[Federal Register: October 13, 2010 (Volume 75, Number 197)]
[Notices]
[Page 62910-62911]
[DOCID:fr13oc10-117]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63042; File No. SR-NSX-2010-13]

 Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the NSX Fee and Rebate Schedule

October 5, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 30, 2010, National Stock Exchange, Inc. filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change, as described in Items I and II below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comment on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The National Stock Exchange, Inc. (``NSX[supreg]'' or the
``Exchange'') is proposing a rule change, operative at commencement of
trading on October 1, 2010, which proposes to amend the NSX Fee and
Rebate Schedule (the ``Fee Schedule'') respect to rebates payable in
the Order Delivery mode of order interaction.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nsx.com, at the principal office of the
Exchange, 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, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

    With this rule change, the Exchange is proposing to modify the Fee
Schedule to lower the volume threshold necessary to obtain the highest
rebate with respect to displayed orders in securities priced one dollar
and above that add liquidity in the Order Delivery mode of order
interaction (``Order Delivery'').\3\
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    \3\ The Exchange's two modes of order interaction are described
in NSX Rule 11.13(b).
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    For displayed orders in securities priced one dollar and above that
add liquidity in Order Delivery, the proposed rule change lowers the
volume threshold necessary to achieve the highest rebate tier. Prior to
the effective date of the proposed rule change, the Fee Schedule
provides a rebate of $0.0008 per share if an ETP Holder's liquidity
adding average daily volume (as fully defined in Endnote 3 of the Fee
Schedule, ``Liquidity Adding ADV'') is at least one million shares and
less than five million shares (``Tier 1''); a rebate of $0.0024 per
share plus 35% of attributable market data revenue if Liquidity Adding
ADV is at least five million shares and less than 30 million shares
(``Tier 2''); and a rebate of $0.0024 per share plus 50% of
attributable market data revenue if Liquidity Adding ADV is at least 30
million shares (``Tier 3'').
    The proposed rule change lowers, from 30 to 15 million, the Tier 3
volume threshold necessary to obtain the highest rebates. Accordingly,
after the effective date, an ETP Holder achieving a Liquidity Adding
ADV of at least 15 million shares will receive a rebate of $0.0024 per
share plus 50% of attributable market data revenue regarding its
displayed orders priced one dollar or higher that add liquidity in
Order Delivery.
    The proposed rule change does not modify other rebates or fees that
are contained in the Fee Schedule.
Rationale
    The Exchange has determined that these changes are necessary to
create further incentive for ETP Holders to submit increased order
volumes and, ultimately, to increase the revenues of the Exchange for
the purpose of continuing to adequately fund its regulatory and general
business functions. The Exchange has further determined that the
proposed fee adjustments are necessary for competitive reasons. The
Exchange believes that these rebate changes will not impair the
Exchange's ability to fulfill its regulatory responsibilities.
    The proposed modifications are reasonable and equitably allocated
to those ETP Holders that submit orders in Order Delivery, and are not
discriminatory because qualified ETP Holders are free to elect whether
or not to send such orders. Based upon the information above, the
Exchange believes that the proposed rule change is consistent with the
protection of investors and the public interest.
Operative Date and Notice
    The Exchange intends to make the proposed modifications, which are
effective on filing of this proposed rule, operative for trading on
October 1, 2010. Pursuant to Exchange Rule 16.1(c), the Exchange will
``provide ETP Holders with notice of all relevant dues, fees,
assessments and charges of the Exchange'' through the issuance of a
Regulatory Circular of the changes to the Fee Schedule and will post a
copy of the rule filing on the Exchange's website (http://www.nsx.com).
Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) of the Act,\4\ in general, and
Section 6(b)(4) of the Act,\5\ in particular, in that it is designed to
provide for the equitable allocation of reasonable dues, fees and other
charges among its members and other persons using the facilities of the
Exchange. Moreover, the proposed rule change is not discriminatory in
that all qualified ETP Holders are eligible to submit (or not submit)
trades and quotes at any price in AutoEx and Order Delivery in all
tapes, as either displayed or undisplayed and as liquidity adding or
liquidity taking, and may do so at their discretion.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any inappropriate burden on competition.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    The proposed rule change has taken effect upon filing pursuant to
Section 19(b)(3)(A)(ii) of the Act \6\ and subparagraph (f)(2) of Rule
19b-4 \7\ thereunder, because, as provided in (f)(2), it changes ``a
due, fee or other charge applicable only to a member'' (known on the
Exchange as an ETP Holder). At any time within sixty (60) days of the
filing of such 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.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \7\ 17 CFR 240.19b-4.
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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-NSX-2010-13 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 20549-9303.
    All submissions should refer to File No. SR-NSX-2010-13. This file
number should be included in the subject line if e-mail is used. To
help the Commission process and review 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 website viewing and
printing in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filings will also 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-NSX-
2010-13 and should be submitted on or before November 3, 2010.

    For the Commission by the Division of Trading and Markets,
pursuant to the delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25622 Filed 10-12-10; 8:45 am]
BILLING CODE 8011-01-P


1. The authority citation for 21 CFR part 300 is revised to read as
follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 361, 371; 42
U.S.C. 262.

0
2. Revise subpart B to read as follows:

Subpart B--Fixed-Combination and Co-Packaged Drugs and Combinations
of Active Ingredients Under Consideration for Inclusion in an Over-
the-Counter (OTC) Monograph

Sec.
300.50 Definitions.
300.51 Applicability.
300.53 Requirements.
300.55 Combining one or more active ingredients with a natural-
source drug, a waived product, or a combination already included in
an OTC monograph.
300.60 Waiver.

Sec.  300.50  Definitions.

    As used in this part:
    Active ingredient means any component that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease, or to affect the
structure or any function of the body of man or other animals. The term
includes those components that may undergo chemical change in the
manufacture of the drug product and be present in the drug product in a
modified form intended to furnish the specified activity or effect.
    Applicant means any person who, to obtain approval of a fixed-
combination or co-packaged drug, submits a new drug application under
section 505 of the Federal Food, Drug, and Cosmetic Act or a biologics
license application under section 351 of the Public Health Service Act.
    Botanical raw material means a fresh or physically processed
material derived from a single part of a single species of plant, or a
fresh or physically processed alga or macroscopic fungus that has not

been genetically modified using recombinant DNA technology or any other
process that deliberately changes the genome.
    Co-packaged drug is a product that contains two or more separate
drugs in their final dosage forms that are intended to be used together
for a common or related therapeutic purpose and that are contained in a
single package or unit.
    Drug has the same meaning given this term in section 201(g) of the
Federal Food, Drug, and Cosmetic Act and includes biological products
as defined in section 351 of the Public Health Service Act that also
meet the definition of ``drug'' in section 201(g) of the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 321(g)), but does not include any
product that meets the definition of device under section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
    Fixed-combination drug means a drug in which two or more active
ingredients are combined at a fixed dosage in a single dosage form.
Natural-source drugs are not included under the definition of ``fixed-
combination drug'' unless those drugs are used as ingredients in
combination with other ingredients in a single dosage form.
    Fungal raw material means a physically processed culture of a
single-cell or multicellular organism, including yeasts, molds, and
smut.
    Interested person means, with regard to a combination of two or
more active ingredients under consideration for inclusion in an OTC
monograph, any person who makes a submission under part 330 of this
chapter regarding safety or effectiveness.
    Natural-source drug means a drug composed of one single animal,
botanical, prokaryotic, fungal, or viral raw material, or derived from
one such material using a manufacturing process that involves only
physical steps (e.g., solvent extraction, condensation, column
purification) and does not involve a chemical reaction (other than
esterification or viral or bacterial inactivation) that would modify
the covalent bonds of any substance in the original material. The
composition of a natural-source drug may be adjusted for the purpose of
assuring quality, but may not be changed in a way that would affect the
product's activity (e.g., by selectively increasing or decreasing the
concentration of particular active ingredients (for drugs that are
biological products) or active moieties (for drugs that are not
biological products)).
    Prokaryotic raw material means a physically processed culture of
bacteria or other cellular organism lacking a true nucleus and nuclear
membrane.
    Rational concurrent therapy means medically appropriate treatment
for a patient population that is defined in the drug's labeling. That
is, the defined patient population can benefit from all of the active
ingredients at the specific doses present, given for a similar duration
of treatment, and not be adversely affected by receiving them in
combination.
    Single animal raw material means a single organ, human cell,
tissue, and cellular- and tissue-based product, or bodily fluid
collected from any human or nonhuman animal species that has not been
genetically modified using recombinant DNA technology or any other
process that deliberately changes the genome. A drug that is derived
from an invertebrate animal species (including multiple parts or all of
an invertebrate animal) may be considered a single animal raw material.
    Viral raw material means a minimally processed culture of a virus.
The virus in culture may exist in nature or may have been attenuated or
inactivated through selection or by physical and/or chemical means or
recombinant technologies.
    Waived product means an approved product or a combination of active
ingredients that has been generally recognized as safe and effective
and included in an OTC monograph for which a waiver has been granted
under Sec.  300.60.

Sec.  300.51  Applicability.

    This subpart applies to both prescription and OTC fixed-combination
and co-packaged drugs that are subject to approval under a new drug
application under section 505 of the Federal Food, Drug, and Cosmetic
Act, or a biologics license application under section 351 of the Public
Health Service Act, and to combinations of active ingredients under
consideration for inclusion in an OTC monograph in accordance with part
330 of this chapter. It does not apply to natural-source drugs unless
those drugs are used as ingredients in combination with other
ingredients in a single dosage form.

Sec.  300.53  Requirements.

    (a) Combinations of active ingredients under consideration for
inclusion in an OTC monograph and fixed-combination and co-packaged
drugs (collectively referred to in this section as ``the combination'')
must meet the following requirements:
    (1) Each active ingredient makes a contribution to the effect(s) of
the combination, enhances the safety or effectiveness of an active
ingredient, or minimizes the potential for abuse of an active
ingredient; and
    (2) The dosage of each active ingredient (amount, frequency of
administration, and duration of use) is such that the combination is
safe and effective and provides rational concurrent therapy.
    (b) Applicants and interested persons must:
    (1) State the intended use of each active ingredient in the
combination; and
    (2) Submit sufficient evidence to demonstrate that the combination
meets the requirements in paragraph (a) of this section, including
evidence demonstrating the contribution of each active ingredient to
the effect(s) of the combination. The amount and types of data and
information needed to demonstrate such a contribution may vary and may
include some or all of the following: Data from adequate and well-
controlled clinical trials, clinical pharmacology data, in vitro and
animal model data, a basis for concluding there is a plausible
pharmacologic rationale for the combination, and other relevant
information.
    (c) The statement and evidence specified in paragraph (b) of this
section must be included in a new drug application under section 505 of
the Federal Food, Drug, and Cosmetic Act, a biologics license
application under section 351 of the Public Health Service Act, or a
submission under part 330 of this chapter to support inclusion of a
combination in an OTC monograph.

Sec.  300.55  Combining one or more active ingredients with a natural-
source drug product or a waived product.

    For combinations not already described in an OTC monograph or for
proposed fixed-combination and co-packaged drugs:
    (a) When a natural-source drug is combined with any other active
ingredient, the natural-source drug will be considered a single active
ingredient for the purposes of fulfilling the requirements of Sec.
300.53.
    (b) When a natural-source drug is combined with one or more
additional natural-source drugs, each natural-source drug in the
combination will be considered a single active ingredient for the
purposes of fulfilling the requirements of Sec.  300.53.
    (c) When a waived product is combined with any other active
ingredient, the waived product will be considered a single active
ingredient for the purposes of fulfilling the requirements of Sec.
300.53.

Sec.  300.60  Waiver.

    (a) FDA may, at the request of an applicant or interested person or
on its own initiative, grant a waiver of any of the requirements under
Sec.  300.53 with regard to a fixed-combination or co-packaged drug
that is the subject of a pending application under section 505 of the
Federal Food, Drug, and Cosmetic Act or section 351 of the Public
Health Service Act, or a combination of active ingredients under
consideration for inclusion in an OTC monograph in accordance with part
330 of this chapter, if it finds one of the following:
    (1)(i) There is a reasonable rationale for the combination of the
individual active ingredients; and
    (ii) Compliance with any of the requirements of Sec.  300.53 would
be infeasible or medically unreasonable or unethical; or
    (2) The product contains all or a subset of the known components in
the same ratio as a natural-source drug or a waived product provided
the product is intended for the same conditions of use as the natural-
source drug or the waived product; there is a reasonable basis to
conclude that the product would provide a comparable clinical effect to
the natural-source drug or the waived product; and, for products
containing large molecules (macromolecules), the macromolecules have
the same principal molecular structural features and overall mechanism
of action as those in the natural-source drug or the waived product.
    (b) If an applicant wishes to request a waiver, it must submit the
waiver request with supporting documentation in an application under
section 505 of the Federal Food, Drug, and Cosmetic Act or section 351
of the Public Health Service Act. If an interested person wishes to
request a waiver, the waiver request must be submitted as part of a
submission under part 330 of this chapter.
    (c) FDA will provide appropriate written notice when the Agency
grants a waiver on its own initiative, or grants or denies a request
for a waiver. Fixed-combination and co-packaged drugs and combinations
of active ingredients under consideration for inclusion in an OTC
monograph for which a waiver is granted must still meet all other
applicable requirements under section 505 of the Federal Food, Drug,
and Cosmetic Act, section 351 of the Public Health Service Act, or
Sec.  330.10(a)(4) of this chapter, as appropriate.

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

0
3. The authority citation for 21 CFR part 330 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

0
4. Amend Sec.  330.10 by revising paragraph (a)(4)(iv) to read as
follows:

Sec.  330.10  Procedures for classifying OTC drugs as generally
recognized as safe and effective and not misbranded, and for
establishing monographs.

* * * * *
    (a) * * *
    (4) * * *
    (iv) A combination of two or more active ingredients that are
individually classified as drugs generally recognized as safe and
effective in accordance with the requirements of Sec.  300.53 of this
chapter must meet the requirements of subpart B of part 300 of this
chapter to be generally recognized as safe and effective and included
in an OTC monograph. If such combination is granted a waiver under
Sec.  300.60 of this chapter, it must still meet all other applicable
requirements of this subparagraph to be generally recognized as safe
and effective and included in an OTC monograph. Unless otherwise
specified in the applicable OTC monograph(s), combinations of active
ingredients that are included in an OTC monograph may be used in either
fixed-combination or co-packaged drugs.
* * * * *

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
5. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

0
6. Amend Sec.  610.17 by revising the section heading, designating the
existing paragraph as paragraph (a), and by adding paragraph (b) to
read as follows:

Sec.  610.17  Permissible fixed-combinations.

    (a) * * *
    (b) A drug product subject to approval under section 351 of the
Public Health Service Act may not be combined with another drug product
except in accordance with subpart B of part 300 of this chapter.

    Dated: December 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32246 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Page 84568]
[FR Doc No: 2016-28167]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-339-000]

96WI 8ME, LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding
96WI 8ME, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 5, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: November 15, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-28167 Filed 11-22-16; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Auction Procedures for Allocating Slots at LaGuardia, John F. Kennedy  International, and Newark Liberty International Airports.


[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Rules and Regulations]
[Pages 64053-64056]
[FR Doc No: 2020-20544]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-HQ-OW-2020-0123; FRL-10013-68-OW]

Wyoming Underground Injection Control Program; Class VI Primacy

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is hereby
approving an application from the State of Wyoming under the Safe
Drinking Water Act (SDWA) to implement an underground injection control
(UIC) program for Class VI injection wells to protect underground
sources of drinking water located within the state, except within
Indian lands. EPA will continue to administer all well classes within
Indian lands. Class VI wells are used for the underground injection of
carbon dioxide into deep subsurface rock formations for long-term
storage.

DATES: This final rule is effective on October 9, 2020. The Director of
the Federal Register approved this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 on October 9, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2020-0123. All documents in the docket are listed on the
https://www.regulations.gov Website. 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, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Molly McEvoy, Drinking Water
Protection Division, Office of Ground Water and Drinking Water (4606M),
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>or Wendy Cheung, Underground Injection Control
Section, U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop
Street, MSC 8WD-SDU, Denver, Colorado 80202; telephone number: (303)
312-6242; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    The State of Wyoming received primacy enforcement responsibility
(primacy) for Class I, III, IV, and V injection wells under the SDWA
section 1422 on August 17, 1983, and Class II injection wells under the
SDWA section 1425 on December 23, 1982. Wyoming has applied to EPA
under section 1422 of the SDWA, 42 U.S.C. 300h-1, for primacy for Class
VI injection wells, except those located on Indian lands. The UIC
program revision package from Wyoming includes a description of the
State Underground Injection Control program for Class VI injection
wells, copies of all applicable rules and forms, a statement of legal
authority, a summary and results of Wyoming's public participation
activities, and a Memorandum of Agreement between Wyoming and EPA's
Regional Administrator for Region 8.
    This action is based on a legal and technical review of the State
of Wyoming's application as directed in the Code of Federal Regulations
(CFR) at 40 CFR part 145. As a result of this review, EPA is approving
Wyoming's application because it meets or exceeds all applicable
requirements for approval under the SDWA section 1422 and the Agency
has determined that the state is capable of administering a Class VI
UIC program in a manner consistent with the terms and purposes of the
SDWA and all applicable regulations to protect underground sources of
drinking water (USDWs).

II. Legal Authorities

    This regulation is being promulgated under authority of the SDWA
sections 1422 and 1450, 42 U.S.C. 300h-1 and 300j-9.

III. Requirements for State UIC Programs

    SDWA section 1421 requires the Administrator of EPA to promulgate
minimum requirements for effective state UIC programs to prevent
underground injection activities that endanger USDWs. SDWA section 1422
establishes requirements for states seeking EPA approval of state UIC
programs.
    For states that seek approval for UIC programs under SDWA section
1422, EPA has promulgated a regulation setting forth the applicable
procedures and substantive requirements, codified at 40 CFR part 145.
It includes requirements for state permitting programs (by referencing
certain provisions of 40 CFR parts 124 and 144), compliance evaluation
programs, enforcement authority, and information sharing.

IV. Wyoming's Application

A. Background

    On January 31, 2020, Wyoming submitted a program revision
application to add Class VI injection wells to the state's SDWA section
1422 UIC program. The UIC program revision package from Wyoming
includes a description of the state UIC program for Class VI injection
wells, copies of all applicable rules and forms, a statement of legal
authority, a summary and results of Wyoming's public participation
activities, and a Memorandum of Agreement between Wyoming and EPA's
Regional Administrator for Region 8. EPA reviewed the application for
completeness and simultaneously performed a technical evaluation of the
application materials.
    On April 14, 2020, EPA published a Federal Register document
announcing Wyoming's submittal of a complete UIC program revision
application to the Agency. In that document, EPA proposed to approve
the application from Wyoming under the SDWA section 1422 to implement a
UIC program for Class VI injection wells located within the state,
except those on Indian country; sought public comments on the Agency's
intent to approve Wyoming's application; and provided an opportunity to
request a public hearing.

B. Public Participation Activities Conducted by the State of Wyoming

    In 2019, Wyoming held two public hearings with public comment
periods on the state's intent to adopt its Class VI UIC regulations.
The Wyoming Water and Waste Advisory Board (WWAB) held the first public
hearing on June 25, 2019, in Casper, Wyoming. The WWAB accepted public
comments beginning on May 17, 2019, through the adjournment of the
public hearing. The Wyoming Environmental Quality Council held the
second public hearing on November 19, 2019, in Cheyenne, Wyoming. The
Wyoming Environmental Quality Council accepted comments on proposed
revisions from September 13, 2019, through October 30, 2019. The
Wyoming Class VI regulations were signed by the Governor of Wyoming on
January 23, 2020. Documentation of all public participation activities,
including those associated with Class VI UIC regulations and subsequent
revisions that the state proposed before 2019 can

be found in EPA's Docket ID No. EPA-HQ-OW-2020-0123.

C. Public Participation Activities Conducted by EPA

    On April 14, 2020, EPA issued a proposed rule (85 FR 20621),
proposing to approve Wyoming's application to implement a UIC program
for Class VI injection wells. This proposed rule provided that a public
hearing would be held if requested. EPA did not receive any requests
for a public hearing.

V. Public Comments Received on the Proposed Rule and EPA's Response to
Comments

    As previously noted, on April 14, 2020, EPA issued a proposal to
approve the Wyoming application to implement the Class VI UIC program
within the state (85 FR 20621) and requested public comments. The
public comment period was open for 45 days and ended on May 29, 2020.
EPA received seven public comment submissions. Of the seven commenters,
all submitted comments in support of the rule and one requested
clarification on certain aspects of Wyoming's UIC Class VI Program.
After close consideration of the comments and coordination with the
Wyoming Department of Environmental Quality, EPA provided clarification
on the areas where the commenter requested clarification. The comments
received and EPA's responses are available in EPA's Docket No. EPA-HQ-
OW-2020-0123.

VI. EPA's Approval--Incorporation by Reference

    In this action, EPA is approving the State of Wyoming's Class VI
UIC program; whereby the state will assume primacy for regulating Class
VI injection wells in the state, except within Indian lands. Wyoming's
statutes and supporting documentation are publicly available in EPA's
Docket No. EPA-HQ-OW-2020-0123. This action amends 40 CFR part 147 and
incorporates by reference EPA-approved state statutes and regulations.
EPA will continue to administer the UIC program for all well classes
within Indian lands.
    The provisions of the State of Wyoming's statutes and regulations
that contain standards, requirements, and procedures applicable to
owners or operators of UIC Class VI wells are incorporated by reference
into 40 CFR 147.2250 by this rule. Provisions of the State of Wyoming's
statutes and regulations that contain standards, requirements, and
procedures applicable to owners or operators of Class I, III, IV, and V
injection wells have already been incorporated by reference into 40 CFR
147.2250 through prior EPA rules. Any provisions incorporated by
reference, as well as all permit conditions or permit denials issued
pursuant to such provisions, will be enforceable by EPA pursuant to the
SDWA section 1423 and 40 CFR 147.1(e).
    In order to better serve the public, EPA is reformatting the
codification of EPA-approved Wyoming SDWA section 1422 UIC program
statutes and regulations for well Classes I, III, IV, V and VI. Instead
of codifying the Wyoming statutes and regulations as separate
paragraphs, EPA is now incorporating by reference a compilation that
contains EPA-approved Wyoming statutes and regulations for well Classes
I, III, IV, V, and VI. This compilation is incorporated by reference
into 40 CFR 147.2250 and is available at https://www.regulations.gov in
the docket for this rule. A complete list of the Wyoming statutes and
regulations contained in the compilation, titled ``EPA-approved Wyoming
SDWA Sec.  1422 Underground Injection Control Program Statutes and
Regulations for Well Classes I, III, IV, V and VI,'' is codified as
Table 1 to paragraph (a) in that section.
    EPA will continue to oversee the State of Wyoming's administration
of the SDWA Class VI program. As part of EPA's oversight
responsibility, EPA will require Wyoming to submit semi-annual reports
of non-compliance and annual UIC performance reports pursuant to 40 CFR
144.8. The Memorandum of Agreement between EPA and the State of
Wyoming, signed by the Regional Administrator on March 20, 2020, makes
available to EPA any information obtained or used by Wyoming's Class VI
UIC program, without restriction.

VII. Effective Date

    This final rule is effective immediately upon publication. Section
553(d) of the Administrative Procedure Act (``APA''), 5 U.S.C. 553(d),
provides that final rules shall not become effective until 30 days
after publication in the Federal Register, ``except . . . as otherwise
provided by the agency for good cause,'' among other exceptions. The
purpose of this provision is to ``give affected parties a reasonable
time to adjust their behavior before the final rule takes effect.''
Omnipoint Corp. v. FCC, 78 F.3d 620, 630 (D.C. Cir. 1996); see also
United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977)
(quoting legislative history). Thus, in determining whether good cause
exists to waive the 30-day delay, an agency should ``balance the
necessity for immediate implementation against principles of
fundamental fairness which require that all affected persons be
afforded a reasonable amount of time to prepare for the effective date
of its ruling.'' Gavrilovic, 551 F.2d at 1105. EPA has determined that
there is good cause for making this final rule effective immediately
because this action will simply provide that the State of Wyoming has
primacy under the SDWA for the UIC Class VI program, pursuant to which
the State of Wyoming will be implementing and enforcing a state
regulatory program that is as stringent as the existing federal
program. At this time, there are no federally permitted Class VI wells
in Wyoming. As a result, there are no current permittees that need time
to prepare for this rule and any prospective permittees will benefit
from the regulatory certainty that an immediate effective date will
provide. This final rule will not require affected persons to take
action or change behavior to come into compliance within the next 30
days. For these reasons, EPA finds that good cause exists under section
5 U.S.C. 553(d)(3) to make this rule effective immediately upon
publication.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review 13563

    This action is exempt from review by the Office of Management and
Budget (OMB) because it is an approval of a state UIC program.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is exempt under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2040-0042. Reporting or recordkeeping requirements will
be based on Wyoming's UIC Regulations, and the State of Wyoming is not
subject to the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. 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, has no
net burden, or otherwise has a positive economic effect on the small
entities subject to the rule. This action does not impose any
requirements or burden on small entities as this action approves a
state program.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector. EPA's approval of
Wyoming's program will not constitute a federal mandate because there
is no requirement that a state establish UIC regulatory programs and
because the program is a state, rather than a federal program.

F. Executive Order 13132: Federalism

    EPA has concluded that this action has federalism implications.
Although federalism concerns were implicated by this action, on the
distribution of power and responsibilities among the state and federal
government, the other criteria identified in Executive Order (E.O.)
13132 do not apply. See E.O. 13132(6)(b)&(c). For example, this action
does not impose substantial direct compliance costs on the state, which
voluntarily sought primacy. Moreover, EPA is required by statute to
approve a primacy application that meets applicable requirements.
Finally, this action does not preempt state law.

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

    This action does not have tribal implications as specified in
Executive Order 13175. This action contains no federal mandates for
tribal governments and does not impose any enforceable duties on tribal
governments. Thus, Executive Order 13175 does not apply to this action.

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

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This action is not subject to Executive Order
13045 because it approves a state program.

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

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    This action does not involve technical standards.

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

    EPA has determined that this action is not subject to Executive
Order 12898 (59 FR 7629, February 16, 1994) because it does not
establish an environmental health or safety standard. This action is
simply approving primacy for Wyoming under the SDWA for the Class VI
UIC program, pursuant to which Wyoming will be implementing and
enforcing a state regulatory program that is as stringent as the
existing federal program.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary, or contrary to the public interest (5
U.S.C. 808(2)). EPA has made a good cause finding for this rule for an
immediate effective date as discussed in Section VII of this document,
which includes the basis for that finding.

List of Subjects in 40 CFR 147

    Environmental protection, Incorporation by reference, Indian lands,
Intergovernmental relations, Reporting and recordkeeping requirements,
Water supply.

Andrew Wheeler,
Administrator.

    For the reasons set forth in the preamble, EPA amends 40 CFR part
147 as follows:

PART 147--STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION
CONTROL PROGRAMS

    The authority citation for part 147 continues to read as follows:

    Authority:  42 U.S.C. 300f et seq.; and 42 U.S.C. 6901 et seq.

0
1. Amend Sec.  147.2550 by:
0
a. Revising the section heading;
0
b. Revising the introductory text and paragraph (a);
0
c. Adding paragraphs (c)(6) and (7), and (d)(3) and (4); and
0
d. Revising paragraph (e).
    The revisions and additions read as follows.

Sec.  147.2550   State-administered program--Class I, III, IV, V and VI
wells.

    The UIC program for Class I, III, IV, and V wells in the State of
Wyoming, except those located on Indian lands, is the program
administered by Wyoming Department of Environmental Quality, approved
by EPA pursuant to the Safe Drinking Water Act (SDWA) section 1422. The
effective date of this program is August 17, 1983. The UIC Program for
Class VI wells in Wyoming, except those located on Indian lands, is the
program administered by Wyoming Department of Environmental Quality,
approved by EPA pursuant to the SDWA section 1422. The effective date
of this program is October 9, 2020. The UIC program for Class I, III,
IV, V, and VI wells in the State of Wyoming, except those located on
Indian lands, consists of the following elements, as submitted to the
EPA in the State's program application and program revision
application.
    (a) Incorporation by reference. The requirements set forth in the
state statutes and regulations approved by the EPA for inclusion in
``EPA-Approved Wyoming SDWA Sec.  1422 Underground Injection Control
Program Statutes and Regulations for Well Classes I, III, IV, V and
VI,'' dated March 31, 2020, and listed in Table 1 to this paragraph
(a), are hereby incorporated by reference and made a part of the
applicable UIC program under the SDWA for Wyoming. The Director of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the State of
Wyoming's regulations that are

incorporated by reference may be inspected at the U.S. Environmental
Protection Agency, Region 8, 1595 Wynkoop Street, MSC 8WD-SDU, Denver,
Colorado 80202 and the Water Docket, EPA Docket Center (EPA/DC) EPA
West, Room 3334, 1301 Constitution Ave., NW, Washington, DC 20460. If
you wish to obtain materials from the EPA Regional Office, please call
(303) 312-7226; for materials from a docket in the EPA Headquarters
Library, please call the Water Docket at<PHONE_NUMBER>. You may also
inspect the materials at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email<EMAIL_ADDRESS>or go to
www.archives.gov/federal-register/cfr/ibr-locations.html.

 Table 1 to Paragraph (a)--EPA-Approved Wyoming SDWA Sec.   1422 Underground Injection Control Program Statutes
                              and Regulations for Well Classes I, III, IV, V and VI
----------------------------------------------------------------------------------------------------------------
                                                                             State
            State citation                       Title/subject             effective      EPA approval date \1\
                                                                             date
----------------------------------------------------------------------------------------------------------------
Wyoming Statutes sections 35-11-101     Wyoming Environmental Quality             1989  March 6, 1991, 56 FR
 through 35-11-115, and 35-11-301        Act.                                            9421.
 through 35-11-305.
Water Quality Rules and Regulations,    Regulations for Permit to                 1983  May 11, 1984, 49 FR
 Wyoming Department of Environmental     Construct, Install or Modify                    20197.
 Quality Chapter III: Regulations for    Public Water Supplies,
 Permit to Construct, Install or         Wastewater Facilities,
 Modify Public Facilities Capable or,    Disposal Systems, Biosolids
 (sic) Causing or Contributing to        Management Facilities,
 Pollution.                              Treated Wastewater Reuse
                                         Systems and Other Facilities
                                         Capable of Causing or
                                         Contributing to Pollution.
Water Quality Rules and Regulations,    Quality Standards for                     1980  May 11, 1984, 49 FR
 Wyoming Department of Environmental     Groundwaters of Wyoming.                        20197.
 Quality, Chapter VIII: Quality
 Standards for Groundwaters of Wyoming.
Water Quality Rules and Regulations,    Wyoming Groundwater Pollution             1980  May 11, 1984, 49 FR
 Wyoming Department of Environmental     Control Permit.                                 20197.
 Quality, Chapter IX: Wyoming
 Groundwater Pollution Control Permit.
Water Quality Rules and Regulations,    Prohibitions of Permits for               1989  March 6, 1991, 56 FR
 Wyoming Department of Environmental     New Hazardous Waste Injection                   9421.
 Quality, Chapter XIII: Prohibitions     Wells.
 of Permits for New Hazardous Waste
 Injection Wells.
Land Quality Rules and Regulations,     In Situ Mining................            1981  May 11, 1984, 49 FR
 Wyoming Department of Environmental                                                     20197.
 Quality, Chapter XXI: In Situ Mining.
Water Quality Rules and Regulations,    Class VI Injection Wells and              2020  October 9, 2020, [Insert
 Wyoming Department of Environmental     Facilities Underground and                      Federal Register
 Quality, Chapter XXIV: Class VI         Injection Control Program.                      citation]
 Injection Wells and Facilities
 Underground and Injection Control
 Program.
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
    (c) * * *
    (6) Memorandum of Agreement addendum between EPA, Region VIII, and
Wyoming Department of Environmental Quality, signed by the EPA Regional
Administrator on March 20, 2020.
    (7) Letter from Governor of Wyoming to Regional Administrator, EPA
Region VIII, ``Re: UIC Program Class VI Application,'' January 23,
2020.
    (d) * * *
    (3) ``Attorney General's Statement--``Attorney General's Statement
to Accompany Wyoming's Underground Injection Control Program Class VI
Primacy Application,'' signed by Attorney General and Assistant
Attorney General for the State of Wyoming, January 9, 2020.
    (4) Letter from the Attorney General for the State of Wyoming to
Regional Counsel, EPA Region VIII, ``Re: Wyoming Underground Injection
Control Program Class VI Regulations,'' October 25, 2019.
    (e) The Program Description and any other materials submitted as
part of the application or amendment thereto, and the Program
Description and any other materials submitted as part of the revision
application or amendment thereto.

[FR Doc. 2020-20544 Filed 10-8-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Notices]
[Page 34342-34345]
[DOCID:fr15jy09-93]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2009-0467; FRL-8424-7]

Lead Wheel Balancing Weights; TSCA Section 21 Petition; Notice of
Receipt and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that EPA has received a petition under
section 21 of the Toxic Substances Control Act (TSCA), and requests
comments on issues raised by the petition. The petition was received
from the Ecology Center of Ann Arbor, Michigan and the Sierra Club et
al., (petitioners) on May 29, 2009. The petition requests that EPA
establish regulations prohibiting the manufacture, processing, and
distribution in commerce of lead wheel balancing weights. EPA must
either grant or deny the petition within 90 days of filing.

DATES: Comments must be received on or before July 30, 2009

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0467, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2009-0467. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0467. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Linter, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    For technical information contact: Mark Henshall, National Program
Chemicals Division (7404T), Office Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to you if you manufacture, process, distribute
or use lead wheel balancing weights or are an automobile tire retailer.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. 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
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 procedures set forth in
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. TSCA Section 21

A. What is a TSCA Section 21 Petition?

    Under section 21 of TSCA (15 U.S.C. 2620), any person can petition
EPA to initiate a proceeding for the issuance, amendment, or repeal of
a rule under TSCA section 4, 6, or 8 or an order under TSCA section
5(e) or 6(b)(2). A TSCA section 21 petition must set forth the facts
that are claimed to establish

the necessity for the action requested. EPA is required to grant or
deny the petition within 90 days of its filing. If EPA grants the
petition, the Agency must promptly commence an appropriate proceeding.
If EPA denies the petition, the Agency must publish its reasons for the
denial in the Federal Register. A petitioner may commence a civil
action in a U.S. district court to compel initiation of the requested
rulemaking proceeding within 60 days of either a denial or if EPA fails
to grant or deny the expiration of the 90-day period.

B. What Criteria Apply to a Decision on a TSCA Section 21 Petition?

    Section 21(b)(1) of TSCA requires that the petition ``set forth the
facts which it is claimed establish that it is necessary'' to issue the
rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21
implicitly incorporates the statutory standards that apply to the
requested actions. In addition, TSCA section 21 establishes standards a
court must use to decide whether to order EPA to initiate rulemaking in
the event of a lawsuit filed by the petitioner after denial of a TSCA
section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA will
refer to the standards in TSCA section 21 and in the provisions under
which actions have been requested to evaluate this petition.

III. Summary of TSCA Section 21 Petition Received

A. What Action was Requested?

    On May 29, 2009, EPA received a petition from the Ecology Center
and the Sierra Club et al., petitioning EPA to establish regulations
prohibiting the manufacture, processing, and distribution in commerce
of lead wheel balancing weights (``wheel weights'').
    The petition and information submitted by the petitioner(s) is
included in the docket at http://www.regulations.gov, under EPA-HQ-
OPPT-2009-0467.

B. What Support Do the Petitioners Offer?

    This petition incorporates by reference a previous petition
submitted by the Ecology Center on May 13, 2005 (OPPT-2005-0032) (70 FR
35667, June 21, 2005) (FRL-7720-5), which requested a very similar
action. In that petition, the Ecology Center asked EPA to prohibit the
manufacturing, processing, distribution in commerce, and use and
improper disposal of lead wheel balancing weights. EPA denied that
petition on August 8, 2005.
    The petitioners note that they have previously highlighted that
automobiles are a significant contributor of ongoing lead releases to
the environment. The previous petition identified lead wheel balancing
weight failure (weights falling off rims into roadways) as one of the
largest ongoing releases of lead to the environment. The previous
petition also noted that lead is consistently found to be in high
concentrations on roadways and in end-of-life, vehicle waste (commonly
called Auto Shredder Residue (ASR)). The petitioners also commented
that lead wheel balancing weights are the second largest ongoing use of
lead in vehicles and play a significant role in the release of lead to
the environment.
    The petitioners also note that on August 29, 2008 EPA announced its
voluntary National Lead-Free Wheel Weight Initiative (NLFWWI). The
Initiative's 40 charter members and four subsequent members include
every new car manufacturer, four domestic lead wheel balancing weight
producers (3M, Hennessy, Perfect, and Plombco), two leading tire
manufacturers (Bridgestone Firestone and Goodyear) and major retailers
(Bridgestone Firestone, Goodyear, Costco, Wal-Mart, and Sam's Club).
These organizations committed in writing to:
     Identify the volume of lead to be eliminated.
     Reduce the use of lead for wheel balancing weights by
December 31, 2011.
     Take responsibility for providing information, education,
and outreach to the public, regarding the benefits of using lead-free
wheel balancing weights.
     Properly collect and recycle used lead wheel balancing
weights in their current inventory or acquired through normal business
operation.
     Publicly endorse the NLFWWI and encourage the use of lead-
free wheel balancing weights by others.
    Petitioners cited EPA's National Lead-Free Wheel Weight Initiative
web page which states:
     12.5 million pounds of lead from wheel balancing weight is
uncontrolled or unmanaged in the environment.
     1.6 million pounds of lead is lost when wheel balancing
weights fall off during normal driving conditions such as hitting a pot
hole.
     10.9 million pounds is sold or given to hobbyists for
recreational purposes.
    Petitioners estimate that no more than one-third of the lead wheel
weight market would potentially be changed to lead-free due to the
NLFWWI.
    Petitioners also point to recent state actions to address wheel
balancing weights. The petition notes that on April 28, 2009, the State
of Washington instituted a ban on lead wheel balancing weights
effective January 1, 2011 and that California, Iowa, and Maine have
similar proposals under consideration. The petition also stated that in
2008, Vermont banned lead wheel balancing weights on state-owned
vehicles by January 1, 2010 and in new motor vehicles as of January 1,
2011.

IV. EPA Seeks Public Comment

    Under TSCA section 21, EPA must either grant or deny a petition
within 90 days. EPA is providing this opportunity for the public to
comment on, or provide any additional information relevant to, the
issues identified in the petition. In order for the Agency to consider
such comments within the 90-day petition review period, EPA must
receive the comments by July 30, 2009 (see ADDRESSES).
    In particular, EPA seeks information on the following:
     Quantitative information, data and/or case examples (e.g.,
recent scientific and technical studies, including analytical data
results, analyses of environmental impacts, and statistical analyses)
associated with the potential environmental releases to the air,
surface water, ground water, and soil (particularly regarding potential
releases within 1 mile of roadways, and potential releases to
particularly sensitive environments or human and ecological
populations) from lead wheel balancing weights and the following
alternatives to lead tire weights: Steel tire weights; zinc alloy wheel
balancing weights; plastic metal composite wheel balancing weights; and
tin wheel balancing weights.
     Quantitative information and data (scientific and
technical studies, including analytical data results, analysis of
environmental impacts, statistical analyses, etc.) associated with
releases of lead to the air, surface water, ground water, and soil
within 1 mile of roadways from wheel balancing weights and all other
sources.
     Information on whether the following list of potential
exposure routes associated with releases from lead (and other
alternative material) wheel balancing weights is complete or accurate,
and whether other possible exposure routes associated with such
releases should be considered: Dust in and near roadways; dust from
roadways migrating to residential front yards, being tracked into
houses and inhaled and/or ingested by children; wheel balancing weights
and/or particles swept up by municipal street cleaners being
incinerated, leading to increased levels of lead in air; wheel
balancing weights and/or particles swept up by municipal street
cleaners and land

filled, leading to increased levels of lead in ground water; vapors
from home smelting of used wheel balancing weights obtained from gas
stations and small tire retailers; wheel balancing weights left on cars
that may be collected and burned in electric arc furnaces, releasing
lead vapor and particulate matter to the air; releases associated with
auto shredder activities (e.g., residues released to air or water); and
releases from roadways to streams resulting in potential exposures to
aquatic and terrestrial species.
     Quantitative or anecdotal information on the current
availability and suitability of lead-free wheel balancing weights as
alternatives, in both original equipment and aftermarket settings,
particularly any comparisons between lead-free and lead wheel balancing
weights in terms of price, ease of installation, durability, and other
attributes of performance and suitability.
    In assessing the usability of any data or information that may be
submitted, EPA plans to follow the guidelines in EPA's ``A Summary of
General Assessment Factors for Evaluating the Quality of Scientific and
Technical Information'' (EPA 100B-03/001), referred to as the
``Assessment Factors Document.'' The ``Assessment Factors Document''
was published in the Federal Register issue of July 1, 2003 (68 FR
39086) (FRL-7520-2) and is available on-line at http://www.epa.gov/osa/
spc/assess.htm.

List of Subjects

    Environmental protection, lead, wheel balancing weights, zinc.

    Dated: July 6, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E9-16815 Filed 7-14-09; 8:45 am]

BILLING CODE 6560-50-S