[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7562-7580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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

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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