[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23850-23851]
[FR Doc No: 2015-09989]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collection and the expected
burden. The Federal Register Notice with a 60-day comment period was
published on January 21, 2015 (Federal Register/Vol. 80, No. 13/pp.
3008-3010).

DATES: Comments must be submitted on or before May 29, 2015.

ADDRESSES:  Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Dr. Amanda M. Kelley,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Evaluation of Correct Child Restraint System Installations.
    Type of Request: New information collection requirement.
    Abstract: Motor vehicle crashes are a leading cause of death to
children in the United States. In 2012, a total of 952 children younger
than 13 years died in motor vehicle traffic crashes, and two-thirds of
these fatalities occurred among children riding in passenger vehicles.
The National Highway Traffic Safety Administration (NHTSA), recommends
that all children ages 12 years and under be properly buckled in an
age- and size-appropriate car seat, booster seat, or seat belt in the
rear seat. Currently, there are four types of child restraint systems
designed for children: Infant, convertible, combination, and belt-
positioning booster seats. Each system is designed to protect a child
within a given height and weight category in the event of a crash.
    While child restraint use has increased over the years, many
children are still fatally injured as a result of motor vehicles
crashes. One possible explanation for this occurrence could be the
large number of child passengers who are either riding unrestrained in
vehicles, improperly placed in a CRS, or prematurely graduated to an
adult vehicle seat belt system. The most prevalent installation errors
observed include: Incorrect harness routing slot used, improper harness
clip position, loose CRS installation, loose harness straps, and
improper lap belt placement (NHTSA, 2012). Researchers have also
identified errors related to caregivers selecting the correct CRS for
the children's ages, heights, and weights.
    Evaluating the causes of the various selection and installation
errors can be challenging. That is, one or more factors may contribute
to any one type of installation error. There are numerous CRS makes and
models marketed to the consumer, each with its own installation
procedures/manual. In addition, vehicle manufacturers design vehicle
restraint systems and vehicle seats that are incompatible with various
CRSs. New vehicles are continually introduced to the fleet, and CRSs
continue to evolve each year. Finally, there is a never-ending flow of
new parents/caregivers who need to be educated on child passenger
safety. Despite their inexperience, new parents may overestimate their
own accuracy in selecting and securely installing a CRS to the vehicle
and securing the child in the CRS.
    In an effort to reduce the number of errors, NHTSA is undertaking a
study to gain some insight into the causes of errors related to
selecting and installing CRSs. To accomplish this, NHTSA will evaluate
installation performance and caregiver confidence for 150 experienced
and novice CRS users and determine which factors contribute to both
installation and securement errors and to determine what factors
related to the CRS, vehicle, and user confidence contribute to errors.
Evaluation measures will involve the independent identification,
collection and evaluation of both qualitative and quantitative data
that specifically document the types of errors made by both user
groups, as well as vehicle and CRS features that might contribute to
those errors. Identifying these causal factors that contribute to
errors related to selecting and installing CRSs, as well as those
factors that contribute to accurately selecting and properly installing
CRSs for both novice and experienced users, will be the first step in
increasing the safety of child passengers in moving vehicles. In
addition, overall findings can be made available to CRS manufacturers
and vehicle manufacturers related to improvements to specific CRS and
vehicle design features that may foster a better fit in the vehicles
and securement for children.
    Affected Public: Participants will represent both ``novice'' and
``experienced'' CRS users recruited from the Greater Washington, DC
area. ``Experienced'' users regularly care for a child under the age of
4 years, transport the child in a vehicle at least twice a week, have
secured the child in a CRS a minimum of five times in the past 6
months, and have installed any type of CRS at least once in the past 12
months. ``Novice'' CRS users do not regularly transport children and
have not installed a CRS in the past 6 months will be recruited for
participation.
    Estimated Total Annual Burden: 300 hours (150 participants,
averaging 2 hours).
    Comments are invited on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed information collection;
    (iii) ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) ways to minimize the burden of the collection of information
on respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

    Authority:  44 U.S.C. Section 3506(c)(2)(A).

    Dated: April 23, 2015.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2015-09989 Filed 4-28-15; 8:45 am]
 BILLING CODE 4910-59-P


EPA420 R 00 022 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ANN ARBOR, MI 48105 OFFICE OF AIR AND RADIATION MEMORANDUM February 2, 2005 SUBJECT: Meeting with Nissan FROM: Alan Stout, Mechanical Engineer Assessment and Standards Division TO: Docket OAR 2004 0017 Mr. Harada and Mr. Kojima from Nissan Industrial Engines came to discuss various aspects of rulemaking requirements for Tier 1 and Tier 2 engines. This discussion included a variety of issues related to the technical amendments, including diagnostic requirements, raw sampling, AECD descriptions in the application for certification, and the use of field testing procedures for production line testing.


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37865-37867]
[FR Doc No: 2022-13528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1152]

Considerations for Rescinding Breakthrough Therapy Designation;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Considerations for Rescinding Breakthrough Therapy Designation.''
This guidance explains how, during its evaluation of a drug development
program, FDA may consider whether to rescind a breakthrough therapy
designation (BTD) that has been granted. The guidance is consistent
with, and supplements, the information on BTD contained in the guidance
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (May 2014) and in other BTD policies and
procedures of the Center for Drug Evaluation and Research (CDER) and
the Center for Biologics Evaluation and Research (CBER) to expedite the
development and review of a breakthrough therapy.

DATES: Submit either electronic or written comments on the draft
guidance by August 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1152 for ``Considerations for Rescinding Breakthrough
Therapy Designation.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Considerations for Rescinding Breakthrough Therapy
Designation.'' This guidance is consistent with, and supplements, the
information on BTD contained in the guidance for industry entitled
``Expedited Programs for Serious Conditions--Drugs and Biologics'' (May
2014),\1\ in CDER's Manual of Policies and Procedures 6025.6 ``Good
Review Practice: Management of Breakthrough Therapy-Designated Drugs
and Biologics,'' and in CBER's Standard Operating Policy and Procedure
8212 Version 2 ``Management of Breakthrough Therapy-Designated
Products: Sponsor Interactions and Status Assessment Including
Rescinding.''
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics.
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    Section 506(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 356(a)) provides for the granting of BTD ``if the drug
is intended, alone or in combination with 1 or more other drugs, to
treat a serious or life-threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on 1 or more clinically
significant endpoints, such as substantial treatment effects observed
early in clinical development.'' The BTD program is intended to
facilitate and expedite the development of those drugs that receive
designation and involves a resource commitment from FDA to provide
early and frequent advice, conduct multidisciplinary meetings involving
senior managers, and expedite the review of resultant marketing
applications. Thus, over the course of product development, it is
important that available evidence relevant to an application continues
to meet the standards for BTD.
    The information and circumstances supporting the original grant of
BTD for a particular application may change over time. For example, if
a different drug is approved to treat the unmet need that informed the
rationale for granting BTD, the designated drug's preliminary clinical
evidence may no longer meet the BTD criteria regarding substantial
improvement over existing therapies (including the newly approved
drug). In other cases, some drugs that appear promising in early
development fail to meet their primary endpoints or the extent of
benefit is more modest in later trials, and the magnitude of a
treatment effect suggested by early development may not be replicable
in later stages of development. Accordingly, in keeping with the
Agency's authority to grant BTD only to drugs that meet the legal
criteria, FDA periodically assesses whether the criteria for BTD
continue to be met for designated products. If the designation is no
longer supported by subsequent data, FDA may rescind the designation.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Considerations for Rescinding Breakthrough Therapy Designation.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have

been approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in section 506 of
the FD&C Act have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13528 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Page 56452]
[FR Doc No: 2019-23005]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4492-003]

Montgomery Worsted Mills, City Winery Hudson Valley LLC; Notice
of Transfer of Exemption

    1. On June 11, 2019, as supplemented July 16, 2019, Montgomery
Worsted Mills, exemptee for the Montgomery Worsted Mills Hydroelectric
Project No. 4492, filed a letter notifying the Commission that the
project was transferred from the Montgomery Worsted Mills to City
Winery Hudson Valley LLC. The exemption from licensing was originally
issued on September 29, 1981.\1\ The project is located on the Wallkill
River, Orange County, NY. The transfer of an exemption does not require
Commission approval.
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    \1\ Steinberger Bros., Inc./Montgomery Worsted Mills, 16 FERC ]
62,610 (1981).
---------------------------------------------------------------------------

    2. City Winery Hudson Valley LLC is now the exemptee of the Worsted
Mills Hydroelectric Project No. 4492. All correspondence must be
forwarded to: Mr. Dylan Rocke, City Winery Hudson Valley LLC, 23
Factory Street, Montgomery, NY 12549, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
     Dated: October 16, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-23005 Filed 10-21-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Proposed Rules]
[Pages 768-770]
[FR Doc No: 2018-00115]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R08-OAR-2017-0552; FRL-_9971-27--Region 8]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Colorado; Control of Emissions From Existing
Commercial and Industrial Solid Waste Incineration Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a Clean Air Act (CAA) section 111(d)/129 plan (the ``plan'')
submitted by the Colorado Department of Public Health and Environment
(CDPHE) on July 14, 2017. The plan would allow for the implementation
of emissions guidelines for existing commercial and industrial solid
waste incineration (CISWI) units within the jurisdiction of the State
of Colorado. The plan creates new enforceable emissions limits and
operating procedures for existing CISWI units within the State of
Colorado in accordance with the requirements established by the revised
CISWI new source performance standards (NSPS) and emission guidelines
(EG), promulgated by the EPA on March 21, 2011, with subsequent final
amendments to the rule promulgated on February 7, 2013. This proposed
plan approval rulemaking is being taken in accordance with the
requirements of sections 111(d) and 129 of the CAA and the relevant
parts and subparts of the Code of Federal Regulations (CFR).

DATES: Written comments must be received on or before February 7, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2017-0552 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from www.regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Gregory Lohrke, Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit CBI to the EPA through http://www.regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information on a disk or CD-ROM that you mail to the 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:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register volume,
date, and page number);
     Follow directions and organize your comments;
     Explain why you agree or disagree;
     Suggest alternatives and substitute language for your
requested changes;
     Describe any assumptions and provide any technical
information and/or data that you used;
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced;
     Provide specific examples to illustrate your concerns, and
suggest alternatives;
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats; and,
     Make sure to submit your comments by the comment period
deadline identified.

II. Background Information

    Sections 111 and 129 of the CAA outline the EPA's statutory
authority for regulating new and existing solid waste incineration
units. Section 111(b) directs the EPA Administrator to publish and
periodically revise a list of source categories which significantly
cause or contribute to air pollution. This subsection also directs the
Administrator to establish federal standards of performance for new
sources within these categories. Section 111(d) grants the EPA
statutory authority to require states to submit to the agency
implementation plans for establishing performance standards applicable
to existing sources belonging to those categories established in
section 111(b). Section 129 specifically addresses solid waste
combustion and requires that the EPA regulate new and existing waste
incineration units pursuant to section 111 of the Act, including the
requirement that a state in which existing designated facilities
operate submit for approval a state plan for each category of regulated
waste incineration units. Section 129(b)(3) requires the EPA to
promulgate a federal plan for existing waste incineration units of any
designated category located

in any state which has not submitted an approvable 111(d)/129 state
plan for said category of waste incineration unit. Such federal plans
remain in effect until the state in question submits a new or revised
state plan and subsequently receives approval and promulgation of the
plan under 40 CFR part 62.
    State plan submittals under CAA sections 111(d) and 129 must be
consistent with the relevant new or revised EG. Section 129(a)(1)(D) of
the Act requires the EPA to develop and periodically revise operating
standards for new and existing CISWI units. The NSPS and EG for CISWI
units were promulgated on December 1, 2000, at 40 CFR part 60, subparts
CCCC and DDDD, respectively. Revisions to the CISWI NSPS and EG were
subsequently promulgated by the EPA on March 21, 2011 (76 FR 15704),
with final actions on reconsideration of the rule published on February
7, 2013 (78 FR 9112), and June 23, 2016 (81 FR 40956). State plan
requirements specific to CISWI units, along with a model rule to ease
adoption of the EG, are found in subpart DDDD, while more general state
plan requirements are found in 40 CFR part 60, subpart B, and part 62,
subpart A. The guidelines found in subpart DDDD require that states
impose emission limits on designated facilities for those pollutants
regulated under section 129, including: Dioxins/furans, carbon
monoxide, metals (cadmium, lead and mercury), hydrogen chloride, sulfur
dioxide, oxides of nitrogen, opacity and particulate matter. The EG
also requires state plans include essential elements pursuant to
section 129 requirements, including: Monitoring, operator training and
facility permitting requirements.
    On July 14, 2017, the CDPHE submitted to the EPA a new section
111(d)/129 state plan for existing CISWI units in the State of
Colorado. The current state plan is a negative declaration letter
certifying the absence of any known designated facilities regulated
under the CISWI rule. The negative declaration was approved and
promulgated by the EPA on September 17, 2003 (68 FR 54373), at 40 CFR
part 62, subpart G. Since the revision of the CISWI rule, the State of
Colorado has identified at least one operational designated facility
which would be regulated under the revised rule, and has submitted a
new state plan, summarized in the following section, to comply with CAA
section 111/129 requirements.

III. Summary of Colorado's Section 111(d)/129 Plan for Existing CISWI
Units

    The EPA has completed a review of the new Colorado section 111(d)/
129 plan submittal in the context of the requirements of 40 CFR part
60, subparts B and DDDD, and part 62, subpart A. The EPA has determined
that the plan submittal meets the requirements found in the above-cited
subparts. Accordingly, the EPA proposes to approve the submitted state
plan. The EPA's proposed approval action is limited to the new CISWI
state plan and the subpart DDDD ``Model Rule'' addressing CISWI units
as they are incorporated by the State of Colorado in the Code of
Colorado Regulations (CCR) at 5 CCR 1001-8 Regulation No. 6, part A,
subpart DDDD. A detailed summary of the submittal's compliance with the
requirements found in the CFR is available in the technical support
document (TSD) associated with this rulemaking action. The TSD will be
available in the docket for this rulemaking action and may be found at
the www.regulations.gov website.

IV. Proposed Action

    The EPA is proposing approval of the Colorado 111(d)/129 state plan
for existing CISWI units because the plan requirements are at least as
stringent as the requirements for existing CISWI units found in 40 CFR
part 60, subpart DDDD. The state plan was submitted pursuant to 40 CFR
part 60, subparts DDDD and B, and part 62, subpart A. Accordingly, the
EPA proposes to amend 40 CFR part 62, subpart G to reflect the
acceptability of the state plan submittal. This proposed approval is
limited to the provisions of 40 CFR parts 60 and 62 for existing CISWI
units, as found in the emission guidelines of Part 60, subpart DDDD.
The EPA Administrator will retain the authorities listed under
Sec. Sec.  60.2542 and 60.2030(c).

V. Statutory and Executive Order Review

    Under the CAA, the Administrator is required to approve a section
111(d)/129 plan submission that complies with the provisions of the Act
and applicable federal regulations at 40 CFR 62.04. Thus, in reviewing
section 111(d)/129 plan submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not expected to be an Executive Order 13771 regulatory
action because this action is not significant under Executive Order
12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Is not subject to Executive Order 12898 (59 FR 7629,
February 16, 1994) because it does not establish an environmental
health or safety standard.
    In addition, this proposed rule is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Commercial and
industrial solid waste incineration, Intergovernmental relations,
Reporting and recordkeeping requirements.

    Dated: January 2, 2018.
Douglas H. Benevento,
Regional Administrator, Region 8.
[FR Doc. 2018-00115 Filed 1-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36620-36621]
[FR Doc No: 2023-11808]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-516, OMB Control No. 3235-0574]

Proposed Collection; Comment Request; Extension: Rule 3a-8

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit the existing collection of information to the Office of
Management and Budget for extension and approval.
    17 CFR 270.3a-8 (rule 3a-8 of the Investment Company Act of 1940
(15 U.S.C. 80a) (the ``Act'')), serves as a nonexclusive safe harbor
from investment company status for certain research and development
companies (``R&D companies'').
    The rule requires that the board of directors of an R&D company
seeking to rely on the safe harbor adopt an appropriate resolution
evidencing that the company is primarily engaged in a non-investment
business and record that resolution contemporaneously in its minute
books or comparable documents.\1\ An R&D company seeking to rely on the
safe harbor must retain these records only as long as such records must
be maintained in accordance with state law.
---------------------------------------------------------------------------

    \1\ Rule 3a-8(a)(6) (17 CFR 270.3a-8(6)).
---------------------------------------------------------------------------

    Rule 3a-8 contains an additional requirement that is also a
collection of information within the meaning of the PRA. The board of
directors of a company that relies on the safe harbor under rule 3a-8
must adopt a written policy with respect to the company's capital
preservation investments. We expect that the board of directors will
base its decision to adopt the resolution discussed above, in part, on
investment guidelines that the company will follow to ensure its
investment portfolio is in compliance with the rule's requirements.
    The collection of information imposed by rule 3a-8 is voluntary
because the rule is an exemptive safe harbor, and therefore, R&D
companies may choose whether or not to rely on it. The purposes of the
information collection requirements in rule 3a-8 are to ensure that:
(i) the board of directors of an R&D company is involved in determining
whether the company should be considered an investment company and
subject to regulation under the Act, and (ii) adequate records are
available for Commission review, if necessary. Rule 3a-8 would not
require the reporting of any information or the filing of any documents
with the Commission.
    Commission staff estimates that there is no annual recordkeeping
burden associated with the rule's requirements. Nevertheless, the
Commission requests authorization to maintain an inventory of one
burden hour for administrative purposes.
    Commission staff estimates that approximately 537,619 R&D companies
may take advantage of rule 3a-8.\2\ Given that the board resolutions
and investment guidelines will generally need to be adopted only once
(unless relevant circumstances change),\3\ the Commission believes that
all the R&D companies that existed prior to the adoption of rule 3a-8
adopted their board resolutions and established written investment
guidelines in 2003 when the rule was adopted. We expect that R&D
companies formed subsequent to the adoption of rule 3a-8 would adopt
the board resolution and investment guidelines simultaneously with
their formation documents in the

ordinary course of business.\4\ Therefore, we estimate that rule 3a-8
does not impose additional burdens.
---------------------------------------------------------------------------

    \2\ See National Science Foundation, National Center for Science
and Engineering Statistics, Business Enterprise Research and
Development, 2020 Data Tables, Table 10, available at: https://ncses.nsf.gov/pubs/nsf23314.
    \3\ In the event of changed circumstances, the Commission
believes that the board resolution and investment guidelines will be
amended and recorded in the ordinary course of business and would
not create additional time burdens.
    \4\ In order for these companies to raise sufficient capital to
fund their product development stage, Commission staff believes that
they will need to present potential investors with investment
guidelines. Investors generally want to be assured that the
company's funds are invested consistent with the goals of capital
preservation and liquidity.
---------------------------------------------------------------------------

    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by August 4, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: May 30, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-11808 Filed 6-2-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76481-76487]
[FR Doc No: 2022-27129]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0732; FRL-9942-02-OCSPP]

Perchloroethylene (PCE); Revision to Toxic Substances Control Act
(TSCA) Risk Determination; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final revision to the risk determination for the
perchloroethylene (PCE) risk evaluation issued under the Toxic
Substances Control Act (TSCA). The revision to the PCE 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 PCE, 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 adequate occupational safety
protections in place at certain 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 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 December 2020

PCE Risk Evaluation and withdraws the associated TSCA order included in
the December 2020 PCE Risk Evaluation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0732, 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>. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kelly Summers, 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 PCE, including PCE 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). Pursuant to
such authority, EPA has reconsidered and is now finalizing a revised
risk determination for PCE.

C. What action is EPA taking?

    EPA is announcing the availability of the final revision to the
risk determination for the PCE risk evaluation issued under TSCA that
published in December 2020 (Ref. 1). In June 2022, EPA sought public
comment on the draft revisions (87 FR 39085, June 30, 2022). EPA
appreciates the public comments received on the draft revision to the
PCE risk determination. After review of these comments and
consideration of the specific circumstances of PCE, EPA concludes that
the Agency's risk determination for PCE 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 December 2020 PCE Risk Evaluation (Ref. 2) where the findings
of unreasonable risk to health were previously made for the individual
conditions of use evaluated. EPA is also withdrawing the previously
issued TSCA section 6(i)(l) order for two conditions of use previously
determined not to present unreasonable risk which was included in
section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2).
    This final revision to the PCE 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.
As a result of this revision, removing the assumption that workers
always and appropriately wear PPE (see Unit II.C.) means that: one
condition of use in addition to the original 59 conditions of use
drives the unreasonable risk for PCE; an additional route of exposure
(i.e., inhalation) is also identified as driving the unreasonable risk
to workers in many of those 59 conditions of use; and additional risks
for acute non-cancer effects and cancer from inhalation and dermal
exposures also drive the unreasonable risk in many of those 59
conditions of use (where previously those conditions of use were
identified as presenting unreasonable risk only for chronic non-cancer
effects or for chronic non-cancer effects and cancer). 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) for the condition of
use that does not drive the unreasonable risk and does not consider the
revised risk determination to constitute a final agency action at this

point in time. Overall, 60 conditions of use out of 61 EPA evaluated
drive the PCE whole chemical unreasonable risk determination due to
risks identified for human health. The full list of the conditions of
use evaluated for the PCE TSCA risk evaluation is in Table 1-4 of the
December 2020 PCE Risk Evaluation (Ref. 2).

II. Background

A. Why is EPA re-issuing the risk determination for the PCE 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. 3, 4, 5, and 6),
EPA reviewed the risk evaluations for the first ten chemical
substances, including PCE, 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 (Ref.
7). Following a review of specific aspects of the December 2020 PCE
Risk Evaluation (Ref. 2) and after considering comments received on a
draft revised risk determination for PCE, EPA has determined that
making an unreasonable risk determination for PCE 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 PCE 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.
    Separately, EPA is conducting a screening approach to assess risks
from the air and water pathways for several of the first 10 chemicals,
including this chemical. For PCE the exposure pathways that were or
could be regulated under another EPA administered statute were excluded
from the final risk evaluation (see section 1.4.2 of the December 2020
PCE Risk Evaluation). This resulted in the ambient air and ambient
water pathways for PCE not being assessed. The goal of the recently-
developed screening approach is to remedy this exclusion and to
determine if there may be risks that were unaccounted for in the PCE
risk evaluation.
    The screening-level approach has gone through public comment and
independent external peer review through the SACC. The Agency received
the final peer review report on May 18, 2022, and has reviewed public
comments and SACC comments. EPA expects to describe its findings
regarding the chemical-specific application of this screening-level
approach in the forthcoming proposed rule under TSCA section 6(a) for
PCE.
    This action pertains only to the risk determination for PCE. 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 PCE 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 PCE (87 FR
39085, June 30, 2022 (FRL-9942-01-OCSPP)), the proposed Risk Evaluation
Procedural Rule (Ref. 8) 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. 8 at pages 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 the 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. 8 at 7480.)
    The final Risk Evaluation Procedural Rule stated (82 FR 33726, July
20, 2017 (FRL-9964-38)) (Ref. 9): ``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. 9 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'' (Ref. 9, 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. 9 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 PCE, EPA has
determined that a whole chemical approach is appropriate for PCE in
order to protect health and the environment. The whole chemical
approach is appropriate for PCE because there are benchmark exceedances
for a substantial number of conditions of use (spanning across most
aspects of the chemical lifecycle--from manufacturing (including
import), processing, industrial and commercial use, consumer use, and
disposal) for workers, occupational non-users, consumers, and
bystanders and risk of irreversible health effects (specifically
neurotoxicity and cancer) associated with PCE 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 PCE 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 December 2020 PCE
Risk Evaluation (Ref. 2)) follow the issuance of a draft revision to
the TSCA PCE unreasonable risk determination (87 FR 39085, June 30,
2022) and the receipt of public comment. A response to comments
document is also being issued with the final revised unreasonable risk
determination for PCE (Ref. 10). The revisions to the unreasonable risk
determination are based on the existing risk characterization section
of the December 2020 PCE Risk Evaluation (Ref. 2) (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 PCE supersede any conflicting
statements in the December 2020 PCE Risk Evaluation (Ref. 2) and the
earlier response to comments document (Ref. 11). 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 PCE as a whole chemical. Under the revised approach,
the ``whole chemical'' risk determination for PCE supersedes the no
unreasonable risk determinations for PCE 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 December 2020 PCE Risk Evaluation (Ref. 2).

C. What revision is EPA now making final about the use of PPE for the
PCE 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 December 2020 PCE Risk Evaluation (Ref. 2), EPA assumed,
based on reasonably available information that workers use PPE--
specifically, respirators with an APF ranging from 25 to 50 and gloves
with PF 10 or 20--for 26 occupational conditions of use. In the
December 2020 PCE Risk Evaluation, EPA determined that there is
unreasonable risk for 25 of those occupational conditions of use.
    EPA is revising the assumption for PCE that workers always and
properly use PPE. However, this does not mean that EPA questions the
veracity of public comments which describe occupational safety
practices often followed by industry. EPA believes it is appropriate
when conducting risk evaluations under TSCA 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 December 2020 PCE Risk Evaluation
(Ref. 2) 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 (Ref. 12).
    Therefore, EPA is making a determination of unreasonable risk for
PCE 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 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. 13), 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 PCE 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 December 2020 PCE
Risk Evaluation (Ref. 2). 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.
    Removing the assumption that workers always and appropriately wear
PPE in making the whole chemical risk determination for PCE means that:
one condition of use in addition to the original 59 conditions of use
drives the unreasonable risk for PCE; an additional route of exposure
(i.e., inhalation) is also identified as driving the unreasonable risk
to workers in many of those 59 conditions of use; and additional risks
for acute non-cancer effects and cancer from inhalation and dermal
exposures also drive the unreasonable risk in many of those 59
conditions of use (where previously those conditions of use were
identified as presenting unreasonable risk only for chronic non-cancer
effects or for chronic non-cancer effects and cancer). The finalized
revision to the PCE risk determination clarifies that EPA does not rely
on the assumed use of PPE when making the risk determination for the
whole substance; rather, the use of PPE as a means of addressing
unreasonable risk will be considered during risk management, as
appropriate.

D. What is PCE?

    PCE is a colorless liquid and a volatile organic compound that is
manufactured (including imported), processed, distributed, used, and
disposed of as part of industrial, commercial, and consumer conditions
of use. PCE has a wide range of uses, including production of
fluorinated compounds and as a solvent in dry cleaning and vapor
degreasing. A variety of consumer and commercial products use PCE, such
as adhesives (arts and crafts, as well as light repairs), aerosol
degreasers, brake cleaners, aerosol lubricants, sealants, stone polish,
stainless steel polish, and wipe cleaners. The total aggregate
production volume reported for PCE under the Chemical Data Reporting
rule ranged from 324 million to 388 million pounds between 2012 and
2015.

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 PCE presents an unreasonable risk to health
under the conditions of use. EPA's unreasonable risk determination for
PCE as a chemical substance 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 as a reactant/intermediate;
     Processing into formulation, mixture or reaction product
for cleaning and degreasing products;

     Processing into formulation, mixture or reaction product
for adhesive and sealant products;
     Processing into formulation, mixture or reaction product
for paint and coating products;
     Processing into formulation, mixture or reaction product
for other chemical products and preparations;
     Processing by repackaging;
     Recycling;
     Industrial and commercial use as solvent for open-top
batch vapor degreasing;
     Industrial and commercial use as solvent for closed-loop
batch vapor degreasing;
     Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
     Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
     Industrial and commercial use as solvent for cold
cleaning;
     Industrial and commercial use as solvent for aerosol spray
degreaser/cleaner;
     Industrial and commercial use as a solvent for aerosol
lubricants;
     Industrial and commercial use as a solvent for penetrating
lubricants and cutting tool coolants;
     Industrial and commercial use in solvent-based adhesives
and sealants;
     Industrial and commercial use in solvent-based paints and
coatings;
     Industrial and commercial use in maskants for chemical
milling;
     Industrial and commercial use as a processing aid in
pesticide, fertilizer and other agricultural chemical manufacturing;
     Industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing;
     Industrial and commercial use in wipe cleaning;
     Industrial and commercial use in other spot cleaning and
spot removers, including carpet cleaning;
     Industrial and commercial use in mold release;
     Industrial and commercial use in dry cleaning and spot
cleaning post-2006 dry cleaning;
     Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th gen only dry cleaning;
     Industrial and commercial use in automotive care products
(e.g., engine degreaser and brake cleaner);
     Industrial and commercial use in non-aerosol cleaner;
     Industrial and commercial use in metal (e.g., stainless
steel) and stone polishes;
     Industrial and commercial use in laboratory chemicals;
     Industrial and commercial use in welding;
     Industrial and commercial use in other textile processing;
     Industrial and commercial use in wood furniture
manufacturing;
     Industrial and commercial use in foundry applications;
     Industrial and commercial use in specialty Department of
Defense uses (oil analysis and water pipe repair);
     Commercial use in inks and ink removal products (based on
printing);
     Commercial use in inks and ink removal products (based on
photocopying);
     Commercial use for photographic film;
     Commercial use in mold cleaning, release and protectant
products;
     Consumer use in cleaners and degreasers (other);
     Consumer use as a dry cleaning solvent;
     Consumer use in automotive care products (brake cleaner);
     Consumer use in automotive care products (parts cleaner);
     Consumer use in aerosol cleaner (vandalism mark and stain
remover);
     Consumer use in non-aerosol cleaner (e.g., marble and
stone polish);
     Consumer use in lubricants and greases (cutting fluid);
     Consumer use in lubricants and greases (lubricants and
penetrating oils);
     Consumer use in adhesives for arts and crafts (including
industrial adhesive, arts and crafts adhesive, gun ammunition sealant);
     Consumer use in adhesives for arts and crafts (livestock
grooming adhesive);
     Consumer use in adhesives for arts and crafts (column
adhesive, caulk and sealant);
     Consumer use in solvent-based paints and coatings (outdoor
water shield (liquid));
     Consumer use in solvent-based paints and coatings
(coatings and primers (aerosol));
     Consumer use in solvent-based paints and coatings (rust
primer and sealant (liquid));
     Consumer use in solvent-based paints and coatings
(metallic overglaze);
     Consumer use in metal (e.g., stainless steel) and stone
polishes;
     Consumer use in inks and ink removal products;
     Consumer use in welding;
     Consumer use in mold cleaning, release and protectant
products; and
     Disposal.
    The following condition of use does not drive EPA's unreasonable
risk determination for PCE:
     Distribution in commerce.
    EPA is not making a condition of use-specific risk determination
for this condition of use, is not issuing a final order under TSCA
section 6(i)(1) for this condition of use and does not consider the
revised risk determination for PCE to constitute a final agency action
at this point in time.
    Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose a risk management regulatory action to the extent
necessary so that PCE 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 20 unique public comments on the June 30,
2022, draft revised risk determination for PCE during the comment
period that ended August 1, 2022. Commenters included trade
organizations, industry stakeholders, environmental groups, and non-
governmental 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 December 2020 PCE Risk Evaluation

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

    EPA is finalizing the revised risk determination for the PCE 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. 3, 4, 5, and 6). 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 PCE 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
December 2020 PCE Risk Evaluation (Ref. 2) pursuant to TSCA section
6(b). Under the revised determination (Ref. 1), EPA concludes that PCE,
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 PCE 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) and section <IP_ADDRESS>
(Occupational Inhalation Exposure Summary and PPE Use Determinations by
OES). 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, section <IP_ADDRESS>
and section <IP_ADDRESS> from the December 2020 PCE Risk Evaluation (Ref.
2), and the response to comments document (Ref. 11).
    The revised unreasonable risk determination for PCE 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
December 2020 PCE Risk Evaluation (Ref. 2).

C. Will the revised risk determination be peer reviewed?

    The risk determination (section 5 of the December 2020 PCE Risk
Evaluation (Ref. 2)) was not part of the scope of the Science Advisory
Committee on Chemicals (SACC) peer review of the PCE risk evaluation.
Thus, consistent with that approach, EPA did not conduct peer review of
the final revised unreasonable risk determination for the PCE 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
December 2020 PCE Risk Evaluation (Ref. 2). This final revised risk
determination supersedes the condition of use-specific no unreasonable
risk determinations in the December 2020 PCE Risk Evaluation (Ref. 2).
The order contained in section 5.5 of the revised risk determination
(Ref. 1) withdraws the TSCA section 6(i)(1) order contained in section
5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2). Consistent
with the statutory requirements of section 6(a), the Agency will
propose risk management action to address the unreasonable risk
determined in the PCE risk evaluation.

VI. 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. Unreasonable Risk Determination for Perchloroethylene (PCE).
December 2022.
2. EPA. Risk Evaluation for Perchloroethylene. December 2020. EPA
Document #740-R1-8011. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0057.
3. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
4. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
5. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
6. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
7. EPA. Press Release; EPA Announces Path Forward for TSCA Chemical
Risk Evaluations. June 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. 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).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
33726, 33744, July 20, 2017).
10. EPA. Response to Public Comments to the Revised Unreasonable
Risk Determination; Perchloroethylene (PCE). December 2022.
11. EPA. Summary of External Peer Review and Public Comments and
Disposition for Perchloroethylene (PCE). December 2020. Available
at: https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0059.
12. Occupational Safety and Health Administration (OSHA). Top 10
Most Frequently Cited Standards for Fiscal Year 2021 (Oct. 1, 2020,
to Sept. 30, 2021). Accessed October 13, 2022. https://www.osha.gov/top10citedstandards.
13. OSHA. Permissible Exposure Limits--Annotated Tables. Accessed
June 13, 2022. https://www.osha.gov/annotated-pels.

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

    Dated: December 9, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-27129 Filed 12-13-22; 8:45 am]
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[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62521-62522]
[FR Doc No: 2019-24767]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-479-000]

Northern Natural Gas Company; Notice of Revised Schedule for
Environmental Review of the Bushton to Clifton A-Line Abandonment
Project

    This notice identifies the Federal Energy Regulatory Commission
(FERC) staff's revised schedule for the completion of the environmental
assessment (EA) for Northern Natural Gas Company's Bushton to Clifton
A-Line Abandonment Project. The first notice of schedule, issued on
July 30, 2019, identified November 8, 2019 as the EA issuance date.
    Because affected landowners were inadvertently excluded from the
environmental mailing list for the Notice of Intent to Prepare an
Environmental Assessment for the Proposed Bushton to Clifton A-line
Abandonment Project issued by the Commission on July 15, 2019, we have
issued a supplemental notice on November 6, 2019 to provide all
affected landowners an opportunity to comment in this proceeding. As a
result, staff has revised the schedule for issuance of the EA to extend
the comment period and give the public an expanded opportunity to
participate in the project's design and implementation.

Schedule for Environmental Review

Issuance of Notice of Availability of the EA--December 17, 2019
90-day Federal Authorization Decision Deadline--March 16, 2019

    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the

documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select ``General
Search'' from the eLibrary menu, enter the selected date range and
Docket Number excluding the last three digits (i.e., CP19-479), and
follow the instructions. For assistance with access to eLibrary, the
helpline can be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: November 7, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-24767 Filed 11-14-19; 8:45 am]
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