervene out-of-time, the movant is required to show good cause why
the time limitation should be waived, and should provide justification
by reference to factors set forth in Rule 214(d)(1) of the Commission's
Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC 61,167 at
50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit original and five copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on June 23, 2020.

    Dated: June 2, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-12406 Filed 6-8-20; 8:45 am]
 BILLING CODE 6717-01-P