[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Proposed Rules]
[Pages 49193-49196]
[FR Doc No: 2015-20245]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2015-0208; FRL-9931-95-OAR]
RIN 2060-AS64

Relaxation of the Federal Reid Vapor Pressure Gasoline Volatility
Standard for Mecklenburg and Gaston Counties, North Carolina

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a request from the state of North Carolina for the EPA to relax
the Reid Vapor Pressure (RVP) standard applicable to gasoline
introduced into commerce from June 1 to September 15 of each year for
Mecklenburg and Gaston counties, North Carolina. Specifically, the EPA
is proposing to amend the regulations to allow the RVP standard for
Mecklenburg and Gaston counties to rise from 7.8 pounds per square inch
(psi) to 9.0 psi for gasoline. The EPA has preliminarily determined
that this change to the federal RVP regulation is consistent with the
applicable provisions of the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 16,
2015 unless a public hearing is requested by September 1, 2015. If the
EPA receives such a request, we will publish information related to the
timing and location of the hearing and a new deadline for public
comment.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2015-0208, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you

consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. If you need to
include CBI as part of your comment, please visit http://www.epa.gov/dockets/comments.html for instructions. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make.
    The EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e. on the web, cloud, or
other file sharing system). For additional submission methods, the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Patty Klavon, Office of Transportation
and Air Quality, Environmental Protection Agency, 2000 Traverwood
Drive, Ann Arbor, Michigan, 48105; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The contents of this preamble are listed in
the following outline:

I. General Information
II. Public Participation
III. Background and Proposal
IV. Direct Final Rule
V. Statutory and Executive Order Reviews
VI. Legal Authority

I. General Information

A. This Proposed Rule Is Published Parallel to a Direct Final Rule

    In the ``Rules and Regulations'' section of this Federal Register,
the EPA is making this revision as a direct final rule without prior
proposal because the EPA views this revision as noncontroversial and
anticipates no adverse comment. The rationale for this rulemaking is
described both in this proposal and in the direct final rule.
    The regulatory text for this proposed rule is included in the
direct final rule, and parties should review that rule for the
regulatory text. If the EPA receives no adverse comment, the EPA will
not take further action on this proposed rule. If the EPA receives
adverse comment on this rule or any portion of this rule, the EPA will
withdraw the direct final rule or the portion of the rule that received
adverse comment. All public comments received will then be addressed in
a subsequent final rule based on this proposed rule. The EPA will not
institute a second comment period on this rulemaking. Any parties
interested in commenting must do so at this time.

B. Does this action apply to me?

    Entities potentially affected by this proposed rule are fuel
producers and distributors who do business in North Carolina.

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                                                               NAICS \1\
         Examples of potentially  regulated entities             codes
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Petroleum refineries.........................................     324110
Gasoline Marketers and Distributors..........................     424710
                                                                  424720
Gasoline Retail Stations.....................................     447110
Gasoline Transporters........................................     484220
                                                                  484230
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\1\ North American Industry Classification System.

    The above table is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be regulated
by this action. The table lists the types of entities of which the EPA
is aware that potentially could be affected by this proposed rule.
Other types of entities not listed on the table could also be affected.
To determine whether your organization could be affected by this
proposed rule, you should carefully examine the regulations in 40 CFR
80.27. If you have questions regarding the applicability of this action
to a particular entity, call the person listed in the FOR FURTHER
INFORMATION CONTACT section of this preamble.

C. What is the agency's authority for taking this action?

    The statutory authority for this action is granted to the EPA by
Sections 211(h) and 301(a) of the Clean Air Act, as amended; 42 U.S.C.
7545(h) and 7601(a).

II. Public Participation

    The EPA will not hold a public hearing on this matter unless a
request is received by the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble by September 1, 2015. If
the EPA receives such a request, we will publish information related to
the timing and location of the hearing and a new deadline for public
comment.

III. Background and Proposal

A. Summary of the Proposal

    The EPA is proposing to approve a request from the state of North
Carolina to change the summertime RVP standard for Mecklenburg and
Gaston counties, North Carolina from 7.8 psi to 9.0 psi by amending the
EPA's regulations at 40 CFR 80.27(a)(2). In a previous rulemaking, the
EPA approved a redesignation request and maintenance plan for the
Charlotte-Gastonia-Salisbury, North Carolina 2008 ozone area (``the
Charlotte area'') and a CAA section 110(l) non-interference
demonstration that relaxing the federal RVP requirement from 7.8 psi to
9.0 psi for gasoline sold from June 1 to September 15 of each year in
Mecklenburg and Gaston counties would not interfere with maintenance of
any NAAQS in the Charlotte area, including the 2008 ozone NAAQS, or
with any other applicable CAA requirement. Mecklenburg and Gaston
counties are part of the Charlotte area. For more information on North
Carolina's redesignation request and maintenance plan for the Charlotte
area, please refer to Docket ID. No. EPA-R04-OAR-2015-0275 for the
rulemaking that was signed on July 17, 2015.
    The preamble for this rulemaking is organized as follows: Section
III.B. provides the history of the federal gasoline volatility
regulation. Section III.C. describes the policy regarding relaxation of
gasoline volatility standards in ozone nonattainment areas that are
redesignated as attainment areas. Section III.D. provides information
specific to North Carolina's request for Mecklenburg and Gaston
counties. Finally, Section IV. briefly discusses the associated direct
final rule.

B. History of the Gasoline Volatility Requirement

    On August 19, 1987 (52 FR 31274), the EPA determined that gasoline
nationwide was becoming increasingly volatile, causing an increase in
evaporative emissions from gasoline-powered vehicles and equipment.
Evaporative emissions from gasoline, referred to as volatile organic
compounds (VOC), are precursors to the formation of tropospheric ozone
and contribute to the nation's ground-level ozone problem. Exposure to
ground-level ozone can reduce lung function, thereby aggravating asthma
and other respiratory conditions, increase susceptibility to
respiratory infection, and may contribute to premature death in people
with heart and lung disease.
    The most common measure of fuel volatility that is useful in
evaluating gasoline evaporative emissions is RVP. Under CAA section
211(c), the EPA promulgated regulations on March 22, 1989 (54 FR 11868)
that set maximum limits for the RVP of gasoline sold during the
regulatory control periods that were established on a state-by-state

basis in the final rule. The regulatory control periods addressed the
portion of the year when peak ozone concentrations were expected. These
regulations constituted Phase I of a two-phase nationwide program,
which was designed to reduce the volatility of gasoline during the high
ozone season. On June 11, 1990 (55 FR 23658), the EPA promulgated more
stringent volatility controls as Phase II of the volatility control
program. These requirements established maximum RVP standards of 9.0
psi or 7.8 psi (depending on the state, the month, and the area's
initial ozone attainment designation with respect to the 1-hour ozone
NAAQS.)
    The 1990 CAA Amendments established a new section 211(h) to address
fuel volatility. CAA section 211(h) requires the EPA to promulgate
regulations making it unlawful to sell, offer for sale, dispense,
supply, offer for supply, transport, or introduce into commerce
gasoline with an RVP level in excess of 9.0 psi during the high ozone
season. CAA section 211(h) also prohibits the EPA from establishing a
volatility standard more stringent than 9.0 psi in an attainment area,
except that the EPA may impose a lower (more stringent) standard in any
former ozone nonattainment area redesignated to attainment.
    On December 12, 1991 (56 FR 64704), the EPA modified the Phase II
volatility regulations to be consistent with CAA section 211(h). The
modified regulations prohibited the sale of gasoline with an RVP above
9.0 psi in all areas designated attainment for ozone, effective January
13, 1992. For areas designated as nonattainment, the regulations
retained the original Phase II standards published on June 11, 1990 (55
FR 23658), which included the 7.8 psi ozone season limitation for
certain areas. As stated in the preamble to the Phase II volatility
controls and reiterated in the proposed change to the volatility
standards published in 1991, the EPA will rely on states to initiate
changes to their respective volatility programs. The EPA's policy for
approving such changes is described below in Section III.C.
    The state of North Carolina has initiated this change by requesting
that the EPA relax the 7.8 psi gasoline RVP standard to 9.0 psi for
Mecklenburg and Gaston counties, which are subject to the 7.8 gasoline
RVP requirement during the summertime ozone season. Accordingly, the
state of North Carolina provided a technical demonstration showing that
relaxing the federal gasoline RVP requirements in the two counties from
7.8 psi to 9.0 psi would not interfere with maintenance of any NAAQS in
the Charlotte area, including the 2008 ozone NAAQS, or with any other
applicable CAA requirement.

C. The EPA's Policy Regarding Relaxation of Gasoline Volatility
Standards in Ozone Nonattainment Areas That Are Redesignated to
Attainment Areas

    As stated in the preamble for the EPA's amended Phase II volatility
standards (56 FR 64706), any change in the gasoline volatility standard
for a nonattainment area that was subsequently redesignated as an
attainment area must be accomplished through a separate rulemaking that
revises the applicable standard for that area. Thus, for former 1-hour
ozone nonattainment areas where the EPA mandated a Phase II volatility
standard of 7.8 psi RVP in the December 12, 1991 rulemaking, the
federal 7.8 psi gasoline RVP requirement remains in effect, even after
such an area is redesignated to attainment, until a separate rulemaking
is completed that relaxes the federal gasoline RVP standard in that
area from 7.8 psi to 9.0 psi.
    As explained in the December 12, 1991 rulemaking, the EPA believes
that relaxation of an applicable gasoline RVP standard is best
accomplished in conjunction with the redesignation process. In order
for an ozone nonattainment area to be redesignated as an attainment
area, CAA section 107(d)(3) requires the state to make a showing,
pursuant to CAA section 175A, that the area is capable of maintaining
attainment for the ozone NAAQS for ten years. Depending on the area's
circumstances, this maintenance plan will either demonstrate that the
area is capable of maintaining attainment for ten years without the
more stringent volatility standard or that the more stringent
volatility standard may be necessary for the area to maintain its
attainment with the ozone NAAQS. Therefore, in the context of a request
for redesignation, the EPA will not relax the gasoline volatility
standard unless the state requests a relaxation and the maintenance
plan demonstrates to the satisfaction of the EPA that the area will
maintain attainment for ten years without the need for the more
stringent volatility standard.
    North Carolina is requesting relaxation of the federal gasoline RVP
standard from 7.8 psi to 9.0 psi for Mecklenburg and Gaston counties
concurrent with its request that the EPA approve a redesignation
request and maintenance plan for the Charlotte area for the 2008 ozone
NAAQS.

D. North Carolina's Request To Relax the Federal Gasoline RVP
Requirement for Mecklenburg and Gaston Counties

    On March 11, 2015, the state of North Carolina, through the North
Carolina Department of Environment and Natural Resources (NCDENR),
submitted a redesignation request and maintenance plan for the
Charlotte area, which was classified as Marginal for the 2008 ozone
NAAQS. Mecklenburg and Gaston counties are part of the Charlotte area.
Additionally, the state submitted a CAA section 110(l) non-interference
demonstration that removal of the federal RVP requirement of 7.8 psi
for gasoline during the summertime ozone season in Mecklenburg and
Gaston counties would not interfere with maintenance of any NAAQS, or
with any other applicable CAA requirement. Specifically, the state
provided a technical demonstration showing that relaxing the federal
gasoline RVP requirement in the two counties from 7.8 psi to 9.0 psi
would not interfere with maintenance of any NAAQS in the Charlotte
area, of which the two counties are part, including the 2008 ozone
NAAQS, or with any other applicable CAA requirement.
    In a rulemaking that was signed on July 17, 2015, the EPA evaluated
and approved North Carolina's March 11, 2015 redesignation request and
maintenance plan for the Charlotte area. See Docket ID. No. EPA-R04-
OAR-2015-0275. In a separate rulemaking signed on July 17, 2015, the
EPA approved North Carolina's non-interference demonstration for
Mecklenburg and Gaston counties. See Docket ID. No. EPA-R04-OAR-2015-
0260.\1\
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    \1\ On March 11, 2015, the NCDENR requested that the EPA
parallel process the approval of the submission.
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    Both rulemakings were subject to public notice-and-comment. The EPA
received two comments on the redesignation request and maintenance plan
rulemaking, and those comments were addressed in the final rule for
that rulemaking. The comments received can be found in the docket for
that rulemaking (Docket ID. No. EPA-R04-OAR-2015-0275). No comments
were received on the non-interference demonstration for Mecklenburg and
Gaston counties (Docket ID. No. EPA-R04-OAR-2015-0260).
    In this action, the EPA is taking the second and final step in the
process by proposing to approve North Carolina's request to relax the
summertime ozone season gasoline RVP standard for Mecklenburg and
Gaston counties from 7.8 psi to 9.0 psi. Specifically, the EPA

is proposing to amend the applicable gasoline RVP standard to allow the
gasoline RVP requirements to rise from 7.8 psi to 9.0 psi provided at
40 CFR 80.27(a)(2) for the two counties. This proposal to approve North
Carolina's request to relax the summertime ozone season gasoline RVP
standard for Mecklenburg and Gaston counties from 7.8 psi to 9.0 psi is
based on the previous approval of North Carolina's March 11, 2015
redesignation request and maintenance plan and non-interference
demonstration. It is also based on the fact that the Charlotte area is
currently in attainment for the both the 1997 ozone NAAQS and the 2008
ozone NAAQS.

IV. Direct Final Rule

    A direct final rule that would make the same changes as those
proposed in this action appears in the Rules and Regulations section of
this Federal Register. The EPA is taking direct final action on these
revisions because the EPA views the revisions as noncontroversial and
anticipates no adverse comment. The EPA has explained the reasons for
the amendments in this proposal and in the direct final rule. If no
adverse comments are received, no further action will be taken on the
proposal, and the direct final rule will become effective as provided
in that action.
    If the EPA receives adverse comments on the rule or any portion of
the rule, the EPA will withdraw the direct final rule or the portion of
the rule that received adverse comment. The EPA will publish a timely
withdrawal in the Federal Register indicating which provisions are
being withdrawn. All public comments received will then be addressed in
a subsequent final rule based on this proposed rule. The EPA will not
institute a second comment period on the subsequent final action. Any
parties interested in commenting must do so at this time.
    The changes to the regulatory text proposed in this document are
identical to those for the direct final rule published in the Rules and
Regulations section of this Federal Register. For further information,
including the regulatory revisions, see the direct final rule published
in a separate part of this Federal Register.

V. Statutory and Executive Order Reviews

    For a complete discussion of all the administrative requirements
applicable to this action, see the direct final rule in the Rules and
Regulations section of this Federal Register.

VI. Legal Authority

    The statutory authority for this action is granted to the EPA by
Sections 211(h) and 301(a) of the Clean Air Act, as amended; 42 U.S.C.
7545(h) and 7601(a).

List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedures,
Air pollution control, Fuel additives, Gasoline, Motor vehicle and
motor vehicle engines, Motor vehicle pollution, Penalties, Reporting
and recordkeeping requirements.

    Dated: August 5, 2015.
Gina McCarthy,
Administrator.
[FR Doc. 2015-20245 Filed 8-14-15; 8:45 am]
 BILLING CODE 6560-50-P


P-18-0187 Sanitized Support Documents Index:
 P-18-0187 Sanitized Determination Document (linked)
 P-18-0187 Sanitized CHEM Report (attached)
 P-18-0187 Sanitized ECO Report (attached)
 P-18-0187 Sanitized ENG Report (attached)
 P-18-0187 Sanitized EXP Report (attached)
 P-18-0187 Sanitized Fate Report (attached)
 P-18-0187 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 76, Number 94 (Monday, May 16, 2011)]
[Notices]
[Pages 28220-28221]
[FR Doc No: 2011-11913]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-86-016; Docket No. EL07-88-016; Docket No. EL07-92-
016]

Notice of Filing

    Ameren Services Company, Northern Indiana Public Service Company
v. Midwest Independent Transmission System Operator, Inc., Great
Lakes Utilities, Indiana Municipal Power Agency, Missouri Joint
Municipal Electric Utility Commission, Missouri River Energy
Services, Prairie Power, Inc., Southern Minnesota Municipal Power
Agency, Wisconsin Public Power Inc. v. Midwest Independent
Transmission System Operator, Inc., Wabash Valley Power Association,
Inc. v. Midwest Independent Transmission System Operator, Inc.

    Take notice that on May 9, 2011, The Midwest Independent
Transmission System Operator, Inc. filed proposed revisions to its Open
Access Transmission, Energy and Operating Reserve Markets Tariff,
pursuant to the Federal Energy Regulatory Commission's Order issued
April 7, 2011, Midwest Indep. Trans. Sys. Operator, Inc., 135 FERC ]
61,007 (2011) (April 7 Rehearing Order).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for 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 e-mail
notification when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 31, 2011.

    Dated: May 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-11913 Filed 5-13-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Rules and Regulations]
[Pages 1121-1124]
[FR Doc No: 2019-28235]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R09-OAR-2019-0393; FRL-10000-52-Region 9]

Partial Approval, Partial Disapproval and Promulgation of State
Plans for Designated Facilities and Pollutants; California; Control of
Emissions From Existing Municipal Solid Waste Landfills

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is partially
approving and partially disapproving a Clean Air Act (CAA) section
111(d) plan submitted by the California Air Resources Board (CARB) to
implement the EPA's Emission Guidelines and Compliance Times for
Municipal Solid Waste Landfills (Emission Guidelines). This State plan
submittal pertains to the regulation of landfill gas and its components
from existing municipal solid waste (MSW) landfills. We are partially
approving the State plan because it meets many of the requirements of
the Emission Guidelines. However, we are partially disapproving the
State plan because it does not fully meet certain provisions of the
Emission Guidelines.

DATES: This final rule is effective on February 10, 2020. The
incorporation by reference of certain material listed in the rule is
approved by the Director of the Federal Register as of February 10,
2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2019-0393. 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.,
Confidential Business Information (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 through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Jeffrey Buss, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On July 30, 2019, the EPA proposed to partially approve and
partially disapprove a section 111(d) plan submitted by CARB for
existing MSW landfills. 84 FR 36863. The submitted section 111(d) plan
was in response to the August 29, 2016 promulgation of revised emission
guidelines requirements for MSW landfills, 40 CFR part 60, subpart
Cf.\1\ Included within the section 111(d) plan are regulations under
the California Code of Regulations (CCR), at 17 CCR 95460-95476,
entitled, ``Methane Emissions from Municipal Solid Waste Landfills.'' A
detailed explanation of the rationale behind the proposed approval is
available in the Technical Support Document in the docket for this
rulemaking.
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    \1\ 81 FR 59276.
---------------------------------------------------------------------------

    We proposed to partially approve this plan because we determined
that it complies with the relevant CAA requirements, with the exception
of the omission of the following operational, monitoring,
recordkeeping, and corrective action requirements related either to
temperature and/or oxygen or nitrogen: 40 CFR 60.34f(c), 60.36f(a)(5),
60.37f(a)(2) and (3), 60.38f(k), and 60.39f(e)(2) and (5). Upon
promulgation of the Federal plan in accordance with 40 CFR 60.27(c),
the EPA plans to update 40 CFR part 62, subpart F, to identify the
omitted requirements (40 CFR 60.34f(c), 60.36f(a)(5), 60.37f(a)(2) and
(3), 60.38f(k), and 60.39f(e)(2) and (5)) that MSW landfills in
California will have to implement in addition to the approved portion
of the California plan.\2\ Our proposed action at 84 FR 36863 (July 30,
2019) contains more information on the plan and our evaluation, and we
incorporate that information by reference here.
---------------------------------------------------------------------------

    \2\ The EPA is required to promulgate regulations setting forth
a federal plan on or before November 6, 2019. State of California v.
EPA, No. 4:18-cv-03237 (N.D. Cal. 2019) (Court Order issued May 6,
2019). Pending before the court is a motion to vacate the deadline
for promulgation of a federal plan, based on EPA's recent
finalization of revisions to emission guidelines implementing
regulations. Id., Motion to Amend Order and Judgment (filed August
26, 2019) (citing 84 FR at 44556 (codified at 40 CFR 60.30f(b)).
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II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period we received one comment, from CARB.
    Comment: CARB stated that California law currently satisfies what
the EPA identified as deficiencies in its July 30, 2019 proposed
partial disapproval of the California plan. In support of its argument,
CARB submitted rules with its comment regarding the regulation of MSW
landfills from 32 of California's 35 local air districts, and
documentation regarding public hearings related to their adoption. CARB
also submitted a table summarizing the rules and a previously submitted
letter addressing questions the EPA had asked about the California
plan.\3\ CARB requests that the EPA withdraw its proposed partial
disapproval of the California plan and approve it in its entirety, or,
in the alternative, that the EPA incorporate the provisions of the
rules and regulations into the State's plan and then fully approve the
plan.
---------------------------------------------------------------------------

    \3\ Appendix C to CARB's comment letter is entitled, ``Air
District Rules, Regulations, and Permit Conditions.'' The EPA found
district rules and regulations in Appendix C, but was unable to find
permit conditions in the document.
---------------------------------------------------------------------------

    Response: Pursuant to 40 CFR 60.24(c), a state plan must contain
standards of performance that are no less stringent than the
corresponding emission guideline(s) specified in subpart C of part 60.
Subpart Cf sets

forth clear mandatory requirements for an approvable state plan.
Sections 60.34f, 60.36f, 60.37f, 60.38f, and 60.39f each include the
specific phrase: ``For approval, a state plan must include,'' which is
then followed by a reference to specific requirements such as
``provisions for the operational standards in this section,'' ``the
compliance provisions in this section,'' ``the monitoring provisions in
this section,'' ``the reporting provisions listed in this section,'' or
``the recordkeeping provisions in this section.'' As explained in our
proposed action, the California plan, as submitted, omits these
provisions.
    We note that CARB's comment does not dispute that the California
state plan lacks the operational, monitoring, recordkeeping, and
corrective action requirements previously identified by EPA, namely,
those set forth in 40 CFR 60.34f(c), 60.36f(a)(5), 60.37f(a)(2) and
(3), 60.38f(k), and 60.39f(e)(2) and (5). Nor does CARB dispute that
the California State plan, which incorporates the California
regulation, ``Methane Emissions from Municipal Solid Waste Landfills,''
does not itself contain these operational, monitoring, recordkeeping,
and corrective action requirements.
    Instead, CARB argues that other provisions that ``are already part
of California law,'' and that appear in the rules and regulations of 32
of California's 35 air districts, can stand in lieu of what EPA
identified as the operational, monitoring, recordkeeping, and
corrective action requirements that are omitted from the California
State plan. Although CARB provided these rules and regulations in an
appendix to its comments, the rules and regulations are not part of
CARB's submitted plan, and the EPA does not have authority to
incorporate all or part of them into the plan on behalf of CARB. The
EPA cannot approve a state plan that omits certain required elements on
the basis that some other local regulation or permit that is not part
of the submitted plan contains provisions that may resemble those
elements. In accordance with CAA section 111(d)(1)(B),\4\ EPA's
implementing regulations,\5\ and the Emission Guidelines,\6\ the
required elements must be in the plan itself.
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    \4\ 42 U.S.C. 7411(d)(1)(B) (state plans must ``provide[] for
the implementation and enforcement of [] standards of
performance'').
    \5\ 40 CFR 60.25(b) (state plans must include monitoring,
recordkeeping, and reporting requirements).
    \6\ See, e.g., 40 CFR 60.36f (``For approval, a state plan must
include the compliance provisions in this section.'').
---------------------------------------------------------------------------

    Additionally, even if CARB had properly incorporated the rules and
regulations into its plan, the EPA notes that the rules and regulations
for the most part cross-reference older EPA regulations that apply to
MSW landfills for which the applicability threshold is 50 megagrams/
year (Mg/yr) of non-methane organic compounds (NMOC) emissions. Those
older EPA regulations do not apply to MSW landfills whose emissions of
NMOC are below 50 Mg/yr but above the currently applicable threshold in
Subpart Cf, 34 Mg/yr.\7\ This discrepancy means that landfills in
California with NMOC emissions greater than 34 Mg/yr but less than 50
Mg/yr would not be required to comply with the requirements of 40 CFR
60.34f, 60.36f, 60.37f, 60.38f, and 60.39f.\8\
---------------------------------------------------------------------------

    \7\ Attachment A to CARB's letter indicates that many local
rules cross-reference 40 CFR part 60, subparts Cc and WWW. The
applicability threshold in subparts Cc and WWW is 50 Mg/yr NMOC. See
40 CFR 60.33c(e)(2)(i) and 60.752(b)(2), respectively.
    \8\ As a condition for state plan approval, subpart Cf requires
that a state's regulations control emissions at 34 Mg/yr or higher,
regardless of whether a state has landfills at 34 Mg/yr. The EPA
estimates, however, that 15 to 20 landfills in California fall
within the range of 34 Mg/yr to 50 Mg/yr. See Emission Inventory for
year 2019: MSW Landfill Federal Plan.
---------------------------------------------------------------------------

    Many of the rules cited by CARB are requirements for 40 CFR part 70
operating permit programs pursuant to title V of the CAA. Again, the
EPA does not have the authority to incorporate California's local
rules, regulations, and permit conditions into its state plan.
Moreover, it is unclear whether a state's part 70 program or permit
conditions--even if they were properly incorporated into a state plan--
could provide the requisite elements for an approvable state plan.
    In addition, CARB's comment included problematic requests to the
EPA to take certain procedural steps regarding the submitted local
rules. Again, the EPA lacks the authority to incorporate regulations
into the California plan; only California can revise its plan by
incorporating appropriate measures and then submit the revised plan to
the EPA. The EPA can then review the revised plan as submitted to
determine whether it is approvable.\9\
---------------------------------------------------------------------------

    \9\ CARB's letter appears to acknowledge that additional
procedural steps, at the state and/or local level, may be necessary
for the local rules to be ``properly'' incorporated into the
California plan. See CARB Letter at page 2 and Attachment A at page
8.
---------------------------------------------------------------------------

III. EPA Action

    For the reasons discussed in our proposed action and above, as
authorized in 40 CFR 60.27(b), the EPA is partially approving and
partially disapproving the plan submitted by CARB. The EPA's partial
approval of the California plan is limited to those landfills that meet
the criteria established in subpart Cf.

IV. Incorporation by Reference

    In accordance with the requirements of 1 CFR 51.5, the EPA is
finalizing regulatory text that includes the incorporation by reference
of 17 CCR 95460-95476, (collectively, subarticle 6 entitled ``Methane
Emissions from Municipal Solid Waste Landfills,'') operative June 17,
2010, which is part of the CAA section 111(d) plan applicable to
existing MSW landfills in California as discussed in section I of this
preamble. The regulatory provisions in 17 CCR 95460-95476 establish
requirements to reduce air emissions of methane and other landfill
gases from all MSW landfills located in California that received solid
waste after January 1, 1977. The regulations include measures related
to emission standards, installation of emission control systems,
testing, monitoring, reporting, and recordkeeping provisions. The EPA
has made, and will continue to make, the entire California plan
generally available through www.regulations.gov, Docket No. EPA-R09-
OAR-2019-0393, and at the EPA Region IX Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). This incorporation by reference
has been approved by the Office of the Federal Register and the plan is
federally enforceable under the CAA, and is limited to those sources
subject to 40 CFR part 60, subpart Cf, as of the effective date of this
final rulemaking.

V. Statutory and Executive Order Reviews

    Under the CAA, the EPA Administrator is required to approve section
111(d) state plan submissions that comply with the provisions of the
Act and applicable Federal regulations. 42 U.S.C. 7411(d); 40 CFR part
60, subparts B and Cf; and 40 CFR part 62, subpart A. Thus, in
reviewing CAA section 111(d) state plan submissions, the EPA's role is
to approve state choices, provided that they meet the criteria of the
Act and implementing regulations. Accordingly, this action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under

Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because this action is not significant under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the CAA section 111(d) plans are not approved to apply
in Indian country, as defined at 18 U.S.C. 1151, located in the state.
As such, this rule does not have tribal implications, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), and it will not
impose substantial direct costs on tribal governments or preempt tribal
law.
    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. The EPA will submit a report containing this action 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).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 9, 2020. Filing a petition for
reconsideration by the EPA Administrator of this final rule does not
affect the finality of this action for the purposes of judicial review
nor does it extend the time within which a petition for judicial review
may be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Landfills,
Incorporation by reference, Intergovernmental relations, Methane,
Ozone, Reporting and recordkeeping requirements, Sulfur Oxides,
Volatile organic compounds.

    Dated: September 6, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 62 as follows:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Amend Sec.  62.1100 by:
0
a. In paragraph (b)(3)(i) introductory text, removing ``rules;'' and
adding ``rules.'' in its place;
0
b. Redesignating paragraphs (b)(3)(i)(a) through (c) as paragraphs
(b)(3)(i)(A) through (C), respectively;
0
c. In paragraph (b)(3)(vi) introductory text, removing the semicolon
and adding a period in its place;
0
d. Redesignating paragraphs (b)(3)(vi)(a) through (d) as paragraphs
(b)(3)(vi)(A) through (D), respectively; and
0
e. Adding paragraphs (b)(7) and (d).
    The additions read as follows:

Sec.  62.1100  Identification of plan.

* * * * *
    (b) * * *
    (7) State of California's Section 111(d) Plan for Existing
Municipal Solid Waste Landfills, including 17 CCR 95460-95476
(collectively, subarticle 6 entitled ``Methane Emissions from Municipal
Solid Waste Landfills,'') operative June 17, 2010, submitted on May 30,
2017 by the California Air Resources Board to implement 40 CFR part 60,
subpart Cf. The Plan does not include provisions relating to 40 CFR
60.34f(c), 60.36f(a)(5), 60.37f(a)(2) and (3), 60.38f(k), and
60.39f(e)(2) and (5). The Plan includes the regulatory provisions cited
in paragraph (d) of this section, which the EPA incorporates by
reference.
* * * * *
    (d)(1) The material incorporated by reference in this section was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of the material
at the EPA Region 9 office, 75 Hawthorne Street, San Francisco, CA
94105,<PHONE_NUMBER> or from the source listed in paragraph (d) of this
section. Copies may be inspected 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.
    (2) State of California, Barclays Official California Code of
Regulations.
    (i) 17 CCR, Division 3. Air Resources, Chapter 1. Air Resources
Board, Subchapter 10. Climate Change, Article 4. Regulations to Achieve
Greenhouse Gas Emission Reductions, Subarticle 6. Methane Emissions
from Municipal Solid Waste Landfills, sections 95460-95476, operative
June 17, 2010.
    (ii) [Reserved]

0
3. Section 62.1115 is revised to read as follows:

Sec.  62.1115  Identification of sources.

    (a) The plan in Sec.  62.1100(b)(5) applies to existing municipal
solid waste landfills for which construction, reconstruction, or
modification was commenced before May 30, 1991, as described in 40 CFR
part 60, subpart Cc.
    (b) The plan in Sec.  62.1100(b)(7) applies to existing municipal
solid waste landfills that commenced construction, modification or
reconstruction on or before July 17, 2014.
    (1) After February 10, 2020, the substantive requirements of the
municipal solid waste landfills State plan are contained in paragraph
(b) of this section and owners and operators of municipal solid waste
landfills in

California must comply with the requirements in paragraph (b) of this
section.
    (2) [Reserved]
    (c)(1) The effective date of the plan in Sec.  62.1100(b)(5) by the
California Air Resources Board for municipal solid waste landfills is
November 22, 1999.
    (2) The effective date of the plan in Sec.  62.1100(b)(7) by the
California Air Resources Board for municipal solid waste landfills is
February 10, 2020.

[FR Doc. 2019-28235 Filed 1-8-20; 8:45 am]
BILLING CODE 6560-50-P


January 18, 2007

Public Information and Records Integrity Branch (PIRIB)

Office of Pesticide Programs (OPP)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW.

Washington, DC  20460-0001

Re: Soil Fumigant Cluster Risk Assessment Supplemental Information

To Whom It May Concern:

The following information is being provided to supplement comments
submitted to the Agency on Oct 12, 2005 in response to Docket No.
EPA-HQ-OPP-2005-0124 and EPA-HQ-OPP-2005-0125 for 1,3-dichloropropene
and metam sodium risk assessments, respectively.

The Kern County Agricultural Commission’s fumigant permitting
documents* state that metam sodium applications via sprinkler require a
buffer zone of 500 feet from a sensitive area, defined as a residential
area, school, hospital, labor camp, or other area designated by the
commissioner.  Shank injection, flood or drip applications require a
buffer zone of up to 500 feet depending on the season.  For
1,3-dichloropropene, a 100-foot buffer zone is required and, as per the
label, is increased to 300 feet for the next three years.  If a
sensitive area is unoccupied, the field receiving fumigant applications
is exempt from the buffer zone requirements and applications may occur
to the property line.

This being said, we would like to bring to your attention a common
practice employed by the California carrot industry with regard to
fumigant application.  When fields near residences are to be fumigated,
the practice is to offer to arrange for the residents to stay in a hotel
until fumigation has been completed, thereby eliminating the possibility
of exposure.

We ask that this information be included in the comments previously
submitted for the Soil Fumigant Cluster risk assessment on behalf of the
California Fresh Carrot Advisory Board.

Sincerely,

Robert Schramm

* Metam Sodium/Metam Potassium Kern County Permit Conditions (Revised
September 2003) and Kern County Permit Conditions for using
1,3-Dichloropropene (Telone) Pesticides (Fumigant)’ (Established
September 12, 2002).


54416 Federal Register / Vol. 67, No. 163 / Thursday, August 22, 2002 / Notices 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's Web site at http:// www. ferc. gov using the `` RIMS'' link, select `` Docket #'' and follow the instructions (call 202– 208– 2222 for assistance). Protests and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001( a)( 1)( iii) and the instructions on the Commission's Web site under the `` e Filing'' link.

Linwood A. Watson, Jr., Deputy Secretary. [FR Doc. 02– 21382 Filed 8– 21– 02; 8: 45 am]

BILLING CODE 6717– 01– P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98– 1– 000]

Regulations Governing Off the Record Communications; Public Notice August 16, 2002. This constitutes notice, in accordance with 18 CFR 385.2201( h), of the receipt of exempt and prohibited off the record communications. Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive an exempt or a prohibited off the record communication relevant to the merits of a contested on the record proceeding, to deliver a copy of the communication, if written, or a summary of the substance of any oral communication, to the Secretary. Prohibited communications will be included in a public, non decisional file associated with, but not part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become part of the decisional record, the prohibited offthe record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off the record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such requests only when it determines that fairness so requires. Any person identified below as having made a prohibited off the record communication should serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010. Exempt off the record communications will be included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201( e)( 1)( v). The following is a list of exempt and prohibited off the record communications recently received in the Office of the Secretary. Copies of these filings are on file with the Commission and are available for public inspection. The documents may be viewed on the web at http:// www. ferc. gov using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, call (202) 508– 8222 or for TTY, (202) 208– 1659.

EXEMPT Docket No. Date filed Presenter or requester 1. Project No. 2612– 005. 8– 5– 02 Don Klima.

Linwood A. Watson, Jr., Deputy Secretary. [FR Doc. 02– 21387 Filed 8– 21– 02; 8: 45 am]

BILLING CODE 6717– 01– P ENVIRONMENTAL PROTECTION AGENCY [OPPT– 2002– 0035; FRL– 7187– 6]

Substantial Risk Information Reporting under Section 8( e) of the Toxic Substances Control Act; Request for Comment on Renewal of Information Collection Activities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 U. S. C. 3501 et seq.), EPA is seeking public comment on the following Information Collection Request (ICR): Substantial Risk Information Reporting under Section 8( e) of the Toxic Substances Control Act (TSCA) (EPA ICR No. 0794.10, OMB No. 2070– 0046). This ICR involves a collection activity that is currently approved and scheduled to expire on January 31, 2003. The information collected under this ICR relates to reporting requirements placed on persons who manufacture, import, process, or distribute in commerce chemical substances or mixtures and who obtain information that such substances or mixtures present a substantial risk of injury to health or the environment. Before submitting this ICR to the Office of Management and Budget (OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection. DATES: Written comments, identified by the docket ID number OPPT– 2002– 0035, must be received on or before October 21, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT– 2002– 0035 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554– 1404; e mail address: TSCA Hotline@ epa. gov. For technical information contact: Richard Hefter, Risk Assessment Division (7403M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564– 7649; fax number: (202) 564– 1626; e mail address: hefter. richard@ epa. gov. SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me? You may be potentially affected by this action if you are a company that manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and which obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of VerDate Aug< 2,> 2002 14: 58 Aug 21, 2002 Jkt 197001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22AUN1. SGM pfrm17 PsN: 22AUN1 54417 Federal Register / Vol. 67, No. 163 / Thursday, August 22, 2002 / Notices injury to health or the environment. Potentially affected categories and entities may include, but are not limited to:

Type of business NAICS codes Chemical manufacturing 325 Petroleum refineries 32411 This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. The North American Industrial Classification System (NAICS) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. 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.

II. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

A. Electronically You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. On the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/.

B. Fax on Demand Using a faxphone call (202) 564– 3119 and select item 4096 for a copy of the ICR.

C. In Person The Agency has established an official record for this action under docket ID number OPPT– 2002– 0035. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B– 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260– 7099.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit the Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT– 2002– 0035 on the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 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 (202) 564– 8930. 3. Electronically. Submit your comments and/ or data electronically by e mail to: oppt. ncic@ epa. gov, or mail your computer disk to the address identified in Units III. A. 1. and 2. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPPT– 2002– 0035. Electronic comments may also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI that I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider when I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

D. What Information is EPA Particularly Interested in?

Pursuant to section 3506( c)( 2)( A) of the PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology,

VerDate Aug< 2,> 2002 14: 58 Aug 21, 2002 Jkt 197001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22AUN1. SGM pfrm17 PsN: 22AUN1 54418 Federal Register / Vol. 67, No. 163 / Thursday, August 22, 2002 / Notices e. g., permitting electronic submission of responses.

IV. What Information Collection Activity or ICR Does this Action Apply to? EPA is seeking comments on the following ICR: Title: Substantial Risk Information Reporting under Section 8( e) of the Toxic Substances Control Act (TSCA). ICR numbers: EPA ICR No. 0794.10, OMB No. 2070– 0046. ICR status: This ICR is currently scheduled to expire on January 31, 2003. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that is subject to approval under PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections appear on the collection instruments or instructions, in the Federal Register notices for related rulemakings and ICR notices, and, if the collection is contained in a regulation, in a table of OMB approval numbers in 40 CFR part 9. Abstract: TSCA section 8( e) requires that any person who manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and which obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment must immediately inform EPA of such information. EPA routinely disseminates TSCA section 8( e) data it receives to other Federal agencies to provide information about newly discovered chemical hazards and risks. Responses to the collection of information are mandatory (see 15 U. S. C. 2607( e)). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

V. What are EPA's Burden and Cost Estimates for this ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to range between 5.0 hours and 27.0 hours per response, depending upon the nature of the response. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: 218. Frequency of response: On occasion. Estimated average number of responses for each respondent: 1. Estimated total annual burden hours: 6,431. Estimated total annual burden costs: $675,255.

VI. Are There Changes in the Estimates from the Last Approval?

There is a decrease of 1,778 hours (from 8,209 hours to 6,431 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This change results from an overall decrease in section 8( e) reporting, primarily from a reduction in the number of follow up/ supplemental section 8( e) notices received. In previous ICR renewals, EPA used an historical average of 2.2 followup notices per each initial submission. This figure was based on EPA's experience and system for reviewing section 8( e) notices in place pre 1990. During that time EPA received fewer than 100 initial notices per year and was able to perform a much more detailed review of each notice received. The consequence of that review was that there was much more interaction with the submitting companies generating numerous follow up notices and information submissions. However, during and since the 1991 Compliance Audit Program, because of the increase in initial notices submitted, EPA has contacted submitters for additional information only for those initial notices that are identified during the preliminary screening evaluation as needing additional information from the submitters. Consequently, the number of follow up notices has fallen due to the changed nature of EPA's review of initial notices. Over the last 3 fiscal years, EPA has received 341 follow up notices versus 653 initial notices, or approximately 0.5 follow up notices per initial notice.

VII. What is the Next Step in the Process for this ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects Environmental protection, Reporting and recordkeeping requirements.

Dated: August 9, 2002.

Susan B. Hazen,

Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[FR Doc. 02– 21444 Filed 8– 21– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [FRL– 7265– 5]

Agency Information Collection Activities; OMB Responses AGENCY: Environmental Protection Agency (EPA).

ACTION: Notices.

SUMMARY: This document announces the Office of Management and Budget's (OMB) responses to Agency clearance requests, in compliance with the Paperwork Reduction Act (44 U. S. C. 3501 et seq.). 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 are listed in 40 CFR part 9 and 48 CFR Chapter 15.

FOR FURTHER INFORMATION CONTACT: Susan Auby at (202) 566– 1672, or e mail at Auby. susan@ epa. gov. and please refer to the appropriate EPA Information Collection Request (ICR) Number.

SUPPLEMENTARY INFORMATION:

VerDate Aug< 2,> 2002 14: 58 Aug 21, 2002 Jkt 197001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22AUN1. SGM pfrm17 PsN: 22AUN1


[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Page 36768]
[FR Doc No: 2013-14577]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-1646-000]

Electron Hydro, 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,
of Electron Hydro, LLC's application for market-based rate authority,
with an accompanying rate schedule, 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 July 3, 2013.
    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(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for 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: June 13, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-14577 Filed 6-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Pages 42710-42711]
[FR Doc No: 2023-14050]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2242-000]

Lazbuddie Wind Energy Holdings 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 of
Lazbuddie Wind Energy Holdings 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 July 17, 2023.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC

20426. Hand delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 27, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-14050 Filed 6-30-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 232 (Tuesday, December 3, 2019)]
[Proposed Rules]
[Pages 66096-66098]
[FR Doc No: 2019-26002]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2019-0656; FRL-10002-64-Region 7]

Air Plan Approval; Missouri; Sampling Methods for Air Pollution
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
approval of revisions to the State Implementation Plan (SIP) submitted
by the State of Missouri to EPA on October 25, 2019. The purpose of the
revisions is to provide a more efficient way to perform emissions
sampling on air pollution sources throughout Missouri. The State is
requesting approval of incorporating by reference the federally defined
methods for stack testing. These proposed revisions are administrative
in nature and do not affect the stringency of the SIP.

DATES: Comments must be received on or before January 2, 2020.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2019-0656 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: Jan Simpson, Environmental Protection
Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219; telephone number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?

III. Have the requirements for approval of a SIP revision been met?
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-
0656, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve revisions to the Missouri SIP
submitted by the State of Missouri to the EPA on October 25, 2019. The
revisions to the previously federally approved Missouri State rule 10
CSR 10-6.030 Sampling Methods for Air Pollution Sources are
administrative in nature and do not affect the stringency of the SIP.
If approved, the revisions will provide a more efficient way to perform
emissions sampling by incorporating by reference (IBR) federally
promulgated methods.
    In sections (1) through subsection (5)(b) and sections (6) through
(16) the State removed the title of the sampling method and added a
reference to the IBR at section (22) of the revised rule. The sampling
method required in each section was not changed. In subsection (5)(c)
through (5)(f) the State removed the title of the sampling method and
added a reference to the IBR at section (21) of the revised rule. The
sampling method required in each subsection was not changed. In section
(17) the State removed the title of the sampling method and added a
reference to the IBR section (23) of the revised rule. The sampling
method required in each section was not changed. At section (20) the
State updated its IBR information and documentation identification.
    In order to consolidate IBRs and for ease of updating the IBRs in
the future, the State is adding sections (21), (22) and (23), of the
Federal rule, effective July 1, 2018. Section (21) incorporates by
reference 40 CFR part 51, appendix M ``Recommended Test Methods for
State Implementation Plans''. Section (22) incorporates by reference 40
CFR part 60, appendix A ``Test Methods'', appendix B ``Performance
Specifications'', and appendix F ``Quality Assurance Procedures''.
Section (23) incorporates by reference 40 CFR part 61, appendix B
``Test Methods''.

III. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from May 15, 2018 to
August 2, 2018 and received eight comments. Based on the comments
received the State made revisions to rule text in sections (21), (22),
and (23) that incorporated by reference specific appendices and
subparts. The State provided a second public notice on this SIP
revision from April 15, 2019 to June 6, 2019 and received no comments.
In addition, as explained above, the revision meets the substantive SIP
requirements of the Clean Air Act (CAA), including section 110 and
implementing regulations.

IV. What action is the EPA taking?

    We are processing this as a proposed action because we are
soliciting comments on this proposed action. Final rulemaking will
occur after consideration of any comments.

V. Incorporation by Reference

    In this document, the EPA is proposing to include regulatory text
in an EPA final rule that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, the EPA is proposing to
incorporate by reference the Missouri Regulation described in the
proposed amendments to 40 CFR part 52 set forth below. The EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 7 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub.L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian

country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 22, 2019.
James Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry ``10-6.030'' to read as follows:

Sec.  52.1320   Identification of plan.

* * * * *
    (c)* * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State        EPA approval
       Missouri citation              Title        effective date        date                Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
    Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control
                                      Regulations for the State of Missouri
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-6.030......................  Sampling Methods       11/30/2019  January 3, 2020,  ...........................
                                 for Air                            [Federal
                                 Pollution                          Register
                                 Sources.                           citation of the
                                                                    final rule].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-26002 Filed 12-2-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28733-28734]
[FR Doc No: 2014-11516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0057]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ELELYSO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ELELYSO and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination

of the length of a regulatory review period for a human drug product
will include all of the testing phase and approval phase as specified
in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ELELYSO
(taliglucerase alfa). ELELYSO is indicated for long-term enzyme
replacement therapy for adults with a confirmed diagnosis of Type 1
Gaucher disease. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for ELELYSO (U.S.
Patent No. 7,951,557) from Protalix Ltd., and the Patent and Trademark
Office requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated February 19,
2013, FDA advised the Patent and Trademark Office that this human drug
product had undergone a regulatory review period and that the approval
of ELELYSO represented the first permitted commercial marketing or use
of the product. Thereafter, the Patent and Trademark Office requested
that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
ELELYSO is 2,483 days. Of this time, 1,746 days occurred during the
testing phase of the regulatory review period, while 737 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: July 16, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 16, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 26,
2010. FDA has verified the applicant's claim that the new drug
application (NDA) for ELELYSO (NDA 22-458) was submitted on April 26,
2010.
    3. The date the application was approved: May 1, 2012. FDA has
verified the applicant's claim that NDA 22-458 was approved on May 1,
2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 336 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 18, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by November 17, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11516 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P