82 FR 2354 - Granting Petitions To Add n-Propyl Bromide to the List of Hazardous Air Pollutants

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 5 (January 9, 2017)

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.

[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2354-2362]
From the Federal Register Online  [www.thefederalregister.org]
[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.

[[Page 2355]]


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 protected].

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

[[Page 2356]]

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

[[Page 2357]]

``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.
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    \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.'').
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    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.
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    \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).
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    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

[[Page 2358]]

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

[[Page 2359]]

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

[[Page 2360]]

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

[[Page 2361]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    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

[[Page 2362]]

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