[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47485-47487]
[FR Doc No: 2021-18259]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD21-13-000]

Climate Change, Extreme Weather, and Electric System Reliability;
Correction

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice; correction.

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SUMMARY: The Federal Energy Regulatory Commission published a notice in
the Federal Register of August 17, 2021, inviting comments to address a
list of questions that were inadvertently omitted from the notice.

FOR FURTHER INFORMATION CONTACT: Rahim Amerkhail,<PHONE_NUMBER> or
Michael Haddad,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of August 17, 2021, in FR Doc. 2021-17626,
on page

45980, in the first column after the words ``Kimberly D. Bose,
Secretary'' insert the following additional text:

Post-Technical Conference Questions for Comment

    1. Multiple panelists at the technical conference suggested that
utilities and other industry participants should engage in an
assessment of climate change risks to their systems.\1\ Should public
utilities be required to engage in either a one-time assessment or
periodic assessments of climate change risks to their assets and/or on
how their system is expected to perform under expected climate change
driven scenarios? If so, should such requirements be incorporated into
jurisdictional local transmission planning and/or regional transmission
planning/cost allocation process tariff provisions? Similarly, should
such requirements be incorporated into FERC-jurisdictional resource
adequacy tariff provisions?
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    \1\ See June 1 Tr. at 14 (Adam Smith); 17 (Jessica Hogle); 55,
83 (Romany Webb); 79 (Derek Stenclik).
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    2. Several panelists at the technical conference suggested that
greater use of probabilistic approaches could provide a more robust
approach to accounting for extreme weather.\2\ Would incorporating
probabilistic methods into local transmission planning and/or regional
transmission planning/cost allocation processes allow public utility
transmission providers to more effectively assess low probability/high
impact events and common mode failures? \3\ If so, should such
practices be incorporated into public utility transmission providers'
local transmission planning and/or regional transmission planning/cost
allocation processes? What, if any, jurisdictional tariff changes would
be necessary to incorporate these practices into existing transmission
planning and cost allocation processes? Similarly, should such
practices be incorporated into any resource adequacy assessments
carried out under FERC-jurisdictional tariff provisions?
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    \2\ See June 1 Tr. at 36-37, 81 (Lisa Barton); 53, 69-70 (Judy
Chang); 79, 92 (Derek Stenclik); 83 (Romany Webb); 119 (Richard
Tabors); 129 (Neil Millar).
    \3\ As described in the March 15, 2021 Supplemental Notice of
Technical Conference Inviting Comments in this proceeding, common
mode failures occur where, due to climate change or an extreme
weather event, a large number of facilities critical to electric
reliability (e.g., generation resources, transmission lines,
substations, and natural gas pipelines) experience outages or
significant operational limitations, either simultaneously or in
close succession.
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    3. At the technical conference, panelists noted the importance of
coordinating transfers across the seams between Regional Transmission
Organizations/Independent System Operators (RTOs/ISOs) and non-RTO/ISO
areas to both reduce costs and improve the resilience of the
transmission grid during extreme weather events.\4\ How do RTO/ISO and
non-RTO/ISO transmission providers manage congestion at system seams?
What are the benefits and drawbacks of the current management regime,
from the perspectives of cost, resource participation, and ability to
maximize reliability and other benefits of transmission service? Can
more cost-effective congestion management at the border between RTOs/
ISOs and neighboring non-RTO/ISO transmission providers be facilitated
through new pro forma Open Access Transmission Tariff (OATT)
provisions? If so, how could the pro forma OATT be modified to achieve
this enhanced coordination? For example, could existing pro forma OATT
section 33.2 (Transmission Constraints), which permits a transmission
provider to use redispatch to maintain reliability during transmission
constraints, be modified to enhance coordination with a neighboring
RTO/ISO during such redispatch? Are there any other potential
modifications to the pro forma OATT that might facilitate cost-
effective congestion management at the border between RTOs/ISOs and
neighboring non-RTO/ISO transmission providers? If so, please describe
them in as much detail as possible. If such modifications were made to
the pro forma OATT, could they also help improve coordination between
RTOs/ISOs and non-jurisdictional entities through their inclusion in
the reciprocity tariffs that are voluntarily filed by some non-
jurisdictional entities? What challenges would any such modifications
need to address?
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    \4\ See June 2 Tr. at 64, 66-67 (Renuka Chatterjee); 68 (Amanda
Frazier); 153 (Dan Scripps); 66 (David Patton).
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    4. RTOs/ISOs currently have differing levels of authority to
approve or recall outages.\5\ Can generation and transmission outage
scheduling practices be improved? For example, should RTOs/ISOs have
greater authority to deny generation and transmission outage requests,
such as having the ability to deny such a request based on estimated
economic impact, as ISO New England currently has? Similarly, should
transmission owners be given an incentive to schedule transmission
outages more efficiently by making transmission owners responsible for
uplift they cause from outages, as the New York Independent System
Operator currently does? Would such changes help system operators
better prepare for or respond to extreme weather events?
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    \5\ See June 2 Tr. at 21-23, 32 (Wesley Yeomans); 23-24 (Renuka
Chatterjee); 30-31, 74-75 (David Patton).
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    5. Transmission topology optimization (also sometimes known as
transmission switching) involves dynamically modifying transmission
topology as a component of determining optimal day-ahead and real-time
energy market solutions.\6\ Should RTOs/ISOs be required to incorporate
transmission switching or transmission topology optimization in their
day-ahead and real-time energy markets? Could the adoption of such
optimization approaches both reduce costs and improve the resilience of
the transmission grid?
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    \6\ See June 2 Tr. at 7(Amanda Frazier), 55 (Renuka Chatterjee),
55-57 (Mads Almassalkhi), 58-59 (David Patton), 60-61 (Robin Broder-
Hytowitz), 61-62 (Anne Hoskins), 94-96 (Charles Long), 97-98 (Daniel
Brooks), 136 (Letha Tawney).
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    6. Panelists at the technical conference suggested that current
requirements for system performance under extreme weather scenarios may
need to evolve.\7\ Should the transmission planning requirements
established under North American Electric Reliability Corporation
(NERC) reliability standard TPL-001-4/5 be modified to better assess
and mitigate the risk of extreme weather events and associated common
mode failures? Should any additional changes be considered to the NERC
Reliability Standards to address the risk of extreme weather events?
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    \7\ June 1 Tr. at 138-40 (Mark Lauby).
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    7. Multiple panelists at the conference emphasized the need to
establish a requirement for interregional transmission planning and
improve existing interregional cost allocation methods to prepare for
extreme weather events.\8\ How can the existing requirement to have an
interregional transmission coordination (not planning) and cost
allocation process be modified to better account for the benefits that
interregional transmission facilities provide during extreme weather
events? Would defining a set of uniform transmission benefit metrics
that can be used across regions in the interregional transmission
coordination and cost allocation processes help interregional
transmission projects come to fruition? If so, please propose such
metrics in as much detail as possible.
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    \8\ June 2 Tr. at 64-66 (Renuka Chatterjee), 147 (Patricia
Hoffman), 153 (Dan Scripps).
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    8. Would having a target level of interregional transfer capacity
help facilitate more effective development of interregional
transmission projects?

Should minimum amounts of interregional transmission transfer
capability be required or encouraged as a way to improve the resilience
of the power system? \9\ If so, how should such minimums be determined
(e.g., a stated MW or percentage of load basis), and how specifically
should such minimum requirements be implemented (e.g., NERC reliability
standards or new tariff requirements)?
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    \9\ June 2 Tr. at 64-66 (Renuka Chatterjee).
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    9. Multiple panelists at the conference suggested that the current
reliance on the 1 day in 10-year Loss of Load Expectation is
outmoded.\10\ Are there alternative resource adequacy planning
approaches that could be more robust alternatives to the use of the 1
day in 10-year Loss of Load Expectation standard? Please describe such
alternatives, including describing whether such alternatives have been
used either in the United States or elsewhere.
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    \10\ See June 1 Tr. at 85 (Judy Chang), 119 (Richard Tabors),
122-123 (Alison Silverstein), 125 (Devin Hartman), 127 (Mark Lauby).

    Dated: August 19, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-18259 Filed 8-24-21; 8:45 am]
BILLING CODE 6717-01-P


C:\ dmautop\ temp\ dwcgi 17529 1034890015 416068000.wpd May 2001 PBT Profiler Fact Sheet Modified from: http:// www. epa. gov/ opptintr/ pbt/ toolbox. htm EPA has developed a PBT Profiler. The PBT Profiler is a subset of methods included in the P2 Framework which is an approach to risk screening that incorporates pollution prevention principles in the design and development of chemicals. The objective of the P2 Framework approach is to inform decision making at early stages of development and promote the selection and application of safer chemicals and processes. This approach is implemented by means of a subset of estimation methods included in OPPT's P2 Framework. The P2 Framework project description and manual are available at: http:// www. epa. gov/ opptintr/ p2framework How does the PBT Profiler work? EPA has taken methods for estimating environmental persistence (P), bioconcentration potential (B), and aquatic toxicity (T) and integrated these into a PBT Profiler. The PBT Profiler will predict P, B, and T characteristics from chemical structure. When the user accesses the PBT Profiler on the Internet, the program prompts the user to enter the Chemical Abstract Service (CAS) number of chemicals under consideration. The PBT Profiler is linked a database containing CAS numbers and associated chemical structure for over 100,000 discrete chemical substances. If the CAS number is in the database, the PBT Profiler will translate the CAS number into a chemical structure, predict the PBT characteristics, and provide a PBT Profile in a easy to understand format. A drawing program is available so that the user can draw and enter the structure if the CAS number is not in the database. The structure can also be entered as a SMILES Notation.

In addition, the PBT Profiler compares the results of a profile with the PBT criteria established for Premanufacture Notices (PMNs) submitted under section 5 of TSCA; and the final rule for reporting chemicals under the Toxic Chemical Release Inventory (TRI), under section 313 of the Emergency Planning and Community Right toKnow Act (EPCRA). A sample model run from the PBT Profiler of a known PBT chemical (CAS 56 55 3) is shown printed in the color version. A Black & White version is also available.

Status of the PBT Profiler: EPA has initiated a formal scientific peer review of the revised, updated, PBT Profiler. This peer review is being conducted under EPA's Peer Review Policy and in accordance with the Agency's peer review procedures. The PBT Profiler will be publicly available when the peer review is completed, and the PBT Profiler is revised to reflect peer review comments received.

The PBT Profiler was beta tested by industry and other stakeholders to further evaluate the technical accuracy of the PBT Profiler and to solicit comments on the format, content, and interpretation of results of the PBT Profiler. Based on the results of the beta test, the Agency made revisions to the PBT Profiler. Several beta testers are currently helping develop Case Studies screening chemicals using the PBT Profiler.

EPA does not rely solely on results of screening level methods, such as the PBT Profiler, to regulate chemicals! Users should remember that this is a screening level method that provides estimates of PBT characteristics, and is useful for establishing priorities for chemical evaluation when chemical specific data are lacking. This, and any screening level method, should be used with caution! If the PBT Profiler identifies an issue of potential concern, additional data should be gathered and/ or additional analyses conducted to come to an informed decision about the chemicals under review.

There are limitations associated with the PBT Profiler. These limitations are highlighted and explained for the user within the model itself. For information on the PBT Profiler, please contact: Bill Waugh, Program Manager, ph: 202 260 3489 fax: 202 260 1216 waugh. bill@ epa. gov Maggie Wilson, Technical Lead, ph: 202 260 3902 fax: 202 260 1216 wilson. maggie@ epa. gov


[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8286-8287]
[FR Doc No: 2018-03848]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0510]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Prohibited
From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
28, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0627.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Substances Prohibited From Use in Animal Food or Feed--21 CFR 589.2001

OMB Control Number 0910-0627--Extension

    This information collection supports Agency regulations regarding
substances prohibited from use in animal food or feed. Bovine
spongiform encephalopathy (BSE) is a progressive and fatal neurological
disorder of cattle that results from an unconventional transmissible
agent. BSE belongs to the family of diseases known as transmissible
spongiform encephalopathies (TSEs). All TSEs affect the central nervous
system of infected animals. Our regulation at Sec.  589.2001 (21 CFR
589.2001) entitled ``Cattle materials prohibited in animal food or feed
to prevent the transmission of bovine spongiform encephalopathy'' is
designed to further strengthen existing safeguards against the
establishment and amplification of BSE in the United States through
animal feed. The regulation prohibits the use of certain cattle origin
materials in the food or feed of all animals. These materials are
referred to as ``cattle materials prohibited in animal feed'' or CMPAF.
Under Sec.  589.2001, no animal feed or feed ingredient can contain
CMPAF. As a result, we impose requirements on renderers of specifically
defined cattle materials, including reporting and recordkeeping
requirements. For purposes of the regulation, we define a renderer as
any firm or individual that processes slaughter byproducts, animals
unfit for human consumption, including carcasses of dead cattle, or
meat scraps. Reporting and recordkeeping requirements are necessary
because once materials are separated from an animal it may not be
possible, without records, to know whether the cattle material meets
the requirements of our regulation.
    Recordkeeping: Renderers that receive, manufacture, process, blend,
or distribute CMPAF, or products that contain or may contain CMPAF,
must take measures to ensure that the materials are not introduced into
animal feed, including maintaining adequate written procedures
specifying how such processes are to be carried out (Sec.
589.2001(c)(2)(ii)). Renderers that receive, manufacture, process,
blend, or distribute CMPAF, are required to establish and maintain
records sufficient to track the CMPAF to ensure that they are not
introduced into animal feed (Sec.  589.2001(c)(2)(vi)).
    Renderers that receive, manufacture, process, blend, or distribute
any cattle materials must establish and maintain records sufficient to
demonstrate that material rendered for use in animal feed was not
manufactured from, processed with, or does not otherwise contain, CMPAF
(Sec.  589.2001(c)(3)(i)).
    Renderers that receive, manufacture, process, blend, or distribute
any cattle materials must, if these materials were obtained from an
establishment that segregates CMPAF from other materials, establish and
maintain records to demonstrate that the supplier has adequate
procedures in place to effectively exclude CMPAF from any materials
supplied (Sec.  589.2001(c)(3)(i)). Records will meet this requirement
if they include either: (1) Certification or other documentation from
the supplier that materials supplied do not include CMPAF (Sec.
589.2001(c)(3)(i)(A)) or (2) documentation of another method acceptable
to FDA, such as third-party certification (Sec.  589.2001(c)(3)(i)(B)).
    Reporting: Under our regulations, we may designate a country from
which cattle materials are not considered CMPAF. Section 589.2001(f)
provides that a country seeking to be so designated must send a written
request to the Director of the Center for Veterinary Medicine. The
information the country is required to submit includes information
about that country's BSE case history, risk factors, measures to
prevent the introduction and transmission of BSE, and any other
information relevant to determining whether the cattle materials from
the requesting country do or do not meet the definitions set forth in
Sec.  589.2001(b)(1). We use the information to determine whether to
grant a request for designation and to impose conditions if a request
is granted. Section 589.2001(f) further states that countries
designated under that section will be subject to our future review to
determine whether their designations remain appropriate. As part of
this process, we may ask designated countries from time to time to
confirm that their BSE situation and the information submitted by them
in support of their original application remains unchanged. We may
revoke a country's designation if we determine that it is no longer
appropriate. Therefore, designated countries may respond to our
periodic requests by

submitting information to confirm their designations remain
appropriate. We use the information to ensure their designations remain
appropriate.
    Description of Respondents: Respondents to this information
collection include rendering facilities, feed manufacturers, livestock
feeders, and foreign governments seeking designation under Sec.
589.2001(f).
    In the Federal Register of November 3, 2017 (82 FR 51279), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received four comments, which were not
responsive to the four collection of information topics solicited, and
therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section             Number of       records per    Total annual         per         Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
589.2001(c)(2)(ii), maintain                  50               1              50              20           1,000
 written procedures............
589.2001(c)(2)(vi) and                       175               1             175              20           3,500
 (c)(3)(i), maintain records...
589.2001(c)(3)(i)(A) and (B),                175               1             175              26           4,550
 certification or documentation
 from the supplier.............
                                --------------------------------------------------------------------------------
    Total......................  ...............  ..............  ..............  ..............           9,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Except where otherwise noted, this estimate is based on our
estimate of the number of facilities affected by the final rule
entitled ``Substances Prohibited From Use in Animal Food or Feed''
published in the Federal Register of April 25, 2008 (73 FR 22720 at
22753). The estimated recordkeeping burden is derived from Agency
resources and discussions with affected industry. Our regulations
require the maintenance of certain written procedures if cattle not
inspected and passed for human consumption are to be rendered for use
in animal feed. The recordkeeping burden associated with the
requirement to maintain written procedures (Sec.  589.2001(c)(2)(ii))
will apply to only those renderers that choose to render for use in
animal feed cattle not inspected and passed for human consumption. The
recordkeeping requirement in Sec.  589.2001(c)(2)(vi) will apply to the
limited number of renderers that will handle CMPAF. We estimate that
the recordkeeping burden associated with Sec.  589.2001(c)(3)(i) would
apply to the balance of the rendering firms not handling CMPAF. Table 1
also reflects the estimated 26 hours each renderer will need to satisfy
the requirement in Sec.  589.2001(c)(3)(i)(A) and (B) under which
renderers must maintain records from their supplier, certifying that
materials provided were free of CMPAF.

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                    Number of
         21 CFR section             Number of     responses per    Total annual   Average burden    Total hours
                                   respondents      respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
589.2001(f); request for                      1                1               1              80              80
 designation...................
589.2001(f); response to                      1                1               1              26              26
 request for review by FDA.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the reporting burden for designation under Sec.
589.2001(f) is based on estimates in the final rule entitled
``Substances Prohibited From Use in Animal Food or Feed'' published in
the Federal Register of April 25, 2008, our experience, and the average
number of requests for designation received in the past 3 years. The
reporting burden for Sec.  589.2001(f) is minimal because requests for
designation are seldom submitted. Since 2009, we have received two
requests for designation. In the last 3 years, we have not received any
new requests for designation; therefore, we estimate that one or fewer
requests for designation will be submitted annually. Although we have
not received any new requests for designation in the last 3 years, we
believe these information collection provisions should be extended to
provide for the potential future need of a foreign government to
request designation under Sec.  589.2001(f). Table 2, row 1, presents
the expected burden of requests for designation. Countries designated
under Sec.  589.2001(f) are subject to review by FDA to ensure that
their designation remains appropriate. We assume a country's response
to a request for review will take about one third the time and effort
of a request for designation. Table 2, row 2, presents the expected
burden of a request for review. The burden for this information
collection has not changed since the last OMB approval.

    Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03848 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Notices]
[Page 33317]
[DOCID:fr11jn10-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Antibacterial Resistance and Diagnostic Device and Drug
Development Research for Bacterial Diseases; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop jointly sponsored by the National Institute of Allergy and
Infectious Diseases and the Infectious Diseases Society of America
(IDSA) regarding scientific and potential research issues in
antibacterial drug resistance, rapid diagnostic device development for
bacterial diseases, and antibacterial drug development. The workshop
will address antibacterial drug resistance, mechanisms of resistance,
epidemiology of resistance, and issues in the development of rapid
diagnostic devices and antibacterial drugs for the diagnosis and
treatment of bacterial diseases. The input from this public workshop
will help in developing topics for further discussion.
    Dates and Times: The public workshop will be held on July 26, 2010,
from 8 a.m. to 5:30 p.m. and on July 27, 2010, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Crowne Plaza
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited
and available only on a first-come, first-served basis.
    Contact Persons: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited. Seating will be available on a first-come, first-served basis.
To register electronically, e-mail registration information (including
name, title, firm name, address, telephone, and fax number) to
<EMAIL_ADDRESS>Persons without access to the Internet can call
Chris Moser or Lori Benner at<PHONE_NUMBER> to register. Persons needing
a sign language interpreter or other special accommodations should
notify Christine Moser or Lori Benner (see Contact Persons) at least 7
days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, jointly
sponsored by the National Institute of Allergy and Infectious Diseases
and the Infectious Diseases Society of America, regarding scientific
issues in antibacterial drug resistance and product development for
bacterial diseases. Topics for discussion include the following: (1) An
overview and discussion of the scale of the current bacterial
resistance problem, (2) current understanding of the science and
mechanisms of bacterial resistance, (3) the use of rapid diagnostics in
the diagnosis and management of bacterial infections, and (4) the
science of antibacterial drug development. The input from this workshop
will help in the further consideration of potential areas of research
in antibacterial resistance and help in developing topics in
antibacterial drug development and rapid diagnostic development for
further discussion.
    The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
    Webcasting: The workshop will be simultaneously webcast. The public
may view the live webcast free by registering through IDSA's Web site
at http://www.idsociety.org until 24 hours prior to the workshop. IDSA
will do its best to accommodate members of the public who register
after this time. Videotaped workshop presentations will also be
available free on IDSA's Web site following the workshop.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857. Transcripts will also be available
on the Internet at http://www.fda.gov/FDAgov/Drugs/NewsEvents/
ucm211146.htm approximately 45 days after the workshop.

    Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14048 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S


(A) For a thermal vapor incinerator that demonstrates during the performance test conducted under §63.1282(d) that combustion zone temperature is an accurate indicator of performance, a temperature monitoring device equipped with a continuous recorder. The monitoring device shall have a minimum accuracy of +-1 percent of the temperature being monitored in degrees C, or +-2.5 degrees C, whichever value is greater. The temperature sensor shall be installed at a location representative of the combustion zone temperature.
	(B) For a catalytic vapor incinerator, a temperature monitoring device equipped with a continuous recorder. The device shall be capable of monitoring temperatures at two locations and have a minimum accuracy of +-1 percent of the temperatures being monitored in degrees C, or +-2.5 degrees C, whichever value is greater. One temperature sensor shall be installed in the vent stream at the nearest feasible point to the catalyst bed inlet and a second temperature sensor shall be installed in the vent stream at the nearest feasible point to the catalyst bed outlet.
* * * * *
	(D) For a boiler or process heater, a temperature monitoring device equipped with a continuous recorder. The temperature monitoring device shall have a minimum accuracy of +-1 percent of the temperature being monitored in degrees C, or +-2.5 degrees C, whichever value is greater. The temperature sensor shall be installed at a location representative of the combustion zone temperature.
	(E) For a condenser, a temperature monitoring device equipped with a continuous recorder. The temperature monitoring device shall have a minimum accuracy of +-1 percent of the temperature being monitored in degrees C, or +-2.8 degrees C, whichever value is greater. The temperature sensor shall be installed at a location in the exhaust vent stream from the condenser.
	(F) * * *
	(1) A continuous parameter monitoring system to measure and record the average total regeneration stream mass flow or volumetric flow during each carbon bed regeneration cycle. The flow sensor must have a measurement sensitivity of 5 percent of the flow rate or 10 cubic feet per minute, whichever is greater. The mechanical connections for leakage must be checked at least every month, and a visual inspection must be performed at least every 3 months of all components of the flow CPMS for physical and operational integrity and all electrical connections for oxidation and galvanic corrosion if your flow CPMS is not equipped with a redundant flow sensor; and
	(2) A continuous parameter monitoring system to measure and record the average carbon bed temperature for the duration of the carbon bed steaming cycle and to measure the actual carbon bed temperature after regeneration and within 15 minutes of completing the cooling cycle. The temperature monitoring device shall have a minimum accuracy of +-1 percent of the temperature being monitored in degrees C, or +-2.5 degrees C, whichever value is greater.
	(G) For a nonregenerative-type carbon adsorption system, the owner or operator shall monitor the design carbon replacement interval established using a performance test performed in accordance with §63.1282(d)(3) and shall be based on the total carbon working capacity of the control device and source operating schedule.
	(H) For a control device model tested under §63.1282(g):
	(1) A continuous monitoring system that measures gas flow rate at the inlet to the control device. The monitoring instrument shall have an accuracy of plus or minus 2 percent or better.
	(2) A heat sensing monitoring device equipped with a continuous recorder that indicates the continuous ignition of the pilot flame.
* * * * *
	(4) Using the data recorded by the monitoring system, except for inlet gas flowrate, the owner or operator must calculate the daily average value for each monitored operating parameter for each operating day. If the emissions unit operation is continuous, the operating day is a 24-hour period. If the emissions unit operation is not continuous, the operating day is the total number of hours of control device operation per 24-hour period. Valid data points must be available for 75 percent of the operating hours in an operating day to compute the daily average.
	(5) * * *
	(i) The owner or operator shall establish a minimum operating parameter value or a maximum operating parameter value, as appropriate for the control device, to define the conditions at which the control device must be operated to continuously achieve the applicable performance requirements of §63.1281(d)(1), (e)(3)(ii), or (f)(1). Each minimum or maximum operating parameter value shall be established as follows:
	(A) If the owner or operator conducts performance tests in accordance with the requirements of §63.1282(d)(3) to demonstrate that the control device achieves the applicable performance requirements specified in §63.1281(d)(1), (e)(3)(ii), or (f)(1), then the minimum operating parameter value or the maximum operating parameter value shall be established based on values measured during the performance test and supplemented, as necessary, by a condenser design analysis or control device manufacturer's recommendations or a combination of both.
	(B) If the owner or operator uses a condenser design analysis in accordance with the requirements of §63.1282(d)(4) to demonstrate that the control device achieves the applicable performance requirements specified in §63.1281(d)(1), (e)(3)(ii), or (f)(1), then the minimum operating parameter value or the maximum operating parameter value shall be established based on the condenser design analysis and may be supplemented by the condenser manufacturer's recommendations.
	(C) If the owner or operator operates a control device where the performance test was conducted under §63.1282(g) to demonstrate that the control device achieves the applicable performance requirements specified in §63.1281(d)(1), (e)(3)(ii) or (f)(1), then the maximum inlet gas flow rate shall be established based on the performance test and supplemented, as necessary, by the manufacturer recommendations.
	(ii) * * *
	(A) If the owner or operator conducts a performance test in accordance with the requirements of §63.1282(d)(3) to demonstrate that the condenser achieves the applicable performance requirements in §63.1281(d)(1), (e)(3)(ii), or (f)(1), then the condenser performance curve shall be based on values measured during the performance test and supplemented as necessary by control device design analysis, or control device manufacturer's recommendations, or a combination or both.
	(B) If the owner or operator uses a control device design analysis in accordance with the requirements of §63.1282(d)(4)(i) to demonstrate that the condenser achieves the applicable performance requirements specified in §63.1281(d)(1), (e)(3)(ii), or (f)(1), then the condenser performance curve shall be based on the condenser design analysis and may be supplemented by the control device manufacturer's recommendations.
	(C) As an alternative to paragraph (d)(5)(ii)(B) of this section, the owner or operator may elect to use the procedures documented in the GRI report entitled, "Atmospheric Rich/Lean Method for Determining Glycol Dehydrator Emissions" (GRI - 95/0368.1) as inputs for the model GRI-GLYCalc[TM] , Version 3.0 or higher, to generate a condenser performance curve.
	(6) An excursion for a given control device is determined to have occurred when the monitoring data or lack of monitoring data result in any one of the criteria specified in paragraphs (d)(6)(i) through (d)(6)(v) of this section being met. When multiple operating parameters are monitored for the same control device and during the same operating day, and more than one of these operating parameters meets an excursion criterion specified in paragraphs (d)(6)(i) through (d)(6)(iv) of this section, then a single excursion is determined to have occurred for the control device for that operating day.* * * * *
	(ii) For sources meeting §63.1281(d)(1)(ii), an  excursion occurs when average condenser efficiency calculated according to the requirements specified in §63.1282(f)(2)(iii) is less than 95.0 percent, as specified in §63.1282(f)(3). For sources meeting §63.1281(f)(1), an excursion occurs when the 30-day average condenser efficiency calculated according to the requirements of §63.1282(f)(2)(iii) is less than the identified 30-day required percent reduction.
* * * * *
	(v) For control device models tested under §63.1282(g) an excursion occurs when:
	(A) The inlet gas flow rate exceeds the maximum established during the test conducted under §63.1282(g).
	(B) Failure of the monthly visible emissions test conducted under §63.1282(h)(3) occurs.
	(8) * * *
	(i) * * *
	(A) During a malfunction when the affected facility is operated during such period in accordance with §63.6(e)(1); or
* * * * *
	(ii) For each control device, or combinations of control devices, installed on the same emissions unit, one excused excursion is allowed per semiannual period for any reason. The initial semiannual period is the 6-month reporting period addressed by the first Periodic Report submitted by the owner or operator in accordance with §63.1285(e) of this subpart.
* * * * *
	31. Section 63.1284 is amended by:
	a. Revising paragraph (b)(3) introductory text;
	b. Deleting and reserving paragraph (b)(3)(ii);
	c. Revising paragraph (b)(4)(ii) introductory text;
	d. Adding paragraph (b)(4)(ii)(A) through (C);
	e. Adding paragraph (b)(7)(ix); and
	f. Adding paragraph (f) and (g) to read as follows:
§63.1284 Recordkeeping requirements.
* * * * *
	(b) * * *
* * * * *
	(3) Records specified in §63.10(c) for each monitoring system operated by the owner or operator in accordance with the requirements of §63.1283(d). Notwithstanding the previous sentence, monitoring data recorded during periods identified in paragraphs (b)(3)(i) through (iv) of this section shall not be included in any average or percent leak rate computed under this subpart. Records shall be kept of the times and durations of all such periods and any other periods during process or control device operation when monitors are not operating or failed to collect required data.
* * * * *
	(ii) [Reserved]
* * * * *
	(4) * * *
* * * * *
	(ii) Records of the daily average value of each continuously monitored parameter for each operating day determined according to the procedures specified in §63.1283(d)(4) of this subpart, except as specified in paragraphs (b)(4)(ii)(A) through (C) of this section.
	(A) For flares, the records required in paragraph (e) of this section.
	(B) For condensers installed to comply with §63.1275, records of the annual 30-day rolling average condenser efficiency determined under §63.1282(f) shall be kept in addition to the daily averages.
	(C) For control device model tested under §63.1282(g), the records required in paragraph (g) of this section.
* * * * *
	(7) * * *
	(ix)  Records identifying the carbon replacement schedule under §63.1281(d)(5) and records of each carbon replacement.
* * * * *
	(f) The owner or operator of an affected source subject to this subpart shall maintain records of the occurrence and duration of each malfunction of operation (i.e., process equipment) or the air pollution control equipment and monitoring equipment. The owner or operator shall maintain records of actions taken during periods of malfunction to minimize emissions in accordance with §63.1274(a), including corrective actions to restore malfunctioning process and air pollution control and monitoring equipment to its normal or usual manner of operation.
	(g) Record the following when using a control device tested under §63.1282(g) to comply with §63.1281(d), (e)(3)(ii) or (f)(1):
	(1) All visible emission readings and flowrate measurements made during the compliance determination required by §63.1282(h); and
	(2) All hourly records and other recorded periods when the pilot flame is absent.
	32. Section 63.1285 is amended by:
	a. Revising paragraph (b)(1) introductory text;
	b. Adding paragraphs (b)(1)(i) and (ii);
	c. Revising paragraph (b)(6);
	d. Deleting paragraph (b)(7);
	e. Revising paragraph (d)(1) introductory text;
	f. Revising paragraphs (d)(1)(i)
	g. Revising paragraph (d)(1)(ii) introductory text;
	h. Revising paragraph (d)(1)(iv);
	i. Revising paragraph (d)(2) introductory text;
	j. Revising paragraph (d)(2)(ii);
	k. Revising paragraph (d)(4)(ii);
	l. Adding paragraph (d)(4)(iv);
	m. Revising paragraph (d)(10);
	n. Adding paragraphs (d)(11) and (d)(12);
	o. Revising paragraphs (e)(2)(ii)(B) and (C);
	p. Adding paragraphs (e)(2)(ii)(D) and (E);
	q. Adding paragraphs (e)(2)(x) and (xi); and
	r. Adding paragraph (g) to read as follows:
§63.1285 Reporting requirements.
* * * * *
	(b) * * *
	(1) The initial notifications required for existing affected sources under §63.9(b)(2) shall be submitted as provided in paragraphs (b)(1)(i) and (ii) of this section.
	(i)  Except as otherwise provided in paragraph (ii), the initial notification shall be submitted by 1 year after an affected source becomes subject to the provisions of this subpart or by June 17, 2000, whichever is later. Affected sources that are major sources on or before June 17, 2000 and plan to be area sources by June 17, 2002 shall include in this notification a brief, nonbinding description of a schedule for the action(s) that are planned to achieve area source status.
	(ii) An affected source identified under §63.1270(d)(3) shall submit an initial notification required for existing affected sources under §63.9(b)(2) within 1 year after the affected source becomes subject to the provisions of this subpart or by one year after publication of the final rule in the Federal Register, whichever is later. An affected source identified under §63.1270(d)(3) that plans to be an area source by 3 years after publication of the final rule in the Federal Register, shall include in this notification a brief, nonbinding description of a schedule for the action(s) that are planned to achieve area source status.
* * * * *
	(6) If there was a malfunction during the reporting period, the Periodic Report specified in paragraph (e) of this section shall include the number, duration, and a brief description for each type of malfunction which occurred during the reporting period and which caused or may have caused any applicable emission limitation to be exceeded. The report must also include a description of actions taken by an owner or operator during a malfunction of an affected source to minimize emissions in accordance with §63.1274(h), including actions taken to correct a malfunction.* * * * *
	(d) * * *
	(1) If a closed-vent system and a control device other than a flare are used to comply with §63.1274, the owner or operator shall submit the information in paragraph (d)(1)(iv) of this section and the information in either paragraph (d)(1)(i), (ii) or (iii) of this section.
	(i) The condenser design analysis documentation specified in §63.1282(d)(4) of this subpart if the owner or operator elects to prepare a design analysis; or
	(ii) If the owner or operator is required to conduct a performance test, the performance test results including the information specified in paragraphs (d)(1)(ii)(A) and (B) of this section. Results of a performance test conducted prior to the compliance date of this subpart can be used provided that the test was conducted using the methods specified in §63.1282(d)(3), and that the test conditions are representative of current operating conditions.
	(iii) If the owner or operator operates a combustion control device model tested under §63.1282(g), an electronic copy of the performance test results shall be submitted via email to Oil and Gas<EMAIL_ADDRESS>	(iv) The results of the closed-vent system initial inspections performed according to the requirements in §63.1283(c)(2)(i) and (ii).
	(2) If a closed-vent system and a flare are used to comply with §63.1274, the owner or operator shall submit performance test results including the information in paragraphs (d)(2)(i) and (ii) of this section. The owner or operator shall also submit the information in paragraph (d)(2)(iii) of this section.
* * * * *
	(ii) A statement of whether a flame, as defined in this subpart, was present at the pilot light over the full period of the compliance determination.* * * * *
	(4) * * *
* * * * *
	(ii) An explanation of the rationale for why the owner or operator selected each of the operating parameter values established in §63.1283(d)(5) of this subpart. This explanation shall include any data and calculations used to develop the value, and a description of why the chosen value indicates that the control device is operating in accordance with the applicable requirements of §63.1281(d)(1), (e)(3)(ii), or (f)(1).
* * * * *
	(iv) For each carbon adsorber, the predetermined carbon replacement schedule as required in §63.1281(d)(5)(i).
* * * * *
	(10) The owner or operator shall submit the analysis prepared under §63.1281(e)(2) to demonstrate that the conditions by which the facility will be operated to achieve the HAP emission reduction of 95.0 percent, or the BTEX limit in §63.1275(b)(1)(iii) through process modifications or a combination of process modifications and one or more control devices.
	(11)  If the owner or operator installs a combustion control device model tested under the procedures in §63.1282(g), the data listed under §63.1282(g)(8).
      (12)  For each combustion control device model tested under §63.1282(g), the information listed in paragraphs (d)(12)(i) through (vi) of this section.
      (i) Name, address and telephone number of the control device manufacturer.
      (ii) Control device model number.
      (iii) Control device serial number.
      (iv) Date of control device certification test.
      (v) Manufacturer's HAP destruction efficiency rating.
	(vi) Control device operating parameters, maximum allowable inlet gas flowrate.
* * * * *
	(e) * * *
* * * * *
	(2) * * *
* * * * *
	(ii) * * *
* * * * *
	(B) For each excursion caused when the 30-day average condenser control efficiency is less than the value, as specified in §63.1283(d)(6)(ii), the report must include the 30-day average values of the condenser control efficiency, and the date and duration of the period that the excursion occurred.
* * * * *
	(D) For each excursion caused when the inlet gas flow rate identified under §63.1282(g) exceeds the maximum specified value, the report must include the values of the inlet gas identified and the date and duration of the period that the excursion occurred.
	(E) For each excursion caused when visible emissions determined under §63.1282(h) exceed the maximum allowable duration, the report must include the date and duration of the period that the excursion occurred.
* * * * *
	(x)  The results of any periodic test as required in §63.1282(d)(3) conducted during the reporting period.
	(xi) For each carbon adsorber used to meet the control device requirements of §63.1281(d)(1), records of each carbon replacement that occurred during the reporting period.
* * * * *
	(g) Electronic Reporting. (1) As of January 1, 2012, and within 60 days after the date of completing each performance test, as defined in §63.2 and as required in this subpart, you must submit performance test data, except opacity data, electronically to the EPA's Central Data Exchange (CDX) by using the Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/ert tool.html/). Only data collected using test methods compatible with ERT are subject to this requirement to be submitted electronically into the EPA's WebFIRE database.
	(2) All reports required by this subpart not subject to the requirements in paragraphs (g)(1) of this section must be sent to the Administrator at the appropriate address listed in §63.13. If acceptable to both the Administrator and the owner or operator of a source, these reports may be submitted on electronic media. The Administrator retains the right to require submittal of reports subject to paragraph (g)(1) of this section in paper format.
* * * * *
	33. Section 63.1287 is amended by revising paragraph (a) to read as follows:
		(a) If, in the judgment of the Administrator, an alternative means of emission limitation will achieve a reduction in HAP emissions at least equivalent to the reduction in HAP emissions from that source achieved under the applicable requirements in §§63.1274 through 63.1281, the Administrator will publish a notice in the Federal Register permitting the use of the alternative means for purposes of compliance with that requirement. The notice may condition the permission on requirements related to the operation and maintenance of the alternative means.
	34. Appendix to Subpart HHH of Part 63  -  Table is amended by revising Table 2 to read as follows:
Appendix to Subpart HHH of Part 63 -- Tables
* * * * *
Table 2 to Subpart HHH of Part 63 -- Applicability of 40 CFR Part 63 General Provisions to Subpart HHH
General provisions reference
Applicable to
subpart HHH
Explanation
§63.1(a)(1)
Yes.

§63.1(a)(2)
Yes.

§63.1(a)(3)
Yes.

§63.1(a)(4)
Yes.

§63.1(a)(5)
No
Section reserved.
§63.1(a)(6)
through (a)(8)
Yes.

§63.1(a)(9)
No
Section reserved.
§63.1(a)(10)
Yes.

§63.1(a)(11)
Yes.

§63.1(a)(12)	 through (a)(14)
Yes.

§63.1(b)(1)
No
Subpart HHH specifies applicability.
§63.1(b)(2)
Yes.

§63.1(b)(3)
No.

§63.1(c)(1)
No
Subpart HHH specifies applicability.
§63.1(c)(2)
No.

§63.1(c)(3)
No
Section reserved.
§63.1(c)(4)
Yes.

§63.1(c)(5)
Yes.

§63.1(d)
No
Section reserved.
§63.1(e)
Yes.

§63.2
Yes
Except definition of major source is unique for this source category and there are additional definitions in subpart HHH.
§63.3(a) through (c)
Yes.

§63.4(a)(1)	 through (a)(3)
Yes.

§63.4(a)(4)
No
Section reserved.
§63.4(a)(5)
Yes.

§63.4(b)
Yes.

§63.4(c)
Yes.

§63.5(a)(1)
Yes.

§63.5(a)(2)
No
Preconstruction review required only for major sources that commence construction after promulgation of the standard.
§63.5(b)(1)
Yes.

§63.5(b)(2)
No
Section reserved.
§63.5(b)(3)
Yes.

§63.5(b)(4)
Yes.

§63.5(b)(5)
Yes.

§63.5(b)(6)
Yes.

§63.5(c)
No
Section reserved.
§63.5(d)(1)
Yes.

§63.5(d)(2)
Yes.

§63.5(d)(3)
Yes.

§63.5(d)(4)
Yes.

§63.5(e)
Yes.

§63.5(f)(1)
Yes.

§63.5(f)(2)
Yes.

§63.6(a)
Yes.

§63.6(b)(1)
Yes.

§63.6(b)(2)
Yes.

§63.6(b)(3)
Yes.

§63.6(b)(4)
Yes.

§63.6(b)(5)
Yes.

§63.6(b)(6)
No
Section reserved.
§63.6(b)(7)
Yes.

§63.6(c)(1)
Yes.

§63.6(c)(2)
Yes.

§63.6(c)(3) and (c)(4)
No
Section reserved.
§63.6(c)(5)
Yes.

§63.6(d)
No
Section reserved.
§63.6(e)
Yes.

§63.6(e)
Yes
Except as otherwise specified.
§63.6(e)(1)(i)
No
See §63.1274(h) for general duty requirement.
§63.6(e)(1)(ii)
No.

§63.6(e)(1)(iii)
Yes.

§63.6(e)(2)
Yes.

§63.6(e)(3)
No.

§63.6(f)(1)
No.

§63.6(f)(2)
Yes.

§63.6(f)(3)
Yes.

§63.6(g)
Yes.

§63.6(h)
No
Subpart HHH does not contain opacity or visible emission standards.
§63.6(i)(1)	 through (i)(14)
Yes.

§63.6(i)(15)
No
Section reserved.
§63.6(i)(16)
Yes.

§63.6(j)
Yes.

§63.7(a)(1)
Yes.

§63.7(a)(2)
Yes
But the performance test results must be submitted within 180 days after the compliance date.
§63.7(a)(3)
Yes.

§63.7(b)
Yes.

§63.7(c)
Yes.

§63.7(d)
Yes.

§63.7(e)(1)
No.

§63.7(e)(2)
Yes.

§63.7(e)(3)
Yes.

§63.7(e)(4)
Yes.

§63.7(f)
Yes.

§63.7(g)
Yes.

§63.7(h)
Yes.

§63.8(a)(1)
Yes.

§63.8(a)(2)
Yes.

§63.8(a)(3)
No
Section reserved.
§63.8(a)(4)
Yes.

§63.8(b)(1)
Yes.

§63.8(b)(2)
Yes.

§63.8(b)(3)
Yes.

§63.8(c)(1)
Yes.

63.8(c)(1)(i).
§63.8(c)(1)(ii).
§63.8(c)(1)(iii)
No
Yes
Pending

§63.8(c)(2)
Yes.

§63.8(c)(3)
Yes.

§63.8(c)(4)
No.

§63.8(c)(5)	 through (c)(8)
Yes.

§63.8(d)
Yes.

§63.8(d)(3)
Yes
Except for last sentence, which refers to an SSM plan. SSM plans are not required.
§63.8(e)
Yes
Subpart HHH does not specifically require continuous emissions monitor performance evaluations, however, the Administrator can request that one be conducted.
§63.8(f)(1)	 through (f)(5)
Yes

§63.8(f)(6)
No
Subpart HHH does not require continuous emissions monitoring.
§63.8(g)
No
Subpart HHH specifies continuous monitoring system data reduction requirements.
§63.9(a)
Yes.

§63.9(b)(1)
Yes.

§63.9(b)(2)
Yes
Existing sources are given 1 year (rather than 120 days) to submit this notification.
§63.9(b)(3)
Yes.

§63.9(b)(4)
Yes.

§63.9(b)(5)
Yes.

§63.9(c)
Yes.

§63.9(d)
Yes.

§63.9(e)
Yes.

§63.9(f)
No.

§63.9(g)
Yes.

§63.9(h)(1)	 through (h)(3)
Yes.

§63.9(h)(4)
No
Section reserved.
§63.9(h)(5) and	 (h)(6)
Yes.

§63.9(i)
Yes.

§63.9(j)
Yes.

§63.10(a)
Yes.

§63.10(b)(1)
Yes
Section 63.1284(b)(1) requires sources to maintain the most recent 12 months of data on-site and allows offsite storage for the remaining 4 years of data.
§63.10(b)(2)
Yes.

§63.10(b)(2)(i)
No

§63.10(b)(2)(ii)
No
See §63.1284(f) for recordkeeping of occurrence, duration, and actions taken during malfunction
§63.10(b)(2)(iii)
Yes.

§63.10(b)(2)(iv)	 through (b)(2)(v)
No.

§63.10(b)(2)(vi)	 through (b)(2)(xiv)
Yes.

§63.10(b)(3)
No.

§63.10(c)(1)
Yes.

§63.10(c)(2)	 through (c)(4)
No
Sections reserved.
§63.10(c)(5)	 through (c)(8)
Yes.

§63.10(c)(9)
No
Section reserved.
§63.10(c)(10) and (c)(11)
No
See §63.1284(f)for recordkeeping of malfunctions
§63.10(c)(12)	 through (c)(14)
Yes.

§63.10(c)(15)
No.

§63.10(d)(1)
Yes.

§63.10(d)(2)
Yes.

§63.10(d)(3)
Yes.

§63.10(d)(4)
Yes.

§63.10(d)(5)
No
See §63.1285(b)(6) for reporting of malfunctions.
§63.10(e)(1)
Yes.

§63.10(e)(2)
Yes.

§63.10(e)(3)(i)
Yes
Subpart HHH requires major sources to submit Periodic Reports semi-annually.
§63.10(e)(3)(i)(A)
Yes.

§63.10(e)(3)(i)(B)
Yes.

§63.10(e)(3)(i)(C)
No
Subpart HHH does not require quarterly reporting for excess emissions.
§63.10(e)(3)(ii)	 through (e)(3)(viii)
Yes.

§63.10(f)
Yes.

§63.11(a) and (b)
Yes.

§63.11(c), (d),	 and (e)
Yes.

§63.12(a) through	 (c)
Yes.

§63.13(a) through	 (c)
Yes.

§63.14(a) and (b)
Yes.

§63.15(a) and (b)
Yes.


[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Proposed Rules]
[Page 60110]
[FR Doc No: 2015-25154]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0008; FRL-9934-10-Region 5]

Air Plan Approval; Illinois; Volatile Organic Compounds
Definition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Under the Clean Air Act, the Environmental Protection Agency
(EPA) is proposing to approve a revision to the Illinois State
Implementation Plan. The revision amends the Illinois Administrative
Code by updating the definition of volatile organic material or
volatile organic compounds to exclude 2,3,3,3-tetrafluoropropene. This
revision is in response to an EPA rulemaking in 2013 which exempted
this compound from the Federal definition of volatile organic compounds
on the basis that the compound makes a negligible contribution to
tropospheric ozone formation.

DATES: Comments must be received on or before November 4, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0008, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: September 8, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-25154 Filed 10-2-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Page 80357]
[FR Doc No: 2015-32418]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9024-6]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EISs)
Filed 12/14/2015 Through 12/18/2015
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20150358, Draft, USACE, FL, Herbert Hoover Dike Dam Safety
Modification, Comment Period Ends: 02/08/2016, Contact: Stacie
Auvenshine<PHONE_NUMBER>.
EIS No. 20150359, Draft, USFS, OR, Gap Landscape Restoration Project,
Comment Period Ends: 02/08/2016, Contact: Gary Asbridge<PHONE_NUMBER>.
EIS No. 20150360, Final, FERC, FL, Southeast Market Pipelines Project,
Review Period Ends: 01/25/2016, Contact: John Peconom<PHONE_NUMBER>.
EIS No. 20150361, Draft Supplement, FTA, CA, Transbay Transit Center
Program, Comment Period Ends: 02/29/2016, Contact: Brenda Perez 415-
744-2731.
EIS No. 20150362, Final Supplement, FTA, CA, Regional Connector Transit
Corridor, Review Period Ends: 01/25/2016, Contact: Mary Nguyen 213-202-
3960.

    Dated: December 21, 2015.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2015-32418 Filed 12-23-15; 8:45 am]
BILLING CODE 6560-50-P


MAC   SH Fact Sheet

Hot Work on Hollow or Enclosed Structures in Shipyard Employment

Failure to test the atmosphere prior to hot work on hollow structures
could result in an explosion or injury.

Hot work on a hollow or enclosed structure on a vessel or shore side
can present a hazard to both the worker and a vessel or a facility
asset. OSHA has regulations which detail safe practices when working on
any hollow or enclosed structure. However, these regulations only apply
to shipyard work and to vessel repair outside of shipyards. The OSHA
longshoring standards found in 29 CFR address the hazards of this type
of work shore side within a longshoring facility.

What is a hollow or enclosed space?

A hollow or enclosed space is a structure which is not vented to the
atmosphere. It is normally hollow but may be filled with some material
such as foam, or a preservative to prevent corrosion. Some common
examples are skegs, masts, booms, rudders support stanchions, pipe
stanchions, hatches or railings. Shore side some hollow structures may
include crane legs and supports, drums, mooring bits and tanks. This is
a very limited list and these structures can come in a variety of sizes
and shapes both shipboard and also shore side. It becomes dependent on
the person doing the hot work to recognize if they will be doing hot
work on a hollow structure.

Figure 1. A hollow area under a mooring bit

What hazards may you encounter when performing hot work on these
structures?

The main hazard that may be found in a hollow structure is an explosive
atmosphere. Performing hot work on a hollow structure with and internal
explosive atmosphere will present the obvious danger of an explosion.
The hot work will present an ignition source which if combined with an
explosive atmosphere will result in ignition.

Another hazard which you may encounter is that a hollow structure may be
filled with a material which could either catch fire or release toxic
vapors. One common material is insulating foam which can catch fire and
gives off noxious gasses.

Where do explosive atmospheres come from?

Flammable or explosive atmospheres in hollow structures can come from
many sources. One method is if the internal metal is painted and then
sealed up. The paint may continue to release solvents from the paint
which can cause the atmosphere to become flammable. Another way is that
frequently internals are coated with an oil based preservative to
prevent corrosion. While the preservative is intentionally introduced,
repairs can present an unforeseen hazard. This is especially true with
rudders and skegs.

Additionally, the rusting process of metal can also present an explosive
atmosphere. Water vapor combined with steel causes oxidation or rusting
and in the process can release explosive hydrogen gas.

The process of welding can release carbon monoxide gas into the hollow
structure. Carbon monoxide in high enough concentrations can become an
explosive gas.

Another source of an explosive atmosphere can be due to a leak from an
adjacent space, cargo tank or even a spill which may have caused some
flammable liquid or gas to enter the internal space of the hollow
structure.

You may also have a mixture of the processes above causing an explosive
atmosphere.

In the case of a hollow structure which is filled with foam or a similar
material, atmospheric testing may not indicate an explosive atmosphere,
but that does not mean that a hazard may not exist. Special precautions
must be used to prevent fires from starting when welding against this
material.

Figure 2. Hollow Skegs

How do you test the internal atmosphere?

The safest way to determine if you have an explosive environment is to
have a qualified individual test the atmosphere in the space. In order
to do this you must be able to sample the internal atmosphere. If the
hollow structure has a method to do this such as a vent plug then all
you have to do is remove the plug and test the atmosphere. If no plug is
available, the most common method to test the atmosphere is to drill a
hole into the structure. Since you are drilling into an unknown
atmosphere care must be taken not to overheat the drill bit. This can be
accomplished by using a lubricant to keep the bit cool.

 Testing the internal atmosphere:

 Once an access hole is established the internal atmosphere can be
tested. It is important to have a qualified individual use a calibrated
meter to test the atmosphere. Due to several issues such as response
factors and unknown gasses, it is important that a qualified individual
test the atmosphere and understand the results to establish safe
conditions.

Figure 3. A vent plug indicating leaking product

What do you do if an explosive atmosphere is found?

If, after testing, an explosive atmosphere is found then there are
several ways to eliminate this hazard. The easiest method is to drill
another vent hole and introduce compressed air and ventilate the space
until testing determines that all of the explosive gas has been
eliminated.

However, in some cases such as when an oil based preservative has been
introduced or a flammable liquid has entered the space, another method
of eliminating the hazard may be needed. This is normally done by
purging the space with an inert gas such as carbon dioxide or nitrogen.
This practice should only be done by an experienced professional as
failure to do this properly may not eliminate the hazard.

In the case of foam or similar material it may be necessary to purge the
area with an inert gas, use special welding methods or to cold cut the
void and remove the foam. The use of a professional may be required in
this situation also.

Once the hazard has been eliminated then hot work can safely proceed.
Depending on the length of the hot work it is a good practice to
occasionally test the atmosphere to ensure that safe conditions remain.

To Obtain Professional Assistance for Hollow Structure Testing:

www.MarineChemist.org

  HYPERLINK "http://www.aiha.org"  www.aiha.org

http://www.osha.gov/SLTC/etools/shipyard/index.html

Local Safety Suppliers or Consultants

Exhibit 15

This is one in a series of informational fact sheets highlighting OSHA
programs, policies or standards.  It does not impose any new compliance
requirements.  For a comprehensive list of compliance requirements of
OSHA standards or regulations, refer to Title 29 of the Code of Federal
Regulations.  This information will be made available to sensory
impaired individuals upon request.  The voice phone is<PHONE_NUMBER>;
teletypewriter (TTY) number:<PHONE_NUMBER>.


June 8, 2009

MEMORANDUM

TO:			Air Docket EPA-HQ-OAR-2005-0161

SUBJECT:	Instructions for Accessing the Forest and Agricultural Sector
Optimization Model (FASOM) and the Food and Agricultural Policy Research
Institute (FAPRI) Models

To provide additional information on the agricultural economic models
used in the RFS2 NPRM, this memo provides instructions on how to access
the FAPRI model as modified by the Center for Agricultural and Rural
Development (CARD) at Iowa State University, as well as the FASOM model.

The FAPRI model can be accessed via the docket at Docket ID:
EPA-HQ-OAR-2005-0161.  Please refer to the following files:

US Crops Model EPA Reference Case.xls

US Dairy Model EPA Reference Case.xls

US Livestock Model EPA Reference Case.xls

International Biodiesel Model EPA Reference Case.xls

International Oilseed Model EPA Reference Case.xls

International Ethanol Model EPA Reference Case.xls

International Dairy Model EPA Reference Case.xls

International Grains Model EPA Reference Case.xls

International Livestock Model EPA Reference Case.xls

International Sugar Model EPA Reference Case.xls

For the output files used in the RFS2 NPRM analysis, please refer to
Document ID: EPA-HQ-OAR-2005-0161-0945.

The FASOM model can also be accessed, free of charge, but subject to
customary use restrictions to protect the proprietary nature of the
model. To access the FASOM model, please contact:

Jefferson Cole

Transportation Climate Division

Environmental Protection Agency

1200 Pennsylvania Ave, N.W.

Room 6510Z, Mail Code: 6401A

Phone:<PHONE_NUMBER>   Fax:<PHONE_NUMBER>

Email<EMAIL_ADDRESS>

For the FASOM output files used in the RFS2 NPRM analysis, please refer
to:

Document ID: EPA-HQ-OAR-2005-0161-0948

Document ID: EPA-HQ-OAR-2005-0161-0929

Document ID: EPA-HQ-OAR-2005-0161-0859

Document ID: EPA-HQ-OAR-2005-0161-0860

Document ID: EPA-HQ-OAR-2005-0161-0861

Document ID: EPA-HQ-OAR-2005-0161-0862

Document ID: EPA-HQ-OAR-2005-0161-0863


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Proposed Rules]
[Pages 3522-3525]
[FR Doc No: 2015-00958]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-1049; Directorate Identifier 2013-NM-110-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 &
440) airplanes. This proposed AD was prompted by reports of the
horizontal stabilizer trim actuator (HSTA) spur gear bolts inside the
gearbox found loose, broken, or backed out due to incorrect bending of
the anti-rotation tab washer and the improper application of glue
during installation. This proposed AD would require replacing certain
HSTAs with a new HSTA. This proposed AD would also require revising the
airplane flight manual (AFM) and the maintenance or inspection program,
as applicable. We are proposing this AD to prevent failure of the HSTA
and subsequent loss of control of the airplane.

DATES: We must receive comments on this proposed AD by March 9, 2015.

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 service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. 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 Management Facility
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 Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Luke Walker, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; 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-2014-1049; Directorate
Identifier 2013-NM-110-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2013-14, dated June 4, 2013 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. The MCAI states:

    There have been a number of reports where the HSTA spur gear
bolts inside the gearbox were found loose, broken or backed out.
Investigation revealed that the root cause is incorrect bending of
the anti-rotation tab washer and the improper application of Loctite
glue during installation.
    The function of these bolts is to generate sufficient preload
between the two spur gears such that the full torque is transferred
by friction between the two spur gears. Loosening of the bolts would
reduce the pre-load between two spur gears and decrease the torque
transfer. Partial or full torque would be re-distributed to the
secondary load path (Tie-Rod) in torsion. The Tie-Rod is designed to
withstand axial load only in case of failure of the primary load
path (ACME screw), and not torsional load. The secondary load path
(Tie-Rod) is therefore considered ineffective and no longer provides
protection as a failsafe design of the system. Loose bolt(s) on the
HSTA spur gear combined with the failure of the primary load path,
could lead to failure of the HSTA and subsequent loss of the
aeroplane.
    In addition, Bombardier Aerospace (BA) has introduced a modified
HSTA [part number] P/N 601R92305-5 (vendor P/N 8396-4) to rectify
the loose bolt problem. However, this modified HSTA, has several
quality control problems which could affect safety.
    This [Canadian] AD is issued to mandate the replacement of the
affected HSTA(s) with the new HSTA P/N 601R92305-7 (vendor P/N 8396-
5).

This proposed AD also would require revising the AFM and maintenance or
inspection program, as applicable. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-1049.

Related Service Information

    Bombardier has issued the following service information.
     Bombardier Service Bulletin 601R-27-161, Revision A, dated
January 30, 2014. This service information describes procedures for
installing an HSTA.
     Bombardier CL-600-2B19, Temporary Revision 2A-56, dated
June 4, 2012, to Appendix A, Certification Maintenance Requirements
(CMR), of Part 2, Airworthiness Requirements, of the Bombardier CL-600-
2B19 Maintenance Requirements Manual (MRM). This service information
adds new CMR tasks to the Airworthiness Requirements of the MRM. These
CMR tasks include an inspection, functional check, and operational
check.
     Bombardier Model CL-600-2B19 Airplane Flight Manual, CSP
A-012, Volume 3, Revision 61, dated April 2, 2013. This service
information revises the Limitations section of the AFM to include a
horizontal stabilizer trim check before the first flight of the day. In
addition, this service information revises the Normal Procedures
section of the AFM to include details for the horizontal stabilizer
trim check portion of the procedure.
    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

    We estimate that this proposed AD affects 85 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
HSTA replacement...................  8 work-hours x $85 per hour         $38,569         $39,249      $3,336,165
                                      = $680.
Revise airplane flight manual......  1 work-hour x $85 per hour                0              85           7,225
                                      = $85.
Revise maintenance or inspection     1 work-hour x $85 per hour                0              85           7,225
 program.                             = $85.
----------------------------------------------------------------------------------------------------------------

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.

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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2014-1049; Directorate Identifier
2013-NM-110-AD.

(a) Comments Due Date

    We must receive comments by March 9, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7003 and subsequent, equipped with horizontal
stabilizer trim actuator (HSTA) part number (P/N) 601R92305-1
(vendor P/N 8396-2), 601R92305-3 (vendor P/N 8396-3), or 601R92305-5
(vendor P/N 8396-4).

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Reason

    This AD was prompted by reports of the HSTA spur gear bolts
inside the gearbox found loose, broken, or backed out due to
incorrect bending of the anti-rotation tab washer and the improper
application of Loctite glue during installation. We are issuing this
AD to prevent failure of the HSTA and subsequent loss of control of
the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Airplane Flight Manual (AFM) Revision

    Within 30 days after the effective date of this AD, revise the
Limitations section and Normal Procedures section of the AFM to
include the information in Supplement 23, ``Horizontal Stabilizer
Trim Check,'' of Chapter 7 ``Supplements,'' of Bombardier CL-600-
2B19 Airplane Flight Manual CSP A-012, Volume 3, Revision 61, dated
April 2, 2013.

(h) Maintenance/Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate
Task C27-40-103-04, ``Operational Check (ground maintenance test) of
the horizontal stabilizer trim control unit,'' specified in
Bombardier CL-600-2B19 Temporary Revision 2A-56, dated June 4, 2012,
to Appendix A, Certification Maintenance Requirements, of Part 2,
Airworthiness Requirements, of the Bombardier CL-600-2B19
Maintenance Requirements Manual (MRM). The compliance time for the
initial operational check is within 500 flight hours after the
effective date of this AD.

(i) No Alternative Actions or Intervals

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative actions (e.g., inspections) and/or intervals
may be used unless the actions and/or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (m) of this AD.

(j) HSTA Replacement

    (1) For airplanes equipped with an HSTA having P/N 601R92305-1
(vendor P/N 8396-2) or P/N 601R92305-3 (vendor P/N 8396-3): At the
earlier of the times specified in paragraphs (j)(1)(i) and
(j)(1)(ii) of this AD, replace the HSTA with a new HSTA having P/N
601R92305-7 (vendor P/N 8396-5), in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 601R-27-
161, Revision A, dated January 30, 2014. The compliance times
specified in paragraphs (j)(1)(i) and (j)(1)(ii) of this AD do not
alleviate any existing life limit requirements.
    (i) Within 3,700 flight hours after the effective date of this
AD.
    (ii) Within 27 months after the effective date of this AD.
    (2) For airplanes equipped with an HSTA having P/N 601R92305-5
(vendor P/N 8396-4): At the earlier of the times specified in
paragraphs (j)(2)(i), (j)(2)(ii), and (j)(2)(iii) of this AD,
replace the HSTA with a new HSTA having P/N 601R92305-7 (vendor P/N
8396-5), in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 601R-27-161, Revision A, dated January
30, 2014. The compliance times specified in paragraphs (j)(2)(i),
(j)(2)(ii), and (j)(2)(iii) of this AD do not alleviate any existing
life limit requirements.
    (i) Within 4,400 flight hours after the effective date of this
AD.
    (ii) Within 32 months after the effective date of this AD.
    (iii) Before the accumulation of 10,000 total flight hours on
HSTA P/N 60192305-5 (vendor P/N 8396-4).

(k) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (j) of this AD, if those actions were performed before the
effective date of this AD using Bombardier Service Bulletin 601R-27-
161, dated May 31, 2012, which is not incorporated by reference in
this AD.

(l) Parts Installation Limitations

    (1) As of the effective date of this AD, no person may install
an HSTA, P/N 601R92305-1 (vendor P/N 8396-2) or P/N 601R92305-3
(vendor P/N 8396-3) on any Model CL-600-2B19 airplane.
    (2) As of the effective date of this AD, no person may install
an HSTA, P/N 601R92305-5 (vendor P/N 8396-4) having serial number
(S/N) 287, 724, 813, 841, 998, 1031, 1035, 1049, 1053, 1067, 1068,
1136, 1252, 1268, 1303, 1319, 1338, 1354, 1374, 1378, 1445, 1470,
1498, 1513, 1546, 1632, 1736, 1766, 1846, 1849, 2002 through 2009
inclusive, 2011, 2013 through 2016 inclusive, 2019, 2020, or 2022,
on any Model CL-600-2B19 airplane.
    (3) As of the effective date of this AD: Replacement of an HSTA,
P/N 601R92305-1 (vendor P/N 8396-2), P/N 601R92305-3 (vendor P/N
8396-3), or P/N 601R92305-5 (vendor P/N 8396-4), with an HSTA having
P/N 601R92305-5 (vendor P/N 8396-4) that is not identified in
paragraph (l)(2) of this AD, is acceptable, provided the actions
required by paragraph (j)(2) of this AD are accomplished within the
compliance time specified in that paragraph.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
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) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada
Civil Aviation (TCCA); or

Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2013-14, dated June 4,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-1049.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 13, 2015.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-00958 Filed 1-22-15; 8:45 am]
BILLING CODE 4910-13-P