[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30957-30961]
[FR Doc No: 2022-10925]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0517]

Medical Devices; 510(k) Sterility Change Master File Pilot
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Center
for Devices and Radiological Health (CDRH or Center) is announcing its
510(k) Sterility Change Master File Pilot Program (``510(k) Sterility
Pilot Program''). The 510(k) Sterility Pilot Program is voluntary and
intends to give interested companies that terminally sterilize single-
use devices (``sterilization providers'') using certain sterilization
methods a pathway to submit a Master File for FDA's review. FDA will
accept a Master File into the 510(k) Sterility Pilot Program when it
determines, among other things, that there is not a likelihood that
switching from a fixed chamber ethylene oxide (EtO) sterilization
method to the sterilization method described in the Master File could
significantly affect the safety or effectiveness of a 510(k)-cleared
device that meets the product definition in the Master File and that
satisfies other conditions outlined in this document. If a Master File
is accepted into the 510(k) Sterility Pilot Program, manufacturers of
510(k)-cleared devices (``510(k) holders'') may choose to reference the
Master File in internal documentation in support of a justification for
not submitting a new premarket notification (510(k)) under certain
conditions as outlined in this document. This voluntary pilot program
seeks to encourage industry to consider new, innovative ways to
sterilize devices that reduce the potential impact of EtO on the
environment and on public health, while ensuring consistent patient
access to safe devices and providing a framework for future regulatory
approaches that would help address potential device shortages related
to EtO sterilization.

DATES: FDA is seeking participation in the voluntary 510(k) Sterility
Pilot Program beginning May 20, 2022. See the ``Participation'' section
for selection criteria for sterilization providers to participate in
the 510(k) Sterility Pilot Program and the ``Procedures'' section for
instructions on how to submit a Master File for consideration for
inclusion into the 510(k) Sterility Pilot Program. Up to nine eligible
sterilization providers may be selected for participation in the 510(k)
Sterility Pilot Program.

FOR FURTHER INFORMATION CONTACT: Clarence W. Murray, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring MD 20993, 301-796-
0270, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    EtO sterilization is an important sterilization method that is
widely used to keep devices safe. It is estimated that approximately 50
percent of all sterile devices in the United States are sterilized
using EtO (Ref. 1). For many devices, sterilization with EtO may be the
only method \1\ currently evaluated that effectively sterilizes and
does not damage the device during the sterilization process. However,
there have been concerns about the effects of EtO exposure and
environmental emissions.
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    \1\ In this notice, ``method'' generally refers to the type of
sterilization and ``processes'' generally refers to steps within
that method to achieve a sterile device.
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    In 2019, FDA was made aware of closures of device sterilization
facilities due to concerns about the level of EtO emissions (Ref. 2).
The Agency closely monitored the situation and worked with device
manufacturers affected by the closures to minimize impact to patients
who needed device access. Future losses of sterilization capacity due
to facility closure have the potential to result in shortages of
sterile devices if an alternative for sterilization is not readily
available for the devices sterilized at a closed facility. FDA
continues to work with manufacturers on site changes, engage with
manufacturers about potential solutions to shortage concerns, and
collaborate with external stakeholders to help reduce barriers to the
utilization of innovative device sterilization technologies. FDA has
also taken several actions to advance device sterilization, including
sponsoring two innovation challenges to identify alternatives to EtO
sterilization methods (Ref. 3) and approaches to reduce EtO emissions
(Ref. 4); convening the General Hospital and Personal Use Devices Panel
on November 6 and 7, 2019 (``November 2019 Panel Meeting''), to discuss
the role of EtO sterilization in maintaining public health (84 FR
46546, September 9, 2019; see also Ref. 5); and announcing an Ethylene
Oxide Sterilization Master File Pilot Program (``EtO Pilot Program'')
for devices subject to Premarket Application (``PMA'') approval (84 FR
65162, November 26, 2019; see also Ref. 1).
    For devices subject to 510(k) requirements, before most sterile
devices are cleared for marketing, FDA reviews the submitted 510(k)
information to determine, among other considerations, if the provided
sterility information is adequate (e.g., in accordance with
internationally agreed upon voluntary consensus standards that FDA
recognizes). In some cases, if a device manufacturer changes the
sterilization method or process for sterilizing the device identified
in its original 510(k) submission, the manufacturer may need to submit
a new 510(k) for FDA review of these changes and clearance prior to
marketing (Ref. 6). However, in addition to public

health and environmental concerns regarding EtO emissions, FDA
recognizes the need to facilitate timely sterilization method changes
to keep device supply chain interruptions at a minimum and to
facilitate changes to sterilization processes that utilize reduced EtO
concentrations or that utilize other sterilization methods. At the
November 2019 Panel Meeting, FDA received feedback from Panel members
and stakeholders that the Agency could help prevent device shortages
and advance device sterilization by facilitating the development and
utilization of safe and effective alternative sterilization methods
that 510(k) holders may wish to consider for select sterile devices
(Ref. 5).\2\
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    \2\ Further, FDA more generally seeks to improve and strengthen
the device supply chain through other broader initiatives, such as
the planned Resilient Supply Chain and Shortages Prevention Program
(RSCSPP). See FDA's Budget, Medical Device Supply Chain and
Shortages Prevention Program, https://www.fda.gov/news-events/fda-voices/fdas-budget-medical-device-supply-chain-and-shortages-prevention-program.
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    In general, a change from a fixed chamber EtO sterililzation method
to a sterilization method characterized as ``Established Category B''
or ``Novel'' by FDA's guidance, Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile (Ref. 7), would likely require a new 510(k) because
this change could significantly affect the safety or effectiveness of
the device (Ref. 6).\3\ Under Sec.  807.81(a)(3)) 21 CFR 807.81(a)(3),
the submission of a new 510(k) is required prior to a change or
modification that could significantly affect the safety or
effectiveness of the device, or that is a major change or modification
in the intended use of the device. However, FDA also recognizes that
for some 510(k)-cleared devices, a change from a fixed chamber EtO
sterilization method to an Established Category B or Novel method does
not typically significantly affect the safety or effectiveness of the
device in certain cases, and therefore may not require submission of a
new 510(k) in these cases.
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    \3\ FDA also notes that changes that constitute a major change
or modificiation in the intended use of a device would require a new
510(k) submission. Sec.  807.81(a)(3)(ii). Such changes fall outside
the scope of this pilot program.
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    For these reasons, FDA is announcing and soliciting participation
in the 510(k) Sterility Pilot Program. Under this pilot program,
sterilization providers that sterilize single-use devices using certain
sterilization methods characterized as ``Established Category B'' or
``Novel'' may submit a Master File for their sterilization method for
FDA review.\4\ This review would include consideration of various
evaluation and validation methods (described below) that a
sterilization provider would ultimately propose to a 510(k) holder
interested in implementing a sterilization method other than fixed
chamber EtO sterilization. Interested 510(k) holders may use this
information in reaching device-specific determinations of whether a
change in sterilization method from fixed chamber EtO sterilization to
the alternative sterilization method could significantly affect safety
or effectiveness of the subject device. For 510(k) holders who are
granted a right of reference to an accepted Master File for a
particular 510(k)-cleared device under the conditions described below,
FDA believes there is a likelihood that switching to the sterilization
method described in the Master File could not significantly affect the
safety or effectiveness of such device. Accordingly, if a Master File
submitted by a 510(k) holder's sterilization provider is accepted by
FDA, the 510(k) holder could, under certain conditions and on a
voluntary basis, reference the Master File in the 510(k) holder's
internal documentation,\5\ without submitting a new 510(k) for a
sterilization method change from a fixed chamber EtO method to the
method described in the Master File. The pilot program is intended to
provide expeditious review and feedback to sterilization providers on
Master File submissions that may support sterilization changes to
510(k) cleared devices. FDA intends to evaluate pilot participation and
the progress of the pilot in 6 months and provide any updates to the
pilot in a subsequent notice, if appropriate. At this time, 510(k)s
reviewed by the Center for Biologics Evaluation and Research (CBER) and
510(k)s for combination products \6\ are outside the scope of this
pilot.
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    \4\ FDA is not including ``Established Category A'' methods
within the scope of the pilot program at this time. Manufacturers of
510(k) devices seeking to change from a fixed chamber EtO
sterilization method to an ``Established Category A'' method should
evaluate the change according to FDA's guidance, ``Deciding When to
Submit a 510(k) for a Change to an Existing Device'' in determining
whether a new 510(k) is required (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device). In general, for changes from
one ``Established Category A'' method to another ``Established
Category A'' method, it is unlikely submission of a new 510(k) is
required if the change could not significantly affect the
performance or biocompatibility of the device, or constitute a major
change or modification in the intended use of the device.
    \5\ Whenever a manufacturer changes its device, it must take
certain actions to comply with the Quality System Regulation (QSR),
part 820 (21 CFR part 820), unless a regulatory exemption exists.
The QSR requires that design changes and production and process
changes be documented prior to implementation. See Sec. Sec.
820.30(i) and 820.70(b).
    \6\ See 21 CFR 3.2(e).
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    For the purposes of this document, the term ``sterilization
provider'' is used to refer to a device manufacturer's own in-house
sterilization facility or a device manufacturer's contract
sterilization provider, and encompasses any subcontractor facilities
utilizing the same quality system as the contract sterilization
provider, as applicable. This document and the proposed 510(k)
Sterility Pilot Program do not otherwise remove or replace applicable
statutory or regulatory requirements for EtO-sterilized devices subject
to 510(k) submissions.

A. Participation

    Up to nine sterilization providers may be eligible to participate
in this voluntary 510(k) Sterility Pilot Program. The pilot program is
limited to sterilization providers that meet the following selection
qualities:
    1. Be a sterilization provider of a single-use device that is
provided sterile;
    2. Be in good compliance standing with the Agency; and
    3. Submit a Master File in accordance with the procedures set forth
in section I.B for a validated sterilization method that may be
considered an ``Established Category B'' or ``Novel'' sterilization
method as described in FDA's guidance entitled Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile (Ref. 7).
    The following are outside the scope of the 510(k) Sterility Pilot
Program and are inappropriate for inclusion in this program:
    1. Reusable devices, reprocessed single-use devices, or devices
that are provided non-sterile.
    2. Combination products.
    3. Devices regulated by CBER.
    4. Changes to device design, specifications, or materials.
    5. Sterilization changes for which there is a likelihood that the
change could significantly affect device specifications, device
performance, material compatibility, or biocompatibility, or otherwise
could significantly affect device safety or
effectiveness.7 8
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    \7\ Under Sec.  807.81(a)(3), the submission of a new 510(k) is
required prior to a change or modification that could significantly
affect the safety or effectivess of the device, or that is a major
change or modification in the intended use of the device. FDA's
guidance entitled ``Deciding When to Submit a 510(k) for a Change to
an Existing Device'' discusses specific factors to consider when
assessing if a change to a 510(k) cleared device, including a
sterilization change, may require a new 510(k) pursuant to Sec.
807.81. This guidance is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
    \8\ The responsibility for determining whether a change from EtO
sterilization to the sterilization method described in a Master File
could significantly affect the safety or effectiveness of a
particular 510(k)-cleared device continues to rest with the 510(k)
holder. FDA's acceptance of a Master File into the 510(k) Sterility
Pilot Program should not be understood to supplant a 510(k) holder's
obligation to conduct a device-specific evaluation of whether the
change described in the Master File could significantly affect the
safety or effectiveness of a device in a particular case.

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    6. Sterilization processes used only for intermediate processing
prior to final device assembly.
    7. Devices with alternate sterility assurance levels (SAL) other
than 10-6.

B. Procedures

    While the sterilization provider serves as the primary participant
of the 510(k) Sterility Pilot Program, FDA anticipates that close
collaboration between sterilization providers and 510(k) holders will
be necessary to ensure the success of the pilot program. Accordingly,
the procedures for sterilization providers and 510(k) holders are set
forth below.
1. Procedures for Sterilization Providers
    To be considered for the voluntary 510(k) Sterility Pilot Program,
a sterilization provider should submit the following information in a
Master File for the Agency's review with a cover sheet clearly
indicating ``510(k) Sterility Change Master File Pilot Program'' in the
subject heading:
    1. Name, address, and FDA Establishment Identification (FEI) number
of the sterilization facility.
    2. Clear identification of all responsibilities of the
sterilization facility and device manufacturers with respect to
sterilization validation.
    3. Information regarding the sterilization method and the
operations of the sterilization provider including:
     Methodology for Installation Qualification, Operational
Qualification, and Performance Qualification.
     Installation and operational requalification schedule to
support continuous process effectiveness.
     Identification and explanation of management structure and
involvement for process and facility review.
     Identification and description of a structured program and
schedule for independent audits and monitors.
     The sterilization facility's inspectional history and
history of compliance with applicable regulations (including, but not
limited to, requirements under part 820 (21 CFR part 820).
     Identification and explanation of common potential
protocol deviations, along with proposed mitigation of potential
deviations. The Master File should also include a strategy to address
any deviations that could significantly affect the safety or
effectiveness of a device and any deviations not addressed in the
Master File.
    4. Technical information regarding the sterilization method:
     A description of the sterilization system including system
specifications, process parameters and monitors, and a description of
the hardware components in the sterilization system.
     An overview of the sterilization cycle(s) and process
definition that includes an overview and discussion of the
sterilization process and cycle profile(s), as well as a detailed
description of the critical parameters, specific exposure conditions
for cycles, sterilant, sterilant concentration, and sterilant shelf-
life.
     A description of the intended sterilization load and
product definition that includes defining the critical load
characteristics and ranges, and describes the procedure used to
determine if a device meets the product definition.
     Generally applicable microbiological testing information
and the validation methodology and results used to demonstrate that the
process can achieve an SAL of 10-6 when carried out on a
device. This information should support that the test microorganism(s)
used to validate and monitor the sterilization cycle is the most
resistant microorganism(s) and provide resistance characteristics for
the most resistant microorganism(s). This testing may include
sporicidal testing, D-value determination based upon survivor curve
analysis and fraction negative analysis, half cycle testing, total kill
endpoint testing, and external process challenge device (ePCD) and
internal process challenge device (iPCD) lethality testing. The
generalized sterilization method development and validation information
provided in the proposed Master File should be consistent with ANSI/
AAMI/ISO 14937:2009/(R)2013, Sterilization of health care products--
General requirements for characterization of a sterilizing agent and
the development, validation and routine control of a sterilization
process for medical devices.
     A summary of how the biological performance testing is
used to define process parameters, and a summary of physical tests
which demonstrate that the sterilizer achieves and maintains the
required physical/chemical process lethality conditions within
specifications. These data should be from repeated runs with varying
load conditions (e.g., minimum and maximum loading configurations).
     A description of the validated biological and/or chemical
indicators used with the sterilization method and how the indicators
are used to monitor sterilization cycles. Describe the types of
packaging used with the validated cycles in order to maintain
sterility.
     Identification of compatible/incompatible materials and
describe how material compatibility is assessed for devices sterilized
with the method.
     A description of how biocompatibility is assessed for
devices that are switched to the method to ensure that biocompatibility
is not significantly affected, and an assessment of toxicity for the
sterilant and any common byproducts. Describe how removal or
dissipation of the sterilant and byproducts is achieved.
     Identification of all relevant consensus standards used
and any aspects of the standards that were not met. Deviations should
be identified, addressed and justified or mitigated, as applicable.
     If leveraging or referencing previous interactions with
FDA (e.g., Innovation Challenge discussions, Q-Submissions, etc.) in
the Master File, provide the submission number as a reference.
    For more information on Master Files, see FDA's website: https://www.fda.gov/medical-devices/premarket-approval-pma/master-files.
    Following receipt of a Master File containing the information
described in section I.B.1 of this document, FDA will determine
eligibility for the pilot program by evaluating whether the criteria
outlined in Sections I.A and I.B.1 of this document have been met, and
provide written feedback that FDA either accepts the Master File into
the 510(k) Sterility Pilot Program or has determined that the Master
File is outside the scope of the pilot program. FDA intends to work
interactively with the Master File holder to address any deficiencies
with the information provided in the Master File. If a Master File is
outside the scope of the pilot program, the written feedback will
identify the reasons the Master File was determined to be out of scope.
    If accepted into the pilot program, the Master File holder should
submit amendments to FDA every 6 months with information on any process
changes, a list of devices for which the sterilization method has been
changed from fixed chamber EtO sterilization to the sterilization
method described in the

Master File and for which a right of reference to the Master File has
been granted (except devices which have already been identified in a
prior amendment), and any other changes to the information contained in
the Master File, to maintain participation in the pilot program. If
there have been no updates or changes, the Master File holder should
notify FDA of the absence of any updates or changes in lieu of
submitting an amendment. The description included in the amendments of
devices for which the sterilization method has been changed from fixed
chamber EtO sterilization to the sterilization method described in the
Master File, and for which a right of reference to the Master File has
been granted, should include:
    1. The manufacturer(s) of the device(s);
    2. Each device name;
    3. The 510(k) number(s) for the device(s); and
    4. A description of how each device added to the Master File meets
the product definition in the accepted Master File.
    This information may be used to inform FDA's understanding of how
the product definition is being interpreted and applied in practice.
Following receipt of an amendment, FDA will evaluate whether the Master
File, as amended, remains within the scope of the pilot program, and
will notify the Master File holder that FDA either accepts the
amendment, or has determined that the amendment, in whole or in part,
would cause the Master File to be outside the scope of the pilot
program.
    If a sterilization provider is accepted into the pilot program and
does not maintain participation (e.g., through non-submission of
amendments, updates, or other information requested by FDA under the
pilot program) or no longer wishes to participate in the pilot program,
the sterilization provider should notify 510(k) holders for whom they
granted a right of reference to the Master File. If the Master File
holder does not maintain participation in the pilot program, FDA may
determine that the Master File for that sterilization process is
outside the scope of the pilot program.
2. Procedures for 510(k) Holders
    510(k) holders who wish to change their sterilization method for a
previously cleared device from a fixed chamber EtO sterilization method
to the sterilization method described in a Master File that has been
accepted into the pilot program should use the following procedures.
Once a sterilization provider has proposed, and FDA has accepted, a
Master File into the pilot program, interested 510(k) holders may
choose to review the information in the Master File in carrying out
device-specific analyses of whether the alternative sterilization
method could significantly affect safety or effectiveness. If the
510(k) holder has determined that the alternative sterilization method
could not significantly affect safety or effectiveness of the subject
device, and if the 510(k) holder has a right of reference to the Master
File granted by the Master File holder, the 510(k) holder may reference
the Master File in internal documentation supporting the change from a
fixed chamber EtO sterilization method to the method described in the
referenced Master File. The internal documentation supporting the
change should include:
    1. Name, address, and FEI number of the sterilization facility.
    2. Master File number in which the referenced sterilization
procedures are described, with signed right of reference from the
Master File holder identifying the devices to be sterilized under the
Master File.
    3. List of device(s) to be sterilized (identified by manufacturer,
trade name, model number, and 510(k) number).
    4. A summary of the information used to support the conclusion of
the 510(k) holder that the method described in the Master File achieves
an SAL of 10-6 for the subject device and that the
sterilization method could not significantly affect the device's
design, specifications, performance, or biocompatibility, or otherwise
could not significantly affect device safety or effectiveness.
    This Pilot Program does not otherwise remove or replace any
requirements, such as, but not limited to, recordkeeping requirements
under part 820, premarket notification requirements under part 807 (21
CFR part 807), subpart E, and labeling requirements under 21 CFR part
801. It is the manufacturer's responsibility to ensure compliance with
applicable laws and regulations.
    During this voluntary 510(k) Sterility Pilot Program, CDRH staff
intends to be available to answer questions or concerns that may arise.
The 510(k) Sterility Pilot Program participants may comment on and
discuss their experiences with the Center.

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 820, regarding the Quality System
regulations, have been approved under OMB control number 0910-0073. The
collections of information in part 807, subpart E, regarding premarket
notification submission, have been approved under OMB control number
0910-0120.

III. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. U.S. Food and Drug Administration, ``Ethylene Oxide Sterilization
for Medical Devices,'' available at: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices.
2. U.S. Food and Drug Administration, ``Statement on Concerns With
Medical Device Availability Due to Certain Sterilization Facility
Closures,'' available at: https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures.
3. U.S. Food and Drug Administration, ``FDA Innovation Challenge 1:
Identify New Sterilization Methods and Technologies,'' available at:
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies.
4. U.S. Food and Drug Administration, ``FDA Innovation Challenge 2:
Reduce Ethylene Oxide Emissions,'' available at: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions.
5. U.S. Food and Drug Administration, ``November 6 and 7, 2019:
General Hospital and Personal Use Devices Panel of the Medical
Devices Advisory Committee Meeting Announcement,'' available at:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee.
6. U.S. Food and Drug Administration, ``Deciding When to Submit a
510(k) for a Change to an Existing Device,'' available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.

7. U.S. Food and Drug Administration, ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile,'' available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled.

    Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10925 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 10 (Wednesday, January 15, 2020)]
[Rules and Regulations]
[Pages 2309-2311]
[FR Doc No: 2020-00298]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0820]
RIN 1625-AA00

Safety Zone; Ohio River, Owensboro, KY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Ohio River, extending the entire width of
the river, from mile marker (MM) 756.4 to MM 757.4 in Owensboro, KY.
This safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards created by a fireworks
display. Entry into, transiting through or anchoring within this zone
is

prohibited unless authorized by the Captain of the Port Sector Ohio
Valley (COTP) or a designated representative.

DATES: This rule is effective from 10 p.m. through 11 p.m. on January
18, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0820 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email Petty Officer Riley Jackson, Coast Guard
Sector Ohio Valley, Louisville, KY; telephone<PHONE_NUMBER> or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
MM Mile Marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On September 9, 2019, the River View Coal, LLC notified the Coast
Guard that it will be conducting a fireworks display from 10 p.m.
through 11 p.m. on January 18, 2020, to celebrate the previous year. In
response, on October 28, 2019, the Coast Guard published a notice of
proposed rulemaking (NPRM) under document number USCG-2019-0820 (84 FR
57666). There we stated why we issued the NPRM, and invited comments on
our proposed regulatory action related to this fireworks display.
During the comment period that ended November 27, 2019, we received
three (3) comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential hazards associated with the
fireworks display on January 18, 2020 will be a safety concern for
anyone within a 1-mile radius of the barge. The purpose of this rule is
to ensure safety of vessels and the navigable waters in the safety zone
before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received three (3) comments on our NPRM
published on October 28, 2019. From the comments received, two were
duplicates, with the original comment in agreement with the COTP's
decision to establish a safety zone. The third comment was withdrawn.
There are no changes in the regulatory text of this rule from the
proposed rule in the NPRM.
    This rule establishes a safety zone from 10 p.m. through 11 p.m. on
January 18, 2020. The safety zone would cover the entire width of the
Ohio River from Mile Marker (MM) 756.4 to MM 757.4 in Owensboro, KY.
The duration of the zone is intended to ensure the safety of vessels
and the navigable waters before, during, and after the scheduled
fireworks display. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. The temporary safety zone
would only be in effect for one hour and limit access to a one-mile
stretch of the Ohio River. The Coast Guard expects minimum adverse
impact to mariners. Also, mariners would be permitted to request
authorization from the COTP or a designated representative to transit
the temporary safety zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct

effect on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. We have
analyzed this rule under that order and have determined that it is
consistent with the fundamental federalism principles and preemption
requirements described in Executive Order 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting one hour, that will prohibit entry within a 1-mile
stretch of the Ohio River. It is categorically excluded from further
review under paragraph L60a of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
Recordkeeping Requirements, Security Measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0820 to read as follows:

Sec.  165.T08-0820  Safety zone; Ohio River, Owensboro, KY.

    (a) Location. All navigable waters of the Ohio River between mile
marker (MM) 756.4 to MM 757.4 in Owensboro, KY.
    (b) Period of enforcement. This section will be enforced from 10
p.m. through 11 p.m. on January 18, 2020.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless specifically
authorized by the Captain of the Port Sector Ohio Valley (COTP) or a
designated representative. Persons or vessels desiring to enter into or
pass through the zone must request permission from the COTP or a
designated representative. They may be contacted on VHF-FM radio
channel 16 or phone at 1-800-253-7465.
    (2) Persons and vessels permitted to enter this safety zone must
transit at the slowest safe speed and comply with all lawful directions
issued by the COTP or a designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public through Broadcast Notices to
Mariners and the Local Notice to Mariners of the enforcement period for
the temporary safety zone as well as any changes in the planned
schedule.

    Dated: January 7, 2020.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2020-00298 Filed 1-14-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: February 22, 2006 (Volume 71, Number 35)]
[Proposed Rules]
[Page 9064-9070]
[DOCID:fr22fe06-39]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2005-0170; FRL-8035-3]

Regulation of Fuels and Fuel Additives: Removal of Reformulated
Gasoline Oxygen Content Requirement for California Gasoline and
Revision of Commingling Prohibition To Address Non-Oxygenated
Reformulated Gasoline in California

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: In the Energy Policy Act of 2005 (Energy Act), Congress
removed the oxygen content requirement for reformulated gasoline (RFG)
in Section 211(k) of the Clean Air Act (CAA). The Energy Act specified
that this change was to be immediately effective in California, and
that it would be effective 270 days after enactment for the rest of the
country. This proposed rule would amend the fuels regulations to remove
the oxygen content requirement for RFG for gasoline produced and sold
for use in California, thereby making the fuels regulations consistent
with amended Section 211(k). In addition, for gasoline produced and
sold for use in California, this rule would extend the current
prohibition against combining VOC-controlled RFG blended with ethanol
with VOC-controlled RFG blended with any other type of oxygenate from
January 1 through September 15, to also prohibit combining VOC-
controlled RFG blended with ethanol with non-oxygenated VOC-controlled
RFG during that time period, except in limited circumstances authorized
by the Act.
    The removal of the RFG oxygen content requirement and revision of
the commingling prohibition for gasoline produced and sold for use in
all areas of the country is being published in a separate rulemaking
that would have a later effective date than this California specific
rulemaking.
    In the ``Rules and Regulations'' section of the Federal Register,
we are issuing these amendments to the RFG regulations as a direct
final rule without prior proposal because we view them as
noncontroversial amendments and anticipate no adverse comment. We have
explained our reasons for these amendments in the preamble to the
direct final rule. If we receive no adverse comment, we will not take
further action on this proposed rule. If we receive adverse comment, we
will withdraw the direct final fuel and it will not take effect. We
will address all public comments in a subsequent final rule based on
this proposed rule. We will not institute a second comment period on
this action. Any parties interested in commenting must do so at this
time.

DATES: Comments: Comments must be received on or before March 24, 2006.
Under the Paperwork Reduction Act, comments on the information
collection provisions must be received by OMB on or before March 24,
2006.
    Hearings: If EPA receives a request from a person wishing to speak
at a public hearing by March 9, 2006, a public hearing will be held on
March 24, 2006. If a public hearing is requested, it will be held at a
time and location to be announced in a subsequent Federal Register
notice. To request to speak at a public hearing, send a request to the
contact in FOR FURTHER INFORMATION CONTACT.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2005-0170 by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    2. E-mail: Group<EMAIL_ADDRESS>Attention Docket ID No.
OAR-2005-0170.
    4. Mail: Air and Radiation Docket, Environmental Protection Agency,
Mailcode: 6406J, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of two copies. In addition, please mail a copy
of your comments on the information collection provisions to the Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attn: Desk Officer for EPA, 725 17th St. NW., Washington, DC
20503.
    5. Hand Delivery: EPA Docket Center, Environmental Protection
Agency, 1301 Constitution Avenue, NW, Room B102, Mail Code 6102T,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2005-0170. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' systems, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    We are only taking comment on issues related to the removal of the
oxygen requirement for RFG produced and sold for use in California, and
the provisions regarding the combining of ethanol blended California
RFG with non-oxygenated California RFG and provisions for retailers
regarding the combining of ethanol blended California RFG with non-
ethanol blended California RFG. Comments on any other issues or
provisions in the RFG regulations are beyond the scope of this
rulemaking.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material,

will be publicly available only in hard copy. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at the Air and Radiation Docket,

EPA/DC, EPA West, Room B102, 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
Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Marilyn Bennett, Transportation and
Regional Programs Division, Office of Transportation and Air Quality
(6406J), Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action that is located in the
``Rules and Regulations'' section of this Federal Register publication.

I. General Information

A. Does This Action Apply to Me?

    Entities potentially affected by this action include those involved
with the production and importation of conventional gasoline motor
fuel. Regulated categories and entities affected by this action
include:

------------------------------------------------------------------------
                       NAICS codes   SIC codes   Examples of potentially
       Category            \a\          \b\         regulated parties
------------------------------------------------------------------------
Industry.............       324110         2911  Petroleum Refiners,
                                                  Importers.
Industry.............       422710         5171  Gasoline Marketers and
                                                  Distributors.
                            422720         5172  .......................
Industry.............       484220         4212  Gasoline Carriers.
                            484230         4213  .......................
------------------------------------------------------------------------
\a\ North American Industry Classification System (NAICS).
\b\ Standard Industrial Classification (SIC) system code.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could be potentially regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your entity is regulated by this action, you should carefully examine
the applicability criteria of Part 80, subparts D, E and F of title 40
of the Code of Federal Regulations. If you have any question regarding
applicability of this action to a particular entity, consult the person
in the preceding FOR FURTHER INFORMATION CONTACT section above.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of

the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR Part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.
    3. Docket Copying Costs. You may be charged a reasonable fee for
photocopying docket materials, as provided in 40 CFR part 2.

C. Outline of This Preamble

I. General Information
II. Removal of the RFG Oxygen Content Requirement for California
Gasoline
III. Combining Ethanol Blended RFG With Non-Ethanol Blended RFG
IV. Environmental Effects of This Action
V. Statutory and Executive Order Reviews
VI. Statutory Provisions and Legal Authority

II. Removal of the RFG Oxygen Content Requirement for California
Gasoline

    Section 211(k) of the 1990 Amendments to the CAA required
reformulated gasoline (RFG) to contain oxygen in an amount that equals
or exceeds 2.0 weight percent. CAA Section 211(k)(2)(B). Accordingly,
EPA's current regulations require RFG refiners, importers and oxygenate
blenders to meet a 2.0 or greater weight percent oxygen content
standard. 40 CFR 80.41. Recently, Congress passed legislation which
amended Section 211(k) of the CAA to remove the RFG oxygen
requirement.\1\ The Energy Act specified that this change was to be
immediately effective in California, and that it would be effective 270
days after enactment for the rest of the country. To make the fuels
rules consistent with the current Section 211(k), today's rule would
modify the RFG regulations to remove the oxygen standard in Sec.  80.41
for gasoline produced and sold for use in California.\2\ (Modifications
to the RFG regulations to remove the oxygen standard for gasoline
produced and sold for use in all areas of the country are

being published in a separate rulemaking.)
---------------------------------------------------------------------------

    \1\ Energy Policy Act of 2005, Pub. L. 109-58 (HR6), section
1504(a), 119 STAT 594, 1076-1077(2005).
    \2\ The RFG regulations were promulgated under authority of CAA
Section 211(c) as well as CAA Section 211(k). The regulations were
adopted under section 211(c) primarily for the purpose of applying
the preemption provisions in Section 211(c)(4). See 59 FR 7809
(February 16, 1994.)
---------------------------------------------------------------------------

    Today's rule also would modify other provisions of the RFG
regulations which relate to the removal of the oxygen content
requirement for gasoline produced and sold for use in California. The
modifications to the affected sections are listed in the following
table:
---------------------------------------------------------------------------

    \3\ The regulations also include oxygen minimum standards for
simple model RFG and Phase I complex Model RFG, and an oxygen
maximum standard for simple model RFG. See Sec. Sec.  80.41(a)
through (d), and (g). These standards are no longer in effect and
today's rule would not modify the regulations to remove these
standards or compliance requirements relating to these standards,
except where such requirements are included in provisions requiring
other changes in today's rule.

Sec.  Sec.   80.41(e) and (f).............  Would remove the per-gallon
                                             and averaged oxygen
                                             standards for Phase II
                                             Complex Model RFG for
                                             gasoline produced and sold
                                             for use in California.\3\
Sec.   80.41(o)...........................  Would add a provision which
                                             specifies that the
                                             requirements in Sec.
                                             80.41(o) do not apply to
                                             California gasoline.
Sec.   80.78(a)...........................  Would remove the prohibition
                                             against producing and
                                             marketing California RFG
                                             that does not meet the
                                             oxygen minimum standard
                                             since the oxygen standard
                                             has been removed. Also
                                             would remove requirements
                                             for California gasoline to
                                             meet the oxygen minimum
                                             standard during transition
                                             from RBOB to RFG in a
                                             storage tank. (Today's rule
                                             also would remove the
                                             provision in Sec.
                                             80.78(a)(1) regarding
                                             compliance with the maximum
                                             oxygen standard in Sec.
                                             80.41 for simple model RFG.
                                             See footnote 3.)
Sec.   80.79..............................  Would remove quality
                                             assurance requirement to
                                             test California gasoline
                                             for compliance with the
                                             oxygen standard.
Sec.   80.81(d)...........................  Would remove requirement for
                                             oxygenate blenders to
                                             exclude California gasoline
                                             from compliance
                                             calculations since
                                             oxygenate blenders are no
                                             longer required to
                                             demonstrate compliance with
                                             a standard.
Sec.   80.81(e)...........................  Would remove Sec.
                                             80.81(e)(2) which required
                                             refiners, importers and
                                             oxygenate blenders to
                                             provide written
                                             notification to EPA to
                                             produce or import gasoline
                                             certified under Title 13 of
                                             the California Code of
                                             Regulations, sections 2265
                                             or 2266, or to comply with
                                             an oxygen content
                                             compliance survey option,
                                             since these requirements
                                             related to ensuring
                                             compliance with the Federal
                                             RFG oxygen content
                                             standard. Also removes
                                             reference to oxygenate
                                             blenders in Sec.
                                             80.81(e)(3) regarding
                                             withdrawal of California
                                             gasoline exemptions for
                                             parties who have violated
                                             California or federal RFG
                                             regulations.
Sec.   80.81(h)...........................  Would remove provisions for
                                             oxygenate blenders to use
                                             California test methods for
                                             purposes of compliance
                                             testing, since oxygenate
                                             blenders are no longer
                                             required to conduct testing
                                             for compliance with the
                                             oxygen standard.

III. Combining Ethanol Blended California RFG With Non-Ethanol Blended
California RFG

    As discussed above, Section 211(k) required RFG to contain a
minimum of 2.0 weight percent oxygen, and the current fuels regulations
reflect this requirement. Refiners, importers and oxygenate blenders
have used different oxygenates to meet this requirement. RFG that
contains ethanol must be specially blended to account for the RVP
``boost'' that ethanol provides, and the consequent possibility of
increased VOC emissions. EPA's existing regulations prohibit the
commingling of ethanol-blended RFG with RFG containing other oxygenates
because the non-ethanol RFG is typically not able to be mixed with
ethanol and still comply with the VOC performance standards. Since all
RFG is currently required to contain oxygen, the regulations do not now
contain a prohibition against combining ethanol-blended RFG with non-
oxygenated RFG. With the removal of the oxygen content requirement for
RFG, EPA expects that refiners and importers will be producing some RFG
without oxygen and some with ethanol or other oxygenates. Mixing
ethanol-blended RFG with non-oxygenated RFG has the same potential to
create an RVP ``boost'' for the non-oxygenated gasoline as mixing
ethanol-blended RFG with RFG blended with other oxygenates. This is of
particular concern regarding RFG because most refiners and importers
comply with the RFG VOC emissions performance standard on an annual
average basis calculated at the point of production or importation. All
downstream parties are prohibited from marketing RFG which does not
comply with a less stringent downstream VOC standard. However, even
though the combined gasoline may meet the downstream VOC standard,
combining ethanol-blended RFG with non-oxygenated RFG may cause some
gasoline to have VOC emissions which are higher on average than the
gasoline as produced or imported. Thus, with regard to gasoline
produced and sold for use in California, today's rule would extend the
commingling prohibition currently in the fuels regulations to include a
prohibition against combining VOC-controlled ethanol-blended RFG with
VOC-controlled non-oxygenated RFG during the period January 1 through
September 15, with one exception, described below.
    The Energy Act contains a provision which specifically addresses
the combining of ethanol-blended RFG with non-ethanol-blended RFG.\4\
Under this new provision, retail outlets are allowed to sell non-
ethanol-blended RFG which has been combined with ethanol-blended RFG
under certain conditions. First, each batch of gasoline to be blended
must have been ``individually certified as in compliance with
subsections (h) and (k) prior to being blended.'' Second, the retailer
must notify EPA prior to combining the gasolines and identify the exact
location of the retail outlet and specific tank in which the gasoline
is to be combined. Third, the retailer must retain, and, upon request
by EPA, make available for inspection certifications accounting for all
gasoline at the retail outlet. Fourth, retailers are prohibited from
combining VOC-controlled gasoline with non-VOC-controlled gasoline
between June 1 and September 15. Retailers are also limited with regard
to the frequency in which batches of non-ethanol-blended RFG may be
combined with ethanol-blended RFG. Retailers may combine such batches
of RFG a maximum of two periods between May 1 and September 15. Each
period may be no more than ten consecutive calendar days. This proposed
rule would implement this provision of the Energy Act for California
gasoline. A separate rule will implement this provision for the rest of
the country, with a later effective date coinciding with the removal of
the RFG oxygen content requirement for such areas.
---------------------------------------------------------------------------

    \4\ Energy Policy Act of 2005, Pub. L. 109-58 (HR6), section
1513, 119 STAT 594, 1088-1090 (2005).
---------------------------------------------------------------------------

    This new provision will typically be used by retail outlets to
change from the use of RFG containing ethanol to RFG not containing
ethanol or vice versa. (Such a change is usually referred to as a
``tank turnover.'') Such blending can result in additional VOC
emissions,

perhaps resulting in gasoline that does not comply with downstream VOC
standards. The Energy Act is unclear as to when the gasoline in the
tank where blending occurs must be in compliance with the downstream
VOC standard.
    EPA has already promulgated regulations setting out a methodology
for making tank turnovers. 40 CFR 80.78(a)(10). EPA believes retailers
and wholesale purchaser-consumers should have additional flexibility
during the time that they are converting their tanks from one type of
RFG to another, while minimizing the time period during which non-
compliant gasoline is present in their tanks and being sold. Today's
changes would provide additional flexibility to the regulated parties
by interpreting the Energy Act to provide retailers and wholesale
purchaser-consumers with relief from compliance with the downstream VOC
standard during the ten-day blending period, but requiring that the
gasoline in the tank thereafter be in compliance or be deemed in
compliance with the downstream VOC standard.
    To provide assurance that gasoline is in compliance with the
downstream VOC standard after the ten-day period, today's regulations
would provide two options for retailers and wholesale purchaser-
consumers. Under the first option, the retailer may add both ethanol-
blended RFG and non-ethanol-blended RFG to the same tank an unlimited
number of times during the ten-day period, but must test the gasoline
in the tank at the end of the ten-day period to make sure that the RFG
is in compliance with the VOC standard. Under the second option, the
retailer must draw the tank down as much as practicable at the start of
the ten-day period, before RFG of another type is added to the tank,
and add only RFG of one type to the tank during the ten-day period.
That is, the retailer may not add both ethanol-blended RFG and non-
ethanol-blended RFG to the tank during the ten-day period, but may add
only one of these types of RFG. EPA believes that when retailers and
wholesale purchaser-consumers use this second option it is likely that
their gasoline will comply with the downstream VOC standard at the end
of the ten-day period, so that testing will not be necessary. We also
believe that this approach is compatible with current practices of most
retailers and wholesale purchaser-consumers, and expect that most will
find it preferable to testing at the end of the ten-day period.
    The commingling provisions would apply at a retail level such that
each retailer may take advantage of a maximum of two ten-day blending
periods between May 1 and September 15 of each calendar year. Thus, the
options described above would be available to each retail outlet for
each of two ten-day periods during the VOC control period. During each
ten-day period the options would be available for all tanks at that
retail outlet.
    Regarding the requirement that each batch of gasoline to be blended
must have been individually certified as in compliance with subsections
(h) and (k), EPA notes that all gasoline in compliance with RFG
requirements is deemed certified under Section 211(k) pursuant to Sec.
80.40(a). Section 211(h) addresses RVP requirements for gasoline, but
EPA does not have a program to certify gasoline as in compliance with
this provision. For purposes of the commingling exception for retail
outlets incorporated today in Sec.  80.78(a)(8), EPA would deem
gasoline that is in compliance with the regulatory requirements
implementing Section 211(h) to be certified under that section.
Regarding the requirement that retailers retain and make available to
EPA upon request ``certifications'' accounting for all gasoline at the
retail outlet, EPA would deem this requirement fulfilled where the
retailer retains and makes available to EPA, upon request, the product
transfer documentation required under Sec.  80.77 for all gasoline at
the retail outlet.
    Under this proposed rule, the provisions which allow retailers to
sell non-ethanol-blended California RFG that has been combined with
ethanol-blended California RFG would also apply to wholesale purchaser-
consumers. Like retailers, wholesale purchaser-consumers are parties
who dispense gasoline into vehicles, and EPA interprets the Energy Act
reference to retailers as applying equally to them. As a result,
wholesale purchaser-consumers are treated in the same manner as
retailers under this rule. This is consistent with the manner in which
wholesale purchaser-consumers have been treated in the past under the
fuels regulations.
    Most of the provisions of this rule are necessary to implement
amendments to the Clean Air Act included in the Energy Act that
eliminate the RFG oxygen content requirement and allow limited
commingling of ethanol-blended and non-ethanol-blended RFG. The
extension of the general commingling prohibition in the fuels
regulations to cover non-oxygenated RFG is necessary because of the
Energy Act amendments, but is issued pursuant to authority of CAA
Section 211(k). This provision extends the current program to reflect
the presence of non-oxygenated RFG, and is designed to enhance
environmental benefits of the RFG program at reasonable cost to
regulated parties.

IV. Environmental Effects of This Action

    We anticipate that little or no environmental impact would occur as
a result of today's proposed action to remove the oxygenate requirement
for RFG. The RFG standards consist of content and emission performance
standards. Refiners and importers would have to continue to meet all
the emission performance standards for RFG whether or not the RFG
contains any oxygenate. This includes both the VOC and NOX
emission performance standards, as well as the air toxics emission
performance standards which were tightened in the mobile source air
toxics (MSAT) rule in 2001.\5\ New MSAT standards currently under
development are anticipated to achieve even greater air toxics emission
reductions.
---------------------------------------------------------------------------

    \5\ 66 FR 17230 (March 29, 2001).
---------------------------------------------------------------------------

    We have analyzed the potential impacts on emissions that could
result from removal of the oxygenate requirement in the context of
requests for waivers of the Federal oxygen requirement.\6\ We found
that changes in ethanol use could lead to small increases in some
emissions and small decreases in others while still meeting the RFG
performance standards. These potential impacts are associated with the
degree to which ethanol would continue to be blended into RFG after
removal of the oxygen requirement. Past analyses have projected
significant use of ethanol in RFG in California despite removal of the
oxygenate requirement.\7\ Given current gasoline prices and the
tightness in the gasoline market, the favorable economics of ethanol
blending, a continuing concern over MTBE use by refiners, the emission
performance standards still in place for RFG, and the upcoming
renewable fuels mandate,\8\ we believe that ethanol will continue to be
used in RFG in California after the oxygen requirement is

removed. As a result, we believe that the removal of the oxygenate
mandate would have little or no environmental impact in the near
future. We will be looking at the long term effect of oxygenate use in
the context of the rulemaking to implement the renewable fuels mandate.
---------------------------------------------------------------------------

    \6\ See e.g., California Oxygen Waiver Decision, EPA420-S-05-005
(June 2005); Analysis of and Action on New York Department of
Conservation's Request for a Waiver of the Oxygen Content
Requirement in Federal Reformulated Gasoline, EPA420-D-05-06 (June
2005).
    \7\ Technical Support Document: Analysis of California's Request
for Waiver of the Reformulated Gasoline Oxygen Content Requirement
for California Covered Areas, EPA420-R-01-016 (June 2001).
    \8\ Energy Policy Act of 2005, Pub. L. 109-58 (HR6), section
1501, 119 STAT 594, 1067-1076, (2005).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    It has been determined that this direct final rule does not satisfy
the criteria stated above. As a result, this rule is not a
``significant regulatory action'' under the terms of Executive Order
12866 and is therefore not subject to OMB review. Today's rule would
remove certain requirements for all refiners, importers and oxygenate
blenders of RFG in California. As a result, this rule is expected to
greatly reduce overall compliance costs for all refiners, importers and
oxygenate blenders of California RFG. This rule also would provide
options for gasoline retailers in California to commingle certain
compliant gasolines which otherwise would be prohibited from being
commingled. Although there may be small compliance costs associated
with one of these options, we believe that the additional flexibility
provided by this option would reduce overall compliance costs for these
parties.

B. Paperwork Reduction Act

    This proposed action would not impose any new information
collection burden. Refiners, importers and oxygenate blenders of
California RFG are exempt from the reporting and recordkeeping
requirements under the RFG regulations. 40 CFR 80.81. Therefore, the
removal of the oxygen requirement for California RFG would not have any
ICR implications for refiners, importers and oxygenate blenders of
California RFG. Small testing costs may be associated with one of the
options for California gasoline retailers to commingle compliant
gasolines. However, these testing costs are expected to be minimal and
would be greatly outweighed by the flexibility provided by the option
to commingle compliant gasolines. The Office of Management and Budget
(OMB) has previously approved the information collection requirements
contained in the existing regulations in 40 CFR Part 80 under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0277, EPA ICR number 1591.15. A
copy of the OMB approved Information Collection Request (ICR) may be
obtained from Susan Auby, Collection Strategies Division; U.S.
Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW.,
Washington, DC 20460 or by calling<PHONE_NUMBER>.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR Part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act or any other statute unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's regulations at 13 CFR 121.201);
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's rule on small
entities, EPA certifies that this action would not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may conclude that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule.
    This proposed rule would remove certain requirements for all
refiners, importers and oxygenate blenders of California RFG, including
small business refiners, importers and oxygenate blenders.
Specifically, this rule would remove the burden on refiners, importers
and oxygenate blenders to comply with the RFG oxygen requirement and
associated compliance requirements. This rule also would provide
options for gasoline retailers to commingle certain compliant gasolines
which otherwise would be prohibited from being commingled. Although one
option requires some compliance testing, the testing costs are expected
to be minimal. As a result, we have concluded that this proposed rule,
overall, would relieve regulatory burden for small entities subject to
the RFG regulations. We continue to be interested in the potential
impacts of the proposed rule on small entities and

welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    This proposed rule contains no Federal mandates (under the
regulatory provisions of Title II of the UMRA) for State, local or
tribal governments or the private sector that will result in
expenditures of $100 million or more. This rule would affect gasoline
refiners, importers and oxygenate blenders by removing the oxygen
content requirement for RFG and associated compliance requirements, and
would allow gasoline retailers options for commingling compliant
gasolines which otherwise would be prohibited from being commingled.
This rule would have the overall effect of reducing the burden of the
RFG regulations on these regulated parties. Therefore, the requirements
of the Unfunded Mandates Act do not apply to this action.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations 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.''
    This proposed rule does not have federalism implications. It would
not 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,
as specified in Executive Order 13132. This rule would remove the
burden on regulated parties of having to comply with the oxygen
standard for RFG in California, and would allow gasoline retailers to
commingle certain compliant gasolines which otherwise would be
prohibited from being commingled. Thus, Executive Order 13132 does not
apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
    This proposed rule does not have tribal implications. It would not
have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
This rule would apply to gasoline refiners, importers, oxygenate
blenders and retailers who supply RFG in California. This action
contains certain modifications to the Federal requirements for RFG, and
would not impose any enforceable duties on communities of Indian tribal
governments. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under the Order has the potential to influence
the regulation. This proposed rule is not subject to Executive Order
13045 because it is not economically significant and does not establish
an environmental standard intended to mitigate health or safety risks.

H. Executive Order 13211: Acts That Significantly Affect Energy Supply,
Distribution, or Use

    This proposed rule is not an economically ``significant energy
action'' as defined in Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355 (May 22, 2001)) because it does not have a
significant adverse effect on the supply, distribution, or use of
energy. This rule would eliminate the oxygen content requirement for
RFG in California. This change would have the effect of reducing
burdens on suppliers of RFG, which, in turn, may have a positive effect
on gasoline supplies. RFG refiners and blenders may continue to use
oxygenates at their discretion where and when it is most economical to
do so. With the implementation of the renewable fuels standard also
contained in the Energy Act, the blending of

ethanol, in particular, into gasoline is expected to increase
considerably, not decrease. Therefore, despite this action to remove
the oxygenate mandate for RFG in California, when viewed in the context
of companion energy legislation, overall use of oxygenates is expected
to increase in the future. This rule also would allow gasoline
retailers to commingle certain compliant gasolines which otherwise
would be prohibited from being commingled. This also may have a
positive effect on gasoline supplies.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Pub. L. 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This proposed would not establish new technical standards within
the meaning of the NTTAA. Therefore, EPA did not consider the use of
any voluntary consensus standards.

VI. Statutory Provisions and Legal Authority

    The statutory authority for the actions in today's direct final
rule comes from sections 211(c), 211(k) and 301(a) of the CAA.

List of Subjects in 40 CFR Part 80

    Environmental protection, Air pollution control, Fuel additives,
Gasoline, Motor vehicle pollution, Reporting and recordkeeping
requirements.

    Dated: February 14, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. 06-1614 Filed 2-21-06; 8:45 am]

BILLING CODE 6560-50-P