Proposed Rule: Mandatory Reporting of Greenhouse Gas Emissions:
“Revisions”

Meeting Documentation:  Weyerhaeuser

Date	Staff Contact Information (Name, email, phone #)	Name of
Organization (Attach list of all attendees names and emails if possible)
	Summary of Discussion (e.g., applicability, reporting requirements,
etc.)	Written Comments Provided?

Did they also submit to Docket?	Date sent to EPA- CCD

8/3/2010

Lisa Hanle

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
 	Weyerhaeuser<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>
	 EPA provided the general background on proposed changes related to the
reporting requirements for biogenic emissions.  Specifically the
proposal to all the option for separate reporting of biogenic emissions
for units following Part 75 methods.   Weyerhaeuser had a number of
questions about the proposed changes and discussed concerns associated
with the option to report biogenic emissions separately for all units
using Part 75 methods.  They expressed concern that EPA would be missing
key data.	No written comments were submitted at meeting.  They will
provide written comments.

	8/5/10


[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51412-51413]
[FR Doc No: 2022-18011]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0116; FRL-9412-16-OCSPP]

Certain New Chemicals or Significant New Uses; Statements of
Findings for May, June, and July 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to
publish in the Federal Register a statement of its findings after its
review of certain TSCA submissions when EPA makes a finding that a new
chemical substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment. Such
statements apply to premanufacture notices (PMNs), microbial commercial
activity notices (MCANs), and significant new use notices (SNUNs)
submitted to EPA under TSCA. This document presents statements of
findings made by EPA on such submissions during the period from May 1,
2022 to July 31, 2022.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0116, is available online
at https://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. For the latest status information on EPA/DC services
and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Rebecca Edelstein, New Chemical Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-1667; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action provides information that is directed to the public in
general.

B. What action is the Agency taking?

    This document lists the statements of findings made by EPA after
review of submissions under TSCA section 5(a) that certain new chemical
substances or significant new uses are not likely to present an
unreasonable risk of injury to health or the environment. This document
presents statements of findings made by EPA during the reporting
period.

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

    TSCA section 5(a)(3) requires EPA to review a submission under TSCA
section 5(a) and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
    Under TSCA, the unreasonable risk findings must be made without
consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant under the conditions of use. The term
``conditions of use'' is defined in TSCA section 3 to mean ``the
circumstances, as determined by the Administrator, under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed
of.''
    TSCA section 5(g) requires EPA to publish in the Federal Register a
statement of its findings after its review of a submission under TSCA
section 5(a) when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before commencing manufacture of the new
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

II. Statements of Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
    The following list provides the EPA case number assigned to the
TSCA section 5(a) submission and the chemical identity (generic name if
the specific name is claimed as CBI).
     J-22-0012, J-22-0013, Genetically modified microorganism
for the production of a chemical substance (Generic Name).
    To access EPA's decision document describing the basis of the ``not
likely to present an unreasonable risk'' finding

made by EPA under TSCA section 5(a)(3)(C), look up the specific case
number at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: August 15, 2022.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2022-18011 Filed 8-19-22; 8:45 am]
BILLING CODE 6560-50-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on January 11, 2007

NOTICE OF ACTION TAKEN -- DOCKET OST-2001-11152

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of US AIRWAYS, INC. (US AIRWAYS) filed 12/21/06 for:

XX  Renewal of exemption under 49 U.S.C. 40109 to provide the following
service:

Scheduled foreign air transportation of persons, property, and mail
between Charlotte, North Carolina, Chicago, Illinois, Washington, D.C.,
and Ft. Lauderdale, Florida, on the one hand, and Bermuda, on the other
hand.

Applicant rep: Howard Kass<PHONE_NUMBER>	DOT Analyst:  Thuy H. Cooper
(202) 366-5423

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: January 11, 2007, through
January 11, 2009.

Action taken by:  Paul L. Gretch, Director

		    Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and the United Kingdom.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated: XX  Holder’s
certificates of public convenience and necessity

                XX  Standard Exemption Conditions (attached)

________________________________________________________________________
_________________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served;

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

11/2006


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Proposed Rules]
[Pages 49731-49736]
[FR Doc No: 2014-20032]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0522; FRL-9915-48-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Infrastructure Requirements for the 2010 Sulfur Dioxide
National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
Commonwealth of Virginia pursuant to the Clean Air Act (CAA). Whenever
new or revised National Ambient Air Quality Standards (NAAQS) are
promulgated, the CAA requires states to submit a plan for the
implementation, maintenance, and enforcement of such NAAQS. The plan is
required to address basic program elements including, but not limited
to, regulatory structure, monitoring, modeling, legal authority, and
adequate resources necessary to assure attainment and maintenance of
the standards. These elements are referred to as infrastructure
requirements. The Commonwealth of Virginia has made a submittal
addressing the infrastructure requirements for the 2010 sulfur dioxide
(SO2) NAAQS.

DATES: Written comments must be received on or before September 22,
2014.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2014-0522 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2014-0522, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Air Protection Division,
Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2014-0522. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the

www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 23, 2014, the Commonwealth of
Virginia through the Virginia Department of Environmental Quality
(VADEQ) submitted a revision to the Commonwealth's SIP to satisfy the
requirements of Section 110(a)(2) of the CAA for the 2010
SO2 NAAQS.

I. Background

    On June 22, 2010, (75 FR 35520), EPA promulgated a revised NAAQS
for the 1-hour primary SO2 at a level of 75 parts per
billion (ppb), based on a 3-year average of the annual 99th percentile
of 1-hour daily maximum concentrations. Section 110(a) of the CAA
requires states to submit SIPs to provide for the implementation,
maintenance, and enforcement of a new or revised NAAQS. Specifically,
Section 110(a)(1) requires states to submit SIPs meeting the applicable
requirements of Section 110(a)(2) within three years following the
promulgation of such NAAQS, or within such shorter period as EPA may
prescribe, and Section 110(a)(2) requires states to address specific
elements for monitoring, basic program requirements and legal authority
that are designed to assure attainment and maintenance of the newly
established or revised NAAQS. The contents of a submission may vary
depending upon the facts and circumstances. In particular, the data and
analytical tools available at the time the state develops and submits
the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains.

II. Summary of SIP Revision

    On June 23, 2014, VADEQ provided a SIP revision to satisfy certain
Section 110(a)(2) requirements of the CAA for the 2010 SO2
NAAQS. This revision addressed the following infrastructure elements
which EPA is proposing to approve: Section 110(a)(2)(A), (B), (C),
(D)(i)(II) (prevention of significant deterioration), (D)(ii), (E)(i),
(E)(iii), (F), (G), (H), (J) (consultation, public notification, and
prevention of significant deterioration), (K), (L), and (M). A detailed
summary of EPA's review and rationale for approving Virginia's
submittal may be found in the Technical Support Document (TSD) for this
rulemaking action which is available on line at www.regulations.gov,
Docket ID Number EPA-R03-OAR-2014-0522.
    This rulemaking action does not include any proposed action on
Section 110(a)(2)(I) of the CAA which pertains to the nonattainment
requirements of part D, Title I of the CAA, because this element is not
required to be submitted by the 3-year submission deadline of CAA
Section 110(a)(1), and will be addressed in a separate process. This
rulemaking action also does not include proposed action on Section
110(a)(2)(D)(i)(I) of the CAA because Virginia's submittal did not
include a submittal for this element; therefore, EPA will take later,
separate action on Section 110(a)(2)(D)(i)(I) for the 2010
SO2 NAAQS for Virginia. At this time, EPA is not proposing
action on Section 110(a)(2)(D)(i)(II) or (J) for visibility protection
for the 2010 SO2 NAAQS. Although Virginia's infrastructure
SIP submittal for the 2010 SO2 NAAQS referred to Virginia's
regional haze SIP for addressing requirements in Section
110(a)(2)(D)(i)(II) and (J) for visibility protection, EPA intends to
take separate action on Virginia's submittal for these elements at a
later date as explained in the TSD. Finally, EPA will take later,
separate action with respect to Section 110(a)(2)(E)(ii) regarding CAA
Section 128 requirements for State Boards for the 2010 SO2
NAAQS. EPA is soliciting public comments on the issues discussed in
this document. These comments will be considered before taking final
action.

III. EPA's Approach To Review Infrastructure SIPs

    EPA is acting upon the SIP submission from Virginia that addresses
the infrastructure requirements of Section 110(a)(1) and (2) of the CAA
for the 2010 SO2 NAAQS. The requirement for states to make a
SIP submission of this type arises out of Section 110(a)(1). Pursuant
to Section 110(a)(1), states must make SIP submissions ``within 3 years
(or such shorter period as the Administrator may prescribe) after the
promulgation of a national primary ambient air quality standard (or any
revision thereof),'' and these SIP submissions are to provide for the
``implementation, maintenance, and enforcement'' of such NAAQS. The
statute directly imposes on states the duty to make these SIP
submissions, and the requirement to make the submissions is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address.
    EPA has historically referred to these SIP submissions made for the
purpose of satisfying the requirements of Section 110(a)(1) and (2) as
``infrastructure SIP'' submissions. Although the term ``infrastructure
SIP'' does not appear in the CAA, EPA uses the term to distinguish this
particular type of SIP submission from submissions that are intended to
satisfy other SIP requirements under the CAA, such as ``nonattainment
SIP'' or ``attainment plan SIP'' submissions to address the
nonattainment planning requirements of part D of title I of the CAA,
``regional haze SIP'' submissions required by EPA rule to address the
visibility protection requirements of CAA Section 169A, and
nonattainment new source review permit program submissions to address
the permit requirements of CAA, title I, part D.
    Section 110(a)(1) addresses the timing and general requirements for
infrastructure SIP submissions and Section 110(a)(2) provides more
details concerning the required contents of these submissions. The list
of required elements provided in Section 110(a)(2) contains a wide
variety of disparate provisions, some of which pertain to required
legal authority, some of which pertain to required substantive program
provisions, and some of which pertain to requirements for both
authority and substantive program provisions.\1\ EPA therefore believes
that while the timing requirement in Section 110(a)(1) is unambiguous,
some of the other statutory provisions are ambiguous. In particular,
EPA believes that the list of

required elements for infrastructure SIP submissions provided in
Section 110(a)(2) contains ambiguities concerning what is required for
inclusion in an infrastructure SIP submission.
---------------------------------------------------------------------------

    \1\ For example: Section 110(a)(2)(E)(i) provides that states
must provide assurances that they have adequate legal authority
under state and local law to carry out the SIP; Section 110(a)(2)(C)
provides that states must have a SIP-approved program to address
certain sources as required by part C of title I of the CAA; and
Section 110(a)(2)(G) provides that states must have legal authority
to address emergencies as well as contingency plans that are
triggered in the event of such emergencies.
---------------------------------------------------------------------------

    The following examples of ambiguities illustrate the need for EPA
to interpret some Section 110(a)(1) and Section 110(a)(2) requirements
with respect to infrastructure SIP submissions for a given new or
revised NAAQS. One example of ambiguity is that Section 110(a)(2)
requires that ``each'' SIP submission must meet the list of
requirements therein, while EPA has long noted that this literal
reading of the statute is internally inconsistent and would create a
conflict with the nonattainment provisions in part D of title I of the
CAA, which specifically address nonattainment SIP requirements.\2\
Section 110(a)(2)(I) pertains to nonattainment SIP requirements and
part D addresses when attainment plan SIP submissions to address
nonattainment area requirements are due. For example, Section 172(b)
requires EPA to establish a schedule for submission of such plans for
certain pollutants when the Administrator promulgates the designation
of an area as nonattainment, and Section 107(d)(1)(B) allows up to two
years or in some cases three years, for such designations to be
promulgated.\3\ This ambiguity illustrates that rather than apply all
the stated requirements of Section 110(a)(2) in a strict literal sense,
EPA must determine which provisions of Section 110(a)(2) are applicable
for a particular infrastructure SIP submission.
---------------------------------------------------------------------------

    \2\ See, e.g., ``Rule To Reduce Interstate Transport of Fine
Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions
to Acid Rain Program; Revisions to the NOX SIP Call;
Final Rule,'' 70 FR 25162, at 25163-65 (May 12, 2005) (explaining
relationship between timing requirement of Section 110(a)(2)(D)
versus Section 110(a)(2)(I)).
    \3\ EPA notes that this ambiguity within Section 110(a)(2) is
heightened by the fact that various subparts of part D set specific
dates for submission of certain types of SIP submissions in
designated nonattainment areas for various pollutants. Note, e.g.,
that Section 182(a)(1) provides specific dates for submission of
emissions inventories for the ozone NAAQS. Some of these specific
dates are necessarily later than three years after promulgation of
the new or revised NAAQS.
---------------------------------------------------------------------------

    Another example of ambiguity within Section 110(a)(1) and (2) with
respect to infrastructure SIPs pertains to whether states must meet all
of the infrastructure SIP requirements in a single SIP submission, and
whether EPA must act upon such SIP submission in a single action.
Although Section 110(a)(1) directs states to submit ``a plan'' to meet
these requirements, EPA interprets the CAA to allow states to make
multiple SIP submissions separately addressing infrastructure SIP
elements for the same NAAQS. If states elect to make such multiple SIP
submissions to meet the infrastructure SIP requirements, EPA can elect
to act on such submissions either individually or in a larger combined
action.\4\ Similarly, EPA interprets the CAA to allow it to take action
on the individual parts of one larger, comprehensive infrastructure SIP
submission for a given NAAQS without concurrent action on the entire
submission. For example, EPA has sometimes elected to act at different
times on various elements and sub-elements of the same infrastructure
SIP submission.\5\
---------------------------------------------------------------------------

    \4\ See, e.g., ``Approval and Promulgation of Implementation
Plans; New Mexico; Revisions to the New Source Review (NSR) State
Implementation Plan (SIP); Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NNSR) Permitting,'' 78 FR
4339 (January 22, 2013) (EPA's final action approving the structural
PSD elements of the New Mexico SIP submitted by the State separately
to meet the requirements of EPA's 2008 PM2.5 NSR rule),
and ``Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Infrastructure and Interstate Transport Requirements for
the 2006 PM2.5 NAAQS,'' 78 FR 4337 (January 22, 2013)
(EPA's final action on the infrastructure SIP for the 2006
PM2.5 NAAQS).
    \5\ On December 14, 2007, the State of Tennessee, through the
Tennessee Department of Environment and Conservation, made a SIP
revision to EPA demonstrating that the State meets the requirements
of Sections 110(a)(1) and (2). EPA proposed action for
infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR
3213) and took final action on March 14, 2012 (77 FR 14976). On
April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA
took separate proposed and final actions on all other Section
110(a)(2) infrastructure SIP elements of Tennessee's December 14,
2007 submittal.
---------------------------------------------------------------------------

    Ambiguities within Section 110(a)(1) and (2) may also arise with
respect to infrastructure SIP submission requirements for different
NAAQS. Thus, EPA notes that not every element of Section 110(a)(2)
would be relevant, or as relevant, or relevant in the same way, for
each new or revised NAAQS. The states' attendant infrastructure SIP
submissions for each NAAQS therefore could be different. For example,
the monitoring requirements that a state might need to meet in its
infrastructure SIP submission for purposes of Section 110(a)(2)(B)
could be very different for different pollutants, for example because
the content and scope of a state's infrastructure SIP submission to
meet this element might be very different for an entirely new NAAQS
than for a minor revision to an existing NAAQS.\6\
---------------------------------------------------------------------------

    \6\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    EPA notes that interpretation of Section 110(a)(2) is also
necessary when EPA reviews other types of SIP submissions required
under the CAA. Therefore, as with infrastructure SIP submissions, EPA
also has to identify and interpret the relevant elements of Section
110(a)(2) that logically apply to these other types of SIP submissions.
For example, Section 172(c)(7) requires that attainment plan SIP
submissions required by part D have to meet the ``applicable
requirements'' of Section 110(a)(2). Thus, for example, attainment plan
SIP submissions must meet the requirements of Section 110(a)(2)(A)
regarding enforceable emission limits and control measures and Section
110(a)(2)(E)(i) regarding air agency resources and authority. By
contrast, it is clear that attainment plan SIP submissions required by
part D would not need to meet the portion of Section 110(a)(2)(C) that
pertains to the prevention of significant deterioration (PSD) program
required in part C of title I of the CAA, because PSD does not apply to
a pollutant for which an area is designated nonattainment and thus
subject to part D planning requirements. As this example illustrates,
each type of SIP submission may implicate some elements of Section
110(a)(2) but not others.
    Given the potential for ambiguity in some of the statutory language
of Section 110(a)(1) and Section 110(a)(2), EPA believes that it is
appropriate to interpret the ambiguous portions of Section 110(a)(1)
and Section 110(a)(2) in the context of acting on a particular SIP
submission. In other words, EPA assumes that Congress could not have
intended that each and every SIP submission, regardless of the NAAQS in
question or the history of SIP development for the relevant pollutant,
would meet each of the requirements, or meet each of them in the same
way. Therefore, EPA has adopted an approach under which it reviews
infrastructure SIP submissions against the list of elements in Section
110(a)(2), but only to the extent each element applies for that
particular NAAQS.
    Historically, EPA has elected to use guidance documents to make
recommendations to states for infrastructure SIPs, in some cases
conveying needed interpretations on newly arising issues and in some
cases conveying interpretations that have already been developed and
applied to individual SIP submissions for particular elements.\7\ EPA
most recently

issued guidance for infrastructure SIPs on September 13, 2013 (2013
Guidance).\8\ EPA developed this document to provide states with up-to-
date guidance for infrastructure SIPs for any new or revised NAAQS.
Within this guidance, EPA describes the duty of states to make
infrastructure SIP submissions to meet basic structural SIP
requirements within three years of promulgation of a new or revised
NAAQS. EPA also made recommendations about many specific subsections of
Section 110(a)(2) that are relevant in the context of infrastructure
SIP submissions.\9\ The guidance also discusses the substantively
important issues that are germane to certain subsections of Section
110(a)(2). Significantly, EPA interprets Section 110(a)(1) and (2) such
that infrastructure SIP submissions need to address certain issues and
need not address others. Accordingly, EPA reviews each infrastructure
SIP submission for compliance with the applicable statutory provisions
of Section 110(a)(2), as appropriate.
---------------------------------------------------------------------------

    \7\ EPA notes, however, that nothing in the CAA requires EPA to
provide guidance or to promulgate regulations for infrastructure SIP
submissions. The CAA directly applies to states and requires the
submission of infrastructure SIP submissions, regardless of whether
or not EPA provides guidance or regulations pertaining to such
submissions. EPA elects to issue such guidance in order to assist
states, as appropriate.
    \8\ ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),''
Memorandum from Stephen D. Page, September 13, 2013.
    \9\ EPA's September 13, 2013, guidance did not make
recommendations with respect to infrastructure SIP submissions to
address Section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly
after the U.S. Supreme Court agreed to review the DC Circuit
decision in EME Homer City, 696 F.3d 7 (D.C. Cir. 2012) which had
interpreted the requirements of Section 110(a)(2)(D)(i)(I). In light
of the uncertainty created by ongoing litigation, EPA elected not to
provide additional guidance on the requirements of Section
110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding
nor required by statute, whether EPA elects to provide guidance on a
particular section has no impact on a state's CAA obligations.
---------------------------------------------------------------------------

    As an example, Section 110(a)(2)(E)(ii) is a required element of
Section 110(a)(2) for infrastructure SIP submissions. Under this
element, a state must meet the substantive requirements of Section 128,
which pertain to state boards that approve permits or enforcement
orders and heads of executive agencies with similar powers. Thus, EPA
reviews infrastructure SIP submissions to ensure that the state's SIP
appropriately addresses the requirements of Section 110(a)(2)(E)(ii)
and Section 128. The 2013 Guidance explains EPA's interpretation that
there may be a variety of ways by which states can appropriately
address these substantive statutory requirements, depending on the
structure of an individual state's permitting or enforcement program
(e.g., whether permits and enforcement orders are approved by a multi-
member board or by a head of an executive agency). However they are
addressed by the state, the substantive requirements of Section 128 are
necessarily included in EPA's evaluation of infrastructure SIP
submissions because Section 110(a)(2)(E)(ii) explicitly requires that
the state satisfy the provisions of Section 128.
    As another example, EPA's review of infrastructure SIP submissions
with respect to the PSD program requirements in Section 110(a)(2)(C),
(D)(i)(II), and (J) focuses upon the structural PSD program
requirements contained in part C and EPA's PSD regulations. Structural
PSD program requirements include provisions necessary for the PSD
program to address all regulated sources and NSR pollutants, including
Green House Gases (GHGs). By contrast, structural PSD program
requirements do not include provisions that are not required under
EPA's regulations at 40 CFR 51.166 but are merely available as an
option for the state, such as the option to provide grandfathering of
complete permit applications with respect to the 2013 PM2.5
NAAQS. Accordingly, the latter optional provisions are types of
provisions EPA considers irrelevant in the context of an infrastructure
SIP action.
    For other Section 110(a)(2) elements, however, EPA's review of a
state's infrastructure SIP submission focuses on assuring that the
state's SIP meets basic structural requirements. For example, Section
110(a)(2)(C) includes, inter alia, the requirement that states have a
program to regulate minor new sources. Thus, EPA evaluates whether the
state has an EPA-approved minor new source review program and whether
the program addresses the pollutants relevant to that NAAQS. In the
context of acting on an infrastructure SIP submission, however, EPA
does not think it is necessary to conduct a review of each and every
provision of a state's existing minor source program (i.e., already in
the existing SIP) for compliance with the requirements of the CAA and
EPA's regulations that pertain to such programs.
    With respect to certain other issues, EPA does not believe that an
action on a state's infrastructure SIP submission is necessarily the
appropriate type of action in which to address possible deficiencies in
a state's existing SIP. These issues include: (i) Existing provisions
related to excess emissions from sources during periods of startup,
shutdown, or malfunction that may be contrary to the CAA and EPA's
policies addressing such excess emissions (SSM); (ii) existing
provisions related to ``director's variance'' or ``director's
discretion'' that may be contrary to the CAA because they purport to
allow revisions to SIP-approved emissions limits while limiting public
process or not requiring further approval by EPA; and (iii) existing
provisions for PSD programs that may be inconsistent with current
requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR 80186
(December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (NSR
Reform). Thus, EPA believes it may approve an infrastructure SIP
submission without scrutinizing the totality of the existing SIP for
such potentially deficient provisions and may approve the submission
even if it is aware of such existing provisions.\10\ It is important to
note that EPA's approval of a state's infrastructure SIP submission
should not be construed as explicit or implicit re-approval of any
existing potentially deficient provisions that relate to the three
specific issues just described.
---------------------------------------------------------------------------

    \10\ By contrast, EPA notes that if a state were to include a
new provision in an infrastructure SIP submission that contained a
legal deficiency, such as a new exemption for excess emissions
during SSM events, then EPA would need to evaluate that provision
for compliance against the rubric of applicable CAA requirements in
the context of the action on the infrastructure SIP.
---------------------------------------------------------------------------

    EPA's approach to review of infrastructure SIP submissions is to
identify the CAA requirements that are logically applicable to that
submission. EPA believes that this approach to the review of a
particular infrastructure SIP submission is appropriate, because it
would not be reasonable to read the general requirements of Section
110(a)(1) and the list of elements in Section 110(a)(2) as requiring
review of each and every provision of a state's existing SIP against
all requirements in the CAA and EPA regulations merely for purposes of
assuring that the state in question has the basic structural elements
for a functioning SIP for a new or revised NAAQS. Because SIPs have
grown by accretion over the decades as statutory and regulatory
requirements under the CAA have evolved, they may include some outmoded
provisions and historical artifacts. These provisions, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP
submission. EPA believes that a

better approach is for states and EPA to focus attention on those
elements of Section 110(a)(2) of the CAA most likely to warrant a
specific SIP revision due to the promulgation of a new or revised NAAQS
or other factors.
    For example, EPA's 2013 Guidance gives simpler recommendations with
respect to carbon monoxide than other NAAQS pollutants to meet the
visibility requirements of Section 110(a)(2)(D)(i)(II), because carbon
monoxide does not affect visibility. As a result, an infrastructure SIP
submission for any future new or revised NAAQS for carbon monoxide need
only state this fact in order to address the visibility prong of
Section 110(a)(2)(D)(i)(II).
    Finally, EPA believes that its approach with respect to
infrastructure SIP requirements is based on a reasonable reading of
Section 110(a)(1) and (2) because the CAA provides other avenues and
mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow EPA to take appropriately
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or to otherwise comply with the CAA.\11\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\12\ Significantly, EPA's
determination that an action on a state's infrastructure SIP submission
is not the appropriate time and place to address all potential existing
SIP deficiencies does not preclude EPA's subsequent reliance on
provisions in Section 110(a)(2) as part of the basis for action to
correct those deficiencies at a later time. For example, although it
may not be appropriate to require a state to eliminate all existing
inappropriate director's discretion provisions in the course of acting
on an infrastructure SIP submission, EPA believes that Section
110(a)(2)(A) may be among the statutory bases that EPA relies upon in
the course of addressing such deficiency in a subsequent action.\13\
---------------------------------------------------------------------------

    \11\ For example, EPA issued a SIP call to Utah to address
specific existing SIP deficiencies related to the treatment of
excess emissions during SSM events. See ``Finding of Substantial
Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revisions,'' 74 FR 21639 (April 18, 2011).
    \12\ EPA has used this authority to correct errors in past
actions on SIP submissions related to PSD programs. See ``Limitation
of Approval of Prevention of Significant Deterioration Provisions
Concerning Greenhouse Gas Emitting-Sources in State Implementation
Plans; Final Rule,'' 75 FR 82536 (December 30, 2010). EPA has
previously used its authority under CAA Section 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62 FR
34641 (June 27, 1997) (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67062, November 16, 2004
(corrections to California SIP); and 74 FR 57051 (November 3, 2009)
(corrections to Arizona and Nevada SIPs).
    \13\ See, e.g., EPA's disapproval of a SIP submission from
Colorado on the grounds that it would have included a director's
discretion provision inconsistent with CAA requirements, including
Section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21,
2010) (proposed disapproval of director's discretion provisions); 76
FR 4540 (January 26, 2011) (final disapproval of such provisions).
---------------------------------------------------------------------------

IV. Proposed Action

    EPA is proposing to approve the following elements of Virginia's
June 23, 2014 SIP revision for the 2010 SO2 NAAQS: Section
110(a)(2)(A), (B), (C), (D)(i)(II) (prevention of significant
deterioration), (D)(ii), (E)(i), (E)(iii), (F), (G), (H), (J)
(consultation, public notification, and prevention of significant
deterioration), (K), (L), and (M). Virginia's SIP revision provides the
basic program elements specified in Section 110(a)(2) necessary to
implement, maintain, and enforce the 2010 SO2 NAAQS. This
proposed rulemaking action does not include action on Section
110(a)(2)(I) which pertains to the nonattainment planning requirements
of part D, Title I of the CAA, because this element is not required to
be submitted by the 3-year submission deadline of Section 110(a)(1) of
the CAA, and will be addressed in a separate process. Additionally, EPA
will take later, separate action on Section 110(a)(2)(D)(i)(I)
(interstate transport of emissions), (D)(i)(II) (visibility
protection), (J) (visibility protection) and (E)(ii) (Section 128,
``State Boards'') for the 2010 SO2 NAAQS as discussed above
and in the TSD. EPA is soliciting public comments on the issues
discussed in this document. These comments will be considered before
taking final action.

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. . .'' The opinion concludes
that ``[r]egarding Sec.  10.1-1198, therefore, documents or other
information needed for civil or criminal enforcement under one of these
programs could not be privileged because such documents and information
are essential to pursuing enforcement in a manner required by Federal
law to maintain program delegation, authorization or approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting

such immunity would not be consistent with Federal law, which is one of
the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, Sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under Section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

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 CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 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 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, this proposed rule, which satisfies certain
infrastructure requirements of Section 110(a)(2) of the CAA for the
2010 SO2 NAAQS for the Commonwealth of Virginia, does not
have tribal implications as specified by Executive Order 13175 (65 FR
67249, November 9, 2000), because the SIP is not approved to apply in
Indian country located in the state, and EPA notes that it will not
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Sulfur oxides.

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

    Dated: August 5, 2014.
William C. Early,
Acting, Regional Administrator, Region III.
[FR Doc. 2014-20032 Filed 8-21-14; 8:45 am]
BILLING CODE 6560-50-P


October 29, 2010

The Honorable Lisa Jackson
Administrator
United States Environmental Protection Agency
Ariel Rios Building (Mail Code 1101)
1200 Pennsylvania Ave., NW
Washington, D.C.  20460

Re: 	Petition for Reconsideration of Portions of the Final Rule: National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines

Dear Administrator Jackson:

I am writing in support of the National Rural Electric Cooperative Association's (NRECA) October 19, 2020, Petition for Reconsideration of portions of the Final National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines promulgated on August 20, 2010, (75 Fed. Reg. 51,570).

Northwest Iowa Power Cooperative (NIPCO) is a Generation and Transmission Cooperative headquartered in Le Mars, Iowa.  NIPCO provides power and various services to its 7 member cooperatives and municipals in western Iowa that covers 6,500 square miles.  NIPCO and its Member Systems have also had a very successful active load management system in place since 1983.  Over 50% of the 31,000 consumer-owners participate in this demand-side management program.

If left in place, the EPA National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines (RICE NESHAP) rule will severely restrict and limit our ability to maximize efficient operations of our electric systems.  This ruling will also have negative power supply implications as we will be unable to operate our system as efficiently as we current do. This will increase our costs and ultimately our rates to the consumer-owners.  Along with other parts of our country, western Iowa struggles to meet the challenges of the downturn in the country's economy.  Unemployment is high, people are struggling to make ends meet and businesses are fighting to stay open.  This is certainly not the time to place additional burdens on them.

Distribution cooperatives, having no major electric generation facilities of their own, are concerned primarily with distributing electric power to their retail consumers.  They simply do not have the resources or a practical reason to keep track of and review the many EPA rulemaking activities under the Clean Air Act to see if one of these rulemakings may have an impact on their operation of delivering electrical power.  Without an outreach from EPA, which was absent in these rulemakings, these small entities could not anticipate that the proposed rule for emergency generators would undermine and destroy their very practical and highly successful peak shaving programs.
The bulk of the small emergency generating units, the subject matter of this petition, are owned by the rural consumer-owners of the electric cooperatives and not by the individual electric cooperatives.  These small emergency generating units are utilized in an efficient and productive manner for the benefit of their rural consumer-owners.  It is hard to understand and explain that the efficiency benefits derived from the use of these resources would be wiped out by a Federal Government that professes goals of increased energy efficiency and resource conservation.

NRECA's petition addresses restrictions contained in the final rule that prohibit the use of small emergency generating units for peak shaving programs and limits demand reduction service beginning in 2013 without the addition of expensive emission reduction technology on units larger than a specified size.

To help operate our electric system more efficiently and maximize our power supply, our load management system includes a peak shaving program that uses the engines you will be regulating and restricting the use of.  Without the use of these back-up generators, the cost of power will increase as there will be no other cost-effective option to reduce our demand during peak usage times.  The added capital expenditures placed on our consumer-owner to make the required upgrades under this regulatory mandate places a very significant financial burden on them.  This may force us to cease future peak shaving demand side management program as they will no longer be cost effective for us or the consumer-owner to consider.

We support the recommendation contained in NRECA's petition regarding removal of the restrictions on the use of these engines for peak shaving and demand reduction purposes in the 100 hours of non-emergency operations allowed in the rule.  The use of these engines up to 100 hours for non-emergency operation per year, as already allowed in the final rule, would not cause any additional emissions and therefore, no additional health risk or environmental harm above that already contemplated in the rule.

In conclusion, NIPCO, its Member Cooperatives support protecting public health and the environment.  However, in this case the restrictions are unnecessary, too severe, will cause a significant detriment to our consumer-owners, and will not result in any meaningful environmental benefit.  We urge the agency to reconsider these restrictions on peak shaving and demand reduction contained in the final rules and amend the rules avoid diminishing the value of these programs and increase the cost of power to our consumer-owners.

If you have any questions or need additional information, please contact me at<PHONE_NUMBER>.  Thank you Administrator Jackson for your consideration of our request.  On behalf of our 31,000 consumer-owners, we express our desire you will respond favorably on this critically important issue.

Sincerely,

Kent D. Pauling

Executive Vice President and General Manager

cc: 	Robert Wayland
	Melanie King
	Kevin Bromberg, SBA


OMB Control No. XXXX XXXX EPA XXX X XX XXX Approval Expires XX/ XX/ XX ENERGY STAR ® Indoor Air Package Commitment Form By completing this form, our organization commits to participating in a pilot of the ENERGY STAR ® Indoor Air Package Program. We have read and understand the program's specifications ( attached) and agree to:

  Build and label at least one home annually that is verified to meet the specifications of the ENERGY STAR ® Indoor Air Package;   Ensure that all of our ENERGY STAR Indoor Air Package homes are also verified to earn the ENERGY STAR Qualified Home label;   Provide marketing materials related to the ENERGY STAR Indoor Air Package to EPA for review and approval. EPA will review within three working days.   Monitor the results of our efforts to build and market qualifying homes;   Provide EPA with an informal evaluation of our experience during the pilot;   Use the ENERGY STAR Indoor Air Package mark consistent with the requirements of the ENERGY STAR brand identify guidelines contained in the document, Using the ENERGY STAR Identity to Maintain and Use Value; and   Discontinue our use of the ENERGY Indoor Air Package label if we are not constructing homes to the label's specifications.

We understand that the construction practices and technical specifications that comprise the ENERGY STAR Indoor Air Package are designed to contribute to improved indoor air quality in new homes compared to standard code built homes. However, these measures alone will not guarantee that homebuyers will not experience air quality problems in their homes. Rather, the Indoor Air Package should be viewed as a way to reduce the likelihood of experiencing such problems. For example, factors such as unforeseen construction issues and homeowner behavior may negatively impact the home's indoor air quality and the performance of the measures specified in the Indoor Air Package.

We understand that during the pilot program, EPA will   Maintain and update the Indoor Air Package technical specifications as needed;   Develop consumer education materials ( such as brochures, ad templates, banners); and   Provide recognition to participating builders through EPA's Web site, award ceremonies and press releases.   Provide a copy of this commitment form signed by EPA's authorized representative to make this commitment form effective.

We also agree that:

  The activities we undertake in connection with the Indoor Air Package Program are completely voluntary and not intended to provide services to the Federal government. As such, we will not submit a claim of compensation to any Federal agency; The government estimates the average time needed to review and fill out this form is 15 minutes and welcomes suggestions for reducing this level of effort. Send comments ( referencing OMB Control Number) to the Director, Collection Strategies Division, U. S. EPA ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460.   We may not construe, claim or imply that our use of the ENERGY STAR Indoor Air Package label constitutes federal government approval, acceptance, or endorsement of our company, homes or services;   Based on the results of the pilot, EPA may revise the program's name, specifications, and marketing support; and   If the Indoor Air Package Program is offered nationally, we will update our ENERGY STAR Partnership Agreement to continue to receive recognition for our participation.

Authorized Company Representative:

Printed Name: ____________________________________________

Company Name: __________________________________________

Title: ____________________________________________________

Signature: ________________________________________________

Date: ___________________________________________________

Mail this completed form to: OR Fax this completed form to:

ENERGY STAR for Homes ( 202) 343 2200 US EPA ( mail code 6202J) 1200 Pennsylvania Ave, NW Washington, DC 20460 Authorized EPA Representative:

Kathleen Hogan Director Climate Protection Partnership Division Signature: _

Date _


[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Page 48667]
[FR Doc No: 2013-19291]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12576-011]

Western Minnesota Municipal Power Agency; Notice of Application
Accepted for Filing, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment to License
    b. Project No: 12576-011
    c. Date Filed: June 04, 2013
    d. Applicant: Western Minnesota Municipal Power Agency
    e. Name of Project: Red Rock Hydroelectric Project
    f. Location: The project is located at the U.S. Army Corps of
Engineers Lake Red Rock Dam on the Des Moines River in Marion County,
Iowa.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r
    h. Applicant Contact: Raymond J. Wahle PE, Missouri River Energy
Services, 3724 W. Avera Drive, PO Box 88920, Sioux Falls, SD 57109,
Phone:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>    i. FERC Contact: Mr. Mo Fayyad<PHONE_NUMBER> or<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: September 9, 2013.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments. Please include the
project number (P-12576-011) on any comments or motions filed.
    k. Description of Request: The applicant proposes to amend the
unconstructed project's license to modify the design of the intake
structure, the upstream submerged weir, the penstock geometry, the
penstock liner, the reinforced concrete diaphragm wall, the cutoff
wall, the temporary construction laydown yard/future vehicle turnaround
at the intake structure, the flow bypass conduit, and the substation
elevation. The applicant does not propose any change to the authorized
installed capacity or maximum hydraulic capacity. The proposed changes
would revise the project boundary, which would increase the area of
Lands of the United States within the project boundary from 28.3 acres
to 31.1 acres.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-12576-011) excluding the last
three digits in the docket number field to access the document. You may
also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, call 1-866-
208-3676 or email<EMAIL_ADDRESS>for TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). Any filing made by an intervener must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: August 5, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-19291 Filed 8-8-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26577-26580]
[FR Doc No: 2018-12339]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2018-N-1863]

Medical Devices; Orthopedic Devices; Classification of the In
Vivo Cured Intramedullary Fixation Rod

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the in vivo cured intramedullary fixation rod into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the in vivo cured intramedullary fixation rod's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective June 8, 2018. The classification was
applicable on December 19, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Allen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1512, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the in vivo cured intramedullary
fixation rod as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by

reducing regulatory burdens by placing the device into a lower device
class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On December 28, 2016, IlluminOss Medical, Inc. submitted a request
for De Novo classification of the IlluminOss Photodynamic Bone
Stabilization System. FDA reviewed the request in order to classify the
device under the criteria for classification set forth in section
513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 19, 2017, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 888.3023. We have named
the generic type of device in vivo cured intramedullary fixation rod,
and it is identified as a prescription implanted device consisting of a
balloon that is inserted into the medullary canal of long bones for the
fixation of fractures. The balloon is infused with, and completely
encapsulates, a liquid monomer that is exposed to a curing agent that
polymerizes the monomer within the balloon creating a hardened rigid
structure.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--In Vivo Cured Intramedullary Fixation Rod Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction resulting from:  Biocompatibility evaluation and
                                          Labeling.
     Balloon leakage...........
     Device materials..........
Infection, including wound               Sterilization validation,
 complications.                           Reprocessing validation, Shelf
                                          life testing, Pyrogenicity
                                          testing, and Labeling.
Bone fracture resulting from:..........  Non-clinical performance
                                          testing and Labeling.
     Device bending, cracking,
     or fracture.
     Device migration or
     instability, including initial
     inadequate fixation.
     Inability to properly
     deploy or remove device.
Soft tissue damage including             Non-clinical performance
 transection or laceration of neural,     testing and Labeling.
 vascular, or muscular structures.
Pain and/or loss of function resulting   Non-clinical performance
 from:.                                   testing and Labeling.
     Balloon leakage...........
     Device bending, cracking,
     or fracture.

     Device migration or
     instability, including initial
     inadequate fixation.
     Inability to properly
     deploy or remove device.
Revision...............................  Non-clinical performance
                                          testing and Labeling.
Electric shock or interference with      Electrical safety testing,
 other electrical devices.                Electromagnetic compatibility
                                          testing, and Labeling.
Exothermic reaction leading to tissue    Non-clinical performance
 injury.                                  testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, in vivo cured intramedullary
fixation rods are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 is revised to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  888.3023 to subpart D to read as follows:

Sec.  888.3023  In vivo cured intramedullary fixation rod.

    (a) Identification. An in vivo cured intramedullary fixation rod is
a prescription implanted device consisting of a balloon that is
inserted into the medullary canal of long bones for the fixation of
fractures. The balloon is infused with, and completely encapsulates, a
liquid monomer that is exposed to a curing agent which polymerizes the
monomer within the balloon creating a hardened rigid structure.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Mechanical testing must be conducted on the final device to
assess burst, abrasion, bending, and torsion in static and dynamic
conditions.
    (ii) Mechanical testing must demonstrate the integrity of the
balloon including testing for leaks, ruptures, and release of cured/
uncured material.
    (iii) Performance testing must demonstrate that the device can be
inserted and removed.
    (iv) Performance testing must demonstrate the ability, in the event
of a leak, to remove the uncured material from its in vivo location.
    (v) Performance testing must demonstrate the reliability and
accuracy of the curing method used.
    (vi) Thermal safety testing must be conducted to evaluate the
temperature rise during curing.
    (2) Electrical safety, electromagnetic compatibility (EMC) testing,
and electromagnetic interference (EMI) testing must be conducted for
all electrical components.
    (3) All patient-contacting components must be demonstrated to be
biocompatible.
    (4) Performance data must demonstrate the sterility and
pyrogenicity of patient contacting components of the device that are
provided sterile.
    (5) Performance data must validate the reprocessing instructions
for any reusable components or instruments.
    (6) Performance data must support the shelf life of the system by
demonstrating continued sterility, package integrity, and system
functionality over the established shelf life.
    (7) Technological characterization of the device must include
materials, curing agents, and a description of the operating principles
of the device, including the delivery system and devices which initiate
the curing process.
    (8) Labeling must include the following:
    (i) A detailed summary of the device technical parameters.
    (ii) Information describing all materials of the device.
    (iii) Information describing how to perform the procedure and use
the device, including the delivery system and devices which initiate
the curing process, as well as how to remove the device and any uncured
materials.
    (iv) A shelf life.
    (v) Validated methods and instructions for reprocessing any
reusable components or instruments.

    Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12339 Filed 6-7-18; 8:45 am]
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