[Federal Register: January 4, 2008 (Volume 73, Number 3)]
[Proposed Rules]
[Page 830-833]
[DOCID:fr04ja08-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0414; Directorate Identifier 2007-NM-340-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model CL-600-2C10 (Regional
Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series
705), and CL-600-2D24 (Regional Jet Series 900) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank safety standards * * *.
    [A]ssessment showed that supplemental maintenance tasks [for the
fuel tank wiring harness installation, and the hydraulic system No.
3 temperature transducer, among other items] are required to prevent
potential ignition sources inside the fuel system, which could
result in a fuel tank explosion. * * *

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by February 4,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the

regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Rocco Viselli, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0414;
Directorate Identifier 2007-NM-340-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2007-28, dated November 22, 2007 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank standards introduced in
Chapter 525 of the Airworthiness Manual through Notice of Proposed
Amendment (NPA) 2002-043. The identified non-compliances were then
assessed using Transport Canada Policy Letter No. 525-001, to
determine if mandatory corrective action is required.
    The assessment showed that supplemental maintenance tasks [for
the fuel tank wiring harness installation, and the hydraulic system
No. 3 temperature transducer, among other items] are required to
prevent potential ignition sources inside the fuel system, which
could result in a fuel tank explosion. Revision has been made to
Canadair Regional Jet Models CL-600-2C10, CL-600-2D15 and CL-600-
2D24 Maintenance Requirements Manual, CSP B-053, Part 2, Section 3
``Fuel System Limitations'' to introduce the required maintenance
tasks.

The corrective action is revising the Airworthiness Limitations Section
of the Instructions for Continued Airworthiness to incorporate new
limitations for fuel tank systems. You may obtain further information
by examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Bombardier has issued a revision to Canadair Regional Jet Model CL-
600-2C10, -2D15, and -2D24 Airworthiness Limitations (ALIs) in the
Maintenance Requirements Manual, CSP B-053, Part 2, Section 3, ``Fuel
System Limitations,'' Revision 9, dated July 20, 2007. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This proposed AD would also allow accomplishing the AWL revision in
accordance with later revisions of the MPD as an acceptable method of
compliance if the limit or interval is part of a later approved
Maintenance Requirements Manual revision or the limit or interval is
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (g) of this proposed AD.
    In most ADs, we adopt a compliance time allowing a specified amount
of time after the AD's effective date. In this case, however, the FAA
has already issued regulations that require operators to revise their
maintenance/inspection programs to address fuel tank safety issues. The
compliance date for these regulations is December 16, 2008. To provide
for coordinated implementation of these regulations and this proposed
AD, we are using this same compliance date in this proposed AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S.

operators and is enforceable. In making these changes, we do not intend
to differ substantively from the information provided in the MCAI and
related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 289 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $23,120, or $80 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Bombardier, Inc. (Formerly Canadair): Docket No. FAA-2008-0414;
Directorate Identifier 2007-NM-340-AD.

Comments Due Date

    (a) We must receive comments by February 4, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Bombardier Model CL-600-2C10
(Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional
Jet Series 705), and CL-600-2D24 (Regional Jet Series 900)
airplanes, certificated in any category, all serial numbers.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane. The FAA has
provided guidance for this determination in Advisory Circular (AC)
25-1529-1.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank standards introduced in
Chapter 525 of the Airworthiness Manual through Notice of Proposed
Amendment (NPA) 2002-043. The identified non-compliances were then
assessed using Transport Canada Policy Letter No. 525-001, to
determine if mandatory corrective action is required.
    The assessment showed that supplemental maintenance tasks [for
the fuel tank wiring harness installation, and the hydraulic system
No. 3 temperature transducer, among other items] are required to
prevent potential ignition sources inside the fuel system, which
could result in a fuel tank explosion. Revision has been made to
Canadair Regional Jet Models CL-600-2C10, CL-600-2D15 and CL-600-
2D24 Maintenance Requirements Manual, CSP B-053, Part 2, Section 3
``Fuel System Limitations'' to introduce the required maintenance
tasks.

The corrective action is revising the Airworthiness Limitations
Section (ALS) of the Instructions for Continued Airworthiness to
incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 60 days after the effective date of this AD, or on or
before December 16, 2008, whichever occurs first, revise the ALS of
the Instructions for Continued Airworthiness to incorporate the
inspection requirements of Canadair Regional Jet Model CL-600-2C10,
-2D15, and -2D24 Airworthiness Limitations (ALIs) in the Maintenance
Requirements Manual, CSP B-053, Part 2, Section 3, ``Fuel System
Limitations,'' Revision 9, dated July 20, 2007 (``the MRM''). For
task numbers 24-90-00-601, 24-90-00-602, 28-00-00-601, 28-11-23-601,
28-11-23-602, 28-12-13-601, 29-30-00-601, and 29-30-00-602, the
initial compliance times start from the later of the times specified
in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD, and the
repetitive inspections must be accomplished thereafter at the
interval specified in the MRM, except as provided by paragraph (g)
of this AD. Accomplishing the revision in accordance with a later
revision of the MRM is an acceptable method of compliance if the
revision is approved by the Manager, New York Aircraft Certification
Office (ACO), FAA.
    (i) The effective date of this AD.
    (ii) The date of issuance of the original Canadian standard
airworthiness certificate or the date of issuance of the original
Canadian export certificate of airworthiness.
    (2) Except as provided by paragraph (g) of this AD: After
accomplishing the actions specified in paragraphs (f)(1) of this AD,
no alternative inspections or inspection intervals may be used,
unless the limit or interval is part of a later approved revision of
the Canadair Regional Jet Model CL-600-2C10, -2D15, and -2D24
Maintenance Requirements Manual, CSP B-053, Part 2,

Section 3, ``Fuel System Limitations,'' Revision 9, dated July 20,
2007, or the limit or interval is approved as an alternative method
of compliance (AMOC) in accordance with the procedures specified in
paragraph (g) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Rocco Viselli, Aerospace
Engineer, Airframe and Propulsion Branch, ANE-171, FAA, New York
Aircraft Certification Office, 1600 Stewart Avenue, Suite 410,
Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516) 794-
5531. Before using any approved AMOC on any airplane to which the
AMOC applies, notify your appropriate principal inspector (PI) in
the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2007-28,
dated November 22, 2007; and Canadair Regional Jet Model CL-600-
2C10, -2D15, and -2D24 Airworthiness Limitations (ALIs) in the
Maintenance Requirements Manual, CSP B-053, Part 2, Section 3,
``Fuel System Limitations,'' Revision 9, dated July 20, 2007; for
related information.

    Issued in Renton, Washington, on December 21, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E7-25619 Filed 1-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Proposed Rules]
[Pages 84249-84251]
[FR Doc No: 2023-26675]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 /
Proposed Rules

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0907]
RIN 1625-AA00

Safety Zone; Fireworks Display, Pacific Ocean, Westport, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of the Pacific Ocean. This action is necessary
to provide for the safety of life on these navigable waters near
Westport, WA, during a fireworks display December 31, 2023, to January
1, 2024. This proposed rulemaking would prohibit persons and vessels
from entering the safety zone unless authorized by the Captain of the
Port Sector Columbia River or a designated representative. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before December 20, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0907 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments. This notice of proposed rulemaking
with its plain-language, 100-word-or-less proposed rule summary will be
available in this same docket.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Carlie Gilligan,
Waterways Management Division, Sector Columbia River, Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Columbia River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On October 23, 2023, an organization notified the Coast Guard that
it will be conducting a fireworks display from 12 to 12:30 a.m. on
January 1, 2024. The fireworks are to be launched from a site in
Westport, WA at approximate location 46[deg]54'17'' N; 124[deg]05'59''
W. Hazards from firework displays include accidental discharge of
fireworks, dangerous projectiles, and falling hot embers or other
debris. The Captain of the Port Sector Columbia River (COTP) has
determined that potential hazards associated with the fireworks to be
used in this display would be a safety concern for anyone within a 600-
foot radius of the launch site.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 600-foot radius of the fireworks
barge before, during, and after the scheduled event. The Coast Guard is
proposing this rulemaking under authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 11:30 p.m. on
December 31, 2023 to 1 a.m. on January 1, 2024. The safety zone would
cover all navigable waters within 600 feet of the launch site in
Westport, WA located at approximate location 46[deg]54'17'' N;
124[deg]05'59'' W. The duration of the zone is intended to ensure the
safety of vessels and these navigable waters before, during, and after
the scheduled 12 to 12:30 a.m. fireworks display. No vessel or person
would be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative. The regulatory
text we are proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed 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. This NPRM has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. Vessel traffic would be able
to safely transit around this safety zone which will impact a small
designated area of the Pacific Ocean for less than 2 hours on two
evenings when vessel traffic is normally low. Moreover, the Coast Guard
would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the zone, and the rule would allow vessels to seek permission to
enter the 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 certifies under 5 U.S.C. 605(b) that this
proposed rule would 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
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it

qualifies and how and to what degree this rule would economically
affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed 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. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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 proposed 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 proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 made
a preliminary determination 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 proposed rule involves a safety
zone lasting 1.5 hours that would prohibit entry within 600 feet of a
fireworks launch site. Normally such actions are categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary 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. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0907 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

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 proposes
to amend 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, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T13-0907 to read as follows:

Sec.  165.T13-0907  Safety Zone; Fireworks Display, Pacific Ocean,
Westport, WA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Pacific Ocean, surface to bottom, 600 feet from the
fireworks display site at

approximately 46[deg]54'17'' N; 124[deg]05'59'' W. These coordinates
are based on the launch site located on the Pacific Ocean near
Firecracker Point, Westport, WA.
    (b) Definitions. As used in this section--
    Designated representative means a commissioned, warrant, or petty
officer of the U.S. Coast Guard assigned to a unit under the
operational control of the U.S. Coast Guard Sector Columbia River and
designated by or assisting the Captain of the Port Columbia River
(COTP) in the enforcement of the regulations in this section.
    (c) Regulations.
    (1) Under the general safety zone regulations in subpart C of this
part, you may not enter the safety zone described in paragraph (a) of
this section unless authorized by the COTP or the COTP's designated
representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling<PHONE_NUMBER> or the Sector Columbia River
Command Center on Channel 16 VHF-FM. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 11:30
p.m. on December 31, 2023 through 1:00 a.m. on January 1, 2024.

    Dated: November 29, 2023.
J.W. Noggle,
Captain, U.S. Coast Guard, Captain of the Port Columbia River.
[FR Doc. 2023-26675 Filed 12-4-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Notices]
[Page 17970-17971]
[DOCID:fr02ap08-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0588; FRL-8357-9]

Acrolein Revised Risk Assessments; Notice of Availability and
Solicitation of Risk Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's revised risk
assessments for the pesticide acrolein. In addition, this notice
solicits public comment on risk reduction and alternative options for
acrolein (Phase 5 of 6-Phase Process). The public is encouraged to
suggest risk management ideas or proposals to address the risks
identified. EPA is developing a Reregistration Eligibility Decision
(RED) for acrolein through the full, 6-Phase public participation
process that the Agency uses to involve the public in developing
pesticide reregistration and tolerance reassessment decisions. Through
these programs, EPA is ensuring that all pesticides meet current health
and safety standards.

DATES: Comments must be received on or before June 2, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0588, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0588. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although, listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
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:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is making available the Agency's revised risk assessments for
both ecological and human health risk, initially issued for comment
through two Federal Register notices published on July 25, 2007 (72 FR
40857 (FRL-8140-8) and November 2, 2007 (72 FR 62230 -) (FRL-8154-4),
respectively; a response to comments, and related documents for
acrolein. EPA also is soliciting public comment on risk reduction and
alternative options for acrolein. In addition, in order to allow a more
completed benefits assessment for identified risks of concern, the
Agency is soliciting information to several questions referenced in
their alternative assessment summary and uncertainties document to help
better understand the importance of acrolein to irrigation. EPA
developed the risk assessments for acrolein as part of its public
process for making pesticide reregistration eligibility and tolerance
reassessment decisions. Through these programs, EPA is ensuring that
pesticides meet current standards under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
    Acrolein is registered as a non-food use aquatic herbicide
Magnacide H: (EPA Registration: 10707-9) used in irrigation
canals and holding ponds. It is a non-specific biocide that controls
aquatic weeds by breaking down their cell walls. Acrolein is formulated
as a liquid, and is metered directly into irrigation canals and
reservoirs. Acrolein is also used as a bactericide Magnacide B: (EPA
Registration : 10707-10) during the production of petroleum.
This product is used to control bacteria that produce corrosive
hydrogen sulfide in oil water ststems. For the bactericide use,
acrolein is injected deep into oil field wells.
    EPA is providing an opportunity, through this notice, for
interested parties to provide risk management proposals or otherwise
comment on risk management for acrolein. Risks of concern that exceed
the Agency's level of concern associated with the use of acrolein are
exposure to bystanders during application to irrigation canals. In
addition, the Agency has identified several ecological risks that
exceed its level of concern following acute exposures to freshwater
fish, invertebrates, non-target aquatic plants, and estuarine/marine
invertebrates. In targeting these risks of concern, the Agency solicits
information on effective and practical risk reduction measures.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its acute risks, multiple ecological incidents, and worker
incidents acrolein is being reviewed through the full 6-Phase public
participation process.
    All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments and
proposals will become part of the Agency Docket for acrolein. Comments
received after the close of the comment period will be marked ``late''.
EPA is not required to consider these late comments.
    After considering comments received, EPA will develop and issue for
comment the acrolein RED.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in product
specific data on individual end-use products and either reregistering
products or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 25, 2008.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.

[FR Doc. E8-6817 Filed 4-1-08; 8:45 a.m.]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54491-54496]
[FR Doc No: 2022-19093]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0725; FRL-9403-02-OCSPP]

Colour Index Pigment Violet 29 (PV29); Revision to the Toxic
Substances Control Act (TSCA) Risk Determination; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final revision to the risk determination for the
Colour Index Pigment Violet 29 (PV29) risk evaluation issued under the
Toxic Substances Control Act (TSCA). The revision to the PV29 risk
determination reflects the announced policy changes to ensure the
public is protected from unreasonable risks from chemicals in a way
that is supported by science and the law. EPA determined that PV29, as
a whole chemical substance, presents an unreasonable risk of injury to
health when evaluated under its conditions of use. In addition, this
revised risk determination does not reflect an assumption that workers
always appropriately wear personal protective equipment (PPE). EPA
understands that there could be occupational safety protections in
place at workplace locations; however, not assuming use of PPE reflects
EPA's recognition that unreasonable risk may exist for subpopulations
of workers that may be highly exposed because they are not covered by
Occupational Safety and Health Administration (OSHA) standards, or
their employers are out of compliance with OSHA standards, or because
many of OSHA's chemical-specific permissible exposure limits largely
adopted in the 1970's are described by OSHA as being ``outdated and
inadequate for ensuring protection of worker health,'' or because OSHA
has not issued a chemical-specific permissible exposure limit (PEL) (as
is the case for PV29), or because EPA finds unreasonable risk for
purposes of TSCA notwithstanding OSHA requirements. This revision
supersedes the condition of use-specific no unreasonable risk
determinations in the January 2021 PV29 Risk Evaluation and withdraws
the associated TSCA order included in the January 2021 PV29 Risk
Evaluation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0725, is available online
at https://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Dyllan Taylor, Office of
Pollution Prevention and Toxics (7404T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422

South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-
1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to those involved in the manufacture, processing,
distribution, use, disposal, and/or the assessment of risks involving
chemical substances and mixtures. You may be potentially affected by
this action if you manufacture (defined under TSCA to include import),
process (including recycling), distribute in commerce, use or dispose
of PV29, including PV29 in products. Since other entities may also be
interested in this revision to the risk determination, EPA has not
attempted to describe all the specific entities that may be affected by
this action.

B. What is EPA'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
(PESS) 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).
    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).
    EPA has inherent authority to reconsider previous decisions and to
revise, replace, or repeal a decision to the extent permitted by law
and supported by reasoned explanation. FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983).

C. What action is EPA taking?

    EPA is announcing the availability of the final revision to the
risk determination for the PV29 risk evaluation issued under TSCA that
published in January 2021. In March 2022, EPA sought public comment on
the draft revisions (87 FR 12690, March 7, 2022). EPA appreciates the
public comments received on the draft revision to the PV29 risk
determination. After review of these comments and consideration of the
specific circumstances of PV29, EPA concludes that the Agency's risk
determination for PV29 is better characterized as a whole chemical risk
determination rather than condition-of-use-specific risk
determinations. Accordingly, EPA is revising and replacing section 5 of
the January 2021 PV29 Risk Evaluation (Ref. 1) where the findings of
unreasonable risk to health and the environment were previously made
for the individual conditions of use evaluated. EPA is also withdrawing
the previously issued TSCA section 6(i)(l) order for four conditions of
use previously determined not to present unreasonable risk which was
included in section 5.4.1 of the January 2021 PV29 Risk Evaluation
(Ref. 1).
    This final revision to the PV29 risk determination is consistent
with EPA's plans to revise specific aspects of the first ten TSCA
chemical risk evaluations to ensure that the risk evaluations better
align with TSCA's objective of protecting health and the environment.
The ten conditions of use identified in the January 2021 PV29 Risk
Evaluation (Ref. 1) as presenting unreasonable risk still drive the
unreasonable risk determination for PV29. Removing the assumption that
workers always and appropriately wear PPE (see unit II.C) does not
alter the conditions of use or worker subpopulations driving the
unreasonable risk determination for PV29. Four out of 14 conditions of
use do not drive the unreasonable risk determination for PV29, and
those conditions of use have been identified in the final revised
unreasonable risk determination. However, EPA is not making condition-
of-use-specific risk determinations for those conditions of use, and
for purposes of TSCA section 6(i), EPA is not issuing a final order
under TSCA section 6(i)(1) and does not consider the revised risk
determination to constitute a final agency action at this point in
time. Overall, ten conditions of use drive the PV29 whole chemical
unreasonable risk determination due to risks identified for human
health. The full list of the conditions of use evaluated for the PV29
TSCA risk evaluation is in table 1-3 of the 2021 PV29 Risk Evaluation
(Ref. 1) available here: https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf.

II. Background

A. Why is EPA re-issuing the risk determination for the PV29 risk
evaluation conducted under TSCA?

    In accordance with Executive Order 13990 (``Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis'') and other Administration priorities (Refs. 2, 3, 4, and 5),
EPA reviewed the risk evaluations for the first ten chemical
substances, including PV29, to ensure that they meet the requirements
of TSCA, including conducting decision-making in a manner that is
consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific
aspects of the first ten risk evaluations in order to ensure that the
risk evaluations appropriately identify unreasonable risks and thereby
help ensure the protection of human health and the environment
(available here: https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations). Following a review of specific
aspects of the January 2021 PV29 Risk Evaluation (Ref. 1) and after
considering comments received on a

draft revised risk determination for PV29, EPA has determined that
making an unreasonable risk determination for PV29 as a whole chemical
substance, rather than making unreasonable risk determinations
separately on each individual condition of use evaluated in the risk
evaluation, is the most appropriate approach for PV29 under the statute
and implementing regulations. In addition, EPA's final risk
determination is explicit insofar as it does not rely on assumptions
regarding the use of PPE in making the unreasonable risk determination
under TSCA section 6, even though some facilities might be using PPE as
one means to reduce worker exposures; rather, the use of PPE as a means
of addressing unreasonable risk will be considered during risk
management, as appropriate.
    This action pertains only to the risk determination for PV29. While
EPA intends to consider and may take additional similar actions on
other of the first ten chemicals, EPA is taking a chemical-specific
approach to reviewing these risk evaluations and is incorporating new
policy direction in a surgical manner, while being mindful of
Congressional direction on the need to complete risk evaluations and
move toward any associated risk management activities in accordance
with statutory deadlines.

B. What is a whole chemical view of the unreasonable risk determination
for the PV29 risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical
substance presents unreasonable risk under its conditions of use.
Stakeholders have disagreed over whether a chemical substance should
receive: A single determination that is comprehensive for the chemical
substance after considering the conditions of use, referred to as a
whole-chemical determination; or multiple determinations, each of which
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
    As explained in the Federal Register document announcing the
availability of the draft revised risk determination for PV29 (87 FR
12690, March 7, 2022), the proposed Risk Evaluation Procedural Rule
(Ref. 6) was premised on the whole chemical approach to making
unreasonable risk determinations. In that proposed rule, EPA
acknowledged a lack of specificity in statutory text that might lead to
different views about whether the statute compelled EPA's risk
evaluations to address all conditions of use of a chemical substance or
whether EPA had discretion to evaluate some subset of conditions of use
(i.e., to scope out some manufacturing, processing, distribution in
commerce, use, or disposal activities), but also stated that ``EPA
believes the word `the' [in TSCA section 6(b)(4)(A)] is best
interpreted as calling for evaluation that considers all conditions of
use.'' The proposed rule, however, was unambiguous on the point that
unreasonable risk determinations would be for the chemical substance as
a whole, even if based on a subset of uses. See Ref. 6 at 7565-66
(``TSCA section 6(b)(4)(A) specifies that a risk evaluation must
determine whether `a chemical substance' presents an unreasonable risk
of injury to health or the environment `under the conditions of use.'
The evaluation is on the chemical substance--not individual conditions
of use--and it must be based on `the conditions of use.' In this
context, EPA believes the word `the' is best interpreted as calling for
evaluation that considers all conditions of use.''). In proposed
regulatory text, EPA proposed to determine whether the chemical
substance presents an unreasonable risk of injury to health or the
environment under the conditions of use. (Ref. 6 at 7480).
    The final Risk Evaluation Procedural Rule stated (82 FR 33726, July
20, 2017 (FRL-9964-38)) (Ref. 7): ``As part of the risk evaluation, EPA
will determine whether the chemical substance presents an unreasonable
risk of injury to health or the environment under each condition of
uses [sic] within the scope of the risk evaluation, either in a single
decision document or in multiple decision documents'' (40 CFR 702.47).
For the unreasonable risk determinations in the first ten risk
evaluations, EPA applied this provision by making individual risk
determinations for each condition of use evaluated as part of each risk
evaluation document (i.e., the condition-of-use-specific approach to
risk determinations). That approach was based on one particular passage
in the preamble to the final Risk Evaluation Rule which stated that EPA
will make individual risk determinations for all conditions of use
identified in the scope. (Ref. 7 at 33744).
    In contrast to this portion of the preamble of the final Risk
Evaluation Rule, the regulatory text itself and other statements in the
preamble reference a risk determination for the chemical substance
under its conditions of use, rather than separate risk determinations
for each of the conditions of use of a chemical substance. In the key
regulatory provision excerpted previously from 40 CFR 702.47, the text
explains that, ``[a]s part of the risk evaluation, EPA will determine
whether the chemical substance presents an unreasonable risk of injury
to health or the environment under each condition of uses [sic] within
the scope of the risk evaluation, either in a single decision document
or in multiple decision documents'' (emphasis added). Other language
reiterates this perspective. For example, 40 CFR 702.31(a) states that
the purpose of the rule is to establish the EPA process for conducting
a risk evaluation to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment as required
under TSCA section 6(b)(4)(B). Likewise, there are recurring references
to whether the chemical substance presents an unreasonable risk in 40
CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which explains
that the extent to which EPA will refine its evaluations for one or
more condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk.
Notwithstanding the one preambular statement about condition-of-use-
specific risk determinations, the preamble to the final rule also
contains support for a risk determination on the chemical substance as
a whole. In discussing the identification of the conditions of use of a
chemical substance, the preamble notes that this task inevitably
involves the exercise of discretion on EPA's part, and ``as EPA
interprets the statute, the Agency is to exercise that discretion
consistent with the objective of conducting a technically sound,
manageable evaluation to determine whether a chemical substance--not
just individual uses or activities--presents an unreasonable risk.''
(Ref. 7 at 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk
evaluation regulation to also allow the Agency to issue whole-chemical
risk determinations. Either approach is permissible under the
regulation. A panel of the Ninth Circuit Court of Appeals also
recognized the ambiguity of the regulation on this point. Safer
Chemicals v. EPA, 943 F.3d 397, 413 (9th Cir. 2019) (holding a
challenge about ``use-by-use risk evaluations [was] not justiciable
because it is not clear, due to the ambiguous text of the Risk
Evaluation Rule, whether the Agency will actually conduct risk
evaluations in the manner Petitioners fear'').
    EPA plans to consider the appropriate approach for each chemical
substance

risk evaluation on a case-by-case basis, taking into account
considerations relevant to the specific chemical substance in light of
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's
ability to evaluate and manage unreasonable risk from individual
chemical substances. EPA believes this is a reasonable approach under
TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of PV29, EPA has
determined that a whole chemical approach is appropriate for PV29 in
order to protect health and the environment. The whole chemical
approach is appropriate for PV29 because there are benchmark
exceedances for substantial number of conditions of use (spanning
across most aspects of the chemical lifecycle--from manufacturing
(including import), processing, industrial and commercial use, and
disposal) for health of workers and occupational non-users and severe
health effects (specifically alveolar hyperplasia) associated with PV29
exposures. Because these chemical-specific properties cut across the
conditions of use within the scope of the risk evaluation, a
substantial amount of the conditions of use drive the unreasonable
risk; therefore, it is appropriate for the Agency to make a
determination for PV29 that the whole chemical presents an unreasonable
risk.
    As explained later in this document, the revisions to the
unreasonable risk determination (section 5 of the 2021 PV29 Risk
Evaluation (Ref. 1)) follow the issuance of a draft revision to the
TSCA PV29 unreasonable risk determination (87 FR 12690, March 07, 2022)
and the receipt of public comment. A response to comments document is
also being issued with the final revised unreasonable risk
determination for PV29. The revisions to the unreasonable risk
determination are based on the existing risk characterization section
of the 2021 PV29 Risk Evaluation (Ref. 1) (section 4) and do not
involve additional technical or scientific analysis. The discussion of
the issues in this Federal Register document and in the accompanying
final revised risk determination for PV29 supersede any conflicting
statements in the January 2021 PV29 Risk Evaluation (Ref. 1) and the
earlier response to comments document (Ref. 8). EPA views the peer
reviewed hazard and exposure assessments and associated risk
characterization as robust and upholding the standards of best
available science and weight of the scientific evidence per TSCA
sections 26(h) and (i).
    For purposes of TSCA section 6(i), EPA is making a risk
determination on PV29 as a whole chemical. Under the revised approach,
the ``whole chemical'' risk determination for PV29 supersedes the no
unreasonable risk determinations for PV29 that were premised on a
condition-of-use-specific approach to determining unreasonable risk and
also contains an order withdrawing the TSCA section 6(i)(1) order in
section 5.4.1 of the January 2021 PV29 Risk Evaluation (Ref. 1).

C. What revision is EPA now making final about the use of PPE for the
PV29 risk evaluation?

    In the risk evaluations for the first ten chemical substances, as
part of the unreasonable risk determination, EPA assumed for several
conditions of use that workers were provided and always used PPE in a
manner that achieves the stated assigned protection factor (APF) for
respiratory protection, or used impervious gloves for dermal
protection. In support of this assumption, EPA used reasonably
available information such as public comments indicating that some
employers, particularly in the industrial setting, provide PPE to their
employees and follow established worker protection standards (e.g.,
OSHA requirements for protection of workers).
    For the January 2021 PV29 Risk Evaluation (Ref. 1), EPA assumed,
based on information provided by the manufacturer of PV29, that workers
use PPE--specifically, respirators with an APF ranging from 10 to 25--
for eight conditions of use. In the January 2021 PV29 Risk Evaluation
(Ref. 1), however, EPA determined that there is unreasonable risk to
these workers even with this assumed PPE use.
    EPA is revising the assumption for PV29 that workers always or
properly use PPE, although it does not question the public comments
received regarding the occupational safety practices often followed by
industry respondents. When characterizing the risk to human health from
occupational exposures during risk evaluation under TSCA, EPA believes
it is appropriate to evaluate the levels of risk present in baseline
scenarios where PPE is not assumed to be used by workers. This approach
of not assuming PPE use by workers considers the risk to potentially
exposed or susceptible subpopulations of workers who may not be covered
by OSHA standards, such as self-employed individuals and public sector
workers who are not covered by a State Plan. It should be noted that,
in some cases, baseline conditions may reflect certain mitigation
measures, such as engineering controls, in instances where exposure
estimates are based on monitoring data at facilities that have
engineering controls in place.
    In addition, EPA believes it is appropriate to evaluate the levels
of risk present in scenarios considering applicable OSHA requirements
(e.g., chemical-specific permissible exposure limits (PELs) and/or
chemical-specific PELs with additional substance-specific standards) as
well as scenarios considering industry or sector best practices for
industrial hygiene that are clearly articulated to the Agency.
Consistent with this approach, the January 2021 PV29 Risk Evaluation
(Ref. 1) characterized risk to workers both with and without the use of
PPE. By characterizing risks using scenarios that reflect different
levels of mitigation, EPA risk evaluations can help inform potential
risk management actions by providing information that could be used
during risk management to tailor risk mitigation appropriately to
address any unreasonable risk identified, or to ensure that applicable
OSHA requirements or industry or sector best practices that address the
unreasonable risk are required for all potentially exposed and
susceptible subpopulations (including self-employed individuals and
public sector workers who are not covered by an OSHA State Plan).
    When undertaking unreasonable risk determinations as part of TSCA
risk evaluations, however, EPA does not believe it is appropriate to
assume as a general matter that an applicable OSHA requirement or
industry practice related to PPE use is consistently and always
properly applied. Mitigation scenarios included in the EPA risk
evaluation (e.g., scenarios considering use of various PPE) likely
represent what is happening already in some facilities. However, the
Agency cannot assume that all facilities have adopted these practices
for the purposes of making the TSCA risk determination.
    Therefore, EPA is making a determination of unreasonable risk for
PV29 from a baseline scenario that does not assume compliance with OSHA
standards, including any applicable exposure limits or requirements for
use of respiratory protection or other PPE. Making unreasonable risk
determinations based on the baseline scenario should not be viewed as
an indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread non-
compliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that

unreasonable risk may exist for subpopulations of workers that may be
highly exposed because they are not covered by OSHA standards, such as
self-employed individuals and public sector workers who are not covered
by a State Plan, or because their employer is out of compliance with
OSHA standards, or because their employer is out of compliance with
OSHA standards, or because many of OSHA's chemical-specific permissible
exposure limits largely adopted in the 1970's are described by OSHA as
being ``outdated and inadequate for ensuring protection of worker
health,'' (Ref. 9), or because OSHA has not issued a permissible
exposure limit (PEL) (as is the case for PV29), or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements.
    In accordance with this approach, EPA is finalizing the revision to
the PV29 risk determination without relying on assumptions regarding
the occupational use of PPE in making the unreasonable risk
determination under TSCA section 6; rather, information on the use of
PPE as a means of mitigating risk (including public comments received
from industry respondents about occupational safety practices in use)
will be considered during the risk management phase, as appropriate.
This represents a change from the approach taken in the 2021 PV29 Risk
Evaluation (Ref. 1). As a general matter, when undertaking risk
management actions, EPA intends to strive for consistency with
applicable OSHA requirements and industry best practices, including
appropriate application of the hierarchy of controls, to the extent
that applying those measures would address the identified unreasonable
risk, including unreasonable risk to potentially exposed or susceptible
subpopulations. Consistent with TSCA section 9(d), EPA will consult and
coordinate TSCA activities with OSHA and other relevant Federal
agencies for the purpose of achieving the maximum applicability of TSCA
while avoiding the imposition of duplicative requirements. Informed by
the mitigation scenarios and information gathered during the risk
evaluation and risk management process, the Agency might propose rules
that require risk management practices that may be already common
practice in many or most facilities. Adopting clear, comprehensive
regulatory standards will foster compliance across all facilities
(ensuring a level playing field) and assure protections for all
affected workers, especially in cases where current OSHA standards may
not apply or be sufficient to address the unreasonable risk.
    By removing the assumption of PPE use in making the whole chemical
risk determination for PV29, there are no additional conditions of use
or worker subpopulations that drive the unreasonable risk
determination. The same ten conditions of use continue to drive EPA's
unreasonable risk determination for PV29 as a whole chemical. The
finalized revision to the PV29 risk determination clarifies that EPA
does not rely on the assumed use of PPE when making the risk
determination for the whole substance.

D. What is PV29?

    PV29 is a high color strength, weather fast and heat stable pigment
used in various industrial, commercial, and consumer applications.
Domestic manufacture of PV29 is conducted by a sole manufacturer.
Imported PV29 pigment, without being processed into a different
product, makes up a very small market share of the PV29 supply chain.
Leading applications for PV29 include use as an intermediate to create
or adjust color of other perylene pigments, incorporation into paints
and coatings used in the automobile industry, incorporation into
plastic and rubber products used in automobiles and industrial
carpeting, use in merchant ink for commercial printing, and use in
consumer watercolors and acrylic artist paint.

E. What conclusions is EPA finalizing today in the revised TSCA risk
evaluation based on the whole chemical approach and not assuming the
use of PPE?

    EPA determined that PV29 presents an unreasonable risk to health
under the conditions of use. EPA's unreasonable risk determination for
PV29 is driven by risks associated with the following conditions of
use, considered singularly or in combination with other exposures:
     Manufacturing--Domestic manufacture;
     Manufacturing--Import;
     Processing: Incorporation into formulation, mixture, or
reaction products in paints and coatings;
     Processing: Incorporation into formulation, mixture, or
reaction products in plastic and rubber products;
     Processing: Intermediate in the creation or adjustment of
color of other perylene pigments;
     Processing: Recycling;
     Industrial/commercial use in paints and coatings for
automotive (OEM and refinishing);
     Industrial/commercial use in paints and coatings for
coatings and basecoats;
     Industrial/commercial use in merchant ink for commercial
printing; and
     Disposal.
    The following conditions of use do not drive EPA's unreasonable
risk determination for PV29:
     Distribution in commerce;
     Industrial/commercial use in plastic and rubber products--
automobile plastics;
     Industrial/commercial use in plastic and rubber products--
industrial carpeting; and
     Consumer use in professional quality watercolor and
acrylic artist paint.
    EPA is not making condition of use-specific risk determinations for
these conditions of use, is not issuing a final order under TSCA
section 6(i)(1) for these conditions of use, and does not consider the
revised risk determination for PV29 to constitute a final agency action
at this point in time.
    Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose risk management regulatory action to the extent
necessary so that PV29 no longer presents an unreasonable risk. EPA
expects to focus its risk management action on the conditions of use
that drive the unreasonable risk. However, it should be noted that,
under TSCA section 6(a), EPA is not limited to regulating the specific
activities found to drive unreasonable risk and may select from among a
suite of risk management requirements in section 6(a) related to
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal as part of its regulatory options to
address the unreasonable risk. As a general example, EPA may regulate
upstream activities (e.g., processing, distribution in commerce) to
address downstream activities (e.g., consumer uses) driving
unreasonable risk, even if the upstream activities do not drive the
unreasonable risk.

III. Summary of Public Comments

    EPA received a total of 14 public comments on the March 7, 2022,
draft revised risk determination for PV29 during the comment period
that ended April 21, 2022. Commenters included trade organizations,
industry stakeholders, environmental groups, and non-governmental and
health advocacy organizations. A separate document that summarizes all
comments submitted and EPA's responses to those comments has been
prepared and is available in the docket for this notice (Ref. 10).

IV. Revision of the January 2021 PV29 Risk Evaluation

A. Why is EPA revising the risk determination for the PV29 risk
evaluation?

    EPA is finalizing the revised risk determination for the PV29 risk
evaluation pursuant to TSCA section 6(b) and consistent with Executive
Order 13990 (``Protecting Public Health and the Environment and
Restoring Science to Tackle the Climate Crisis'') and other
Administration priorities (Refs. 2, 3, 4, and 5). EPA is revising
specific aspects of the first ten TSCA existing chemical risk
evaluations in order to ensure that the risk evaluations better align
with TSCA's objective of protecting health and the environment. For the
PV29 risk evaluation, this includes: (1) making the risk determination
in this instance based on the whole chemical substance instead of by
individual conditions of use and (2) emphasizing that EPA does not rely
on the assumed use of PPE when making the risk determination.

B. What are the revisions?

    EPA is now finalizing the revised risk determination for the 2021
PV29 Risk Evaluation (Ref. 1) pursuant to TSCA section 6(b). Under the
revised determination, EPA concludes that PV29, as evaluated in the
risk evaluation as a whole, presents an unreasonable risk of injury to
health when evaluated under its conditions of use. This revision
replaces the previous unreasonable risk determinations made for PV29 by
individual conditions of use, supersedes the determinations (and
withdraws the associated order) of no unreasonable risk for the
conditions of use identified in the TSCA section 6(i)(1) no
unreasonable risk order, and clarifies the lack of reliance on assumed
use of PPE as part of the risk determination.
    These revisions do not alter any of the underlying technical or
scientific information that informs the risk characterization, and as
such the hazard, exposure, and risk characterization sections are not
changed, except to statements about PPE assumptions in section <IP_ADDRESS>
(Consideration of Engineering Controls and PPE), paragraph four, and
section 4.2.3 (table 4-5, Assumed PPE Protection Considered for Risk
Determination by COU, and introductory text). The discussion of the
issues in this Notice and in the accompanying final revision to the
risk determination supersede any conflicting statements in the prior
executive summary, and section <IP_ADDRESS> and section 4.2.3 (table 4-5)
from the January 2021 PV29 Risk Evaluation (Ref. 1) and the response to
comments document (Ref. 8).
    The revised unreasonable risk determination for PV29 includes
additional explanation of how the risk evaluation characterizes the
applicable OSHA requirements, or industry or sector best practices, and
also clarifies that no additional analysis was done, and the risk
determination is based on the risk characterization (section 4) of the
2021 PV29 Risk Evaluation (Ref. 1).

C. Will the revised risk determination be peer reviewed?

    The risk determination (section 5 of the 2021 PV29 Risk Evaluation
(Ref. 1)) was not part of the scope of the Science Advisory Committee
on Chemicals (SACC) peer review of the PV29 risk evaluation. Thus,
consistent with that approach, EPA did not conduct peer review of the
final revised unreasonable risk determination for the PV29 risk
evaluation because no technical or scientific changes were made to the
hazard or exposure assessments or the risk characterization.

V. Order Withdrawing Previous Order Regarding Unreasonable Risk
Determinations for Certain Conditions of Use

    EPA is also issuing a new order to withdraw the TSCA section
6(i)(1) no unreasonable risk order issued in section 5.4.1 of the 2021
PV29 Risk Evaluation (Ref. 1). This final revised risk determination
supersedes the condition of use-specific no unreasonable risk
determinations in the January 2021 PV29 Risk Evaluation (Ref. 1). The
order contained in section 5.5 of the revised risk determination (Ref.
11) withdraws the TSCA section 6(i)(1) order contained in section 5.4.1
of the January 2021 PV29 Risk Evaluation (Ref. 1). Consistent with the
statutory requirements of section 6(a), the Agency will propose risk
management action to address the unreasonable risk determined in the
PV29 risk evaluation.

IV. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Risk Evaluation for C.I. Pigment Violet 29. EPA Document
#740-R-18-015. January 2021. https://www.epa.gov/sites/default/files/2021-01/documents/1_final_risk_evaluation_for_c.i._pigment_violet_29.pdf.
2. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, of January 25, 2021).
3. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
4. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
5. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
6. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
7562, January 19, 2017) (FRL-9957-75).
7. EPA. Final Rule Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act. Federal Register (82 FR 33726,
33744, July 20, 2017).
8. EPA. Summary of External Peer Review and Public Comments and
Disposition for Colour Index Pigment Violet 29 (PV29). January 2021.
Available at: https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0126.
9. Occupational Safety and Health Administration. Permissible
Exposure Limits--Annotated Tables. Accessed June 13, 2022. https://www.osha.gov/annotated-pels.
10. EPA. Response to Public Comments to the Revised Unreasonable
Risk Determination; Colour Index Pigment Violet 29 (PV29). July
2022.
11. EPA. Unreasonable Risk Determination for Colour Index Pigment
Violet 29 (PV29). July 2022.

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

    Dated: August 30, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-19093 Filed 9-2-22; 8:45 am]
BILLING CODE 6560-50-P