[Federal Register: December 8, 2009 (Volume 74, Number 234)]
[Proposed Rules]
[Page 64643-64658]
[DOCID:fr08de09-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-HQ-RCRA-2005-0017; FRL-9089-5]
RIN 2050-AG57

Withdrawal of the Emission-Comparable Fuel Exclusion Under RCRA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to withdraw the conditional exclusion from
regulations promulgated on December 19, 2008 under subtitle C of the
Resource Conservation and Recovery Act (RCRA) for so-called Emission
Comparable Fuel (ECF). These are fuels produced from hazardous
secondary materials which, when burned in industrial boilers under
specified conditions, generate emissions that are comparable to
emissions from burning fuel oil in those boilers. EPA is proposing to
withdraw this conditional exclusion because ECF appears to be better
regarded as being a discarded material and regulated as a hazardous
waste. The exclusions for comparable fuel and synthesis gas fuel are
not addressed or otherwise affected by this proposed rule.

DATES: Comments must be received on or before January 22, 2010. Under
the Paperwork Reduction Act, comments on the information collection
provisions are best assured of having their full effect if the Office
of Management and Budget (OMB) receives a copy of your comments on or
before January 7, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2005-0017, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket, Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of two copies. We request that you also send a
separate copy of your comments to the contact person listed below (see
FOR FURTHER INFORMATION CONTACT). In addition, please mail a copy of
your comments on the information collection provisions to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC
20503.
     Hand Delivery: RCRA Docket, EPA Docket Center (2822T), EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. Please include a total of two copies. We request
that you also send a separate copy of each comment to the contact
person listed below (see FOR FURTHER INFORMATION CONTACT).
    Instructions: Direct your comments to Docket ID No EPA-HQ-RCRA-
2005-0017. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comments include information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Clearly mark the part or
all of the information that you claim to be CBI. The http://
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to 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, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/
dockets.htm. We also request that interested parties who would like
information they previously submitted to EPA to be considered as part
of this action, to identify the relevant information by docket entry
numbers and page numbers.
    Docket: All documents in the docket are listed in the http://
www.regulations. gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations. gov or in hard copy at the RCRA Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
The 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
RCRA Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mary Jackson, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, Mailcode: 5304P, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703)
308-8453; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

A. Does This Action Apply to Me?

    Categories and entities potentially affected by this action
include:

                Examples of Potentially Affected Entities
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            NAICS code                      Industry description
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3251..............................  Basic Chemical Manufacturing.
3241..............................  Petroleum and Coal Products
                                     Manufacturing.
4884..............................  Support Activities for Road
                                     Transportation.
5622..............................  Waste Treatment and Disposal.
3252..............................  Resin, Synthetic Rubber, and
                                     Artificial Synthetic Fibers and
                                     Filaments Manufacturing.
3259..............................  Other Chemical Product and
                                     Preparation Manufacturing.
3254..............................  Pharmaceutical and Medicine
                                     Manufacturing.
9281..............................  National Security and International
                                     Affairs.
3255..............................  Paint, Coating, and Adhesive
                                     Manufacturing.
5614..............................  Business Support Services.
3273..............................  Cement Manufacturing.
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    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be impacted by this
action. This table lists examples of the types of entities EPA is aware
of that could potentially be regulated by this action. Other types of
entities not listed could also be affected. To determine whether your
facility, company, business, organization, etc., is affected by this
action, you should examine the applicability criteria in this proposed
rule. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Send or deliver information
identified as CBI to the following address: Ms. LaShan Haynes, RCRA
Document Control Officer, EPA (Mail Code 5305W), Attention Docket ID
No. EPA-HQ-RCRA-2005-0017, 1200 Pennsylvania Avenue, NW., Washington DC
20460. Clearly mark the part or all of the information that you claim
to be CBI. For CBI information in a disk or CD ROM that you mail to
EPA, mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with the procedures set forth in 40 CFR
part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible,
     Make sure to submit your comments by the comment period
deadline identified.
    3. Docket Copying Costs. You may copy a maximum of 100 pages from
any regulatory docket at no charge. Additional copies are 15 cents/
page.
    4. How Do I Obtain a Copy of This Document and Other Related
Information? In addition to being available in the docket, an
electronic copy of today's proposed rule will also be available on the
Worldwide Web (WWW). Following the Administrator's signature, a copy of
this document will be posted on the WWW at http://www.epa.gov/hwcmact.
This Web site also provides other information related

to the NESHAP for hazardous waste combustors.
    5. Index of contents. The information presented in this preamble is
organized as follows:

I. Statutory Authority
II. Background
    A. What Is the Intent of the Proposed Rule?
    B. Who Will Be Affected by the Proposed Rule?
III. Summary of the Proposed Rule
IV. Rationale for Proposing To Revoke the Exclusion for ECF
    A. ECF May Be Classified as a Waste Rather Than a Product
    B. Why EPA Now Proposes To Reclassify ECF as a Waste
V. State Authority
    A. Applicability of the Rule in Authorized States
    B. Effect on State Authorization
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Usage
    I. National Technology Transfer Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. Statutory Authority

    The emission-comparable fuel (ECF) regulations were promulgated
under the authority of sections 1004 and 2002 of the Solid Waste
Disposal Act of 1970, as amended by the Resource Conservation and
Recovery Act of 1976 (RCRA), as amended by the Hazardous and Solid
Waste Amendments of 1984 (HSWA), 42 U.S.C. 6903 and 6912. Withdrawal of
the rule would be issued under the same authority, and hazardous waste
fuels are regulated pursuant to section 3004(q) of RCRA.

II. Background

A. What Is the Intent of the Proposed Rule?

    This rule proposes to withdraw the conditional exclusion from
regulation under subtitle C of RCRA for ECF, as codified at Sec.
261.38.\1\ The conditional exclusion states that hazardous secondary
materials that meet all of the hazardous constituent specifications
applicable to comparable fuel, except concentration limits for
oxygenates and hydrocarbons, and that are stored and burned under
prescribed conditions, are not discarded and thus, are not solid
wastes.
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    \1\ See 73 FR 77954 (December 19, 2008).
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    EPA notes, however, that classification of ECF as a non-waste is
not legally compelled, and an alternative classification is
permissible. As discussed in more detail in the following section, ECF
is a hazardous secondary material which can reasonably be regarded as
discarded when stored and burned because: (1) The material can have
substantially higher concentrations of hazardous oxygenates and
hydrocarbons than fuel oil, and thus, lacking physical identity to
fossil fuel, combustion of the material may be considered to be similar
to incinerating or destroying it, a form of discarding; (2) the
exclusion is conditioned on extensive, substantive requirements on
burning, similar to the requirements for permitted hazardous waste
combustors, which conditions are needed to prevent discard; and (3) the
exclusion is conditioned on extensive, substantive requirements on
storage, similar to the requirements for permitted hazardous waste
storage units. EPA has the authority to adopt conditional exclusions
from the definition of solid waste; however, when conditions grow ever
more elaborate and extensive and are more and more comparable (or
identical) to those required for the management of hazardous waste, the
question is raised as to whether the material is discarded because of
the necessity for waste management-like conditions on its handling. Put
another way, the conditions can become a surrogate for RCRA's cradle-
to-grave hazardous waste management system, and the hazardous secondary
materials to which such conditions pertain can be classified as
discarded. Given the elements of discard involved in combusting ECF,
and the extensive waste management-related types of conditions EPA
developed for this conditional exclusion, it is now EPA's view, subject
to consideration of public comment, that these materials should be
classified as solid waste and, when listed or when exhibiting a
characteristic, hazardous wastes rather than as products.
    This proposal would not affect the exclusions for comparable fuel
and synthesis gas fuel that were promulgated in 1998 \2\ (also codified
in Sec.  261.38), nor is EPA soliciting comment on those exclusions or
otherwise reconsidering or reopening them. In addition, this proposal
does not affect the clarifications and revisions to the conditions for
comparable fuel that EPA promulgated concurrently with the ECF
exclusion.\3\
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    \2\ See 63 FR 33782 (June 19, 1998).
    \3\ See 73 FR at 77963-64.
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B. Who Will Be Affected by the Proposed Rule?

    Entities that generate, burn, and store ECF would be potentially
affected by this proposed rule. The basic structure of the exclusion is
that ECF is not a solid (and hazardous) waste as generated, and hence
is not subject to the subtitle C regulations. Under today's proposal to
withdraw the exclusion of ECF, ECF would again be classified as a
hazardous waste, and all entities managing such hazardous secondary
materials would again be subject to all applicable subtitle C hazardous
waste standards. Since the rule was promulgated in December 2008 and
became effective in January 2009, and since we are not aware that any
States have adopted or applied for authorization for this rule, we
would expect that very few facilities, if any, are managing their
hazardous secondary materials pursuant to this rule. However, the
Agency requests comments on whether any generators or burners are
managing ECF pursuant to the terms of the conditional exclusion.
    We are also not aware of any commercial hazardous waste combustors
that are no longer receiving newly excluded hazardous secondary
materials subject to the ECF rule, because the materials are now being
managed under the ECF conditional exclusion. To the extent this is
occurring, however, the commercial hazardous waste combustors in
question would have lost the waste management revenues for those
diverted fuels and may have needed to meet their heat input
requirements by using other waste fuels or fossil fuels. Under today's
proposal to withdraw the ECF exclusion, those hazardous secondary
materials that were managed as excluded ECF would again be classified
as hazardous waste fuels. Thus, those affected commercial hazardous
waste combustors may have the opportunity to provide hazardous waste
management services for hazardous secondary materials managed as ECF.
However, as noted above, we suspect that very few facilities, if any,
are already managing ECF under the conditional exclusion. If that is
the case, commercial hazardous waste combustors have likely experienced
very little change.

III. Summary of the Proposed Rule

    This proposed rule would withdraw the conditional exclusion for ECF
under Sec.  261.38, including the exclusion itself in Sec.
261.4(a)(16), specifications and associated conditions applicable to
ECF under Sec.  261.38(a), the implementation conditions applicable to
ECF under Sec.  261.38(b), the storage and burning conditions for ECF
under Sec.  261.38(c), the provisions for failure to comply with the
conditions for the ECF exclusion under Sec.  261.38(d)(2), the
alternative storage conditions for ECF under Sec.  261.38(e), and the
notification of closure of an ECF storage unit under Sec.  261.38(f).
    As noted above, this proposed rule would not affect, however, the
exclusion for comparable fuel or synthesis gas fuel, including the
specifications and associated conditions for these materials under
Sec.  261.38(a), the implementation conditions applicable to these
materials under Sec.  261.38(b), and the provision for failure to
comply with the conditions for exclusion of these materials under Sec.
261.38(d)(1).
    Finally, the proposed rule would not affect the clarifications and
revisions to the conditions for comparable fuel that EPA promulgated
concurrently with the ECF exclusion; specifically: (1) Clarification
that comparable fuel that is spilled or leaked and that no longer meets
the conditions of the exclusion must be managed as a hazardous waste if
it exhibits a characteristic of hazardous waste or if it is otherwise a
listed hazardous waste (Sec.  261.38(b)(15)); (2) clarification that
the comparable fuel tank system and container storage units become
subject to the RCRA hazardous waste facility standards if not cleaned
of liquids and accumulated solids within 90 days of ceasing operations
as a comparable fuel storage unit (Sec.  261.38(b)(13)); (3) waiver of
the RCRA closure requirements for tank systems and container storage
units that were used only to store hazardous wastes that are
subsequently excluded as comparable fuel (Sec.  261.38(b)(14)); (4)
clarification that boiler residues, including bottom ash and emission
control residue, from burning comparable fuel would be subject to
regulation as hazardous waste if they exhibit a hazardous waste
characteristic (Sec.  261.38(b)(12)); and (5) a condition \4\ requiring
that the one-time notice by the generator to regulatory officials must
include an estimate of the average and maximum monthly and annual
quantity of comparable fuel for which an exclusion is claimed (Sec.
261.38(b)(2)(i)(A)).
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    \4\ Please note that this condition applies prospectively to
generators that newly claim the comparable fuel exclusion after
December 19, 2008 and to generators that must submit a revised
notification after December 19, 2008 because of a substantive change
in the information required by the notice.
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IV. Rationale for Proposing To Revoke the Exclusion for ECF

A. ECF May Be Classified as a Waste Rather than as a Product

    Since 1998, hazardous secondary materials (i.e., spent materials,
sludges, byproducts, and off-specification commercial chemical
products) which have fuel value and whose hazardous constituent levels
are comparable to those found in fuel oil that could be burned in their
place have been excluded from the definition of solid waste (and,
hence, cannot be hazardous waste). See Sec.  261.38.\5\ These materials
are called comparable fuels.
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    \5\ See 63 FR 33782 (June 19, 1998).
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    On December 19, 2008,\6\ EPA added an additional group of hazardous
secondary materials to the exclusions in Sec.  261.38. These are
hazardous secondary materials that, as generated, are handled as fuel
products through all phases of management. The rule sought to assure
that this will occur through a series of conditions on the
circumstances of their storage and burning, and based on their
substantial physical identity--except for their level of hydrocarbons
and oxygenates--with fuel oil. These hazardous secondary materials must
meet all of the hazardous constituent specifications for comparable
fuel, except those for oxygenates and hydrocarbons. These excluded
fuels are termed ``emission-comparable fuel'' (or ``ECF'') because the
emissions from an industrial boiler burning these hazardous secondary
materials under the conditions of the exclusion are comparable to the
emissions from an industrial boiler burning fuel oil, the fossil fuel
for which ECF could substitute. See 73 FR at 77956.
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    \6\ See 73 FR 77954.
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    However, ECF is a hazardous secondary material because the material
can have substantially higher concentrations of hazardous oxygenates
and hydrocarbons than fuel oil, and thus, lacking physical identity to
fossil fuel, can also be reasonably considered to be discarded when
burned (and when accumulated/stored prior to burning). Hazardous
oxygenates and hydrocarbons contribute fuel value (and are often found
at some level in petroleum-based fuel products albeit less than allowed
in ECF); however, several of these compounds (e.g., polycyclic aromatic
hydrocarbons, naphthalene, benzene, and acrolein) are also highly toxic
\7\ to human health and to the environment. EPA based the ECF exclusion
on its view that these hazardous compounds would be destroyed in the
combustion process, to the extent that their concentration in the
emissions would be comparable to that in the emissions from the
combustion of fuel oil in industrial boilers. However, to ensure
comparable emissions, EPA conditioned the exclusion on extensive,
substantive requirements on burning that are in fact similar to the
requirements for permitted hazardous waste combustors--including
conditions on the type of unit in which ECF can be combusted,
constituent-by-constituent feedrate limits controlling the amount of
ECF which may be burned (some of which are miniscule),\8\ and boiler
operating conditions (e.g., CO control, dioxin/furan control, automatic
ECF cutoff systems, and operator training). See Sec.  261.38(c)(2). In
the case of ECF, because it was necessary to preclude discard by
meeting conditions tantamount to satisfying the substantive subtitle C
regulatory regime, EPA concludes that the hazardous secondary material
is more waste-like than product-like.
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    \7\ USEPA, ``Final Technical Support Document for the Exclusion
of Emission Comparable Fuels,'' November 2008, Section 2.4.
    \8\ We note that the maximum firing rate for ECF containing a
polynuclear aromatic hydrocarbon (among the hydrocarbons which can
be present in unlimited concentrations in ECF) when the ECF is co-
fired with natural gas is 0.55% on a heat input basis (i.e., the ECF
can contribute only 0.55% of the heat input to the boiler), and the
maximum firing rate for such an ECF would be virtually zero if it
were to be co-fired with fuel oil. See USEPA, ``Final Technical
Support Document for the Exclusion of Emission Comparable Fuels,''
November 2008, Table 6-5. These feedrate restrictions are needed to
ensure that emissions from burning ECF are comparable to emissions
from burning fuel oil, but are so restrictive that they indicate the
hazardous secondary material is more waste-like than product-like
since virtually none of it could be burned in order to preserve
emission comparability.
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    Similarly, the exclusion contains extensive conditions on storage
that are virtually identical to the requirements for permitted
hazardous waste storage units. See Sec.  261.38(c)(1). That is, while
EPA has the authority to establish storage conditions in order to
identify hazardous secondary materials that are not discarded, the
collection of storage conditions on products and by-products that EPA
adopted for ECF to prevent discard are so similar to the requirements
for hazardous waste storage units under Subparts I and J of Part 264
that they become a surrogate to those required for the management of
hazardous waste, and thus, the material may be more waste-like than
product-like, and can reasonably be classified as

discarded. Put another way, if it is necessary to preclude discard by
meeting conditions tantamount to satisfying the substantive subtitle C
regulatory regime, then the secondary material may be classified as a
waste in the first instance.

B. Why EPA Now Proposes To Reclassify ECF as a Waste

    We have explained how ECF could be classified as a waste rather
than as a product. We explain here the rationale underlying EPA's
proposal choosing to reclassify ECF as a waste.
    The fundamental premise of the ECF rule is that ECF is no more
hazardous than burning fuel oil, because combustion of this material
will have comparable emissions. However, to ensure that the material
does not pose greater risks, EPA felt compelled to promulgate a very
detailed set of conditions--the equivalent of a detailed regulatory
scheme--for both the storage and combustion of ECF. As noted, the
conditions of the exclusion are virtually the same in many critical
instances as the substantive rules which apply while storing and
combusting hazardous waste. For example, EPA concluded that burning ECF
can lead to greater concentrations of hazardous constituents in air
emissions under ``normal'' combustion conditions. Therefore, EPA
imposed special design and operational conditions to ensure effective
combustion of ECF, which are similar to the requirements for industrial
boilers burning hazardous wastes under the exemption from stack
emissions testing for destruction and removal efficiency (DRE) provided
by 40 CFR 266.110. Therefore, upon further consideration, the Agency
believes that burning of ECF under the conditional exclusion is really
not much different from burning hazardous waste in a hazardous waste
combustion unit. We note that a number of commenters on the proposed
rule raised these same concerns.
    As a matter of policy, the nature of these requirements related to
burning ECF is such that, in EPA's view, they are most appropriately
applied through a careful review process, overseen by the regulator
with an opportunity for public comment. For example, a formal review of
an ECF burner's operations would ensure that the boiler meets the
design conditions, and that the required operating limits (e.g., CO
limit, ECF feedrate limit, boiler load, gas temperature for dioxin/
furan control) are properly monitored and linked to an automatic ECF
feed cutoff system. However, facilities that burn ECF, under the ECF
rule, would satisfy these conditions absent the formal process to apply
for and obtain an operating permit. That is, facilities would be
allowed to comply with this complicated set of operating conditions
without any type of review process. Although the Agency contemplated
that the authorized permitting authority would ensure compliance
through enforcement oversight rather than through the permitting
process, the Agency now believes it is important that each ECF burner
undergoes a thorough review on the operation of the combustion unit as
part of the existing subtitle C permitting structure. Indeed, EPA, on
reconsideration (but subject to consideration of public comment), has
concluded that the ECF rule will actually require more resources and
more attention from the regulatory agency than a subtitle C approach to
reach a comparable level of assurance that appropriate combustion
conditions are met. Under the ECF rule, the burden would be on State
enforcement personnel to ensure that the conditions are met after the
fact, while under a permit system, the burden is on the regulated
entity to demonstrate to the regulatory authority that the terms of the
regulations are met. In many cases, regulations that are directly
enforced make sense, but where regulations govern specialized
combustion conditions, and where technical judgments are important in
determining compliance, the permit process provides important
protections.
    With respect to storage, ECF contains higher (potentially
unlimited) concentrations of hazardous hydrocarbons and oxygenates than
fuel oil, and so poses a greater storage hazard than fuel oil. In
addition, ECF may often behave as a dense non-aqueous phase liquid and
be more difficult to contain than fuel oil should it leak or spill.
Several of these hazardous hydrocarbons and oxygenates are also highly
volatile, raising concern about the hazard of fugitive air emissions
and resulting in the need for fugitive emission controls. In addition,
since storage units are not subject to closure and financial assurance
conditions under the present rule, ECF storage units may be improperly
closed, which could result in spills or leaks. All of these factors are
reasons why a thorough review on the operation of the storage units
should be undertaken as part of the existing subtitle C permitting
structure, as opposed to a self-implementing structure. Thus, given all
of these potentials for harm in storage--all of which are classic
damage pathways for waste storage--EPA is proposing to remove the
exclusion for ECF when ECF is stored.
    For all these reasons, EPA now concludes, subject to consideration
of public comment, that it is more straightforward and more appropriate
simply to apply the hazardous waste rules directly, i.e., to reclassify
ECF as solid waste subject to a hazardous waste determination and, if
hazardous, the RCRA cradle-to-grave management system.

V. State Authority

A. Applicability of the Rule in Authorized States

    Under section 3006 of RCRA, EPA may authorize qualified States to
administer their own hazardous waste programs in lieu of the Federal
program within the State. Following authorization, EPA retains
enforcement authority under sections 3008, 3013, and 7003 of RCRA,
although authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
Federal program in that State. The Federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that State, since only the State was authorized to
issue RCRA permits. When new, more stringent Federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified time frames. However, the new Federal requirements did
not take effect in an authorized State until the State adopted the
Federal requirements as State law.
    In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. EPA is directed by the statute to
implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While States must still adopt HSWA related
provisions as State law to retain final authorization, EPA implements
the HSWA provisions in authorized States until the States do so.
    Authorized States are required to modify their programs only when
EPA enacts Federal requirements that are

more stringent or broader in scope than the existing Federal
requirements. RCRA section 3009 allows the States to impose standards
more stringent than those in the Federal program (see also 40 CFR
271.1). Therefore, authorized States may, but are not required to,
adopt Federal regulations, both HSWA and non-HSWA, that are considered
less stringent than previous Federal regulations.

B. Effect on State Authorization

    The provisions in today's notice are not being proposed under the
authority of HSWA and are considered to be more stringent than current
requirements. States that have adopted the exclusion would be required
to modify their programs to remove the exclusion for ECF because they
must conform to the Federal regulations that are more stringent than
the authorized State regulations. States that adopted the comparable
fuel exclusion promulgated on June 19, 1998 and codified at Sec.
261.38, but that have not adopted the ECF exclusion, will still need to
revise their programs to adopt the more stringent conditions applicable
to comparable fuel (see 73 FR at 77963-64) that were promulgated
concurrently with the ECF exclusion on December 19, 2008.
    Section 271.21(e)(2) of EPA's State authorization regulations (40
CFR part 271) requires that States with final authorization modify
their programs to reflect Federal program changes and submit the
modifications to EPA for approval. The deadline by which the States
will need to modify their programs is determined by the date of
promulgation of a final rule in accordance with Sec.  271.21(e)(2).
Once EPA approves the modification, the State requirements would become
RCRA subtitle C requirements.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action.'' Pursuant to the
terms of Executive Order 12866, the Agency, in conjunction with the
Office of Management and Budget (OMB), has determined that this
proposed rule is a significant regulatory action because it proposes to
withdraw a rule that OMB previously determined contains novel policy
issues, as defined under part 3(f)(4) of the Order. Accordingly, EPA
submitted this action to OMB for review under EO 12866. Any changes
made in response to OMB recommendations have been documented in the
docket for this action.
    This proposed withdrawal of the RCRA Conditional Exclusion for ECF
would result in lost benefits to society. The economic assessment
(Assessment) \9\ prepared in support of the December 2008 final rule
estimated total annual net social benefits (i.e., net resource savings)
of $13.4 million per year, assuming all authorized States were to adopt
the rule (which as noted earlier, we do not believe has occurred). The
benefits estimate was based on the best available data and information
at the time of the analysis. However, upon further research and
assessment, we have determined that one of our key analytical
assumptions,\10\ derived from data reporting limitations, may not
reflect actual waste management patterns, as reported. Adjusting for
this discrepancy results in a revised annual net social benefits
estimate of approximately $6.6 million, again assuming that the current
rule were to be adopted by all authorized States.\11\ Actual net social
benefits are likely lower since we believe most States have not adopted
the rule. This adjustment indicates that the net annual social benefits
lost by withdrawing the final rule would not be as large as originally
estimated.\12\
---------------------------------------------------------------------------

    \9\ USEPA, ``Assessment of the Potential Costs, Benefits, and
Other Impacts of the Expansion of the RCRA Comparable Fuel
Exclusion--Final Rule,'' May 14, 2008.
    \10\ Our primary data source, USEPA, ``2005 National Biennial
Report,'' does not identify a management method code for wastes that
are combusted in an incinerator and where the heating value of the
wastes is used beneficially in lieu of fossil or other fuels to
combust other waste with little or no heating value. Thus, the vast
majority of the waste that we identify as likely to be excluded as
ECF, and which is currently combusted in incinerators, may already
be burned for energy recovery.
    \11\ USEPA, ``Revised Assessment of the Potential Costs,
Benefits, and Other Impacts of the Expansion of the RCRA Comparable
Fuel Exclusion--Final Rule,'' July 15, 2009.
    \12\ USEPA, ``Assessment of the Potential Costs, Benefits, and
Other Impacts of the Proposed Withdrawal of the Expansion of the
RCRA Comparable Fuel Exclusion--Final Rule,'' July 15, 2009.
---------------------------------------------------------------------------

B. Paperwork Reduction Act

    The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR number 1361.14. Withdrawing the ECF exclusion would
result in an increase in the reporting and recordkeeping burden for ECF
generators and burners, back to the level prior to promulgation of the
exclusion. That is, under the ECF conditional exclusion, because ECF
was no longer classified as a hazardous waste, the generator and burner
would not be required to comply with the paperwork, reporting, and
recordkeeping requirements under the subtitle C hazardous waste
regulations. However, ECF generators and burners would be subject to an
annual public reporting and recordkeeping burden for the collection of
information required under the conditional exclusion. Thus, overall,
the reporting and recordkeeping burden for ECF generators and burners
resulted in a net annual reduction of 32,899 hours (assuming that all
authorized States adopted the rule, which has not occurred) and a
savings of $1.3 million in capital and operation and maintenance costs
(based on the same assumption). Therefore, withdrawing the ECF
conditional exclusion would result in a reporting and recordkeeping
burden of 32,899 hours and a cost of $1.3 million in capital, and
operation and maintenance costs, assuming full adoption by authorized
States. Since we believe this has not occurred, the new burden would be
far less. If authorized States have not fully adopted the rule,
withdrawing the ECF conditional exclusion would not change the
reporting and recordkeeping burden from what existed prior to
promulgation of the conditional exclusion. OMB has previously approved
the information collection requirements contained in the existing
regulations at 40 CFR 261.38 under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2050-0073. Burden is defined at 5 CFR 1320.3(b).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
    To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, EPA has established a public docket for
this rule, which includes this ICR, under Docket ID number EPA-HQ-RCRA-
2005-0017. Submit any comments related to the ICR to EPA and OMB. See
ADDRESSES section at the beginning of this notice for where to submit
comments to EPA. Send comments to OMB at the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725

17th Street, NW., Washington, DC 20503, Attention: Desk Officer for
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after December 8, 2009, a comment to OMB is best
assured of having its full effect if OMB receives it by January 7,
2010. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action would not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    We have determined that the affected ECF generators are not owned
by small governmental jurisdictions or nonprofit organizations.
Therefore, only small businesses were analyzed for small entity
impacts. For the purposes of the impact analyses, small entity is
defined either by the number of employees or by the dollar amount of
sales. The level at which a business is considered small is determined
for each North American Industrial Classification System (NAICS) code
by the Small Business Administration.
    This rule, as proposed, is projected to result in increased costs
to companies that may have started to use the conditional exclusion, as
identified in the ECF Final Rule, although we suspect that very few
facilities, if any, have begun to comply with this rule. However, the
[reversed] cost impacts to potentially affected entities are not
expected to be significant, as discussed under the Regulatory
Flexibility section of the May 14, 2008 Assessment document.\13\ As a
result, the rule would not result in significant adverse economic
impacts to affected small entities. We continue to be interested in the
potential impacts of the proposed rule on small entities and welcome
comments on issues related to such impacts.
---------------------------------------------------------------------------

    \13\ USEPA, ``Assessment of the Potential Costs, Benefits, and
Other Impacts of the Expansion of the RCRA Comparable Fuel
Exclusion--Final Rule,'' May 14, 2008.
---------------------------------------------------------------------------

D. Unfunded Mandates Reform Act

    This proposed rule does not contain a Federal mandate that may
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any one
year. Total annual cost impacts of this action, as proposed, are not
expected to exceed $6.6 million. Thus, this proposed rule is not
subject to the requirements of sections 202 or 205 of UMRA.
    This proposed rule is also not subject to the requirements of
section 203 of UMRA because it contains no regulatory requirements that
might significantly or uniquely affect small governments. No small
governments are known to own or manage any of the affected entities.

E. Executive Order 13132: Federalism

    This action does not have Federalism implications. It would 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. This action primarily and
directly affects generators and burners of ECF. There are no State and
local government bodies that would incur direct compliance costs by
this rulemaking. Thus, Executive Order 13132 does not apply to this
proposed rule.
    In the spirit of Executive Order 13132 and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This proposed
rule would neither impose substantial direct compliance costs on tribal
governments nor preempt tribal law. Thus, Executive Order 13175 does
not apply to this action.
    EPA did not consult directly with representatives of Tribal
governments in the process of developing this proposal. Thus, EPA
solicits comments on this proposed rule from Tribal officials.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to EO 13045 (62 F.R. 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this proposed action
will present a disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Usage

    This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211 (66 FR 28355, May 22, 2001)), because
it is not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations

when the Agency decides not to use available and applicable voluntary
consensus standards.
    Because EPA is proposing to withdraw the conditional exclusion for
ECF under Sec.  261.38, EPA is not considering the use of any voluntary
consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule would not have
disproportionately high and/or adverse human health or environmental
effects on minority or low-income populations because it would require
ECF to be managed under the RCRA Subtitle C hazardous waste
regulations, thereby potentially reducing exposures to the public,
including to minority and low-income populations.

List of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

    Dated: November 30, 2009.
Lisa P. Jackson,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I, of
the Code of Federal Regulations is proposed to be amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

    1. The authority citation for part 261 continues to read as
follows:

    Authority:  42 U.S.C. 6903, 6912(b), 6925.

    2. Section 261.4 is amended by revising paragraph (a)(16) to read
as follows:

Sec.  261.4  Exclusions.

    (a) * * *
    (16) Comparable fuels or comparable syngas fuels that meet the
requirements of Sec.  261.38.
* * * * *
    3. Section 261.38 is revised to read as follows:

Sec.  261.38  Exclusion of comparable fuel and syngas fuel.

    (a) Specifications for excluded fuels. Wastes that meet the
specifications for comparable fuel or syngas fuel under paragraphs
(a)(1) or (a)(2) of this section, respectively, and the other
requirements of this section, are not solid wastes.
    (1) Comparable fuel specifications.--(i) Physical specifications--
(A) Heating value. The heating value must exceed 5,000 BTU/lbs. (11,500
J/g).
    (B) Viscosity. The viscosity must not exceed: 50 cS, as-fired.
    (ii) Constituent specifications. For compounds listed in Table 1 to
this section, the specification levels and, where non-detect is the
specification, minimum required detection limits are: (see Table 1 of
this section).
    (2) Synthesis gas fuel specifications. Synthesis gas fuel (i.e.,
syngas fuel) that is generated from hazardous waste must:
    (i) Have a minimum Btu value of 100 Btu/Scf;
    (ii) Contain less than 1 ppmv of total halogen;
    (iii) Contain less than 300 ppmv of total nitrogen other than
diatomic nitrogen (N2);
    (iv) Contain less than 200 ppmv of hydrogen sulfide; and
    (v) Contain less than 1 ppmv of each hazardous constituent in the
target list of appendix VIII constituents of this part.
    (3) Blending to meet the specifications. (i) Hazardous waste shall
not be blended to meet the comparable fuel specification under
paragraph (a)(1) of this section, except as provided by paragraph
(a)(3)(ii) of this section:
    (ii) Blending to meet the viscosity specification. A hazardous
waste blended to meet the viscosity specification for comparable fuel
shall:
    (A) As generated and prior to any blending, manipulation, or
processing, meet the constituent and heating value specifications of
paragraphs (a)(1)(i)(A) and (a)(1)(ii) of this section;
    (B) Be blended at a facility that is subject to the applicable
requirements of parts 264, 265, or 267 or Sec.  262.34 of this chapter;
and
    (C) Not violate the dilution prohibition of paragraph (a)(6) of
this section.
    (4) Treatment to meet the comparable fuel specifications. (i) A
hazardous waste may be treated to meet the specifications for
comparable fuel set forth in paragraph (a)(1) of this section provided
the treatment:
    (A) Destroys or removes the constituent listed in the specification
or raises the heating value by removing or destroying hazardous
constituents or materials;
    (B) Is performed at a facility that is subject to the applicable
requirements of parts 264, 265, or 267, or Sec.  262.34 of this
chapter; and
    (C) Does not violate the dilution prohibition of paragraph (a)(6)
of this section.
    (ii) Residuals resulting from the treatment of a hazardous waste
listed in subpart D of this part to generate a comparable fuel remain a
hazardous waste.
    (5) Generation of a syngas fuel. (i) A syngas fuel can be generated
from the processing of hazardous wastes to meet the exclusion
specifications of paragraph (a)(2) of this section provided the
processing:
    (A) Destroys or removes the constituent listed in the specification
or raises the heating value by removing or destroying constituents or
materials;
    (B) Is performed at a facility that is subject to the applicable
requirements of parts 264, 265, or 267, or Sec.  262.34 of this chapter
or is an exempt recycling unit pursuant to Sec.  261.6(c); and
    (C) Does not violate the dilution prohibition of paragraph (a)(6)
of this section.
    (ii) Residuals resulting from the treatment of a hazardous waste
listed in subpart D of this part to generate a syngas fuel remain a
hazardous waste.
    (6) Dilution prohibition. No generator, transporter, handler, or
owner or operator of a treatment, storage, or disposal facility shall
in any way dilute a hazardous waste to meet the specifications of
paragraphs (a)(1)(i)(A) or (a)(1)(ii) of this section for comparable
fuel, or paragraph (a)(2) of this section for syngas.
    (b) Implementation--(1) General. (i) Wastes that meet the
specifications provided by paragraph (a) of this section for comparable
fuel or syngas fuel are excluded from the definition of solid waste
provided that the conditions under this section are met. For purposes
of this section, such materials are called excluded fuel; the person
claiming and qualifying for the exclusion is called the excluded fuel
generator and the person burning the excluded fuel is called the
excluded fuel burner.
    (ii) The person who generates the excluded fuel must claim the
exclusion by complying with the conditions of this section and keeping
records necessary to document compliance with those conditions.
    (2) Notices--(i) Notices to State RCRA and CAA Directors in
authorized States or regional RCRA and CAA Directors in unauthorized
States. (A) The generator

must submit a one-time notice, except as provided by paragraph
(b)(2)(i)(C) of this section, to the Regional or State RCRA and CAA
Directors, in whose jurisdiction the exclusion is being claimed and
where the excluded fuel will be burned, certifying compliance with the
conditions of the exclusion and providing the following documentation:
    (1) The name, address, and RCRA ID number of the person/facility
claiming the exclusion;
    (2) The applicable EPA Hazardous Waste Code(s) that would otherwise
apply to the excluded fuel;
    (3) The name and address of the units meeting the requirements of
paragraphs (b)(3) and (c) of this section, that will burn the excluded
fuel;
    (4) An estimate of the average and maximum monthly and annual
quantity of material for which an exclusion would be claimed, except as
provided by paragraph (b)(2)(i)(C) of this section; and
    (5) The following statement, which shall be signed and submitted by
the person claiming the exclusion or his authorized representative:

    Under penalty of criminal and civil prosecution for making or
submitting false statements, representations, or omissions, I
certify that the requirements of 40 CFR 261.38 have been met for all
comparable fuels identified in this notification. Copies of the
records and information required at 40 CFR 261.38(b)(8) are
available at the generator's facility. Based on my inquiry of the
individuals immediately responsible for obtaining the information,
the information is, to the best of my knowledge and belief, true,
accurate, and complete. I am aware that there are significant
penalties for submitting false information, including the
possibility of fine and imprisonment for knowing violations.

    (B) If there is a substantive change in the information provided in
the notice required under this paragraph, the generator must submit a
revised notification.
    (C) Excluded fuel generators must include an estimate of the
average and maximum monthly and annual quantity of material for which
an exclusion would be claimed only in notices submitted after December
19, 2008 for newly excluded fuel or for revised notices as required by
paragraph (b)(2)(i)(B) of this section.
    (ii) Public notice. Prior to burning an excluded fuel, the burner
must publish in a major newspaper of general circulation local to the
site where the fuel will be burned, a notice entitled ``Notification of
Burning a Fuel Excluded Under the Resource Conservation and Recovery
Act'' and containing the following information:
    (A) Name, address, and RCRA ID number of the generating
facility(ies);
    (B) Name and address of the burner and identification of the
unit(s) that will burn the excluded fuel;
    (C) A brief, general description of the manufacturing, treatment,
or other process generating the excluded fuel;
    (D) An estimate of the average and maximum monthly and annual
quantity of the excluded fuel to be burned; and
    (E) Name and mailing address of the Regional or State Directors to
whom the generator submitted a claim for the exclusion.
    (3) Burning. The exclusion applies only if the fuel is burned in
the following units that also shall be subject to Federal/State/local
air emission requirements, including all applicable requirements
implementing section 112 of the Clean Air Act:
    (i) Industrial furnaces as defined in Sec.  260.10 of this chapter;
    (ii) Boilers, as defined in Sec.  260.10 of this chapter, that are
further defined as follows:
    (A) Industrial boilers located on the site of a facility engaged in
a manufacturing process where substances are transformed into new
products, including the component parts of products, by mechanical or
chemical processes; or
    (B) Utility boilers used to produce electric power, steam, heated
or cooled air, or other gases or fluids for sale;
    (iii) Hazardous waste incinerators subject to regulation under
subpart O of parts 264 or 265 of this chapter and applicable CAA MACT
standards.
    (iv) Gas turbines used to produce electric power, steam, heated or
cooled air, or other gases or fluids for sale.
    (4) Fuel analysis plan for generators. The generator of an excluded
fuel shall develop and follow a written fuel analysis plan which
describes the procedures for sampling and analysis of the material to
be excluded. The plan shall be followed and retained at the site of the
generator claiming the exclusion.
    (i) At a minimum, the plan must specify:
    (A) The parameters for which each excluded fuel will be analyzed
and the rationale for the selection of those parameters;
    (B) The test methods which will be used to test for these
parameters;
    (C) The sampling method which will be used to obtain a
representative sample of the excluded fuel to be analyzed;
    (D) The frequency with which the initial analysis of the excluded
fuel will be reviewed or repeated to ensure that the analysis is
accurate and up to date; and
    (E) If process knowledge is used in the determination, any
information prepared by the generator in making such determination.
    (ii) For each analysis, the generator shall document the following:
    (A) The dates and times that samples were obtained, and the dates
the samples were analyzed;
    (B) The names and qualifications of the person(s) who obtained the
samples;
    (C) A description of the temporal and spatial locations of the
samples;
    (D) The name and address of the laboratory facility at which
analyses of the samples were performed;
    (E) A description of the analytical methods used, including any
clean-up and sample preparation methods;
    (F) All quantitation limits achieved and all other quality control
results for the analysis (including method blanks, duplicate analyses,
matrix spikes, etc.), laboratory quality assurance data, and the
description of any deviations from analytical methods written in the
plan or from any other activity written in the plan which occurred;
    (G) All laboratory results demonstrating whether the exclusion
specifications have been met; and
    (H) All laboratory documentation that support the analytical
results, unless a contract between the claimant and the laboratory
provides for the documentation to be maintained by the laboratory for
the period specified in paragraph (b)(9) of this section and also
provides for the availability of the documentation to the claimant upon
request.
    (iii) Syngas fuel generators shall submit for approval, prior to
performing sampling, analysis, or any management of an excluded syngas
fuel, a fuel analysis plan containing the elements of paragraph
(b)(4)(i) of this section to the appropriate regulatory authority. The
approval of fuel analysis plans must be stated in writing and received
by the facility prior to sampling and analysis to demonstrate the
exclusion of a syngas. The approval of the fuel analysis plan may
contain such provisions and conditions as the regulatory authority
deems appropriate.
    (5) Excluded fuel sampling and analysis--(i) General. For wastes
for which an exclusion is claimed under the specifications provided by
paragraphs (a)(1) or (a)(2) of this section, the generator of the waste
must test for all the constituents in appendix VIII to this part,
except those that the generator determines, based on testing or
knowledge, should not be present in the fuel. The generator is required
to document the basis of each determination that a constituent with an
applicable specification should not be present. The generator may not

determine that any of the following categories of constituents with a
specification in Table 1 to this section should not be present:
    (A) A constituent that triggered the toxicity characteristic for
the constituents that were the basis for listing the hazardous
secondary material as a hazardous waste, or constituents for which
there is a treatment standard for the waste code in 40 CFR 268.40;
    (B) A constituent detected in previous analysis of the waste;
    (C) Constituents introduced into the process that generates the
waste; or
    (D) Constituents that are byproducts or side reactions to the
process that generates the waste.

    Note to paragraph (b)(5)(i):  Any claim under this section must
be valid and accurate for all hazardous constituents; a
determination not to test for a hazardous constituent will not
shield a generator from liability should that constituent later be
found in the excluded fuel above the exclusion specifications.

    (ii) Use of process knowledge. For each waste for which the
comparable fuel or syngas exclusion is claimed where the generator of
the excluded fuel is not the original generator of the hazardous waste,
the generator of the excluded fuel may not use process knowledge
pursuant to paragraph (b)(5)(i) of this section and must test to
determine that all of the constituent specifications of paragraphs
(a)(1) and (a)(2) of this section, as applicable, have been met.
    (iii) The excluded fuel generator may use any reliable analytical
method to demonstrate that no constituent of concern is present at
concentrations above the specification levels. It is the responsibility
of the generator to ensure that the sampling and analysis are unbiased,
precise, and representative of the excluded fuel. For the fuel to be
eligible for exclusion, a generator must demonstrate that:
    (A) The 95% upper confidence limit of the mean concentration for
each constituent of concern is not above the specification level; and
    (B) The analyses could have detected the presence of the
constituent at or below the specification level.
    (iv) Nothing in this paragraph preempts, overrides or otherwise
negates the provision in Sec.  262.11 of this chapter, which requires
any person who generates a solid waste to determine if that waste is a
hazardous waste.
    (v) In an enforcement action, the burden of proof to establish
conformance with the exclusion specification shall be on the generator
claiming the exclusion.
    (vi) The generator must conduct sampling and analysis in accordance
with the fuel analysis plan developed under paragraph (b)(4) of this
section.
    (vii) Viscosity condition for comparable fuel. (A) Excluded
comparable fuel that has not been blended to meet the kinematic
viscosity specification shall be analyzed as-generated.
    (B) If hazardous waste is blended to meet the kinematic viscosity
specification for comparable fuel, the generator shall:
    (1) Analyze the hazardous waste as-generated to ensure that it
meets the constituent and heating value specifications of paragraph
(a)(1) of this section; and
    (2) After blending, analyze the fuel again to ensure that the
blended fuel meets all comparable fuel specifications.
    (viii) Excluded fuel must be re-tested, at a minimum, annually and
must be retested after a process change that could change its chemical
or physical properties in a manner than may affect conformance with the
specifications.
    (6) [Reserved]
    (7) Speculative accumulation. Excluded fuel must not be accumulated
speculatively, as defined in Sec.  261.1(c)(8).
    (8) Operating record. The generator must maintain an operating
record on site containing the following information:
    (i) All information required to be submitted to the implementing
authority as part of the notification of the claim:
    (A) The owner/operator name, address, and RCRA ID number of the
person claiming the exclusion;
    (B) For each excluded fuel, the EPA Hazardous Waste Codes that
would be applicable if the material were discarded; and
    (C) The certification signed by the person claiming the exclusion
or his authorized representative.
    (ii) A brief description of the process that generated the excluded
fuel. If the comparable fuel generator is not the generator of the
original hazardous waste, provide a brief description of the process
that generated the hazardous waste;
    (iii) The monthly and annual quantities of each fuel claimed to be
excluded;
    (iv) Documentation for any claim that a constituent is not present
in the excluded fuel as required under paragraph (b)(5)(i) of this
section;
    (v) The results of all analyses and all detection limits achieved
as required under paragraph (b)(4) of this section;
    (vi) If the comparable fuel was generated through treatment or
blending, documentation of compliance with the applicable provisions of
paragraphs (a)(3) and (a)(4) of this section;
    (vii) If the excluded fuel is to be shipped off-site, a
certification from the burner as required under paragraph (b)(10) of
this section;
    (viii) The fuel analysis plan and documentation of all sampling and
analysis results as required by paragraph (b)(4) of this section; and
    (ix) If the generator ships excluded fuel off-site for burning, the
generator must retain for each shipment the following information on-
site:
    (A) The name and address of the facility receiving the excluded
fuel for burning;
    (B) The quantity of excluded fuel shipped and delivered;
    (C) The date of shipment or delivery;
    (D) A cross-reference to the record of excluded fuel analysis or
other information used to make the determination that the excluded fuel
meets the specifications as required under paragraph (b)(4) of this
section; and
    (E) A one-time certification by the burner as required under
paragraph (b)(10) of this section.
    (9) Records retention. Records must be maintained for a period of
three years.
    (10) Burner certification to the generator. Prior to submitting a
notification to the State and Regional Directors, a generator of
excluded fuel who intends to ship the excluded fuel off-site for
burning must obtain a one-time written, signed statement from the
burner:
    (i) Certifying that the excluded fuel will only be burned in an
industrial furnace, industrial boiler, utility boiler, or hazardous
waste incinerator, as required under paragraph (b)(3) of this section;
    (ii) Identifying the name and address of the facility that will
burn the excluded fuel; and
    (iii) Certifying that the State in which the burner is located is
authorized to exclude wastes as excluded fuel under the provisions of
this section.
    (11) Ineligible waste codes. Wastes that are listed as hazardous
waste because of the presence of dioxins or furans, as set out in
appendix VII of this part, are not eligible for these exclusions, and
any fuel produced from or otherwise containing these wastes remains a
hazardous waste subject to the full RCRA hazardous waste management
requirements.
    (12) Regulatory status of boiler residues. Burning excluded fuel
that was otherwise a hazardous waste listed

under Sec. Sec.  261.31 through 261.33 does not subject boiler
residues, including bottom ash and emission control residues, to
regulation as derived-from hazardous wastes.
    (13) Residues in containers and tank systems upon cessation of
operations. (i) Liquid and accumulated solid residues that remain in a
container or tank system for more than 90 days after the container or
tank system ceases to be operated for storage or transport of excluded
fuel product are subject to regulation under parts 262 through 265,
267, 268, 270, 271, and 124 of this chapter.
    (ii) Liquid and accumulated solid residues that are removed from a
container or tank system after the container or tank system ceases to
be operated for storage or transport of excluded fuel product are solid
wastes subject to regulation as hazardous waste if the waste exhibits a
characteristic of hazardous waste under Sec. Sec.  261.21 through
261.24 or if the fuel were otherwise a hazardous waste listed under
Sec. Sec.  261.31 through 261.33 when the exclusion was claimed.
    (iii) Liquid and accumulated solid residues that are removed from a
container or tank system and which do not meet the specifications for
exclusion under paragraphs (a)(1) or (a)(2) of this section are solid
wastes subject to regulation as hazardous waste if:
    (A) The waste exhibits a characteristic of hazardous waste under
Sec. Sec.  261.21 through 261.24; or
    (B) The fuel were otherwise a hazardous waste listed under
Sec. Sec.  261.31 through 261.33. The hazardous waste code for the
listed waste applies to these liquid and accumulated solid resides.
    (14) Waiver of RCRA closure requirements. Interim status and
permitted storage and combustion units, and generator storage units
exempt from the permit requirements under Sec.  262.34 of this chapter,
are not subject to the closure requirements of 40 CFR parts 264, 265,
and 267 provided that the storage and combustion unit has been used to
manage only hazardous waste that is subsequently excluded under the
conditions of this section, and that afterward will be used only to
manage fuel excluded under this section.
    (15) Spills and leaks. (i) Excluded fuel that is spilled or leaked
and that therefore no longer meets the conditions of the exclusion is
discarded and must be managed as a hazardous waste if it exhibits a
characteristic of hazardous waste under Sec. Sec.  261.21 through
261.24 or if the fuel were otherwise a hazardous waste listed in
Sec. Sec.  261.31 through 261.33.
    (ii) For excluded fuel that would have otherwise been a hazardous
waste listed in Sec. Sec.  261.31 through 261.33 and which is spilled
or leaked, the hazardous waste code for the listed waste applies to the
spilled or leaked material.
    (16) Nothing in this section preempts, overrides, or otherwise
negates the provisions in CERCLA Section 103, which establish reporting
obligations for releases of hazardous substances, or the Department of
Transportation requirements for hazardous materials in 49 CFR parts 171
through 180.
    (c) Failure to comply with the conditions of the exclusion. An
excluded fuel loses its exclusion if any person managing the fuel fails
to comply with the conditions of the exclusion under this section, and
the material must be managed as a hazardous waste from the point of
generation. In such situations, EPA or an authorized State agency may
take enforcement action under RCRA section 3008(a).
BILLING CODE 6560-50-P

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[FR Doc. E9-29063 Filed 12-7-09; 8:45 am]

BILLING CODE 6560-50-C


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78669-78670]
[FR Doc No: 2011-32367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0578]

Determination that Bretylium Tosylate Injection, 50 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for Bretylium Tosylate injection, 50 mg/mL, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6246, Silver Spring, MD 20993-0002, (301)
796-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Bretylium Tosylate injection, 50 mg/mL, is the subject of NDA 19-
030, held by Hospira, Inc., and initially approved on April 16, 1986.
Bretylium Tosylate injection, 50 mg/mL, is indicated in the prophylaxis
and therapy of ventricular fibrillation and in the treatment of life-
threatening ventricular arrhythmias, such as ventricular tachycardia,
that have failed to respond to adequate doses of a first-line
antiarrhythmic agent, such as lidocaine.
    In a letter dated June 17, 2010, Hospira, Inc. requested withdrawal
of NDA 19-030 for Bretylium Tosylate injection, 50 mg/mL. In the
Federal Register of June 8, 2011 (76 FR 33310), FDA announced that it
was withdrawing approval of NDA 019030, effective July 8, 2011.
    Academic Pharmaceuticals, Inc. submitted a citizen petition dated
July 27, 2011 (Docket No. FDA-2011-P-0578), under 21 CFR 10.30,
requesting that the Agency determine whether Bretylium Tosylate
injection, 50 mg/mL, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that Bretylium Tosylate injection, 50 mg/mL, was
not withdrawn for reasons of safety or effectiveness. We have carefully
reviewed the information provided by the petitioner and our files for
records concerning the withdrawal of Bretylium

Tosylate injection, 50 mg/mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list Bretylium Tosylate
injection, 50 mg/mL, in the ``Discontinued Drug Product List'' section
of the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to Bretylium Tosylate injection, 50 mg/mL, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: December 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32367 Filed 12-16-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Page 26172]
[FR Doc No: 2019-11934]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission Fixed Income Market Structure
Advisory Committee will hold a public telephonic meeting on Tuesday,
June 11, 2019 at 1:00 p.m.

PLACE: The meeting will be open to the public by telephone at 1-800-
260-0718, participant code 467607 as well as by an audio-only webcast
on the Commission's website at www.sec.gov.

STATUS: The meeting will begin at 1:00 p.m. and will be open to the
public by telephone and an audio-only webcast on the Commission's
website at www.sec.gov.

MATTERS TO BE CONSIDERED: On May 20, 2019, the Commission published
notice of the Committee meeting (Release No. 34-85895), indicating that
the meeting is open to the public, by telephone or an audio-only
webcast, and inviting the public to submit written comments to the
Committee. This Sunshine Act notice is being issued because a majority
of the Commission may attend the meeting.
    The agenda for the meeting will include the consideration of
recommendations from the Technology and Electronic Trading
Subcommittee.

CONTACT PERSON FOR MORE INFORMATION: For further information, please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: June 3, 2019.
Vanessa A. Countryman,
Acting Secretary.
[FR Doc. 2019-11934 Filed 6-3-19; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24763-24764]
[FR Doc No: 2017-10974]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80746; File No. SR-NYSEMKT-2016-103]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendments No. 1 and 2, Allowing the Exchange To Trade,
Pursuant to Unlisted Trading Privileges, Any NMS Stock Listed on
Another National Securities Exchange; Establishing Rules for the
Trading Pursuant to UTP of Exchange-Traded Products; and Adopting New
Equity Trading Rules Relating to Trading Halts of Securities Traded
Pursuant to UTP on the Pillar Platform

May 23, 2017.
    On November 17, 2016, NYSE MKT LLC (``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 (1) allow the
Exchange to trade, pursuant to unlisted trading privileges (``UTP''),
any NMS Stock listed on another national securities exchange; (2)
establish rules for the trading pursuant to UTP of exchange-traded
products; and (3) adopt new equity trading rules relating to trading
halts of securities traded pursuant to UTP on the Pillar platform. The
proposed rule change was published for comment in the Federal Register
on December 1, 2016.\3\ On January 4, 2017, pursuant to Section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On February 24, 2017, the
Commission instituted proceedings under Section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
change.\7\

On March 28, 2017, the Exchange filed Amendment No. 1 to the proposed
rule change.\8\ Amendment No. 1 was published for comment in the
Federal Register on April 27, 2017.\9\ On April 27, 2017, the Exchange
filed Amendment No. 2 to the proposed rule change.\10\ The Commission
has received no comments on the proposed rule change.
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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. 79400 (Nov. 25,
2016), 81 FR 86750.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 79738, 82 FR 3068
(Jan. 10, 2017).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 80097, 82 FR 12251
(Mar. 1, 2017). Specifically, the Commission instituted proceedings
to allow for additional analysis of the proposed rule change's
consistency with Section 6(b)(5) of the Act, 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,'' and
``to protect investors and the public interest.'' See id. at 12252.
    \8\ Amendment No. 1 is available at: https://www.sec.gov/comments/sr-nysemkt-2016-103/nysemkt2016103-1672987-149219.pdf.
    \9\ See Securities Exchange Act Release No. 80500 (Apr. 21,
2017), 82 FR 19416.
    \10\ In Amendment No. 2, the Exchange: (1) Corrected the cross-
reference in footnote 66 of the filing to read ``See supra note
63''; (2) amended proposed Rule 5.2E(j)(6)(B)(V)(2)(a) to read
``may'' instead of ``will''; (3) amended proposed Rule 5.5E(m)(1)(c)
to clarify that the regulatory function described therein would be
exercised by ``the Exchange'' instead of ``Regulation''; (4) amended
Supplementary Material .01 to proposed Rule 8.200E to erase the
repetitive words ``are satisfied'' at the end of the introductory
paragraph; and (5) amended proposed Rule 8.700E(h) to add at the
beginning of the paragraph the sentence ``The Exchange will file
separate proposals under Section 19(b) of the Securities Exchange
Act of 1934 before listing and trading separate and distinct Managed
Trust Securities.'' Amendment No. 2 is available at: https://www.sec.gov/comments/sr-nysemkt-2016-103/nysemkt2016103-1724667-150689.pdf. Because Amendment No. 2 to the proposed rule change does
not materially alter the substance of the proposed rule change or
raise unique or novel regulatory issues, Amendment No. 2 is not
subject to notice and comment.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \11\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on December 1, 2016. May 30, 2017 is 180 days from
that date, and July 29, 2017 is 240 days from that date.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider this proposed
rule change. Accordingly, the Commission, pursuant to Section 19(b)(2)
of the Act,\12\ designates July 29, 2017 as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-NYSEMKT-2016-103).
---------------------------------------------------------------------------

    \12\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(57).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10974 Filed 5-26-17; 8:45 am]
BILLING CODE 8011-01-P