[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42843-42845]
[FR Doc No: 2021-16695]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3741]

Remanufacturing of Medical Devices; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability; Extension of
Comment Period

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending
the comment period for the notice of availability that appeared in the
Federal Register of June 24, 2021. In the notice of availability, FDA
requested comments on draft guidance for industry and FDA staff
entitled ``Remanufacturing of Medical Devices.'' The Agency is taking
this action in response to a request for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of
availability published June 24, 2021 (86 FR 33305). Submit either
electronic or written comments on the draft guidance by September 22,
2021, to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3741 for ``Remanufacturing of Medical Devices.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Remanufacturing of Medical Devices'' to the Office of Policy,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Katelyn Bittleman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002, 240-
402-1478; Joshua Silverstein, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1615, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 24, 2021, FDA published a notice of
availability with a 60-day comment period to request comments on the
draft guidance for industry and FDA staff entitled ``Remanufacturing of
Medical Devices.''
    The Agency has received a request for a 30-day extension of the
comment period. The request conveyed concern that the current 60-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response.
    FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until September 22, 2021.
The Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Remanufacturing of Medical

Devices.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or from the Center for
Biologics Evaluation and Research at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at
https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download
an electronic copy of ``Remanufacturing of Medical Devices'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 17048 and complete
title to identify the guidance you are requesting.

    Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-16695 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Page 45598]
[FR Doc No: 2012-18737]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-93-001]

Enogex LLC; Notice of Filing

    Take notice that on July 19, 2012, Enogex LLC filed to revise its
Storage Statement of Operating Conditions as more fully described in
the filing.
    Any person desiring to participate in this rate filing must file 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 notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    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 7 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 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>.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, July 31, 2012.

    Dated: July 23, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-18737 Filed 7-31-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Rules and Regulations]
[Pages 13936-13945]
[FR Doc No: 2022-05042]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2020-0719; FRL-9530-01-R1]

Air Plan Approval; Connecticut; Regulations To Limit Premises-
Wide Actual and Potential Emissions From Major Stationary Sources of
Air Pollution

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of
Connecticut. This revision approves into the Connecticut SIP state
regulations that apply restrictions on emissions of criteria pollutants
for which EPA has established National Ambient Air Quality Standards.
Separately, we are also approving Connecticut regulations that apply
restrictions on emissions of hazardous air pollutants (HAPs). The
Connecticut regulations impose legally and practicably enforceable
emissions limitations restricting eligible sources' actual and
potential emissions below major stationary source thresholds, if a
source chooses to be covered by the regulations. Such restrictions
generally allow eligible sources to avoid having to comply with
reasonably available control technology (RACT) that would otherwise
apply to major stationary sources, title V operating permit
requirements, or other requirements that apply only to major stationary
sources. This action is being taken under the Clean Air Act.

DATES: This rule is effective on April 11, 2022. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of April 11, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2020-0719. 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, i.e.,
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 at https://www.regulations.gov or at the U.S.
Environmental Protection Agency, EPA Region 1 Regional Office, Air and
Radiation Division, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays and facility
closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Susan Lancey, Air Permits, Toxics and
Indoor Programs Branch, U.S. Environmental Protection Agency, EPA
Region 1, 5 Post Office Square--Suite 100, (Mail code 05-2), Boston, MA
02109-3912, telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On February 8, 2021 (86 FR 8574), EPA published a notice of
proposed rulemaking (NPRM) for the State of Connecticut.
    The NPRM proposed approval of a SIP revision consisting of
Regulations of Connecticut State Agencies (RCSA) section 22a-174-33a,
Limit on Premises-wide Actual Emissions Below 50% of Title V
Thresholds, effective September 24, 2020, and RCSA section 22a-174-33b,
Limit on Premises-wide Actual Emissions Below 80% of Title V
Thresholds, effective September 24, 2020, as the regulations relate to
criteria pollutants. The Connecticut regulations impose legally and
practicably enforceable emissions limitations restricting eligible
sources' actual and potential emissions below major stationary source
thresholds, if a source chooses to be covered by the regulations. The
NPRM separately proposed approval of RCSA sections 22a-174-33a and 22a-
174-33b under section 112(l) of the CAA, as the regulations relate to
HAPs. As noted earlier, RCSA sections 22a-174-33a and 22a-174-33b are
designed to limit air pollutant emissions from major stationary sources
to below major stationary source thresholds by including legally and
practicably enforceable restrictions on potential and actual emissions.
    The formal SIP revision was submitted by Connecticut on October 26,
2020, supplemented on January 12, 2022. In the January 12, 2022 letter,
Connecticut requested to withdraw provision RCSA 22a-174-33b(d)(6) from
consideration as part of the SIP, clarified its interpretation of
several provisions, and provided additional information concerning
implementation of the regulations.
    Connecticut submitted a December 21, 2020 letter requesting
approval of RCSA sections 22a-174-33a and 22a-174-33b under section
112(l) of the CAA.
    The rationale for EPA's proposed approval of the SIP revision and
CAA 112(l) submittal is explained in the NPRM and will not be restated
here.

II. Response to Comments

    We received three comments that supported this action. One
commenter stated that they support approval of the rule. One commenter
stated it is important that air quality plans are passed and that clean
air quality is crucial for anyone in any state. One commenter supports
approval of the rule and believes that a limit on emissions should
occur because of concerns that an increase of pollution affects air
quality; the commenter also made additional statements not germane to
this action. The following provides our responses to adverse comments
received.
    Comment 1: The commenter could not access the docket for this
rulemaking and could not find any results on Regulations.gov.
    Response: The docket was available on February 8, 2021, the
publication date of the proposal. The commenter emailed comments on
February 7th, after the pre-publication proposed rule was posted, but
one day prior to the proposed rule's publication in the Federal
Register on February 8th. The docket only becomes available on the
actual date that a Rulemaking publishes in the Federal Register, and
that it is typically available by 10 a.m. EST. We informed the
commenter on February 8th that the docket was available.
    Comment 2: The commenter was concerned that RCSA section 22a-174-

33a ignores, in the definition of Hazardous Air Pollutant (HAP) in
section (a)(4), HAPs added to the CAA 112(b) HAPs list. The commenter
pointed out that there are several petitions in front of EPA, being
reconsidered by EPA, or headed for or in litigation to add HAPs to the
HAPs list. The commenter asserted that 22a-174-33a would ignore these
added HAPs and thus isn't approvable. The commenter stated that without
a change in the regulation to address this issue, sources could be over
the major source threshold, and would not be covered by the regulation,
by virtue of a HAP which is added to the HAP list but does not appear
in CAA 112(b). The commenter submitted the same comment in relation to
Connecticut's regulation at RCSA 22a-174-33b.
    Response: The definition of Hazardous Air Pollutant (HAP) in
Section 22a-174-33a(a)(4) and 33b(a)(10) means ``notwithstanding the
definition in Section 22a-174-1 of the Regulations of Connecticut State
Agencies (RCSA), any air pollutant listed in section 112(b) of the
Federal Clean Air Act excluding any air pollutants that are removed
from such list.'' We agree that Connecticut's definition does not
include air pollutants that are added to the list. However, this should
not be a reason to disapprove Connecticut's requested CAA 112(l)
submission. On January 5, 2022, EPA added a new HAP, 1-bromopropane, to
the CAA HAP list by amending 40 CFR part 63, subpart C. (See 87 FR 393)
As a result, Connecticut should now amend its regulations to add 1-
bromopropane to its definition of Hazardous Air Pollutant so that
sources emitting 1-bromopropane may be covered by Connecticut's
regulation. EPA could then approve a subsequent State submittal
including 1-bromopropane under Section 112(l). It is not a legal
requirement of the CAA that all sources be regulated by the regulation
in question. A source that is a major source if not regulated pursuant
to this CAA 112(l) approval will have to comply with any applicable
major source requirements unless and until Connecticut amends its rule
to include the added HAP. In a letter dated January 12, 2022,
Connecticut Department of Energy and Environmental Protection (DEEP)
clarified its implementation with respect to HAPs added to the HAP
list. Connecticut's January 12, 2022 letter provided that ``To the
extent that a hazardous air pollutant (HAP) is added to the Clean Air
Act (CAA) HAP list but does not appear in CAA Section 112(b), if DEEP
identifies a facility with potential emissions of such a HAP not listed
in CAA Section 112(b), DEEP shall not allow such facility to operate
under RCSA section 22a-174-33a or RCSA section 22a-174-33b until such
time as DEEP adopts regulatory revisions to include such a newly listed
HAP within the definitions that apply to RCSA sections 22a-174-33a and
22a-174-33b. As 1-bromopropane has recently been added to the CAA list
of HAPs and does not appear in CAA Section 112(b), neither RCSA section
22a-174-33a nor RCSA section 22a-174-33b is a regulatory compliance
option available for a facility that emits 1-bromopropane to limit the
potential to emissions [sic] of criteria pollutants and hazardous air
pollutants.'' Thus, the commenter's concerns are unwarranted.
    Comment 3: The commenter was concerned that section (d)(1) of
Connecticut's regulation ignores VOC and NOX emissions in
areas that are marginal, moderate, or extreme ozone nonattainment
areas, as well as areas designated attainment but located inside the
ozone transport region. Connecticut currently contains one marginal
ozone nonattainment area and one moderate nonattainment area for the
2015 ozone National Ambient Air Quality Standard (NAAQS). The commenter
asserted that the fact that those areas are currently designated as
serious nonattainment areas for the 2008 ozone NAAQS does not fix this
problem as that could change in the future if those areas were
redesignated to attainment for the 2008 ozone NAAQS. The commenter
believes the current rule would leave a gap by not placing emission
limits on NOX and VOC emissions and thus is not approvable.
The commenter asserts that the same is true if those areas were to be
``bumped up'' to extreme nonattainment areas for the 2008 ozone NAAQS.
The same comment was submitted for Connecticut's regulation at RCSA
22a-174-33b.
    Response: By definition, any source in Connecticut eligible to be
regulated by this rule could avail itself of the limits contained
within the regulation. The definition of ``Serious non-attainment area
for ozone'' in Connecticut's SIP-approved regulation at RCSA Section
22a-174-1 means ``all towns within the State of Connecticut, except
those towns located in the severe non-attainment area for ozone.'' The
SIP-approved definition of ``Severe non-attainment area for ozone'' in
Connecticut's regulation at RCSA 22a-174-1 means the towns of Bethel,
Bridgeport, Bridgewater, Brookfield, Danbury, Darien, Easton,
Fairfield, Greenwich, Monroe, New Canaan, New Fairfield, New Milford,
Newtown, Norwalk, Redding, Ridgefield, Sherman, Stamford, Stratford,
Trumbull, Weston, Westport, and Wilton. These serious and severe non-
attainment areas, as defined, represent Connecticut's nonattainment
area classifications under the one-hour ozone standard, encompassing
all locations in the State of Connecticut and thereby all sources
eligible to be regulated by this rule. Because Connecticut's
regulations define all areas as serious nonattainment for ozone, except
for towns located in a severe nonattainment area for ozone, the state
definitions are equivalent to or more stringent than the current
classifications under the 2008 and 2015 ozone standards. EPA can
request in the future that Connecticut amend its regulation if any area
in Connecticut were to be reclassified. Reclassifying an area, for
example from serious to severe, would be done through a proposed and
final rulemaking process. Connecticut would then have to make any
regulatory changes as needed. In addition, in a letter dated January
12, 2022, Connecticut stated that ``To the extent that EPA changes the
ozone attainment designations applicable to Connecticut, DEEP will act
with all due haste to make necessary revisions to the relevant
definitions in Connecticut's regulations and in the SIP.''
    Comment 4: The commenter was concerned that RCSA 33a(d)(4)(F) is a
``director's discretion'' provision which the commenter asserted is
illegal. The same comment was submitted for Connecticut's regulation at
RCSA 22a-174-33b(d)(4)(F).
    Response: Connecticut's regulations at sections 33a(d)(4)(F) and
33b(d)(4)(F) provide that ``if the data in subparagraphs (A), (B), (C),
(D) and (E) of this subdivision are unavailable, the emission rate
shall be calculated using another source of emissions data that is
approved by the Commissioner and the Administrator. Such approval shall
be obtained prior to operating in accordance with this section.'' In a
letter dated January 12, 2022, Connecticut clarified implementation of
these provisions. Connecticut stated that ``Sections 22a-174-
33a(d)(4)(F) and 22a-174-33b(d)(4)(F) of the Regulations of Connecticut
State Agencies (RCSA) are the final alternatives in a hierarchy of data
acceptable for a source owner to determine actual emissions. The two
provisions allow for the use of data not otherwise specified in the
hierarchy with the prior approval of the Commissioner and
Administrator. DEEP understands the approval of the Commissioner and
Administrator to be achieved via DEEP's submission of a

single-source SIP revision that would be subject to the procedural
requirements of 40 CFR part 51, subpart F, and DEEP will proceed
according to this understanding should any requests be received under
one of these two provisions. DEEP further understands that such
exercise of discretion will not have an effect on the existing SIP
requirement until such time as the single-source SIP revision has been
approved by the Administrator.'' The commenters concerns are
unwarranted because any alternatives approved by EPA and DEEP under
RCSA Sections 33a(d)(4)(F) or 33b(d)(4)(F) would be accomplished by a
SIP revision with an opportunity for public review and comment.
    Comment 5: The commenter stated that the regulations are not
enforceable as a practical matter because they do not ensure actual
emissions stay below the thresholds in section (d)(1) of the
regulation. Section (d)(4)(A) requires the use of a Continuous Emission
Monitoring System (CEMS) if the data is available. The commenter was
concerned that while CEMS are a good monitoring method, Section
(d)(4)(A) does not require data substitution or gap filling when CEMS
data for certain time periods are not available, and potential to emit
and actual emissions that trigger title V and reasonably available
control technology (RACT) applicability don't allow for ignoring
emissions. The commenter asserted that, for example, CEMS are often not
required to gather data during periods of startup and shutdown even
though some emission sources, such as combustion devices, can have
substantially higher emissions during those periods. The commenter
cites generally to Weiler v. Chatham Forest Products, 392 F.3d 532, 535
(2nd Cir. 2004). Also, the commenter stated that CEMS have downtime,
both planned downtime to do testing and also unplanned downtime, and
section (d)(4)(A) of Connecticut's regulation does not address these
situations so it would be arbitrary and capricious for EPA to approve
this regulation.
    The commenter was concerned that Section (d)(4)(B) suffers from
similar flaws as discussed above but much worse. For example, the
commenter asserted that stack tests are not performed during startups
or shutdowns. The commenter stated that by using stack test data to
calculate ``actual'' emissions on an annual basis, Section (d)(4)(B)
ignores an important part of the problem, that is actual emissions
during periods of startup, shutdown, process malfunctions, control
equipment malfunctions or operations at different parameters that are
not startup and shutdown. The commenter stated that the problem isn't
limited to startup or shutdown. The commenter stated that the fact that
a source emitted at a certain rate during a stack test does not prove
that a source emits at that same rate every other hour that it
operates. The commenter stated that this flaw is further compounded by
the lack of a requirement for the frequency of stack testing, because a
stack test performed 20 years ago, for example, provides no reliable
data on current emissions.
    The commenter was concerned that Section (d)(4)(C) of Connecticut's
regulation suffers from the same problems discussed above but noted
that it also ignores a host of other considerations. The commenter
questioned whether, for example, the source that is going to use this
rule is defective in some way or not properly installed. The commenter
stated that if that is the case, the manufacturers' testing doesn't
provide reliable data on emissions from the source in question. The
commenter pointed to the introduction section of AP-42, Compilation of
Air Pollutant Emission Factors, which states ``Average emissions differ
significantly from source to source and, therefore, emission factors
frequently may not provide adequate estimates of the average emissions
for a specific source. The extent of between-source variability that
exists, even among similar individual sources, can be large depending
on process, control system, and pollutant. Although the causes of this
variability are considered in emission factor development, this type of
information is seldom included in emission test reports used to develop
AP-42 factors.'' As a result, some emission factors are derived from
tests that may vary by an order of magnitude or more. Similarly, the
commenter was concerned whether the conditions of the source in any way
match the conditions of the manufacturer's test. The commenter stated
that if the manufacturer did its testing in a high-altitude desert,
that could create radically different conditions from sea level winter
conditions than a source in Connecticut faces. The commenter stated
that this difference in altitude and weather can result in very
different combustion and evaporation conditions which change emissions.
    The commenter was concerned that Sections (d)(4)(D) and (E) are
much worse than prior sections of Connecticut's regulation and use
calculations which are in no way rationally related to actual
emissions. The commenter believes that these sections allow the use of
absolutely no actual emissions data to determine ``actual'' emissions
and that they suffer from most of the same faults discussed above.
Furthermore, the commenter questioned how a pertinent material balance
would account for thermal NOX emissions, that is
NOX that is formed in combustion processes because our air
is 78% nitrogen, regardless of the composition of the fuel. The
commenter stated that thermal NOX formation is greatly
influenced by temperature in combustion processes but (d)(4)(D) does
not require any parametric monitoring, much less restrictions, on
operating temperature. Thus, the commenter states the rule is ignoring
this important aspect of the problem such that the calculated emissions
from application of (d)(4)(D) would not be rationally related to actual
emissions. As to AP-42, the commenter stated that EPA's position has
been that AP-42 should not be used for ensuring compliance with
synthetic minor limits. The commenter stated that AP-42 clearly states
that it is used for ``estimating emissions'', See, e.g., AP-42
Introduction at 1, but a synthetic minor limit is not an estimate. The
commenter stated that actual and potential to emit emissions have to be
below the applicable threshold. The commenter asserted that actual
emissions and an estimate of emissions are two separate things; that
AP-42 emission factors come with ratings. The commenter stated that a
``D'' rating is below average and an ``E'' rating is poor. See AP-42
Introduction at 10. The commenter stated that Section (d)(4)(E) allows
the use of even emission factors which EPA itself describes as
``Poor'', and it is arbitrary for EPA to allow the use of ``Poor''
``estimates'' to provide actual emissions.
    Therefore, the commenter believes EPA must disapprove this SIP
submittal.
    The commenter submitted the same comments in relation to
Connecticut's regulation at RCSA 22a-174-33b.
    Response: The Commenter asserts that ``the regulations are not
enforceable as a practical matter because they do not ensure actual
emissions stay below the thresholds in section (d)(1).'' As a general
matter, a source may avoid treatment as a major source if its
``potential to emit'' (PTE) pollutants is below the relevant major
source thresholds. See for example the definition of ``major source''
in 40 CFR part 63, subpart A, and 40 CFR 70.2. In addition, 40 CFR 63.2
defines ``potential to emit'' as the maximum capacity of a stationary
source to emit a pollutant under its physical and operational design.
Any physical or operational limitation on the capacity of the

stationary source to emit a pollutant, including air pollution control
equipment and restrictions on hours of operation or on the type or
amount of material combusted, stored, or processed, shall be treated as
part of its design if the limitation or the effect it would have on
emissions is enforceable. The Connecticut regulations under RCSA
section 22a-174-33a allow sources to elect to comply with emission
limitations set at 50% of the title V operating permit program
thresholds for a major source; or, alternatively, under RCSA section
22a-174-33b, certain specified source categories may commit to be
limited to emissions up to, but no more than, 80% of the title V
operating permit program thresholds for a major stationary source
provided the owner or operator conducts the additional specified
monitoring and any other additional requirements required by RCSA 22a-
174-33b for the relevant source category. The commenter essentially
maintains that the limits in question are not enforceable because of
flawed or inadequate methods for determining compliance with the
applicable limits.
    Connecticut's RCSA sections 22a-174-33a and 22a-174-33b require the
owner or operator committing to operate pursuant to the applicable
regulations to submit a notification to the State and to keep records
that include, among other things, calculation of a source's actual
emissions on a monthly and 12-month rolling basis for regulated air
pollutants and a detailed description of the methodology used to
calculate those actual emissions. The methodology used by an eligible
source to calculate emissions must be selected from a preferential
hierarchy of methodologies explicitly identified in the regulations.
    The commenter cites generally to Weiler v. Chatham Forest Products,
392 F.3d 532, 535 (2nd Cir. 2004), which held that a group of citizens
could bring an action under CAA 304(a)(3) against an owner or operator
of a proposed source for which New York had issued a synthetic minor
source construction permit, where the citizens contended that the
controls or limitations on the source's potential to emit were neither
practicably effective nor enforceable and where the source was to be
constructed in a nonattainment area. The Court concluded that the plain
language of the CAA allowed citizen suits to challenge a state's
determination that no major source permit is necessary. In reaching
this conclusion, the Court reviewed EPA's treatment of a source's
``potential to emit,'' as relevant to determining whether a source is a
major source, and summarized EPA's position that a source that
otherwise might be considered a major emitting facility may be treated
as not such a source if ``there are legally and practicably enforceable
mechanisms in place to make certain that the emissions remain below the
relevant levels.'' The Court did not reach the question of whether the
controls or limitations at issue in New York were ``legally and
practicably enforceable.'' Connecticut's regulation is legally
enforceable because it was properly promulgated under state law. In
addition, Connecticut's regulation states that no owner or operator of
any premises operating in accordance with the rule shall cause or allow
the emission of any regulated air pollutant during each and every
consecutive 12-month period to be equal to or exceed the emission
limitations in the regulation.
    Connecticut's approach was developed in accordance with an EPA
guidance document titled ``Options for Limiting Potential to Emit of a
Stationary Source under Section 112 and Title V of the Clean Air Act,''
issued by John Seitz, Office of Air Quality Planning and Standards
(OAQPS) to EPA Air Division Directors, dated January 25, 1995 \1\
(January 25, 1995 OAQPS PTE memorandum). This guidance lays out the key
criteria for practical enforceability of limits on PTE, which EPA later
incorporated into its rationale, in part, for the 2002 New Source
Review (NSR) Reform rule (2002 final rule).\2\ In the 2002 final rule,
EPA stated that practical enforceability for a source-specific permit
will be achieved if the permit's provisions specify: (1) A technically-
accurate limitation and the portions of the source subject to the
limitation; (2) the time period for the limitation (hourly, daily,
monthly, and annual limits such as rolling annual limits); and (3) the
method to determine compliance, including appropriate monitoring,
recordkeeping, and reporting. For rules and general permits that apply
to categories of sources, practicable enforceability additionally
requires that the provisions: (1) Identify the types or categories of
sources that are covered by the rule; (2) where coverage is optional,
provide for notice to the permitting authority of the source's election
to be covered by the rule; and (3) specify the enforcement consequences
relevant to the rule. EPA also stated in the 2002 final rule that ``
`[e]nforceable as a practical matter' will be achieved if a requirement
is both legally and practically enforceable.'' Among several other
provisions, the 2002 final rule established provisions for Plantwide
Applicability Limitations (PALs).\3\
---------------------------------------------------------------------------

    \1\ The January 25, 1995 OAQPS memo was predicated on a view
that federal enforceability is an essential element in establishing
potential to emit limits. A court decision in the National Mining
Association (NMA) v. EPA, 59 F.3d 1351, 1363-1365 (D.C. Cir. 1995)
remanded the Federal enforceability provision. Consistent with this
decision, EPA's longstanding policy allows for any physical or
operational limitation on the capacity of the stationary source to
emit a pollutant to be treated as part of the source's design if the
limitation or the effect it would have on emissions is, first,
either federally enforceable or legally enforceable by a state or
local permitting authority and, second, practicably enforceable. See
December 20, 1999, memorandum titled ``Third Extension of January
25, 1995 Potential to Emit Transition Policy.'' Available in the
docket for this rulemaking.
    \2\ PSD and NSR: Baseline Emissions Determination, Actual-to-
Future-Actual Methodology, Plantwide Applicability Limitations,
Clean Unit, Pollution Control Projects. 67 FR 80190-80191 (December
31, 2002).
    \3\ The PAL regulations were upheld by the Court in New York v.
EPA, 413 F.3d 3, 22 (D.C. Cir. 2005).
---------------------------------------------------------------------------

    To make a PAL enforceable as a practical matter, the EPA
regulations require a source to conduct monitoring, recordkeeping and
reporting of the actual emissions of a PAL pollutant on a 12-month
rolling total basis. A PAL monitoring system must employ one or more of
four general approaches meeting minimum requirements specified in the
regulations. These include mass balance calculations for activities
using coatings or solvents, CEMS, continuous parameter monitoring
systems (CPMS) or predictive emissions monitoring systems (PEMS), and
emission factors. 40 CFR 52.21(aa)(12)(i)(b), (aa)(12)(ii). The
regulations also provide for alternative monitoring approaches that are
approved by the reviewing authority. 40 CFR 52.21(aa)(12)(i)(c).
Connecticut's RCSA Sections 33a and 33b contain monitoring and
recordkeeping requirements that are substantially consistent with those
in the EPA PAL regulations, supporting the conclusion that the limits
in Connecticut's RCSA Sections 33a and 33b are enforceable as a
practical matter.
    As stated above, EPA's January 25, OAQPS PTE memorandum and EPA's
2002 final rule provide specific criteria for practical enforceability
to be achieved. Connecticut's rules include requirements that meet
these criteria. Specifically, 33a(d) and 33b(d) specify technically-
accurate emission limitations that apply premises-wide on a 12-month
rolling annual basis. Sections 33a(d) and 33b(d) specify a preferential
hierarchy for determining compliance with the emission limitations, as
well as monitoring, reporting and recordkeeping. In addition, Sections
33a(g) and 33b(h) require a notification to the permitting

authority for sources that elect coverage under the rules. Sections
33a(b) and 33b(c) include duty to comply provisions, as well as a
required certification statement in 33a(c) and 33b(k) to be submitted
that the information submitted is true, accurate and complete. These
provisions require the certifier to acknowledge that any false
statements may be punishable as a criminal offense under Connecticut's
statutes. In addition, Sections 33a(j) and 33b(k) provide that nothing
in these sections precludes the Commissioner from requiring a source to
obtain a title V operating permit. Lastly, Sections 33a(f)(2)(A) and
33b(g)(3)(A) require the owner or operator to determine the cause of
any emission limitation exceedance, correct such exceedance, mitigate
its results, and prevent any further exceedance.
    In addition to providing practical enforceability criteria, the
January 25, 1995 OAQPS PTE memo indicates that one approach to
establishing appropriately enforceable limitations is by general rules
creating enforceable restrictions at one time for many sources. The
memo discusses a California model rule developed in consultation with
EPA as an example of such an approach. The California model rule is
designed to place smaller sources under annual emissions limits which
restrict their ``potential to emit'' and thus their exposure to ``major
source'' requirements of the Clean Air Act. The California model rule
ensures compliance with the annual limit through a series of
recordkeeping and reporting requirements. These requirements are
tapered to reduce burdens as source size (as it relates to emissions)
decreases. The California model rule provides a hierarchy of data for
sources to calculate actual emissions for every consecutive 12-month
period.
    Connecticut's RCSA Sections 33a and 33b are consistent with the
approach taken in the California model rule, cited approvingly as an
example by EPA. The California model rule and Connecticut's rules
require a detailed hierarchy for sources to calculate emissions.
Specifically, Connecticut's Section 22a-174-33a(d)(4) requires:

    (A) If data are available from CEM equipment, such data shall be
used to determine the rate of emissions. Only CEM installed,
operated, and certified in accordance with a permit or order,
regulation issued or administered by the Commissioner or the
Administrator, or a Commissioner approved voluntarily installed CEM
may be used to satisfy the requirements of this subdivision;
    (B) If the data in subparagraph (A) of this subdivision are
unavailable but stack testing data are available, such stack testing
data shall be used to determine the rate of emissions, provided such
testing was conducted in accordance with protocols approved in
writing by the Commissioner or the Administrator in advance of
testing and a representative of the Commissioner or the
Administrator was provided the opportunity to witness such testing;
    (C) If the data in subparagraphs (A) and (B) of this subdivision
are unavailable, the rate of emissions shall be calculated using
data supplied by the manufacturer of the subject emission unit or
units, which data were derived from EPA approved emissions testing
of such unit performed by or for the manufacturer;
    (D) If the data in subparagraphs (A), (B) and (C) of this
subdivision are unavailable, the rate of emissions shall be
calculated using data derived from an analysis of pertinent material
balances;
    (E) If the data in subparagraphs (A), (B), (C) and (D) of this
subdivision are unavailable, the rate of emissions shall be
calculated using the data or emissions estimation technique from the
following EPA publications that results in the highest rate of
emissions:
    (i) Compilation of Air Pollutant Emission Factors (AP-42),
    (ii) AIRS Facility Subsystem Emission Factors, or
    (iii) The Emission Inventory Improvement Program; and
    (F) If the data in subparagraphs (A), (B), (C), (D) and (E) of
this subdivision are not available, the emission rate shall be
calculated using another source of emissions data that is approved
by the Commissioner and the Administrator. Such approval shall be
obtained prior to operating in accordance with this section.

    Connecticut's rules include a preferential hierarchy to use the
best data to calculate actual emissions when available. Actual
emissions are required to be calculated for the premises for each and
every consecutive 12-month period. Connecticut set the emissions
limitation in Section 33a at 50% of the major source threshold to
create a sufficient buffer to account for variability that may exist in
calculating emissions using the methods allowed in the preferential
hierarchy. Section 33b sets the premises wide limit to below 80% of the
major source threshold for certain source categories and requires
additional monitoring and recordkeeping for these source categories.
    In addition to the preferential hierarchy, Connecticut's RCSA
Sections 33a and 33b also require detailed records and emissions
calculations including a log of:

    (i) The total amount of fuels, solvents, coatings, raw
materials, or other such material, used by each emission unit during
each month,
    (ii) An identification of such fuels, solvents, coatings, raw
materials, or other such material used, by each emission unit during
each month,
    (iii) The actual operating hours of each emission unit during
each month, as necessary to calculate emissions,
    (iv) Any other documentation the Commissioner deems necessary to
reliably calculate the emission of air pollutants regulated under
this section, and
    (v) All purchase orders, invoices, Material Safety Data Sheets,
test results, certifications or other documents necessary to verify
information and calculations in the monthly log.

    In addition, Connecticut's RCSA 33a and 33b require sources to
maintain a log of annual actual emissions of each regulated air
pollutant emitted from the premises, including a detailed description
of the methodology the owner or operator used to calculate such
emissions and the basis thereof.
    Connecticut's 33a and 33b also require the facility to submit
annual compliance certifications. Section 33b, which limits sources to
up to, but not more than, 80% of the major title v operating source
threshold, requires sources with actual emissions >50% of the major
source threshold to report emissions for each and every 12-month
period. Sections 33a and 33b further allow DEEP to request any
additional information in writing to verify actual emissions. (See RCSA
22a-174-33a(f) and 33b(g)) Connecticut's rules also require sources to
maintain records of any other documentation the Commissioner deems
necessary to reliably calculate the emission of air pollutants
regulated. (See RCSA 22a-174-33a(e)(1)(B)(iv) and 33b(f)(1)(B)(iv))
    In addition to this regulatory oversight of sources by the State,
in a letter dated January 12, 2022, Connecticut provided that:

    DEEP has a robust federally enforceable minor source new source
review (NSR) permit program that governs operations of individual
pieces of equipment. Section 22a-174-33a and Section 22a-174-33b do
not shield pieces of equipment from Connecticut's minor source NSR
program. Consequently, pieces of equipment subject to minor source
NSR at facilities operating under RCSA Section 22a-174-33a or
Section 22a-174-33b would be subject to Best Achievable Control
Technology, ambient air quality impact analysis, monitoring, record
keeping and reporting to assure compliance with individual pollutant
limits contained in the permits. Permits for many pieces of
equipment require periodic emissions testing and/or continuous
emission monitoring systems (CEMS) to assure compliance with permit
limits. The permits contain limits on allowable materials, material
composition and material throughput and include monitoring, record
keeping and reporting to assure that sources are operating as
expected. Where applicable, many permits limit startup and shutdown
emissions and require

monitoring and record keeping of startup and shutdown emissions to
assure compliance with annual emissions limits.
    Finally, concerning DEEP's compliance oversight of sources
operating under RCSA sections 22a-174-33a and -33b, DEEP offers the
following information. . . . DEEP's five-year inspection frequency
for RCSA section 22a-174-33b sources is consistent with the
frequency stipulated in EPA's CAA CMS policy for synthetic minor 80
percent (SM-80) sources. Note that under EPA's CAA CMS, an SM-80
source is one with a premises-wide potential to emit (including any
federally or legally and practicably enforceable physical or
operational limitations on such source's capacity) greater than or
equal to 80% and less than 100% of the major source thresholds,
whereas an RCSA section 22a-174-33b source is limited to premises-
wide emissions less than 80% of the major source thresholds. See
EPA's CAA Stationary Source CMS, October 2016, section IV [available
in the docket for this rulemaking]. Since EPA's CMS does not
establish a minimum inspection frequency for true minor sources or
synthetic minor sources that do not qualify as SM-80s, the five-year
FCE [full compliance evaluation] frequency to which DEEP has
committed for the RCSA section 22a-174-33b source universe is more
stringent than required by EPA's CMS.
    Sources operating under RCSA section 22a-174-33a are subject to
inspection at DEEP's discretion. Such inspections may take the form
of an on-site FCE or an off-site partial compliance evaluation
(e.g., the issuance of an information request under RCSA section
22a-174-4 and the subsequent inspection of responsive records).
    In inspecting synthetic minor sources operating under RCSA
sections 22a-174-33a and -33b, DEEP ensures proper calculation of
facility-wide emissions, including the appropriateness of the
selected emission factors, pursuant to the hierarchy of emission
calculation methodologies established in subsection (d)(4) of either
regulation. This approach is consistent with DEEP's handling of
sources previously registered under DEEP's General Permit to Limit
the Potential to Emit (GPLPE). In inspecting sources that calculate
emissions using CEMS data, DEEP ensures that such CEMS meet
applicable performance specifications, quality assurance (QA)
requirements, and operational requirements by (i) reviewing relative
accuracy test audit (RATA) protocols and results and auditing such
test programs as resources allow; (ii) reviewing quarterly excess
emission and downtime reports; (iii) verifying that the required QA
activities are completed and passed; and (iv) during on-site FCEs,
conducting a physical inspection of the CEMS. In inspecting sources
that calculate emissions using stack test data, DEEP ensures the
validity of stack testing--including the utilization of appropriate
test methods, conformance with such methods, and the proper
reduction and accuracy of the test results--by reviewing all stack
test protocols and results and auditing such test programs as
resources allow. Furthermore, DEEP verifies that testing is
conducted under the most challenging representative operating
conditions. See, e.g., EPA's CAA National Stack Testing Guidance,
April 2009, section 5 and DEEP's Source Emission Monitoring Test
Guidelines, Version 2.0, April 2019, section 8 [available in the
docket for this rulemaking].
    Furthermore, consistent with its handling of GPLPE reports, DEEP
reviews all reports submitted in accordance with RCSA sections 22a-
174-33a and -33b upon their submission, including annual compliance
certifications; emission exceedance reports; and, for sources
operating under RCSA section 22a-174-33b, annual emission reports.
In reviewing emission reports, DEEP ensures proper calculation of
facility-wide emissions, including the appropriateness of the
selected emission factors, pursuant to the hierarchy of emission
calculation methodologies established in the regulations.\4\
---------------------------------------------------------------------------

    \4\ EPA notes that when Connecticut DEEP refers to the GPLPE,
they are referring to a prior general permit designed to limit air
pollutant emissions from major stationary sources to below major
source thresholds by including legally and practicably enforceable
permit restrictions on potential and actual emissions. Connecticut
adopted new RCSA sections 22a-174-33a and 22a-174-33b as a
replacement program for the GPLPE. On April 24, 2017, EPA approved
Connecticut's GPLPE issued on November 9, 2015. See 82 FR 18868.

    In summary, Connecticut's regulatory scheme includes significant
oversight; emission limitations containing a sufficient buffer below
the major source thresholds to account for variability that may exist
in calculating emissions; the requirement to use methods to calculate
emissions from a preferential hierarchy; and requirements for
monitoring, reporting and recordkeeping. The overall regulatory scheme
is based on a model rule contained in EPA guidance, California's model
rule, and establishes a program that EPA finds legally and practicably
enforceable to limit a sources potential to emit.
    While EPA provides a general response to the adverse comment above,
for purposes of clarity, below we have broken down the comment into its
specific parts and provide additional responses for specific issues
raised within the comment.
    Comment 5a: The commenter stated that while CEMS are a good method,
Section (d)(4)(A) does not require data substitution or gap filling
when CEMS data for certain time periods are not available, and that
potential to emit and actual emissions which trigger title V and RACT
applicability don't allow for ignoring certain periods of emissions.
The commenter is concerned about periods of startup and shutdown when
CEMS may not be operating or other times when CEMS data is unavailable.
The commenter states that CEMS are often not required to gather data
during periods of startup and shutdown even though some emission
sources, such as combustion devices, can have substantially higher
emissions during those periods and cites generally to Weiler v. Chatham
Forest Products, 392 F.3d 532, 535 (2nd Cir. 2004). The commenter also
stated that CEMS have downtime, both planned downtime to do testing and
unplanned downtime, and because (d)(4)(A) does not address this, it
would be arbitrary and capricious for EPA to approve this.
    Response: EPA disagrees with the commenter and finds that the
portions of Connecticut's rules that allow for calculating premises-
wide emissions using CEMS data sufficiently accounts for determining
actual emissions over a 12-month rolling period. Only CEMS installed,
operated, and certified in accordance with a permit, order, or
regulation issued or administered by the Commissioner or EPA, or a
Commissioner approved voluntarily installed CEMS may be used to
calculate emissions. (See RCSA 33a(d)(4)(A) and 33b(d)(4)A)) In
addition, the regulations specify when data from CEMS are not
available, the next method in the hierarchy, if available, is to be
used to calculate emissions, so the regulations do not allow data gaps
in calculating actual emissions. Connecticut's CEMS rules do not allow
for the exclusion of startup and shutdown emissions. Connecticut's CEMS
regulations also specify quality assurance requirements for CEMS,
minimum CEMS data availability, and prohibit shutdown of monitoring
equipment. (See RCSA 22a-174-4(c)(4)-(5), and 22a-174-7) Connecticut's
regulations specify that CEMS data shall be available no less than 90%
of the total operating hours of a source per calendar quarter, except
for sources operated less than 336 hours and approved by the
Commissioner. In addition, Connecticut's rule is written to provide a
sufficient buffer below the major source threshold by setting the
premises-wide limit to below 50% of the major source threshold or
alternatively, setting the premises-wide limit in Connecticut's 33b to
below 80% of the major source threshold for certain source categories
with additional required monitoring and recordkeeping. Connecticut's
requirements for minimum CEMS data availability ensure that sufficient
data is being collected for calculating emissions, which combined with
the buffer below the major source thresholds, ensure that sources'
emissions stay below the major source thresholds. In light of the
overall regulatory scheme, the PTE limits in Connecticut's regulation
are not

rendered practicably unenforceable because of the use of CEMS.
    Comment 5b: The commenter was concerned that stack tests are not
performed during startups or shutdowns. The commenter stated that by
using stack test data to calculate ``actual'' emissions on an annual
basis, Section (d)(4)(B) ignores an important part of the problem, that
is actual emissions during periods of startup, shutdown, process
malfunctions, control equipment malfunctions or operations at different
operating periods that are not startup and shutdown. The commenter
asserted that the problem isn't limited to startup or shutdown because
the fact that a source emitted at a certain rate during a stack test
does not prove that a source emits at that same rate every other hour
that it operates. The commenter asserted that this flaw is further
compounded by the lack of a requirement for the frequency of stack
testing. The commented asserted that a stack test performed 20 years
ago, for example, provides no reliable data on current emissions.
    Response: Connecticut's 33a(d)(4)(B) and 33b(d)(4)(B) only allow
stack tests if such testing is conducted in accordance with protocols
approved in writing by the Commissioner or the Administrator in advance
of testing and when a representative of the Commissioner or the
Administrator has been provided the opportunity to witness such
testing. Should parametric monitoring, specifically required by RCSA
22a-174-33b, indicate that operations are outside of the ranges
occurring during the most recent test, or for any other reason,
Connecticut has the authority to mandate emissions testing to assure
compliance with applicable limits under RCSA 22a-174-5(e)(2). In
addition, Connecticut's rule is written to provide a sufficient buffer
below the major source threshold by setting the premises wide limit to
below 50% of the major source threshold or alternatively, setting the
premises wide limit in Connecticut's 33b to below 80% of the major
source threshold for certain source categories with additional required
monitoring and recordkeeping. Although stack tests are not conducted
during startup or shutdown, stack tests are required to be conducted
under conditions representative of a source's operations and that would
be reviewed during the required approval of the test protocol. Stack
test data, combined with the buffer below the major source thresholds,
ensure that sufficient data is being collected to ensure that sources'
emissions stay below the major source thresholds. In light of the
overall regulatory scheme, the PTE limits in Connecticut's regulations
are not rendered practicably unenforceable because of the allowance for
stack testing.
    Comment 5c: Regarding manufacturers' data to calculate emissions,
the commenter is concerned that the manufactures' testing may not
provide reliable data on emissions from the source in question if the
source that is going to use this rule is defective in some way or not
properly installed. The commenter is also concerned about the
conditions of the source matching the conditions of the manufacturer's
test. The commenter states that if the manufacturer did its testing in
a high-altitude desert, that could create radically different
conditions from sea level winter conditions that a source in
Connecticut faces. This difference in altitude and weather can result
in very different combustion and evaporation conditions which change
emissions.
    Response: Connecticut's 33a(d)(4)(C) and 33b(d)(4)(C) only allow
the rate of emissions to be calculated using data supplied by the
manufacturer of the subject emission unit or units, when such data were
derived from EPA approved emissions testing of such unit performed by
or for the manufacturer. Should parametric monitoring, specifically
required by RCSA 22a-174-33b, indicate that operations are outside of
the ranges occurring during the most recent test, or for any other
reason, Connecticut has the authority to mandate emissions testing to
assure compliance with applicable limits under RCSA 22a-174-5(e)(2).
Regarding the commenter's concern that the source may be defective or
not installed properly, Connecticut's RCSA 22a-174-7(b) prohibits the
deliberate shut down of air pollution control equipment or monitoring
equipment except to perform maintenance as specified. In addition,
Connecticut has committed to conduct inspections every 5 years for
sources covered by RCSA 22a-174-33b, and sources covered by RCSA 22a-
174-33a are subject to inspection at DEEP's discretion. Lastly,
Connecticut's rule is written to provide a sufficient buffer below the
major source threshold by setting the premises wide limit to below 50%
of the major source threshold or alternatively, setting the premises
wide limit in Connecticut's 33b to below 80% of the major source
threshold for certain source categories with additional required
monitoring and recordkeeping. Manufacturers' test data, combined with
Connecticut's oversight and the buffer below the major source
thresholds, ensures that sufficient data is being collected to ensure
that sources stay below the major source thresholds. In light of the
overall regulatory scheme, the PTE limits in Connecticut's regulations
are not rendered practicably unenforceable by the allowance, under
certain circumstances, of the use of manufacturers' data to calculate
emissions.
    Comment 5d: The commenter is concerned that 33a(d)(4)(D) and
33b(d)(4)(D), a requirement in the hierarchy to use pertinent material
balances, is not rationally related to actual emissions. The commenter
questioned how a pertinent material balance would account for thermal
NOX emissions, that is NOX that is formed in
combustion processes because our air is 78% nitrogen, regardless of the
composition of the fuel. The commenter stated that thermal NOx
formation is greatly influenced by temperature in combustion processes
but (d)(4)(D) does not require any parametric monitoring, much less
restrictions, on operating temperature.
    Response: EPA disagrees that a source would be required to use
material balances to calculate thermal NOX formation.
Sections 33a(d)(4)(E) and 33b(d)(4)(E) require that if pertinent
material balance data is not available, for example, to calculate
thermal NOX emissions, and other preferential methods in the
hierarchy were not available, sources should use the data or emissions
estimation technique from the following EPA publications that results
in the highest rate of emissions: (i) Compilation of Air Pollutant
Emission Factors (AP-42), (ii) AIRS Facility Subsystem Emission
Factors, or (iii) The Emission Inventory Improvement Program (EIIP). In
addition, emissions can be calculated for a premise using a combination
of methods in the hierarchy depending on the operations. That is
because the hierarchy does not require the exclusive use of one method
for calculating emissions if data in the hierarchy is available for
certain operations and not for others. Material balances, combined with
the buffer below the major source thresholds, ensures that sufficient
data is being collected to ensure that sources stay below the major
source thresholds. In light of the overall regulatory scheme, the PTE
limits in Connecticut's regulations are not rendered practicably
unenforceable by the allowance, under certain circumstances, of the use
of material balances to calculate emissions.
    Comment 5e: The commenter is concerned that 33a(d)(4)(E) and
33b(d)(4)(E) are not rationally related to actual emissions. The
commenter points to the introduction section of AP-42, Compilation of
Air Pollutant Emission Factors which provides ``Average

emissions differ significantly from source to source and, therefore,
emission factors frequently may not provide adequate estimates of the
average emissions for a specific source. The extent of between-source
variability that exists, even among similar individual sources, can be
large depending on process, control system, and pollutant. Although the
causes of this variability are considered in emission factor
development, this type of information is seldom included in emission
test reports used to develop AP-42 factors.'' As a result, some
emission factors are derived from tests that may vary by an order of
magnitude or more. The commenter states that EPA's position has been
that AP-42 should not be used for ensuring compliance with synthetic
minor limits. The commenter states that AP-42 clearly states that it is
used for ``estimating emissions'' but a synthetic minor limit is not an
estimate. The commenter states that actual and potential to emit
emissions have to be below the applicable threshold, and that actual
emissions and an estimate of emissions are two separate things. The
commenter is also concerned that AP-42 emission factors come with
ratings. A ``D'' rating is below average and an ``E'' rating is Poor.
The commenter states that Section (d)(4)(E) allows the use of even
emission factors which EPA itself describes as ``Poor'', and that it is
arbitrary for EPA to allow the use of ``Poor'' ``estimates'' to provide
actual emissions.
    Response: Sections 33a(d)(4)(E) and 33b(d)(4)(E) require that if
other preferential methods in the hierarchy are not available, sources
should use the data or emissions estimation technique from the
following EPA publications that results in the highest rate of
emissions: (i) Compilation of Air Pollutant Emission Factors (AP-42),
(ii) AIRS Facility Subsystem Emission Factors, or (iii) The Emission
Inventory Improvement Program (EIIP). In calculating emissions using
emission factors when other data are not available, Connecticut
conservatively requires the highest rate of emissions from these
publications to be used. The calculation of emissions and assurance of
compliance with the limits is not reliant on this alone but also on
parametric monitoring, which is explicitly required by RCSA 22a-174-
33b. Should parametric monitoring indicate that operations are outside
of the ranges occurring during the most recent test, or for any other
reason, Connecticut has the authority to mandate emissions testing to
assure compliance with applicable limits under RCSA 22a-174-5(e)(2). As
noted above, emissions can be calculated for a premise using a
combination of methods in the hierarchy depending on the operations,
because the hierarchy does not require the exclusive use of one method
if data in the hierarchy is available for certain operations and not
for others.
    EPA acknowledges that in the AP-42 Introduction document we state
that use of these factors as source-specific permit limits and/or as
emission regulation compliance determinations is not recommended by
EPA. However, we also state that emission factors are frequently the
best or only method available for estimating emissions, despite their
limitations. And we further provide that if representative source-
specific data cannot be obtained, emissions information from equipment
vendors, particularly emission performance guarantees or actual test
data from similar equipment, is a better source of information for
permitting decisions than an AP-42 emission factor. When such
information is not available, use of AP-42 emission factors may be
necessary as a last resort. Sources that reach this level of the data
hierarchy in Connecticut's rules would typically be the smallest
sources of emissions and it would be unreasonably costly to require
such small sources to install a CEMS or conduct a stack test to
calculate emissions for purposes of demonstrating emissions remain
below the major source thresholds.\5\
---------------------------------------------------------------------------

    \5\ See AP-42, Introduction at 3. ``Where the risks of using a
poor estimate are low, and the costs of more extensive methods are
unattractive, then less expensive estimation methods such as
emission factors and emission models may be both satisfactory and
appropriate.''
---------------------------------------------------------------------------

    In addition, Connecticut's rule is written to provide a sufficient
buffer below the major source threshold by setting the premises wide
limit in Connecticut's 33a to below 50% of the major source threshold,
or alternatively, setting the premises wide limit in Connecticut's 33b
to below 80% of the major source threshold for certain source
categories with additional required monitoring and recordkeeping. In
light of all the material provisions of Connecticut's regulatory scheme
including the buffer below the major source thresholds, the possibility
of the use of AP-42 emissions factors when other data in the hierarchy
are not available does not render the PTE limits practicably
unenforceable.

III. Final Action

    EPA is approving Connecticut's RCSA section 22a-174-33a, Limit on
Premises-wide Actual Emissions Below 50% of Title V Thresholds,
effective September 24, 2020, and RCSA section 22a-174-33b, Limit on
Premises-wide Actual Emissions Below 80% of Title V Thresholds,
effective September 24, 2020 (excluding the following provision: RCSA
22a-174-33b(d)(6)) as a revision to the Connecticut SIP with respect to
criteria pollutants and is separately approving the regulations under
section 112(l) of the Act with respect to HAPs. EPA is approving
Connecticut's request in accordance with the requirements of sections
110 and 112 of the CAA.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Connecticut Regulations described in the amendments to 40 CFR part 52
set forth below. The EPA has made, and will continue to make, these
documents generally available through https://www.regulations.gov and
at the EPA Region 1 Office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
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);
     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 Clean Air Act; 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, 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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this 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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 10, 2022. Filing a
petition for reconsideration by the 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 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: March 4, 2022.
David Cash,
Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

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 H--Connecticut

0
2. Section 52.370 is amended by adding paragraph (c)(127) to read as
follows:

 Sec.  52.370   Identification of plan.

* * * * *
    (c) * * *
    (127) Revisions to the State Implementation Plan submitted by the
Connecticut Department of Energy and Environmental Protection on
October 26, 2020, supplemented on January 12, 2022.
    (i) Incorporation by reference. (A) Regulations of Connecticut
State Agencies section 22a-174-33a, Limit on Premises-wide Actual
Emissions Below 50% of Title V Thresholds, effective September 24,
2002.
    (B) Regulations of Connecticut State Agencies section 22a-174-33b,
Limit on Premises-wide Actual Emissions Below 80% of Title V
Thresholds, effective September 24, 2020, excluding section (d)(6).
    (ii) Additional materials. (A) Letter from the Connecticut
Department of Energy and Environmental Protection dated October 26,
2020, submitting a revision to the Connecticut State Implementation
Plan.
    (B) Letter from the Connecticut Department of Energy and
Environmental Protection dated January 12, 2022, withdrawing
Regulations of Connecticut State Agencies section 22a-174-33b(d)(6)
from its SIP submittal.

0
3. Section 52.385 is amended in Table 52.385 by adding state citations
for 22a-174-33a and 22a-174-33b in alphanumerical order to read as
follows:

Sec.  52.385   EPA-approved Connecticut regulations.

* * * * *

                                     Table 52.385--EPA-Approved Regulations
----------------------------------------------------------------------------------------------------------------
                                                  Dates
                                       --------------------------
 Connecticut  State     Title/subject       Date         Date     Federal Register    Section       Comments/
      citation                           adopted by  approved by       citation       52.370       description
                                           State         EPA
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
22a-174-33a.........  Limit on            9/24/2020    3/11/2022  [Insert Federal      (c)127   ................
                       Premises-wide                               Register
                       Actual                                      citation].
                       Emissions Below
                       50% of Title V
                       Thresholds.
22a-174-33b.........  Limit on            9/24/2020    3/11/2022  [Insert Federal      (c)127   Approved with
                       Premises-wide                               Register                      the exception
                       Actual                                      citation].                    of section
                       Emissions Below                                                           (d)(6) which
                       80% of Title V                                                            Connecticut
                       Thresholds.                                                               withdrew from
                                                                                its SIP
                                                                                submittal.

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

[FR Doc. 2022-05042 Filed 3-10-22; 8:45 am]
BILLING CODE 6560-50-P


September 3 4, 2003 NEDA/ CARP ATTENDEES At OAQPS Meetings Roy Carwile Evelyn Wilke ALCOA, Inc. Koch Industries New York Kansas Mike Palazollo Robert Morehouse ALCOA, Inc. William Priebe Pennsylvania ExxonMobil Texas Matthew Frank Chuck Feerick Boeing ExxonMobil Virginia Virginia Deb Rowe Todd Hyde DaimlerChrysler Merck Michigan New Jersey Mary Snow Cooper A1 Collins DaimlerChrysler Occidental Petroleum Michigan Washington, D. C. Bernie Paul, NEDA/ CARP Jan Laughlin Chairman ConocoPhillips Jodie Mitchell Texas Eli Lilly Indiana Maxine Dewbury Procter & Gamble Barbara Bankoff Ohio Eli Lilly Washington, D. C. Leslie Ritts NEDA/ CARP Matt Tanzer Washington, D. C. General Electric Connecticut. Tammy Wyles GeorgiaPacific Washington, D / C / Rob Kaufmann GeorgiaPacific Washington, D / C /

\\\ DC  64622/ 0001  1637315 v1


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Proposed Rules]
[Pages 10693-10695]
[FR Doc No: 2012-4209]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0150; Directorate Identifier 2011-NM-234-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A318 series airplanes, Airbus Model A319 series airplanes,
Airbus Model A320 series airplanes, and Airbus Model A321 series
airplanes. This proposed AD was prompted by reports of oil residue
between the stator and the rotor parts of the position resolvers of the
angle of attack (AOA) vane, which was a result of incorrect removal of
the machining oil during the manufacturing process of the AOA
resolvers. This proposed AD would require inspecting to determine if
certain AOA probes are installed, and replacing the affected AOA probe
if necessary. We are proposing this AD to prevent erroneous AOA
information and consequent delayed or non-activation of the AOA
protection systems which, during flight at a high angle of attack,
could result in reduced control of the airplane.

DATES: We must receive comments on this proposed AD by April 9, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For Airbus service information identified in this proposed AD,
contact Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. For Thales Avionics service information
identified in this proposed AD, contact Thales Avionics, Retrofit
Manager, 105, Avenue du G[eacute]n[eacute]ral Eisenhower, BP 63647,
31036 Toulouse Cedex 1, France; telephone +33 5 61 19 76 95; fax +33 5
61 19 68 20; email<EMAIL_ADDRESS>Internet http://www.thalesgroup.com/aerospace. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0150;
Directorate Identifier 2011-NM-234-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European

Community, has issued EASA Airworthiness Directive 2011-0203, dated
October 13, 2011 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    During Airbus Final Assembly Line flight tests, AoA [angle of
attack] data from two different aeroplanes were found inaccurate,
which was confirmed by flight data analysis.

Investigation conducted by Airbus and Thales on the removed probes
revealed oil residue between the stator and the rotor parts of the
AoA vane position resolvers. This oil residue was the result of
incorrect removal of machining oil during the manufacturing process
of the AoA resolvers. At low temperatures, this oil residue becomes
viscous (typically in cruise), causing delayed and/or reduced AoA
vane movement. Multiple AOA probes could be simultaneously affected,
providing incorrect indications of the AoA of the aeroplane.

This condition, if not corrected, could lead to erroneous AoA
information and consequent delayed or non-activation of the AoA
protection systems which, during flight at a high angle of attack,
could result in reduced control of the aeroplane.

For the reasons described above, this [EASA] AD requires the
identification of the serial number (s/n) of each installed Thales
Avionics Part Number (P/N) C16291AA AOA probe and the replacement of
all suspect units with serviceable ones. This AD also prohibits the
(re)installation of these same s/n probes on any aeroplane, unless
corrective measures have been accomplished.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Service Bulletin A320-34-1452, including Appendix
01, dated January 29, 2010. Thales Avionics has issued Service Bulletin
C16291A-34-007, Revision 01, dated December 3, 2009. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 755 products of U.S. registry. We also estimate that
it would take about 2 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $128,350, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours and require parts costing $0, for a cost of
$255 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-0150; Directorate Identifier 2011-NM-
234-AD.

(a) Comments Due Date

    We must receive comments by April 9, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -
133 airplanes; Model A320-111, -211, -212, -214, -231, -232, and -
233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -
231, and -232 airplanes; certificated in any category; all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 34: Navigation.

(e) Reason

    This AD was prompted by reports of oil residue between the
stator and the rotor parts of the position resolvers of the angle of
attack (AOA) vane, which was a result of incorrect removal of the
machining oil during the manufacturing process of the AOA resolvers.
We are issuing this AD to prevent erroneous AOA information and
consequent delayed or non-activation of the AOA protection systems
which, during flight at a high angle of attack, could result in
reduced control of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Except as provided by paragraph (h) of this AD: Within 12 months
after the effective date of this AD, inspect to determine the part
number and serial number of each Thales Avionics AOA probe, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-34-1452, excluding Appendix 01, dated January 29,
2010. If any probe is found having part number (P/N) C16291AA and
having a serial number listed in Thales Avionics Service Bulletin
C16291A-34-007, Revision 01, dated December 3, 2009: Within 12
months after the effective date of this AD, replace the AOA probe,
in accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-34-1452, excluding Appendix 01, dated January 29,
2010. A review of airplane maintenance records is acceptable in lieu
of this inspection if the part number and serial number of the
installed AOA probes can be conclusively determined from that
review.

(h) Exception

    For any airplane on which Airbus modification 150006
(installation of Thales Avionics AOA probes P/N C16291AB) or
modification 26934 (installation of Goodrich AOA probes P/N 0861ED)
has been embodied in production and on which no AOA probe
replacement has been made since first flight: The actions specified
in paragraph (g) of this AD are not required.

(i) Parts Installation

    As of the effective date of this AD, no person may install a
Thales Avionics AOA probe, P/N C16291AA, having a serial number
listed in Thales Avionics Service Bulletin C16291A-34-007, Revision
01, dated December 3, 2009, on any airplane, unless that Thales
Avionics probe has been inspected, re-identified and tested, in
accordance with the Accomplishment Instructions of Thales Avionics
Service Bulletin C16291A-34-007, Revision 01, dated December 3,
2009.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to Attn: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0203, dated October 13, 2011; Airbus Service Bulletin
A320-34-1452, excluding Appendix 01, dated January 29, 2010; and
Thales Avionics Service Bulletin C16291A-34-007, Revision 01, dated
December 3, 2009; for related information.

    Issued in Renton, Washington, on February 6, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2012-4209 Filed 2-22-12; 8:45 am]
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