[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Rules and Regulations]
[Page 33712-33724]
[DOCID:fr15jn10-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-HQ-RCRA-2005-0017; FRL-9160-9]
RIN 2050-AG57

Withdrawal of the Emission-Comparable Fuel Exclusion Under RCRA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final action withdraws 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 withdrawing
this conditional exclusion because the Agency has concluded that ECF is
more appropriately classified as 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 final rule.

DATES: This final rule is effective June 15, 2010.

ADDRESSES: The official public docket is identified by Docket ID No.
EPA-HQ-RCRA-2005-0017. 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: 5302P, 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:

                Example of Potentially Affected Entities
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          NAICS code                      Industry description
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3241.........................  Petroleum and Coal Products
                                Manufacturing.
3251.........................  Basic Chemical Manufacturing.
3252.........................  Resin, Synthetic Rubber, and Artificial
                                Synthetic Fibers and Filaments
                                Manufacturing.
3254.........................  Pharmaceutical and Medicine
                                Manufacturing.
3255.........................  Paint, Coating, and Adhesive
                                Manufacturing.
3259.........................  Other Chemical Product and Preparation
                                Manufacturing.
3273.........................  Cement Manufacturing.
4884.........................  Support Activities for Road
                                Transportation.
5614.........................  Business Support Services.
5622.........................  Waste Treatment and Disposal.
9281.........................  National Security and International
                                Affairs.
------------------------------------------------------------------------

    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 final
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. Docket Copying Costs

    You may copy a maximum of 100 pages from any regulatory docket at
no charge. Additional copies are 15 cents/page.

C. 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 final rule will also be available on the Internet. Following
the Administrator's signature, a copy of this document will be posted
at http://www.epa.gov/hwcmact. This Web site also provides other
information related to the NESHAP for hazardous waste combustors.

D. 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 rule?
    B. Who is affected by the rule?
III. Final Rule
IV. State Authority
    A. Applicability of the Rule in Authorized States
    B. Effect on State Authorization
V. 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 Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. Statutory Authority

    This regulation is 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.

II. Background

A. What is the intent of the rule?

    This rule withdraws the conditional exclusion from regulation under
subtitle C of RCRA for Emission Comparable Fuel, as codified at Sec.
261.38.\1\ The conditional exclusion stated 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. 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 discussed in the
proposed rule, (Withdrawal of the ECF Exclusion Proposed Rule (74 FR
64643, December 8, 2009)), the existing subtitle C permitting process
provides for the necessary review on the operation of the combustion
units and the storage units to assure that the appropriate storage and
combustion conditions are met.
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    \1\ See 73 FR 77954 (December 19, 2008).
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    This rule does not affect the exclusions for comparable fuel and
synthesis gas fuel that were promulgated in 1998 \2\ (also codified in
Sec.  261.38). In addition, this rule 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 is affected by the rule?

    Entities that generate, burn, and store ECF would be potentially
affected by this final rule. The rationale for the exclusion was that
ECF is not a solid (and hazardous) waste as generated, and hence is not
subject to the subtitle C regulations. Under today's rule, ECF is again
classified as a hazardous waste, and all entities managing such
hazardous secondary materials are again subject to all applicable
subtitle C hazardous waste standards. Since the ECF exclusion 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, were managing hazardous secondary materials pursuant to this
rule.

III. Final Rule

    On December 8, 2009, EPA proposed to withdraw the conditional
exclusion for ECF under 261.38, including the exclusion itself in Sec.
261.38(a), the 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).
EPA received no major comments on the proposed rule to withdraw the ECF
exclusion, and therefore today's action makes final, with no changes,
the withdrawal of the conditional exclusion for ECF under Sec.  261.38,
as previously described. (The one comment that EPA received on the
proposal, along with EPA's response to the comment are contained in the
docket to today's final rule.) Information on the intent and rationale
of the exclusion can be found in the Withdrawal of the ECF Exclusion
Proposed Rule (74 FR 64643, December 8, 2009) and is part of the record
for this final rule.
    As noted above, this rule does not affect the exclusions 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, today's final rule does 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 hazardous waste characteristic or if it is otherwise a
listed hazardous waste (Sec.  261.38(b)(15)); (2) clarification that
comparable fuel tank systems 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. 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

    By removing the ECF provisions, while maintaining the more
stringent conditions applicable to comparable fuel in today's notice,
it leads to final regulations that are considered to be more stringent
than the current requirements; these provisions were not promulgated
under the authority of HSWA. Therefore, States that have adopted the
exclusion are required to modify their programs to remove the exclusion
for ECF because they must conform to 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.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR

51735, October 4, 1993) and is therefore not subject to review under
the EO. Our impact assessment \5\ suggests that lost benefits would be,
at most, $6.6 million per year. If fewer States were to have adopted
the December 2008 exclusion rule, the value of lost benefits would be
smaller.
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    \5\ Assessment of the Potential Costs, Benefits, and Other
Impacts of the Withdrawal of the Emission-Comparable Fuel Exclusion
Under RCRA--Final Rule, May 11, 2010.
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B. Paperwork Reduction Act

    The information collection requirements in this final 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 requirements are not enforceable until OMB
approves them.
    The Information Collection Request (ICR) document prepared by EPA
has been assigned EPA ICR number 1361.15. Withdrawing the ECF exclusion
will 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 were not required to comply with the paperwork, reporting, and
recordkeeping requirements under the subtitle C hazardous waste
regulations. However, ECF generators and burners were 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 32,900 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 will result in a reporting and recordkeeping
burden of 32,900 hours and a cost of $1.3 million in capital, and
operation and maintenance costs, again assuming full adoption by
authorized States. However, since we believe this has not occurred, the
new burden would be significantly less. If authorized States have not
adopted the rule, withdrawing the ECF conditional exclusion will 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). EPA has
established a public docket for this final rule, which includes the ICR
prepared in support of the final action. The Docket ID number is EPA-
HQ-RCRA-2005-0017.
    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.

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 today's rule on small
entities, small entity is defined as: (1) A small business, as defined
by 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 today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this final rule are facilities that
generate, burn on-site, and store ECF. 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. A 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.
    We have determined that this final rule 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 actually begun to comply
with this rule. However, any cost impacts to potentially affected small
entities are not expected to be significant. The May 14, 2008 economic
assessment \6\ identified 34 facilities projected to take advantage of
the ECF final rule (see Appendix E to the economic assessment
document). Based on the corporate ownership of these facilities, one
facility was confirmed as a small business based on the Small Business
Administration size standards.\7\ The size category of one other
facility was undetermined. All other facilities were found to be owned
by large businesses or the Federal government (e.g., DOE). For the one
identified small business and the one of undetermined size, impacts to
these companies was estimated to be up to a maximum of one percent of
gross annual revenues. This impact estimate was based on the average
annual gross revenues for the NAICS category (2002 Census data) and the
average cost savings per generator, as reported in Exhibit 15 of the
revised assessment.\8\ This impact finding assumes both ``small
businesses'' have fully implemented the ECF final rule and would
therefore experience cost increases as a result of this withdrawal.
However, as discussed above, we suspect that very few facilities, if
any, have begun to comply with this rule.
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    \6\ USEPA, ``Assessment of the Potential Costs, Benefits, and
Other Impacts of the Expansion of the RCRA Comparable Fuel
Exclusion-Final Rule,'' May 14, 2008.
    \7\ http://www.sba.gov/idc/groups/public/documents/sba_
homepage/serv_sstd_tablepdf.pdf.
    \8\ 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.
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D. Unfunded Mandates Reform Act

    This 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 are not expected to exceed
$6.6 million. Thus, this final rule is not subject to the requirements
of sections 202 or 205 of UMRA.
    This 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 potentially
affected entities.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It 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. This rulemaking 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
final rule.

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 final rule
will neither impose substantial direct compliance costs on Tribal
governments nor preempt Tribal law. Thus, Executive Order 13175 does
not apply to this action.
    Although Executive Order 13175 does not apply to this action, EPA
specifically solicited comment on the proposed action from Tribal
officials. No comments were received.

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

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this final rule present a disproportionate
risk to children. This action's health and risk assessments are
contained in the original document(s) that established these materials
as hazardous waste.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and 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 withdrawing the conditional exclusion for ECF under
Sec.  261.38, EPA is not using 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 final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This action reverses the ECF final rule thereby
reinstating the more stringent management requirements for these
materials.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective June 15, 2010.

List of Subjects in 40 CFR Part 261

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

    Dated: June 7, 2010.
Lisa P. Jackson,
Administrator.

0
For the reasons set out in the preamble, title 40, chapter I, of the
Code of Federal Regulations is amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

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

0
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.
* * * * *
0
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 constituents 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 constituents 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): 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 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

[GRAPHIC] [TIFF OMITTED] TR15JN10.021

[GRAPHIC] [TIFF OMITTED] TR15JN10.022

[GRAPHIC] [TIFF OMITTED] TR15JN10.023

[GRAPHIC] [TIFF OMITTED] TR15JN10.024

[GRAPHIC] [TIFF OMITTED] TR15JN10.025

[FR Doc. 2010-14097 Filed 6-14-10; 8:45 am]
BILLING CODE 6560-50-C


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Page 30956]
[FR Doc No: 2013-12352]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0039]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by documents dated
April 2, 2013, and April 24, 2013, the City of Burlington, WI (City),
and Wisconsin Central Ltd. (WCL) have jointly petitioned the Federal
Railroad Administration (FRA) for a waiver of compliance from certain
provisions of the Federal railroad safety regulations contained at 49
CFR part 222, Use of Locomotive Horns at Public Highway-Rail Grade
Crossings. FRA assigned the petition Docket Number FRA-2013-0039.
    The City and CL (jointly referred to as Petitioners) seek a waiver
from the requirements of 49 CFR 222.41(c)(2)(i)(B), which provides that
a detailed plan for quiet zone improvements must be filed with FRA by
June 24, 2008, in order to continue existing locomotive horn
restrictions. The Petitioners also seek a waiver from the requirements
of 49 CFR 222.41(c)(3), which provides that locomotive horn
restrictions may continue until June 24, 2013, for a pre-rule quiet
zone that was not able to be established by automatic approval, had
been continued under the provisions of 49 CFR 222.31(c)(1) and 49 CFR
222.31(c)(2), and for which the State agency had provided a
comprehensive statewide implementation plan. Specifically, the
Petitioners request that the City be granted permission to correct the
detailed plan that FRA has on file. The Petitioners also wish to retain
the present locomotive horn restriction as trains approach the public
highway-rail grade crossings at Roberts Street (DOT 689851C),
Adams Street (DOT 689853R), Jefferson Street (DOT
689854X), Milwaukee Avenue (DOT 689857T), and
Chestnut Street (DOT 689856L) until June 24, 2015.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Ave.
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by July 8, 2013 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as is practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on May 20, 2013.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-12352 Filed 5-22-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21355-21356]
[FR Doc No: 2016-08153]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-N-0564, FDA-2015-N-0797, FDA-2012-N-0021, FDA-
2012-N-0280, FDA-2007-D-0372, FDA-2014-D-0044]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Labeling of Dietary Supplements as             0910-0642       2/28/2019
 Required by the Dietary Supplement and
 Nonprescription Drug Consumer
 Protection Act.........................
Foreign Supplier Verification Programs         0910-0752       2/28/2019
 for Importers of Food for Humans and
 Animals................................
Substances Generally Recognized as Safe:       0910-0342       3/31/2019
 Notification Procedure.................
Financial Disclosure by Clinical               0910-0396       3/31/2019
 Investigators..........................
Adverse Event Reporting and                    0910-0635       3/31/2019
 Recordkeeping for Dietary Supplements
 as Required by the Dietary Supplement
 and Nonprescription Drug Consumer
 Protection Act.........................
Exempt Infant Formula Production:              0910-0811       3/31/2019
 Current Good Manufacturing Practices
 (CGMPs), Quality Control Procedures,
 Conduct of Audits, and Records.........
------------------------------------------------------------------------

    Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08153 Filed 4-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5845-5846]
[DOCID:fr04fe10-99]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on October 16, 2009, vol. 74, no. 199, page
53315-53316. The FAA uses this information for determining program
compliance or non-compliance of regulated aviation employers, oversight
planning, determining who must provide annual MIS testing information,
and communicating with entities subject to the program regulations.

DATES: Please submit comments by March 8, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Anti-Drug Program for Personnel Engaged in Specified
Aviation Activities.
    Type of Request: Extension without change of a currently approved
collection.
    OMB Control Number: 2120-0535.
    Form(s): There are no FAA forms associated with this collection.
    Affected Public: An estimated 7,000 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 4.3 minutes
per response.
    Estimated Annual Burden Hours: An estimated 22,902 hours annually.
    Abstract: This information is used for determining program
compliance of regulated aviation employers, oversight planning,
determining who must provide annual MIS testing information, and
communicating with entities subject to the program regulations. The
information is also used to ensure that appropriate action is taken in
regard to crew members and other safety-sensitive employees who have
tested positive for drugs or alcohol, or have refused to submit to
testing.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to oira_
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on January 27, 2010.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-2472 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13694-13696]
[FR Doc No: 2011-5718]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64050; File No. SR-NASDAQ-2011-034]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Enhance the Investor Support Program

March 8, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on February 28, 2011, The NASDAQ Stock Market LLC (the
``Exchange'' or ``NASDAQ'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by
NASDAQ. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ proposes changes to the fee provisions of Rule 7014
(Investor Support Program) to increase the rebate for adding targeted
liquidity within the Investor Support Program. The Exchange also
proposes to amend a typographical error.
    NASDAQ has designated this fee change proposal effective and
operative upon filing.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange is proposing changes to the fee provisions of Rule
7014 to increase the rebate for adding targeted liquidity within the
Investor Support Program. The Exchange also proposes to amend a
typographical error.
    The Exchange established an Investor Support Program (``ISP'') that
enables NASDAQ members to earn a monthly fee credit for providing
additional liquidity to NASDAQ and increasing the NASDAQ-traded volume
of what are generally considered to be retail and institutional
investor orders in exchange-traded securities (``targeted
liquidity'').\3\ The goal of the ISP is to incentivize members to
provide such targeted liquidity to the NASDAQ Market Center.\4\ The
Exchange noted in

the ISP Filing that maintaining and increasing the proportion of orders
in exchange-listed securities executed on a registered exchange (rather
than relying on any of the available off-exchange execution methods)
would help raise investors' confidence in the fairness of their
transactions and would benefit all investors by deepening NASDAQ's
liquidity pool, supporting the quality of price discovery, promoting
market transparency and improving investor protection.
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    \3\ For a detailed description of the Investor Support Program,
see Securities Exchange Act Release No. 63270 (November 8, 2010), 75
FR 69489 (November 12, 2010) (NASDAQ-2010-141) (notice of filing and
immediate effectiveness) (the ``ISP Filing''). See also Securities
Exchange Act Release Nos. 63414 (December 2, 2010), 75 FR 76505
(December 8, 2010) (NASDAQ-2010-153) (notice of filing and immediate
effectiveness); 63628 (January 3, 2011), 76 FR 1201 (January 7,
2011) (NASDAQ-2010-154) (notice of filing and immediate
effectiveness); and 63891 (February 11, 2011), 76 FR 9384 (February
17, 2011) (NASDAQ-2011-022) (notice of filing and immediate
effectiveness).
    \4\ The Commission has recently expressed its concern that a
significant percentage of the orders of individual investors are
executed at over the counter (``OTC'') markets, that is, at off-
exchange markets; and that a significant percentage of the orders of
institutional investors are executed in dark pools. Securities
Exchange Act Release No. 61358 (January 14, 2010), 75 FR 3594
(January 21, 2010) (Concept Release on Equity Market Structure,
``Concept Release''). In the Concept Release, the Commission has
recognized the strong policy preference under the Act in favor of
price transparency and displayed markets. The Commission published
the Concept Release to invite public comment on a wide range of
market structure issues, including high frequency trading and un-
displayed, or ``dark,'' liquidity. See also Mary L. Schapiro,
Strengthening Our Equity Market Structure (Speech at the Economic
Club of New York, Sept. 7, 2010) (``Schapiro Speech,'' available on
the Commission Web site) (comments of Commission Chairman on what
she viewed as a troubling trend of reduced participation in the
equity markets by individual investors, and that nearly 30 percent
of volume in U.S.-listed equities is executed in venues that do not
display their liquidity or make it generally available to the
public).
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    The Exchange now proposes an adjustment to the Investor Support
Program, in the form of an increase in the rebate for the ISP for
members that exceed the Baseline Participation Ratio \5\ by at least
0.86%. The primary objective in making this adjustment is to further
incentivize members to provide targeted liquidity to the Exchange by
increasing the rebate for those that bring even larger amounts of
liquidity to NASDAQ.
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    \5\ The term ``Participation Ratio'' is defined as: for a given
member in a given month, the ratio of (i) the number of shares of
liquidity provided in orders entered by the member through any of
its Nasdaq ports and executed in the Nasdaq Market Center during
such month to (ii) the Consolidated Volume. Rule 7014(d)(4). The
term ``Consolidated Volume'' is defined as: for a given member in a
given month, the consolidated volume of shares of System Securities
in executed orders reported to all consolidated transaction
reporting plans by all exchanges and trade reporting facilities
during such month. Rule 7014(d)(6).
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    The ISP generally compares a member's Participation Ratio for the
current month to the same member's Participation Ratio in August 2010
(known as the ``Baseline Participation Ratio''). This ratio is
determined by measuring the number of shares in liquidity-providing
orders entered by the member (through any NASDAQ port) and executed on
NASDAQ and dividing this number by the consolidated (across all trading
venues) share volume of System Securities \6\ traded in the given
month.\7\ To determine the amount of the ISP credit pursuant to the
program, pursuant to sub-section (b), NASDAQ would multiply $0.0003 or
$0.0004 by the lower of: the number of shares of displayed liquidity
provided in orders entered by the member thorough its ISP-designated
ports and executed in the NASDAQ Market Center during the given month;
or the amount of Added Liquidity \8\ for the given month, which is
compared to the member's Baseline Participation Ratio. The Exchange
proposes to increase the tiered rebate to a rate of $0.0005 for members
that bring a greater amount of targeted liquidity.
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    \6\ The term ``System Securities'' is defined as: all securities
listed on NASDAQ and all securities subject to the Consolidated Tape
Association Plan and the Consolidated Quotation Plan. Rule 4751(b).
    \7\ See Rule 7014(d)(2) and (d)(4).
    \8\ The term ``Added Liquidity'' is defined as: for a given
member in a given month, the number of shares calculated by (i)
subtracting from such member's Participation Ratio for that month
the member's Baseline Participation Ratio, and then (ii) multiplying
the resulting difference by the average daily consolidated volume of
shares of System Securities in executed orders reported to all
consolidated transaction reporting plans by all exchanges and trade
reporting facilities during such month; provided that if the result
is a negative number, the Added Liquidity amount shall be deemed
zero. Rule 7014(d)(1).
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    Specifically, the Exchange proposes to clarify subsection (b) to
state that, subject to the conditions set forth in subsection (c),\9\
in addition to the current tiered rebate rates of $0.0003 or $0.0004,
the rebate rate may also be $0.0005. The Exchange adds proposed sub-
section (c)(3) to indicate that the $0.0005 rebate rate is available to
those members that bring in an even greater amount of liquidity by
exceeding the Baseline Participation Ratio by at least 0.86%. Thus, to
qualify for the $0.0005 rebate rate, a member would essentially have to
bring twice as much targeted liquidity to the Exchange (in the form of
Added Liquidity relative to the Baseline Participation Ratio) as the
member would need to bring to the Exchange to qualify for the next-
lower $0.0004 rebate rate.\10\
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    \9\ Subsection (c)(1) states that a member shall not be entitled
to receive any ISP credit pursuant to (b) for a given month if any
of the following applies: (A) the member's ISP Execution Ratio for
the month in question is 10 or above; or (B) the average daily
number of shares of liquidity provided in orders entered by the
member through its ISP-designated ports and executed in the Nasdaq
Market Center during the month is below 10 million, provided that in
calculating such average, Nasdaq will exclude days when it is open
for less than the entire regular trading day.
    \10\ Subsections (c)(2) and (c)(3) as amended state: (2) A
member shall not be entitled to receive an ISP credit pursuant to
section (b) of this Rule at the $0.0004 rate if for a given month
the member does not exceed its Baseline Participation Ratio by at
least 0.43%. (3) A member shall not be entitled to receive an ISP
credit pursuant to section (b) of this Rule at the $0.0005 rate if
for a given month the member does not exceed its Baseline
Participation Ratio by at least 0.86%.
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    The Exchange believes that the increased rebate rate should
encourage members to strive to bring even more retail and institutional
orders in exchange-traded securities to the Exchange. The Exchange
notes that the rebate concept remains the same after this filing: the
more added liquidity a member brings to the Exchange, the higher the
member's potential rebate rate may be within the parameters of Rule
7014.
    The ISP is designed to operate on a monthly cycle, both from the
perspective of targeted flow brought to the Exchange and ISP rebates to
members that brought such flow. Since its inception,\11\ the ISP fee
program has been, and continues to be, non-discriminatory, reasonable,
and effective in attracting targeted liquidity to the NASDAQ Market
Center. The primary objective in making the proposed adjustment is to
encourage members to bring larger amounts of targeted liquidity to the
Exchange by increasing the rebate for such liquidity. The Exchange
believes that its proposal is decidedly non-discriminatory because it
does not favor or distinguish any group of ISP participants while
promoting the clear goal of the ISP.
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    \11\ See Securities Exchange Act Release No. 63270 (November 8,
2010), 75 FR 69489 (November 12, 2010) (NASDAQ-2010-141) (notice of
filing and immediate effectiveness).
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    In terms of housekeeping changes, the Exchange proposes to correct
a typographical error in subsection (c)(2) of Rule 7014. On February 2,
2011, the Exchange filed an immediately effective fee proposal
regarding the Investor Support Program. By this fee filing, the
Exchange stated in subsection (b) of Rule 7014 that, subject to the
conditions set forth in section (c) of Rule 7014 the ISP rebate rate
may be $0.0004 (as discussed herein); and stated in sub-section (c)(2)
that the additional tiered rebate rate would be available to those
members that bring in an even greater amount of liquidity by exceeding
the Baseline Participation Ratio by at least 0.43% (the ``$0.0004
filing'').\12\
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    \12\ See Securities Exchange Act Release No. 63891 (February 11,
2011) (NASDAQ-2011-022) (notice of filing and immediate
effectiveness).
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    In the $0.0004 filing, the Exchange correctly stated, four times in
the body of its filing, that the new additional rebate rate was
$0.0004. The Exchange likewise correctly stated in the rule text, as
reflected in subsection (b) of Rule 7014, that the additional rebate
rate was $0.0004. However, in the second reference to the additional
rebate rate in the rule text at subsection (c)(2) of the $0.0004
filing, the Exchange made a typographical error by adding an extra zero
to the rebate rate of $0.0004 (e.g. $.00004).
    The Exchange believes that it is clear from the $0.0004 filing that
the Exchange intended to add an additional tiered rebate rate of
$0.0004. The Exchange now corrects this typographical error by removing
the extraneous zero so that the rebate rate in

subsection (c)(2) is reflected as $0.0004, in conformity with
subsection (b) of Rule 7014.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\13\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\14\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which NASDAQ operates or controls, and it is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market,
and, in general, to protect investors and the public interest.
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    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(4) and (5).
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    The Investor Support Program encourages members to add targeted
liquidity that is executed in the NASDAQ Market Center. The primary
objective in making this enhancement to the Investor Support Program is
to add an even greater amount of targeted liquidity to the Exchange.
The rule change proposal, like the ISP, is ``not designed to permit
unfair discrimination'' \15\ but, rather, is intended to promote
submission of liquidity-providing orders to NASDAQ, which would benefit
all NASDAQ members and all investors. Likewise, the proposal, like the
ISP, is consistent with the Act's requirement ``for the equitable
allocation of reasonable dues, fees, and other charges.'' \16\ As
explained in the immediately preceding paragraphs, the proposal
enhances the goal of the ISP. Members who choose to significantly
increase the volume of ISP-eligible liquidity-providing orders that
they submit to NASDAQ would be benefitting all investors, and therefore
an additional credit, as contemplated in the proposed enhanced program,
is equitable. Finally, NASDAQ notes that the intense competition among
several national securities exchanges and numerous OTC venues
effectively guarantees that fees and credits for the execution of
trades in NMS securities remain equitable and are not unfairly
discriminatory.\17\
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    \15\ See Section 6(b)(5) of the Act, 15 U.S.C. 78f(b)(5).
    \16\ See Section 6(b)(4) of the Act, 15 U.S.C. 78f(b)(4).
    \17\ See, e.g., Concept Release (discusses the various venues
where trades are executed).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\18\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
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    \18\ 15 U.S.C. 78s(b)(3)(a)(ii).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-034 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-034. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2011-034 and should be submitted on or before April 4, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-5718 Filed 3-11-11; 8:45 am]
BILLING CODE 8011-01-P