[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56598-56599]
[FR Doc No: 2020-20169]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-27-000]

North Baja Pipeline, LLC; Notice of Availability of the
Environmental Assessment for the Proposed North Baja Xpress Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the North
Baja XPress Project, proposed by North Baja Pipeline, LLC (North Baja)
in the above-referenced docket. North Baja requests authorization to
modify an existing compressor station in La Paz County, Arizona, as
well as install additional flow measurement facilities and piping
modifications at two existing meter stations in La Paz County, Arizona,
and Imperial County, California, respectively. The project would enable
the transport of 495,000 dekatherms per day to the United States/Mexico
border. North Baja states that the purpose of the project is to create
capacity to meet growing market demand and provide transportation of
feed gas for the Energia Costa Azul liquefied natural gas terminal in
Baja California, Mexico.
    The EA assesses the potential environmental effects of the
construction and operation of the North Baja XPress Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate

mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The U.S. Department of the Interior Bureau of Land Management (BLM)
participated as a cooperating agency in the preparation of the EA.
Cooperating agencies have jurisdiction by law or special expertise with
respect to resources potentially affected by the proposal and
participate in the NEPA analysis. The BLM will adopt and use the EA to
consider the issuance of a right-of-way grant for the use of a
potential temporary workspace on BLM-administered public lands adjacent
to the Ogilby Meter Station. North Baja submitted an application
requesting a right-of-way for use of a temporary workspace on BLM-
administered public lands.
    The proposed North Baja XPress Project includes the following
facilities:
     The construction of one new 31,900-horsepower compressor
unit and restaging of two existing 7,700-horsepower compressor units at
North Baja's existing Ehrenberg Compressor Station in La Paz County,
Arizona; and
     the addition of flow measurement facilities and piping
modifications at North Baja's existing El Paso and Ogilby Meter
Stations in La Paz County, Arizona and Imperial County, California,
respectively.
    The Commission mailed a copy of the Notice of Availability for the
project to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
project area. The EA is only available in electronic format. It may be
viewed and downloaded from the FERC's website (www.ferc.gov), on the
natural gas environmental documents page (https://www.ferc.gov/industries-data/naturalgas/environment/environmental-documents). In
addition, the EA may be accessed by using the eLibrary link on the
FERC's website. Click on the eLibrary link (https://www.ferc.gov/ferc-online/elibrary/overview), select ``General Search'' and enter the
docket number in the ``Docket Number'' field, excluding the last three
digits (i.e. CP20-27). Be sure you have selected an appropriate date
range. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    The EA is not a decision document. It presents Commission staff's
independent analysis of the environmental issues for the Commission to
consider when addressing the merits of issues raised in this
proceeding. Any person wishing to comment on the EA may do so. Your
comments should focus on the EA's disclosure and discussion of
potential environmental effects, reasonable alternatives, and measures
to avoid or lessen environmental impacts. The more specific your
comments, the more useful they will be. To ensure that the Commission
has the opportunity to consider your comments prior to making its
decision on this project, it is important that we receive your comments
in Washington, DC on or before 5:00 p.m. Eastern Time on October 8,
2020.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to FERC Online. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP20-
27-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, MD 20852.
    Filing environmental comments will not give you intervenor status,
but you do not need intervenor status to have your comments considered.
Only intervenors have the right to seek rehearing or judicial review of
the Commission's decision. At this point in this proceeding, the
timeframe for filing timely intervention requests has expired. Any
person seeking to become a party to the proceeding must file a motion
to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the
Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and
(d)) and show good cause why the time limitation should be waived.
Motions to intervene are more fully described at https://www.ferc.gov/ferc-online/ferc-online/how-guides.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: September 8, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-20169 Filed 9-11-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 7, 2006 (Volume 71, Number 215)]
[Notices]
[Page 65094]
[DOCID:fr07no06-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-35-000]

Chandeleur Pipe Line Company; Notice of Proposed Changes in FERC
Gas Tariff

October 30, 2006.
    Take notice that on October 25, 2006, Chandeleur Pipe Line Company
(Chandeleur) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, the following tariff sheets, to become effective
December 1, 2006:

Sixth Revised Sheet No. 3
Nineteenth Revised Sheet No. 5
First Revised Sheet No. 64

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
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 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-18676 Filed 11-6-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6322-6323]
[FR Doc No: 2021-01229]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0604; FRL-10017-50]

C.I. Pigment Violet 29; Final Toxic Substances Control Act (TSCA)
Risk Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of C.I. Pigment Violet 29. The purpose of conducting risk
evaluations under TSCA is to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment
under the conditions of use, including an unreasonable risk to a
relevant potentially exposed or susceptible subpopulation, without
consideration of costs or other nonrisk factors. EPA has determined
that specific conditions of use of C.I. Pigment Violet 29 present an
unreasonable risk of injury to health or the environment. For those
conditions of use for which EPA has found an unreasonable risk, EPA
must move to address that unreasonable risk through risk management
measures enumerated in TSCA. EPA has also determined that specific
conditions of use do not present unreasonable risk of injury to health
or the environment. For those conditions of use for which EPA has found
no unreasonable risk to health or the environment, the Agency's
determination is a final Agency action and is issued via order in the
risk evaluation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0604, is available online
at http://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Seema Schappelle, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8006; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be interested in risk
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be interested in this final risk
evaluation, the EPA has not attempted to describe all the specific
entities that may be affected by this action.

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

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to ``determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator,
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements
applicable to this process, including provisions that provide
instruction on chemical substances that must undergo evaluation, the
minimum components of a TSCA risk evaluation, and the timelines for
public comment and completion of the risk evaluation. TSCA also
requires that EPA operate in a manner that is consistent with the best
available science, make decisions based on the weight of the scientific
evidence and consider reasonably available information. 15 U.S.C.
2625(h), (i), and (k). TSCA section 6(i) directs that a determination
of ``no unreasonable risk'' shall be issued by order and considered to
be a final Agency action, while a determination of ``unreasonable
risk'' is not considered to be a final Agency action. 15 U.S.C.
2605(i).
    The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) Integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed
within a specified timeframe and provide an opportunity for public
comment on a draft risk evaluation prior to publishing a final risk
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.4.1 of the final risk evaluation for C.I. Pigment
Violet 29 constitutes the order required under TSCA section 6(i)(1),
and the ``no unreasonable risk'' determinations in that subsection are
considered to be a final Agency action effective on the date

of issuance of the order. In conducting risk evaluations, ``EPA will
determine whether the chemical substance presents an unreasonable risk
of injury to health or the environment under each condition of use
within the scope of the risk evaluation . . . .'' 40 CFR 702.47. Under
EPA's implementing regulations, ``[a] determination by EPA that the
chemical substance, under one or more of the conditions of use within
the scope of the risk evaluation, does not present an unreasonable risk
of injury to health or the environment will be issued by order and
considered to be a final Agency action, effective on the date of
issuance of the order.'' 40 CFR 702.49(d). For purposes of TSCA section
19(a)(1)(A), the date of issuance of the TSCA section 6(i)(1) order for
C.I. Pigment Violet 29 shall be at 1:00 p.m. Eastern time (standard or
daylight, as appropriate) on the date that is two weeks after the date
when this notice is published in the Federal Register, which is in
accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the
chemical substance identified in Unit II. In this risk evaluation EPA
has made unreasonable risk determinations on some of the conditions of
use within the scope of the risk evaluation for this chemical. For
those conditions of use for which EPA has found an unreasonable risk of
injury to health or the environment, EPA must initiate regulatory
action to address those risks through risk management measures
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required
to be provided publicly with each risk evaluation, which is available
online at http://www.regulations.gov in the dockets identified. 40 CFR
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID
No. EPA-HQ-OPPT-2016-0725);
     Draft risk evaluation, revised draft risk evaluation and
final risk evaluation (in Docket ID No. EPA-HQ-OPPT-2018-0604);
     All notices, determinations, findings, consent agreements,
and orders (in Docket ID No. EPA-HQ-OPPT-2018-0604);
     Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0725 and Docket
ID No. EPA-HQ-OPPT-2018-0604);
     A nontechnical summary of the risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2018-0604);
     A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for
C.I. Pigment Violet 29) in Docket ID No. EPA-HQ-OPPT-2018-0604);
     The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
ID No. EPA-HQ-OPPT-2018-0604); and
     Response to public comments received on the draft scope,
the draft risk evaluation and revised draft risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2018-0604).

II. TSCA Risk Evaluation

A. What is EPA's risk evaluation process for existing chemicals under
TSCA?

    The risk evaluation process is the second step in EPA's existing
chemical process under TSCA, following prioritization and before risk
management. As this chemical is one of the first ten chemical
substances undergoing risk evaluation, the chemical substance was not
required to go through prioritization (81 FR 91927, December 19, 2016)
(FRL-9956-47). The purpose of conducting risk evaluations is to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, not consider costs or other nonrisk factors,
use reasonably available information and approaches in a manner that is
consistent with the requirements in TSCA for the use of the best
available science, and ensure decisions are based on the weight of the
scientific evidence.
    The specific risk evaluation process that EPA has established by
rule to implement the statutory process is set out in 40 CFR part 702
and summarized on EPA's website at http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B will be followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
    Prior to the publication of this final risk evaluation, a draft
risk evaluation and a revised draft risk evaluation were subject to
peer review and public comment. EPA reviewed the peer review reports
from the Science Advisory Committee on Chemicals (SACC), a Letter Peer
Review, and public comments and has supplemented the risk evaluation in
response to these comments as appropriate. Prior to the publication of
the draft risk evaluation, EPA made available the scope and problem
formulation, and solicited public input on uses and exposure. EPA's
documents, the peer review report, and the public comments are in
Docket EPA-HQ-OPPT-2018-0604 at http://www.regulations.gov.
Additionally, information about the scope, problem formulation, and
draft risk evaluation phases of the TSCA risk evaluation for this
chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-pigment-violet-29-anthra219-def6510.

B. What is C.I. Pigment Violet 29?

    C.I. Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d'e'f']
diisoquinoline-1,3,8,10(2H,9H)-tetrone) is a perylene derivative used
to color materials and as an intermediate for other perylene pigments.
C.I. Pigment Violet 29 is currently manufactured (including imported),
processed, distributed, used, and disposed of as part of industrial,
commercial, and consumer conditions of use. Leading applications for
C.I. Pigment Violet 29 include use as an intermediate to create or
adjust color of other perylene pigments, incorporation into paints and
coatings used primarily in the automobile industry, incorporation into
plastic and rubber products used primarily in automobiles and
industrial carpeting, use in merchant ink for commercial printing, and
use in consumer watercolors and artistic color.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2021-01229 Filed 1-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64094-64095]
[FR Doc No: 2019-25144]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0878]

Notice of Public Meeting on Consistent Implementation of
Regulation 14.1.3 of MARPOL Annex VI (Global 0.50% Sulfur Limit)

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

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SUMMARY: The United States Coast Guard will conduct a public meeting in
Washington, DC on consistent implementation of regulation 14.1.3 of
MARPOL Annex IV (Global 0.50% Sulfur Limit). The purpose of this
meeting will be to review the MARPOL Annex VI provisions for
implementing the Global 0.50% Sulfur Limit and the associated guidance
developed through the International Maritime Organization, as well as
discuss related issues and Coast Guard enforcement plans.

DATES: This public meeting will be held on Thursday, December 5,
beginning at 9:30 a.m. and ending at 3:00 p.m., Eastern Time. This
meeting is open to the public.

ADDRESSES: The public meeting will be held in Room 3, located on the
first floor near the main entrance of the United States Department of
Transportation building in Washington, DC. The United States Department
of Transportation building is located at 1200 New Jersey Ave. SE, in
Washington, DC, across the street from the Navy Yard-Ballpark Metro
Station. Due to security requirements, each visitor must present a
valid government-issued photo identification (for example, a driver's
license) in order to gain entrance to the building. Those desiring to
attend the public meeting should contact the Coast Guard ahead of the
meeting (see FOR FURTHER INFORMATION CONTACT) to facilitate the
security process related to building access, or to request reasonable
accommodation.

FOR FURTHER INFORMATION CONTACT: For additional information about this
public meeting you may contact Mr. Wayne Lundy by telephone at (202)
372-1379 or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Annex VI to the International Convention for
the Prevention of Pollution from Ships (MARPOL Annex VI) addresses air
pollution from ships. Regulation 14 addresses particulate matter (PM)
and sulfur oxide (SOX) emissions through fuel sulfur content
limits. Beginning on January 1, 2015, fuel used in ships operating in
designated Emission Control Areas (ECAs), including the North American
and U.S. Caribbean Sea ECAs, may not exceed 1,000 ppm. Outside of
designated ECAs, the sulfur content of marine fuel currently may not
exceed 35,000 ppm; this limit will be reduced to 5,000 ppm beginning on
January 1, 2020.
    As required by Regulation 14.8 of Annex VI, the 2020 global sulfur
limit was reviewed and the limit was confirmed by the Marine
Environment Protection Committee at its 70th session in November, 2016.
At the 71st session, the Marine Environment Protection Committee agreed
on a new work output to consider measures to promote consistent
implementation of the global sulfur limit to address industry concerns
and promote a level playing field with regard to compliance and
enforcement of the new standards.
    The Coast Guard will conduct a meeting on Thursday, December 5 at
the United States Department of Transportation building in Washington,
DC, provide an overview of the MARPOL Annex VI provisions for
implementing the Global 0.50% Sulfur Limit and the associated guidance
developed through the International Maritime Organization. Related
issues will also be discussed, including enforcement in the United
States, changes to Port State Control procedures, fuel oil non-
availability notices, Ship Implementation Plans, in-use and onboard
fuel oil sampling, and Exhaust Gas Cleaning Systems.
    This meeting is open to the public. Please note that the public
meeting has a limited number of seats. Also, the meeting may close
early if all business is finished. Those interested in attending should
contact Mr. Wayne Lundy by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the

meeting, contact Mr. Wayne Lundy at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>as soon as possible.

    Dated: November 14, 2019.
J.G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2019-25144 Filed 11-19-19; 8:45 am]
 BILLING CODE P


[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Rules and Regulations]
[Page 68064-68070]
[DOCID:fr04de07-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210 and 211

[Docket No. 2007N-0280]

Amendment to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending certain
regulations as the first phase of an incremental approach to modifying
the current good manufacturing practice (CGMP) regulations for finished
pharmaceuticals. We are amending the regulations to modernize or
clarify some of the CGMP requirements, as well as harmonize some of the
CGMP requirements with those of other foreign regulators and other FDA
regulations. These amendments are also consistent with current industry
practice. We are taking this action as part of our continuing effort to
revise outdated regulations without diminishing public health
protection. We are issuing a direct final rule for this action because
FDA expects there will be no significant adverse comments on these
amendments. Elsewhere in this issue of the Federal Register, we are
publishing a companion proposed rule, under our usual notice-and-
comment rulemaking procedures, to provide a procedural framework to
finalize the rule in the event the agency receives any significant
adverse comments and withdraws this direct final rule. The companion
proposed rule and direct final rule are substantively identical.

DATES:  This rule is effective April 17, 2008. Submit written or
electronic comments on or before February 19, 2008. If we receive no
significant adverse comments during the specified comment period, we
intend to publish a notice in the Federal Register no later than March
18, 2008, confirming the effective date of the direct final rule. If we
receive any timely significant adverse comments during the comment
period, we will publish a notice of significant adverse comment in the
Federal Register withdrawing this direct final rule before its
effective date.

ADDRESSES:  You may submit comments, identified by Docket No. 2007N-
0280, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulation.gov.

Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information provided.

    For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Mary Malarkey, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448,<PHONE_NUMBER>, or
    Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
6956, or
    Frederick Blumenschein, Center for Drug Evaluation and Research
(HFD-326), Food and Drug Administration, 11919 Rockville Pike,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the development of the CGMP regulations in 1962, FDA has
balanced the need for easily understood minimum standards with the need
to encourage innovation and the development of improved manufacturing
technologies. We strive to give manufacturers latitude to determine how
to achieve the level of control necessary for CGMP compliance,
recognizing that, in some instances, more direction from FDA is
necessary to provide a uniform standard for the entire industry or
because of the potential for harm, or the narrow range of acceptable
means to accomplish a particular CGMP objective. FDA periodically
reassesses and revises the CGMP regulations to accommodate advances in
technology that further safeguard the drug manufacturing process and
the public health. As technology and scientific knowledge related to
CGMP evolve, so does

understanding of the material, equipment, and process variables, as
well as the operational procedures and oversight methods that must be
defined and controlled to achieve assurance of drug product quality.
    In 1996, as part of this reassessment process, FDA proposed a
significant revision to the CGMP regulations for finished
pharmaceuticals to clarify certain manufacturing, quality control, and
documentation requirements, and to ensure that the regulations more
accurately encompass current industry practice (61 FR 20103, May 3,
1996) (1996 proposed rule). Subsequently, as a part of the risk-based
pharmaceutical CGMPs for the 21st century initiative, FDA created a
CGMP Harmonization Analysis Working Group (CGMP Working Group) to
analyze related CGMP requirements in effect in the United States and
internationally, including those related to quality systems. The CGMP
Working Group compared parts 210 and 211 (21 CFR parts 210 and 211) to
the GMPs of the European Union (EU), as well as other FDA regulations
(e.g., the Quality Systems Regulation, 21 CFR part 820) to identify the
differences and consider the value of supplementing or changing the
current regulations. Based on the CGMP Working Group's analysis, we
decided to take an incremental approach to modifying parts 210 and 211
(see http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm#_Toc84065744
).

    Because of this change in approach, FDA decided not to finalize the
1996 proposed rule. Therefore, elsewhere in this issue of the Federal
Register, we are publishing a notice withdrawing the 1996 proposed
rule.
    This direct final rule is intended to clarify and modernize the
CGMP regulations, as well as harmonize the regulations with
international GMP requirements and other FDA regulations. This direct
final rule represents the first increment of modifications to parts 210
and 211. We believe that these updating changes are noncontroversial.

II. Description of the Direct Final Rule

A. Plumbing

    This rule deletes from Sec.  211.48(a) the current requirement of
adherence to a specific U.S. Environmental Protection Agency (EPA)
water standard and instead simply requires that the plumbing system
contain water that is ``safe for human consumption.'' In an effort to
improve harmonization with foreign regulations (particularly the
European Union and Japan) and to make the U.S. regulation more
consistent with that of the United States Pharmacopeia standard, which
is satisfied by compliance with the regulations of the European Union
(EU) and Japan, this revision requires that water supplied by the
plumbing system and used to prepare water for pharmaceutical purposes
be ``safe for human consumption,'' and continues the requirement that
it ``be supplied under continuous positive pressure in a plumbing
system free of defects that could contribute contamination to any drug
product.'' Compliance with the standards set forth in the regulations
currently prescribed by the EPA would be acceptable under this
revision, as would compliance with the standards set forth in the
current regulations of the EU or Japan for potable water used to
prepare water for pharmaceutical purposes.

B. Aseptic Processing

    The current regulations related to aseptic processing have not been
updated to reflect current industry standards and practices. In
September 2004, we issued ``Guidance for Industry: Sterile Drug
Products Produced by Aseptic Processing--Current Good Manufacturing
Practice'' (see http://www.fda.gov/cder/guidance/5882.fnl.htm''). The

issuance of this document was the culmination of several years of work,
including soliciting input from external stakeholders, such as
described below.
    In 2002, we began work on a draft guidance that was intended to
replace the 1987 Guideline on Sterile Drug Products Produced by Aseptic
Processing. A concept paper was presented to FDA's Advisory Committee
on Pharmaceutical Science on October 22, 2002, for comment. Among other
things, the Committee recommended that we work with the Pharmaceutical
Quality Research Institute (PQRI) for resolution of major issues. The
PQRI Aseptic Processing Working Group (Aseptic Processing Working
Group), composed of members from FDA, industry, and academia, was
formed to provide scientifically based input targeting specific aseptic
processing topics (e.g., media fills). PQRI performed a survey of the
industry on these topics, the results of which were presented to the
Aseptic Processing Working Group for consideration. The Aseptic
Processing Working Group also considered scientific publications and
other regulatory documents in preparing recommendations concerning
specific aseptic processing topics. These recommendations were
discussed by the Aseptic Processing Working Group on February 27 and
28, 2003 (http://www.pqri.org/commworking/minutes/mtc.asp) and presented to

the Manufacturing Subcommittee of FDA's Advisory Committee on
Pharmaceutical Science on May 22, 2003.
    In its September 2003, ``Pharmaceutical CGMPs for the 21st
Century--A Risk-Based Approach: Second Progress Report and
Implementation Plan,'' FDA announced the issuance of the draft
guidance. See http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm. At

the time, the agency noted that the guidance was intended to clarify
regulatory expectations, including relevant regulatory standards for
sterile drug products. FDA believed the guidance would help reduce the
incidence of manufacturing problems with sterile drug products and
related drug shortages. The guidance was also consistent with agency
efforts to harmonize with international regulatory standards and
develop more science-based guidance documents. As noted previously, FDA
issued the final guidance in September 2004.
    After the GMP Harmonization Analysis Working Group completed its
formal analysis comparing parts 210 and 211 with the GMPs of the EU as
well as with other FDA current good manufacturing practice regulations,
it recommended that part 211 be modernized by adding more clarification
about aseptic processing in an effort to harmonize with current
industry standards and practices. Therefore, we are now amending
several regulations related to aseptic processing to clarify the
regulatory requirements to reflect currently accepted industry practice
as well as, in some cases, to harmonize with international regulatory
standards. The revision to Sec.  211.113(b) applies specifically to
validation of aseptic processes, but the revisions to the other four
sections discussed below apply, as appropriate, to both aseptic and
other types of processes and operations. These revisions clarify and
reflect longstanding agency interpretation of these regulations and
industry practices. The agency notes that these clarifications of the
regulations with respect to aseptic processing do not affect the
applicability of the final guidance issued in September 2004. The
guidance's recommendations on the ways in which manufacturers can
satisfy certain aseptic processing regulatory requirements still apply.
    Section 211.67(a) Equipment cleaning and maintenance is being
revised to add the phrase ``and/or sterilized'' after the word
``sanitized'' in the current

regulation. This change updates the terminology to reflect the fact
that, in the context of sterile drug products, the appropriate form of
sanitization would be sterilization. This is consistent with our
interpretation of this regulation for more than 20 years and reflects
the currently accepted industry practice.
    Section 211.84(d)(6) Testing and approval or rejection of
components drug product containers, and closures, is being revised to
change the phrase ``that is liable to microbiological contamination,''
to ``with potential for microbiological contamination.'' We believe
this revision provides additional clarity without changing the meaning
or intent of the regulation.
    Section 211.94(c) Drug product containers and closures is being
revised to clarify that validation is required for the processes used
to remove pyrogenic properties (depyrogenation processes). The revision
reflects currently accepted industry practice and the agency's
longstanding interpretation of this regulation. To assure that certain
drug products are suitable for their intended use, drug product
containers and closures are required to be sterilized and depyrogenated
to remove microbial contamination and pyrogens or endotoxin. It has
been longstanding industry practice to validate the sterilization and
depyrogenation processes used for drug product containers and closures
to assure consistent removal of microbial contamination and pyrogens or
endotoxin. Lack of evidence of such validation and inadequacies in the
validation studies have been cited in FDA actions throughout the years
based on this regulation. Accordingly, this rule simply clarifies Sec.
211.94(c) by adding a new sentence at the end which states; ``Such
depyrogenation processes shall be validated.''
    Paragraph (a) of Sec.  211.110 Sampling and testing of in-process
materials and drug products is being revised to include bioburden
process control procedures and tests, where appropriate. The existing
regulation provides five examples of control procedures and tests that
must be addressed, where appropriate, to monitor the output and to
validate the performance of manufacturing processes that may be
responsible for causing variation in the characteristics of in-process
material and drug product. The existing regulation also acknowledges
that the examples are not an all inclusive list of necessary process
control procedures and tests. For in-process materials and drug
products that are produced by aseptic processing, testing for bioburden
is a well established industry standard to ensure that the finished
dosage form will be sterile and that the process is not shifting from
established limits that may affect control. The revised regulation will
add bioburden testing as the sixth example of process control
procedures.
    Paragraph (b) of Sec.  211.113 Control of microbiological
contamination is being revised to include validation of aseptic
processes for drug products that are purported to be sterile. The
current regulation mentions only validation of sterilization processes,
not aseptic processes. Even before 1987, when the Guideline for Sterile
Drug Products Produced by Aseptic Processing was issued, industry
routinely conducted validation studies that substituted microbiological
media for the actual product to demonstrate that its aseptic processes
were validated. These parts of validation studies are often referred to
as media fills. We believe that this revision clarifies existing
practices and serves to harmonize the CGMP requirements with Annex 1 of
the EU GMPs, which requires such validation.

C. Asbestos Filters

    Our current regulations for filters used in processing liquid
injectable products need to be updated. The current regulations require
manufacturers, before using asbestos-containing filters, to submit
proof to FDA that an alternative filter will or is more likely to
result in product contamination. However, we are not aware that
asbestos filters are currently commercially manufactured for
pharmaceutical use or that they are currently used in the production of
pharmaceuticals. Indeed, their use would no longer be considered a good
manufacturing practice. Therefore, we are revising Sec. Sec.
210.3(b)(6) and 211.72 to remove an outdated regulation permitting
limited use of asbestos-containing filters. This revision also provides
consistency with international standards.
    We removed from the definition of ``non-fiber releasing filter,''
the statement that ``All filters composed of asbestos are deemed to be
fiber-releasing filters''; because the revised regulation does not
permit any use of asbestos-containing filters. Thus, this sentence is
no longer necessary. Because other nonasbestos, fiber-releasing filters
may still be used, the revised regulation retains the current
requirement that allows the use of fiber-releasing filters only when
necessary, and only if another filter is also used specifically to
reduce the amount of shed fibers in the finished pharmaceutical.
    It is noteworthy that the current CGMP regulation at paragraph (a)
of Sec.  211.65 Equipment construction, requires equipment, including
filters, to be constructed so that ``surfaces that contact components,
in-process materials, or drug products shall not be reactive, additive,
or absorptive so as to alter the safety, identity, strength, quality,
or purity of the drug product beyond the official or other established
requirements.'' We are not changing this requirement, which also
restricts the amount and type of objectionable particulates in drug
products resulting from contact with equipment.

D. Verification by Second Individual

    Under the current CGMP regulations, several regulations include
requirements that certain activities be performed by one person and
checked as specified by a second person. Section 211.101(c) requires
that each container of component dispensed for use in manufacturing be
examined by a second person to assure that it was released by the
quality control unit, that the weight or measure is correct as stated
in the batch production records, and that the containers are properly
identified. Section 211.101(d) requires that each component shall be
added to the batch by one person and verified by a second person.
Section 211.103 requires that specified yield calculations shall be
performed by one person and independently verified by a second person.
Section 211.182 requires that the persons performing and double-
checking the cleaning and maintenance of major equipment shall date and
sign or initial equipment logs indicating that the work was performed.
Finally, Sec.  211.188(b)(11) requires that batch production and
control records shall include identification of the persons performing
and directly supervising or checking each significant step in the
operation.
    When the CGMP regulations were amended in 1978, FDA issued Sec.
211.68, which provides that automatic, mechanical, or electronic
equipment or other types of equipment, including computers, or related
systems that will perform a function satisfactorily, may be used in the
manufacture, processing, packing, and holding of a drug product,
subject to certain requirements that the controls used are designed to
assure proper performance of such equipment, to assure that changes to
records are made only by authorized personnel, to check the input and
output for accuracy, and to provide for appropriate backup of data.
    FDA has periodically been asked whether the requirements for

verification by a second individual in Sec. Sec.  211.101(c) and (d),
211.103, 211.182, and 211.188(b)(11) are applicable in situations where
operations are performed by various types of automated equipment rather
than by an individual. When these regulations were adopted in 1978, the
preamble addressed this issue in response to several comments about the
second checking requirements of Sec.  211.101 for charge-in of
components when automated systems are used. We specifically noted that
the use of automated systems is permitted under section 211.68 and that
the requirement of 211.101 would be met if the second individual
verifies that the automated system is working properly (43 FR 45013 to
45087 at 45051, September 29, 1978). Thus, in this situation, the first
individual is replaced by a machine or other automated process, and
only one person is necessary to verify that the automated system is
functioning as intended.
    Due to periodic questions received by FDA about the performance and
checking requirements required by Sec. Sec.  211.101(c) and (d),
211.103, 211.182, and 211.188(b)(11) when the operations are performed
by automated equipment, such as the widespread and increasing use of
computer-controlled operations, we are revising these sections. The
revisions will clarify our long-standing interpretation and policy that
verification by a second individual may not be necessary when automatic
equipment is used under Sec.  211.68. Rather, in these situations, only
one person is needed to verify that the automated equipment is
functioning adequately. In cases where there is an operator for the
automated equipment, the verifying individual may be, but is not
required to be, the operator.
    Thus, we are amending Sec. Sec.  211.101(c) and (d), 211.103,
211.182, and 211.188(b)(11) to indicate that the use of automated
equipment under Sec.  211.68 may eliminate the need for verification by
a second individual and that in those situations only one person is
needed to verify that the automated equipment is functioning properly.
In addition, we are amending section 211.68 to provide a consistent
clarification of this point.

E. Miscellaneous Minor Changes Based on 1996 Proposal

    We are revising Sec.  211.82(b) by replacing the phrase ``as
appropriate'' by the phrase ``whichever is appropriate'' to eliminate
any ambiguity in the regulation and to emphasize that it is, in fact,
accepted industry practice to conduct some testing or examination
before the components, drug product containers, or closures are
released from quarantine.
    We are revising Sec.  211.84(c)(1) by replacing the phrases ``where
necessary, by appropriate means'' with ``when necessary in a manner to
prevent introduction of contaminants into the component.'' This change
will clarify that the act of cleaning is done for a particular purpose,
to prevent the introduction of contaminants, and must be done unless
such cleaning is not necessary to prevent such an introduction of
contaminants.
    In addition, two editorial changes are being made to Sec.
211.84(d)(3) by replacing the word ``conformance'' with ``conformity''
and ``procedure'' with ``specifications.'' Similarly, two minor
editorial changes are being made to the first sentence of Sec.
211.160(b)(1) by replacing the word ``conformance'' with ``conformity''
and ``appropriate'' with ``applicable.'' We believe that these
revisions provide clarity without changing the meaning or intent of the
regulations.

III. Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
published a notice of availability of a guidance document that explains
when and how we intend to employ direct final rulemaking. We have
determined that this rule is appropriate for direct final rulemaking
because we believe that it includes only noncontroversial amendments
and we anticipate no significant adverse comments. Consistent with our
procedures on direct final rulemaking, FDA is publishing elsewhere in
this issue of the Federal Register a companion proposed rule to revise
the CGMP regulations for finished pharmaceuticals. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event that the direct final rule is withdrawn as a
result of any significant adverse comments. The comment period for the
direct final rule runs concurrently with the companion proposed rule.
Any comments received in response to either of these rules will be
considered as comments to the other.
    We are providing a comment period on the direct final rule of 75
days after the date of the publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register. A significant adverse comment is defined as a
comment that explains why the rule would be inappropriate, including
challenges to the rule's underlying premise or approach, or would be
ineffective or unacceptable without a change. In determining whether an
adverse comment is significant and warrants terminating a direct final
rulemaking, we will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-
comment process in accordance with section 553 of the Administrative
Procedure Act (5 U.S.C. 553). Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
significant or adverse under this procedure. A comment recommending a
regulation change in addition to those in the rule would not be
considered a significant adverse comment unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subjects of a significant adverse comment.
    If any significant adverse comments are received during the comment
period, FDA will publish, within 30 days after the close of the comment
period, a notice of significant adverse comment and will withdraw the
direct final rule. If we withdraw the direct final rule, any comments
received will be applied to the proposed rule and will be considered in
developing a final rule using the usual notice-and-comment procedures.
    If FDA receives no significant adverse comments during the
specified comment period, FDA intends to publish a document confirming
the effective date of the direct final rule within 30 days after the
comment period ends.

IV. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of this direct final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive

impacts; and equity). The agency believes that this direct final rule
is not a significant regulatory action as defined by the Executive
order, because the rule generally either clarifies the agency's
longstanding interpretation of, or increases latitude for manufacturers
in complying with, preexisting CGMP requirements. The Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities.
Because this direct final rule does not impose any new regulatory
obligations, the agency certifies that it would not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.
    The purpose of this direct final rule is to update the codified
language to reflect current practice and to harmonize requirements in
the CGMP regulations with international GMP requirements and other FDA
regulations. It would not impose any additional requirements;
therefore, industry would not incur incremental compliance costs for
these changes.

B. Environmental Impact

    Issuing these clarifying amendments to the CGMP regulations will
not have a significant impact on the human environment. Therefore, an
environmental impact statement is not required.

C. Federalism

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
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. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive Order and, consequently, a
federalism summary impact statement is not required.

V. Paperwork Reduction Act of 1995

    The provisions of this direct final rule contain requirements that
were submitted for review and approval to the Director of the Office of
Management and Budget (OMB), as required by section 3507(d) of the
Paperwork Reduction Act of 1995. The requirements were approved and
assigned OMB control number 0910-0139.

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this direct
final rule. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that any individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

List of Subjects

21 CFR Part 210

    Drugs, Packaging and containers.

21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and Containers,
Prescription drugs, Reporting and recordkeeping requirements,
Warehouses.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
210 and 211 are amended as follows:

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

0
1. The authority citation for 21 CFR part 210 continues to read as
follows;

    Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42
U.S.C. 216, 262, 263a, 264.

0
2. Section 210.3 is amended by revising paragraph (b)(6) to read as
follows:

Sec.  210.3  Definitions.

    (b) * * *
    (6) Nonfiber releasing filter means any filter, which after
appropriate pretreatment such as washing or flushing, will not release
fibers into the component or drug product that is being filtered.
* * * * *

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS

0
3. The authority citation for 21 CFR part 211 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42
U.S.C. 216, 262, 263a, 264.

0
4. Section 211.48 is amended by revising paragraph (a) to read as
follows:

Sec.  211.48  Plumbing.

    (a) Water supplied by the plumbing system of the facility must be
safe for human consumption. This water shall be supplied under
continuous positive pressure in a plumbing system free of defects that
could contribute contamination to any drug product.
* * * * *

0
5. Section 211.67 is amended by revising paragraph (a) to read as
follows:

Sec.  211.67  Equipment cleaning and maintenance.

    (a) Equipment and utensils shall be cleaned, maintained, and
sanitized and/or sterilized at appropriate intervals to prevent
malfunctions or contamination that would alter the safety, identity,
strength, quality, or purity of the drug product beyond the official or
other established requirements.
* * * * *

0
6. Section 211.68 is amended by adding paragraph (c) to read as
follows:

Sec.  211.68  Automatic, mechanical, and electronic equipment.

* * * * *
    (c) Such automated equipment used for performance of operations
addressed by Sec. Sec.  211.101(c) or (d), 211.103, 211.182, or
211.188(b)(11) can satisfy the requirements included in those sections
for the performance of an operation by one person and checking by
another person if such equipment is used in conformity with this
section and one person verifies that the operations addressed in those
sections are performed accurately by such equipment.

0
7. Section 211.72 is revised to read as follows:

Sec.  211.72  Filters.

    Filters for liquid filtration used in the manufacture, processing,
or packing of injectable drug products intended for human use shall not
release fibers into such products. Fiber-releasing filters may not be
used in the manufacture, processing, or packing of these

injectable drug products unless it is not possible to manufacture such
drug products without the use of such filters. If use of a fiber-
releasing filter is necessary, an additional nonfiber-releasing filter
of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing
conditions so dictate) shall subsequently be used to reduce the content
of particles in the injectable drug product.

0
8. Section 211.82 is amended by revising paragraph (b) to read as
follows:

Sec.  211.82  Receipt and storage of untested components, drug product
containers, and closures.

* * * * *
    (b) Components, drug product containers, and closures shall be
stored under quarantine until they have been tested or examined,
whichever is appropriate, and released. Storage within the area shall
conform to the requirements of Sec.  211.80.

0
9. Section 211.84 is amended by revising paragraphs (c)(1), (d)(3), and
(d)(6) to read as follows:

Sec.  211.84  Testing and approval or rejection of components, drug
product containers, and closures.

* * * * *
    (c) * * *
    (1) The containers of components selected shall be cleaned when
necessary in a manner to prevent introduction of contaminants into the
component.
* * * * *
    (d) * * *
    (3) Containers and closures shall be tested for conformity with all
appropriate written specifications. In lieu of such testing by the
manufacturer, a certificate of testing may be accepted from the
supplier, provided that at least a visual identification is conducted
on such containers/closures by the manufacturer and provided that the
manufacturer establishes the reliability of the supplier's test results
through appropriate validation of the supplier's test results at
appropriate intervals.
* * * * *
    (6) Each lot of a component, drug product container, or closure
with potential for microbiological contamination that is objectionable
in view of its intended use shall be subjected to microbiological tests
before use.
* * * * *

0
10. Section 211.94 is amended by revising paragraph (c) to read as
follows:

Sec.  211.94  Drug product containers and closures.

* * * * *
    (c) Drug product containers and closures shall be clean and, where
indicated by the nature of the drug, sterilized and processed to remove
pyrogenic properties to assure that they are suitable for their
intended use. Such depyrogenation processes shall be validated.
* * * * *

0
11. Section 211.101 is amended by revising paragraphs (c) and (d) to
read as follows:

Sec.  211.101  Charge-in of components.

* * * * *
    (c) Weighing, measuring, or subdividing operations for components
shall be adequately supervised. Each container of component dispensed
to manufacturing shall be examined by a second person to assure that:
    (1) The component was released by the quality control unit;
    (2) The weight or measure is correct as stated in the batch
production records;
    (3) The containers are properly identified. If the weighing,
measuring, or subdividing operations are performed by automated
equipment under Sec.  211.68, only one person is needed to assure
conditions of paragraphs (c)(1), (c)(2), and (c)(3) of this section
have been met.
    (d) Each component shall either be added to the batch by one person
and verified by a second person or, if the components are added by
automated equipment under Sec.  211.68, only verified by one person.

0
12. Section 211.103 is revised to read as follows:

Sec.  211.103  Calculation of yield.

    Actual yields and percentages of theoretical yield shall be
determined at the conclusion of each appropriate phase of
manufacturing, processing, packaging, or holding of the drug product.
Such calculations shall either be performed by one person and
independently verified by a second person, or, if the yield is
calculated by automated equipment under Sec.  211.68, be independently
verified by one person.

0
13. Section 211.110 is amended by revising paragraph (a) introductory
text and by adding paragraph (a)(6) to read as follows:

Sec.  211.110  Sampling and testing of in-process materials and drug
products.

    (a) To assure batch uniformity and integrity of drug products,
written procedures shall be established and followed that describe the
in-process controls, and tests, or examinations to be conducted on
appropriate samples of in-process materials of each batch. Such control
procedures shall be established to monitor the output and to validate
the performance of those manufacturing processes that may be
responsible for causing variability in the characteristics of in-
process material and the drug product. Such control procedures shall
include, but are not limited to, the following, where appropriate:
* * * * *
    (6) Bioburden testing.
* * * * *

0
14. Section 211.113 is amended by revising paragraph (b) to read as
follows:

Sec.  211.113  Control of microbiological contamination.

* * * * *
    (b) Appropriate written procedures, designed to prevent
microbiological contamination of drug products purporting to be
sterile, shall be established and followed. Such procedures shall
include validation of all aseptic and sterilization processes.

0
15. Section 211.160 is amended by revising paragraph (b)(1) to read as
follows:

211.160  General requirements.

* * * * *
    (b) * * *
    (1) Determination of conformity to applicable written
specifications for the acceptance of each lot within each shipment of
components, drug product containers, closures, and labeling used in the
manufacture, processing, packing, or holding of drug products. The
specifications shall include a description of the sampling and testing
procedures used. Samples shall be representative and adequately
identified. Such procedures shall also require appropriate retesting of
any component, drug product container, or closure that is subject to
deterioration.
* * * * *

0
16. Section 211.182 is revised to read as follows:

Sec.  211.182  Equipment cleaning and use log.

    A written record of major equipment cleaning, maintenance (except
routine maintenance such as lubrication and adjustments), and use shall
be included in individual equipment logs that show the date, time,
product, and lot number of each batch processed. If equipment is
dedicated to manufacture of one product, then individual equipment logs
are not required, provided that lots or batches of such product follow
in numerical order and are manufactured in numerical sequence. In cases
where dedicated equipment is employed, the records of cleaning,
maintenance, and

use shall be part of the batch record. The persons performing and
double-checking the cleaning and maintenance (or, if the cleaning and
maintenance is performed using automated equipment under Sec.  211.68,
only the person verifying the cleaning and maintenance done by the
automated equipment) shall date and sign or initial the log indicating
that the work was performed. Entries in the log shall be in
chronological order.

0
17. Section 211.188 is amended by revising paragraph (b)(11) to read as
follows:

Sec.  211.188  Batch production and control records.

* * * * *
    (b) * * *
    (11) Identification of the persons performing and directly
supervising or checking each significant step in the operation, or if a
significant step in the operation is performed by automated equipment
under Sec.  211.68, the identification of the person checking the
significant step performed by the automated equipment.
* * * * *

    Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23294 Filed 12-3-07; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Notices]
[Page 17245]
[FR Doc No: 2017-07026]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R07-OAR-2016-0779; FRL-9960-71-Region 7]

Adequacy Determination for the St. Louis Area 2008 8-Hour Ozone
Redesignation Request and Maintenance State Implementation Plan, Motor
Vehicle Emissions Budgets for Transportation Conformity Purposes; State
of Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy determination.

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SUMMARY: The Environmental Protection Agency (EPA) is notifying the
public that the St. Louis area 2008 8-hour ozone redesignation request
and maintenance plan motor vehicle emission budgets (MVEBs) for
volatile organic compounds (VOCs) and nitrogen oxides (NOX)
are adequate for transportation conformity purposes. As a result, these
budgets must be used by the State of Missouri for future transportation
conformity determinations for the St. Louis area.

DATES: This document is effective April 24, 2017.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, at<PHONE_NUMBER>,
by email at<EMAIL_ADDRESS>or by mail at U.S. Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. The word ``budget(s)'' refers to the motor
vehicle emission budgets (MVEBs) for volatile organic compounds and
nitrogen oxides. For the purposes of this document, ``SIP'' refers to
the St. Louis Area 2008 8-Hour Ozone Redesignation Request and
Maintenance State Implementation Plan, submitted by Missouri Department
of Natural Resources to EPA as a SIP revision on September 12, 2016.
    This document is an announcement of a finding that EPA has already
made. EPA Region 7 sent a letter to Missouri Department of Natural
Resources on December 21, 2016, stating that the MVEBs contained in the
Redesignation Request and Maintenance Plan are adequate for
transportation conformity purposes. As a result of EPA's finding, the
State of Missouri must use the MVEBs from the September 12, 2016,
Redesignation Request and Maintenance Plan or future transportation
conformity determinations for the St. Louis area. The finding is
available at EPA's conformity Web site: https://www.epa.gov/state-and-local-transportation.
    Transportation conformity is required by section 176(c) of the
Clean Air Act, as amended in 1990. EPA's conformity rule requires that
transportation plans, programs and projects conform to state air
quality implementation plans and establishes the criteria and procedure
for determining whether or not they do. Conformity to a SIP means that
transportation activities will not produce new air quality violations,
worsen existing violations, or delay timely attainment of the national
ambient air quality standards.
    The criteria by which we determine whether a SIP's motor vehicle
emission budgets are adequate for conformity purposes are outlined in
40 CFR 93.118(e)(4). Please note that an adequacy review is separate
from EPA's completeness review, and it should not be used to prejudge
EPA's ultimate approval of the SIP. EPA plans to take action on the SIP
at a later date. We have described our process for determining the
adequacy of submitted SIP budgets in 40 CFR 93.118(f), and have
followed this rule in making our adequacy determination.

    Authority:  42 U.S.C. 7401-7671q.

    Dated: March 20, 2017.
Edward H. Chu,
Acting Regional Administrator, Region 7.
[FR Doc. 2017-07026 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P


Subpart 2 Nonattainment Areas with additional needed controls from ROP Base Case 2010 VOC Emissions ( tons) Estimated Additional VOC Reductions to Meet a Stringent 15% RFP Requirement ( tons) Estimated Additional VOC Reductions Observed in 2010 as a % of 2010 Base Case Emissions Chicago 124683 1731 1.4% Cleveland 143384 3049 2.1% Milwaukee 78997 803 1.0% Providence 57929 8209 14.0% Sheboygan 7576 402 5.3% Attachment: Analysis of Potential Impacts of ROP on Ozone in Five Cities to Support Response to Comments Background:

In the Response to Comments ( RTC) document for the CAIR final rule, EPA addresses the comment that locally mandated Part D emission controls must be included in the base case analysis for nonattainment areas that EPA plans to designate for PM2.5 and ozone. The comment concludes that it is not reasonable for EPA to assume that these local control programs will not significantly impact the attainment status of many of the areas that the EPA analysis predicts future nonattainment. Within the RTC document, EPA concluded that five nonattainment areas with significance linkages to upwind States may be required to achieve additional rate of progress ( ROP) reductions in VOC by 2008 that are not accounted for in the CAIR 2010 base case modeling scenarios. However, EPA does not believe that VOC reductions of this magnitude would be enough to bring these areas into attainment in 2010. This document presents the analysis that supports the above assertion.

Table 1.1 shows the initial ROP analysis for the five areas determined to potentially need additional reductions in VOC emissions to achieve a 15 percent reduction. ( Dallas may also need additional VOC controls, but since no States are covered in CAIR due to a linkage with Denton or Tarrant counties, this area was not considered in this analysis.)

Table 1.1. Emissions information for the subpart 2 nonattainment areas that are expected to need additional controls from rate of progress requirements.

EPA has not done any 2010 CAMx modeling that includes the additional VOC reductions shown in the far right column of Table 1.1. However, we have completed a series of sensitivity analyses using the same ozone modeling platform used in modeling ozone for CAIR ( i. e., the 2010 base case) looking at the impacts of NOx and VOC controls in residual nonattainment areas. This modeling platform is described in the CAIR Notice of Final Rulemaking Air Quality Modeling Technical Support Document. A number of sensitivity runs were completed considering NOx only reductions and combined NOx/ VOC reductions at 10 and 25 percent. Only manmade emissions within the 2010 projected nonattainment areas were reduced. A plot of these areas is shown in Figure 1.1. No modeling runs were completed for VOC only runs, but as a first Grids Affected by 2004 Analysis Areas 1,280 Grids in 146 Counties, 17 Analysis Areas approximation it is possible to compare the model response from the NOx only runs against the NOx/ VOC runs to get an estimate of the signal from VOC only controls. Figure 1.1. Map of areas in which anthropogenic emissions were reduced in the 10% and 25% sensitivity modeling.

Results:

Table 1.2 shows the sensitivity modeling results over the five nonattainment areas of interest. For each nonattainment area, there is a single county that has the controlling site ( i. e., has the highest ozone projections for the area). The Chicago and Milwaukee nonattainment areas share the same controlling site, Kenosha Co., WI. From the information in tables 1.1 and 1.2 it is possible to combine the percentage level of needed VOC controls with the estimated effect of those controls to develop an rough estimate of the 2010 design value projections for these five areas had the ROP controls been included in the base case.

For example, Providence RI was estimated to need an additional 14% VOC control due to the ROP requirements. The projected design value in this area in 2010 without these controls is 86.4 ppb. Based on the sensitivity modeling, we see that 10 25% additional VOC control ( in all nonattainment areas, not just Providence) will lower the future design value by 0.5 to 0.9 ppb. Even at a 25% level, the additional VOC reductions then would not be enough to reach attainment ( 86.4  0.9 = 85.5). This conclusion also holds for the other four areas where the unaccounted ROP VOC reductions are even smaller and the excess above the 85 ppb attainment threshold is larger.

Nonattainment area County Name 2010 Base Case projection ( ppb) type of emissions control 10% reduction simulations 25% reduction simulations Chicago Kenosha WI 91.3 NOx only 91.3 90.5 NOx + VOC 90.7 89.3 VOC only 90.7 90.1 Cleveland Geauga OH 87.1 NOx only 86.0 84.0 NOx + VOC 85.8 83.4 VOC only 86.9 86.5 Milwaukee Kenosha WI 91.3 NOx only 91.3 90.5 NOx + VOC 90.7 89.3 VOC only 90.7 90.1 Providence Kent RI 86.4 NOx only 85.4 83.1 NOx + VOC 84.9 82.2 VOC only 85.9 85.5 Sheboygan Sheboygan WI 88.3 NOx only 87.2 85.3 NOx + VOC 87.1 85.0 VOC only 88.2 88.0 Table 1.2. Summary of 2010 base case and sensitivity modeling for the five cities of interest. All units are ppb. The " VOC only" runs were not modeled but were estimated based on the other two sets of runs.

Based on this sensitivity modeling we do not believe VOC reductions of the magnitude estimated to be needed for ROP purposes would alter the receptors in residual nonattainment in 2010. As noted in the response to comments, even if our conclusion was incorrect, and all five cities did attain as a result of 8 hour ROP reductions, this would not alter our conclusions about the States subject to CAIR. All upwind States are linked to other nonattainment receptors as well as those five cities shown in Table 1.1. For these reasons, we believe that the impact of subpart 2 requirements for 8 hour ozone areas is adequately captured in our CAIR base case and that our findings are valid concerning both: a) the receptors remaining in nonattainment in 2010 and b) the covered States that result from those receptors.


[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19636-19637]
[FR Doc No: 2023-06853]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP23-592-000.
    Applicants: Gulf Run Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: New NRA--TGC to be effective
4/1/2023.

    Filed Date: 3/27/23.
    Accession Number: 20230327-5133.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-593-000.
    Applicants: ANR Pipeline Company.
    Description: Compliance filing: ANR OFO Waiver Request to be
effective N/A.
    Filed Date: 3/27/23.
    Accession Number: 20230327-5155.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-594-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Filing--Other Shippers 5 NRA's to be effective 4/1/2023.
    Filed Date: 3/27/23.
    Accession Number: 20230327-5172.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-595-000.
    Applicants: Nautilus Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--HE&D
Offshore, L.P. to be effective 3/24/2023.
    Filed Date: 3/27/23.
    Accession Number: 20230327-5194.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-596-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Chevron 41610 eff 3-27-23) to be effective 3/27/2023.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5018.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-597-000.
    Applicants: Horizon Pipeline Company, L.L.C.
    Description: Compliance filing: Horizon Penalty Revenue Crediting
report for Year 2022 to be effective N/A.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5019.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-598-000.
    Applicants: Database returns error. There is a problem with archive
data and system. Contact Administrator.
    Description: Compliance filing: Penalty Revenue Crediting Report
from July through December 2022 to be effective N/A.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5020.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-599-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Filing--Multiple Shippers (15 NRA's) to be effective 4/1/2023.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5051.
    Comment Date: 5 p.m. ET 4/10/23.

    Docket Numbers: RP23-600-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--ESS--Spire
Alabama to be effective 4/1/2023.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5145.
    Comment Date: 5 p.m. ET 4/10/23.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 28, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-06853 Filed 3-31-23; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

                    WASHINGTON, DC

Issued by the Department of Transportation on October 2, 2002

   NOTICE OF ACTION TAKEN -- DOCKET OST-2002-13400

________________________________________________________________________
_________________________________

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

Joint application of AEROVIAS DE MEXICO, S.A. DE C.V. and DELTA AIR
LINES, INC., filed  9/19/02 for:

XX  Exemption for Aeromexico for one year under 49 U.S.C. 40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between Mazatlan, Mexico, and San Diego, California.  Aeromexico intends
to operate this service under a code-share arrangement with Delta on
flights operated by Aeromexico.

XX  Exemption for Delta for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between Mazatlan, Mexico, and San Diego, California.  Delta also
requests to integrate this authority with its existing certificate and
exemption authority.

XX  Statement of authorization for Aeromexico for indefinite duration
under 14 CFR Part 212 of the Department’s Regulations to:

Display Delta’s “DL” designator code in conjunction with scheduled
foreign air transportation of persons, property, and mail on flights
operated by Aeromexico between Mazatlan, Mexico, and San Diego,
California.

Applicant rep: Robert E.Cohn,<PHONE_NUMBER> (Delta)

                        William C. Evans,<PHONE_NUMBER> (Aeromexico)

DOT Analyst:  Keith A. Glatz,<PHONE_NUMBER>

D I S P O S I T I O N

XX Granted (subject to conditions, see below)

The above action, granting new exemption authority to Aeromexico was
effective when taken:

October 2, 2002, through   October 2, 2003.

The above action, granting new exemption authority to Delta was
effective when taken:

October 2, 2002, through   October 2, 2004.

The above action, granting a statement of authorization to Aeromexico
was effective when taken:

October 2, 2002, and will remain in effect indefinitely, subject to the
conditions listed below.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

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

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

   XX  Aeromexico’s foreign air carrier permit

	   XX  Delta’s certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

______________

Conditions:  The U.S.-Mexico exemption authority granted to Delta is
subject to the dormancy notice requirements set forth in condition 7 of
Appendix A of Order 88-10-2, and is limited to operations conducted on a
code-share basis only.

The route integration authority granted is subject to the condition that
any service provided under this exemption shall be consistent with all
applicable agreements between the United States and the foreign
countries involved.  Furthermore, (a) nothing in the award of the route
integration authority granted should be construed as conferring upon
Delta rights (including fifth-freedom intermediate and/or beyond rights)
to serve markets where U.S. carrier entry is limited unless Delta
notifies the Department of its intent to serve such a market and unless
and until the Department has completed any necessary carrier selection
procedures to determine which carrier(s) should be authorized to
exercise such rights; and (b) should there be a request by any carrier
to use the limited-entry route rights that are included in Delta’s
authority by virtue of the route integration exemption granted here, but
that are not then being used by Delta, the holding of such authority by
route integration will not be considered as providing any preference to
Delta in a competitive carrier selection proceeding to determine which
carrier(s) should be entitled to use the authority at issue.

The Statement of Authorization granted Aeromexico is subject to the
following conditions:

 The statement of authorization will remain in effect only as long as
Delta and Aeromexico continue to hold the underlying authority to
operate the code-share services at issue, and the code-share agreement
providing for the code-share operations remains in effect.

 Delta and/or Aeromexico must promptly notify the Department (Office of
International Aviation) if the code-share agreement is no longer
effective or if the carriers decide to cease operating all of a portion
of the approved code-share services. (Such notice should be filed in
Docket OST-2002-13.)

The code-sharing operations conducted under this authority must comply
with 14 CFR 257 and with any amendment to the Department’s regulations
concerning code-share arrangements that may be adopted.  Notwithstanding
any provisions in the contract between the carriers, our approval here
is expressly conditioned upon the requirements that the subject foreign
air transportation be sold in the name of the carrier holding out such
service in computer reservation systems and elsewhere; that the carrier
selling such transportation (i.e., the carrier shown on the ticket)
accept responsibility for the entirety of the code-share journey for all
obligations established in its contract of carriage with the passenger;
and that the passenger liability of the operating carrier be unaffected;
and the operating carrier shall not permit the code of its U.S.
code-sharing partner to be carried on any flight that enters, departs,
or transits the airspace of any area for whose airspace the Federal
Aviation Administration has issued a flight prohibition; and

The authority granted here is specifically conditioned so that neither
Delta nor Aeromexico shall give any force or effect to any contractual
provisions between themselves that are contrary to these conditions.

Remarks:  We acted on this application without awaiting expiration of
the 15-day answer period with the consent of all parties served.

________________________________________________________________________
______________

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

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our

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

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

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

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

           Attachment

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITYIn the conduct of the
operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).

U.S. Department of Transportation

Office of the Secretary of Transportation
(41301/40109) 7/2002			              									        Attachment

U.S. CARRIER Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

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

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

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

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

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

(6)  Comply with the applicable requirements of the Federal Aviation
Administration (FAA), and with all U.S. Government requirements
concerning security; and

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

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

 We expect this notification to be received within 10 days of such
non-effectiveness or of such decision.