                            Memorandum of Agreement
     Delegation of Authority of the Sewage Sludge Incinerator Federal Plan
                                    Between
             Pennsylvania Department of Environmental Protection
             and the United States Environmental Protection Agency

 GENERAL
 This Memorandum of Agreement (hereinafter MoA) defines policies, responsibilities, and procedures pursuant to 40 Code of Federal Regulations (CFR) 60.5045 and 40 CFR Part 62, Subpart LLL (Federal Plan Requirements for Sewage Sludge Incineration Units), by which the Federal Plan Requirements for Sewage Sludge Incineration Units (Federal Plan) will be administered by the Pennsylvania Department of Environmental Protection (PADEP). The Environmental Protection Agency (EPA) retains the authorities outlined in 40 CFR 62.16050.  This MoA will be maintained consistent with the Clean Air Act (hereinafter the Act) and its regulations and the Pennsylvania Air Pollution Control Act and its regulations.  The provisions of this MoA include the terms, conditions, and the effective date of the delegation of the Federal Plan.  This MoA shall serve as the mechanism for the transfer of authority to PADEP.  The delegation of the Federal Plan to PADEP will be in effect until there are no sewage sludge incinerator (SSI) facilities subject to the Federal Plan in Pennsylvania, EPA publishes an approval of a State Plan that PADEP has submitted, or EPA withdraws delegation of the Federal Plan according to the provisions of this MoA, whichever occurs the earliest.
 In a letter dated September 12, 2016, Krishnan Ramamurthy, Acting Director of PADEP Bureau of Air Quality requested from EPA delegation of authority to implement and enforce the Federal Plan.  The geographic area covered by this MoA is the Commonwealth of Pennsylvania.
 Nothing in this MoA shall be construed to constrain in any way EPA's authority to fulfill its oversight and enforcement responsibilities under the Act.  Nothing in this MoA shall be construed to contravene any provision of 40 CFR Part 62, Subpart LLL.  This MoA does not modify the Federal Plan's requirements that all submissions be made to EPA, except to the extent that this MoA requires that all submissions be made to PADEP in addition to EPA.  This MoA is in addition to, and does not contravene, EPA's other approvals and/or delegations under the Act.
 EPA shall have the authority to revoke all or part of this delegation if EPA determines that the State has failed to properly implement or enforce the Federal Plan.
 This MoA is effective upon authorized signature by both the PADEP and the EPA and shall have an effective date of the last date on which it is signed.  The delegation of the Federal Plan to PADEP shall become effective upon publication of the delegation in the Federal Register.
 This MoA may be modified only after mutual consent of both parties for any purpose. EPA and PADEP reserve the right to revisit the MoA if the Federal Plan is revised after the effective date of the delegation of authority.  Any revisions or modifications to this MoA must be in writing and must be signed by both PADEP and EPA.
 Policy Statement
 Each party is responsible, as outlined below, for ensuring that their obligations under 40 CFR Part 62, Subpart LLL are met.  Both parties agree to maintain a high level of communication, cooperation, and coordination between their respective staffs to assure successful and effective administration of the Federal Plan.
 PADEP shall have primary responsibility for:
 Administering the Federal Plan in accordance with 40 CFR Part 62, Subpart LLL, applicable State/local law, the purposes of the Act, and this MoA.
 Making any changes in implementing the delegated Federal Plan, as necessitated by regulatory changes.
 Sharing information with EPA regarding administration of the Federal Plan.
 EPA shall have responsibility for:
 Providing effective oversight of the Federal Plan to ensure consistency with 40 CFR Part 62, Subpart LLL and this MoA, and to promote national consistency in implementation of the Act.
 Providing ongoing technical and other assistance on SSI matters as requested.
 Informing the PADEP as soon as possible about the EPA's new regulations and any related litigation results or settlements, new Federal standards, implementation information and related Federal policies, as related to SSI matters, the effect of these new requirements, and the action needed by the PADEP.
 Informing the PADEP as soon as possible about the EPA's decisions to revoke any, or all, of the authority granted to the State for delegation purposes.
 Program Implementation
 PADEP agrees to do the following:
 Enforce the Federal Plan in accordance with the provisions of 40 CFR Part 62, Subpart LLL.
 Require all facilities, identified in paragraph 10 herein, to simultaneously submit all reporting, as stipulated in Table 6 of the Federal Plan, to PADEP in addition to EPA.
 Administer and oversee performance testing and monitoring requirements.
 Administer and oversee compliance reporting and recordkeeping requirements.
 Inspect all Sewage Sludge Incinerators in accordance with the most recent Compliance Monitoring Strategy (CMS) work plan approved by EPA and report the minimum data requirements to EPA via the ICIS-AIR, or comparable system specified by EPA, with a special emphasis on updating the facility compliance status.
 Perform follow-up inspections or review of facility records to ensure correction of violations discovered during routine inspections.
 Review Excess Emissions Reports and stack test reports to ascertain compliance and report information concerning federal "High Priority Violations" to EPA via ICIS-AIR (through the state eFACTS system), or comparable system specified by EPA, with a special emphasis on updating the facility compliance status.
 Address violations that meet the definition of "High Priority Violations," in accordance with most recent version of EPA's Enforcement Policy (currently the "Timely and Appropriate Enforcement Response to High Priority Violations  -  Revised 2014," August 25, 2014) and Federally-Reportable Violations policy (currently the "Guidance on Federally-Reportable Violations under the CAA," September 23, 2014).
 Coordinate closely with EPA on enforcement matters related to compliance for the following facilities in PA:
 East Norriton-Plymouth-Whitpain Joint Sewer Authority
 City of Erie Waste Water Treatment Plant
 Delaware County Western Regional Treatment Plant
 Hatfield Township Municipal Authority
 Upper Moreland -Hatboro Joint Sewer Authority
 Wyoming Valley Treatment Plant
 EPA agrees to do the following:
 Provide technical support and assistance, and training opportunities for interpretation of national regulations, development of technology-based requirements for automated transmission of data to EPA databases, and other areas as requested by PADEP.
 Make reasonable efforts to communicate to PADEP when additional legal, technical, and financial resources may be necessary to implement new Clean Air Act Section 129 requirements as they become applicable.
 Program Overview
 To assure that program requirements are met, EPA agrees to do the following:
 Expeditiously review and respond, as appropriate, to requests for information or assistance by PADEP, in connection with its implementation of the Federal Plan.
 Take final action on any substantial modification to this MoA agreed to by PADEP and EPA.  Provide for final action in the Federal Register as soon as practicable or within 180 days of the submission/initiation of MoA modification.
 PADEP and EPA agree that EPA will assess PADEP's administration of the Federal Plan on an ongoing basis for consistency with 40 CFR Part 62, Subpart LLL, and all other requirements of the Act.
 EPA's assessment of PADEP's administration of the Federal Plan will be accomplished by EPA review of information, including, but not limited to, information submitted by PADEP to EPA for permit review, compliance and enforcement review; and comments received from regulated persons, the public, and Federal, State, and local agencies.  Copies of any comments received from such sources, other than PADEP, will be provided to PADEP.

 EPA may audit PADEP files and documents at PADEP offices for selected SSI facilities to determine, for example, that annual emission rate reports, increments of progress notices, materials separation plans, copies of notices of public meetings, documents summarizing responses to public comments, construction notices and fuel reports, as applicable, are received, processed, and enforced in a manner consistent with federal requirements.  Audits may be conducted on an as needed basis, and EPA will give reasonable notice to PADEP prior to initiating any audit.
 If EPA determines that PADEP is not adequately administering or enforcing the Federal Plan, EPA will notify PADEP of the determination as soon as possible and provide the reasons for the determination; PADEP and EPA will then determine the process and time frame for correcting the deficiencies in an expeditious manner.
 PADEP agrees to allow EPA access to all files and other requested information deemed necessary by EPA to assess PADEP's administration of the delegated Federal Plan as described herein, subject to the confidentiality provisions of this MoA.
 Responsibilities of PADEP under delegation of the Federal Plan
 PADEP agrees to do the following:
 Ensure affected Pennsylvania facilities comply with the "operator certification requirements" section of the Federal Plan by obtaining copies of the operator certifications.
 Ensure affected Pennsylvania facilities comply with the "operator training requirements" of the Federal Plan, 40 CFR §§ 62.15920 through 62.15950.
 Ensure facility compliance with the establishment of operating parameters for SSI units as stipulated in Table 4 of the Federal Plan.
 Ensure facility compliance with the reporting requirements for SSI units as stipulated in Table 6 of the Federal Plan.
 Ensure Final Compliance with the compliance schedule of facilities as stipulated in Table 1 and 40 CFR 62.15875 of the Federal Plan.
 Delegable Authorities
 Following execution of this MoA, EPA intends to delegate to PADEP the authority to implement and enforce the Federal Plan.
 These authorities are retained by EPA pursuant to 40 CFR 62.16050:
 Approval of alternatives to the emission limits and standards in Tables 2 and 3 of the Federal Plan and operating limits established under 40 CFR § 62.15965 or § 62.15985.
 Approval of major alternatives to test methods.
 Approval of major alternatives to monitoring.
 Approval of major alternatives to recordkeeping and reporting.
 The requirements in 40 CFR 62.15965.
 The requirements of 40 CFR 62.15945(b)(2).
 Performance test and data reduction waivers under 40 CFR 60.8 (b).
 EPA agrees to notify PADEP as expeditiously as possible when the authorities retained by EPA are exercised.
 Reporting and Transmittal of Information
 PADEP agrees to submit information to EPA Region 3 in accordance with the most recent version of the CMS workplan, High Priority Violator Policy, stacktesting protocol, and Title V/NSR Operating Permits Programs and Air Compliance Program Memorandum of Understanding, Implementation Agreement for Pennsylvania's Title V Operating Permits Program, as applicable.  PADEP also agrees to submit state progress reports to EPA in accordance with 40 CFR § 62.15865(a)(2) and § 60.5015(a)(7).  EPA will request any additional information needed from the state as it is needed.
 EPA agrees to submit copies of any transmittal letters for 114 actions by EPA on affected SSI facilities to PADEP Bureau of Air Quality Chief of Division of Compliance and Enforcement in accordance with the most recent version of the CMS workplan.
 PADEP and EPA agree to the following procedures with respect to confidentiality of information.
 Any information obtained or used in the administration of the Federal Plan shall be available to EPA or PADEP upon the other party's request, as allowed by applicable federal and state regulations.  If the information has been submitted to PADEP under a claim of confidentiality, PADEP must submit that claim to EPA when providing the information.
 If any information is submitted to PADEP under a claim of confidentiality for the purposes of the SSI Federal Plan and Pennsylvania statutes prohibit submitting that information to EPA, PADEP will require the source to submit the information directly to EPA.
 EPA will treat any information obtained from PADEP or from a source subject to a claim of confidentiality in accordance with the regulations in 40 CFR Part 2.
 Signatures
	For the United States,
	United States Environmental Protection Agency, Region 3

      By:	__________/s/________________________		Date:     ______3/1/19_____
		Cosmo Servidio
		Regional Administrator

	For the Commonwealth of Pennsylvania,
	Pennsylvania Department of Environmental Protection

      By:	_________/s/________________________		Date: 	_______1/25/19______
		Patrick McDonnell
		Secretary


[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]
[Page 11616-11617]
[DOCID:fr18mr09-88]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form 12b-25, OMB Control No. 3235-0058, SEC File No. 270-71.

    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 (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    The purpose of Form 12b-25 (17 CFR 240.12b-25) is to provide notice
to the Commission and the marketplace that a

public company will be unable to timely file a required periodic or
transition report pursuant to the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.) and the Investment Company Act of 1940 (15 U.S.C.
80a et seq.). If all the filing conditions of the form are met, the
company is granted an automatic filing extension. The information
required is filed on occasion and is mandatory. All information is
available to the public for review. Publicly held companies file Form
12b-25. Approximately 7,799 registrants file Form 12b-25 and it takes
approximately 2.5 hours per response for a total of 19,498 burden
hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503; and an e-mail to Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/CIO, Securities
and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, VA 22312; or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: March 11, 2009.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-5768 Filed 3-17-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50881-50882]
[FR Doc No: 2021-19609]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0365; FRL-8947-01-ORD]

Board of Scientific Counselors (BOSC) Air Climate and Energy
Subcommittee Meeting--October 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: The Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a series of virtual meetings of
the Board of Scientific Counselors (BOSC) Air, Climate and Energy (ACE)
Subcommittee to discuss emerging pollutants and sources and the
changing environment.

DATES: 1. The meeting will be held over three days via videoconference:
    a. Tuesday, October 12, 2021, from 12 p.m. to 5 p.m. (EDT);
    b. Wednesday, October 13, 2021, from 12 p.m. to 5 p.m. (EDT); and
    c. Thursday, October 14, 2021, from 12 p.m. to 5 p.m. (EDT).
    Attendees must register by October 8, 2021.

    2. A BOSC deliberation videoconference will be held on October 27,
2021, from 2 p.m. to 5 p.m. (EDT).
    Attendees must register by October 26, 2021.
    3. A final BOSC deliberation videoconference will be held on
November 12, 2021, from 2 p.m. to 5 p.m. (EDT). Attendees must register
by November 10, 2021.
    Meeting times are subject to change. This series of meetings is
open to the public. Comments must be received by October 8, 2021, to be
considered by the subcommittee. Requests for the draft agenda or making
a presentation at the meeting will be accepted until October 8, 2021.

ADDRESSES: Instructions on how to connect to the videoconference will
be provided upon registration at: https://www.eventbrite.com/e/us-epa-bosc-air-and-energy-subcommittee-meeting-tickets-150790601749.
    Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0365 by one
of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.
    [ssquf] Note: Comments submitted to the www.regulations.gov website
are anonymous unless identifying information is included in the body of
the comment.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0365.
    [ssquf] Note: Comments submitted via email are not anonymous. The
sender's email will be included in the body of the comment and placed
in the public docket which is made available on the internet.
    Instructions: All comments received, including any personal
information provided, will be included in the public docket without
change and may be made available online at www.regulations.gov.
Information claimed to be Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute will not be
included in the public docket and should not be submitted through
www.regulations.gov or email. For additional information about the
EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Public Docket: Publicly available docket materials may be accessed
Online at www.regulations.gov.
    Copyrighted materials in the docket are only available via hard
copy. The telephone number for the ORD Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO),
Tom Tracy, via phone/voicemail at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>    Any member of the public interested in receiving a draft agenda,
attending the meeting, or making a presentation at the meeting should
contact Tom Tracy no later than October 8, 2021.

SUPPLEMENTARY INFORMATION: The Board of Scientific Counselors (BOSC) is
a federal advisory committee that provides advice and recommendations
to EPA's Office of Research and Development on technical and management
issues of its research programs. The meeting agenda and materials will
be posted to https://www.epa.gov/bosc.
    Proposed agenda items for the meeting include, but are not limited
to, the following: Emerging pollutants and sources and the changing
environment.
    Information on Services Available: For information on translation
services, access, or services for individuals with disabilities, please
contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>To request
accommodation of a disability, please contact Tom Tracy at least ten
days prior to the meeting to give the EPA adequate time to process your
request.
    Authority: Pub. L. 92-463, 1, Oct. 6, 1972, 86 Stat. 770.

Mary Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2021-19609 Filed 9-10-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2354-2362]
[FR Doc No: 2017-00158]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2014-0471; FRL-9958-00-OAR]
RIN 2060-AS26

Granting Petitions To Add n-Propyl Bromide to the List of
Hazardous Air Pollutants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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SUMMARY: The Environmental Protection Agency (EPA) is publishing a
draft notice of the rationale for granting petitions to add n-propyl
bromide (nPB), also known as 1-bromopropane (1-BP), (Chemical Abstract
Service No. 106-94-5) to the list of hazardous air pollutants (HAP)
contained in section 112(b)(1) of the Clean Air Act (CAA). The
Halogenated Solvents Industry Alliance (HSIA) and New York State
Department of Environmental Conservation (NYSDEC) submitted petitions
requesting that nPB be added to the list of HAP. In response to the EPA
requests for additional data, HSIA subsequently supplemented its
petition. Petitions to add a substance to the list of HAP are permitted
under the CAA section 112(b)(3).
    Based on the EPA's evaluation of the petitioners' showing
concerning potential hazards, emissions, and atmospheric dispersion
modeling that provided estimates of ambient concentrations of nPB, the
EPA has determined that there is adequate evidence to support a
determination that emissions and ambient concentrations of nPB may
reasonably be anticipated to cause adverse health effects.

DATES: Comments must be received on or before March 10, 2017.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2014-0471, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from 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: For questions about this proposed
action, contact Ms. Elineth Torres, Sector Policies and Programs
Division, Policies and Strategies Group (D205-02), Office of Air
Quality Planning and Standards, Environmental Protection Agency,
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-4347; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Docket: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2014-0471. All documents in the docket are
listed in the http://www.regulations.gov index. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy form. Publicly available docket materials are available
either electronically at: http://www.regulations.gov, or in hard copy
at the EPA Docket Center, EPA WJC West Building, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the EPA Docket Center is (202)
566-1742.
    Instructions: All submissions must include agency name and docket
number or Regulatory Information Number (RIN) for this rulemaking.
Direct your comments to Docket ID No. EPA-HQ-OAR-2014-0471. The EPA's
policy is that all comments received will be included in the public
docket and may be made available online at: http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be CBI, or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI, or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through http://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, the 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 the EPA cannot read your
comment due to technical difficulties, and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
information about the EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/dockets.
    Acronyms. A number of acronyms are used in this document. To ease
the reading of the document and for reference purposes, the following
acronyms are defined as follows:

1-BP 1-Bromopropane (also known as n-propyl bromide, nPB)
ATSDR Agency for Toxic Substances and Disease Registry
CAA Clean Air Act
CBI Confidential Business Information
EPA U.S. Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
ETI Enviro Tech International
HAP Hazardous Air Pollutants
HSIA Halogenated Solvents Industry Alliance
IRIS Integrated Risk Information System
nPB n-Propyl Bromide (also known as 1-bromopropane, 1-BP)
NESHAP National Emissions Standards for Hazardous Air Pollutants
NTP National Toxicology Program
NYSDEC New York State Department of Environmental Conservation
OMB Office of Management and Budget
PPA Pollution Prevention Act
PERC Perchloroethylene
SNAP Significant New Alternatives Policy
TCE Trichloroethylene
TRI Toxics Release Inventory

    Organization of This Document. The information presented in this
document is organized as follows:

I. General Information
    A. What should I consider as I prepare my comments for the EPA?
    B. Where can I get a copy of this document?
II. Background Information
    A. What is the list of HAP?
    B. CAA Authority: Petitions To Modify the List of HAP
    C. Criteria for Listing
III. Summary of Petitions
    A. Background
    B. Public Comments Received on EPA's Notice of Complete Petition
IV. EPA's Technical Review of the Petitions
    A. Chemical Characteristics, Uses, Sources, and Emissions of nPB
    B. nPB Health Effects
    C. Potential Human Exposure and Cancer Risk
V. EPA's Decision To Grant the Petitions
VI. Statutory and Executive Order Review
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review

I. General Information

A. What should I consider as I prepare my comments for the EPA?

    Submitting CBI. Do not submit information that you consider to be
CBI electronically through http://www.regulations.gov or email. Send or
deliver information identified as CBI to only the following address:
OAQPS Document Control Officer (Room C404-02), Environmental Protection
Agency, Research Triangle Park, North Carolina 27711; Attn: Docket ID
No. EPA-HQ-OAR-2014-0471.
    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 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. If you submit a CD-ROM or disk that
does not contain CBI, mark the outside of the disk or CD-ROM clearly
that it does not contain CBI. Information marked as CBI

will not be disclosed except in accordance with procedures set forth in
40 Code of Federal Regulations part 2.
    If you have any questions about CBI or the procedures for claiming
CBI, please consult the person identified in the FOR FURTHER
INFORMATION CONTACT section of this document.

B. Where can I get a copy of this document?

    In addition to being available in the docket, the electronic copy
of this document will be available on the World Wide Web. Following
signature, a copy of this document will be posted on at the following
address: https://www.epa.gov/haps/initial-list-hazardous-air-pollutants-modifications.

II. Background Information

A. What is the list of HAP?

    The list of HAP, which can be found in CAA section 112(b)(1), is a
list of a wide variety of organic and inorganic substances that
Congress identified as hazardous air pollutants in the 1990 CAA
Amendments. These HAP have been associated with a wide variety of
adverse health effects, including cancer, neurological effects,
reproductive effects, and developmental effects. The health effects
associated with various HAP differ depending upon the toxicity of the
individual HAP and the particular circumstances of exposure, such as
the amount of chemical present, the length of time a person is exposed,
and the stage of life at which the person is exposed. The CAA directs
the EPA to first identify and list source categories that emit HAP and
then to set emission standards for those listed source categories.
Standards promulgated under CAA section 112(d) are commonly referred to
as National Emission Standards for Hazardous Air Pollutants (NESHAP).

B. CAA Authority: Petitions To Modify the List of HAP

    CAA section 112(b)(3)(A) specifies that any person may petition the
Administrator to modify the list of HAP contained in CAA section
112(b)(1) by adding or deleting a substance. CAA section 112(b)(3)(B)
sets out the substantive criteria for granting a petition. It calls for
the Administrator to add a substance to the CAA section 112(b)(1) list
``upon a showing by the petitioner or on the Administrator's own
determination that the substance is an air pollutant and that
emissions, ambient concentrations, bioaccumulation or deposition of the
substance are known to cause or may reasonably be anticipated to cause
adverse effects to human health or adverse environmental effects.'' The
Administrator is required under CAA section 112(b)(3)(A) to either
grant or deny a petition within 18 months of the receipt of a complete
petition by publishing a written explanation of the reasons for the
Administrator's decision. The Administrator may not deny a petition
solely on the basis of inadequate resources or time for review.
    CAA section 112(b)(2) gives the Administrator authority to add to
the CAA section 112(b)(1) list ``pollutants which present, or may
present through inhalation or other routes of exposure, a threat of
adverse human health effects (including, but not limited to,
substances, which are known to be, or may reasonably be anticipated to
be, carcinogenic, mutagenic, teratogenic, neurotoxic, which cause
reproductive dysfunction or which are acutely or chronically toxic) or
adverse environmental effects whether through ambient concentrations,
bioaccumulation, deposition or otherwise.'' CAA section 302(k) defines
an air pollutant as ``any air pollution agent or combination of such
agents, including any physical, chemical, biological, radioactive . . .
substance or matter which is emitted into or otherwise enters the
ambient air.'' CAA section 112(a)(7) specifically defines the term
``adverse environmental effect'' as ``any significant and widespread
adverse effect, which may reasonably be anticipated, to wildlife,
aquatic life, or other natural resources, including adverse impacts on
populations of endangered or threatened species or significant
degradation of environmental quality over broad areas.''
    The EPA reviews petitions to add substances to the HAP list in two
phases: (1) A completeness determination and (2) a substantive
technical review. During the completeness determination, we conduct a
broad review of the petition to determine whether the necessary subject
areas have been addressed and whether reasonable information and
analyses are present for each of the subject areas. Once we determine
the petition complete, we publish a notice of receipt of a complete
petition in the Federal Register and request public comment and/or
additional data.
    During the technical review, we conduct an evaluation of both the
petition and the information received from the public in response to
the Federal Register notice of complete petition to determine whether
the data, analyses, interpretations, and conclusions in the petition
are adequate. Based on this review, we decide whether the petition
satisfies the requirements of CAA section 112(b)(3)(B) and adequately
supports a decision to grant the petition. Upon conclusion of this
review, we publish a draft notice in the Federal Register with the
written explanation of the Administrator's decision to grant the
petition. After considering the comments received on the draft
document, we publish a final notice in the Federal Register. A final
notice granting a petition to add a pollutant to the HAP list in CAA
section 112(b)(1) brings sources emitting that HAP into consideration
in the EPA's program to promulgate NESHAP.
    Finally, under CAA section 112(e)(4), the Administrator's action to
add a pollutant to the CAA section 112(b)(1) HAP list is not a final
agency action subject to judicial review, except that any such action
may be reviewed when the Administrator promulgates applicable CAA
section 112(d) standards for the pollutant. Thus, any final decision to
grant petitions to add nPB to the HAP list would not be subject to
review until the Administrator promulgates applicable CAA section
112(d) standards addressing emissions of nPB.

C. Criteria for Listing

    As previously explained, CAA section 112(b)(3)(A) allows any person
to petition the EPA to modify the CAA section 112(b)(1) list of HAP by
adding or deleting a substance. A petitioner must make ``a showing . .
. that there is adequate data on the health or environmental effects of
the pollutant or other evidence adequate to support the petition.'' CAA
section 112(b)(3)(A). Thus, this section places the burden on a
petitioner to demonstrate that the data sufficiently support an
affirmative determination that the substantive criteria contained in
CAA section 112(b)(3)(B) have been met. In other words, a petitioner
bears the burden of showing that emissions, ambient concentrations,
bioaccumulation or deposition of a substance are known to cause or may
reasonably be anticipated to result in adverse human health or
environmental effects. ``The statutory language unambiguously places on
a [ ]listing petitioner the burden to make a `showing' that `there is
adequate data' about a substance to determine exposure to it `may . . .
reasonably be anticipated to cause' adverse effects.'' Am. Forest &
Paper Ass'n v. EPA, 294 F.3d 113, 119 (D.C. Cir. 2002) (emphasis in
original). The statute does not further define what constitutes
adequate data and we believe that by employing the term

``adequate,'' the statute acknowledges the limitations of data on human
health and environment and gives the Administrator discretion to
determine what constitutes sufficient or adequate information for
purposes of a listing petition. We also note that CAA section 112(b)(4)
allows the Administrator to ``acquire'' information ``when she
determines that information on the health or environmental effects of a
substance is not sufficient to make a determination,'' under CAA
section 112(b)(3). Moreover, Congress could have provided, but did not
provide, specific criteria to guide the Administrator's exercise of her
discretion in deciding whether the data presented are sufficient under
CAA section 112(b)(3)(A).\1\ Thus, we interpret the statutory silence
in CAA section 112(b)(3)(A) as allowing the Administrator to apply her
expertise when reviewing data/information provided by the petitioner to
make the demonstration required by CAA section 112(b)(3)(B), as well as
to consider limitations and difficulties inherent in information on
public health, welfare, and/or the environment.
---------------------------------------------------------------------------

    \1\ This is in contrast to various provisions in the CAA that
specify listing criteria for pollutants(See for example, CAA section
108(a)(2), which states that within 12 months of the listing of a
pollutant under CAA section 108(a), the Administrator must issue
``air quality criteria'' that ``accurately reflect the latest
scientific knowledge useful in indicating the kind and extent of all
identifiable effects on public health or welfare which may be
expected from the presence of such pollutant in the ambient air, in
varying quantities.'').
---------------------------------------------------------------------------

    As previously noted, CAA section 112(b)(3)(B) calls for the
Administrator to add to the CAA section 112(b)(1) list of HAP a
substance that is shown to be ``an air pollutant and that emissions,
ambient concentrations, bioaccumulation or deposition of the substance
are known to cause or may reasonably be anticipated to cause adverse
effects to human health or adverse environmental effects.'' CAA section
112(b)(2) provides additional guidance on how the Administrator's
decision is to be formed by identifying carcinogenicity, mutagenicity,
teratogenicity, neurotoxicity, reproductive dysfunction, and acute or
chronic toxicity as types of adverse health effects. Further, the
language used in CAA section 112(b)(3)(B) does not call for either
complete substantiation or require absolute certainty that a substance
will cause adverse effects to human health or the environment. In fact,
it calls for listing a substance that ``may reasonably be anticipated
to cause'' certain impacts. The EPA interprets this language as
recognizing the limitations and difficulties associated with
information on public health and environment. Typically, questions as
to whether a substance presents adverse health and welfare effects and
the types of effects border on the frontiers of scientific knowledge
and are given to uncertainty because there is either insufficient or
inconsistent data. For example, there might be limited scientific
knowledge of exposure effects on human health and the environment. Some
substances have no known safe level. There might also be limited
emissions data on a substance that is considered for addition to the
list given that it would be largely unregulated.
    Moreover, the CAA is a protective or preventive statute. One of its
stated purposes is ``to protect and enhance the quality of the Nation's
air resources so as to promote the public health and welfare.'' CAA
section 101(b)(1). Relevant legislative history also provides support
for this stated purpose. (The CAA is ``to assure that regulatory action
can effectively prevent harm before it occurs; to emphasize the
predominant value of protection of public health.'' H.R. Rep. No. 95-
294, 95th Cong., 1st Sess. 49 (1977)). Such statutes do not call for
certainty of harm, but rather accord a decision maker flexibility in
taking regulatory action that is protective of public health and the
environment. They allow a decision maker to exercise discretion when
forming her judgement, which would likely involve balancing of factors
that are uniquely within her expertise and policy choices, and
predictions on the frontiers of scientific knowledge. (``[A]n agency
[has] latitude to exercise its discretion in accordance with the
remedial purposes of the controlling statute where relevant facts
cannot be ascertained or are on the frontiers of scientific inquiry.''
Nat'l Lime Ass'n v. EPA, 627 F.2d 416, 454 (D.C. Cir. 1980)).
    Further, requiring data/information that provides absolute
certainty of the adverse health effects of a substance would likely
result in making listing decisions similar to the risk- and health-
based approach employed prior to the 1990 CAA Amendments. See S. Rep.
No. 101-228 at 3, 128 (1989); see also H.R. Rep. No. 101-490, pt. 1, at
322 (1990). Up until then, the EPA was required to list HAP for
regulation based on a conclusion that they could ``cause or contribute
to, an increase in mortality, an increase in serious irreversible, or
incapacitating reversible illness.'' Section 112(a)(1), CAA, Pub. L.
91-604, 84 Stat. 1676, 1685 (1970).\2\ In doing so, the EPA would
consider emissions levels at which health effects have previously been
observed and factor in an ample margin of safety to protect public
health. This approach proved unsatisfactory in achieving the goal of
improved public health and in the 1990 CAA Amendments, Congress
dispensed with this provision, listed 189 HAP in CAA section 112(b)(1)
for regulation, and provided for modifications of the HAP list either
by petition or on the Administrator's determination in CAA sections
112(b)(3)(A) and (B). Thus, we interpret CAA section 112(b)(3)(B) as
invoking the Administrator's expertise in considering information/data
that addresses the potential or likelihood of harm rather than concrete
proof of actual harm. We also believe that CAA section 112(b)(3)(B)
would allow the Administrator to act in the face of uncertainty as to
the proven health effects of a substance, draw inferences from the data
before her, as well as err on the side of caution in determining
whether the data are sufficient to support listing a substance. This
determination would likely take into account the risks associated with
not taking an action as compared to taking action and granting the
petition to add a substance to the CAA section 112(b)(1) HAP list.
---------------------------------------------------------------------------

    \2\ Additionally, until 1990, a HAP was defined as an ``air
pollutant . . . which in the judgment of the Administrator cause, or
contribute to, air pollution which may reasonably be anticipated to
result in an increase in mortality or an increase in serious
irreversible, or incapacitating reversible, illness.'' Section
112(a)(1), CAA, Public Law 91-604, 84 Stat. 1676, 1685 (1970).
---------------------------------------------------------------------------

    We note that the Administrator's discretion is neither unbounded
nor limitless, but rather constrained by the EPA's duty to protect
human health and welfare. See Massachusetts v. EPA, 127 S. Ct. 1438,
1462. (The goal of the CAA is ``to protect and enhance the quality of
the Nation's air resources so as to promote the public health and
welfare and the productive capacity of its population.'' CAA section
101(b)(1)). Therefore, we believe that CAA section 112(b)(3) would
allow the Administrator to make a comparative assessment of adverse
health or environment effects of a substance, projections, or
predictions of future possibilities of harm, consideration of
uncertainties, and extrapolation of limited and even imperfect
scientific data. We also believe that it would allow the Administrator
to balance the likelihood of adverse health effects against limited
scientific data and to err on the side of caution in making her
decision in light of uncertainties in scientific data. Any projections,
assessments, and estimations, however, must be

reasonable and not based on conjecture. She must also make any
necessary policy choices and considerations. Therefore, we do not read
CAA section 112(b)(3)(B) as requiring a bright-line test on how a CAA
section 112(b)(1) listing decision should be made. The Administrator
will neither require nor base her determination solely on a single
parameter or measure, i.e., in arriving at her decision, no one set of
data will outweigh the other. Rather, the Administrator's decision to
list a HAP would be made on a case-by-case basis and involve a thorough
and comprehensive review of factual issues, scientific evidence, and
data provided in support of a petition to add a substance to the CAA
section 112(b)(1) HAP list.
    In summary, we read CAA section 112(b)(3)(B) as allowing the
Administrator to exercise her expertise to decide, based on all
relevant considerations, whether the data presented in a petition are
adequate to support a decision to add a substance to the CAA section
112(b)(1) list of HAP. In other words, to determine whether a
petitioner has shown that emissions of a substance cause or may
reasonably be anticipated to cause adverse effects to human health or
the environment. The Administrator would also likely assess potential
or probable public health and environmental risks rather than proof of
actual harm and consider necessary policy issues. The burden, however,
remains on a petitioner to provide data sufficient to support an
affirmative determination that emissions of a substance may cause or
may reasonably be anticipated to cause adverse human health or
environmental effects. Thus, a petitioner must provide a detailed
assessment of the available data concerning the substance's potential
adverse human health and environmental effects and, where appropriate,
characterize the potential for human and environmental exposures
resulting from emissions of the substance. We expect that such data
would most likely demonstrate that emissions, ambient concentrations,
bioaccumulation, or deposition of the substance may reasonably be
anticipated to cause adverse effects to human health or the
environment. We believe this is a reasonable and proper manner of
giving effect to the Administrator's duty to address public health and
environmental effects under CAA section 112(b)(3).

III. Summary of Petitions

A. Background

    HSIA and NYSDEC submitted petitions to add nPB, also known as 1-BP,
to the CAA section 112(b)(1) list of HAP on October 28, 2010, and
November 24, 2011, respectively. On November 28, 2012, in response to
the EPA's requests for additional data, HSIA supplemented its petition.
The petitions to add nPB to the list of HAP presented the following
information:
     Background data on nPB, including chemical properties,
physical properties, production data, and use data;
     Toxicological evidence describing the human health effects
of nPB;
     Estimation of an inhalation unit risk;
     nPB emissions estimates and atmospheric dispersion
modeling estimating potential ambient concentrations of nPB adjacent to
facilities that emit it; and
     Characterization of potential risks to human health due to
potential exposure to ambient air concentrations of nPB.
    We discuss in detail the information presented in the petitions in
section IV of this document, titled EPA's Technical Review of the
Petitions.
    Following the receipt of the petitions, the EPA conducted a review
to determine whether the petitions were complete according to the
agency criteria. After reviewing these petitions and supplemental
information, the EPA determined that the petitions addressed all of the
necessary subject areas for the agency to assess whether emissions,
ambient concentrations, bioaccumulation, or deposition of nPB are known
to cause or may reasonably be anticipated to cause adverse human health
effects or adverse environmental effects. The EPA determined the
petitions to add nPB to the list of HAP to be complete and published a
notice of receipt of a complete petition in the Federal Register on
February 6, 2015, and invited the public to comment on the technical
merits of these petitions and to submit any information relevant to the
technical review of the petitions.

B. Public Comments Received on EPA's Notice of Complete Petition

    We received 17 submissions in response to the request for comments
and additional information. The submissions are in the docket. Almost
all the submissions agreed with the EPA's completeness determination of
the petitions to add nPB to the CAA section 112(b)(1) HAP list. The
majority of commenters referenced the National Toxicology Program (NTP)
Report on Carcinogens (RoC), 13th Edition, 2014 (NTP, 2014) in which
the NTP classified nPB, identified as 1-BP, as being reasonably
anticipated to be a human carcinogen.
    Both petitioners, HSIA and NYSDEC, provided comments and additional
information on occupational hazards and toxicity of nPB to support
their petitions. Albemarle Corporation and Enviro Tech International
(ETI), a manufacturer and a supplier of nPB respectively, disagreed
with the EPA's completeness determination and provided their own
evaluation of the emissions estimates, nPB carcinogenicity, as well as
the exposure and cancer risk assessment included in the HSIA petition.
Both Albemarle and ETI did not support the granting of petitions to add
nPB to the HAP list based on their risk assessment. Submissions from
various states, the city of Philadelphia, and groups representing state
air pollution control agencies supported the EPA's completeness
determination, presented state-specific information regarding the uses
of nPB in dry cleaning and as a solvent in adhesives and degreaser
operations, provided information on nPB state-specific studies and
regulations, and supported the granting of the petitions to add nPB to
the HAP list.
    Submissions from national environmental organizations and other
members of the public provided the EPA with additional references to
studies on nPB's carcinogenic potential and neurotoxicity as well as
information relevant to the NTP's peer-reviewed report on the
carcinogenicity of nPB, and to the occupational exposure limits for
nPB. These commenters also referenced the EPA's addition of nPB to the
list of toxic chemicals subject to reporting requirements under section
313 of the Emergency Planning and Community Right-to-Know Act (EPCRA)
and section 6607 of the Pollution Prevention Act (PPA). We considered
all comments in our technical review.

IV. EPA's Technical Review of the Petitions

    In this section, we present the EPA's evaluation of the evidence
provided by the petitioners and information submitted by commenters
beyond what was provided in the petitions relevant to our technical
review. The purpose of this evaluation is to determine whether the
data, analyses, interpretations, and conclusions in the petitions are
adequate and whether they support a determination under CAA section
112(b)(3) that the substance is an air

pollutant and that emissions, ambient concentrations, bioaccumulation,
or deposition of the substance are known to cause or may reasonably be
anticipated to cause adverse effects to human health or adverse
environmental effects.
    The EPA's technical review focuses on the evidence provided by
petitioners and commenters regarding emissions, ambient concentrations,
and health effects of nPB. We are seeking comments on the EPA's
technical review of the HSIA and NYSDEC petitions, on whether the
criteria for listing have been met, and the agency's rationale for the
decision to grant these petitions.

A. Chemical Characteristics, Uses, Sources, and Emissions of nPB

    nPB, also known as 1-BP or 1-propyl bromide (CAS # 106-94-5), is a
brominated organic colorless liquid that is insoluble in water, but
soluble in ethanol and ether. Both petitioners and public commenters
provided background information regarding nPB's chemical properties,
physical properties, production, and usage. nPB is used as an
intermediate chemical in the manufacture of pharmaceuticals and
agricultural products, as well as a carrier solvent in aerosols and
adhesives. The petitioners presented information on specific
applications of nPB, including its use in aerosol solvents, adhesives,
dry cleaning, and for open vapor degreasing applications in electronic,
metal, and precision cleaning operations. Many commenters raised
concerns with the use of nPB as a replacement of perchloroethylene
(PERC), a HAP, in the dry cleaning industry and as replacement for HAP
chlorinated solvents, like trichloroethylene (TCE), in solvent cleaning
operations. Commenters pointed out that nPB's vapor pressure (146
millimeters of mercury (mm Hg) at 20 [deg]C) is higher than the vapor
pressure for PERC (14 mm Hg at 20 [deg]C) and TCE (58 mm Hg at 20
[deg]C) and that indoor and outdoor air emissions associated with nPB
use are likely to be higher than those caused by similar use of other
solvents with lower vapor pressure.
    The petitioners expressed the difficulty in obtaining data on
production, uses, and emissions of nPB due to the lack of publically
available data. HSIA estimated the global production of nPB in 2007 was
20,000-30,000 metric tons and projected the use of nPB as a solvent in
the U.S. to be growing at a rate of 15-20 percent per year (5,000
metric tons or 5,511 short tons). ETI commented on the HSIA's estimates
and presented its own data on the use of nPB in the U.S. in the
precision cleaning industry sector, dry cleaning industry, and the
adhesive, coatings, and inks sectors. Per ETI, in 2014 the U.S. used a
total of 4,080 short tons of nPB within these three sectors.
    The EPA agrees with the petitioners that since nPB has not been a
regulated pollutant under CAA section 112 and reporting data under the
Toxics Release Inventory (TRI) Program will not be available until July
2017,\3\ it is difficult to ascertain public data on usage, sources,
and emissions. Nevertheless, in evaluating the information included in
the petitions regarding uses and sources of nPB, the EPA compared the
information with previous assessments of nPB performed by the EPA for
the Significant New Alternatives Policy (SNAP) program and TRI. Based
on this review, the EPA finds that the petitioner's showing of
information regarding nPB uses and sources is reasonable.
---------------------------------------------------------------------------

    \3\ The final rule adding 1-BP to the list of toxic chemicals
subject to reporting under section 313 of the EPCRA and section 6607
of the PPA, 80 FR 72906, November 23, 2015, became effective on
November 30, 2015. The reporting year began on January 1, 2016, with
reports due on July 1, 2017.
---------------------------------------------------------------------------

    To assess nPB air emissions, HSIA estimated nPB emissions for five
facilities: A narrow tube manufacturing/degreasing operation, two dry
cleaners, and two furniture manufacturing/spray adhesive facilities.
HSIA's emission estimates are based on the internal concentration of
nPB as measured by industrial hygiene studies or based on permit files
and assuming that nPB is emitted in quantities similar to what would be
expected for volatile organic compounds, TCE, or PERC. HSIA
acknowledged in their petition that since the emission estimates have
been made without access to the facilities, specific nPB use data
provided by the facilities, or stack testing data, actual nPB emissions
for these facilities could be different from the emission estimates. In
their comments, Albemarle presented their own nPB emissions estimates
for the same facilities included in the HSIA petition. The EPA believes
the emissions estimates provided by HSIA and Albemarle represent a
reasonable range of potential nPB emissions, with HSIA providing more
conservative (higher) emissions estimates. The EPA finds that HSIA has
presented adequate evidence to support the determination that nPB is an
air pollutant as defined by CAA section 302(k).

B. nPB Health Effects

    To support their request for listing nPB as a HAP, the petitioners
provided citations for peer-reviewed published papers and reports
describing health effects of nPB. The summary from HSIA's original
petition focused on reproductive effects, carcinogenicity, and
neurotoxicity. When the EPA requested additional information, HSIA
supplemented the information with additional scientific literature on
these primary health outcomes. The NYSDEC's petition addressed these
same health effects. The petitioners submitted summaries of 2-year
bioassays in rats and mice, along with recommendations of the NTP
Technical Reports Review Subcommittee, as evidence of carcinogenic
activity (NTP, 2011). Claims of neurotoxicity are supported by the
laboratory animal studies, as well as occupational studies and case
reports of altered peripheral nerve function in workers exposed to
concentrations of nPB as low as 1-3 parts per million (ppm).
Developmental and reproductive effects, which were described by the EPA
SNAP rule (72 FR 30142, May 30, 2007), were referenced by the
petitioners. The petitioners claimed that the data are sufficient to
conclude that nPB can and does produce adverse human health outcomes.
Public comments mostly concurred with this description of health
effects. In particular, Dr. Adam Finkel (a subject-matter expert on
chemical toxicology) provided comments expanding upon the submitted
evidence to lend more support and explanations of nPB toxicity.
Regarding these health effects, Albemarle provided comments and
summaries of additional studies to refute conclusions of
carcinogenicity and to discount methods used in one human occupational
study.
1. Cancer Effects
    The petitions included a draft report of the NTP Technical Reports
Review Subcommittee, followed by the final NTP report summarizing the
carcinogenicity bioassays in rats and mice (NTP, 2011).\4\ This NTP
report concluded ``clear evidence of carcinogenicity'' of nPB based on
increased incidences of alveolar/bronchiolar neoplasms in female mice
and intestinal adenomas in female rats and ``some evidence of
carcinogenicity'' based on skin neoplasms and intestinal adenomas in
male rats. There were also increased incidences of non-neoplastic
lesions in both rats and mice. More recently the NTP has synthesized
information from the existing animal and mechanistic studies, public
comments, and peer review and

concluded that nPB is ``reasonably anticipated to be a human
carcinogen'' in the NTP's 13th RoC (NTP, 2014). The EPA has reviewed
that assessment to assure its consistency with the EPA Guidelines for
Carcinogen Risk Assessment and agreed with the conclusions and
classification by the NTP (U.S. EPA Office of Environmental
Information, 2014); the details of the EPA's review of these data were
presented in the proposed (80 FR 20189, April 15, 2015) and final (80
FR 72906, November 23, 2015) documents to add nPB to the TRI list.
---------------------------------------------------------------------------

    \4\ References used in the evaluation of nPB health effects are
available in the docket of this action.
---------------------------------------------------------------------------

    Comments submitted by Albemarle regarding these HAP listing
petitions are the same as those submitted on the EPA's proposed TRI
action (80 FR 20189, April 15, 2015). Detailed responses by the EPA to
these comments are described therein. Albemarle disputed the use of the
alveolar/bronchiolar adenomas in the cancer assessment, suggesting a
lack of human relevance of these mouse tumors. While this topic has
been debated in the scientific literature and was the topic of a
technical workshop convened by the EPA (U.S. EPA, 2014),\5\ there is no
cross-chemical consensus on the human relevance of mouse lung tumors;
each chemical will need to be judged separately regarding relevance.
Furthermore, the NTP conclusions, supported by the EPA, do not rely
solely on the lung tumor data, but rather on the totality of the
available information. The commenter also claimed that the EPA has not
considered potential uncertainties in the mutagenicity, genotoxicity,
and carcinogenicity data for nPB. The NTP review, however, assessed
available mutagenicity data in its review. This took into account
reports of mutations in bacterial and mammalian cells and limited data
on DNA damage in nPB-exposed workers. Furthermore, it is noted that
metabolic pathways are similar in humans and experimental animals, and
several metabolites of nPB have been identified as mutagens and are
known to cause DNA damage. Results from some of these in vitro assays
are mixed, and confounding factors may include the volatility of nPB or
active metabolites. Finally, the commenter provided a summary of an
unpublished study they commissioned showing negative results in the
Ames assay; however, the EPA is not persuaded, and these results do not
change the conclusion regarding the mutagenicity of nPB and its
metabolites. Another commenter (Dr. Adam Finkel) provided counter-
arguments to each of Albemarle's points and strongly encouraged the EPA
to grant the petitions and to add nPB to the CAA 112(b)(1) list of
hazardous pollutants. Considering the available information, including
that presented in the petitions and in public comments, the EPA
continues to agree with NTP's conclusion that nPB is ``reasonably
anticipated to be a human carcinogen.''
---------------------------------------------------------------------------

    \5\ U.S. EPA. Summary Report: State-of-the-Science Workshop on
Chemically-Induced Mouse Lung Tumors: Applications to Human Health
Assessments. U.S. Environmental Protection Agency, Washington, DC,
EPA/600/R-14/002, 2014. Available at https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=291094&CFID=67867665&CFTOKEN=37343828.
---------------------------------------------------------------------------

2. Non-Cancer Effects
a. Developmental/Reproductive Toxicity
    In a previous SNAP ruling (72 FR 30142, May 30, 2007), the EPA
reviewed a two-generation study (WIL Research, 2001) and concluded that
reproductive toxicity, specifically changes in sperm motility and
estrus cycles, was the most sensitive effect of nPB. The petition
repeated this information, added references to literature studies that
replicated these changes, and suggested that a metabolite may be
responsible for the spermatotoxicity (Liu et al., 2009; Banu et al.,
2007; Garner et al., 2007; Yamada et al., 2003). These effects are
reported at inhalation exposures >= 200 ppm in rats and >= 50 ppm in
mice. The petition also summarized the deliberations of the NTP Center
for the Evaluation of Risks of Human Reproduction (NTP-CERHR), an
expert panel that evaluated the available scientific literature on the
potential for nPB to adversely affect human reproduction or development
(NTP-CERHR, 2003). That monograph summarized nPB effects, including
alterations in sperm count and motility, estrus cyclicity, follicular
count, and reproductive organ weights. The impact of these changes is
evident in the two-generation study that reported decreased fertility,
increased post-implantation loss, and decreased number of litters, and
live litter size. Decreased fetal weight and skeletal abnormalities, as
well as depressed postnatal weight gain have also been reported in the
literature. Using a weight-of-evidence approach, the panel concluded
that there is clear evidence of adverse developmental/reproductive
toxicity in laboratory animals and serious concern for adverse effects
in humans at levels of occupational exposures.
    The EPA has previously reviewed the reproductive and developmental
data and agreed with the NTP panel's conclusions. In its SNAP ruling
(72 FR 30142, May 30, 2007), the descriptions and evaluations of these
data were provided in considerable detail. At that time the data on
sperm counts and estrus cyclicity were used for derivations of
acceptable exposure levels. In a recent draft report (81 FR 12099,
March 8, 2016), the EPA again described nPB-induced reproductive and
developmental toxicity, supplemented with studies made available after
the 2003 NTP report (NTP-CERHR, 2003). These studies confirm and extend
the findings of spermatotoxicity, alterations in estrous cycles, and
decreased reproductive organ weights. In this recent report, the EPA
considered decreased live litter size (WIL Research, 2001) to be among
the most sensitive endpoints for dose-response modeling. Public
comments received on the Federal Register notice of complete petition
(80 FR 6676, February 6, 2015) supported and reiterated concern for
this health outcome and noted that nPB is listed as a developmental/
reproductive toxicant under Proposition 65 in California.
    Given the available information in the petitions, and as described
by the EPA in other agency actions on nPB,\6\ the EPA concludes that
there is clear evidence that nPB produces adverse developmental and
reproductive effects.\7\
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    \6\ See 72 FR 30142, May 30, 2007; 80 FR 20189, April 15, 2015;
80 FR 72906, November 23, 2015; and 81 FR 12098, March 8, 2016.
    \7\ In January, 2016, the Agency for Toxic Substances and
Disease Registry published a Draft Toxicological Profile for nPB
that includes an analysis of the available data on the toxicity of
nPB that provides further support for the evidence presented in this
notice on the adverse health effects of nPB. The document can be
found at https://www.atsdr.cdc.gov/ToxProfiles/tp209.pdf.
---------------------------------------------------------------------------

b. Neurotoxicity
    The petitions presented data from published studies in humans and
laboratory animals that demonstrate that both the peripheral and
central nervous systems are sensitive targets of nPB exposure. The
petitions described case reports of severe neurotoxicity requiring
hospitalization and potentially irreversible effects (Perrone et al.,
2008; Majersik et al., 2007; Sclar, 1999). There are also
epidemiological studies that describe concentration-related
neurological impacts at relatively low levels; these findings were
initially reported in small worker populations while later studies
expanded testing to larger groups from several Chinese production
facilities (Li et al., 2010; Ichihara et al., 2004; Ichihara et al.,
2002). Measurements used in these occupational studies included tuning
fork vibration sensitivity and neurophysiological measures of

conduction velocity and latency in motor and sensory nerves. Li et al.
(2010) allocated exposure levels (measured by passive sampling) into
tertiles with medians of 1.28 to 22.58 ppm for female workers and
conducted the analyses using time-weighted averages and cumulative
exposures. Vibration sensitivity, the most sensitive endpoint,
significantly decreased in all exposure groups, and tibial motor distal
latency and sural nerve conduction velocity were altered in the middle
and/or high exposure groups. Hematological and hormonal changes were
also reported in some or all groups.
    The petitions also referenced a number of animal studies showing
hind limb weakness, altered neurophysiological measures, and ataxic
gait from nPB exposure, which are qualitatively similar to the reported
human neurological outcomes. Behavioral measures of neuromuscular
function are sensitive measures of nPB neurotoxicity (Banu et al.,
2007; Honma et al., 2003; Ichihara et al., 2000). Significant changes
were documented at exposures as low as 50 ppm for 21 days (Honma et
al., 2003) and changes may be slow or not reversible (Banu et al.,
2007). Motor nerve conduction velocity and latency measured in the rat
tail nerve were altered at higher concentrations with progressive
changes from 4 to 12 weeks of exposure (Yu et al., 2001; Ichihara et
al., 2000). Studies of very high exposures report severely altered
gait, weakness or loss of hind limb control, convulsions, and death
(Banu et al., 2007; Yu et al., 2001; Ichihara et al., 2000; Ohnishi et
al., 1999), as well as peripheral nerve degeneration, myelin sheath
abnormalities, and spinal cord axonal swelling (Wang et al., 2002; Yu
et al., 2001; Ichihara et al., 2000). The petitions included studies of
potential mechanisms including neurotransmitter dysregulation (Suda et
al., 2008; Wang et al., 2002) and disinhibition in paired-pulse
stimulation of hippocampal slices (Fueta et al., 2007).
    Some of these neurotoxic effects were described in the EPA's SNAP
ruling (72 FR 30142, May 30, 2007), and the conclusions of that review
are in agreement with the claims of the petitioners. Since then, the
EPA has reviewed the larger literature on the neurotoxicity of nPB and
has described the physiological, behavioral, and biochemical measures
that characterize and develop exposure-response data for neurological
effects (81 FR 12098, March 8, 2016). The EPA has concluded that the
concordance of outcomes across humans and laboratory rodents provides
striking evidence of neurotoxic effects.
    One commenter (Albemarle) expressed concerns regarding the validity
and conduct of the tuning fork test of peripheral neuropathy (Li et
al., 2010) for risk assessment purposes. The EPA is not persuaded by
these objections given that electrophysiological measures of peripheral
nerve function were also altered in that and other studies, and,
furthermore, considerations regarding hazard do not rely solely on that
endpoint. The conclusion of nPB neurotoxicity is supported by the EPA's
review of numerous human reports and the preponderance of studies in
laboratory animals.
3. Inhalation Unit Risk
    HSIA and Albemarle each submitted separate quantitative estimates
of cancer unit risk. In addition, the 2010 HSIA petition recommended a
non-cancer reference value based on a larger composite uncertainty
factor than was used in the SNAP rule's acceptable exposure level. When
using quantitative reference values for determining risk from chronic
cancer and non-cancer effects, for CAA section 112 actions, the EPA
uses only final values that have undergone a rigorous development and
review process,\8\ i.e., the EPA Integrated Risk Information System
(IRIS), the Agency for Toxic Substances and Disease Registry (ATSDR)
\9\ and the California Office of Environmental Health Hazards
Assessment. At this time, there are no final dose-response values for
chronic cancer and non-cancer effects for nPB from these sources.
Notwithstanding, the EPA acknowledges that the petitioners have shown
that adequate information exists to develop such values and that this
provides additional support for the potential cancer and non-cancer
hazards from exposure to nPB.
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    \8\ https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.
    \9\ In January 2016 ATSDR published a draft toxicological
profile for nPB. The document can be found at the effects of nPB.
The document can be found at https://www.atsdr.cdc.gov/ToxProfiles/tp209.pdf.
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C. Potential Human Exposure and Cancer Risk

    The petition submitted by HSIA, including supplemental information
and analyses submitted through February 2016, contains an exposure
assessment and estimates of lifetime potential cancer risks for
populations downwind of the five facilities discussed in section IV.A
of this document. The petitioner's assessment used the latest version
of the EPA's Human Exposure Model (HEM) \10\ to model estimated
facility emissions and account for the effects on plume dispersion from
building downwash and whether the facility was located in an urban or
rural area. Census block centroids from the 2010 Census are used as
model receptors in HEM and are surrogates for locations of human
exposure. The petitioner supplemented these default receptor locations
with the locations of actual residences near the facilities. The
petitioner applied its derived cancer unit risk estimate to the modeled
ambient concentrations to estimate potential lifetime individual cancer
risks and population risks. The petitioner's estimates of potential
risk range from 5-in-1 million to 40-in-1 million, with about 9,000
people estimated to have cancer risk greater than 1-in-1 million.
---------------------------------------------------------------------------

    \10\ https://www.epa.gov/fera/risk-assessment-and-modeling-human-exposure-model-hem.
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    A commenter (Albemarle) noted issues with several aspects of the
estimation of ambient concentration and potential cancer risks
originally submitted by the petitioner, including the use of an
outdated model, which used old census and meteorological data, failure
to consider the urban heat island effect, incorrect source release
parameters, and failure to diurnally vary source emissions. Most of the
concerns raised by this commenter have been addressed by the
petitioner's use of the latest model version in its most recently
submitted assessment, which used current census data, recent
meteorological data from a larger library of meteorological stations,
and specified urban or rural dispersion for each facility. Although the
petitioner did not make any revisions to source release parameters nor
temporalize source emissions, the EPA concludes that the petitioner's
assessment is to be viewed less as a refined assessment of these
specific facilities, but rather as an indication that it is reasonable
that nPB emissions and ambient concentrations have the potential to
cause elevated risks. It is important to note that the commenter's own
assessment of the facilities modeled by the petitioner indicate cancer
risk estimates as high as 10-in-1 million.
    Moreover, as explained earlier in section II.C of this document,
CAA section 112(b)(3)(B) does not specifically require an exposure
assessment as a criterion for listing a substance. Rather it requires
the EPA to consider whether ``emissions, ambient concentrations,
bioaccumulation or deposition of the substance are known to cause or
may reasonably be

anticipated to cause adverse effects to human health or adverse
environmental effects.'' In contrast, EPCRA section 313(d)(2)(A)
mandates that the EPA consider whether ``a chemical is known to cause
or can reasonably be anticipated to cause significant adverse acute
human health effects at concentration levels that are reasonably likely
to exist beyond facility site boundaries.'' The contrast demonstrates
that when Congress intends to specifically require a risk assessment,
it does so. It decided not to do so in CAA section 112(b)(3). The CAA
is silent on the issue of noncancer hazards and quantitative cancer
risk evaluation and does not explicitly prohibit the EPA from
considering it when making a determination under CAA section
112(b)(3)(B). As previously explained in section II.C, the EPA also
believes that in meeting its obligation under CAA section 112(b)(3)(B),
the Administrator has discretion in forming her decision to either
grant or deny a petition to add a substance to the CAA section
112(b)(1) HAP list. We believe this discretion would allow her, where
appropriate, to consider risk evaluation of a substance in order to
make the requisite determination as to whether a substance is ``known
to cause or may reasonably be anticipated to cause adverse effects to
human health or adverse environmental effects,'' under CAA section
112(b)(3)(B).
    Thus, the EPA concludes that the petitioners have met the CAA
section 112(b)(3)(A) requisite showing of adequate data by estimating
nPB emissions and ambient concentrations that are likely to result
beyond a facility's fence line and providing adequate evidence of
adverse health effects of nPB. Because the EPA is granting the petition
for reasons stated above, the agency does not find it necessary to make
determinations regarding other elements of the petition, such as a
petitioner's noncancer hazards and quantitative cancer risk evaluation,
or whether nPB presents adverse environmental effects.

V. EPA's Decision To Grant the Petitions

    Based on the EPA's evaluation of the petitions submitted by HSIA
and NYSDEC, we conclude that the petitioners have provided sufficient
information demonstrating the adverse health effects of nPB. The
documented adverse health effects of nPB, which are based on
established sound scientific principles, include carcinogenicity,
reproductive toxicity, and neurotoxicity. The EPA also concludes that
the petitioner's assessment regarding estimates of potential ambient
concentrations of nPB that are likely to result at a facility's fence
line and process emissions related information and chemical usage
information representative of normal operating conditions are
reasonable. The EPA concludes that there is adequate evidence to
support a determination that nPB is an air pollutant and that emissions
and ambient concentrations of nPB may reasonably be anticipated to
cause adverse effects to human health. As mentioned above, we are
seeking comments on all aspects of this notice, including EPA's
technical review of the HSIA and NYSDEC petitions, whether the criteria
for listing have been met, and the agency's rationale for the decision
to grant these petitions.

VI. Statutory and Executive Order Review

    Additional information about this Executive Order can be found at
http://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review because it
raises novel legal or policy issues. Any changes made in response to
OMB recommendations have been documented in the docket.
    Accordingly, the EPA is issuing this draft notice announcing the
decision to grant petitions to add nPB to the CAA section 112(b)(1) HAP
list.

    Dated: December 28, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2017-00158 Filed 1-6-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Rules and Regulations]
[Pages 28992-28993]
[FR Doc No: 2023-09593]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0340]

Safety Zones; Fireworks Displays in the Fifth Coast Guard
District--Philadelphia, PA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Delaware River, Philadelphia,
PA

Safety Zone on May 27, 2023, or on a rain date of May 28, 2023, to
provide for the safety of life on navigable waterways during a barge-
based fireworks display. Our regulation for marine events within the
Fifth Coast Guard District identifies the boundaries of the regulated
area. During the enforcement period, no person or vessel may enter,
remain in, or transit through the regulated area, and anyone in the
vicinity must comply with directions from the Patrol Commander or any
Official Patrol displaying a Coast Guard ensign.

DATES: The portion of the regulation 33 CFR 165.506 for Philadelphia,
PA, as identified in entry 10 of table 1 to paragraph (h)(1), will be
enforced from 8:45 p.m. through 9:35 p.m. on May 27, 2023, or on a rain
date of May 28, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, you may call or email Petty Officer Dylan
Caikowski, U.S. Coast Guard, Sector Delaware Bay, Waterways Management
Division, telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry No. 10 for a
barge-based fireworks display from 8:45 p.m. through 9:35 p.m. on May
27, 2023, or on a rain date of May 28, 2023. This action is necessary
to ensure safety of life on the navigable waters of the United States
immediately prior to, during, and immediately after a fireworks
display. Our regulation for safety zones of fireworks displays within
the Fifth Coast Guard District, table 1 to paragraph (h)(1) to 33 CFR
165.506, entry 10 specifies the location of the regulated area as all
waters of the Delaware River, adjacent to Penn's Landing, Philadelphia,
PA, within a 500-yard radius of the fireworks barge position. The
approximate position for the display is latitude 39[deg]56'52'' N,
longitude 075[deg]08'09'' W. During the enforcement period, as
reflected in Sec.  165.506(d), vessels may not enter, remain in, or
transit through the safety zone unless authorized by the Captain of the
Port or designated Coast Guard patrol personnel on-scene.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via Local Notice to Mariners and Broadcast Notice to Mariners.

    Dated: May 1, 2023.
Jonathan D. Theel,
Captain, U.S. Coast Guard Captain of the Port Delaware Bay.
[FR Doc. 2023-09593 Filed 5-4-23; 8:45 am]
BILLING CODE 9110-04-P