82_FR_7574 82 FR 7562 - Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act

82 FR 7562 - Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range7562-7580
FR Document2017-01224

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This proposed rule identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA is proposing that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High- Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required ``form and criteria'' applicable to such manufacturer requests.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7562-7580]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01224]



[[Page 7561]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part XVII





 Environmental Protection Agency





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40 CFR Part 702





 Procedures for Chemical Risk Evaluation Under the Amended Toxic 
Substances Control Act; Proposed Rule

Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules

[[Page 7562]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 702

[EPA-HQ-OPPT-2016-0654; FRL-9957-75]
RIN 2070-AK20


Procedures for Chemical Risk Evaluation Under the Amended Toxic 
Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: As required under section 6(b)(4) of the Toxic Substances 
Control Act (TSCA), EPA is proposing to establish a process for 
conducting risk evaluations to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment, 
without consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible 
subpopulation, under the conditions of use. Risk evaluation is the 
second step, after Prioritization, in a new process of existing 
chemical substance review and management established under recent 
amendments to TSCA. This proposed rule identifies the steps of a risk 
evaluation process including scope, hazard assessment, exposure 
assessment, risk characterization, and finally a risk determination. 
EPA is proposing that this process be used for the first ten chemical 
substances to be evaluated from the 2014 update of the TSCA Work Plan 
for Chemical Assessments, chemical substances designated as High-
Priority Substances during the prioritization process, and those 
chemical substances for which EPA has initiated a risk evaluation in 
response to manufacturer requests. The proposed rule also includes the 
required ``form and criteria'' applicable to such manufacturer 
requests.

DATES: Comments must be received on or before March 20, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0654, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Susanna W. Blair, Immediate 
Office, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (202) 564-4371; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    EPA is primarily proposing to establish requirements on the Agency. 
However this proposal also includes the process and requirements that 
manufacturers (including importers) would be required to follow when 
they request an Agency-conducted risk evaluation on a particular 
chemical substance. This action may, therefore, be of interest to 
entities that are manufacturing or importing, or may manufacture or 
import a chemical substance regulated under TSCA (e.g., entities 
identified under North American Industrial Classification System 
(NAICS) codes 325 and 324110). Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities and corresponding NAICS codes for entities that may be 
interested in or affected by this action.

B. What action is the agency taking?

    EPA is proposing to establish the process by which the Agency would 
conduct risk evaluations on chemical substances under TSCA. The 
proposal identifies the necessary components of a risk evaluation, 
including a scope (composed of a conceptual model and an analysis 
plan), a hazard assessment, an exposure assessment, a risk 
characterization, and a risk determination. The proposed rule would 
also establish the process by which manufacturers (including importers) 
would request an Agency-conducted risk evaluation, and the criteria by 
which the EPA would evaluate such requests.

C. What is the agency's authority for taking this action?

    EPA is proposing this rule pursuant to the authority in TSCA 
section 6(b)(4), as amended (15 U.S.C. 2605(b)). See also the 
discussion in Units II.A. and B.

D. What are the estimated incremental impacts of this action?

    Although this proposal focuses on the process and activities that 
apply to EPA, it also proposes the process and requirements that 
manufacturers (including importers) would be required to follow when 
they request an Agency-conducted risk evaluation on a particular 
chemical substance. Since these requirements qualify as an information 
collection under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., EPA has prepared an Information Collection Request (ICR) to 
estimate the potential burden and costs associated with the proposed 
requirements for submitting a request for an Agency-conducted risk 
evaluation on a particular chemical substance. The ICR, which is 
available in the docket, is discussed in Unit VI.B. and is briefly 
summarized here. (Ref. 1).
    The total estimated annual burden is 960.3 hours and $69,353, which 
is based on an estimated per request burden of 96.03 hours.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets.

[[Page 7563]]

II. Background

A. Recent Amendments to TSCA

    On June 22, 2016, the President signed into law the ``Frank R. 
Lautenberg Chemical Safety for the 21st Century Act,'' which imposed 
sweeping reforms to TSCA. The bill received broad bipartisan support in 
the U.S. House of Representatives and Senate, and its passage was 
heralded as the most significant update to an environmental law in over 
20 years. The amendments give EPA improved authority to take actions to 
protect people and the environment from the effects of dangerous 
chemical substances. Additional information on the new law is available 
on EPA's Web site at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.
    When TSCA was originally enacted in 1976, it established an EPA-
administered health and safety review process for new chemical 
substances prior to allowing their entry into the marketplace. However, 
tens of thousands of chemical substances in existence at that time were 
``grandfathered in'' with no requirement for EPA to ever evaluate their 
risks to health or the environment. The absence of a review requirement 
or deadlines for action, coupled with a burdensome statutory standard 
for taking risk management action on existing chemical substances, 
resulted in very few chemical substances ever being assessed for safety 
by EPA, and even fewer subject to restrictions to address identified 
risks.
    One of the key features of the new law is the requirement that EPA 
now systematically prioritize and assess existing chemicals, and manage 
identified risks. Through a combination of new authorities, a risk-
based safety standard, deadlines for action, and minimum throughput 
requirements, TSCA effectively creates a ``pipeline'' by which EPA will 
conduct existing chemicals review and management. This new pipeline--
from prioritization to risk evaluation to risk management (when 
warranted)--is intended to drive steady forward progress on the backlog 
of existing chemical substances left largely unaddressed by the 
original law. Risk evaluation is the second step of this process, after 
prioritization, which is being addressed in a separate rulemaking.

B. Statutory Requirements for Risk Evaluation

    TSCA section 6(b)(4) requires EPA to establish, by rule, a process 
to conduct risk evaluations. Specifically, EPA is directed to use this 
process to ``determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant to the risk evaluation by the Administrator 
under the conditions of use.'' (15 U.S.C. 2605(b)(4)(A)). TSCA sections 
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements 
applicable to this process, including provisions that direct which 
chemical substances must undergo evaluation, the development of 
criteria for manufacturer-requested evaluations, the minimum components 
of an Agency risk evaluation, and the timelines for public comment and 
ultimate completion of the risk evaluation.
    1. Chemical substances to undergo risk evaluation. TSCA section 
6(b) identifies the chemical substances that are subject to this 
process; these are: (1) Ten chemical substances the Agency is required 
to identify from the 2014 update to the TSCA Work Plan within the first 
180 calendar days after the signing of TSCA (15 U.S.C. 2605(b)(2)); (2) 
the chemical substances determined as High-Priority Substances through 
the prioritization process that is being proposed in a separate 
rulemaking; and (3) requested chemicals submitted by manufacturers that 
have met the criteria for EPA to conduct a risk evaluation as outlined 
by this rule. Assuming a sufficient number of requests that have met 
the criteria outlined in this proposed rule are received, subsection 
(E) specifies that the number of manufacturer-requested evaluations be 
25 to 50 percent of the number of ``High Priority'' risk evaluations 
ongoing at any one time. Since the number of manufacturer-requested 
evaluations is expressed as a percentage of the number of High-Priority 
Substance evaluations, not as a percentage of the total, the number of 
manufacturer-requested evaluations will likely comprise between 1/5 and 
1/3 of the number of total ongoing evaluations, assuming a sufficient 
number of compliant requests are received. Any manufacturer requested 
chemical substances on the 2014 update of the TSCA Work Plan (Ref. 2) 
are exempt from the percentage limitations.
    2. Manufacturer-requested risk evaluations. TSCA section 6(b)(4)(C) 
directs EPA to establish the ``form and manner'' and ``criteria'' that 
govern manufacturer requests that a substance that they manufacture 
undergo an EPA conducted risk evaluation. EPA has broad discretion to 
establish these criteria, but relatively less discretion over whether 
to grant requests that comply with EPA's criteria. EPA must grant any 
request that complies with EPA's criteria, until the statutory minimum 
of 25 percent has been met. Assuming EPA receives requests in excess of 
this threshold, EPA interprets this provision to grant EPA discretion 
to determine whether to grant further requests, up to the maximum 50 
percent level. In such circumstances, the EPA is directed to give 
preference to manufacturer requests for which the EPA determines that 
restrictions imposed by one or more states have the potential to 
significantly impact interstate commerce, or health or the environment. 
15 U.S.C. 2605(b)(4)(E)(iii). As discussed elsewhere in this preamble, 
EPA is also proposing to give preference to requests where EPA 
estimates there may be relatively high exposure(s) and/or hazard(s) 
under one or more conditions of use.
    3. Components of a risk evaluation. The statute identifies the 
minimum components EPA must include in all chemical substance risk 
evaluations. For each risk evaluation, EPA must publish a document that 
outlines the scope of the risk evaluation that will be conducted, and 
that includes the hazards, exposures, conditions of use, and the 
potentially exposed or susceptible subpopulations the EPA expects to 
consider. 15 U.S.C 2605(b)(4)(D). The statute provides that the scope 
of the risk evaluation must be published no later than six months after 
the initiation of the risk evaluation.
    Each risk evaluation must also: (1) ``integrate and assess 
available information on hazards and exposure for the conditions of use 
of the chemical substance, including information on specific risks of 
injury to health or the environment and information on potentially 
exposed or susceptible subpopulations;'' (2) ``describe whether 
aggregate or sentinel exposures were considered and the basis for that 
consideration;'' (3) ``take into account, where relevant, the likely 
duration, intensity, frequency, and number of exposures under the 
conditions of use;'' (4) ``describe the weight of scientific evidence 
for the identified hazards and exposure.'' 15 U.S.C. 
2605(b)(4)(F)(i),(iii)-(v). The risk evaluation must not consider costs 
or other non-risk factors. 15 U.S.C. 2605(b)(4)(F)(ii).
    Many stakeholders have expressed concern as to how EPA will apply 
``weight of scientific evidence'' under

[[Page 7564]]

the amended TSCA. EPA is providing, for the purposes of background, a 
description of how the Agency has consistently interpreted and applied 
that concept. EPA is not proposing to modify this process as part of 
this rule. Nor is EPA proposing to codify it; this process has and will 
continue to evolve with changing scientific methods and innovation. 
Codifying a specific definition can inhibit the flexibility of the 
Agency to quickly adopt and implement changing science.
    The phrase weight-of-evidence (WoE) is used by EPA and other 
scientific bodies to describe the strength of the scientific inferences 
that can be drawn from a given body of evidence, specifically referring 
to how studies are selected, the quality of the studies evaluated, and 
how findings are assessed and integrated. Weight-of-evidence is a 
complex issue and as stated by the National Academies this is ``because 
scientific evidence used in WOE evaluations varies greatly among 
chemicals and other hazardous agents in type, quantity, and quality, it 
is not possible to describe the WoE evaluation in other than relatively 
general terms. It is thus not unexpected that WoE judgements in 
particular cases can vary among experts and that consensus is sometimes 
difficult to achieve'' (NAS, 2009) (Ref. 3). The following is a brief 
description of how WoE is used at EPA, serving as an example of 
successful application of WOE in making the scientific determinations.
    EPA utilizes the WoE approach in existing programs including IRIS 
and the Endocrine Disruptor Screening Program among others, and in the 
classification of carcinogens. In the 1999 Guidelines for Carcinogen 
Risk Assessment (Ref. 4) EPA refers to the WoE approach as ``. . . a 
collective evaluation of all pertinent information so that the full 
impact of biological plausibility and coherence is adequately 
considered (Ref. 5). The Endocrine Disruptor Screening and Testing 
Advisory Committee (EDSTAC) referred to the WoE approach as ``. . . a 
process by which trained professionals judge the strengths and 
weaknesses of a collection of information to render an overall 
conclusion that may not be evident from consideration of the individual 
data'' (Ref. 6).
    WoE is the process for characterizing the extent to which the 
available data support a hypothesis that an agent causes a particular 
effect (Ref. 4 and 5). This process involves a number of steps starting 
with assembling the relevant data, evaluating that data for quality and 
relevance, followed by an integration of the different lines of 
evidence to support conclusions concerning a property of the substance. 
WoE is not a simple tallying of the number of positive and negative 
studies, but rather it relies on professional judgment. The significant 
issues, strengths, and limitations of the data and the uncertainties 
that deserve serious consideration are presented, and the major points 
of interpretation are highlighted.
    This WoE analysis is conducted on a case-by-case basis by first 
assembling and assessing the individual lines of evidence and then 
performing an integrated analysis of those lines of evidence. All data 
considered in the WoE analysis need to be documented and scientifically 
acceptable. A WoE analysis typically begins with a careful evaluation 
of each individual study. The process of evaluating the individual 
lines of evidence includes assembling the data, evaluating that data 
against current acceptance and quality criteria, and presenting the 
conclusions regarding the results for each study. The reviews of the 
available studies need to be transparent about what studies were 
considered or not, and how the quality of a study was judged.
    After assembling and assessing the individual lines of data, an 
integrated analysis is performed. This means the results from all 
scientifically relevant published or publically available peer-reviewed 
studies, which are of sufficient quality and reliability, are evaluated 
across studies and endpoints into an overall assessment. In general, 
the WoE analysis examines multiple lines of evidence considering a 
number of factors, including for example the nature of the effects 
within and across studies, including number, type, and severity/
magnitude of effects and strengths and limitations of the information.
    A summary WoE narrative or characterization generally accompanies 
the detailed analysis of the individual studies and the integrative 
analysis of the multiple lines of evidence. Inclusion of a WoE 
narrative is common in WoE assessments and judgments (Ref. 4 and 7). 
The narrative/characterization is intended to be transparent and allow 
the reader to clearly understand the reasoning behind the conclusions. 
The narrative will generally explain the selection of the studies or 
effects used as the main lines of evidence and relevant basis for 
conclusions. The overall strength of the evidence supporting a 
conclusion from the WoE evaluation needs to be described.
    The National Toxicology Program of the National Institute of 
Environmental Health Sciences has developed a tool called ``systematic 
review'' to assist in WoE evaluations particularly for hazard 
identification (https://ntp.niehs.nih.gov/pubhealth/hat/noms/index-2.html). This tool uses a defined set of processes to identify, select, 
critically assess, and synthesize evidence to arrive at a hazard 
conclusion for a chemical. It is designed to enhance transparency and 
informs scientific judgments. The evidence synthesis step involves 
considering factors that decrease confidence in the body of evidence 
for a particular health endpoint (e.g. risk of bias, inconsistencies 
across studies, imprecision) as well as factors that increase 
confidence (e.g. magnitude of the effect, residual confounding, 
consistency). By evaluating study design (e.g., consistent with study 
guidelines issued by OECD, and test guidelines issued by the Office of 
Chemical Safety and Pollution Prevention), and study quality (e.g., 
studies that comply with Good Laboratory Practices (GLP) like those 
applicable generally (https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies) and those issued by EPA for studies submitted under TSCA and 
FIFRA (https://www.epa.gov/compliance/good-laboratory-practices-standards-compliance-monitoring-program)), and integrating negative 
data (and consideration of the quality of those data), the confidence 
in hazard conclusions can be increased.
    The NIEHS systematic review tool is one example of a documented 
systematic review approach. EPA believes the proposed risk evaluation 
process generally reflects the use of systematic review approaches that 
are appropriate for the types and quantity of information used in a 
chemical risk evaluation. EPA requests comment on this view. EPA is 
also requesting comment on the need for regulatory text requiring the 
use of specific elements of a systematic review approach for hazard 
identification, including the appropriateness of specific elements that 
might be included and/or concerns about codifying such an approach.
    4. Timeframe. TSCA requires that the risk evaluation process last 
no longer than three years with a possible six-month extension. 15 
U.S.C. 2605(b)(4)(G).
    5. Opportunities for public participation. The statute requires 
that the Agency allow for at least one 30 day public comment period on 
the draft risk evaluation, prior to publishing a final risk evaluation. 
15 U.S.C. 2605(b)(4)(H).
    6. Metals and metal compounds. When evaluating metals or metal 
compounds, EPA must ``use'' the March

[[Page 7565]]

2007 Framework for Metals Risk Assessment of the Office of the Science 
Advisor (Ref. 8) or a successor document that addresses metals risk 
assessment and is peer-reviewed by the Science Advisory Board.
    7. Other statutory requirements. TSCA imposes new requirements on 
EPA in a number of different areas that EPA is not proposing to 
incorporate or otherwise address in this proposed rule. For example, 
amendments to TSCA section 4 require EPA to ``. . . reduce and replace, 
to the extent practicable, [. . .] the use of vertebrate animals in the 
testing of chemical substances . . .'' and to develop a strategic plan 
to promote such alternative test methods. 15 U.S.C. 2603(h). Likewise, 
TSCA section 26 requires, to the extent that EPA makes a decision based 
on science under TSCA sections 4, 5, or 6, that EPA uses certain 
scientific standards and bases those decisions on the weight of the 
scientific evidence. 15 U.S.C. 2625(h) and (i). While these 
requirements are relevant to the risk evaluation of chemical 
substances, EPA is not obliged to repeat them in this proposed rule. As 
statutory requirements, they apply to EPA's decisions under TSCA 
section 6. Moreover, in contrast to TSCA section 6, Congress has not 
directed EPA to implement these other requirements ``by rule;'' it is 
well-established that where Congress has declined to require 
rulemaking, the implementing agency has complete discretion to 
determine the appropriate method by which to implement those 
provisions.

C. EPA Risk Assessment

    Since EPA's inception, human health and ecological risk assessment 
has informed decisions made to protect humans and the environment. Risk 
assessments performed by the Agency inform a broad range of regulatory 
decisions, and, over time, the scientific approaches and methods 
employed for these risk assessments have evolved. In developing and 
refining risk assessment processes, frameworks, and guidance documents, 
EPA has incorporated recommendations from expert technical panels, 
internal and external peer reviews, and a number of influential reports 
from the National Academy of Sciences (NAS) National Research Council 
(NRC) including Risk Assessment in the Federal Government (1983) (Ref. 
9), Science and Judgement in Risk Assessment. (1994) (Ref. 10), 
Understanding Risk: Informing Decisions in a Democratic Society (1996) 
(Ref. 11), Toxicity Testing in the 21st Century: A Vision and a 
Strategy (2007) (Ref. 12), Phthalates and Cumulative Risk Assessment: 
The Tasks Ahead (2008) (Ref. 8), and Science and Decisions: Advancing 
Risk Assessment (2009) (Ref. 3). Specifically, the NAS NRC Science and 
Decisions Report (Ref. 3) recommended that EPA focus on the important 
roles of scoping or problem formulation so that a risk assessment will 
serve a specific and documented purpose. An additional recommendation 
encouraged EPA to develop risk assessments that are well-tailored to 
the problems and decisions at hand so that they can inform the 
decision-making process in the most meaningful way. EPA has evaluated, 
and will continue to evaluate chemical risks in a manner that is best 
suited for the particular chemical substance, including its 
manufacture, processing, formulation, uses, and disposal, and the 
evaluations may vary as necessary to best characterize potential risks 
related to the chemical substance under review.
    As stated, TSCA requires EPA to evaluate risk to relevant 
potentially exposed or susceptible subpopulations identified by EPA as 
relevant to the risk evaluation under the conditions of use. 15 U.S.C. 
2605(b)(4)(A). Although this was added as a component of the newly 
amended law, this will not be a new consideration for the Agency; for 
example, see EPA's Policy on Evaluating Health Risks to Children (1995) 
(Ref. 14). The Agency has evaluated the risk of chemical substances to 
all sectors of the population, with particular attention to workers, 
indigenous peoples, pregnant women, children, infants, the elderly, 
environmental justice communities, and fence-line communities, among 
others. The Agency utilizes a number of existing guidance documents 
(including but not limited to Ref. 15, 16, 17, 18, and 19) to evaluate 
risk at various life stages, and will use and refine these processes to 
protect the most vulnerable.
    1. Differences between previous EPA risk assessments under TSCA and 
proposed new risk evaluations. In this proposed rule, EPA does not 
propose a new method of risk evaluation, but builds upon existing and 
proven methodologies for evaluating risk. Also as required by the 
statute, the rule includes opportunities for public participation, 
statutory deadlines, necessary components of a risk evaluation, and 
methods for manufacturer requested risk evaluation. Above and beyond 
the statute, the proposed rule provides an additional opportunity for 
public participation, added detail as to components of the scope, 
hazard and exposure assessments, risk characterization, and increases 
transparency in the risk evaluation process. EPA requests comment on 
whether and how the proposed rule could provide additional 
transparency, public accountability, opportunities for public 
participation, or incorporation of statutory deadlines.
    There are several key differences between previous chemical risk 
assessments conducted under TSCA and the new risk evaluation process 
mandated by TSCA amendments and established under these proposed 
regulations. These differences include considerations of conditions of 
use, timelines, and determination of unreasonable risk, and are 
discussed in more detail under those topics in this unit. This proposed 
rule and procedures described herein apply to risk evaluations 
conducted under TSCA, and do not apply to risk evaluations conducted by 
EPA pursuant to other statutes or programs.
    2. Conditions of use. Prior to the amended TSCA, EPA was free to 
and did conduct risk assessments on selected uses of chemical 
substances. In contrast, EPA interprets the amended TSCA as requiring 
that risk evaluations encompass all manufacture, processing, 
distribution in commerce, use, and disposal activities that constitute 
the conditions of use within the meaning of TSCA section 3. That is to 
say, a risk evaluation must encompass all known, intended, and 
reasonably foreseen activities associated with the subject chemical 
substance. This issue has been the subject of considerable discussion 
since the enactment of the new law, and EPA acknowledges that different 
readings of the law may be possible. For example, TSCA section 
6(b)(4)(D) requires EPA to identify the conditions of use that the 
Agency expects to consider in a risk evaluation, suggesting that EPA 
does not need to consider all conditions of use.
    Overall, the statutory text and purpose are best effectuated 
through a more encompassing reading. TSCA section 6(b)(4)(A) specifies 
that a risk evaluation must determine whether ``a chemical substance'' 
presents an unreasonable risk of injury to health or the environment 
``under the conditions of use.'' The evaluation is on the chemical 
substance--not individual conditions of use--and it must be based on 
``the conditions of use.'' In this context, EPA believes the word 
``the'' is best interpreted as calling for evaluation that considers 
all conditions of use. First, if EPA were free to base its 
determination of whether a chemical substance, as a whole, presents an 
unreasonable risk or injury (as the statute requires) on merely a 
subset of individual uses, it could, for example,

[[Page 7566]]

determine that a chemical substance with 10 known uses does not present 
an unreasonable risk of injury based on an evaluation of a single one 
of those uses, with no further obligation to evaluate the remaining 
uses within the three-year statutory deadline. This is a strained 
reading of the commands to determine whether the chemical substance 
presents an unreasonable risk, under the conditions of use, and to 
complete that evaluation ``for a chemical substance'' within three 
years of initiation. See 15 U.S.C (b)(4)(G)(i).
    Second, a major objective of the new law is to require EPA to 
systematically evaluate existing chemical substances to determine 
whether or not they present unreasonable risk, and, if necessary, 
regulate them based on the results of the evaluation. Given the large 
number of existing chemical substances, it would not be feasible to 
complete risk evaluations on any significant number of them if EPA were 
to continually need to re-evaluate chemical substances based on 
different subset of uses. Rather the law's purposes will be best 
fulfilled by judging in a comprehensive way whether a chemical 
substance, under the known, intended, and reasonably foreseen uses and 
other activities, presents an unreasonable risk; ensuring through 
regulation that it does not present an unreasonable risk, if necessary; 
and then presumptively being done with that chemical substance (pending 
re-prioritization for some unforeseen reason). Finally, EPA notes that, 
if the law is read as allowing EPA to select particular conditions of 
use, it provides no criteria for EPA to apply in making such a 
selection.
    Given these considerations, the instruction in TSCA section 
6(b)(4)(D) for the Agency to identify the conditions of use it expects 
to consider in a risk evaluation is best read as directing the Agency 
to identify the uses and other activities that it has determined 
constitute the conditions of use, not as a license to choose among 
conditions of use.
    Concerns have been raised about EPA's ability to meet the statutory 
risk evaluation deadlines if all conditions of use must be considered. 
Concerns have also been raised about ensuring that EPA can act promptly 
to address any unreasonable risks identified for particular conditions 
of use. EPA acknowledges that this will be challenging but based on the 
procedures outlined in this proposal, expects it will be manageable. 
First, a use or other activity constitutes a condition of use under the 
definition only if EPA determines that it does. EPA has authority to 
exercise judgment in making its determination of whether a condition of 
use is known, intended, or reasonably foreseen. Moreover, in this 
proposed rule EPA proposes to ``lock down'' the conditions of use 
included in a risk evaluation at the time of scoping, by providing 
opportunity for comment on the scoping document and specifying that any 
objections to the draft scope document are waived if not raised during 
this process. It will not be practicable to meet the statutory 
deadlines if stakeholders are free to identify additional conditions of 
use later in the process--for example, on the proposed risk 
determination.
    As explained elsewhere in this preamble, EPA also generally intends 
to initiate risk evaluation on a chemical substance only when EPA 
determines that sufficient reasonably available information exists to 
complete the evaluation, and when it has already identified all of the 
conditions of use. As also explained elsewhere in this preamble, under 
certain circumstances EPA may expedite an evaluation for a particular 
condition of use to move more rapidly to risk management under TSCA 
section 6(a).
    Finally, the proposed rule provides that EPA will rely on a 
combination of information, accepted science policies (e.g., defaults 
and uncertainty factors), models and screening methodologies in 
conducting risk evaluations, with considerations of evolving science 
and technology. It further provides that the balance of information, 
science policy decisions, models, and screening methodologies used in 
risk evaluation will be informed by the deadlines specified in TSCA 
section 6(b)(4)(G) for completing such evaluations, and by the extent 
to which the generation of additional information is warranted by the 
reduction in uncertainty that the information would afford in 
determining whether a chemical substance presents an unreasonable risk 
of injury to health or the environment.
    In this regard, EPA is also proposing to require that the 
components of its risk evaluations will be ``fit for purpose.'' All 
conditions of use will not warrant the same level of evaluation, and 
EPA expects it may be able to reach conclusions without extensive or 
quantitative evaluations of risk. For example, lower-volume or less 
dispersive uses might receive less quantitative, data-driven 
evaluations than uses with more extensive or complicated exposure 
patterns. Consistent with EPA's current practice in conducting risk 
assessments, technically sound risk determinations can be made, 
consistent with the best available science, through a combination of 
different types of information and other approaches.
    In sum, Congress intended to create obligations that EPA can 
actually meet, and EPA intends to conduct risk evaluations in a way 
that is manageable given the statutory deadlines.
    3. Timelines and guidance regarding assessing risks of existing 
chemical substances. Prior to the amended TSCA, EPA was not required to 
evaluate or manage the risk of the thousands of existing chemical 
substances grandfathered in under the 1976 Act. As discussed 
previously, the amended TSCA affirmatively requires EPA to evaluate 
existing chemical substances more quickly, instructs EPA on how many of 
these chemical substances the Agency must evaluate at any given time, 
and places time limits on when these evaluations must be completed. 15 
U.S.C. 2605(b)(2)-(4).
    4. Determination of unreasonable risk. Under TSCA section 6(b) (15 
U.S.C. 2605(b)(4)(B)), EPA must establish a risk evaluation process to 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment. Prior to the passage of the 
amended TSCA, chemical substance risk assessments did not include a 
determination of unreasonable risk. This step was reserved for risk 
management rulemaking. The amended statute now requires that a risk 
evaluation include a risk assessment as well as the EPA's determination 
of unreasonable risk, and, most significantly, requires that this 
determination be independent of cost or other non-risk factors. 15 
U.S.C. 2506(b)(4)(A) and (F)(iii).
    In general, EPA may weigh a variety of factors in determining 
unreasonable risk. These factors include, but are not limited to, 
characterization of cancer and non-cancer risks (including margins of 
exposure for non-cancer risks), the population exposed (including any 
susceptible populations), the severity of hazard (the nature of the 
hazard), the irreversibility of hazard, uncertainties, and estimates of 
cumulative exposure. Because of the case-by-case nature of each of 
these factors EPA has purposely not proposed a definition of 
unreasonable risk in this rule. However, EPA is specifically requesting 
comments on whether EPA should define unreasonable risk in the final 
rule. If so, acknowledging that the statute precludes consideration of 
costs and other non-risk factors at this step, what factors should EPA 
consider in making such a determination?
    5. Manufacturer-requested evaluations and draft risk evaluations by 
interested persons. The newly

[[Page 7567]]

amended TSCA requires that a portion of ongoing risk evaluations be 
conducted on chemical substances requested by manufacturers ``in a form 
and manner and using criteria'' EPA prescribes by rule. 15 U.S.C. 
2605(b)(4)(C)(ii),(E)(i). The statute also requires EPA to develop 
guidance (which will be forthcoming) to assist interested persons in 
submitting draft risk evaluations, and requires EPA to consider such 
submitted drafts. 15 U.S.C. 2625(l)(5).

D. Stakeholder Feedback

    On August 9, 2016, EPA held a one-day public meeting to obtain 
public comment and feedback regarding the development and 
implementation of the risk evaluation rule. The meeting began with an 
explanation of how the Agency currently conducts risk assessments (see 
https://www.epa.gov/sites/production/files/2016-08/documents/risk_evaluation_9_august_2016.pdf). The remainder of the day was 
reserved for public comment. Each commenter was provided four minutes 
to comment and there was a total of 47 oral comments on the risk 
evaluation rule. Additionally, EPA opened a docket for submission of 
written comments and received 57 comments, many of which were from the 
same commenters at the public meeting. These comments, and a transcript 
of the meeting are accessible in the meeting's docket, identified by 
Docket ID No. EPA-HQ-OPPT-2016-0399, which is available online at 
https://www.regulations.gov/.
    The commenters included industry, environmental groups, academics, 
private citizens, trade associations, and health care interest groups 
and representatives. The comments were very informative for both rule 
development and risk evaluation implementation. While not all of the 
comments are captured here, there were a number of themes that emerged. 
Overall, there was a general expression of support for the new law and 
EPA's inclusive approach to implementation. Many of the commenters 
agreed the rule has the potential to increase transparency in EPA's 
chemical substance risk evaluation process. Many urged the Agency to 
work towards this goal, while creating an open scientific dialogue.
    Questions arose about how the Agency will determine ``unreasonable 
risk'' and implement TSCA section 26 requirements including ``best 
available science'' and ``weight of scientific evidence.'' Some 
suggested that EPA should codify in this rule the meaning of these 
terms along with other details of the risk evaluation process. Due to 
changes in the law, manufacturers are now able to submit their own 
draft risk evaluations. Commenters noted that if these submitted 
evaluations are to be equivalent as Agency draft risk evaluations, 
having specific criteria, such as specific types of exposure and hazard 
information would ensure the Agency and the manufacturers were held to 
the same standard. Stakeholders also suggested that holding a public 
comment period for the draft risk evaluation scope would increase the 
transparency of each risk evaluation early in the process and allow the 
public to comment on any data gaps or discrepancies.
    Other stakeholders urged the Agency to reserve specific scientific 
processes regarding hazard and exposure information for Agency guidance 
and discretion, suggesting the rule should address only the process and 
procedure. This approach would allow the Agency to be flexible and 
adapt to the changing science of risk evaluation and the science that 
informs risk evaluation.
    A number of commenters spoke about the statute's requirement that 
the Agency determine the specific risk to ``potentially exposed or 
susceptible subpopulation[s]''. Although the law defines this term to 
include ``infants, children, pregnant women, workers, or the elderly,'' 
many encouraged the Agency to consider expanding the definition to 
include for example: environmental justice communities, Arctic 
communities, American Indian communities, communities with little 
access to preventative health-care, subsistence fishers, and fence-line 
communities. There were a number of stakeholders who encouraged the 
Agency to work with the Occupational Safety & Health Administration 
(OSHA), the National Institute for Occupational Safety and Health 
(NIOSH), and the Consumer Product Safety Commission (CPSC), among other 
federal agencies, to better protect against occupational and consumer 
exposures. Also regarding exposure, stakeholders encouraged the 
examination of cumulative and low dose exposures in risk evaluations, 
which are not specifically mentioned in the new statute.
    A number of commenters emphasized the need for EPA to maximize 
transparency throughout the evaluation process. The EPA received a 
number of comments about the science used to inform individual risk 
evaluations, including the types of data, models, policy assumptions 
(e.g., default factors) and computational approaches. A number of 
commenters argued that a lack of data does not equate to a lack of 
risk. Stakeholders encouraged the Agency to engage with industry to 
obtain hazard and exposure data and to utilize the new order authority 
allowed under the law (TSCA section 4). Commenters suggested an 
increased use of EPA's Office of Research and Development (ORD) and 
internationally accepted data, models, and products. A number of 
stakeholders expressed their support for the new provision in the law 
that requires the Agency to reduce and replace vertebrate testing (TSCA 
section 4(h)) in obtaining chemical substance hazard and exposure data.
    EPA considered all of these comments in the development of this 
proposed rule, and welcomes additional feedback from stakeholders on 
the proposed process and requirements presented in this document.

III. The Proposed Rule

A. Policy Objectives

    The risk evaluation process under TSCA is ultimately how EPA will 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment. The overall objective of this 
action is to propose to codify the process by which the Agency 
evaluates risk from chemical substances for purposes of TSCA section 6. 
In this proposed rule, the Agency details those components of TSCA risk 
evaluation and key factors that EPA deems are necessary to consider in 
each risk evaluation to ensure that the public has a full understanding 
of how risk evaluations will be conducted. However, EPA is not 
proposing to establish highly detailed provisions that will address 
every eventuality or possible consideration that might arise. Due to 
the rapid advancement of the science of risk evaluation and the science 
and technology that inform risk evaluation, this proposed rule seeks to 
balance the need for the risk evaluation procedures to be transparent, 
without unduly restricting the specific science that will be used to 
conduct the evaluations, allowing the Agency flexibility to adapt and 
keep current with changing science as it conducts TSCA evaluations into 
the future.

B. Interagency Collaboration

    EPA recognizes that other Federal agencies may be able to provide 
important use, exposure and hazard information that is likely to be 
relevant to a risk evaluation of chemical substances. EPA is committed 
to interagency engagement and dialogue throughout its risk evaluation 
process, including data sharing, information requests, and consultation 
regarding specific chemicals of interest. As such,

[[Page 7568]]

EPA has reached out to other agencies, inviting them to join the agency 
in an open and collaborative dialogue. EPA intends to continue and 
expand its interagency collaboration efforts for chemicals management 
and risk evaluations under TSCA.
    To coordinate with other agencies on TSCA implementation generally, 
EPA intends to continue to use--and expand where appropriate--existing 
interagency groups, such as the OMNE (OSHA-MSHA-NIOSH-NIEHS-EPA) 
Committee and the National Science and Technology Council (NSTC)'s 
Committee on Environment, Natural Resources, and Sustainability's new 
Toxicity Assessment Committee. EPA is also committed to interagency 
engagement at the working level on individual chemical evaluations.
    To ensure that such collaboration can occur in a timely manner when 
needed, EPA intends to initiate interagency consultation through the 
existing mechanisms early in the process, and document these measures 
in the scope document. However, EPA is concerned that imposing a 
single, pre-determined consultation step might lead to an overly 
bureaucratic process that could limit or complicate ongoing 
collaboration efforts, and so is not proposing to codify any particular 
process in this regulation.

C. Scope of Evaluations

    TSCA requires risk evaluations to determine whether or not a 
chemical substance presents an unreasonable risk of injury to health or 
the environment under the conditions of use, with conditions of use 
being defined as ``the circumstances, as determined by the EPA, under 
which a chemical substance is intended, known, or reasonably foreseen 
to be manufactured, processed, distributed in commerce, used, or 
disposed of.'' 15 U.S.C. 2602(4).
    Although some of the commenters during the public meeting suggested 
that EPA could evaluate a specific use of a chemical substance, EPA is 
not choosing to adopt such an interpretation, for the reasons explained 
previously. Also, EPA recognizes that under certain circumstances it 
may be necessary to expedite an evaluation for a particular condition 
of use to move more rapidly to risk management under TSCA section 6(a) 
(15 U.S.C. 2605(a)): this could include a situation in which a single 
use presented an unreasonable risk of injury for the population as a 
whole or for a susceptible subpopulation (e.g., one use results in 
risks that EPA would determine unreasonable regardless of the risk 
posed by other uses). However, in any case where EPA would find it 
necessary to pursue a risk evaluation in phases, the Agency will still 
complete the full risk evaluation on all identified conditions of use 
within the statutory 3-year deadline. Therefore, relying on this 
discretion, EPA is proposing to explicitly recognize its authority to 
complete risk evaluations in phases, and to manage unreasonable risks 
as they are identified through those phases under TSCA section 6(a) in 
the regulation.

D. Definitions

    TSCA defines a number of key terms necessary for interpretation of 
the new law. The definitions within the law apply to this proposed 
rule. EPA has also included some additional definitions in the proposed 
rule for further clarification; these are noted and defined later in 
this document. The law requires EPA to evaluate risk to ``potentially 
exposed or susceptible subpopulation[s],'' and although the law 
elaborates on this phrase, EPA is proposing to expand the definition 
for TSCA purposes. TSCA states that ``the term `potentially exposed or 
susceptible subpopulation' means a group of individuals within the 
general population identified by the EPA who, due to either greater 
susceptibility or greater exposure, may be at greater risk than the 
general population of adverse health effects from exposure to a 
chemical substance or mixture, such as infants, children, pregnant 
women, workers, or the elderly.'' 15 U.S.C. 2602(12). EPA is proposing 
to incorporate the phrase ``including but not limited to'' before the 
specific subpopulations identified in the statutory definition, to 
further clarify that EPA may identify additional subpopulations, where 
warranted. As suggested by the statute, EPA is also proposing to 
include specific authorization for EPA to consider both intrinsic 
(e.g., life stage, reproductive status, age, gender, genetic traits) 
and acquired (e.g., pre-existing disease, geography, socioeconomic, 
cultural, workplace) factors when identifying this population.
    TSCA section 26(k) (15 U.S.C. 2625(k)) states that in carrying out 
risk evaluations, EPA shall consider information that is ``reasonably 
available,'' but the statute does not further define this phrase. EPA 
is proposing a definition for ``reasonably available'' to mean existing 
information that EPA possesses, or can reasonably obtain and synthesize 
for use in risk evaluations, considering the deadlines for completing 
the evaluation. Generally speaking, EPA does not consider information 
that has not yet been generated, as reasonably available, because it 
will typically not be feasible for EPA to require significant chemical 
testing and receive and assess those test results during the three to 
three and a half year window allotted for risk evaluation. Accordingly, 
EPA intends to generally ensure that sufficient information to complete 
a risk evaluation exists and is available to the Agency prior to 
initiating the evaluation (indeed, prior to initiating prioritization). 
EPA also generally intends to use its authority under TSCA to require 
the development of new information, as necessary, prior to risk 
prioritization.
    TSCA requires EPA, as a part of the risk evaluation, to document 
whether the Agency has considered aggregate or sentinel exposure, and 
the basis for that decision. 15 U.S.C. 2605(b)(4)(F)(ii). These terms 
are not defined in the law, so EPA has proposed a definition for 
aggregate exposure that is consistent with current Agency policies and 
practices. ``Aggregate exposure'' means the combined exposures to an 
individual from a single chemical substance across multiple routes and 
across multiple pathways (Ref. 20). ``Sentinel'' means the exposure(s) 
of greatest significance, which may be the maximum exposure to an 
individual, population (or subpopulation), or the environment to the 
chemical substance of interest (or any combination thereof). Although 
sentinel exposure is not a novel way of characterizing exposure, this 
is a new term for EPA.
    Other terms defined in the proposed rule are designed to provide 
clarity regarding the science that will be used to conduct an 
evaluation. ``Pathways'' of exposure refers to the mode through which 
one is exposed to a chemical substance, including but not limited to: 
food, water, soil, and air (Ref. 20). ``Routes'' of exposure refer to 
the particular manner which a chemical substance may contact the body, 
including absorption via ingestion, inhalation, or dermally (Ref. 20). 
The statute requires EPA to consider ``the extent to which the 
variability and uncertainty . . . are evaluated and characterized.'' 15 
U.S.C. 2625(h). EPA is adopting definitions for both ``variability'' 
and ``uncertainty'' from existing Agency guidance. ``Uncertainty'' 
means the imperfect knowledge or lack of precise knowledge either for 
specific values of interest or in the description of a system (Ref. 
21). ``Variability'' means the inherent natural variation, diversity, 
and heterogeneity across time and/or space or among individuals within 
a population (Ref. 21).

[[Page 7569]]

E. Timing of Risk Evaluations

    As indicated, the statute requires EPA to complete risk evaluations 
within three years, with the possibility of a six month extension 
beyond the three year timeframe. This proposed rule simply adopts these 
timeframes without modification or elaboration. EPA acknowledges this 
is a relatively short timeframe, and, as discussed elsewhere in this 
preamble, is proposing to adopt other procedures that will allow the 
Agency to meet these deadlines.

F. Chemical Substances for Risk Evaluation

    As identified previously, chemical substances that will undergo 
risk evaluation can be put into three groups: (1) The first ten 
chemical substances the Agency is required to identify within the first 
180 calendar days of enacting the amendments to TSCA (15 U.S.C. 
2605(b)(2)); (2) the chemical substances determined as High-Priority 
Substances through the prioritization process proposed in a separate 
rulemaking; and (3) requested chemical substances submitted by 
manufacturers that meet the criteria for EPA to conduct an Agency risk 
evaluation.

G. Process for Manufacturer Requested Risk Evaluations

    TSCA allows a manufacturer or group of manufacturers to submit 
requests for Agency conducted risk evaluations for chemical substances 
that they manufacture. EPA is proposing the necessary components of the 
request in the proposed regulatory text. EPA is proposing to require 
that manufacturers demonstrate in their request that there is 
sufficient, reasonably available information for the Agency to conduct 
a risk evaluation on the chemical substance under the conditions of 
use. EPA must complete any manufacturer-requested risk evaluation that 
it determines meets the criteria within the statutory three years. 
Unlike those chemical substances that have come through the 
prioritization process, manufacturer-requested chemical substances have 
not undergone initial risk screening and therefore EPA will not assign 
such chemicals a high- or low-priority designation. The purpose of the 
requirements proposed as the necessary components of the request, is to 
allow the Agency to determine whether sufficient information is 
``reasonably available'' for EPA to complete a risk evaluation of the 
requested chemical under the conditions of use, as that term is defined 
under TSCA section 3.
    EPA is proposing to require a manufacturer to submit a list (e.g., 
citations) of the reasonably available information on hazard and 
exposure for all the conditions of use. EPA is not requesting 
manufacturers submit copies of the cited information. Manufacturers 
must include a commitment to provide EPA any referenced data if they 
are not publicly available, and must certify that the information 
submitted is accurate and complete. EPA will not accept a manufacturer 
request where any of the relevant data is not in the possession of the 
requestor but is with another entity.
    Consistent with TSCA section 6(b)(4)(E)(iii), EPA will prioritize 
requests where there is evidence that restrictions imposed by one or 
more States have the potential to have a significant impact on 
interstate commerce or health or the environment, and is therefore 
proposing to allow (but not require) manufacturers to include any 
evidence to support such a finding. Following this required initial 
prioritization, EPA is proposing to further prioritize chemical 
substances for risk evaluation based on initial estimates of 
exposure(s) and/or hazard(s) under one or more conditions of use or any 
other factor that EPA determines may be relevant. In general, EPA plans 
to prioritize those chemical substances where there is evidence of 
relatively high risk over those with less evidence of risk.
    Instructions for submitting CBI are also included in the proposed 
rule. EPA believes that TSCA section 14(c)(3) is best read as requiring 
upfront substantiation of non-exempt CBI claims. In addition, EPA 
believes the obligation to review all non-exempt chemical 
identification claims and 25 percent of all other non-exempt claims 
will be best effectuated by requiring substantiation at the time of 
submission.
    Chemical substances that EPA has prioritized through the 
prioritization process (proposed in a separate rulemaking), are subject 
to two separate public comment periods prior to the completion of the 
prioritization process. EPA expects that these comment periods will 
ensure that EPA has the necessary information to evaluate the chemical 
substances, including information on all conditions of use. 
Consequently, in order to ensure that chemical substances subject to 
manufacturer requests undergo risk evaluation only if the available 
information is comparable to what EPA will identify or generate through 
the measures identified in the proposed prioritization framework rule, 
EPA is proposing opportunities to collect additional information from 
the public.
    Upon receipt of the request, EPA is proposing to verify that the 
request is facially valid, i.e., that information has been submitted 
that is consistent with the regulatory requirements. EPA is proposing 
that within 30 business days of a receiving a facially valid request, 
EPA will submit for publication an announcement of the receipt of the 
request in the Federal Register, open a docket for the request, and 
provide no less than a 30 calendar day comment period, to allow the 
public to identify and/or submit any reasonably available information 
regarding hazard, exposure, potentially exposed population(s) and 
subpopulation(s), and conditions of use that may help inform a risk 
evaluation, including identifying information gaps. The requesting 
manufacturer may also submit any additional material during this time.
    Within 9 months after the end of the comment period, EPA will 
review the request along with any additional information received 
during the comment period to determine whether the request meets the 
regulatory criteria and will notify the manufacturer(s) accordingly. 
This time will allow EPA to develop the equivalent of a conceptual 
model to describe actual or predicted relationships between the 
chemical substance and the receptors, either human or environmental, 
with consideration of potential hazards throughout the life cycle of 
the chemical substance--from manufacturing, processing, distribution in 
commerce, storage, use, or disposal. If EPA determines that the request 
is compliant (i.e., it has the required information necessary for 
conducting a risk evaluation), EPA will begin the risk evaluation 
process consistent with TSCA section 6(b)(4)(E)(i). If the request is 
found insufficient EPA will identify the information that would be 
necessary to conduct the risk evaluation in its notification to the 
manufacturer. The manufacturer will have 60 calendar days from receipt 
of EPA's determination to submit the additional information. EPA will 
consider the request withdrawn if the manufacturer(s) fails to submit 
the additional information identified. The process for conducting the 
risk evaluation will otherwise be identical to the process for those 
chemical substance identified as a High-Priority Substance through the 
Prioritization Process, which is addressed in a separate proposed rule.

H. Risk Evaluation General Provisions

    1. Agency guidance. EPA has a number of existing guidance documents 
that inform Agency risk assessment.

[[Page 7570]]

EPA has been using risk assessments to characterize the nature and 
magnitude of health risks to humans and ecological receptors from 
chemical contaminants and other stressors that may be present in the 
environment since its inception. Over the years, EPA has worked with 
the scientific community and other stakeholders to develop a variety of 
guidance, guidelines, methods and models for use in conducting 
different kinds of assessments. A compendium of existing Agency 
guidance related to risk assessments is maintained at https://www.epa.gov/risk/risk-assessment-guidelines. A compendium of guidance, 
databases and models used for assessing pesticide risks is available at 
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks, 
and information about available predictive models and tools for 
assessing chemicals under TSCA can be found at https://www.epa.gov/tsca-screening-tools. Each of these Web sites identify and link to a 
number of written guidance documents, tools and models. Rather than 
starting anew, EPA intends to take advantage of existing guidance, 
tools and models that are relevant and available for use in conducting 
a risk evaluation under this program.
    Since the law requires the development of additional ``policies, 
procedures, and guidance the Administrator determines are necessary'' 
to carry out the process in TSCA (15 U.S.C. 2625(l)). EPA may also 
develop additional guidance(s) for risk evaluation in the future.
    2. Categories of chemical substances. TSCA provides EPA with 
authority to take action on categories of chemical substances: groups 
of chemical substances which are, for example, similar in molecular 
structure, in physical, chemical, or biological properties, in use, or 
in mode of entrance into the human body or into the environment. 
Although the proposed rule most often references ``chemical 
substances,'' EPA is also proposing to include a clear statement in the 
regulation that nothing in the proposed rule shall be construed as a 
limitation on EPA's authority to take action with respect to categories 
of chemical substances, and that, where appropriate, EPA can prioritize 
and evaluate categories of chemical substances.
    3. Information and information sources. As discussed, the timeframe 
for completing risk evaluation is compressed. For those chemical 
substances chosen by EPA to undergo the risk evaluation process, EPA 
expects to only initiate the process when EPA has determined that most 
of the information necessary to complete the evaluation is reasonably 
available, which in most cases means the information already exists. As 
appropriate, however, EPA will exercise its TSCA information 
collection, testing, and subpoena authorities, including those under 
TSCA sections 4, 8, and 11(c) to develop the information needed for a 
risk evaluation. Pursuant to TSCA section 8(e), the law requires that 
any person who manufacturers, processes, or distributes in commerce a 
chemical substance or mixture and who obtains information which 
supports the conclusion that this substance presents a substantial risk 
of injury to health or the environment, shall immediately inform the 
Agency.
    To conduct a risk evaluation, EPA will rely on a combination of 
information, models, screening methods, and accepted science policies, 
which include defaults, reasonable estimates, and uncertainty factors, 
in addition to considering information generated from evolving science 
and technology. EPA expects to obtain scientific advice from the 
Science Advisory Committee on Chemicals, which the Agency is required 
to develop and convene under TSCA section 26(o). In compliance with the 
statute, EPA will work to reduce and replace, to the extent 
practicable, the use of vertebrate animals in testing chemical 
substances as outlined in TSCA section 4(h).

I. Risk Evaluation Steps

    1. Scope. The first step of a risk evaluation is the development of 
the scope. In compliance with the statute, the scope will identify the 
conditions of use, hazards, exposures, and any potentially exposed or 
susceptible subpopulations that the EPA expects to consider. EPA is 
also proposing to include additional information in the scoping 
document, including any models, screening methods, and any accepted 
science policies expected to be used during the risk evaluation. EPA is 
further proposing to include a conceptual model that will describe the 
actual or predicted relationships between the chemical substance and 
the receptors, either human or environmental, with consideration of 
potential hazards throughout the life cycle of the chemical substance--
from manufacturing, processing, distribution in commerce, storage, use, 
to release or disposal. Also included will be an analysis plan, which 
will identify the approaches and methods EPA plans to use to assess 
exposure, effects, and risk, including associated uncertainty and 
variability, as well as a strategy for approaching science policy 
decisions (e.g., defaults or uncertainty factors).
    The announced availability of the final scope will be published in 
the Federal Register within six months of the initiation of the risk 
evaluation. Although not required under the statute, EPA has proposed 
to provide a draft scope for a 45 calendar day public comment period 
during this six month period. EPA welcomes all public participation, 
but specifically encourages commenters to provide information they 
believe might be missing or may further inform the risk evaluation. 
That said, EPA expects to use the comment periods during the 
prioritization process to reduce the likelihood of significant comments 
on the draft scope. Consequently, the proposed rule makes clear that 
all comments that could be raised on information and approaches 
presented in the scope must be presented during this comment period. 
Any issues related to scope not raised in comments at this time cannot 
form the basis for an objection or challenge in a future administrative 
or judicial proceeding. This is a well-established principle of 
administrative law and practice, see, e.g., Nuclear Energy Institute v. 
EPA, 373 F.3d 1251, 1290-1291 (D.C. Cir. 2004), and the need for such a 
provision is reinforced by the statutory deadlines under which EPA must 
operate for completing TSCA risk evaluations. Note that EPA is not 
proposing to preclude parties from raising newly discovered 
information, or from raising issues that could not have been fairly 
raised during this comment period. Rather, EPA seeks merely to prevent 
parties from delaying the risk evaluation by withholding information or 
by providing it piecemeal.
    2. Hazard assessment. In compliance with TSCA section 6(b)(4)(F), 
EPA is proposing that a hazard assessment be conducted on each chemical 
substance or category. A hazard assessment identifies the types of 
adverse health or environmental effects that can be caused by exposure 
to some agent in question, and to characterize the quality and weight 
of evidence supporting this identification. Hazard Identification is 
the process of determining whether exposure to a stressor can cause an 
increase in the incidence of specific adverse health or environmental 
effects (e.g., cancer, developmental toxicity).
    This hazard assessment may include, but may not be limited to, 
evaluation of the potential toxicity of the chemical substance with 
respect to cancer, mutation, reproductive, developmental, respiratory, 
immune, metabolic, and cardiovascular impacts, and

[[Page 7571]]

neurological impairments. The assessment will evaluate effects at life 
stage(s) most appropriate for a receptor target. The hazard assessment 
will consider the dose or concentration and resulting effect or 
response. Potential information sources that may support the health 
assessment include but are not limited to: Human epidemiological 
studies; in vivo and/or in vitro laboratory studies; mechanistic or 
kinetic studies in a variety of test systems, including but not limited 
to toxicokinetics and toxicodynamics, computational toxicology; data 
from structure-activity relationships, high-throughput assays, genomic 
response assays, and ecological field data. Specifically, for human 
health hazards, the assessment will consider all potentially exposed or 
susceptible subpopulation(s) identified in the scope and use 
appropriate combination, if available, of population-based 
epidemiological studies, information related to geographic location of 
susceptible subpopulations, models representing health effects to the 
population, and any other relevant, scientifically valid information or 
methodology. In an environmental hazard assessment, the relationship 
between the chemical substance and the occurrence of an ecological 
response will be evaluated using field or laboratory data, modeling 
strategies, and species extrapolations.
    Where possible, a hazard assessment also will include a dose-
response assessment. A dose-response relationship describes how the 
likelihood and severity of adverse health effects (the responses) are 
related to the amount and condition of exposure to an agent (the dose 
provided). The same principles generally apply for studies where the 
exposure is to a concentration of the agent (e.g., airborne 
concentrations applied in inhalation exposure studies or water or other 
media concentrations for ecological exposure studies), and the 
resulting information is referred to as the concentration-response.
    3. Exposure assessment. Pursuant to TSCA section 6(b)(4)(F), EPA, 
where relevant, will take into account the likely duration, intensity, 
frequency, and number of exposures under the conditions of use in an 
exposure assessment. An exposure assessment includes some discussion of 
the size, nature, and types of individuals or populations exposed to 
the agent, as well as discussion of the uncertainties in this 
information. Exposure can be measured directly, but more commonly is 
estimated indirectly through consideration of measured concentrations 
in the environment, consideration of models of chemical transport and 
fate in the environment, and estimates of human intake or environmental 
exposure over time.
    Using reasonably available information, exposures will be estimated 
(usually quantitatively) for the identified conditions of use. For 
human health exposure, the assessment would consider all potentially 
exposed or susceptible subpopulation(s) identified in the scope and 
utilize any combination, as available, of population-based 
epidemiological studies, information related to geographic location of 
susceptible subpopulations, models representing exposures to the 
population, measurements in human tissues or relevant environmental or 
exposure media, and any other relevant, scientifically valid 
information or methodology. In an environmental health exposure 
assessment, the interaction of the chemical substance with any 
ecological characteristics identified in the scope will be 
characterized and evaluated.
    4. Risk characterization. TSCA requires that a risk evaluation 
``integrate and assess available information on hazards and 
exposures''. (15 U.S.C 2605(b)(4)(F). A risk characterization conveys 
the risk assessor's judgment as to the nature and presence or absence 
of risks, along with information about how the risk was assessed, where 
assumptions and uncertainties still exist, and where policy choices 
will need to be made. Risk characterization takes place for both human 
health risk assessments and ecological risk assessments.
    In practice, each component of the risk assessment (e.g. hazard 
assessment, dose-response assessment, exposure assessment) has an 
individual characterization written to carry forward the key findings, 
assumptions, limitations, and uncertainties. The set of these 
individual characterizations provide the information basis to write an 
integrative risk characterization analysis. The final, overall risk 
characterization thus consists of the individual component 
characterizations plus an integrative analysis.
    Each risk evaluation will quantitatively and/or qualitatively 
estimate and characterize risk for the identified populations and 
ecological characteristics under the conditions of use. The risk 
characterization will also describe whether aggregate or sentinel 
exposures were considered and provide the evidence and information to 
support the consideration.
    In the risk characterization, EPA will further carry out the 
obligations under TSCA section 26(h) (15 U.S.C 2625(h)); for example, 
by assessing uncertainty and variability in each step of the risk 
evaluation, discussing considerations of data quality such as the 
reliability, relevance and whether the methods utilized were reasonable 
and consistent, explaining any assumptions used, and discussing 
information generated from independent peer review. EPA also may 
exercise it discretion to include a discussion of any alternative 
interpretation of results generated from the risk evaluation. For 
environmental evaluations specifically, EPA plans to include a 
discussion of the nature and magnitude of the effects, the spatial and 
temporal patterns of the effects, implications at the individual, 
species, and community level, and the likelihood of recovery subsequent 
to exposure to the chemical substance.
    5. Peer review. For each risk evaluations conducted on chemicals 
identified pursuant to TSCA section 6(b)(4)(A), EPA will conduct peer 
reviews using the guidance provided in executive branch peer review 
directives included in the Office of Management and Budget Final 
Information Quality Bulletin for Peer Review (OMB Bulletin) (Ref. 22) 
and the guidance set forth in the EPA Peer Review Handbook (2015) (Ref. 
23) or its updates.
    The goal of the peer review process is to obtain independent review 
from experts who have not contributed to its development. According to 
EPA's peer review policy, peer review of all scientific and technical 
information that is intended to inform or support Agency decisions is 
encouraged and expected. Both the EPA Peer Review Handbook and the OMB 
Bulletin provide standards for when and how to conduct peer review on 
science documents. The documents do not contemplate that peer review is 
necessary for every document or risk assessment, but is expected to 
occur for those documents that have either:
     Influential scientific information: scientific information 
that the Agency reasonably can determine will have or does have a clear 
and substantial impact on important public policies or private sector 
decisions, or
     Highly influential scientific assessment: a subset of 
influential scientific information that could have a potential impact 
of more than $500 million in any year on either the public or private 
sector or is novel, controversial, or precedent-setting, or has 
significant interagency interest.
    The EPA Peer Review Handbook, first released in 1998 and last 
updated in

[[Page 7572]]

2015, has also been instrumental in providing guidance on the methods 
for conducting peer review at the Agency for the past two decades. 
According to the Handbook the peer review approach can consist of 
internal or external reviewers and can range from a letter review, an 
ad hoc expert panel review, review of a journal manuscript by a 
referred scientific journal, review by an established Federal Advisory 
Committee (FAC), review by an Agency-appointed special board or 
commission, or review by the National Academy of Science. Given that 
this guidance reflects long-standing and well-accepted EPA practices on 
peer review, and given the public's familiarity with it, the Agency is 
proposing to continue to rely on that established guidance, rather than 
attempt to modify it or create some new methodology in this rulemaking. 
As discussed earlier in this proposal, EPA will identify aspects of the 
analysis on which peer review will be conducted, and the planned 
methodologies, as part of the draft scoping document that will undergo 
public comment for each chemical substance that undergoes risk 
evaluation. These may include novel models or analyses that warrant an 
in-depth peer review. In addition to any targeted peer review of 
specific aspects of the analysis, the entire risk assessment will also 
undergo peer review, as it is important for peer reviewers to consider 
how the various underlying analyses fit together to produce an 
integrated risk characterization which will form the basis of an 
unreasonable risk determination.
    The peer review will address aspects of the science underlying the 
assessment, including, but not limited to hazard assessment, assessment 
of dose-response, exposure assessment, and risk characterization. 
Please note, however, EPA will not seek review of any determination as 
to whether the risks are ``unreasonable'', which is an Agency policy 
judgement. The purpose of peer review is for independent review of the 
science underlying the risk assessment, not to evaluate EPA's policy 
judgments. TSCA expressly reserves to the Agency the final 
determination of whether risk posed by a chemical substance is 
``unreasonable.'' 15 U.S.C 2605(i). EPA nevertheless will include its 
unreasonable risk judgment as part of the risk evaluation that is 
subject to public review and comment.
    6. Unreasonable risk determination. The final step of a risk 
evaluation is for the EPA to determine whether the chemical substance 
presents an unreasonable risk of injury to health or the environment. 
The EPA may find that the substance does not present an unreasonable 
risk of injury to health or the environment under the conditions of 
use. This will be issued by order, published in the Federal Register, 
and considered to be a final EPA action. Alternatively, the EPA may 
determine that the substance does present an unreasonable risk under 
one or more conditions of use, in which case EPA must, pursuant to TSCA 
section 6(a) (15 U.S.C. 2605(a)), impose requirements to the extent 
necessary so that the substance no longer presents such risk.
    EPA will announce in the Federal Register the availability of and 
solicit public comment on the draft risk evaluation, including the 
unreasonable risk determination. All comments that could be raised on 
components of the draft risk evaluation must be presented during this 
comment period. Any issues not raised during this time will be 
considered to have been waived, and may not form the basis for an 
objection or challenge in any subsequent administrative or judicial 
proceeding.
    7. Additional publically available information. Pursuant to TSCA 
section 26(j), EPA will make available: (1) All notices, 
determinations, findings, consent agreements, and orders; (2) any 
information required to be provided by the EPA under 15 U.S.C. 2603; 
(3) a nontechnical summary of the risk evaluation; (4) a list of the 
studies with the results of the studies, considered in carrying out 
each risk evaluation; and (5) the final peer review report, including 
the response to peer review comments.
    8. Reassessment of unreasonable risk determination. EPA may 
reassess a final unreasonable risk determination of a chemical 
substance at any time based on information available to the Agency.

IV. Request for Comments

    While EPA is seeking public comment on all aspects of this proposed 
rule, there are areas where the Agency specifically requesting public 
input.
    1. Redefining scientific terms. EPA received a number of 
stakeholder comments regarding EPA's approach to defining a number of 
important terms within this rule. These terms include ``best available 
science'', ``weight-of-the-evidence'', ``sufficiency of information'', 
``unreasonable risk'', and ``reasonably available information'' among 
others. Many of the terms used in the proposed rule are not novel 
concepts and are already in use and the meaning of which is discussed 
extensively in existing Agency guidance. For example, extensive 
descriptions for the phrases ``best available science'', ``weight-of-
the-evidence'', and ``sufficiency of information'' can be found in 
EPA's Risk Characterization Handbook (Ref. 24), and in other existing 
Agency guidance.
    EPA believes further defining these and other terms in the proposed 
rule is unnecessary and ultimately problematic. These terms have and 
will continue to evolve with changing scientific methods and 
innovation. Codifying specific definitions for these phrases in this 
rule may inhibit the flexibility of the Agency to quickly adapt and 
implement changing science. The Agency intends to use existing guidance 
definitions and will update definitions and guidance as necessary.
    However, the Agency welcomes public comments regarding the pros and 
cons of codifying these or other definitions and/or approaches for 
these or any other terms. EPA encourages commenters to suggest 
alternative definitions the Agency should consider for codification in 
this procedural rule. Please explain your views as clearly as possible, 
providing specific examples to illustrate your concerns and suggest 
alternate wording, where applicable. EPA is specifically requesting 
comments on whether EPA should define unreasonable risk in the final 
rule. If so, acknowledging that the statute precludes consideration of 
costs and other non-risk factors at this step, what factors should EPA 
consider in making such a determination.
    2. Margin of exposure. EPA currently uses a margin-of-exposure 
(MOE) approach in risk characterization of TSCA risk assessments. 
Please comment on the strengths and weaknesses of the MOE approach. Are 
there other approaches (e.g. use of hazard indices, use of 
probabilistic risk assessment) that might better suit the TSCA Risk 
Evaluation Program? Are there other approaches that provide 
quantifiable non-cancer risks?
    3. Systematic Review. While EPA has included a systematic review 
approach in the past, and intends to continue to do so, please comment 
on the need for regulatory text prescribing a specific systematic 
review approach for hazard identification, including the 
appropriateness of elements that might be included or concerns about 
codifying an approach.
    4. Manufacturer Requests. EPA anticipates that some chemical 
substances prioritized for risk evaluation have been manufactured by 
persons who possess unpublished information that could impact the 
chemical's risk determination. For chemical substances prioritized for 
risk evaluation, the Agency generally expects to exercise, as needed, 
among

[[Page 7573]]

other authorities, its information-gathering authority pursuant to 15 
U.S.C. 2607(a) and 2607(d), likely very early in the process. EPA is 
specifically requesting comment on approaches to utilizing its 
information gathering authorities to assure that EPA has the most 
complete information to make its risk determination. For example, one 
option might be to incorporate its 15 U.S.C. 2607(a) and 2607(d) 
authority into the ``Information and information sources'' section of 
this rule to allow EPA to require, by notice in the Federal Register, 
manufacturers with information subject to 15 U.S.C. 2607(a)(2) and 
2607(d) to submit that information to EPA for use in a risk evaluation. 
EPA is requesting comment on this option and on any more effective 
alternative methods to exercise this authority within the rule to 
assure the completeness of the information relevant to the risk 
evaluation.
    The Agency also anticipates the possibility that one manufacturer 
requests a risk evaluation but other manufacturers of the same chemical 
who have not joined in the request also possess relevant unpublished 
information. For manufacturer requests for risk evaluation, the burden 
is on the requester to include or reference all information that is 
necessary for EPA to conduct a risk evaluation. Although EPA could use 
its data collection authority to access information, including 
unpublished studies, held by entities other than the requestor, the 
Agency intends to deny requests for risk evaluation if the requester 
does not have access to the information necessary for risk evaluation.
    5. Peer Review. As discussed in both the OMB Bulletin and the EPA 
Peer Review Handbook, there are specific exemption criteria for 
information that does not necessitate peer review, even if it might be 
considered to be influential or highly influential. A number of 
specific circumstances where peer review is not necessary are discussed 
in section 3.3 of the EPA Peer Review Handbook. Examples of these 
circumstances include information involving a health or safety issue 
where the Agency determines that the dissemination is time-sensitive or 
if an application of an adequately peer-reviewed work product does not 
depart significantly from its scientific or technical approach. In 
addition, EPA expects that there will be individual circumstances where 
a chemical substance is found to not present an unreasonable risk or 
that findings are similar or the same as other jurisdictions (states or 
countries) that have reached similar conclusions based on the same 
information, such that the Agency could determine that peer review is 
not necessary for that chemical risk evaluation.
    EPA expects that many of the risk evaluations conducted under TSCA 
will necessitate peer review. In cases in which a chemical substance is 
determined to present an unreasonable risk, the Agency must promptly 
move to manage the risk, a circumstance that would typically qualify 
the assessment as ``influential scientific information'' under current 
guidance and practice. The Agency also expects that some risk 
evaluations would also be highly influential scientific assessments, 
e.g., contain novel, controversial, or precedent-setting science with 
significant interagency interest. EPA also expects that peer review 
will be warranted in many cases where the Agency determines a chemical 
substance does not present an unreasonable risk. Aspects of the 
evaluation may qualify as influential scientific information or highly 
influential scientific assessment, and thus warrant peer review. Other 
circumstances where the Agency may determine that peer review is 
warranted could include circumstances where there are existing private 
sector standards suggesting concern for a given chemical substance, 
where existing state assessments differ from the EPA evaluation, or 
where the public has expressed general concern about the chemical 
substances effects.
    As required under the amended TSCA, chemical substances must be 
prioritized as either low or high. Those categorized as high are 
subject to a risk evaluation, and those determined to be low are not. 
The bar for prioritizing a chemical as a low priority as required under 
the amended TSCA is fairly high. As such, EPA expects that, as an 
increasing number of chemical risk evaluations are completed, those 
chemical substances that present risk to human health or the 
environment will be managed accordingly, leaving an increasing number 
of chemicals that do not present an unreasonable risk. The Agency 
questions whether all future risk evaluations warrant peer review.
    EPA is specifically requesting public comment on whether there are 
circumstances where conducting peer review may not be warranted. What 
circumstances might qualify, and whether the regulatory text should be 
adjusted to require EPA to make a case by case determination of whether 
and to what extent, consistent with the EPA Peer Review Handbook, peer 
review is warranted for the chemical substance undergoing a risk 
evaluation. In all cases, the rule would require that this 
determination, and any peer review activities that are conducted, be 
documented for each chemical evaluation, starting with the scope 
document.
    6. Reliance on existing guidance and procedures for conducting risk 
evaluations. As discussed in Unit III.G.1., EPA intends to take 
advantage of existing guidance, tools and models that are relevant and 
available for use in conducting a risk evaluation under this program. 
Since each risk evaluation is based on the specific circumstances 
surrounding the chemical being assessed, EPA has not attempted to 
codify any specific guidance, method or model. EPA believes that this 
is necessary to ensure that there is flexibility to address potentially 
unique circumstances on a chemical basis. EPA is interested in your 
comments about this approach, and where there is any existing guidance 
that may be of particular interest for consideration in conducting 
these risk evaluations. Additionally, EPA asks if the current guidance 
documents are sufficient and whether there are additional guidance 
documents that should be relevant but may not be on the lists available 
on EPA's Web site (https://www.epa.gov/risk/risk-assessment-guidelines). Finally, should EPA consider requiring that a list of 
appropriate guidance documents be included on a case-by-case basis as 
part of the scoping document that undergoes public review and comment.
    7. Interagency collaboration. As discussed in Unit III.B., EPA is 
committed to ensuring there is interagency engagement and dialogue 
throughout its risk evaluation process, and has chosen not the limit 
the potential interagency collaboration by proposing to codify any 
particular process. EPA is concerned that imposing a single, pre-
determined consultation step might lead to an overly bureaucratic 
process that could limit or complicate ongoing collaboration efforts, 
and so is not proposing to codify any particular process in this 
regulation. However, EPA is requesting specific public comment on 
whether codifying this collaboration at a specific point in the 
regulation is necessary.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included

[[Page 7574]]

in the docket, even if the referenced document is not physically 
located in the docket. For assistance in locating these other 
documents, please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

1. USEPA. Information Collection Request (ICR) for the Proposed 
Rule: Procedures for Chemical Risk Evaluation Under TSCA. EPA ICR 
No.: 2559.01 and OMB No. 2070--[NEW].
2. EPA. TSCA Work Plan Chemical Assessments: 2014 Update-Final. 
Office of Pollution Prevention and Toxics. October 2014. https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
3. National Research Council. Science and Decisions: Advancing Risk 
Assessment. The National Academies Press. Washington, DC 2009. 
http://www.nap.edu/catalog.php?record_id=12209.
4. EPA. Guidelines for Carcinogen Risk Assessment. Risk Assessment 
Forum, Washington, DC. EPA/630/P-03/001F. Washington, DC 2005. 
https://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf.
5. EPA. Guidelines for Carcinogen Risk Assessment, Review Draft, 
CEA-F-0644, Office of Research and Development. Washington, DC 1999. 
http://cfpub.epa.gov/ncea/raf/cancer.cfm.
6. EDSTAC. Endocrine Disruptor Screening and Testing Advisory 
Committee, Final Report, Volume I-II. Washington, DC 1998. http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm.
7. EPA. Endocrine Disruptor Screening Program; Weight-of-Evidence: 
Evaluating Results of EDSP Tier 1 Screening to Identify the Need for 
Tier 2 Testing, Washington, DC 2011. https://www.regulations.gov/document?D=EPA-HQ-OPPT-2010-0877-0021.
8. EPA. Framework for Metals Risk Assessment of the Office of the 
Science Advisor, Risk Assessment Forum. Washington, DC March 2007.
9. National Research Council. Risk Assessment in the Federal 
Government: Managing the Process. The National Academies Press. 
Washington, DC 1983. http://www.nap.edu/openbook.php?isbn=0309033497.
10. National Research Council. Science and Judgment in Risk 
Assessment. The National Academies Press. Washington, DC 1994. 
http://www.nap.edu/catalog.php?record_id=2125.
11. National Research Council. Understanding Risk: Informing 
Decisions in a Democratic Society. The National Academies Press. 
Washington, DC 1996. http://www.nap.edu/openbook.php?isbn=030905396X.
12. National Research Council. Toxicity Testing in the 21st Century: 
A Vision and a Strategy. The National Academies Press. Washington, 
DC 2007. http://www.nap.edu/catalog.php?record_id=11970.
13. National Research Council. Phthalates and Cumulative Risk 
Assessment: The Tasks Ahead. National Academy Press. Washington, DC 
2008. http://www.nap.edu/catalog.php?record_id=12528.
14. USEPA. Policy on Evaluating Health Risks to Children. 1995. 
https://www.epa.gov/sites/production/files/2014-05/documents/1995_childrens_health_policy_statement.pdf.
15. USEPA. Guidelines for Developmental Toxicity Risk Assessment. 
EPA/600/FR-91/001. Risk Assessment Forum. Washington, DC 1991. 
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=23162.
16. USEPA. Guide to Considering Children's Health When Developing 
EPA Actions: Implementing Executive Order 13045 and EPA's Policy on 
Evaluating Health Risks to Children. Office of Policy, Economics and 
Innovation. Washington, DC 2006. http://yosemite.epa.gov/ochp/
ochpweb.nsf/content/ADPguide.htm/$File/EPA_ADP_Guide_508.pdf.
17. USEPA. Guidance on Selecting Age Groups for Monitoring and 
Assessing Childhood Exposures to Environmental Contaminants. Final. 
EPA/630/P-03/003F. Risk Assessment Forum. Washington, DC 2005. 
http://www.epa.gov/raf/publications/guidance-on-selecting-age-groups.htm.
18. USEPA. Supplemental Guidance for Assessing Susceptibility from 
Early-Life Exposure to Carcinogens. EPA/630/R-03/003F. Risk 
Assessment Forum. Washington, DC 2005. http://www.epa.gov/ttn/atw/childrens_supplement_final.pdf.
19. USEPA. A Framework for Assessing Health Risk of Environmental 
Exposures to Children. Final. EPA/600/R-05/093F. Office of Research 
and Development, National Center for Environmental Assessment. 
Washington, DC 2006. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=158363.
20. USEPA. Exposure Factors Handbook. EPA/600/R-090/052F. Office of 
Research and Development, National Center for Environmental 
Assessment. Washington, DC 2011. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
21. USEPA. Framework for Human Health Risk Assessment to Inform 
Decision Making. EPA/100/R-14/001. Office of the Science Advisor, 
Risk Assessment Forum. 2014. https://archive.epa.gov/raf/web/pdf/hhra-framework-final-2014.pdf.
22. Office of Management and Budget Final Information Quality 
Bulletin for Peer Review.
23. USEPA. Peer Review Handbook. 3rd ed. EPA/100/B-06/002. Science 
Policy Council. Washington, DC 2006. https://www.epa.gov/osa/peer-review-handbook-4th-edition-2015.
24. Risk Characterization Handbook. Science Policy Council Handbook: 
Risk Characterization, EPA 100-B-00-002, Washington, DC December 
2000. https://www.epa.gov/risk/risk-characterization-handbook.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.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 under Executive 
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, 
January 21, 2011). Any changes made in response to OMB recommendations 
have been documented in the docket.

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with this proposed 
rule have been submitted to OMB for review and approval under the PRA, 
44 U.S.C. 3501 et seq. Specifically, EPA has prepared an ICR to 
estimate the potential burden and costs associated with the proposed 
requirements for submitting a request for an Agency-conducted risk 
evaluation on a particular chemical substance. The ICR, which is 
available in the docket, has been assigned the EPA ICR number 2559.01. 
You can find a copy of the ICR in the docket for this proposed rule 
(Ref. 1), and it is briefly summarized here.
    Respondents/affected entities: Manufacturers (including importers).
    Respondent's obligation to respond: Optional, i.e., needed only if 
they are requesting an EPA-conducted risk evaluation for a particular 
chemical substance.
    Estimated number of respondents: 10.
    Frequency of response: On occasion.
    Total estimated annual burden: 960.3 hours. Burden is defined in 5 
CFR 1320.3(b).
    Total estimated annual cost: $69,353 for burden hours. There are no 
M&O costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden to EPA using the docket identified at 
the beginning of this proposed rule. You may also send your ICR-related 
comments to OMB's Office of

[[Page 7575]]

Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for the EPA. Since 
OMB is required to make a decision concerning the ICR between 30 and 60 
calendar days after receipt, OMB must receive comments no later than 
February 21, 2017. Any ICR-related comments will be addressed with the 
final rule.

C. Regulatory Flexibility Act (RFA)

    EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et 
seq., that this action will not have a significant economic impact on a 
substantial number of small entities. Although this proposed rule 
primarily addresses internal EPA procedures and activities associated 
with conducting risk evaluations for chemical substances as required by 
TSCA, EPA is also proposing the process and content requirements for a 
manufacturer (including importer) to request that EPA conduct a risk 
evaluation on a particular chemical substance. EPA has determined that 
the process and content requirements proposed will have minimal impact 
on an entity, regardless of size, because there is no mandate for them 
to make such a request, and the information they must provide should 
they decide to make such a request, which involves basic information 
about the chemical substance and the manufacturer's reasons for 
requesting the EPA-conducted risk evaluation on that chemical 
substance, should be readily available to the manufacturer. Estimated 
potential burden and costs are presented in the ICR (Ref. 1).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes. Thus, Executive Order 13175 does not 
apply to this action.

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

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 
1997) as applying only to those regulatory actions that concern 
environmental health or safety risks that the EPA has reason to believe 
may disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, distribution 
or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards, and is 
therefore not subject to considerations under NTTAA section 12(d), 15 
U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not establish an environmental health or safety 
standard, and is therefore not is not subject to environmental justice 
considerations under Executive Order 12898 (59 FR 7629, February 16, 
1994). This is procedural rule that will not affect the level of 
protection provided to human health or the environment.

List of Subjects in 40 CFR Part 702

    Environmental protection, Chemicals, Chemical Substance, Hazardous 
substances, Health and safety, Risk Evaluation.

    Dated: January 12, 2017,
Gina McCarthy,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I, subchapter R, be 
amended as follows:

PART 702--GENERAL PRACTICES AND PROCEDURES

0
 1. The authority citation for part 702 is revised to read as follows:

     Authority:  15 U.S.C. 2605 and 2619.

0
 2. Add subpart B to part 702 to read as follows:

Subpart B--Procedures for Chemical Substance Risk Evaluations

Sec.
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances designated for risk evaluation.
702.37 Submission of manufacturer requests for risk evaluations.
702.39 Evaluation requirements.
702.41 Risk characterization and peer review procedures.
702.43 Unreasonable risk determination.
702.45 Risk Evaluation timeframes and actions.
702.47 Publically available information.


Sec.  702.31   General provisions.

    (a) Purpose. This subpart establishes the EPA process for 
conducting a risk evaluation to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment as 
required under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)).
    (b) Scope. These regulations establish the general procedures, key 
definitions, and timelines EPA will use in a risk evaluation conducted 
pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)).
    (c) Applicability. The requirements of this part apply to all 
chemical substance risk evaluations initiated pursuant to TSCA section 
6(b) (15 U.S.C. 2605(b)).
    (d) Enforcement. Submission to EPA of inaccurate, incomplete, or 
misleading information by a manufacturer pursuant to a risk evaluation 
conducted pursuant to 15 U.S.C. 2605(b)(4)(B) is a prohibited act under 
15 U.S.C. 2614, subject to penalties under 15 U.S.C. 2615 and Title 18 
of the U.S. Code.


Sec.  702.33   Definitions.

    All definitions in TSCA apply to this subpart. In addition the 
following definitions apply:
    Act means the Toxic Substances Control Act, as amended (15 U.S.C. 
2601 et seq.).
    Aggregate exposure means the combined exposures to an individual

[[Page 7576]]

from a single chemical substance across multiple routes and across 
multiple pathways.
    EPA means the U.S. Environmental Protection Agency.
    Pathways means the mode through which one is exposed to a chemical 
substance, including but not limited to: Food, water, soil, and air.
    Potentially exposed or susceptible subpopulation means a group of 
individuals within the general population identified by the Agency who, 
due to either greater susceptibility or greater exposure, may be at 
greater risk than the general population of adverse health effects from 
exposure to a chemical substance or mixture, including but not limited 
to, infants, children, pregnant women, workers, or the elderly. EPA may 
identify a susceptible subpopulation in an individual risk evaluation 
upon consideration of various intrinsic (e.g., life stage, reproductive 
status, age, gender, genetic traits) or acquired (e.g., pre-existing 
disease, geography, workplace) characteristics that may affect exposure 
or modify the risk of illness or disease.
    Reasonably available information means existing information that 
EPA possesses or can reasonably obtain and synthesize for use in risk 
evaluations, considering the deadlines specified in TSCA section 
6(b)(4)(G) for completing such evaluation.
    Routes means the particular manner which a chemical substance may 
contact the body, including absorption via ingestion, inhalation, or 
dermally (integument).
    Sentinel exposure means the exposure(s) of greatest significance, 
which may be the plausible maximum exposure to an individual, 
population (or subpopulation), or the environment to the chemical 
substance of interest (or any combination thereof).
    Uncertainty means the imperfect knowledge or lack of precise 
knowledge either for specific values of interest or in the description 
of a system.
    Variability means the inherent natural variation, diversity, and 
heterogeneity across time and/or space or among individuals within a 
population.


Sec.  702.35   Chemical substances designated for risk evaluation.

    (a) Chemical Substances Undergoing Risk Evaluation. A risk 
evaluation for a chemical substance designated by the Agency as a High-
Priority Substance pursuant to the prioritization process described in 
subpart A, identified under 15 U.S.C. 2605(b)(2)(A), or initiated at 
the request of a manufacturer or manufacturers under 40 CFR 702.37, 
will be conducted in accordance with this part, except that risk 
evaluations that are initiated prior to the effective date of this rule 
will be conducted in accordance with this part to the maximum extent 
practicable.
    (b) Percentage Requirements. The Agency will ensure that, of the 
number of chemical substances that undergo risk evaluation under 15 
U.S.C. 2605(b)(4)(C)(i), the number of chemical substances undergoing 
risk evaluation under 15 U.S.C. 2605(b)(4)(C)(ii) is not less than 25%, 
if sufficient requests that comply with 40 CFR 702.37 are made by 
manufacturers, and not more than 50%.
    (c) Manufacturer Requests for Work Plan Chemical Substances. 
Manufacturer requests for risk evaluations, described in 40 CFR 
702.35(a), for chemical substances that are drawn from the 2014 update 
of the TSCA Work Plan for Chemical Assessments or its relevant and 
applicable successor document will be granted at the discretion of the 
Agency. Such evaluations are not subject to the percentage requirements 
in 40 CFR 702.35(b).


Sec.  702.37   Submission of manufacturer requests for risk 
evaluations.

    (a) General Provision. Any request for EPA to conduct a risk 
evaluation on a chemical substance pursuant to this part must comply 
with all the procedures and criteria in this section to be eligible to 
be granted by EPA. A request will meet EPA's criteria if the request 
includes or references all the information that is necessary for EPA to 
conduct a risk evaluation addressing all the circumstances that 
constitute conditions of use of the chemical substance within the 
meaning of TSCA section 3 (i.e., all circumstances under which the 
chemical substance is intended, known, or reasonably foreseen to be 
manufactured, processed, distributed in commerce, used, or disposed 
of).
    (b) Method for Submission. One or more manufacturers of a chemical 
substance can request that EPA conduct a risk evaluation on the 
chemical substance by providing all the following information:
    (1) Name, mailing address, and contact information of the entity 
(or entities) submitting the request. If more than one manufacturer 
submits the request, all individual manufacturers must provide their 
contact information.
    (2) Full information on the chemical identity of the chemical 
substance that is the subject of the request. At a minimum, this 
includes, all known names of the chemical substance, including common 
or trades names, chemical identity, CAS number, and molecular structure 
of the chemical substance.
    (3) A complete list of the reasonably available information that is 
consistent with the standards in TSCA section 26(h) and that is 
relevant to whether the chemical substance presents an unreasonable 
risk of injury to health or the environment. The list must be 
accompanied by an explanation as to why such information is adequate to 
permit EPA to complete a risk evaluation addressing all the 
circumstances that constitute conditions of use of the chemical 
substance within the meaning of TSCA section 3 (i.e., all circumstances 
under which the chemical substance is intended, known, or reasonably 
foreseen to be manufactured, processed, distributed in commerce, used, 
or disposed of). The request need not include copies of the 
information; citations are sufficient. The request must include or 
reference all reasonably available information on the health and 
environment hazard(s) of the chemical substance, health and 
environmental exposure(s), and exposed population(s). At a minimum this 
must include information relevant to the following:
    (i) The chemical substance's hazard and exposure potential;
    (ii) The chemical substance's persistence and bioaccumulation;
    (iii) Potentially exposed or susceptible subpopulations they 
believe to be relevant and that EPA should evaluate in the risk 
evaluation;
    (iv) Whether there is any storage of the chemical substance near 
significant sources of drinking water;
    (v) The chemical substance's conditions of use or significant 
changes in conditions of use;
    (vi) The chemical substance's production volume or significant 
changes in production volume; and
    (vii) Any other information relevant to the risks potentially 
presented by the chemical substance.
    (4) The request must include a commitment to provide to EPA any 
referenced information upon request. In addition, if the manufacturer 
previously conducted its own risk assessment of the chemical substance, 
or possesses or can reasonably obtain any other pre-existing risk 
assessment, the request must include a commitment to provide such 
assessments to EPA upon request.
    (5) A signed certification that all information contained in the 
request is accurate and complete, as follows:

    I certify under penalty of law that this document and all 
attachments were prepared under my direction or supervision and the 
information contained therein, to the best of

[[Page 7577]]

my knowledge is, true, accurate, and complete and I have not 
withheld any relevant information. I am aware there are significant 
penalties for submitting incomplete, false and/or misleading 
information, including the possibility of fine and imprisonment for 
knowing violations.

    (c) Optional Elements. A manufacturer may provide evidence to 
demonstrate that restrictions imposed by one or more States have the 
potential to have a significant impact on interstate commerce or health 
or the environment, and that as a consequence the request is entitled 
to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).
    (d) Confidential Business Information. (1) Persons submitting a 
request under this subpart are subject to EPA confidentiality 
regulations at 40 CFR part 2, subpart B.
    (2) In submitting a claim of confidentiality, a person must certify 
the truth of the following statements concerning all information 
claimed as confidential:

    I hereby certify to the best of my knowledge and belief that all 
information entered on this form is complete and accurate. I further 
certify that, pursuant to 15 U.S.C. 2613(c), for all claims for 
confidentiality made with this submission, all information submitted 
to substantiate such claims is true and correct, and that it is true 
and correct that
    (i) My company has taken reasonable measures to protect the 
confidentiality of the information;
    (ii) I have determined that the information is not required to 
be disclosed or otherwise made available to the public under any 
other Federal law;
    (iii) I have a reasonable basis to conclude that disclosure of 
the information is likely to cause substantial harm to the 
competitive position of my company; and
    (iv) I have a reasonable basis to believe that the information 
is not readily discoverable through reverse engineering.

    (3) Each claim of confidentiality, other than a claim pertaining to 
information described in TSCA section 14(c)(2), must be accompanied by 
a substantiation in accordance with 40 CFR 2.204(e)(4).
    (4) Manufacturers must supply a structurally descriptive generic 
name where specific chemical identity is claimed as CBI.
    (5) Any knowing and willful misrepresentation is subject to 
criminal penalty pursuant to 18 U.S.C. 1001.
    (e) EPA Process for Evaluating Manufacturer Requests. (1) Review 
for completeness. Upon receipt of the request, EPA will verify that the 
request is facially valid, i.e., that information has been submitted 
that is consistent with the requirements in 40 CFR 702.37(b) through 
(d). EPA will inform the submitting manufacturer(s) if EPA has 
determined that the request is incomplete and cannot be processed. 
Complete requests will be processed as described in this subpart.
    (2) Public notice and comment. Within 30 business days of receiving 
a request that EPA has determined to be valid under paragraph (e)(1) of 
this section, EPA will submit for publication the receipt of the 
request in the Federal Register, open a docket for that request and 
provide no less than a 30 calendar day public comment period, during 
which time the public may submit comments and information relevant to 
whether the chemical substance presents an unreasonable risk of injury 
to health or the environment under the conditions of use. In 
particular, comments identifying any information gaps in the request 
(e.g., any conditions of use not identified in the request).
    (3) Supplementation of original request. (i) At any time prior to 
the end of the comment period, manufacturer(s) may supplement the 
original request with any new information it receives/obtains.
    (ii) At any point prior to the completion of a risk evaluation 
conducted on a chemical substance at the request of a manufacturer(s), 
manufacturer(s) are required to supplement the original request upon 
receipt of information that meets the criteria in 15 U.S.C. 2607(e) and 
40 CFR 702.37, or other information that has the potential to change 
EPA's evaluation of the risk of the chemical substance. Such 
information must be submitted within 30 calendar days of discovery.
    (4) EPA determination. Within 9 months of the end of the comment 
period provided in paragraph (e)(2) of this section, EPA will review 
the request along with any additional information received during the 
comment period to determine whether the request meets the criteria and 
requirements of 40 CFR 702.37. EPA will notify the submitting 
manufacturer(s) of its determination.
    (i) Request is lacking required information. (A) The 
manufacturer(s) have 60 calendar days from receipt of EPA's 
determination to submit any additional information identified as 
lacking in the notification.
    (B) Failure to submit the additional information will be considered 
to be a withdrawal of the request to initiate a risk evaluation on the 
named chemical substance.
    (C) Notwithstanding any such withdrawal, manufacturer(s) may submit 
a subsequent request on the same chemical substance.
    (ii) Compliant request. EPA will initiate a risk evaluation for all 
requests for non-TSCA Work Plan Chemicals that meet the criteria in 
this subpart, until EPA determines that the number of manufacturer-
requested chemical substances undergoing risk evaluation is equal to 
25% of the High-Priority Substances identified in subpart A as 
undergoing risk evaluation. Once that level has been reached, EPA will 
initiate one new manufacturer-requested risk evaluation for each 
manufacturer-requested risk evaluation completed, as needed to ensure 
that the number of manufacturer-requested risk evaluations is equal to 
at least 25% of the High-Priority substances risk evaluation.
    (5) Preferences. In conformance with 40 CFR 702.35(c), in 
evaluating requests for TSCA Work Plan Chemicals and requests for non-
TSCA Work Plan chemicals in excess of the 25% threshold in paragraph 
(e)(4)(ii) of this section, EPA will give preference to requests for 
risk evaluations on chemical substances:
    (i) That demonstrate that restrictions imposed by one or more 
States have the potential to have a significant impact on interstate 
commerce, health or the environment.
    (ii) EPA will also give preference to requests where EPA has 
determined there are relatively high estimates of hazard and/or 
exposure for the chemical substance.
    (iii) Any other factor EPA determines to be relevant.
    (6) Conditions of use considered. EPA will conduct the risk 
evaluation on all of the conditions of use of a chemical substance 
undergoing risk evaluation at the request of a manufacturer, as 
determined through the scoping process outlined in 40 CFR 702.39(c).
    (7) No preferential treatment. EPA will not expedite or otherwise 
provide special treatment to a risk evaluation conducted as a result of 
a manufacturer request.
    (f) Fees. Manufacturers must pay fees to support risk evaluations 
under 15 U.S.C. 2605(b)(4)(C)(ii).


Sec.  702.39   Evaluation Requirements and Peer Review Procedures.

    (a) Considerations. (1) Each risk evaluation will include the 
following components: a Scope, including a Conceptual Model and an 
Analysis Plan; a Hazard Assessment; an Exposure Assessment; a Risk 
Characterization; and a Risk Determination.
    (2) Existing EPA guidance, where available and relevant, will be 
used in conducting the risk evaluation. In addition, other 
scientifically relevant methods or guidance may be used in a risk 
evaluation.

[[Page 7578]]

    (3) Where appropriate, a risk evaluation may be conducted on a 
category of chemical substances. EPA will determine whether to conduct 
an evaluation on a category of chemical substances, and the composition 
of the category based on the considerations listed in 15 U.S.C. 
2625(c). In addition to the factors specifically enumerated in that 
provision, EPA may consider the hazards and exposures associated with 
the category of chemical substances, and the populations likely to be 
exposed.
    (4) EPA will ensure that all supporting analyses and components of 
the risk evaluation are suitable for their intended purpose, and well-
tailored to the problems and decision at hand, in order to inform the 
development of a technically sound determination as to whether a 
chemical substance presents an unreasonable risk of injury to health or 
the environment, based on the weight of the scientific evidence.
    (5) The extent to which EPA will refine its evaluations for 
particular conditions of use in any risk evaluation will vary as 
necessary to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment. To the extent 
a determination as to the level of risk presented by a condition of use 
can be made, for example, by the use of accepted science policies 
(e.g., defaults assumptions or uncertainty factors), and models or 
screening methodologies, EPA may determine that no further information 
or analysis is needed to complete its risk evaluation of the use(s).
    (6) EPA may conduct a risk evaluation on a chemical substance in 
phases to allow the Agency to proceed with risk management on 
particular conditions of use. For example, EPA may determine that a 
chemical substance presents an unreasonable risk of injury to health or 
the environment under one or more conditions of use, and address such 
unreasonable risk through rulemaking under TSCA section 6(a), while 
other conditions of use remain under evaluation. In all cases in which 
EPA conducts its risk evaluations in phases, EPA will nevertheless 
complete a full risk evaluation of the chemical substance for all of 
the conditions of use identified through the scoping process in 40 CFR 
702.39(c) within the time frame in 40 CFR 702.43(d).
    (7) In evaluating chemical substances that are metals or metal 
compounds, EPA will use the Framework for Metals Assessment of the 
Office of the Science Advisor, Risk Assessment Forum dated March 2007, 
or a successor document that addresses metal risk assessment and is 
peer reviewed by the Science Advisory Board.
    (b) Information and information sources. (1) EPA will base each 
risk evaluation on reasonably available information.
    (2) EPA generally expects to initiate a risk evaluation for a 
chemical substance only when EPA believes that all or most of the 
information necessary to perform the risk evaluation already exists and 
is reasonably available. EPA expects to use its authorities under the 
Act, and other information gathering authorities, when necessary to 
generate the information needed to perform a risk evaluation for a 
chemical substance before initiating the risk evaluation for such 
substance. EPA will use such authorities on a case-by-case basis during 
the performance of a risk evaluation to obtain or generate information 
as needed to ensure that EPA has adequate, reasonably available 
information to perform the evaluation.
    (3) Among other sources of information, the Agency will consider 
information and advice provided by the Science Advisory Committee on 
Chemicals established pursuant to 15 U.S.C. 2625.
    (4) In conducting risk evaluations, EPA will rely on an appropriate 
combination of information, accepted science policies (e.g., defaults 
and uncertainty factors), models and screening methodologies. The 
balance of information, accepted science policies models, and screening 
methodologies used in risk evaluation will be informed by the deadlines 
specified in TSCA section 6(b)(4)(G) for completing such evaluations. 
It will also be informed by consideration of the extent to which 
additional information would reduce the uncertainty in determining 
whether a chemical substance presents an unreasonable risk of injury to 
health or the environment.
    (5) Where appropriate, to the extent practicable, and 
scientifically justified, EPA will use information generated without 
the use of testing on vertebrates in performing risk evaluation.
    (c) Scope of the risk evaluation. EPA will determine the scope of 
the risk evaluation to be conducted for each chemical substance based 
on all of the following:
    (1) EPA will identify those uses that constitute the conditions of 
use that will be assessed during the risk evaluation. Those uses shall 
be all circumstances under which the Agency determines that the 
chemical substance is intended, known, or reasonably foreseen to be 
manufactured, processed, distributed in commerce, used, or disposed of.
    (2) When determining the scope, EPA will identify the exposed 
individuals and populations, including any potentially exposed or 
susceptible subpopulations as identified by the Agency that EPA plans 
to evaluate; the ecological characteristics that EPA plans to evaluate; 
and the hazards to health and the environment that EPA plans to 
evaluate.
    (3) The combination of reasonably available information, accepted 
science policies (e.g., defaults and uncertainty factors), models, and 
screening methodologies that EPA plans to use in the risk evaluation 
will be documented.
    (4) Conceptual model. (i) The scope documents will include a 
Conceptual Model that describes actual or predicted relationships 
between the chemical substance and human and environmental receptors.
    (ii) The Conceptual Model will identify human and ecological health 
endpoints the EPA plans to evaluate for the exposure scenarios EPA 
plans to evaluate.
    (iii) Conceptual Model development will consider the life cycle of 
the chemical substance, including manufacture, processing, distribution 
in commerce, storage, use, and disposal.
    (5) Analysis plan. (i) The scope documents will include an analysis 
plan that identifies the approaches, methods, and/or metrics that the 
EPA plans to use to assess exposures, effects, and risk, including 
associated uncertainty and variability for each risk evaluation. The 
analysis plan will also identify the strategy for using information, 
accepted science policies, models, and screening methodologies.
    (ii) Hypotheses about the relationships described in the conceptual 
model will be described. The relative strengths of (any) competing 
hypotheses will be evaluated to determine the appropriate risk 
assessment approaches.
    (6) Developing the Scope. (i) Draft scope. For each risk evaluation 
to be conducted EPA will publish a document in the Federal Register 
that specifies the draft scope of the risk evaluation the Agency plans 
to conduct. The document will address the elements in paragraphs (c)(1) 
through (5) of this section.
    (ii) Timeframes. EPA generally expects to publish the draft scope 
no later than 3 months from the initiation of the risk evaluation 
process for the chemical substance, and to allow a period of 30 
calendar days during which interested persons may submit comment on 
EPA's draft risk evaluation scope. EPA will open a docket to facilitate 
receipt of public comments.
    (iii) Public comments. All comments that could be raised on the 
matters addressed and issues presented in the

[[Page 7579]]

published risk evaluation scope document must be presented during this 
comment period. Any issues not raised at this time will be considered 
to have been waived, and may not form the basis for an objection or 
challenge in any subsequent administrative or judicial proceeding.
    (iv) Final scope. (A) The Agency will, no later than 6 months after 
the initiation of a risk evaluation, publish a document in the Federal 
Register that specifies the final scope of the risk evaluation the 
Agency plans to conduct. The document shall address the elements in 
paragraphs (c)(1) through (5) of this section.
    (B) For a chemical substance designated as a High-Priority 
Substance under 40 CFR part 702 subpart A, EPA will not publish the 
final scope of the risk evaluation until at least 12 months have 
elapsed from the initiation of the prioritization process for the 
chemical substance.
    (d) Hazard assessment. (1) The hazard information relevant to the 
chemical substance will be evaluated using endpoints identified in the 
final scope document published pursuant to paragraph (c)(6)(iv) of this 
section, for the identified exposure scenarios, including any 
identified potentially exposed or susceptible subpopulation(s).
    (2) The hazard assessment process will identify the types of 
hazards to health or the environment posed by the chemical substance. 
This process includes the identification, evaluation, and synthesis of 
information to describe the potential health effects of the chemical 
substance.
    (3) Based on the final scope document published pursuant to 
paragraph (c)(6)(iv) of this section, potential human and environmental 
hazard endpoints will be evaluated, including, as appropriate; acute, 
subchronic, and chronic effects during various stages of reproduction 
or life stage.
    (4) The relationship between the dose of the chemical substance and 
the occurrence of human and environmental health effects or outcomes 
will be evaluated.
    (5) Studies evaluated may include, but would not be limited to: 
Human epidemiological studies, in vivo and/or in vitro laboratory 
studies, mechanistic or kinetic studies in a variety of test systems, 
including but not limited to toxicokinetics and toxicodynamics, 
computational toxicology, data from structure-activity relationships, 
high-throughput assays, genomic response assays, and ecological field 
data.
    (6) Hazard identification will include an evaluation of the 
strengths and limitations of the reasonably available information.
    (7) Human health hazard assessment. The hazard assessment will 
consider all potentially exposed and susceptible subpopulation(s) 
determined to be relevant, as identified in the final scope document 
published pursuant to paragraph (c)(6)(iv) of this section. Reasonably 
available information used to characterize risk to susceptible 
subpopulation(s) may include, but may not be limited to:
    (i) Population-based epidemiology studies that identify risk 
factors and susceptible subpopulations;
    (ii) Information related to geographic location of subpopulations;
    (iii) Models that represent health effects of relevant 
subpopulations; and
    (iv) Any other relevant, scientifically valid information, 
methodology, or extrapolation.
    (8) Environmental health hazard assessment. The relationship 
between the chemical substance and the occurrence of an ecological 
hazard elicited will be evaluated using reasonably available 
information including but not limited to: Field or laboratory 
measurements, modeling strategies, extrapolations or incident data.
    (e) Exposure assessment. (1) Where relevant, the likely duration, 
intensity, frequency, and number of exposures under the conditions of 
use will be considered.
    (2) For the conditions of use, exposures will be evaluated using 
reasonably available information.
    (3) Chemical-specific factors including, but not limited to: 
Physical- chemical properties and environmental fate parameters will be 
examined.
    (4) Human health exposure assessment. The exposure assessment will 
consider all potentially exposed and susceptible subpopulation(s) 
determined to be relevant, as identified in the final scope document 
published pursuant to paragraph (c)(6)(iv) of this section. Reasonably 
available information used to characterize exposure to susceptible 
subpopulation(s) may include:
    (i) Population-based epidemiology studies that identify risk 
factors and susceptible subpopulations;
    (ii) Information related to geographic location of subpopulations;
    (iii) Models that represent exposure or health effects of relevant 
subpopulations; and
    (iv) Any other relevant, scientifically valid information or 
methodology.
    (5) Environmental health exposure assessment. (i) The environmental 
health exposure assessment will characterize and evaluate the 
interaction of the chemical substance with the ecological 
characteristics identified in the final scope document published 
pursuant to paragraph (c)(6)(iv) of this section.
    (ii) Exposures considered will include individuals as well as 
communities, depending on the chemical substance and the ecological 
characteristic involved.


Sec.  702.41   Risk characterization and peer review procedures.

    (a) Risk Characterization Considerations. EPA will: (1) Integrate 
the hazard and exposure assessments into quantitative and/or 
qualitative estimates of risk for the identified populations (including 
any potentially exposed or susceptible subpopulation(s) identified in 
the final scope document published pursuant to 40 CFR 703.39(c)(6)(iv) 
and ecological characteristics for the conditions of use; and
    (2) Describe whether aggregate or sentinel exposures under the 
conditions of use were considered and the basis for that consideration.
    (b) The Risk Characterization will summarize, as applicable, the 
considerations addressed throughout the evaluation components, in 
carrying out the obligations under 15 U.S.C. 2625(h). This summary will 
include, as appropriate, a discussion of:
    (1) Considerations regarding uncertainty and variability. 
Information about uncertainty and variability in each step of the risk 
evaluation (e.g., use of default assumptions, scenarios, choice of 
models and information used for quantitative analysis) will be 
integrated into an overall characterization and/or analysis of the 
impact of the uncertainty and variability on estimated risks. EPA may 
describe the uncertainty using a qualitative assessment of the overall 
strength and limitations of the data used in the assessment.
    (2) Considerations of data quality. A discussion of issues 
associated with data quality (e.g., reliability, relevance, and whether 
methods employed to generate the information are reasonable for and 
consistent with the intended use of the information), as well as 
assumptions used, will be included to the extent necessary. EPA also 
expects to include a discussion of the extent of independent 
verification or peer review of the information or of the procedures, 
measures, methods, protocols, methodologies, or models used in the risk 
evaluation.
    (3) Considerations of alternative interpretations. If appropriate 
and

[[Page 7580]]

relevant, a discussion of alternative interpretations of the data and 
analyses will be included.
    (4) Considerations for environmental risk evaluations. For 
environmental risk evaluations, it may be necessary to discuss the 
nature and magnitude of the effects, the spatial and temporal patterns 
of the effects, implications at the individual, species, and community 
level, and the likelihood of recovery subsequent to exposure to the 
chemical substance.
    (c) Peer Review. The EPA Peer Review Handbook (2015), the Office of 
Management and Budget Final Information Quality Bulletin for Peer 
Review (OMB Bulletin), or other available, relevant and applicable 
methods consistent with 15 U.S.C. 2625, will serve as the guidance for 
peer review activities. Peer review will be conducted on the risk 
evaluations for the chemical substances identified pursuant to 15 
U.S.C. 2605(b)(4)(A).


Sec.  702.43   Unreasonable risk determination.

    The EPA will determine whether the chemical substance presents an 
unreasonable risk of injury to health or the environment under the 
conditions of use as identified in the final scope document published 
pursuant to 40 CFR 702.39(c)(6)(iv).


Sec.  702.45   Risk evaluation timeframes and actions.

    (a) Draft risk evaluation timeframe. The EPA will publish a draft 
risk evaluation in the Federal Register and provide no less than a 30-
day comment period, during which time the public may submit comment on 
EPA's draft risk evaluation.
    (1) EPA will open a docket to facilitate receipt of public comment.
    (2) All comments that could be raised on the matters addressed and 
issues presented in the draft risk evaluation must be presented during 
this comment period. Any issues not raised at this time will be 
considered to have been waived, and may not form the basis for an 
objection or challenge in any subsequent administrative or judicial 
proceeding.
    (b) Final risk evaluation. (1) EPA will complete a risk evaluation 
for the chemical substance as soon as practicable, but not later than 3 
years after the date on which the Agency initiates the risk evaluation.
    (2) The Agency may extend the deadline for a risk evaluation for 
not more than 6 months.
    (3) EPA will publish the final risk evaluation in the Federal 
Register.
    (c) Final determination of unreasonable risk. Upon determination by 
the EPA that a chemical substance does present an unreasonable risk of 
injury to health or the environment, the Agency will initiate action as 
required pursuant to 15 U.S.C. 2605(a).
    (d) Final determination of no unreasonable risk. A determination by 
the EPA that the chemical substance does not present an unreasonable 
risk of injury to health or the environment will be issued by order and 
considered to be a final EPA action, effective on the date of issuance 
of the order.
    (c) Reassessment. EPA may reassess an unreasonable risk 
determination based on a review of available information.


Sec.  702.47   Publically available information.

    For each risk evaluation, EPA will maintain a public docket at 
http://www.regulations.gov to provide public access to the following 
information, as applicable for that risk evaluation:
    (1) The draft scope, final scope, draft risk evaluation, and final 
risk evaluation;
    (2) All notices, determinations, findings, consent agreements, and 
orders;
    (3) Any information required to be provided to the Agency under 15 
U.S.C. 2603;
    (4) A nontechnical summary of the risk evaluation;
    (5) A list of the studies, with the results of the studies, 
considered in carrying out each risk evaluation;
    (6) The final peer review report, including the response to peer 
review comments; and
    (7) Response documents to the public comments on the draft risk 
evaluation.

[FR Doc. 2017-01224 Filed 1-18-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                      7562                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      ENVIRONMENTAL PROTECTION                                Protection Agency, 1200 Pennsylvania                   importers) would request an Agency-
                                                      AGENCY                                                  Ave. NW., Washington, DC 20460–0001.                   conducted risk evaluation, and the
                                                                                                                • Hand Delivery: To make special                     criteria by which the EPA would
                                                      40 CFR Part 702                                         arrangements for hand delivery or                      evaluate such requests.
                                                                                                              delivery of boxed information, please
                                                      [EPA–HQ–OPPT–2016–0654; FRL–9957–75]                    follow the instructions at http://                     C. What is the agency’s authority for
                                                                                                              www.epa.gov/dockets/contacts.html.                     taking this action?
                                                      RIN 2070–AK20                                             Additional instructions on
                                                                                                                                                                       EPA is proposing this rule pursuant to
                                                      Procedures for Chemical Risk                            commenting or visiting the docket,
                                                                                                              along with more information about                      the authority in TSCA section 6(b)(4), as
                                                      Evaluation Under the Amended Toxic                                                                             amended (15 U.S.C. 2605(b)). See also
                                                      Substances Control Act                                  dockets generally, is available at http://
                                                                                                              www.epa.gov/dockets.                                   the discussion in Units II.A. and B.
                                                      AGENCY:  Environmental Protection                       FOR FURTHER INFORMATION CONTACT:                       D. What are the estimated incremental
                                                      Agency (EPA).                                             For technical information contact:                   impacts of this action?
                                                      ACTION: Proposed rule.                                  Susanna W. Blair, Immediate Office,
                                                                                                              Office of Pollution Prevention and                        Although this proposal focuses on the
                                                      SUMMARY:    As required under section                   Toxics, Environmental Protection                       process and activities that apply to EPA,
                                                      6(b)(4) of the Toxic Substances Control                 Agency, 1200 Pennsylvania Ave. NW.,                    it also proposes the process and
                                                      Act (TSCA), EPA is proposing to                         Washington, DC 20460–0001; telephone                   requirements that manufacturers
                                                      establish a process for conducting risk                 number: (202) 564–4371; email address:                 (including importers) would be required
                                                      evaluations to determine whether a                      blair.susanna@epa.gov.                                 to follow when they request an Agency-
                                                      chemical substance presents an                            For general information contact: The                 conducted risk evaluation on a
                                                      unreasonable risk of injury to health or                TSCA-Hotline, ABVI-Goodwill, 422                       particular chemical substance. Since
                                                      the environment, without consideration                  South Clinton Ave., Rochester, NY                      these requirements qualify as an
                                                      of costs or other non-risk factors,                     14620; telephone number: (202) 554–                    information collection under the
                                                      including an unreasonable risk to a                     1404; email address: TSCA-Hotline@                     Paperwork Reduction Act (PRA), 44
                                                      potentially exposed or susceptible                      epa.gov.                                               U.S.C. 3501 et seq., EPA has prepared
                                                      subpopulation, under the conditions of                  SUPPLEMENTARY INFORMATION:                             an Information Collection Request (ICR)
                                                      use. Risk evaluation is the second step,                                                                       to estimate the potential burden and
                                                      after Prioritization, in a new process of               I. Executive Summary                                   costs associated with the proposed
                                                      existing chemical substance review and                  A. Does this action apply to me?                       requirements for submitting a request
                                                      management established under recent                                                                            for an Agency-conducted risk evaluation
                                                      amendments to TSCA. This proposed                          EPA is primarily proposing to
                                                                                                              establish requirements on the Agency.                  on a particular chemical substance. The
                                                      rule identifies the steps of a risk                                                                            ICR, which is available in the docket, is
                                                      evaluation process including scope,                     However this proposal also includes the
                                                                                                              process and requirements that                          discussed in Unit VI.B. and is briefly
                                                      hazard assessment, exposure                                                                                    summarized here. (Ref. 1).
                                                      assessment, risk characterization, and                  manufacturers (including importers)
                                                                                                              would be required to follow when they                     The total estimated annual burden is
                                                      finally a risk determination. EPA is
                                                                                                              request an Agency-conducted risk                       960.3 hours and $69,353, which is based
                                                      proposing that this process be used for
                                                                                                              evaluation on a particular chemical                    on an estimated per request burden of
                                                      the first ten chemical substances to be
                                                                                                              substance. This action may, therefore,                 96.03 hours.
                                                      evaluated from the 2014 update of the
                                                      TSCA Work Plan for Chemical                             be of interest to entities that are
                                                                                                                                                                     E. What should I consider as I prepare
                                                      Assessments, chemical substances                        manufacturing or importing, or may
                                                                                                                                                                     my comments for EPA?
                                                      designated as High-Priority Substances                  manufacture or import a chemical
                                                      during the prioritization process, and                  substance regulated under TSCA (e.g.,                     1. Submitting CBI. Do not submit this
                                                      those chemical substances for which                     entities identified under North                        information to EPA through
                                                      EPA has initiated a risk evaluation in                  American Industrial Classification                     regulations.gov or email. Clearly mark
                                                      response to manufacturer requests. The                  System (NAICS) codes 325 and 324110).                  the part or all of the information that
                                                      proposed rule also includes the required                Since other entities may also be                       you claim to be CBI. For CBI
                                                      ‘‘form and criteria’’ applicable to such                interested, the Agency has not                         information in a disk or CD–ROM that
                                                      manufacturer requests.                                  attempted to describe all the specific                 you mail to EPA, mark the outside of the
                                                                                                              entities and corresponding NAICS codes                 disk or CD–ROM as CBI and then
                                                      DATES: Comments must be received on
                                                                                                              for entities that may be interested in or              identify electronically within the disk or
                                                      or before March 20, 2017.                               affected by this action.                               CD–ROM the specific information that
                                                      ADDRESSES: Submit your comments,
                                                                                                              B. What action is the agency taking?                   is claimed as CBI. In addition to one
                                                      identified by docket identification (ID)
                                                      number EPA–HQ–OPPT–2016–0654, by                           EPA is proposing to establish the                   complete version of the comment that
                                                      one of the following methods:                           process by which the Agency would                      includes information claimed as CBI, a
                                                         • Federal eRulemaking Portal: http://                conduct risk evaluations on chemical                   copy of the comment that does not
                                                      www.regulations.gov. Follow the online                  substances under TSCA. The proposal                    contain the information claimed as CBI
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                                                      instructions for submitting comments.                   identifies the necessary components of                 must be submitted for inclusion in the
                                                      Do not submit electronically any                        a risk evaluation, including a scope                   public docket. Information so marked
                                                      information you consider to be                          (composed of a conceptual model and                    will not be disclosed except in
                                                      Confidential Business Information (CBI)                 an analysis plan), a hazard assessment,                accordance with procedures set forth in
                                                      or other information whose disclosure is                an exposure assessment, a risk                         40 CFR part 2.
                                                      restricted by statute.                                  characterization, and a risk                              2. Tips for preparing your comments.
                                                         • Mail: Document Control Office                      determination. The proposed rule                       When preparing and submitting your
                                                      (7407M), Office of Pollution Prevention                 would also establish the process by                    comments, see the commenting tips at
                                                      and Toxics (OPPT), Environmental                        which manufacturers (including                         http://www.epa.gov/dockets.


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7563

                                                      II. Background                                          risk evaluations. Specifically, EPA is                 conducted risk evaluation. EPA has
                                                                                                              directed to use this process to                        broad discretion to establish these
                                                      A. Recent Amendments to TSCA
                                                                                                              ‘‘determine whether a chemical                         criteria, but relatively less discretion
                                                         On June 22, 2016, the President                      substance presents an unreasonable risk                over whether to grant requests that
                                                      signed into law the ‘‘Frank R.                          of injury to health or the environment,                comply with EPA’s criteria. EPA must
                                                      Lautenberg Chemical Safety for the 21st                 without consideration of costs or other                grant any request that complies with
                                                      Century Act,’’ which imposed sweeping                   non-risk factors, including an                         EPA’s criteria, until the statutory
                                                      reforms to TSCA. The bill received                      unreasonable risk to a potentially                     minimum of 25 percent has been met.
                                                      broad bipartisan support in the U.S.                    exposed or susceptible subpopulation                   Assuming EPA receives requests in
                                                      House of Representatives and Senate,                    identified as relevant to the risk                     excess of this threshold, EPA interprets
                                                      and its passage was heralded as the                     evaluation by the Administrator under                  this provision to grant EPA discretion to
                                                      most significant update to an                           the conditions of use.’’ (15 U.S.C.                    determine whether to grant further
                                                      environmental law in over 20 years. The                 2605(b)(4)(A)). TSCA sections 6(b)(4)(A)               requests, up to the maximum 50 percent
                                                      amendments give EPA improved                            through (H) enumerate the deadlines                    level. In such circumstances, the EPA is
                                                      authority to take actions to protect                    and minimum requirements applicable                    directed to give preference to
                                                      people and the environment from the                     to this process, including provisions                  manufacturer requests for which the
                                                      effects of dangerous chemical                           that direct which chemical substances                  EPA determines that restrictions
                                                      substances. Additional information on                   must undergo evaluation, the                           imposed by one or more states have the
                                                      the new law is available on EPA’s Web                   development of criteria for                            potential to significantly impact
                                                      site at: https://www.epa.gov/assessing-                 manufacturer-requested evaluations, the                interstate commerce, or health or the
                                                      and-managing-chemicals-under-tsca/                      minimum components of an Agency                        environment. 15 U.S.C.
                                                      frank-r-lautenberg-chemical-safety-21st-                risk evaluation, and the timelines for                 2605(b)(4)(E)(iii). As discussed
                                                      century-act.                                            public comment and ultimate                            elsewhere in this preamble, EPA is also
                                                         When TSCA was originally enacted in                  completion of the risk evaluation.                     proposing to give preference to requests
                                                      1976, it established an EPA-                               1. Chemical substances to undergo                   where EPA estimates there may be
                                                      administered health and safety review                   risk evaluation. TSCA section 6(b)                     relatively high exposure(s) and/or
                                                      process for new chemical substances                     identifies the chemical substances that                hazard(s) under one or more conditions
                                                      prior to allowing their entry into the                  are subject to this process; these are: (1)            of use.
                                                      marketplace. However, tens of                           Ten chemical substances the Agency is                     3. Components of a risk evaluation.
                                                      thousands of chemical substances in                     required to identify from the 2014                     The statute identifies the minimum
                                                      existence at that time were                             update to the TSCA Work Plan within                    components EPA must include in all
                                                      ‘‘grandfathered in’’ with no requirement                the first 180 calendar days after the                  chemical substance risk evaluations. For
                                                      for EPA to ever evaluate their risks to                 signing of TSCA (15 U.S.C. 2605(b)(2));                each risk evaluation, EPA must publish
                                                      health or the environment. The absence                  (2) the chemical substances determined                 a document that outlines the scope of
                                                      of a review requirement or deadlines for                as High-Priority Substances through the                the risk evaluation that will be
                                                      action, coupled with a burdensome                       prioritization process that is being                   conducted, and that includes the
                                                      statutory standard for taking risk                      proposed in a separate rulemaking; and                 hazards, exposures, conditions of use,
                                                      management action on existing                           (3) requested chemicals submitted by                   and the potentially exposed or
                                                      chemical substances, resulted in very                   manufacturers that have met the criteria               susceptible subpopulations the EPA
                                                      few chemical substances ever being                      for EPA to conduct a risk evaluation as                expects to consider. 15 U.S.C
                                                      assessed for safety by EPA, and even                    outlined by this rule. Assuming a                      2605(b)(4)(D). The statute provides that
                                                      fewer subject to restrictions to address                sufficient number of requests that have                the scope of the risk evaluation must be
                                                      identified risks.                                       met the criteria outlined in this                      published no later than six months after
                                                         One of the key features of the new law               proposed rule are received, subsection                 the initiation of the risk evaluation.
                                                      is the requirement that EPA now                         (E) specifies that the number of                          Each risk evaluation must also: (1)
                                                      systematically prioritize and assess                    manufacturer-requested evaluations be                  ‘‘integrate and assess available
                                                      existing chemicals, and manage                          25 to 50 percent of the number of ‘‘High               information on hazards and exposure
                                                      identified risks. Through a combination                 Priority’’ risk evaluations ongoing at any             for the conditions of use of the chemical
                                                      of new authorities, a risk-based safety                 one time. Since the number of                          substance, including information on
                                                      standard, deadlines for action, and                     manufacturer-requested evaluations is                  specific risks of injury to health or the
                                                      minimum throughput requirements,                        expressed as a percentage of the number                environment and information on
                                                      TSCA effectively creates a ‘‘pipeline’’ by              of High-Priority Substance evaluations,                potentially exposed or susceptible
                                                      which EPA will conduct existing                         not as a percentage of the total, the                  subpopulations;’’ (2) ‘‘describe whether
                                                      chemicals review and management.                        number of manufacturer-requested                       aggregate or sentinel exposures were
                                                      This new pipeline—from prioritization                   evaluations will likely comprise                       considered and the basis for that
                                                      to risk evaluation to risk management                   between 1/5 and 1/3 of the number of                   consideration;’’ (3) ‘‘take into account,
                                                      (when warranted)—is intended to drive                   total ongoing evaluations, assuming a                  where relevant, the likely duration,
                                                      steady forward progress on the backlog                  sufficient number of compliant requests                intensity, frequency, and number of
                                                      of existing chemical substances left                    are received. Any manufacturer                         exposures under the conditions of use;’’
                                                      largely unaddressed by the original law.                requested chemical substances on the                   (4) ‘‘describe the weight of scientific
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                                                      Risk evaluation is the second step of                   2014 update of the TSCA Work Plan                      evidence for the identified hazards and
                                                      this process, after prioritization, which               (Ref. 2) are exempt from the percentage                exposure.’’ 15 U.S.C.
                                                      is being addressed in a separate                        limitations.                                           2605(b)(4)(F)(i),(iii)–(v). The risk
                                                      rulemaking.                                                2. Manufacturer-requested risk                      evaluation must not consider costs or
                                                                                                              evaluations. TSCA section 6(b)(4)(C)                   other non-risk factors. 15 U.S.C.
                                                      B. Statutory Requirements for Risk                      directs EPA to establish the ‘‘form and                2605(b)(4)(F)(ii).
                                                      Evaluation                                              manner’’ and ‘‘criteria’’ that govern                     Many stakeholders have expressed
                                                        TSCA section 6(b)(4) requires EPA to                  manufacturer requests that a substance                 concern as to how EPA will apply
                                                      establish, by rule, a process to conduct                that they manufacture undergo an EPA                   ‘‘weight of scientific evidence’’ under


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                                                      7564                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      the amended TSCA. EPA is providing,                     support conclusions concerning a                       called ‘‘systematic review’’ to assist in
                                                      for the purposes of background, a                       property of the substance. WoE is not a                WoE evaluations particularly for hazard
                                                      description of how the Agency has                       simple tallying of the number of                       identification (https://ntp.niehs.nih.gov/
                                                      consistently interpreted and applied                    positive and negative studies, but rather              pubhealth/hat/noms/index-2.html).
                                                      that concept. EPA is not proposing to                   it relies on professional judgment. The                This tool uses a defined set of processes
                                                      modify this process as part of this rule.               significant issues, strengths, and                     to identify, select, critically assess, and
                                                      Nor is EPA proposing to codify it; this                 limitations of the data and the                        synthesize evidence to arrive at a hazard
                                                      process has and will continue to evolve                 uncertainties that deserve serious                     conclusion for a chemical. It is designed
                                                      with changing scientific methods and                    consideration are presented, and the                   to enhance transparency and informs
                                                      innovation. Codifying a specific                        major points of interpretation are                     scientific judgments. The evidence
                                                      definition can inhibit the flexibility of               highlighted.                                           synthesis step involves considering
                                                      the Agency to quickly adopt and                            This WoE analysis is conducted on a                 factors that decrease confidence in the
                                                      implement changing science.                             case-by-case basis by first assembling                 body of evidence for a particular health
                                                         The phrase weight-of-evidence (WoE)                  and assessing the individual lines of                  endpoint (e.g. risk of bias,
                                                      is used by EPA and other scientific                     evidence and then performing an                        inconsistencies across studies,
                                                      bodies to describe the strength of the                  integrated analysis of those lines of                  imprecision) as well as factors that
                                                      scientific inferences that can be drawn                 evidence. All data considered in the                   increase confidence (e.g. magnitude of
                                                      from a given body of evidence,                          WoE analysis need to be documented                     the effect, residual confounding,
                                                      specifically referring to how studies are               and scientifically acceptable. A WoE                   consistency). By evaluating study design
                                                      selected, the quality of the studies                    analysis typically begins with a careful               (e.g., consistent with study guidelines
                                                      evaluated, and how findings are                         evaluation of each individual study. The               issued by OECD, and test guidelines
                                                      assessed and integrated. Weight-of-                     process of evaluating the individual                   issued by the Office of Chemical Safety
                                                      evidence is a complex issue and as                      lines of evidence includes assembling                  and Pollution Prevention), and study
                                                      stated by the National Academies this is                the data, evaluating that data against                 quality (e.g., studies that comply with
                                                      ‘‘because scientific evidence used in                   current acceptance and quality criteria,               Good Laboratory Practices (GLP) like
                                                      WOE evaluations varies greatly among                    and presenting the conclusions                         those applicable generally (https://
                                                      chemicals and other hazardous agents in                 regarding the results for each study. The              www.federalregister.gov/documents/
                                                      type, quantity, and quality, it is not                  reviews of the available studies need to               2016/08/24/2016–19875/good-
                                                      possible to describe the WoE evaluation                 be transparent about what studies were                 laboratory-practice-for-nonclinical-
                                                      in other than relatively general terms. It              considered or not, and how the quality                 laboratory-studies) and those issued by
                                                      is thus not unexpected that WoE                         of a study was judged.                                 EPA for studies submitted under TSCA
                                                      judgements in particular cases can vary                    After assembling and assessing the                  and FIFRA (https://www.epa.gov/
                                                      among experts and that consensus is                     individual lines of data, an integrated                compliance/good-laboratory-practices-
                                                      sometimes difficult to achieve’’ (NAS,                  analysis is performed. This means the                  standards-compliance-monitoring-
                                                      2009) (Ref. 3). The following is a brief                results from all scientifically relevant               program)), and integrating negative data
                                                      description of how WoE is used at EPA,                  published or publically available peer-                (and consideration of the quality of
                                                      serving as an example of successful                     reviewed studies, which are of sufficient              those data), the confidence in hazard
                                                      application of WOE in making the                        quality and reliability, are evaluated                 conclusions can be increased.
                                                      scientific determinations.                              across studies and endpoints into an                      The NIEHS systematic review tool is
                                                         EPA utilizes the WoE approach in                     overall assessment. In general, the WoE                one example of a documented
                                                      existing programs including IRIS and                    analysis examines multiple lines of                    systematic review approach. EPA
                                                      the Endocrine Disruptor Screening                       evidence considering a number of                       believes the proposed risk evaluation
                                                      Program among others, and in the                        factors, including for example the                     process generally reflects the use of
                                                      classification of carcinogens. In the 1999              nature of the effects within and across                systematic review approaches that are
                                                      Guidelines for Carcinogen Risk                          studies, including number, type, and                   appropriate for the types and quantity of
                                                      Assessment (Ref. 4) EPA refers to the                   severity/magnitude of effects and                      information used in a chemical risk
                                                      WoE approach as ‘‘. . . a collective                    strengths and limitations of the                       evaluation. EPA requests comment on
                                                      evaluation of all pertinent information                 information.                                           this view. EPA is also requesting
                                                      so that the full impact of biological                      A summary WoE narrative or                          comment on the need for regulatory text
                                                      plausibility and coherence is adequately                characterization generally accompanies                 requiring the use of specific elements of
                                                      considered (Ref. 5). The Endocrine                      the detailed analysis of the individual                a systematic review approach for hazard
                                                      Disruptor Screening and Testing                         studies and the integrative analysis of                identification, including the
                                                      Advisory Committee (EDSTAC) referred                    the multiple lines of evidence. Inclusion              appropriateness of specific elements
                                                      to the WoE approach as ‘‘. . . a process                of a WoE narrative is common in WoE                    that might be included and/or concerns
                                                      by which trained professionals judge the                assessments and judgments (Ref. 4 and                  about codifying such an approach.
                                                      strengths and weaknesses of a collection                7). The narrative/characterization is                     4. Timeframe. TSCA requires that the
                                                      of information to render an overall                     intended to be transparent and allow the               risk evaluation process last no longer
                                                      conclusion that may not be evident from                 reader to clearly understand the                       than three years with a possible six-
                                                      consideration of the individual data’’                  reasoning behind the conclusions. The                  month extension. 15 U.S.C.
                                                      (Ref. 6).                                               narrative will generally explain the                   2605(b)(4)(G).
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                                                         WoE is the process for characterizing                selection of the studies or effects used                  5. Opportunities for public
                                                      the extent to which the available data                  as the main lines of evidence and                      participation. The statute requires that
                                                      support a hypothesis that an agent                      relevant basis for conclusions. The                    the Agency allow for at least one 30 day
                                                      causes a particular effect (Ref. 4 and 5).              overall strength of the evidence                       public comment period on the draft risk
                                                      This process involves a number of steps                 supporting a conclusion from the WoE                   evaluation, prior to publishing a final
                                                      starting with assembling the relevant                   evaluation needs to be described.                      risk evaluation. 15 U.S.C. 2605(b)(4)(H).
                                                      data, evaluating that data for quality and                 The National Toxicology Program of                     6. Metals and metal compounds.
                                                      relevance, followed by an integration of                the National Institute of Environmental                When evaluating metals or metal
                                                      the different lines of evidence to                      Health Sciences has developed a tool                   compounds, EPA must ‘‘use’’ the March


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7565

                                                      2007 Framework for Metals Risk                          Cumulative Risk Assessment: The Tasks                  evaluation process. EPA requests
                                                      Assessment of the Office of the Science                 Ahead (2008) (Ref. 8), and Science and                 comment on whether and how the
                                                      Advisor (Ref. 8) or a successor                         Decisions: Advancing Risk Assessment                   proposed rule could provide additional
                                                      document that addresses metals risk                     (2009) (Ref. 3). Specifically, the NAS                 transparency, public accountability,
                                                      assessment and is peer-reviewed by the                  NRC Science and Decisions Report (Ref.                 opportunities for public participation,
                                                      Science Advisory Board.                                 3) recommended that EPA focus on the                   or incorporation of statutory deadlines.
                                                         7. Other statutory requirements. TSCA                important roles of scoping or problem                     There are several key differences
                                                      imposes new requirements on EPA in a                    formulation so that a risk assessment                  between previous chemical risk
                                                      number of different areas that EPA is                   will serve a specific and documented                   assessments conducted under TSCA and
                                                      not proposing to incorporate or                         purpose. An additional                                 the new risk evaluation process
                                                      otherwise address in this proposed rule.                recommendation encouraged EPA to                       mandated by TSCA amendments and
                                                      For example, amendments to TSCA                         develop risk assessments that are well-                established under these proposed
                                                      section 4 require EPA to ‘‘. . . reduce                 tailored to the problems and decisions                 regulations. These differences include
                                                      and replace, to the extent practicable,                 at hand so that they can inform the                    considerations of conditions of use,
                                                      [. . .] the use of vertebrate animals in                decision-making process in the most                    timelines, and determination of
                                                      the testing of chemical substances . . .’’              meaningful way. EPA has evaluated,                     unreasonable risk, and are discussed in
                                                      and to develop a strategic plan to                      and will continue to evaluate chemical                 more detail under those topics in this
                                                      promote such alternative test methods.                  risks in a manner that is best suited for              unit. This proposed rule and procedures
                                                      15 U.S.C. 2603(h). Likewise, TSCA                       the particular chemical substance,                     described herein apply to risk
                                                      section 26 requires, to the extent that                 including its manufacture, processing,                 evaluations conducted under TSCA, and
                                                      EPA makes a decision based on science                   formulation, uses, and disposal, and the               do not apply to risk evaluations
                                                      under TSCA sections 4, 5, or 6, that EPA                evaluations may vary as necessary to                   conducted by EPA pursuant to other
                                                      uses certain scientific standards and                   best characterize potential risks related              statutes or programs.
                                                      bases those decisions on the weight of                  to the chemical substance under review.                   2. Conditions of use. Prior to the
                                                      the scientific evidence. 15 U.S.C.                         As stated, TSCA requires EPA to                     amended TSCA, EPA was free to and
                                                      2625(h) and (i). While these                            evaluate risk to relevant potentially                  did conduct risk assessments on
                                                      requirements are relevant to the risk                   exposed or susceptible subpopulations                  selected uses of chemical substances. In
                                                      evaluation of chemical substances, EPA                  identified by EPA as relevant to the risk              contrast, EPA interprets the amended
                                                      is not obliged to repeat them in this                   evaluation under the conditions of use.                TSCA as requiring that risk evaluations
                                                      proposed rule. As statutory                             15 U.S.C. 2605(b)(4)(A). Although this                 encompass all manufacture, processing,
                                                      requirements, they apply to EPA’s                       was added as a component of the newly                  distribution in commerce, use, and
                                                      decisions under TSCA section 6.                         amended law, this will not be a new                    disposal activities that constitute the
                                                      Moreover, in contrast to TSCA section 6,                consideration for the Agency; for                      conditions of use within the meaning of
                                                      Congress has not directed EPA to                        example, see EPA’s Policy on Evaluating                TSCA section 3. That is to say, a risk
                                                      implement these other requirements ‘‘by                 Health Risks to Children (1995) (Ref.                  evaluation must encompass all known,
                                                      rule;’’ it is well-established that where               14). The Agency has evaluated the risk                 intended, and reasonably foreseen
                                                      Congress has declined to require                        of chemical substances to all sectors of               activities associated with the subject
                                                      rulemaking, the implementing agency                     the population, with particular attention              chemical substance. This issue has been
                                                      has complete discretion to determine                    to workers, indigenous peoples,                        the subject of considerable discussion
                                                      the appropriate method by which to                      pregnant women, children, infants, the                 since the enactment of the new law, and
                                                      implement those provisions.                             elderly, environmental justice                         EPA acknowledges that different
                                                                                                              communities, and fence-line                            readings of the law may be possible. For
                                                      C. EPA Risk Assessment                                                                                         example, TSCA section 6(b)(4)(D)
                                                                                                              communities, among others. The
                                                        Since EPA’s inception, human health                   Agency utilizes a number of existing                   requires EPA to identify the conditions
                                                      and ecological risk assessment has                      guidance documents (including but not                  of use that the Agency expects to
                                                      informed decisions made to protect                      limited to Ref. 15, 16, 17, 18, and 19) to             consider in a risk evaluation, suggesting
                                                      humans and the environment. Risk                        evaluate risk at various life stages, and              that EPA does not need to consider all
                                                      assessments performed by the Agency                     will use and refine these processes to                 conditions of use.
                                                      inform a broad range of regulatory                      protect the most vulnerable.                              Overall, the statutory text and
                                                      decisions, and, over time, the scientific                  1. Differences between previous EPA                 purpose are best effectuated through a
                                                      approaches and methods employed for                     risk assessments under TSCA and                        more encompassing reading. TSCA
                                                      these risk assessments have evolved. In                 proposed new risk evaluations. In this                 section 6(b)(4)(A) specifies that a risk
                                                      developing and refining risk assessment                 proposed rule, EPA does not propose a                  evaluation must determine whether ‘‘a
                                                      processes, frameworks, and guidance                     new method of risk evaluation, but                     chemical substance’’ presents an
                                                      documents, EPA has incorporated                         builds upon existing and proven                        unreasonable risk of injury to health or
                                                      recommendations from expert technical                   methodologies for evaluating risk. Also                the environment ‘‘under the conditions
                                                      panels, internal and external peer                      as required by the statute, the rule                   of use.’’ The evaluation is on the
                                                      reviews, and a number of influential                    includes opportunities for public                      chemical substance—not individual
                                                      reports from the National Academy of                    participation, statutory deadlines,                    conditions of use—and it must be based
                                                      Sciences (NAS) National Research                        necessary components of a risk                         on ‘‘the conditions of use.’’ In this
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                                                      Council (NRC) including Risk                            evaluation, and methods for                            context, EPA believes the word ‘‘the’’ is
                                                      Assessment in the Federal Government                    manufacturer requested risk evaluation.                best interpreted as calling for evaluation
                                                      (1983) (Ref. 9), Science and Judgement                  Above and beyond the statute, the                      that considers all conditions of use.
                                                      in Risk Assessment. (1994) (Ref. 10),                   proposed rule provides an additional                   First, if EPA were free to base its
                                                      Understanding Risk: Informing                           opportunity for public participation,                  determination of whether a chemical
                                                      Decisions in a Democratic Society                       added detail as to components of the                   substance, as a whole, presents an
                                                      (1996) (Ref. 11), Toxicity Testing in the               scope, hazard and exposure                             unreasonable risk or injury (as the
                                                      21st Century: A Vision and a Strategy                   assessments, risk characterization, and                statute requires) on merely a subset of
                                                      (2007) (Ref. 12), Phthalates and                        increases transparency in the risk                     individual uses, it could, for example,


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                                                      7566                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      determine that a chemical substance                     making its determination of whether a                  combination of different types of
                                                      with 10 known uses does not present an                  condition of use is known, intended, or                information and other approaches.
                                                      unreasonable risk of injury based on an                 reasonably foreseen. Moreover, in this                    In sum, Congress intended to create
                                                      evaluation of a single one of those uses,               proposed rule EPA proposes to ‘‘lock                   obligations that EPA can actually meet,
                                                      with no further obligation to evaluate                  down’’ the conditions of use included in               and EPA intends to conduct risk
                                                      the remaining uses within the three-year                a risk evaluation at the time of scoping,              evaluations in a way that is manageable
                                                      statutory deadline. This is a strained                  by providing opportunity for comment                   given the statutory deadlines.
                                                      reading of the commands to determine                    on the scoping document and specifying                    3. Timelines and guidance regarding
                                                      whether the chemical substance                          that any objections to the draft scope                 assessing risks of existing chemical
                                                      presents an unreasonable risk, under the                document are waived if not raised                      substances. Prior to the amended TSCA,
                                                      conditions of use, and to complete that                 during this process. It will not be                    EPA was not required to evaluate or
                                                      evaluation ‘‘for a chemical substance’’                 practicable to meet the statutory                      manage the risk of the thousands of
                                                      within three years of initiation. See 15                deadlines if stakeholders are free to                  existing chemical substances
                                                      U.S.C (b)(4)(G)(i).                                     identify additional conditions of use                  grandfathered in under the 1976 Act. As
                                                         Second, a major objective of the new                 later in the process—for example, on the               discussed previously, the amended
                                                      law is to require EPA to systematically                 proposed risk determination.                           TSCA affirmatively requires EPA to
                                                      evaluate existing chemical substances to                   As explained elsewhere in this                      evaluate existing chemical substances
                                                      determine whether or not they present                   preamble, EPA also generally intends to                more quickly, instructs EPA on how
                                                      unreasonable risk, and, if necessary,                   initiate risk evaluation on a chemical                 many of these chemical substances the
                                                      regulate them based on the results of the               substance only when EPA determines                     Agency must evaluate at any given time,
                                                      evaluation. Given the large number of                   that sufficient reasonably available                   and places time limits on when these
                                                      existing chemical substances, it would                  information exists to complete the                     evaluations must be completed. 15
                                                      not be feasible to complete risk                        evaluation, and when it has already                    U.S.C. 2605(b)(2)–(4).
                                                      evaluations on any significant number                   identified all of the conditions of use.                  4. Determination of unreasonable risk.
                                                      of them if EPA were to continually need                 As also explained elsewhere in this                    Under TSCA section 6(b) (15 U.S.C.
                                                      to re-evaluate chemical substances                      preamble, under certain circumstances                  2605(b)(4)(B)), EPA must establish a risk
                                                      based on different subset of uses. Rather               EPA may expedite an evaluation for a                   evaluation process to determine
                                                      the law’s purposes will be best fulfilled               particular condition of use to move                    whether a chemical substance presents
                                                      by judging in a comprehensive way                       more rapidly to risk management under                  an unreasonable risk of injury to health
                                                      whether a chemical substance, under                     TSCA section 6(a).                                     or the environment. Prior to the passage
                                                      the known, intended, and reasonably                        Finally, the proposed rule provides                 of the amended TSCA, chemical
                                                      foreseen uses and other activities,                     that EPA will rely on a combination of                 substance risk assessments did not
                                                      presents an unreasonable risk; ensuring                 information, accepted science policies                 include a determination of unreasonable
                                                      through regulation that it does not                     (e.g., defaults and uncertainty factors),              risk. This step was reserved for risk
                                                      present an unreasonable risk, if                        models and screening methodologies in                  management rulemaking. The amended
                                                      necessary; and then presumptively                       conducting risk evaluations, with                      statute now requires that a risk
                                                      being done with that chemical                           considerations of evolving science and                 evaluation include a risk assessment as
                                                      substance (pending re-prioritization for                technology. It further provides that the               well as the EPA’s determination of
                                                      some unforeseen reason). Finally, EPA                   balance of information, science policy                 unreasonable risk, and, most
                                                      notes that, if the law is read as allowing              decisions, models, and screening                       significantly, requires that this
                                                      EPA to select particular conditions of                  methodologies used in risk evaluation                  determination be independent of cost or
                                                      use, it provides no criteria for EPA to                 will be informed by the deadlines                      other non-risk factors. 15 U.S.C.
                                                      apply in making such a selection.                       specified in TSCA section 6(b)(4)(G) for               2506(b)(4)(A) and (F)(iii).
                                                         Given these considerations, the                      completing such evaluations, and by the                   In general, EPA may weigh a variety
                                                      instruction in TSCA section 6(b)(4)(D)                  extent to which the generation of                      of factors in determining unreasonable
                                                      for the Agency to identify the conditions               additional information is warranted by                 risk. These factors include, but are not
                                                      of use it expects to consider in a risk                 the reduction in uncertainty that the                  limited to, characterization of cancer
                                                      evaluation is best read as directing the                information would afford in                            and non-cancer risks (including margins
                                                      Agency to identify the uses and other                   determining whether a chemical                         of exposure for non-cancer risks), the
                                                      activities that it has determined                       substance presents an unreasonable risk                population exposed (including any
                                                      constitute the conditions of use, not as                of injury to health or the environment.                susceptible populations), the severity of
                                                      a license to choose among conditions of                    In this regard, EPA is also proposing               hazard (the nature of the hazard), the
                                                      use.                                                    to require that the components of its risk             irreversibility of hazard, uncertainties,
                                                         Concerns have been raised about                      evaluations will be ‘‘fit for purpose.’’ All           and estimates of cumulative exposure.
                                                      EPA’s ability to meet the statutory risk                conditions of use will not warrant the                 Because of the case-by-case nature of
                                                      evaluation deadlines if all conditions of               same level of evaluation, and EPA                      each of these factors EPA has purposely
                                                      use must be considered. Concerns have                   expects it may be able to reach                        not proposed a definition of
                                                      also been raised about ensuring that                    conclusions without extensive or                       unreasonable risk in this rule. However,
                                                      EPA can act promptly to address any                     quantitative evaluations of risk. For                  EPA is specifically requesting comments
                                                      unreasonable risks identified for                       example, lower-volume or less                          on whether EPA should define
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                                                      particular conditions of use. EPA                       dispersive uses might receive less                     unreasonable risk in the final rule. If so,
                                                      acknowledges that this will be                          quantitative, data-driven evaluations                  acknowledging that the statute
                                                      challenging but based on the procedures                 than uses with more extensive or                       precludes consideration of costs and
                                                      outlined in this proposal, expects it will              complicated exposure patterns.                         other non-risk factors at this step, what
                                                      be manageable. First, a use or other                    Consistent with EPA’s current practice                 factors should EPA consider in making
                                                      activity constitutes a condition of use                 in conducting risk assessments,                        such a determination?
                                                      under the definition only if EPA                        technically sound risk determinations                     5. Manufacturer-requested
                                                      determines that it does. EPA has                        can be made, consistent with the best                  evaluations and draft risk evaluations
                                                      authority to exercise judgment in                       available science, through a                           by interested persons. The newly


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7567

                                                      amended TSCA requires that a portion                    changes in the law, manufacturers are                  Agency to engage with industry to
                                                      of ongoing risk evaluations be                          now able to submit their own draft risk                obtain hazard and exposure data and to
                                                      conducted on chemical substances                        evaluations. Commenters noted that if                  utilize the new order authority allowed
                                                      requested by manufacturers ‘‘in a form                  these submitted evaluations are to be                  under the law (TSCA section 4).
                                                      and manner and using criteria’’ EPA                     equivalent as Agency draft risk                        Commenters suggested an increased use
                                                      prescribes by rule. 15 U.S.C.                           evaluations, having specific criteria,                 of EPA’s Office of Research and
                                                      2605(b)(4)(C)(ii),(E)(i). The statute also              such as specific types of exposure and                 Development (ORD) and internationally
                                                      requires EPA to develop guidance                        hazard information would ensure the                    accepted data, models, and products. A
                                                      (which will be forthcoming) to assist                   Agency and the manufacturers were                      number of stakeholders expressed their
                                                      interested persons in submitting draft                  held to the same standard. Stakeholders                support for the new provision in the law
                                                      risk evaluations, and requires EPA to                   also suggested that holding a public                   that requires the Agency to reduce and
                                                      consider such submitted drafts. 15                      comment period for the draft risk                      replace vertebrate testing (TSCA section
                                                      U.S.C. 2625(l)(5).                                      evaluation scope would increase the                    4(h)) in obtaining chemical substance
                                                                                                              transparency of each risk evaluation                   hazard and exposure data.
                                                      D. Stakeholder Feedback
                                                                                                              early in the process and allow the                        EPA considered all of these comments
                                                         On August 9, 2016, EPA held a one-                   public to comment on any data gaps or                  in the development of this proposed
                                                      day public meeting to obtain public                     discrepancies.                                         rule, and welcomes additional feedback
                                                      comment and feedback regarding the                         Other stakeholders urged the Agency                 from stakeholders on the proposed
                                                      development and implementation of the                   to reserve specific scientific processes               process and requirements presented in
                                                      risk evaluation rule. The meeting began                 regarding hazard and exposure                          this document.
                                                      with an explanation of how the Agency                   information for Agency guidance and
                                                      currently conducts risk assessments (see                discretion, suggesting the rule should                 III. The Proposed Rule
                                                      https://www.epa.gov/sites/production/                   address only the process and procedure.                A. Policy Objectives
                                                      files/2016-08/documents/risk_                           This approach would allow the Agency
                                                      evaluation_9_august_2016.pdf). The                      to be flexible and adapt to the changing                  The risk evaluation process under
                                                      remainder of the day was reserved for                   science of risk evaluation and the                     TSCA is ultimately how EPA will
                                                      public comment. Each commenter was                      science that informs risk evaluation.                  determine whether a chemical
                                                      provided four minutes to comment and                       A number of commenters spoke about                  substance presents an unreasonable risk
                                                      there was a total of 47 oral comments on                the statute’s requirement that the                     of injury to health or the environment.
                                                      the risk evaluation rule. Additionally,                 Agency determine the specific risk to                  The overall objective of this action is to
                                                      EPA opened a docket for submission of                   ‘‘potentially exposed or susceptible                   propose to codify the process by which
                                                      written comments and received 57                        subpopulation[s]’’. Although the law                   the Agency evaluates risk from chemical
                                                      comments, many of which were from                       defines this term to include ‘‘infants,                substances for purposes of TSCA section
                                                      the same commenters at the public                       children, pregnant women, workers, or                  6. In this proposed rule, the Agency
                                                      meeting. These comments, and a                          the elderly,’’ many encouraged the                     details those components of TSCA risk
                                                      transcript of the meeting are accessible                Agency to consider expanding the                       evaluation and key factors that EPA
                                                      in the meeting’s docket, identified by                  definition to include for example:                     deems are necessary to consider in each
                                                      Docket ID No. EPA–HQ–OPPT–2016–                         environmental justice communities,                     risk evaluation to ensure that the public
                                                      0399, which is available online at                      Arctic communities, American Indian                    has a full understanding of how risk
                                                      https://www.regulations.gov/.                           communities, communities with little                   evaluations will be conducted.
                                                         The commenters included industry,                    access to preventative health-care,                    However, EPA is not proposing to
                                                      environmental groups, academics,                        subsistence fishers, and fence-line                    establish highly detailed provisions that
                                                      private citizens, trade associations, and               communities. There were a number of                    will address every eventuality or
                                                      health care interest groups and                         stakeholders who encouraged the                        possible consideration that might arise.
                                                      representatives. The comments were                      Agency to work with the Occupational                   Due to the rapid advancement of the
                                                      very informative for both rule                          Safety & Health Administration (OSHA),                 science of risk evaluation and the
                                                      development and risk evaluation                         the National Institute for Occupational                science and technology that inform risk
                                                      implementation. While not all of the                    Safety and Health (NIOSH), and the                     evaluation, this proposed rule seeks to
                                                      comments are captured here, there were                  Consumer Product Safety Commission                     balance the need for the risk evaluation
                                                      a number of themes that emerged.                        (CPSC), among other federal agencies, to               procedures to be transparent, without
                                                      Overall, there was a general expression                 better protect against occupational and                unduly restricting the specific science
                                                      of support for the new law and EPA’s                    consumer exposures. Also regarding                     that will be used to conduct the
                                                      inclusive approach to implementation.                   exposure, stakeholders encouraged the                  evaluations, allowing the Agency
                                                      Many of the commenters agreed the rule                  examination of cumulative and low                      flexibility to adapt and keep current
                                                      has the potential to increase                           dose exposures in risk evaluations,                    with changing science as it conducts
                                                      transparency in EPA’s chemical                          which are not specifically mentioned in                TSCA evaluations into the future.
                                                      substance risk evaluation process. Many                 the new statute.
                                                                                                                 A number of commenters emphasized                   B. Interagency Collaboration
                                                      urged the Agency to work towards this
                                                      goal, while creating an open scientific                 the need for EPA to maximize                             EPA recognizes that other Federal
                                                      dialogue.                                               transparency throughout the evaluation                 agencies may be able to provide
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                                                         Questions arose about how the                        process. The EPA received a number of                  important use, exposure and hazard
                                                      Agency will determine ‘‘unreasonable                    comments about the science used to                     information that is likely to be relevant
                                                      risk’’ and implement TSCA section 26                    inform individual risk evaluations,                    to a risk evaluation of chemical
                                                      requirements including ‘‘best available                 including the types of data, models,                   substances. EPA is committed to
                                                      science’’ and ‘‘weight of scientific                    policy assumptions (e.g., default factors)             interagency engagement and dialogue
                                                      evidence.’’ Some suggested that EPA                     and computational approaches. A                        throughout its risk evaluation process,
                                                      should codify in this rule the meaning                  number of commenters argued that a                     including data sharing, information
                                                      of these terms along with other details                 lack of data does not equate to a lack of              requests, and consultation regarding
                                                      of the risk evaluation process. Due to                  risk. Stakeholders encouraged the                      specific chemicals of interest. As such,


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                                                      7568                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      EPA has reached out to other agencies,                  case where EPA would find it necessary                 generated, as reasonably available,
                                                      inviting them to join the agency in an                  to pursue a risk evaluation in phases,                 because it will typically not be feasible
                                                      open and collaborative dialogue. EPA                    the Agency will still complete the full                for EPA to require significant chemical
                                                      intends to continue and expand its                      risk evaluation on all identified                      testing and receive and assess those test
                                                      interagency collaboration efforts for                   conditions of use within the statutory 3-              results during the three to three and a
                                                      chemicals management and risk                           year deadline. Therefore, relying on this              half year window allotted for risk
                                                      evaluations under TSCA.                                 discretion, EPA is proposing to                        evaluation. Accordingly, EPA intends to
                                                        To coordinate with other agencies on                  explicitly recognize its authority to                  generally ensure that sufficient
                                                      TSCA implementation generally, EPA                      complete risk evaluations in phases, and               information to complete a risk
                                                      intends to continue to use—and expand                   to manage unreasonable risks as they are               evaluation exists and is available to the
                                                      where appropriate—existing interagency                  identified through those phases under                  Agency prior to initiating the evaluation
                                                      groups, such as the OMNE (OSHA–                         TSCA section 6(a) in the regulation.                   (indeed, prior to initiating
                                                      MSHA–NIOSH–NIEHS–EPA)                                                                                          prioritization). EPA also generally
                                                      Committee and the National Science                      D. Definitions
                                                                                                                                                                     intends to use its authority under TSCA
                                                      and Technology Council (NSTC)’s                            TSCA defines a number of key terms                  to require the development of new
                                                      Committee on Environment, Natural                       necessary for interpretation of the new                information, as necessary, prior to risk
                                                      Resources, and Sustainability’s new                     law. The definitions within the law                    prioritization.
                                                      Toxicity Assessment Committee. EPA is                   apply to this proposed rule. EPA has                      TSCA requires EPA, as a part of the
                                                      also committed to interagency                           also included some additional                          risk evaluation, to document whether
                                                      engagement at the working level on                      definitions in the proposed rule for                   the Agency has considered aggregate or
                                                      individual chemical evaluations.                        further clarification; these are noted and             sentinel exposure, and the basis for that
                                                        To ensure that such collaboration can                 defined later in this document. The law                decision. 15 U.S.C. 2605(b)(4)(F)(ii).
                                                      occur in a timely manner when needed,                   requires EPA to evaluate risk to                       These terms are not defined in the law,
                                                      EPA intends to initiate interagency                     ‘‘potentially exposed or susceptible                   so EPA has proposed a definition for
                                                      consultation through the existing                       subpopulation[s],’’ and although the law               aggregate exposure that is consistent
                                                      mechanisms early in the process, and                    elaborates on this phrase, EPA is                      with current Agency policies and
                                                      document these measures in the scope                    proposing to expand the definition for                 practices. ‘‘Aggregate exposure’’ means
                                                      document. However, EPA is concerned                     TSCA purposes. TSCA states that ‘‘the                  the combined exposures to an
                                                      that imposing a single, pre-determined                  term ‘potentially exposed or susceptible               individual from a single chemical
                                                      consultation step might lead to an                      subpopulation’ means a group of                        substance across multiple routes and
                                                      overly bureaucratic process that could                  individuals within the general                         across multiple pathways (Ref. 20).
                                                      limit or complicate ongoing                             population identified by the EPA who,                  ‘‘Sentinel’’ means the exposure(s) of
                                                      collaboration efforts, and so is not                    due to either greater susceptibility or                greatest significance, which may be the
                                                      proposing to codify any particular                      greater exposure, may be at greater risk               maximum exposure to an individual,
                                                      process in this regulation.                             than the general population of adverse                 population (or subpopulation), or the
                                                                                                              health effects from exposure to a                      environment to the chemical substance
                                                      C. Scope of Evaluations
                                                                                                              chemical substance or mixture, such as                 of interest (or any combination thereof).
                                                         TSCA requires risk evaluations to                    infants, children, pregnant women,                     Although sentinel exposure is not a
                                                      determine whether or not a chemical                     workers, or the elderly.’’ 15 U.S.C.                   novel way of characterizing exposure,
                                                      substance presents an unreasonable risk                 2602(12). EPA is proposing to                          this is a new term for EPA.
                                                      of injury to health or the environment                  incorporate the phrase ‘‘including but                    Other terms defined in the proposed
                                                      under the conditions of use, with                       not limited to’’ before the specific                   rule are designed to provide clarity
                                                      conditions of use being defined as ‘‘the                subpopulations identified in the                       regarding the science that will be used
                                                      circumstances, as determined by the                     statutory definition, to further clarify               to conduct an evaluation. ‘‘Pathways’’ of
                                                      EPA, under which a chemical substance                   that EPA may identify additional                       exposure refers to the mode through
                                                      is intended, known, or reasonably                       subpopulations, where warranted. As                    which one is exposed to a chemical
                                                      foreseen to be manufactured, processed,                 suggested by the statute, EPA is also                  substance, including but not limited to:
                                                      distributed in commerce, used, or                       proposing to include specific                          food, water, soil, and air (Ref. 20).
                                                      disposed of.’’ 15 U.S.C. 2602(4).                       authorization for EPA to consider both                 ‘‘Routes’’ of exposure refer to the
                                                         Although some of the commenters                      intrinsic (e.g., life stage, reproductive              particular manner which a chemical
                                                      during the public meeting suggested                     status, age, gender, genetic traits) and               substance may contact the body,
                                                      that EPA could evaluate a specific use                  acquired (e.g., pre-existing disease,                  including absorption via ingestion,
                                                      of a chemical substance, EPA is not                     geography, socioeconomic, cultural,                    inhalation, or dermally (Ref. 20). The
                                                      choosing to adopt such an                               workplace) factors when identifying this               statute requires EPA to consider ‘‘the
                                                      interpretation, for the reasons explained               population.                                            extent to which the variability and
                                                      previously. Also, EPA recognizes that                      TSCA section 26(k) (15 U.S.C.                       uncertainty . . . are evaluated and
                                                      under certain circumstances it may be                   2625(k)) states that in carrying out risk              characterized.’’ 15 U.S.C. 2625(h). EPA
                                                      necessary to expedite an evaluation for                 evaluations, EPA shall consider                        is adopting definitions for both
                                                      a particular condition of use to move                   information that is ‘‘reasonably                       ‘‘variability’’ and ‘‘uncertainty’’ from
                                                      more rapidly to risk management under                   available,’’ but the statute does not                  existing Agency guidance.
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                                                      TSCA section 6(a) (15 U.S.C. 2605(a)):                  further define this phrase. EPA is                     ‘‘Uncertainty’’ means the imperfect
                                                      this could include a situation in which                 proposing a definition for ‘‘reasonably                knowledge or lack of precise knowledge
                                                      a single use presented an unreasonable                  available’’ to mean existing information               either for specific values of interest or
                                                      risk of injury for the population as a                  that EPA possesses, or can reasonably                  in the description of a system (Ref. 21).
                                                      whole or for a susceptible                              obtain and synthesize for use in risk                  ‘‘Variability’’ means the inherent natural
                                                      subpopulation (e.g., one use results in                 evaluations, considering the deadlines                 variation, diversity, and heterogeneity
                                                      risks that EPA would determine                          for completing the evaluation. Generally               across time and/or space or among
                                                      unreasonable regardless of the risk                     speaking, EPA does not consider                        individuals within a population (Ref.
                                                      posed by other uses). However, in any                   information that has not yet been                      21).


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7569

                                                      E. Timing of Risk Evaluations                              EPA is proposing to require a                          Upon receipt of the request, EPA is
                                                                                                              manufacturer to submit a list (e.g.,                   proposing to verify that the request is
                                                        As indicated, the statute requires EPA                citations) of the reasonably available                 facially valid, i.e., that information has
                                                      to complete risk evaluations within                     information on hazard and exposure for                 been submitted that is consistent with
                                                      three years, with the possibility of a six              all the conditions of use. EPA is not                  the regulatory requirements. EPA is
                                                      month extension beyond the three year                   requesting manufacturers submit copies                 proposing that within 30 business days
                                                      timeframe. This proposed rule simply                    of the cited information. Manufacturers                of a receiving a facially valid request,
                                                      adopts these timeframes without                         must include a commitment to provide                   EPA will submit for publication an
                                                      modification or elaboration. EPA                        EPA any referenced data if they are not                announcement of the receipt of the
                                                      acknowledges this is a relatively short                 publicly available, and must certify that              request in the Federal Register, open a
                                                      timeframe, and, as discussed elsewhere                  the information submitted is accurate                  docket for the request, and provide no
                                                      in this preamble, is proposing to adopt                 and complete. EPA will not accept a                    less than a 30 calendar day comment
                                                      other procedures that will allow the                    manufacturer request where any of the                  period, to allow the public to identify
                                                      Agency to meet these deadlines.                         relevant data is not in the possession of              and/or submit any reasonably available
                                                      F. Chemical Substances for Risk                         the requestor but is with another entity.              information regarding hazard, exposure,
                                                                                                                 Consistent with TSCA section                        potentially exposed population(s) and
                                                      Evaluation
                                                                                                              6(b)(4)(E)(iii), EPA will prioritize                   subpopulation(s), and conditions of use
                                                        As identified previously, chemical                    requests where there is evidence that                  that may help inform a risk evaluation,
                                                      substances that will undergo risk                       restrictions imposed by one or more                    including identifying information gaps.
                                                      evaluation can be put into three groups:                States have the potential to have a                    The requesting manufacturer may also
                                                      (1) The first ten chemical substances the               significant impact on interstate                       submit any additional material during
                                                      Agency is required to identify within                   commerce or health or the environment,                 this time.
                                                      the first 180 calendar days of enacting                 and is therefore proposing to allow (but                  Within 9 months after the end of the
                                                      the amendments to TSCA (15 U.S.C.                       not require) manufacturers to include                  comment period, EPA will review the
                                                      2605(b)(2)); (2) the chemical substances                any evidence to support such a finding.                request along with any additional
                                                      determined as High-Priority Substances                  Following this required initial                        information received during the
                                                      through the prioritization process                      prioritization, EPA is proposing to                    comment period to determine whether
                                                      proposed in a separate rulemaking; and                  further prioritize chemical substances                 the request meets the regulatory criteria
                                                      (3) requested chemical substances                       for risk evaluation based on initial                   and will notify the manufacturer(s)
                                                      submitted by manufacturers that meet                    estimates of exposure(s) and/or                        accordingly. This time will allow EPA
                                                      the criteria for EPA to conduct an                      hazard(s) under one or more conditions                 to develop the equivalent of a
                                                      Agency risk evaluation.                                 of use or any other factor that EPA                    conceptual model to describe actual or
                                                                                                              determines may be relevant. In general,                predicted relationships between the
                                                      G. Process for Manufacturer Requested                   EPA plans to prioritize those chemical                 chemical substance and the receptors,
                                                      Risk Evaluations                                        substances where there is evidence of                  either human or environmental, with
                                                                                                              relatively high risk over those with less              consideration of potential hazards
                                                         TSCA allows a manufacturer or group                  evidence of risk.                                      throughout the life cycle of the chemical
                                                      of manufacturers to submit requests for                    Instructions for submitting CBI are                 substance—from manufacturing,
                                                      Agency conducted risk evaluations for                   also included in the proposed rule. EPA                processing, distribution in commerce,
                                                      chemical substances that they                           believes that TSCA section 14(c)(3) is                 storage, use, or disposal. If EPA
                                                      manufacture. EPA is proposing the                       best read as requiring upfront                         determines that the request is compliant
                                                      necessary components of the request in                  substantiation of non-exempt CBI                       (i.e., it has the required information
                                                      the proposed regulatory text. EPA is                    claims. In addition, EPA believes the                  necessary for conducting a risk
                                                      proposing to require that manufacturers                 obligation to review all non-exempt                    evaluation), EPA will begin the risk
                                                      demonstrate in their request that there                 chemical identification claims and 25                  evaluation process consistent with
                                                      is sufficient, reasonably available                     percent of all other non-exempt claims                 TSCA section 6(b)(4)(E)(i). If the request
                                                      information for the Agency to conduct                   will be best effectuated by requiring                  is found insufficient EPA will identify
                                                      a risk evaluation on the chemical                       substantiation at the time of submission.              the information that would be necessary
                                                      substance under the conditions of use.                     Chemical substances that EPA has                    to conduct the risk evaluation in its
                                                      EPA must complete any manufacturer-                     prioritized through the prioritization                 notification to the manufacturer. The
                                                      requested risk evaluation that it                       process (proposed in a separate                        manufacturer will have 60 calendar
                                                      determines meets the criteria within the                rulemaking), are subject to two separate               days from receipt of EPA’s
                                                      statutory three years. Unlike those                     public comment periods prior to the                    determination to submit the additional
                                                      chemical substances that have come                      completion of the prioritization process.              information. EPA will consider the
                                                      through the prioritization process,                     EPA expects that these comment                         request withdrawn if the
                                                      manufacturer-requested chemical                         periods will ensure that EPA has the                   manufacturer(s) fails to submit the
                                                      substances have not undergone initial                   necessary information to evaluate the                  additional information identified. The
                                                      risk screening and therefore EPA will                   chemical substances, including                         process for conducting the risk
                                                      not assign such chemicals a high- or                    information on all conditions of use.                  evaluation will otherwise be identical to
                                                      low-priority designation. The purpose of                Consequently, in order to ensure that                  the process for those chemical substance
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                                                      the requirements proposed as the                        chemical substances subject to                         identified as a High-Priority Substance
                                                      necessary components of the request, is                 manufacturer requests undergo risk                     through the Prioritization Process,
                                                      to allow the Agency to determine                        evaluation only if the available                       which is addressed in a separate
                                                      whether sufficient information is                       information is comparable to what EPA                  proposed rule.
                                                      ‘‘reasonably available’’ for EPA to                     will identify or generate through the
                                                      complete a risk evaluation of the                       measures identified in the proposed                    H. Risk Evaluation General Provisions
                                                      requested chemical under the                            prioritization framework rule, EPA is                    1. Agency guidance. EPA has a
                                                      conditions of use, as that term is defined              proposing opportunities to collect                     number of existing guidance documents
                                                      under TSCA section 3.                                   additional information from the public.                that inform Agency risk assessment.


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                                                      7570                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      EPA has been using risk assessments to                  information necessary to complete the                  approaching science policy decisions
                                                      characterize the nature and magnitude                   evaluation is reasonably available,                    (e.g., defaults or uncertainty factors).
                                                      of health risks to humans and ecological                which in most cases means the                             The announced availability of the
                                                      receptors from chemical contaminants                    information already exists. As                         final scope will be published in the
                                                      and other stressors that may be present                 appropriate, however, EPA will exercise                Federal Register within six months of
                                                      in the environment since its inception.                 its TSCA information collection, testing,              the initiation of the risk evaluation.
                                                      Over the years, EPA has worked with                     and subpoena authorities, including                    Although not required under the statute,
                                                      the scientific community and other                      those under TSCA sections 4, 8, and                    EPA has proposed to provide a draft
                                                      stakeholders to develop a variety of                    11(c) to develop the information needed                scope for a 45 calendar day public
                                                      guidance, guidelines, methods and                       for a risk evaluation. Pursuant to TSCA                comment period during this six month
                                                      models for use in conducting different                  section 8(e), the law requires that any                period. EPA welcomes all public
                                                      kinds of assessments. A compendium of                   person who manufacturers, processes,                   participation, but specifically
                                                      existing Agency guidance related to risk                or distributes in commerce a chemical                  encourages commenters to provide
                                                      assessments is maintained at https://                   substance or mixture and who obtains                   information they believe might be
                                                      www.epa.gov/risk/risk-assessment-                       information which supports the                         missing or may further inform the risk
                                                      guidelines. A compendium of guidance,                   conclusion that this substance presents                evaluation. That said, EPA expects to
                                                      databases and models used for assessing                 a substantial risk of injury to health or              use the comment periods during the
                                                      pesticide risks is available at https://                the environment, shall immediately                     prioritization process to reduce the
                                                      www.epa.gov/pesticide-science-and-                      inform the Agency.                                     likelihood of significant comments on
                                                      assessing-pesticide-risks, and                             To conduct a risk evaluation, EPA                   the draft scope. Consequently, the
                                                      information about available predictive                  will rely on a combination of                          proposed rule makes clear that all
                                                      models and tools for assessing                          information, models, screening                         comments that could be raised on
                                                      chemicals under TSCA can be found at                    methods, and accepted science policies,                information and approaches presented
                                                      https://www.epa.gov/tsca-screening-                                                                            in the scope must be presented during
                                                                                                              which include defaults, reasonable
                                                      tools. Each of these Web sites identify                                                                        this comment period. Any issues related
                                                                                                              estimates, and uncertainty factors, in
                                                      and link to a number of written                                                                                to scope not raised in comments at this
                                                                                                              addition to considering information
                                                      guidance documents, tools and models.                                                                          time cannot form the basis for an
                                                                                                              generated from evolving science and
                                                      Rather than starting anew, EPA intends                                                                         objection or challenge in a future
                                                                                                              technology. EPA expects to obtain
                                                      to take advantage of existing guidance,                                                                        administrative or judicial proceeding.
                                                                                                              scientific advice from the Science
                                                      tools and models that are relevant and                                                                         This is a well-established principle of
                                                                                                              Advisory Committee on Chemicals,
                                                      available for use in conducting a risk                                                                         administrative law and practice, see,
                                                                                                              which the Agency is required to develop
                                                      evaluation under this program.                                                                                 e.g., Nuclear Energy Institute v. EPA,
                                                                                                              and convene under TSCA section 26(o).
                                                         Since the law requires the                                                                                  373 F.3d 1251, 1290–1291 (D.C. Cir.
                                                                                                              In compliance with the statute, EPA will               2004), and the need for such a provision
                                                      development of additional ‘‘policies,
                                                      procedures, and guidance the                            work to reduce and replace, to the                     is reinforced by the statutory deadlines
                                                      Administrator determines are                            extent practicable, the use of vertebrate              under which EPA must operate for
                                                      necessary’’ to carry out the process in                 animals in testing chemical substances                 completing TSCA risk evaluations. Note
                                                      TSCA (15 U.S.C. 2625(l)). EPA may also                  as outlined in TSCA section 4(h).                      that EPA is not proposing to preclude
                                                      develop additional guidance(s) for risk                 I. Risk Evaluation Steps                               parties from raising newly discovered
                                                      evaluation in the future.                                                                                      information, or from raising issues that
                                                         2. Categories of chemical substances.                  1. Scope. The first step of a risk                   could not have been fairly raised during
                                                      TSCA provides EPA with authority to                     evaluation is the development of the                   this comment period. Rather, EPA seeks
                                                      take action on categories of chemical                   scope. In compliance with the statute,                 merely to prevent parties from delaying
                                                      substances: groups of chemical                          the scope will identify the conditions of              the risk evaluation by withholding
                                                      substances which are, for example,                      use, hazards, exposures, and any                       information or by providing it
                                                      similar in molecular structure, in                      potentially exposed or susceptible                     piecemeal.
                                                      physical, chemical, or biological                       subpopulations that the EPA expects to                    2. Hazard assessment. In compliance
                                                      properties, in use, or in mode of                       consider. EPA is also proposing to                     with TSCA section 6(b)(4)(F), EPA is
                                                      entrance into the human body or into                    include additional information in the                  proposing that a hazard assessment be
                                                      the environment. Although the                           scoping document, including any                        conducted on each chemical substance
                                                      proposed rule most often references                     models, screening methods, and any                     or category. A hazard assessment
                                                      ‘‘chemical substances,’’ EPA is also                    accepted science policies expected to be               identifies the types of adverse health or
                                                      proposing to include a clear statement                  used during the risk evaluation. EPA is                environmental effects that can be caused
                                                      in the regulation that nothing in the                   further proposing to include a                         by exposure to some agent in question,
                                                      proposed rule shall be construed as a                   conceptual model that will describe the                and to characterize the quality and
                                                      limitation on EPA’s authority to take                   actual or predicted relationships                      weight of evidence supporting this
                                                      action with respect to categories of                    between the chemical substance and the                 identification. Hazard Identification is
                                                      chemical substances, and that, where                    receptors, either human or                             the process of determining whether
                                                      appropriate, EPA can prioritize and                     environmental, with consideration of                   exposure to a stressor can cause an
                                                      evaluate categories of chemical                         potential hazards throughout the life                  increase in the incidence of specific
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                                                      substances.                                             cycle of the chemical substance—from                   adverse health or environmental effects
                                                         3. Information and information                       manufacturing, processing, distribution                (e.g., cancer, developmental toxicity).
                                                      sources. As discussed, the timeframe for                in commerce, storage, use, to release or                  This hazard assessment may include,
                                                      completing risk evaluation is                           disposal. Also included will be an                     but may not be limited to, evaluation of
                                                      compressed. For those chemical                          analysis plan, which will identify the                 the potential toxicity of the chemical
                                                      substances chosen by EPA to undergo                     approaches and methods EPA plans to                    substance with respect to cancer,
                                                      the risk evaluation process, EPA expects                use to assess exposure, effects, and risk,             mutation, reproductive, developmental,
                                                      to only initiate the process when EPA                   including associated uncertainty and                   respiratory, immune, metabolic, and
                                                      has determined that most of the                         variability, as well as a strategy for                 cardiovascular impacts, and


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7571

                                                      neurological impairments. The                           concentrations in the environment,                        In the risk characterization, EPA will
                                                      assessment will evaluate effects at life                consideration of models of chemical                    further carry out the obligations under
                                                      stage(s) most appropriate for a receptor                transport and fate in the environment,                 TSCA section 26(h) (15 U.S.C 2625(h));
                                                      target. The hazard assessment will                      and estimates of human intake or                       for example, by assessing uncertainty
                                                      consider the dose or concentration and                  environmental exposure over time.                      and variability in each step of the risk
                                                      resulting effect or response. Potential                    Using reasonably available                          evaluation, discussing considerations of
                                                      information sources that may support                    information, exposures will be                         data quality such as the reliability,
                                                      the health assessment include but are                   estimated (usually quantitatively) for                 relevance and whether the methods
                                                      not limited to: Human epidemiological                   the identified conditions of use. For                  utilized were reasonable and consistent,
                                                      studies; in vivo and/or in vitro                        human health exposure, the assessment                  explaining any assumptions used, and
                                                      laboratory studies; mechanistic or                      would consider all potentially exposed                 discussing information generated from
                                                      kinetic studies in a variety of test                    or susceptible subpopulation(s)                        independent peer review. EPA also may
                                                      systems, including but not limited to                   identified in the scope and utilize any                exercise it discretion to include a
                                                      toxicokinetics and toxicodynamics,                      combination, as available, of                          discussion of any alternative
                                                      computational toxicology; data from                     population-based epidemiological                       interpretation of results generated from
                                                      structure-activity relationships, high-                 studies, information related to                        the risk evaluation. For environmental
                                                      throughput assays, genomic response                     geographic location of susceptible                     evaluations specifically, EPA plans to
                                                      assays, and ecological field data.                      subpopulations, models representing                    include a discussion of the nature and
                                                      Specifically, for human health hazards,                 exposures to the population,                           magnitude of the effects, the spatial and
                                                      the assessment will consider all                        measurements in human tissues or                       temporal patterns of the effects,
                                                      potentially exposed or susceptible                      relevant environmental or exposure                     implications at the individual, species,
                                                      subpopulation(s) identified in the scope                media, and any other relevant,                         and community level, and the
                                                      and use appropriate combination, if                     scientifically valid information or                    likelihood of recovery subsequent to
                                                      available, of population-based                          methodology. In an environmental                       exposure to the chemical substance.
                                                      epidemiological studies, information                    health exposure assessment, the                           5. Peer review. For each risk
                                                      related to geographic location of                       interaction of the chemical substance                  evaluations conducted on chemicals
                                                      susceptible subpopulations, models                      with any ecological characteristics                    identified pursuant to TSCA section
                                                      representing health effects to the                      identified in the scope will be                        6(b)(4)(A), EPA will conduct peer
                                                      population, and any other relevant,                     characterized and evaluated.                           reviews using the guidance provided in
                                                      scientifically valid information or                                                                            executive branch peer review directives
                                                                                                                 4. Risk characterization. TSCA
                                                      methodology. In an environmental                                                                               included in the Office of Management
                                                                                                              requires that a risk evaluation ‘‘integrate
                                                      hazard assessment, the relationship                                                                            and Budget Final Information Quality
                                                                                                              and assess available information on
                                                      between the chemical substance and the                                                                         Bulletin for Peer Review (OMB Bulletin)
                                                                                                              hazards and exposures’’. (15 U.S.C
                                                      occurrence of an ecological response                                                                           (Ref. 22) and the guidance set forth in
                                                                                                              2605(b)(4)(F). A risk characterization
                                                      will be evaluated using field or                                                                               the EPA Peer Review Handbook (2015)
                                                                                                              conveys the risk assessor’s judgment as
                                                      laboratory data, modeling strategies, and                                                                      (Ref. 23) or its updates.
                                                                                                              to the nature and presence or absence of                  The goal of the peer review process is
                                                      species extrapolations.
                                                                                                              risks, along with information about how                to obtain independent review from
                                                         Where possible, a hazard assessment
                                                                                                              the risk was assessed, where                           experts who have not contributed to its
                                                      also will include a dose-response
                                                      assessment. A dose-response                             assumptions and uncertainties still                    development. According to EPA’s peer
                                                      relationship describes how the                          exist, and where policy choices will                   review policy, peer review of all
                                                      likelihood and severity of adverse                      need to be made. Risk characterization                 scientific and technical information that
                                                      health effects (the responses) are related              takes place for both human health risk                 is intended to inform or support Agency
                                                      to the amount and condition of                          assessments and ecological risk                        decisions is encouraged and expected.
                                                      exposure to an agent (the dose                          assessments.                                           Both the EPA Peer Review Handbook
                                                      provided). The same principles                             In practice, each component of the                  and the OMB Bulletin provide standards
                                                      generally apply for studies where the                   risk assessment (e.g. hazard assessment,               for when and how to conduct peer
                                                      exposure is to a concentration of the                   dose-response assessment, exposure                     review on science documents. The
                                                      agent (e.g., airborne concentrations                    assessment) has an individual                          documents do not contemplate that peer
                                                      applied in inhalation exposure studies                  characterization written to carry forward              review is necessary for every document
                                                      or water or other media concentrations                  the key findings, assumptions,                         or risk assessment, but is expected to
                                                      for ecological exposure studies), and the               limitations, and uncertainties. The set of             occur for those documents that have
                                                      resulting information is referred to as                 these individual characterizations                     either:
                                                      the concentration-response.                             provide the information basis to write                    • Influential scientific information:
                                                         3. Exposure assessment. Pursuant to                  an integrative risk characterization                   scientific information that the Agency
                                                      TSCA section 6(b)(4)(F), EPA, where                     analysis. The final, overall risk                      reasonably can determine will have or
                                                      relevant, will take into account the                    characterization thus consists of the                  does have a clear and substantial impact
                                                      likely duration, intensity, frequency,                  individual component characterizations                 on important public policies or private
                                                      and number of exposures under the                       plus an integrative analysis.                          sector decisions, or
                                                      conditions of use in an exposure                           Each risk evaluation will                              • Highly influential scientific
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                                                      assessment. An exposure assessment                      quantitatively and/or qualitatively                    assessment: a subset of influential
                                                      includes some discussion of the size,                   estimate and characterize risk for the                 scientific information that could have a
                                                      nature, and types of individuals or                     identified populations and ecological                  potential impact of more than $500
                                                      populations exposed to the agent, as                    characteristics under the conditions of                million in any year on either the public
                                                      well as discussion of the uncertainties                 use. The risk characterization will also               or private sector or is novel,
                                                      in this information. Exposure can be                    describe whether aggregate or sentinel                 controversial, or precedent-setting, or
                                                      measured directly, but more commonly                    exposures were considered and provide                  has significant interagency interest.
                                                      is estimated indirectly through                         the evidence and information to support                   The EPA Peer Review Handbook, first
                                                      consideration of measured                               the consideration.                                     released in 1998 and last updated in


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                                                      7572                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      2015, has also been instrumental in                     the substance does not present an                      information’’ can be found in EPA’s
                                                      providing guidance on the methods for                   unreasonable risk of injury to health or               Risk Characterization Handbook (Ref.
                                                      conducting peer review at the Agency                    the environment under the conditions of                24), and in other existing Agency
                                                      for the past two decades. According to                  use. This will be issued by order,                     guidance.
                                                      the Handbook the peer review approach                   published in the Federal Register, and                    EPA believes further defining these
                                                      can consist of internal or external                     considered to be a final EPA action.                   and other terms in the proposed rule is
                                                      reviewers and can range from a letter                   Alternatively, the EPA may determine                   unnecessary and ultimately
                                                      review, an ad hoc expert panel review,                  that the substance does present an                     problematic. These terms have and will
                                                      review of a journal manuscript by a                     unreasonable risk under one or more                    continue to evolve with changing
                                                      referred scientific journal, review by an               conditions of use, in which case EPA                   scientific methods and innovation.
                                                      established Federal Advisory Committee                  must, pursuant to TSCA section 6(a) (15                Codifying specific definitions for these
                                                      (FAC), review by an Agency-appointed                    U.S.C. 2605(a)), impose requirements to                phrases in this rule may inhibit the
                                                      special board or commission, or review                  the extent necessary so that the                       flexibility of the Agency to quickly
                                                      by the National Academy of Science.                     substance no longer presents such risk.                adapt and implement changing science.
                                                      Given that this guidance reflects long-                    EPA will announce in the Federal                    The Agency intends to use existing
                                                      standing and well-accepted EPA                          Register the availability of and solicit               guidance definitions and will update
                                                      practices on peer review, and given the                 public comment on the draft risk                       definitions and guidance as necessary.
                                                      public’s familiarity with it, the Agency                evaluation, including the unreasonable                    However, the Agency welcomes
                                                      is proposing to continue to rely on that                risk determination. All comments that                  public comments regarding the pros and
                                                      established guidance, rather than                       could be raised on components of the                   cons of codifying these or other
                                                      attempt to modify it or create some new                 draft risk evaluation must be presented                definitions and/or approaches for these
                                                      methodology in this rulemaking. As                      during this comment period. Any issues                 or any other terms. EPA encourages
                                                      discussed earlier in this proposal, EPA                 not raised during this time will be                    commenters to suggest alternative
                                                      will identify aspects of the analysis on                considered to have been waived, and                    definitions the Agency should consider
                                                      which peer review will be conducted,                    may not form the basis for an objection                for codification in this procedural rule.
                                                      and the planned methodologies, as part                  or challenge in any subsequent                         Please explain your views as clearly as
                                                      of the draft scoping document that will                 administrative or judicial proceeding.                 possible, providing specific examples to
                                                      undergo public comment for each                            7. Additional publically available                  illustrate your concerns and suggest
                                                      chemical substance that undergoes risk                  information. Pursuant to TSCA section                  alternate wording, where applicable.
                                                      evaluation. These may include novel                     26(j), EPA will make available: (1) All                EPA is specifically requesting comments
                                                      models or analyses that warrant an in-                  notices, determinations, findings,                     on whether EPA should define
                                                      depth peer review. In addition to any                   consent agreements, and orders; (2) any                unreasonable risk in the final rule. If so,
                                                      targeted peer review of specific aspects                information required to be provided by                 acknowledging that the statute
                                                      of the analysis, the entire risk                        the EPA under 15 U.S.C. 2603; (3) a                    precludes consideration of costs and
                                                      assessment will also undergo peer                       nontechnical summary of the risk                       other non-risk factors at this step, what
                                                      review, as it is important for peer                     evaluation; (4) a list of the studies with             factors should EPA consider in making
                                                      reviewers to consider how the various                   the results of the studies, considered in              such a determination.
                                                      underlying analyses fit together to                     carrying out each risk evaluation; and                    2. Margin of exposure. EPA currently
                                                      produce an integrated risk                              (5) the final peer review report,                      uses a margin-of-exposure (MOE)
                                                      characterization which will form the                    including the response to peer review                  approach in risk characterization of
                                                      basis of an unreasonable risk                           comments.                                              TSCA risk assessments. Please comment
                                                      determination.                                             8. Reassessment of unreasonable risk                on the strengths and weaknesses of the
                                                         The peer review will address aspects                 determination. EPA may reassess a final                MOE approach. Are there other
                                                      of the science underlying the                           unreasonable risk determination of a                   approaches (e.g. use of hazard indices,
                                                      assessment, including, but not limited                  chemical substance at any time based on                use of probabilistic risk assessment) that
                                                      to hazard assessment, assessment of                     information available to the Agency.                   might better suit the TSCA Risk
                                                      dose-response, exposure assessment,                                                                            Evaluation Program? Are there other
                                                                                                              IV. Request for Comments                               approaches that provide quantifiable
                                                      and risk characterization. Please note,
                                                      however, EPA will not seek review of                       While EPA is seeking public comment                 non-cancer risks?
                                                      any determination as to whether the                     on all aspects of this proposed rule,                     3. Systematic Review. While EPA has
                                                      risks are ‘‘unreasonable’’, which is an                 there are areas where the Agency                       included a systematic review approach
                                                      Agency policy judgement. The purpose                    specifically requesting public input.                  in the past, and intends to continue to
                                                      of peer review is for independent review                   1. Redefining scientific terms. EPA                 do so, please comment on the need for
                                                      of the science underlying the risk                      received a number of stakeholder                       regulatory text prescribing a specific
                                                      assessment, not to evaluate EPA’s policy                comments regarding EPA’s approach to                   systematic review approach for hazard
                                                      judgments. TSCA expressly reserves to                   defining a number of important terms                   identification, including the
                                                      the Agency the final determination of                   within this rule. These terms include                  appropriateness of elements that might
                                                      whether risk posed by a chemical                        ‘‘best available science’’, ‘‘weight-of-the-           be included or concerns about codifying
                                                      substance is ‘‘unreasonable.’’ 15 U.S.C                 evidence’’, ‘‘sufficiency of information’’,            an approach.
                                                      2605(i). EPA nevertheless will include                  ‘‘unreasonable risk’’, and ‘‘reasonably                   4. Manufacturer Requests. EPA
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                                                      its unreasonable risk judgment as part of               available information’’ among others.                  anticipates that some chemical
                                                      the risk evaluation that is subject to                  Many of the terms used in the proposed                 substances prioritized for risk
                                                      public review and comment.                              rule are not novel concepts and are                    evaluation have been manufactured by
                                                         6. Unreasonable risk determination.                  already in use and the meaning of                      persons who possess unpublished
                                                      The final step of a risk evaluation is for              which is discussed extensively in                      information that could impact the
                                                      the EPA to determine whether the                        existing Agency guidance. For example,                 chemical’s risk determination. For
                                                      chemical substance presents an                          extensive descriptions for the phrases                 chemical substances prioritized for risk
                                                      unreasonable risk of injury to health or                ‘‘best available science’’, ‘‘weight-of-the-           evaluation, the Agency generally
                                                      the environment. The EPA may find that                  evidence’’, and ‘‘sufficiency of                       expects to exercise, as needed, among


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7573

                                                      other authorities, its information-                     on the same information, such that the                 cases, the rule would require that this
                                                      gathering authority pursuant to 15                      Agency could determine that peer                       determination, and any peer review
                                                      U.S.C. 2607(a) and 2607(d), likely very                 review is not necessary for that                       activities that are conducted, be
                                                      early in the process. EPA is specifically               chemical risk evaluation.                              documented for each chemical
                                                      requesting comment on approaches to                        EPA expects that many of the risk                   evaluation, starting with the scope
                                                      utilizing its information gathering                     evaluations conducted under TSCA will                  document.
                                                      authorities to assure that EPA has the                  necessitate peer review. In cases in                      6. Reliance on existing guidance and
                                                      most complete information to make its                   which a chemical substance is                          procedures for conducting risk
                                                      risk determination. For example, one                    determined to present an unreasonable                  evaluations. As discussed in Unit
                                                      option might be to incorporate its 15                   risk, the Agency must promptly move to                 III.G.1., EPA intends to take advantage
                                                      U.S.C. 2607(a) and 2607(d) authority                    manage the risk, a circumstance that                   of existing guidance, tools and models
                                                      into the ‘‘Information and information                  would typically qualify the assessment                 that are relevant and available for use in
                                                      sources’’ section of this rule to allow                 as ‘‘influential scientific information’’              conducting a risk evaluation under this
                                                      EPA to require, by notice in the Federal                under current guidance and practice.                   program. Since each risk evaluation is
                                                      Register, manufacturers with                            The Agency also expects that some risk                 based on the specific circumstances
                                                      information subject to 15 U.S.C.                        evaluations would also be highly                       surrounding the chemical being
                                                      2607(a)(2) and 2607(d) to submit that                   influential scientific assessments, e.g.,              assessed, EPA has not attempted to
                                                      information to EPA for use in a risk                    contain novel, controversial, or                       codify any specific guidance, method or
                                                      evaluation. EPA is requesting comment                   precedent-setting science with                         model. EPA believes that this is
                                                      on this option and on any more effective                significant interagency interest. EPA                  necessary to ensure that there is
                                                      alternative methods to exercise this                    also expects that peer review will be                  flexibility to address potentially unique
                                                      authority within the rule to assure the                 warranted in many cases where the                      circumstances on a chemical basis. EPA
                                                      completeness of the information                         Agency determines a chemical                           is interested in your comments about
                                                      relevant to the risk evaluation.                        substance does not present an                          this approach, and where there is any
                                                         The Agency also anticipates the                      unreasonable risk. Aspects of the                      existing guidance that may be of
                                                      possibility that one manufacturer                       evaluation may qualify as influential                  particular interest for consideration in
                                                      requests a risk evaluation but other                    scientific information or highly                       conducting these risk evaluations.
                                                      manufacturers of the same chemical                      influential scientific assessment, and                 Additionally, EPA asks if the current
                                                      who have not joined in the request also                 thus warrant peer review. Other                        guidance documents are sufficient and
                                                      possess relevant unpublished                            circumstances where the Agency may                     whether there are additional guidance
                                                      information. For manufacturer requests                  determine that peer review is warranted                documents that should be relevant but
                                                      for risk evaluation, the burden is on the               could include circumstances where                      may not be on the lists available on
                                                      requester to include or reference all                   there are existing private sector                      EPA’s Web site (https://www.epa.gov/
                                                      information that is necessary for EPA to                standards suggesting concern for a given               risk/risk-assessment-guidelines).
                                                      conduct a risk evaluation. Although                     chemical substance, where existing state               Finally, should EPA consider requiring
                                                      EPA could use its data collection                       assessments differ from the EPA                        that a list of appropriate guidance
                                                      authority to access information,                        evaluation, or where the public has                    documents be included on a case-by-
                                                      including unpublished studies, held by                  expressed general concern about the                    case basis as part of the scoping
                                                      entities other than the requestor, the                  chemical substances effects.                           document that undergoes public review
                                                      Agency intends to deny requests for risk                   As required under the amended                       and comment.
                                                      evaluation if the requester does not have               TSCA, chemical substances must be                         7. Interagency collaboration. As
                                                      access to the information necessary for                 prioritized as either low or high. Those               discussed in Unit III.B., EPA is
                                                      risk evaluation.                                        categorized as high are subject to a risk              committed to ensuring there is
                                                         5. Peer Review. As discussed in both                 evaluation, and those determined to be                 interagency engagement and dialogue
                                                      the OMB Bulletin and the EPA Peer                       low are not. The bar for prioritizing a                throughout its risk evaluation process,
                                                      Review Handbook, there are specific                     chemical as a low priority as required                 and has chosen not the limit the
                                                      exemption criteria for information that                 under the amended TSCA is fairly high.                 potential interagency collaboration by
                                                      does not necessitate peer review, even if               As such, EPA expects that, as an                       proposing to codify any particular
                                                      it might be considered to be influential                increasing number of chemical risk                     process. EPA is concerned that
                                                      or highly influential. A number of                      evaluations are completed, those                       imposing a single, pre-determined
                                                      specific circumstances where peer                       chemical substances that present risk to               consultation step might lead to an
                                                      review is not necessary are discussed in                human health or the environment will                   overly bureaucratic process that could
                                                      section 3.3 of the EPA Peer Review                      be managed accordingly, leaving an                     limit or complicate ongoing
                                                      Handbook. Examples of these                             increasing number of chemicals that do                 collaboration efforts, and so is not
                                                      circumstances include information                       not present an unreasonable risk. The                  proposing to codify any particular
                                                      involving a health or safety issue where                Agency questions whether all future risk               process in this regulation. However,
                                                      the Agency determines that the                          evaluations warrant peer review.                       EPA is requesting specific public
                                                      dissemination is time-sensitive or if an                   EPA is specifically requesting public               comment on whether codifying this
                                                      application of an adequately peer-                      comment on whether there are                           collaboration at a specific point in the
                                                      reviewed work product does not depart                   circumstances where conducting peer                    regulation is necessary.
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                                                      significantly from its scientific or                    review may not be warranted. What
                                                      technical approach. In addition, EPA                    circumstances might qualify, and                       V. References
                                                      expects that there will be individual                   whether the regulatory text should be                    The following is a listing of the
                                                      circumstances where a chemical                          adjusted to require EPA to make a case                 documents that are specifically
                                                      substance is found to not present an                    by case determination of whether and to                referenced in this document. The docket
                                                      unreasonable risk or that findings are                  what extent, consistent with the EPA                   includes these documents and other
                                                      similar or the same as other                            Peer Review Handbook, peer review is                   information considered by EPA,
                                                      jurisdictions (states or countries) that                warranted for the chemical substance                   including documents that are referenced
                                                      have reached similar conclusions based                  undergoing a risk evaluation. In all                   within the documents that are included


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                                                      7574                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      in the docket, even if the referenced                   13. National Research Council. Phthalates              VI. Statutory and Executive Order
                                                      document is not physically located in                        and Cumulative Risk Assessment: The               Reviews
                                                      the docket. For assistance in locating                       Tasks Ahead. National Academy Press.
                                                                                                                   Washington, DC 2008. http://                        Additional information about these
                                                      these other documents, please consult                                                                          statutes and Executive Orders can be
                                                                                                                   www.nap.edu/catalog.php?record_
                                                      the technical person listed under FOR                        id=12528.                                         found at http://www2.epa.gov/laws-
                                                      FURTHER INFORMATION CONTACT.                            14. USEPA. Policy on Evaluating Health                 regulations/laws-and-executive-orders.
                                                      1. USEPA. Information Collection Request                     Risks to Children. 1995. https://
                                                          (ICR) for the Proposed Rule: Procedures                  www.epa.gov/sites/production/files/               A. Executive Order 12866: Regulatory
                                                          for Chemical Risk Evaluation Under                       2014-05/documents/1995_childrens_                 Planning and Review and Executive
                                                          TSCA. EPA ICR No.: 2559.01 and OMB                       health_policy_statement.pdf.                      Order 13563: Improving Regulation and
                                                          No. 2070—[NEW].                                     15. USEPA. Guidelines for Developmental                Regulatory Review
                                                      2. EPA. TSCA Work Plan Chemical                              Toxicity Risk Assessment. EPA/600/FR–
                                                          Assessments: 2014 Update-Final. Office                   91/001. Risk Assessment Forum.                      This action is a significant regulatory
                                                          of Pollution Prevention and Toxics.                      Washington, DC 1991. http://                      action that was submitted to the Office
                                                          October 2014. https://www.epa.gov/sites/                 cfpub.epa.gov/ncea/cfm/                           of Management and Budget (OMB) for
                                                          production/files/2015-01/documents/                      recordisplay.cfm?deid=23162.                      review under Executive Orders 12866
                                                          tsca_work_plan_chemicals_2014_                      16. USEPA. Guide to Considering Children’s             (58 FR 51735, October 4, 1993) and
                                                          update-final.pdf.                                        Health When Developing EPA Actions:               13563 (76 FR 3821, January 21, 2011).
                                                      3. National Research Council. Science and                    Implementing Executive Order 13045
                                                          Decisions: Advancing Risk Assessment.                    and EPA’s Policy on Evaluating Health             Any changes made in response to OMB
                                                          The National Academies Press.                            Risks to Children. Office of Policy,              recommendations have been
                                                          Washington, DC 2009. http://                             Economics and Innovation. Washington,             documented in the docket.
                                                          www.nap.edu/catalog.php?record_                          DC 2006. http://yosemite.epa.gov/ochp/
                                                          id=12209.
                                                                                                                                                                     B. Paperwork Reduction Act (PRA)
                                                                                                                   ochpweb.nsf/content/ADPguide.htm/
                                                      4. EPA. Guidelines for Carcinogen Risk                       $File/EPA_ADP_Guide_508.pdf.                         The information collection activities
                                                          Assessment. Risk Assessment Forum,                  17. USEPA. Guidance on Selecting Age                   associated with this proposed rule have
                                                          Washington, DC. EPA/630/P–03/001F.                       Groups for Monitoring and Assessing               been submitted to OMB for review and
                                                          Washington, DC 2005. https://                            Childhood Exposures to Environmental
                                                          www.epa.gov/sites/production/files/
                                                                                                                                                                     approval under the PRA, 44 U.S.C. 3501
                                                                                                                   Contaminants. Final. EPA/630/P–03/
                                                          2013-09/documents/cancer_guidelines_                                                                       et seq. Specifically, EPA has prepared
                                                                                                                   003F. Risk Assessment Forum.
                                                          final_3-25-05.pdf.                                       Washington, DC 2005. http://                      an ICR to estimate the potential burden
                                                      5. EPA. Guidelines for Carcinogen Risk                       www.epa.gov/raf/publications/guidance-            and costs associated with the proposed
                                                          Assessment, Review Draft, CEA–F–0644,                    on-selecting-age-groups.htm.                      requirements for submitting a request
                                                          Office of Research and Development.                 18. USEPA. Supplemental Guidance for                   for an Agency-conducted risk evaluation
                                                          Washington, DC 1999. http://                             Assessing Susceptibility from Early-Life          on a particular chemical substance. The
                                                          cfpub.epa.gov/ncea/raf/cancer.cfm.                       Exposure to Carcinogens. EPA/630/R–               ICR, which is available in the docket,
                                                      6. EDSTAC. Endocrine Disruptor Screening                     03/003F. Risk Assessment Forum.
                                                          and Testing Advisory Committee, Final                                                                      has been assigned the EPA ICR number
                                                                                                                   Washington, DC 2005. http://                      2559.01. You can find a copy of the ICR
                                                          Report, Volume I–II. Washington, DC                      www.epa.gov/ttn/atw/childrens_
                                                          1998. http://www.epa.gov/scipoly/                                                                          in the docket for this proposed rule (Ref.
                                                                                                                   supplement_final.pdf.
                                                          oscpendo/pubs/edspoverview/                         19. USEPA. A Framework for Assessing                   1), and it is briefly summarized here.
                                                          finalrpt.htm.                                                                                                 Respondents/affected entities:
                                                                                                                   Health Risk of Environmental Exposures
                                                      7. EPA. Endocrine Disruptor Screening                                                                          Manufacturers (including importers).
                                                                                                                   to Children. Final. EPA/600/R–05/093F.
                                                          Program; Weight-of-Evidence: Evaluating                                                                       Respondent’s obligation to respond:
                                                                                                                   Office of Research and Development,
                                                          Results of EDSP Tier 1 Screening to
                                                          Identify the Need for Tier 2 Testing,
                                                                                                                   National Center for Environmental                 Optional, i.e., needed only if they are
                                                          Washington, DC 2011. https://                            Assessment. Washington, DC 2006.                  requesting an EPA-conducted risk
                                                          www.regulations.gov/document?D=EPA-                      http://cfpub.epa.gov/ncea/cfm/                    evaluation for a particular chemical
                                                          HQ-OPPT-2010-0877-0021.                                  recordisplay.cfm?deid=158363.                     substance.
                                                      8. EPA. Framework for Metals Risk                       20. USEPA. Exposure Factors Handbook.
                                                                                                                                                                        Estimated number of respondents: 10.
                                                          Assessment of the Office of the Science                  EPA/600/R–090/052F. Office of Research
                                                                                                                   and Development, National Center for                 Frequency of response: On occasion.
                                                          Advisor, Risk Assessment Forum.                                                                               Total estimated annual burden: 960.3
                                                          Washington, DC March 2007.                               Environmental Assessment. Washington,
                                                      9. National Research Council. Risk                           DC 2011. https://cfpub.epa.gov/ncea/              hours. Burden is defined in 5 CFR
                                                          Assessment in the Federal Government:                    risk/recordisplay.cfm?deid=236252.                1320.3(b).
                                                          Managing the Process. The National                  21. USEPA. Framework for Human Health                     Total estimated annual cost: $69,353
                                                          Academies Press. Washington, DC 1983.                    Risk Assessment to Inform Decision                for burden hours. There are no M&O
                                                          http://www.nap.edu/                                      Making. EPA/100/R–14/001. Office of               costs.
                                                          openbook.php?isbn=0309033497.                            the Science Advisor, Risk Assessment                 An agency may not conduct or
                                                      10. National Research Council. Science and                   Forum. 2014. https://archive.epa.gov/
                                                                                                                                                                     sponsor, and a person is not required to
                                                          Judgment in Risk Assessment. The                         raf/web/pdf/hhra-framework-final-
                                                                                                                   2014.pdf.                                         respond to a collection of information
                                                          National Academies Press. Washington,
                                                          DC 1994. http://www.nap.edu/                        22. Office of Management and Budget Final              unless it displays a currently valid OMB
                                                          catalog.php?record_id=2125.                              Information Quality Bulletin for Peer             control number. The OMB control
                                                      11. National Research Council.                               Review.                                           numbers for the EPA’s regulations in 40
                                                          Understanding Risk: Informing Decisions             23. USEPA. Peer Review Handbook. 3rd ed.               CFR are listed in 40 CFR part 9.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                          in a Democratic Society. The National                    EPA/100/B–06/002. Science Policy                     Submit your comments on the
                                                          Academies Press. Washington, DC 1996.                    Council. Washington, DC 2006. https://            Agency’s need for this information, the
                                                          http://www.nap.edu/                                      www.epa.gov/osa/peer-review-handbook-             accuracy of the provided burden
                                                          openbook.php?isbn=030905396X.                            4th-edition-2015.
                                                                                                                                                                     estimates, and any suggested methods
                                                      12. National Research Council. Toxicity                 24. Risk Characterization Handbook. Science
                                                          Testing in the 21st Century: A Vision                    Policy Council Handbook: Risk                     for minimizing respondent burden to
                                                          and a Strategy. The National Academies                   Characterization, EPA 100–B–00–002,               EPA using the docket identified at the
                                                          Press. Washington, DC 2007. http://                      Washington, DC December 2000. https://            beginning of this proposed rule. You
                                                          www.nap.edu/catalog.php?record_                          www.epa.gov/risk/risk-characterization-           may also send your ICR-related
                                                          id=11970.                                                handbook.                                         comments to OMB’s Office of


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                  7575

                                                      Information and Regulatory Affairs via                  Order 13175 (65 FR 67249, November 9,                    Dated: January 12, 2017,
                                                      email to oira_submission@omb.eop.gov,                   2000). It will not have substantial direct             Gina McCarthy,
                                                      Attention: Desk Officer for the EPA.                    effects on one or more Indian tribes, on               Administrator.
                                                      Since OMB is required to make a                         the relationship between the Federal                     Therefore, it is proposed that 40 CFR
                                                      decision concerning the ICR between 30                  Government and Indian tribes, or on the                chapter I, subchapter R, be amended as
                                                      and 60 calendar days after receipt, OMB                 distribution of power and                              follows:
                                                      must receive comments no later than                     responsibilities between the Federal
                                                      February 21, 2017. Any ICR-related                      Government and Indian tribes. Thus,                    PART 702—GENERAL PRACTICES
                                                      comments will be addressed with the                     Executive Order 13175 does not apply                   AND PROCEDURES
                                                      final rule.                                             to this action.
                                                                                                                                                                     ■  1. The authority citation for part 702
                                                      C. Regulatory Flexibility Act (RFA)
                                                                                                              G. Executive Order 13045: Protection of                is revised to read as follows:
                                                         EPA certifies under section 605(b) of                Children From Environmental Health                         Authority: 15 U.S.C. 2605 and 2619.
                                                      the RFA, 5 U.S.C. 601 et seq., that this                Risks and Safety Risks
                                                      action will not have a significant                                                                             ■ 2. Add subpart B to part 702 to read
                                                      economic impact on a substantial                          The EPA interprets Executive Order                   as follows:
                                                      number of small entities. Although this                 13045 (62 FR 19885, April 23, 1997) as
                                                      proposed rule primarily addresses                       applying only to those regulatory                      Subpart B—Procedures for Chemical
                                                      internal EPA procedures and activities                  actions that concern environmental                     Substance Risk Evaluations
                                                      associated with conducting risk                         health or safety risks that the EPA has                Sec.
                                                      evaluations for chemical substances as                  reason to believe may                                  702.31 General provisions.
                                                      required by TSCA, EPA is also                           disproportionately affect children, per                702.33 Definitions.
                                                      proposing the process and content                       the definition of ‘‘covered regulatory                 702.35 Chemical substances designated for
                                                      requirements for a manufacturer                                                                                     risk evaluation.
                                                                                                              action’’ in section 2–202 of the
                                                      (including importer) to request that EPA                                                                       702.37 Submission of manufacturer
                                                                                                              Executive Order. This action is not                         requests for risk evaluations.
                                                      conduct a risk evaluation on a particular               subject to Executive Order 13045                       702.39 Evaluation requirements.
                                                      chemical substance. EPA has                             because it does not concern an                         702.41 Risk characterization and peer
                                                      determined that the process and content                 environmental health risk or safety risk.                   review procedures.
                                                      requirements proposed will have                                                                                702.43 Unreasonable risk determination.
                                                      minimal impact on an entity, regardless                 H. Executive Order 13211: Actions                      702.45 Risk Evaluation timeframes and
                                                      of size, because there is no mandate for                Concerning Regulations That                                 actions.
                                                      them to make such a request, and the                    Significantly Affect Energy Supply,                    702.47 Publically available information.
                                                      information they must provide should                    Distribution, or Use                                   § 702.31   General provisions.
                                                      they decide to make such a request,
                                                      which involves basic information about                    This action is not a ‘‘significant                      (a) Purpose. This subpart establishes
                                                      the chemical substance and the                          energy action’’ as defined in Executive                the EPA process for conducting a risk
                                                      manufacturer’s reasons for requesting                   Order 13211 (66 FR 28355, May 22,                      evaluation to determine whether a
                                                      the EPA-conducted risk evaluation on                    2001), because it is not likely to have a              chemical substance presents an
                                                      that chemical substance, should be                      significant adverse effect on the supply,              unreasonable risk of injury to health or
                                                      readily available to the manufacturer.                  distribution or use of energy.                         the environment as required under
                                                      Estimated potential burden and costs                                                                           TSCA section 6(b)(4)(B) (15 U.S.C.
                                                                                                              I. National Technology Transfer and                    2605(b)(4)(B)).
                                                      are presented in the ICR (Ref. 1).
                                                                                                              Advancement Act (NTTAA)                                   (b) Scope. These regulations establish
                                                      D. Unfunded Mandates Reform Act                                                                                the general procedures, key definitions,
                                                      (UMRA)                                                    This action does not involve any                     and timelines EPA will use in a risk
                                                                                                              technical standards, and is therefore not              evaluation conducted pursuant to TSCA
                                                         This action does not contain any
                                                      unfunded mandate as described in                        subject to considerations under NTTAA                  section 6(b) (15 U.S.C. 2605(b)).
                                                      UMRA, 2 U.S.C. 1531–1538, and does                      section 12(d), 15 U.S.C. 272 note.                        (c) Applicability. The requirements of
                                                      not significantly or uniquely affect small              J. Executive Order 12898: Federal                      this part apply to all chemical substance
                                                      governments. The action imposes no                      Actions To Address Environmental                       risk evaluations initiated pursuant to
                                                      enforceable duty on any state, local or                 Justice in Minority Populations and                    TSCA section 6(b) (15 U.S.C. 2605(b)).
                                                      tribal governments or the private sector.               Low-Income Populations                                    (d) Enforcement. Submission to EPA
                                                                                                                                                                     of inaccurate, incomplete, or misleading
                                                      E. Executive Order 13132: Federalism                                                                           information by a manufacturer pursuant
                                                                                                                This action does not establish an
                                                         This action does not have federalism                 environmental health or safety standard,               to a risk evaluation conducted pursuant
                                                      implications as specified in Executive                  and is therefore not is not subject to                 to 15 U.S.C. 2605(b)(4)(B) is a prohibited
                                                      Order 13132 (64 FR 43255, August 10,                    environmental justice considerations                   act under 15 U.S.C. 2614, subject to
                                                      1999). It will not have substantial direct              under Executive Order 12898 (59 FR                     penalties under 15 U.S.C. 2615 and Title
                                                      effects on the states, on the relationship              7629, February 16, 1994). This is                      18 of the U.S. Code.
                                                      between the national government and
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                                                                                                              procedural rule that will not affect the               § 702.33   Definitions.
                                                      the states, or on the distribution of                   level of protection provided to human
                                                      power and responsibilities among the                                                                             All definitions in TSCA apply to this
                                                                                                              health or the environment.                             subpart. In addition the following
                                                      various levels of government.
                                                                                                              List of Subjects in 40 CFR Part 702                    definitions apply:
                                                      F. Executive Order 13175: Consultation                                                                           Act means the Toxic Substances
                                                      and Coordination With Indian Tribal                       Environmental protection, Chemicals,                 Control Act, as amended (15 U.S.C.
                                                      Governments                                             Chemical Substance, Hazardous                          2601 et seq.).
                                                        This action does not have tribal                      substances, Health and safety, Risk                      Aggregate exposure means the
                                                      implications as specified in Executive                  Evaluation.                                            combined exposures to an individual


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                                                      7576                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      from a single chemical substance across                 will be conducted in accordance with                   chemical identity, CAS number, and
                                                      multiple routes and across multiple                     this part, except that risk evaluations                molecular structure of the chemical
                                                      pathways.                                               that are initiated prior to the effective              substance.
                                                         EPA means the U.S. Environmental                     date of this rule will be conducted in                   (3) A complete list of the reasonably
                                                      Protection Agency.                                      accordance with this part to the                       available information that is consistent
                                                         Pathways means the mode through                      maximum extent practicable.                            with the standards in TSCA section
                                                      which one is exposed to a chemical                        (b) Percentage Requirements. The                     26(h) and that is relevant to whether the
                                                      substance, including but not limited to:                Agency will ensure that, of the number                 chemical substance presents an
                                                      Food, water, soil, and air.                             of chemical substances that undergo risk               unreasonable risk of injury to health or
                                                         Potentially exposed or susceptible                   evaluation under 15 U.S.C.                             the environment. The list must be
                                                      subpopulation means a group of                          2605(b)(4)(C)(i), the number of chemical               accompanied by an explanation as to
                                                      individuals within the general                          substances undergoing risk evaluation                  why such information is adequate to
                                                      population identified by the Agency                     under 15 U.S.C. 2605(b)(4)(C)(ii) is not               permit EPA to complete a risk
                                                      who, due to either greater susceptibility               less than 25%, if sufficient requests that             evaluation addressing all the
                                                      or greater exposure, may be at greater                  comply with 40 CFR 702.37 are made by                  circumstances that constitute conditions
                                                      risk than the general population of                     manufacturers, and not more than 50%.                  of use of the chemical substance within
                                                      adverse health effects from exposure to                   (c) Manufacturer Requests for Work                   the meaning of TSCA section 3 (i.e., all
                                                      a chemical substance or mixture,                        Plan Chemical Substances.                              circumstances under which the
                                                      including but not limited to, infants,                  Manufacturer requests for risk                         chemical substance is intended, known,
                                                      children, pregnant women, workers, or                   evaluations, described in 40 CFR                       or reasonably foreseen to be
                                                      the elderly. EPA may identify a                         702.35(a), for chemical substances that                manufactured, processed, distributed in
                                                      susceptible subpopulation in an                         are drawn from the 2014 update of the                  commerce, used, or disposed of). The
                                                      individual risk evaluation upon                         TSCA Work Plan for Chemical                            request need not include copies of the
                                                      consideration of various intrinsic (e.g.,               Assessments or its relevant and                        information; citations are sufficient. The
                                                      life stage, reproductive status, age,                   applicable successor document will be                  request must include or reference all
                                                      gender, genetic traits) or acquired (e.g.,              granted at the discretion of the Agency.               reasonably available information on the
                                                      pre-existing disease, geography,                        Such evaluations are not subject to the                health and environment hazard(s) of the
                                                      workplace) characteristics that may                     percentage requirements in 40 CFR                      chemical substance, health and
                                                      affect exposure or modify the risk of                   702.35(b).                                             environmental exposure(s), and exposed
                                                      illness or disease.                                                                                            population(s). At a minimum this must
                                                         Reasonably available information                     § 702.37 Submission of manufacturer
                                                                                                              requests for risk evaluations.
                                                                                                                                                                     include information relevant to the
                                                      means existing information that EPA                                                                            following:
                                                      possesses or can reasonably obtain and                     (a) General Provision. Any request for                (i) The chemical substance’s hazard
                                                      synthesize for use in risk evaluations,                 EPA to conduct a risk evaluation on a                  and exposure potential;
                                                      considering the deadlines specified in                  chemical substance pursuant to this part                 (ii) The chemical substance’s
                                                      TSCA section 6(b)(4)(G) for completing                  must comply with all the procedures                    persistence and bioaccumulation;
                                                      such evaluation.                                        and criteria in this section to be eligible              (iii) Potentially exposed or susceptible
                                                         Routes means the particular manner                   to be granted by EPA. A request will                   subpopulations they believe to be
                                                      which a chemical substance may                          meet EPA’s criteria if the request                     relevant and that EPA should evaluate
                                                      contact the body, including absorption                  includes or references all the                         in the risk evaluation;
                                                      via ingestion, inhalation, or dermally                  information that is necessary for EPA to                 (iv) Whether there is any storage of
                                                      (integument).                                           conduct a risk evaluation addressing all               the chemical substance near significant
                                                         Sentinel exposure means the                          the circumstances that constitute                      sources of drinking water;
                                                      exposure(s) of greatest significance,                   conditions of use of the chemical                        (v) The chemical substance’s
                                                      which may be the plausible maximum                      substance within the meaning of TSCA                   conditions of use or significant changes
                                                      exposure to an individual, population                   section 3 (i.e., all circumstances under               in conditions of use;
                                                      (or subpopulation), or the environment                  which the chemical substance is                          (vi) The chemical substance’s
                                                      to the chemical substance of interest (or               intended, known, or reasonably foreseen                production volume or significant
                                                      any combination thereof).                               to be manufactured, processed,                         changes in production volume; and
                                                         Uncertainty means the imperfect                      distributed in commerce, used, or                        (vii) Any other information relevant to
                                                      knowledge or lack of precise knowledge                  disposed of).                                          the risks potentially presented by the
                                                      either for specific values of interest or                  (b) Method for Submission. One or                   chemical substance.
                                                      in the description of a system.                         more manufacturers of a chemical                         (4) The request must include a
                                                         Variability means the inherent natural               substance can request that EPA conduct                 commitment to provide to EPA any
                                                      variation, diversity, and heterogeneity                 a risk evaluation on the chemical                      referenced information upon request. In
                                                      across time and/or space or among                       substance by providing all the following               addition, if the manufacturer previously
                                                      individuals within a population.                        information:                                           conducted its own risk assessment of
                                                                                                                 (1) Name, mailing address, and                      the chemical substance, or possesses or
                                                      § 702.35 Chemical substances designated                 contact information of the entity (or                  can reasonably obtain any other pre-
                                                      for risk evaluation.                                    entities) submitting the request. If more              existing risk assessment, the request
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                                                        (a) Chemical Substances Undergoing                    than one manufacturer submits the                      must include a commitment to provide
                                                      Risk Evaluation. A risk evaluation for a                request, all individual manufacturers                  such assessments to EPA upon request.
                                                      chemical substance designated by the                    must provide their contact information.                  (5) A signed certification that all
                                                      Agency as a High-Priority Substance                        (2) Full information on the chemical                information contained in the request is
                                                      pursuant to the prioritization process                  identity of the chemical substance that                accurate and complete, as follows:
                                                      described in subpart A, identified under                is the subject of the request. At a                      I certify under penalty of law that this
                                                      15 U.S.C. 2605(b)(2)(A), or initiated at                minimum, this includes, all known                      document and all attachments were prepared
                                                      the request of a manufacturer or                        names of the chemical substance,                       under my direction or supervision and the
                                                      manufacturers under 40 CFR 702.37,                      including common or trades names,                      information contained therein, to the best of



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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7577

                                                      my knowledge is, true, accurate, and                    the submitting manufacturer(s) if EPA                  for non-TSCA Work Plan Chemicals that
                                                      complete and I have not withheld any                    has determined that the request is                     meet the criteria in this subpart, until
                                                      relevant information. I am aware there are              incomplete and cannot be processed.                    EPA determines that the number of
                                                      significant penalties for submitting                    Complete requests will be processed as                 manufacturer-requested chemical
                                                      incomplete, false and/or misleading
                                                      information, including the possibility of fine
                                                                                                              described in this subpart.                             substances undergoing risk evaluation is
                                                      and imprisonment for knowing violations.
                                                                                                                 (2) Public notice and comment.                      equal to 25% of the High-Priority
                                                                                                              Within 30 business days of receiving a                 Substances identified in subpart A as
                                                        (c) Optional Elements. A                              request that EPA has determined to be                  undergoing risk evaluation. Once that
                                                      manufacturer may provide evidence to                    valid under paragraph (e)(1) of this                   level has been reached, EPA will initiate
                                                      demonstrate that restrictions imposed                   section, EPA will submit for publication               one new manufacturer-requested risk
                                                      by one or more States have the potential                the receipt of the request in the Federal              evaluation for each manufacturer-
                                                      to have a significant impact on interstate              Register, open a docket for that request               requested risk evaluation completed, as
                                                      commerce or health or the environment,                  and provide no less than a 30 calendar                 needed to ensure that the number of
                                                      and that as a consequence the request is                day public comment period, during                      manufacturer-requested risk evaluations
                                                      entitled to preference pursuant to 15                   which time the public may submit                       is equal to at least 25% of the High-
                                                      U.S.C. 2605(b)(4)(E)(iii).                              comments and information relevant to                   Priority substances risk evaluation.
                                                        (d) Confidential Business Information.                whether the chemical substance                            (5) Preferences. In conformance with
                                                      (1) Persons submitting a request under                  presents an unreasonable risk of injury                40 CFR 702.35(c), in evaluating requests
                                                      this subpart are subject to EPA                         to health or the environment under the                 for TSCA Work Plan Chemicals and
                                                      confidentiality regulations at 40 CFR                   conditions of use. In particular,                      requests for non-TSCA Work Plan
                                                      part 2, subpart B.                                      comments identifying any information                   chemicals in excess of the 25%
                                                        (2) In submitting a claim of                          gaps in the request (e.g., any conditions              threshold in paragraph (e)(4)(ii) of this
                                                      confidentiality, a person must certify                  of use not identified in the request).                 section, EPA will give preference to
                                                      the truth of the following statements                      (3) Supplementation of original                     requests for risk evaluations on
                                                      concerning all information claimed as                   request. (i) At any time prior to the end              chemical substances:
                                                      confidential:                                           of the comment period, manufacturer(s)                    (i) That demonstrate that restrictions
                                                         I hereby certify to the best of my                   may supplement the original request                    imposed by one or more States have the
                                                      knowledge and belief that all information               with any new information it receives/                  potential to have a significant impact on
                                                      entered on this form is complete and                    obtains.                                               interstate commerce, health or the
                                                      accurate. I further certify that, pursuant to 15           (ii) At any point prior to the
                                                                                                                                                                     environment.
                                                      U.S.C. 2613(c), for all claims for                      completion of a risk evaluation
                                                      confidentiality made with this submission,              conducted on a chemical substance at                      (ii) EPA will also give preference to
                                                      all information submitted to substantiate               the request of a manufacturer(s),                      requests where EPA has determined
                                                      such claims is true and correct, and that it            manufacturer(s) are required to                        there are relatively high estimates of
                                                      is true and correct that                                supplement the original request upon                   hazard and/or exposure for the chemical
                                                         (i) My company has taken reasonable
                                                                                                              receipt of information that meets the                  substance.
                                                      measures to protect the confidentiality of the                                                                    (iii) Any other factor EPA determines
                                                      information;                                            criteria in 15 U.S.C. 2607(e) and 40 CFR
                                                                                                              702.37, or other information that has the              to be relevant.
                                                         (ii) I have determined that the information
                                                      is not required to be disclosed or otherwise            potential to change EPA’s evaluation of                   (6) Conditions of use considered. EPA
                                                      made available to the public under any other            the risk of the chemical substance. Such               will conduct the risk evaluation on all
                                                      Federal law;                                            information must be submitted within                   of the conditions of use of a chemical
                                                         (iii) I have a reasonable basis to conclude          30 calendar days of discovery.                         substance undergoing risk evaluation at
                                                      that disclosure of the information is likely to            (4) EPA determination. Within 9                     the request of a manufacturer, as
                                                      cause substantial harm to the competitive               months of the end of the comment                       determined through the scoping process
                                                      position of my company; and                                                                                    outlined in 40 CFR 702.39(c).
                                                                                                              period provided in paragraph (e)(2) of
                                                         (iv) I have a reasonable basis to believe that                                                                 (7) No preferential treatment. EPA
                                                      the information is not readily discoverable             this section, EPA will review the request
                                                                                                              along with any additional information                  will not expedite or otherwise provide
                                                      through reverse engineering.
                                                                                                              received during the comment period to                  special treatment to a risk evaluation
                                                         (3) Each claim of confidentiality,                   determine whether the request meets                    conducted as a result of a manufacturer
                                                      other than a claim pertaining to                        the criteria and requirements of 40 CFR                request.
                                                      information described in TSCA section                   702.37. EPA will notify the submitting                    (f) Fees. Manufacturers must pay fees
                                                      14(c)(2), must be accompanied by a                      manufacturer(s) of its determination.                  to support risk evaluations under 15
                                                      substantiation in accordance with 40                       (i) Request is lacking required                     U.S.C. 2605(b)(4)(C)(ii).
                                                      CFR 2.204(e)(4).                                        information. (A) The manufacturer(s)
                                                         (4) Manufacturers must supply a                                                                             § 702.39 Evaluation Requirements and
                                                                                                              have 60 calendar days from receipt of
                                                      structurally descriptive generic name                                                                          Peer Review Procedures.
                                                                                                              EPA’s determination to submit any
                                                      where specific chemical identity is                     additional information identified as                      (a) Considerations. (1) Each risk
                                                      claimed as CBI.                                         lacking in the notification.                           evaluation will include the following
                                                         (5) Any knowing and willful                             (B) Failure to submit the additional                components: a Scope, including a
                                                      misrepresentation is subject to criminal                information will be considered to be a                 Conceptual Model and an Analysis
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                                                      penalty pursuant to 18 U.S.C. 1001.                     withdrawal of the request to initiate a                Plan; a Hazard Assessment; an Exposure
                                                         (e) EPA Process for Evaluating                       risk evaluation on the named chemical                  Assessment; a Risk Characterization;
                                                      Manufacturer Requests. (1) Review for                   substance.                                             and a Risk Determination.
                                                      completeness. Upon receipt of the                          (C) Notwithstanding any such                           (2) Existing EPA guidance, where
                                                      request, EPA will verify that the request               withdrawal, manufacturer(s) may                        available and relevant, will be used in
                                                      is facially valid, i.e., that information               submit a subsequent request on the                     conducting the risk evaluation. In
                                                      has been submitted that is consistent                   same chemical substance.                               addition, other scientifically relevant
                                                      with the requirements in 40 CFR                            (ii) Compliant request. EPA will                    methods or guidance may be used in a
                                                      702.37(b) through (d). EPA will inform                  initiate a risk evaluation for all requests            risk evaluation.


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                                                      7578                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         (3) Where appropriate, a risk                        and is peer reviewed by the Science                    and populations, including any
                                                      evaluation may be conducted on a                        Advisory Board.                                        potentially exposed or susceptible
                                                      category of chemical substances. EPA                       (b) Information and information                     subpopulations as identified by the
                                                      will determine whether to conduct an                    sources. (1) EPA will base each risk                   Agency that EPA plans to evaluate; the
                                                      evaluation on a category of chemical                    evaluation on reasonably available                     ecological characteristics that EPA plans
                                                      substances, and the composition of the                  information.                                           to evaluate; and the hazards to health
                                                      category based on the considerations                       (2) EPA generally expects to initiate a             and the environment that EPA plans to
                                                      listed in 15 U.S.C. 2625(c). In addition                risk evaluation for a chemical substance               evaluate.
                                                      to the factors specifically enumerated in               only when EPA believes that all or most                   (3) The combination of reasonably
                                                      that provision, EPA may consider the                    of the information necessary to perform                available information, accepted science
                                                      hazards and exposures associated with                   the risk evaluation already exists and is              policies (e.g., defaults and uncertainty
                                                      the category of chemical substances, and                reasonably available. EPA expects to use               factors), models, and screening
                                                      the populations likely to be exposed.                   its authorities under the Act, and other               methodologies that EPA plans to use in
                                                         (4) EPA will ensure that all                         information gathering authorities, when                the risk evaluation will be documented.
                                                      supporting analyses and components of                   necessary to generate the information                     (4) Conceptual model. (i) The scope
                                                      the risk evaluation are suitable for their              needed to perform a risk evaluation for                documents will include a Conceptual
                                                      intended purpose, and well-tailored to                  a chemical substance before initiating                 Model that describes actual or predicted
                                                      the problems and decision at hand, in                   the risk evaluation for such substance.                relationships between the chemical
                                                      order to inform the development of a                    EPA will use such authorities on a case-               substance and human and
                                                      technically sound determination as to                   by-case basis during the performance of                environmental receptors.
                                                      whether a chemical substance presents                   a risk evaluation to obtain or generate                   (ii) The Conceptual Model will
                                                      an unreasonable risk of injury to health                information as needed to ensure that                   identify human and ecological health
                                                      or the environment, based on the weight                 EPA has adequate, reasonably available                 endpoints the EPA plans to evaluate for
                                                      of the scientific evidence.                             information to perform the evaluation.                 the exposure scenarios EPA plans to
                                                                                                                 (3) Among other sources of                          evaluate.
                                                         (5) The extent to which EPA will
                                                                                                              information, the Agency will consider                     (iii) Conceptual Model development
                                                      refine its evaluations for particular
                                                                                                              information and advice provided by the                 will consider the life cycle of the
                                                      conditions of use in any risk evaluation
                                                                                                              Science Advisory Committee on                          chemical substance, including
                                                      will vary as necessary to determine
                                                                                                              Chemicals established pursuant to 15                   manufacture, processing, distribution in
                                                      whether a chemical substance presents
                                                                                                              U.S.C. 2625.                                           commerce, storage, use, and disposal.
                                                      an unreasonable risk of injury to health                   (4) In conducting risk evaluations,                    (5) Analysis plan. (i) The scope
                                                      or the environment. To the extent a                     EPA will rely on an appropriate                        documents will include an analysis plan
                                                      determination as to the level of risk                   combination of information, accepted                   that identifies the approaches, methods,
                                                      presented by a condition of use can be                  science policies (e.g., defaults and                   and/or metrics that the EPA plans to use
                                                      made, for example, by the use of                        uncertainty factors), models and                       to assess exposures, effects, and risk,
                                                      accepted science policies (e.g., defaults               screening methodologies. The balance of                including associated uncertainty and
                                                      assumptions or uncertainty factors), and                information, accepted science policies                 variability for each risk evaluation. The
                                                      models or screening methodologies,                      models, and screening methodologies                    analysis plan will also identify the
                                                      EPA may determine that no further                       used in risk evaluation will be informed               strategy for using information, accepted
                                                      information or analysis is needed to                    by the deadlines specified in TSCA                     science policies, models, and screening
                                                      complete its risk evaluation of the                     section 6(b)(4)(G) for completing such                 methodologies.
                                                      use(s).                                                 evaluations. It will also be informed by                  (ii) Hypotheses about the
                                                         (6) EPA may conduct a risk evaluation                consideration of the extent to which                   relationships described in the
                                                      on a chemical substance in phases to                    additional information would reduce                    conceptual model will be described.
                                                      allow the Agency to proceed with risk                   the uncertainty in determining whether                 The relative strengths of (any)
                                                      management on particular conditions of                  a chemical substance presents an                       competing hypotheses will be evaluated
                                                      use. For example, EPA may determine                     unreasonable risk of injury to health or               to determine the appropriate risk
                                                      that a chemical substance presents an                   the environment.                                       assessment approaches.
                                                      unreasonable risk of injury to health or                   (5) Where appropriate, to the extent                   (6) Developing the Scope. (i) Draft
                                                      the environment under one or more                       practicable, and scientifically justified,             scope. For each risk evaluation to be
                                                      conditions of use, and address such                     EPA will use information generated                     conducted EPA will publish a document
                                                      unreasonable risk through rulemaking                    without the use of testing on vertebrates              in the Federal Register that specifies the
                                                      under TSCA section 6(a), while other                    in performing risk evaluation.                         draft scope of the risk evaluation the
                                                      conditions of use remain under                             (c) Scope of the risk evaluation. EPA               Agency plans to conduct. The document
                                                      evaluation. In all cases in which EPA                   will determine the scope of the risk                   will address the elements in paragraphs
                                                      conducts its risk evaluations in phases,                evaluation to be conducted for each                    (c)(1) through (5) of this section.
                                                      EPA will nevertheless complete a full                   chemical substance based on all of the                    (ii) Timeframes. EPA generally
                                                      risk evaluation of the chemical                         following:                                             expects to publish the draft scope no
                                                      substance for all of the conditions of use                 (1) EPA will identify those uses that               later than 3 months from the initiation
                                                      identified through the scoping process                  constitute the conditions of use that will             of the risk evaluation process for the
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                                                      in 40 CFR 702.39(c) within the time                     be assessed during the risk evaluation.                chemical substance, and to allow a
                                                      frame in 40 CFR 702.43(d).                              Those uses shall be all circumstances                  period of 30 calendar days during which
                                                         (7) In evaluating chemical substances                under which the Agency determines                      interested persons may submit comment
                                                      that are metals or metal compounds,                     that the chemical substance is intended,               on EPA’s draft risk evaluation scope.
                                                      EPA will use the Framework for Metals                   known, or reasonably foreseen to be                    EPA will open a docket to facilitate
                                                      Assessment of the Office of the Science                 manufactured, processed, distributed in                receipt of public comments.
                                                      Advisor, Risk Assessment Forum dated                    commerce, used, or disposed of.                           (iii) Public comments. All comments
                                                      March 2007, or a successor document                        (2) When determining the scope, EPA                 that could be raised on the matters
                                                      that addresses metal risk assessment                    will identify the exposed individuals                  addressed and issues presented in the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7579

                                                      published risk evaluation scope                         limitations of the reasonably available                characterize and evaluate the interaction
                                                      document must be presented during this                  information.                                           of the chemical substance with the
                                                      comment period. Any issues not raised                      (7) Human health hazard assessment.                 ecological characteristics identified in
                                                      at this time will be considered to have                 The hazard assessment will consider all                the final scope document published
                                                      been waived, and may not form the                       potentially exposed and susceptible                    pursuant to paragraph (c)(6)(iv) of this
                                                      basis for an objection or challenge in                  subpopulation(s) determined to be                      section.
                                                      any subsequent administrative or                        relevant, as identified in the final scope               (ii) Exposures considered will include
                                                      judicial proceeding.                                    document published pursuant to                         individuals as well as communities,
                                                         (iv) Final scope. (A) The Agency will,               paragraph (c)(6)(iv) of this section.                  depending on the chemical substance
                                                      no later than 6 months after the                        Reasonably available information used                  and the ecological characteristic
                                                      initiation of a risk evaluation, publish a              to characterize risk to susceptible                    involved.
                                                      document in the Federal Register that                   subpopulation(s) may include, but may
                                                      specifies the final scope of the risk                                                                          § 702.41 Risk characterization and peer
                                                                                                              not be limited to:
                                                      evaluation the Agency plans to conduct.                                                                        review procedures.
                                                                                                                 (i) Population-based epidemiology
                                                      The document shall address the                          studies that identify risk factors and                    (a) Risk Characterization
                                                      elements in paragraphs (c)(1) through                   susceptible subpopulations;                            Considerations. EPA will: (1) Integrate
                                                      (5) of this section.                                       (ii) Information related to geographic              the hazard and exposure assessments
                                                         (B) For a chemical substance                         location of subpopulations;                            into quantitative and/or qualitative
                                                      designated as a High-Priority Substance                    (iii) Models that represent health                  estimates of risk for the identified
                                                      under 40 CFR part 702 subpart A, EPA                    effects of relevant subpopulations; and                populations (including any potentially
                                                      will not publish the final scope of the                    (iv) Any other relevant, scientifically             exposed or susceptible subpopulation(s)
                                                      risk evaluation until at least 12 months                valid information, methodology, or                     identified in the final scope document
                                                      have elapsed from the initiation of the                 extrapolation.                                         published pursuant to 40 CFR
                                                      prioritization process for the chemical                    (8) Environmental health hazard                     703.39(c)(6)(iv) and ecological
                                                      substance.                                              assessment. The relationship between                   characteristics for the conditions of use;
                                                         (d) Hazard assessment. (1) The hazard                the chemical substance and the                         and
                                                      information relevant to the chemical                    occurrence of an ecological hazard                        (2) Describe whether aggregate or
                                                      substance will be evaluated using                       elicited will be evaluated using                       sentinel exposures under the conditions
                                                      endpoints identified in the final scope                 reasonably available information                       of use were considered and the basis for
                                                      document published pursuant to                          including but not limited to: Field or                 that consideration.
                                                      paragraph (c)(6)(iv) of this section, for               laboratory measurements, modeling                         (b) The Risk Characterization will
                                                      the identified exposure scenarios,                      strategies, extrapolations or incident                 summarize, as applicable, the
                                                      including any identified potentially                    data.                                                  considerations addressed throughout
                                                      exposed or susceptible                                     (e) Exposure assessment. (1) Where                  the evaluation components, in carrying
                                                      subpopulation(s).                                       relevant, the likely duration, intensity,              out the obligations under 15 U.S.C.
                                                         (2) The hazard assessment process                    frequency, and number of exposures                     2625(h). This summary will include, as
                                                      will identify the types of hazards to                   under the conditions of use will be                    appropriate, a discussion of:
                                                      health or the environment posed by the                  considered.                                               (1) Considerations regarding
                                                      chemical substance. This process                           (2) For the conditions of use,                      uncertainty and variability. Information
                                                      includes the identification, evaluation,                exposures will be evaluated using                      about uncertainty and variability in
                                                      and synthesis of information to describe                reasonably available information.                      each step of the risk evaluation (e.g., use
                                                      the potential health effects of the                        (3) Chemical-specific factors                       of default assumptions, scenarios,
                                                      chemical substance.                                     including, but not limited to: Physical-               choice of models and information used
                                                         (3) Based on the final scope document                chemical properties and environmental                  for quantitative analysis) will be
                                                      published pursuant to paragraph                         fate parameters will be examined.                      integrated into an overall
                                                      (c)(6)(iv) of this section, potential                      (4) Human health exposure                           characterization and/or analysis of the
                                                      human and environmental hazard                          assessment. The exposure assessment                    impact of the uncertainty and variability
                                                      endpoints will be evaluated, including,                 will consider all potentially exposed                  on estimated risks. EPA may describe
                                                      as appropriate; acute, subchronic, and                  and susceptible subpopulation(s)                       the uncertainty using a qualitative
                                                      chronic effects during various stages of                determined to be relevant, as identified               assessment of the overall strength and
                                                      reproduction or life stage.                             in the final scope document published                  limitations of the data used in the
                                                         (4) The relationship between the dose                pursuant to paragraph (c)(6)(iv) of this               assessment.
                                                      of the chemical substance and the                       section. Reasonably available                             (2) Considerations of data quality. A
                                                      occurrence of human and                                 information used to characterize                       discussion of issues associated with
                                                      environmental health effects or                         exposure to susceptible                                data quality (e.g., reliability, relevance,
                                                      outcomes will be evaluated.                             subpopulation(s) may include:                          and whether methods employed to
                                                         (5) Studies evaluated may include,                      (i) Population-based epidemiology                   generate the information are reasonable
                                                      but would not be limited to: Human                      studies that identify risk factors and                 for and consistent with the intended use
                                                      epidemiological studies, in vivo and/or                 susceptible subpopulations;                            of the information), as well as
                                                      in vitro laboratory studies, mechanistic                   (ii) Information related to geographic              assumptions used, will be included to
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                                                      or kinetic studies in a variety of test                 location of subpopulations;                            the extent necessary. EPA also expects
                                                      systems, including but not limited to                      (iii) Models that represent exposure or             to include a discussion of the extent of
                                                      toxicokinetics and toxicodynamics,                      health effects of relevant                             independent verification or peer review
                                                      computational toxicology, data from                     subpopulations; and                                    of the information or of the procedures,
                                                      structure-activity relationships, high-                    (iv) Any other relevant, scientifically             measures, methods, protocols,
                                                      throughput assays, genomic response                     valid information or methodology.                      methodologies, or models used in the
                                                      assays, and ecological field data.                         (5) Environmental health exposure                   risk evaluation.
                                                         (6) Hazard identification will include               assessment. (i) The environmental                         (3) Considerations of alternative
                                                      an evaluation of the strengths and                      health exposure assessment will                        interpretations. If appropriate and


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                                                      7580                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      relevant, a discussion of alternative                   evaluation in the Federal Register and                 does not present an unreasonable risk of
                                                      interpretations of the data and analyses                provide no less than a 30-day comment                  injury to health or the environment will
                                                      will be included.                                       period, during which time the public                   be issued by order and considered to be
                                                         (4) Considerations for environmental                 may submit comment on EPA’s draft                      a final EPA action, effective on the date
                                                      risk evaluations. For environmental risk                risk evaluation.                                       of issuance of the order.
                                                      evaluations, it may be necessary to                        (1) EPA will open a docket to                          (c) Reassessment. EPA may reassess
                                                      discuss the nature and magnitude of the                 facilitate receipt of public comment.                  an unreasonable risk determination
                                                      effects, the spatial and temporal patterns                 (2) All comments that could be raised               based on a review of available
                                                      of the effects, implications at the                     on the matters addressed and issues                    information.
                                                      individual, species, and community                      presented in the draft risk evaluation
                                                      level, and the likelihood of recovery                   must be presented during this comment                  § 702.47   Publically available information.
                                                      subsequent to exposure to the chemical                  period. Any issues not raised at this                     For each risk evaluation, EPA will
                                                      substance.                                              time will be considered to have been                   maintain a public docket at http://
                                                         (c) Peer Review. The EPA Peer Review                 waived, and may not form the basis for                 www.regulations.gov to provide public
                                                      Handbook (2015), the Office of                          an objection or challenge in any                       access to the following information, as
                                                      Management and Budget Final                             subsequent administrative or judicial                  applicable for that risk evaluation:
                                                      Information Quality Bulletin for Peer                   proceeding.                                               (1) The draft scope, final scope, draft
                                                      Review (OMB Bulletin), or other                            (b) Final risk evaluation. (1) EPA will             risk evaluation, and final risk
                                                      available, relevant and applicable                      complete a risk evaluation for the                     evaluation;
                                                      methods consistent with 15 U.S.C. 2625,                 chemical substance as soon as                             (2) All notices, determinations,
                                                      will serve as the guidance for peer                     practicable, but not later than 3 years                findings, consent agreements, and
                                                      review activities. Peer review will be                  after the date on which the Agency                     orders;
                                                      conducted on the risk evaluations for                   initiates the risk evaluation.
                                                      the chemical substances identified                                                                                (3) Any information required to be
                                                                                                                 (2) The Agency may extend the                       provided to the Agency under 15 U.S.C.
                                                      pursuant to 15 U.S.C. 2605(b)(4)(A).                    deadline for a risk evaluation for not                 2603;
                                                      § 702.43   Unreasonable risk determination.             more than 6 months.                                       (4) A nontechnical summary of the
                                                        The EPA will determine whether the                       (3) EPA will publish the final risk                 risk evaluation;
                                                      chemical substance presents an                          evaluation in the Federal Register.
                                                                                                                                                                        (5) A list of the studies, with the
                                                      unreasonable risk of injury to health or                   (c) Final determination of
                                                                                                                                                                     results of the studies, considered in
                                                      the environment under the conditions of                 unreasonable risk. Upon determination
                                                                                                                                                                     carrying out each risk evaluation;
                                                      use as identified in the final scope                    by the EPA that a chemical substance
                                                                                                              does present an unreasonable risk of                      (6) The final peer review report,
                                                      document published pursuant to 40 CFR                                                                          including the response to peer review
                                                      702.39(c)(6)(iv).                                       injury to health or the environment, the
                                                                                                              Agency will initiate action as required                comments; and
                                                      § 702.45 Risk evaluation timeframes and                 pursuant to 15 U.S.C. 2605(a).                            (7) Response documents to the public
                                                      actions.                                                   (d) Final determination of no                       comments on the draft risk evaluation.
                                                        (a) Draft risk evaluation timeframe.                  unreasonable risk. A determination by                  [FR Doc. 2017–01224 Filed 1–18–17; 8:45 am]
                                                      The EPA will publish a draft risk                       the EPA that the chemical substance                    BILLING CODE 6560–50–P
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Document Created: 2018-02-01 15:16:19
Document Modified: 2018-02-01 15:16:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before March 20, 2017.
ContactFor technical information contact: Susanna W. Blair, Immediate Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 7562 
RIN Number2070-AK20
CFR AssociatedEnvironmental Protection; Chemicals; Chemical Substance; Hazardous Substances; Health and Safety and Risk Evaluation

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