May 2018
EPA's Responses to Public Comments Received on the Scope Documents for the First Ten
Chemicals for Risk Evaluation under TSCA
This response to comment document addresses cross cutting public comments that may be applicable
to issues impacting all ten chemicals. The responses here represent EPA's preliminary reactions to
some of the comments received, as the Agency has not reached final decisions on the approaches to
the 10 risk evaluations. The Agency invites the public to provide additional comments on these
Problem Formulation documents if their comments/issues have not been sufficiently addressed.
General comments
1. Many commenters asked for clarification on how the problem formulations will be different than
the scope documents. Commenters added that these scopes are not as robust as TSCA demands,
and EPA must address these flaws in the problem formulations. EPA needs to clarify what hazards,
exposures, conditions of use, and susceptible populations are being considered in the risk
evaluations (0741-0059, 0741-0060). One commenter added that "it is often unclear in these scope
documents whether EPA plans to include and evaluate in the risk evaluations the hazards,
exposures, and susceptible populations it has identified. The commenter believes they must be
included: EPA must consider the hazards, exposures, and susceptible populations it has identified.
Response: EPA agrees that TSCA requires that scope documents include the hazards,
exposures, conditions of use, and the potentially exposed or susceptible subpopulations the
Administrator expects to consider. EPA believes the scope documents did that, although without
the level of specificity EPA expects for future risk evaluations. As explained in each of the scope
documents,
"To the extent practicable, EPA has aligned this scope document with the approach set forth in
the risk evaluation process rule; however, the scope documents for the first 10 chemicals in the
risk evaluation process differ from the scope documents that EPA anticipates publishing in the
future. Time constraints have resulted in scope documents for the first 10 chemicals that are not
as refined or specific as future scope documents are anticipated to be.
Because there was insufficient time for EPA to provide an opportunity for comment on a draft of
this scope document, as it intends to do for future scope documents, EPA will publish and take
public comment on a Problem Formulation document which will refine the current scope, as an
additional interim step, prior to publication of the draft risk evaluation for [chemical name]."
EPA has published the Problem Formulation documents which refine these 10 scope documents.
The conceptual models and analysis plans in the problem formulation documents more clearly
identify the hazards, exposures, conditions of use and potentially exposed or susceptible
subpopulations the Administrator expects to consider in risk evaluations for the first ten
chemicals. Additional specificity around some of these general components (e.g., particular
exposure parameters, points of departure for hazards, susceptible subpopulations based on
greater susceptibility) of a risk evaluation cannot be provided until data and models are
reviewed and analyses conducted. These activities and further analyses occur during the
Analysis Phase of risk evaluation and will be presented in the Draft Risk Evaluation.
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Conditions of Use
2. EPA received a number of comments regarding the conditions of use. Commenters urged EPA to
consider the chemical substance as a whole and therefore to consider all conditions of use, and that
EPA does not have discretion to ignore certain uses (0741-0059, 0735-0052), including de minimis
uses (0741-0061). Other commenters added that EPA should consider reasonably foreseeable uses
like accidents, misuses, and off-label uses, whole lifecycle of the chemical including legacy, and non-
TSCA uses (0741-0061, 0741-0062, 0741-0056, 0741-0029). One commenter specifically questioned
the exclusion of accidents, stating that the risk of accidental releases and exposures is very real and
certainly "reasonably foreseen" in many respects, and EPA has authority to mandate steps to reduce
those risks (0741-0059).
Specifically, regarding legacy uses, two commenters added that legacy uses should be considered
(0735-0052) (0741-0057), and others noted that there are six chemicals that contribute to ongoing
exposure and risk as a result of historical manufacturing and processing activities that have been
discontinued. These commenters stated that ongoing use and disposal of chemical products that
are no longer being manufactured fall within the TSCA definition of "conditions of use" and must be
included in problem formulations and assessed in risk evaluations (0741-0060, 0741-0062).
Additionally, one commenter added that by-product or contaminant uses should also be added
(0741-0057).
Response: As discussed at length in the preamble to the final risk evaluation rule, based on
legislative history, statutory structure and language, and other evidence of Congressional intent,
EPA has identified certain activities that may generally not be considered to be conditions of
use. EPA does not generally intend to include intentional misuses (e.g., inhalant abuse), as a
"known" or "reasonably foreseen" activity in a chemical substance's risk evaluation. EPA's
judgment is supported by the legislative history, and public comment suggesting that "the term
'conditions of use' is not intended to include 'intentional misuse' of chemicals." See, for
example Senate Report 114-67, page 7. Similarly, EPA interprets the mandates under section
6(a)-(b) to conduct risk evaluations and any corresponding risk management to focus on uses
for which manufacturing, processing, or distribution in commerce is intended, known to be
occurring, or reasonably foreseen to occur (i.e., is prospective or on-going), and consequently
does not generally intend to evaluate the risks associated with legacy uses, associated disposal,
and legacy disposal.
EPA further explained that it may, on a case-by case basis, exclude certain activities that EPA has
determined to be conditions of use in order to focus its analytical efforts on those exposures
that are likely to present the greatest concern, and consequently merit an unreasonable risk
determination. This includes uses that EPA has sufficient basis to conclude would present only
"de minimis" exposures. This could include uses that occur in a closed system that effectively
precludes exposure, or use as an intermediate. EPA may also exclude a condition of use that has
been adequately assessed by another regulatory agency, particularly where the other agency
has effectively managed the risks. EPA may determine that there are appropriate regulatory
safeguards in place for a particular use or that a particular use is de minimis, and that these uses
can be excluded from further assessment as part of the risk evaluation. Finally, EPA also
identified certain exposure pathways that are under the jurisdiction of regulatory programs and
associated analytical processes carried out under other EPA-administered environmental
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statutes and which EPA does not expect to include in the risk evaluation. See, 82 Fed Reg at
33729-33730 for further details on EPA's reasoning.
EPA also indicated in the preamble to the Risk Evaluation rule, and again in the chemical scope
documents, that it intends to exercise discretion in addressing circumstances where the
chemical substance subject to scoping is unintentionally present as an impurity in another
chemical substance that is not the subject of the pertinent scoping. EPA went on to explain that
there may be several different technical and policy perspectives in which to consider evaluating
the risks of impurities, including to evaluate the potential risks within the scope of the risk
evaluations for the impurity itself, within the scope of the risk evaluation for the separate
chemical substances that bear the impurity, and not including the impurity within any risk
evaluation where EPA has a basis to foresee that the risk from the impurity would be de minimis
or otherwise insignificant.
The problem formulation document for each of the first 10 chemicals has been refined based on
comments and input on the scope documents. The problem formulation more clearly presents
what conditions of use and associated exposure pathways will be evaluated in the risk
evaluation and provides rationales for EPA's decisions.
Systematic Review
3. Two commenters request that the Agency conduct systematic review to identify the hazard as these
methods will strengthen and increase transparency. Specifically, 0741-0052 stated that EPA should
conduct hazard identification by following systematic review processes that integrate animal,
human, and mechanistic evidence and that EPA should heed the NAS recommendation to conduct
risk evaluations by identifying any existing systematic reviews for a chemical substance, determining
if the reviews are of high quality, and for those that are, building upon the reviews by incorporating
any more recent studies that may have become available since the review was conducted (0741-
0052). Another commenter provided a number of ways to improve the Agency's literature search
and systematic review strategies to strengthen its evaluations and increase transparency (0741-
0057).
Response: As stated in the Risk Evaluation rule, EPA believes that integrating systematic review
into the TSCA risk evaluations is critical to meet the statutory requirements of TSCA. EPA agrees
that there are universal components of systematic review that EPA intends to apply in
conducting risk evaluations. EPA has also concluded it would be premature to codify specific
systematic review methods and criteria since these may change as the Agency gains more
experience conducting TSCA risk evaluations.
Along with the problem formulation documents, EPA is publishing a supplemental document,
Application of Systematic Review in TSCA Risk Evaluations, which contains details about the
systematic review process and the evaluation strategy for assessing data quality that OPPT plans
to use for these first ten chemical risk evaluations. Integrating systematic review principles into
the TSCA risk evaluation process is critical to develop transparent, reproducible and scientifically
credible risk evaluations.
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EPA/OPPT plans to implement a structured process of identifying, evaluating and integrating
evidence for both the hazard and exposure assessments developed during the TSCA risk
evaluation process. The systematic review process will use existing assessments as a starting
point to identify relevant references and supplement these with any more recent information.
It is expected that new approaches and/or methods will be developed to address specific
assessment needs for the relatively large and diverse chemical space under TSCA. Thus,
EPA/OPPT expects to document the progress of implementing systematic review in the draft risk
evaluations and through revisions of the Application of Systematic Review in TSCA Risk
Evaluations document, and publication of supplemental documents.
Exposure
4. A number of commenters provided input regarding how the Agency will assess chemical exposures,
specifically with regard to engineering controls. EPA should not rely on labeling and PPE as a basis
to assume low or no exposure, given the major real-world limitations of these measures. EPA should
account for such real-world limitations of PPE in the risk evaluations by either collecting or requiring
the development of empirical data, or, in their absence, using worst-case assumptions to assess the
extent of exposure reduction resulting from labeling and PPE. Reliance on such data clearly
constitutes best available science (a requirement under TSCA § 26), and EPA has clear authority to
collect or require the development of such data under § 4(b)(2)(A). (0741-0059, 0741-0062, 0741-
0029, 0741-0057). Another commenter added that, in evaluating workplace risks, EPA should
recognize and account for the uneven use and effectiveness of engineering controls, labeling and
personal protective equipment in preventing occupational exposure and determine risks to workers
in situations where these measures are not in place or ineffective. The problem formulation
documents should explicitly recognize that industrial hygiene controls do not necessarily provide
reliable and effective protection from exposure and that the adequacy of these controls needs to be
examined on a case-by-case basis in the context of the specific establishments where the chemical is
used, the makeup of the worker population in these establishments and the diligence of employers
in implementing workplace controls (0741-0060).
Response: OPPT's approach for developing exposure assessments for workers is to use best
available information to construct realistic exposure scenarios based on data and information
regarding real-world use of chemicals. When appropriate, in the risk evaluation, OPPT will use
exposure scenarios both with and without engineering controls and/or PPE that may be applicable
to particular worker tasks on a case-by-case basis for a given chemical.
5. There were a number of comments urging EPA to assess aggregate exposures within populations in
the problem formulations, and stating that failing to do so would underestimate the risk of the
chemicals. (0735-0052, 0741-0057, 0741-0060, 0741-0061, 0741-0029)
Response: The statute requires that the Agency describe whether aggregate (or sentinel)
exposures were considered, see 15 USC 2605(b)(4)(F)(ii); whichever exposure assessment
method is ultimately used will be accompanied by an explanation in the Risk Evaluation. In
conducting an aggregate exposure assessment, EPA may also include exposures from non-TSCA
uses, e.g., as part of background; whether and how to account for such exposures will be
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evaluated on a case-by-case basis. EPA will consider whether to assess aggregate exposure
when developing the exposure assessment during the Analysis Phase of the Risk Evaluation.
6. Two commenters asked how EPA will incorporate cumulative risk, as well as aggregate, in the first
10 risk evaluations. Commenters added, to properly apply either or both of these approaches in a
risk evaluation, EPA must determine in advance what methodology it will employ and then
incorporate it in the risk evaluation design in sufficient detail to describe the key data sources it will
use to assess exposure and how they will be used. (0741-0060, 0741-0061)
Response: Cumulative exposure is not required under the statute. EPA retains the discretion to
conduct a cumulative assessment but has not yet determined whether to do so for any of the
first 10 risk evaluations. However, EPA may ultimately determine that for a certain chemical or
category a cumulative exposure assessment is appropriate for certain endpoints.
Hazard
7. One commenter asked EPA not to prejudge the absence of adverse effects for particular end-points
at the scoping stage but to defer such conclusions until the systematic review phase of its risk
evaluation as the law requires (0741-0060).
One commenter expressed concern that EPA says in all the chemical scoping documents in the
Section on Environmental Hazards that it expects to consider other studies, including data from
alternative test methods such as computational toxicology, bioinformatics, high-throughput
screening methods, read-across data, etc. Many of these alternative test methods, and particularly
their application to risk assessment, are still emerging and, although promising, have serious
limitations. However, if utilized prematurely or incorrectly, these tools could allow for the rapid and
erroneous exoneration of harmful chemicals. These tools lack complete biological coverage, cannot
presently evaluate the potential toxicity associated with chemical metabolism and absorption, and
have the potential for high false negatives relative to whole animal studies (0741-0062).
Response: EPA does not intend to prejudge any conclusions before completing the systematic
review process supporting the risk evaluations. OPPT is aware of the status of alternative test
methods with regard to the methodological validation, standardization and acceptance (e.g.,
established OCSPP or OEC Test Guideline vs. basic research approach). Regardless of the level of
regulatory or international recognition, data from other studies and alternative test methods
can inform risk evaluation if they are determined to be consistent with the best available science
and can inform the weight of the scientific evidence. Like other, more traditional testing studies,
studies conducted using non-guideline approaches or using alternative test methods will be
evaluated for quality and relevance following the process described in the supplemental
document, Application of Systematic Review in TSCA Risk Evaluations. In addition, all risk
evaluations will be subject to public comment and independent peer review. OPPT anticipates
use of data from alternative test methods.
TSCA section 26(h) requires that, to the extent that EPA makes a decision based on science
under TSCA sections 4, 5, or 6, EPA must use scientific information, technical procedures,
measures, methods, protocols, methodologies, or models consistent with the best available
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science. TSCA section 26(i) requires EPA to make decisions under TSCA sections 4, 5, and 6 based
on the weight of the scientific evidence. 15 U.S.C. 2625(h) and (i).
8. One commenter stated that three chemicals (carbon tetrachloride, methylene chloride and 1-
bromopropane) have data showing a high ozone depletion potential and that this should fall within
the scope of the risk evaluation (0742-0060).
Response: Regulation of ozone-depleting substances (ODS) falls under the jurisdiction of the
Clean Air Act, administered by EPA's Office of Air and Radiation. Because ozone depletion risks
are adequately assessed and effectively managed under the Clean Air Act, EPA does not expect
to include ozone-depletion potential in risk evaluations for carbon tetrachloride, methylene
chloride or 1-bromopropane. EPA regulations under Sections 601-607 of the Clean Air Act phase
out the production and import of class I and class II ODS (https://www.epa.gov/ods-phaseout)
with limited exceptions. Carbon tetrachloride is subject to these regulations, addressing its
ozone-depletion risks. Furthermore, under Section 612 of the CAA, EPA's Significant New
Alternatives Policy (SNAP) program reviews substitutes for ODS. New chemicals that are
proposed as substitutes are reviewed in coordination with OCSPP's New Chemicals Program,
and significant new uses of existing chemicals are also reviewed under the SNAP
program. Various environmental and health risks of methylene chloride and 1-bromopropane
(n-propyl bromide), including their ozone-depletion potential, have been evaluated for specific
uses under the SNAP program.
Health Protective Defaults
9. A number of commenters urged EPA to use health-protective defaults if the agency lacks
information specific to a chemical, and health-protective methods to quantify risk when
characterizing risk (0741-0052, 0741-0057, 0741-0062). Specifically, for cancer, a commenter
highlighted the NAS recommendation that EPA include a factor to account for human variability in
response to carcinogens, as EPA's current approach inaccurately assumes that there is no variability
in response. Similarly, EPA should increase or add factors that address cancer and non-cancer
susceptibility during early life stages (0741-0057).
One commenter urged EPA not to use MOE (margin of exposure) as an analysis method in the risk
evaluation process, as MOE is not an estimate of risk—it is a single number that is a version of the
"bright line" approach like the Reference Dose (or Reference Concentration for inhalation doses)
(0741-0057).
Response: EPA does not want to a priori preclude the use of any methods or data types, to allow
its evaluations to change as science advances. EPA will utilize current policies, models, and
screening methods, but is committed to being consistent with the best available science and
weight of the scientific evidence approaches to guide the Agency in using this information. EPA
recognizes the advancing science to inform risk evaluation and will not discourage the use of
new methods as long as they are consistent with the standards in section 26 of TSCA. EPA also
recognizes that different approaches require different types and amounts of data and will select
and employ methods that are fit for purpose within the context of a particular risk evaluation.
In some cases, it may be necessary to utilize default parameters in modeling and risk
calculations, and to utilize conservative assumptions, whereas in other cases assumptions may
be replaced with specific or specialized data. It should also be noted, in addition, their use will
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be peer reviewed, and the public will have the opportunity to comment on them during the
public comment periods.
EPA has utilized the MOE approach in previous risk assessments, citing its utility. However, EPA
does agree with comments that there are numerous ways to characterize risk, of which MOE is
just one. There will be risk scenarios where one approach may be better than another and, as
commenters correctly pointed out, the science of risk characterization is still evolving,
particularly for non-cancer hazards. Hence, OPPT will use risk characterization approach(es)
suitable for the purpose of the risk evaluation and that the best available science and data
support. EPA does not agree with the commenter that the use of MOEs is never appropriate.
Confidential business information (CBI)
10. A number of commenters added comments regarding CBI. Two requested EPA require that claims
of confidential business information be fully substantiated by industry and not used to conceal
critical information from the public (0741-0052, 0741-0057, 0074-0059). Another added that EPA
needs to take stronger steps to limit CBI treatment of critical information during the risk evaluation
process so that transparency and public participation in that process are not impaired (0741-0060).
One commenter added that the strategy for conducting literature searches appears to state that
EPA excluded from the search "[djocuments not available to the public, including information stored
within EPA's firewall that is not accessible on the EPA webpage (e.g., TSCA submissions) [and]
Confidential Business Information." But the information EPA has already collected about these
chemicals is potentially relevant to the risks they present, even if the information is not yet publicly
disclosed. This information falls squarely within EPA's definition of "reasonably available
information" as "information that EPA possesses." 40 C.F.R. § 702.33. Indeed, EPA expressly stated
that "[information is reasonably available information whether or not the information is
confidential business information, that is protected from public disclosure under TSCA section 14."
Id. Since this information is reasonably available EPA must review it (0741-0059).
Additionally, this commenter raised the question as to whether this information may not meet the
new, stricter requirements and standards for nondisclosure under TSCA § 14 as amended by the
Lautenberg Act. Historically EPA has failed to review CBI claims, and while the Lautenberg Act
requires EPA to do so, the public has little evidence to date that EPA is complying with this new
mandate. So EPA may never have reviewed the CBI claims for this information, particularly if it was
submitted before passage of the Lautenberg Act (0741-0059).
Response: TSCA requires that CBI claims must be asserted and substantiated concurrently with
the submission of information, except for information that is deemed exempt under TSCA
section 14(c)(2).
The risk evaluation rule does clarify that the agency does consider CBI as "reasonably available
information" and will utilize it in risk evaluations were relevant.
The Strategy for Conducting Literature Searches for each TSCA Scope document described the
procedure for searching the public literature which does not include searching "[djocuments not
available to the public, including information stored within EPA's firewall that is not accessible
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on the EPA webpage (e.g., TSCA submissions) [and] Confidential Business Information".
However, OPPT is searching internal information it may possess as part of the process of
conducting the risk evaluations. This is discussed in the supplemental document, Application of
Systematic Review in TSCA Risk Evaluations.
EPA will comply with TSCA section 14 review and disclosure requirements for data/information
that is claimed confidential and deemed relevant for the risk evaluation.
Potentially exposed and susceptible subpopulations
11. Commenters provided feedback regarding EPA's approach to identifying "potentially exposed or
susceptible subpopulations." One commenter suggested that EPA address susceptible sub-
populations, following recommendations from the National Academies of Sciences (NAS) to identify
susceptible sub-populations based on established extrinsic and intrinsic factors that increase
vulnerability (0741-0057).
Another commenter suggested the language provided in the scopes was general "boilerplate"
descriptions of such subpopulations, adding that further particulars on the size, geographic location,
demographic characteristics and exposure profile of each subpopulation EPA has identified would
provide helpful assurance that the risks to that subpopulation will be characterized with the rigor
that TSCA requires (0741-0060). Similarly, a commenter asked for more clarification in the problem
formulation documents of those populations with greater susceptibility (0741-0059).
Another commenter encouraged EPA to consider for every chemical review: (1) occupational
exposures that are often at much higher exposure levels than the general public, both acutely and
chronically, and can be concurrent with other chemical exposures at the workplace; (2) fence-line
communities who also face multiple exposures to multiple chemicals and suffer from many chronic
health conditions and health inequalities; (3) sensitive time periods during life, such as pregnancy
and during childhood; (4) tribal communities where cultural and lifestyle considerations may result
in very different exposure profiles and where there are often disproportionate adverse health
outcomes; and (5) general variability in human responses. The commenter encouraged EPA to
actively seek input from fence-line and other impacted communities, occupational workers at
manufacturing, processing, distributing, or recycling facilities, concerned members from the public,
and tribal communities and incorporate their concerns in the Agency's evaluations where
appropriate." (0741-0029)
A commenter added comments specifically regarding occupational exposure: Occupational workers
exposed during the manufacture, processing, disposal, etc. of these chemicals should always be
considered separately as a susceptible population. Furthermore, the consideration of exposed
workers should always include the potential for pregnant women and consider both women and
men of childbearing age as a vulnerable population when assessing the risk (0741-0029 and 0741-
0059).
Finally, one commenter urged the agency to seek communities' and public health experts' input as
to the appropriate means to identify vulnerable and chemically overburdened populations when
drafting scoping documents. The commenter also requests that EPA apply its own established
principles for promoting environmental justice when determining the scope of a risk assessment
(0741-0061).
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Response: While EPA wholly agrees that protecting potentially exposed or susceptible
subpopulations is an important part of EPA's mandate, the process for identifying the
subpopulations considered in each risk evaluation will be case specific and, consistent with the
directive in section 6(b)(4)(A), tailored as relevant to the risk evaluation. Furthermore, EPA will
use the best available science and prevailing guidance, such as recommendations of the NAS, in
defining and assessing such subpopulations.
Every risk evaluation must consider any 'potentially exposed or susceptible subpopulations'
determined to be relevant to the risk evaluation under the conditions of use. However,
potentially exposed or susceptible populations and subpopulations can vary depending on the
chemical and conditions of use being evaluated. EPA is required by statute to consider relevant
potentially exposed or susceptible subpopulations, which could include children, pregnant
women, and other subpopulations as appropriate for the assessment. For example, when
appropriate, EPA will include specific life-stages exposure scenarios which may be more
representative of various exposures that affect children.
Likewise, if workers are determined to be a population likely to be exposed to a chemical during
its conditions of use, this population would be included as a 'potentially exposed or susceptible
subpopulation' and therefore considered in the risk evaluation. In fact, in the scope documents,
EPA identified both workers and consumers as susceptible subpopulations on the basis that they
are more exposed than the general population to chemicals and/or products that the general
population does not work with or use. EPA acknowledged in the scope documents that
measurement and evaluation methods for these, and potentially other, subpopulations is still
being refined.
EPA welcomes information from communities and will use it to further refine risk evaluations.
To this end, EPA has already sought input from specific populations and public health experts in
implementing TSCA and will continue to do so. For example, EPA has had discussions on several
occasions with the National Tribal Toxics Council to receive input on tribal lifeways and
exposures. OPPT and the NTTC continue to collaborate on ways to consider tribes in conducting
potentially exposed or susceptible subpopulations analyses for Draft Risk Evaluations. OPPT has
also had several meetings with AFL-CIO about workers as potentially exposed or susceptible
subpopulations and ways in which worker exposure information could be identified and
provided for use in the risk evaluation process. OPPT has also sought advice and input regarding
children as a susceptible subpopulation from the Children's Health Protection Advisory
Committee (CHPAC) through a meeting and recommendations addressing the formal request
from EPA for guidance on how risk evaluation should address children. CHPAC's
recommendations can be found here.
IRIS Assessments
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12. A few commenters urged EPA to use existing IRIS assessments (0741-0061, 0741-0062). Specifically,
EPA should rely on existing IRIS assessments for hazard identification, and moving forward, EPA
should complete hazard identification or add additional studies only through a systematic review
process, which integrates animal, human and mechanistic evidence as recommended by the recent
NAS report (0741-0057). EPA does not need to revisit definitive findings in IRIS assessments since
these assessments represent the Agency's authoritative, peer reviewed determinations on the
health effects of the chemicals they address (0074-0060).
Response: As discussed in the scope documents, where applicable, OPPT has used IRIS
documents as a starting point for identifying key and supporting toxicity studies and initial
hazard identification. However, EPA also expects to consider other available hazard and
exposure data to ensure that all reasonably available information is taken into consideration.
Specifically, EPA will screen information developed after the completion of any IRIS assessment
and evaluate the relevant information using OPPT's structured process described in the
documents Procedures for Chemical Risk Evaluation under the Amended Toxic Substances
Control Act (40 CFR Part 702) and EPA's supplemental document, Application of Systematic
Review in TSCA Risk Evaluations.
Information Gathering
13. EPA received a number of comments on information gathering.
"EPA must consider "reasonably available" information, and thus EPA must consider the information
it already possesses and use its authorities under TSCA [sections] 4 and 8 to obtain additional
information. The scoping documents suggest that EPA will fall far short of meeting this standard. In
all of the scopes, EPA stated that it would search "readily available data and information from public
sources," and "EPA encourages submission of additional existing data, such as full study reports or
workplace monitoring from industry sources" (p.42). But this approach to collecting data is
insufficient as a matter of law. Each scope refers to "readily available" information, but the standard
under TSCA is reasonably available information. Additionally, any information that EPA can obtain
under the exercise of its authorities under §§ 8(d), 8(a), and 8(c) is "reasonably available
information," so EPA must exercise those authorities. EPA must identify any information gaps and
use its authority under TSCA § 4 to the fullest extent possible to fill those gaps." (0741-0059).
Response: The commenter is correct, as the scope documents should refer to "reasonably
available information", not "readily available". In the risk evaluation rule, EPA defined
reasonably available information to mean information that EPA possesses, or can reasonably
obtain and synthesize for use in risk evaluations, considering the deadlines for completing the
evaluation. Below EPA has collated a non-exhaustive list of the information activities associated
with collecting reasonably available information. EPA notes that it selected the first 10
chemicals for risk evaluation based in part on its assessment that these chemicals could be
assessed without the need for regulatory information collection or development.
Generate: EPA explained in the risk evaluation rulemaking that reasonably available information
includes information that could be generated through testing, where that information can be
generated and synthesized within the statutory timeframes and would be of sufficient value to
merit the testing. As of now, EPA has not identified the need for any such testing for the first 10
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chemicals. In the timeframe allotted to initiate the risk evaluation process and develop the
scoping documents for the initial ten chemicals subject to risk evaluation following the 2016
amendments to TSCA, EPA consulted a variety of information sources, both internally and
externally, and currently believes the information obtained through these investigations is
sufficient to make the necessary determinations. As we have previously indicated (for instance,
in the scope documents for the first ten chemicals), in the future prioritization (and pre-
prioritization) processes, EPA will have additional time prior to risk evaluation to evaluate data
landscapes and judge whether testing would be appropriate. While the timeframes for these
first 10 risk evaluations have necessarily constrained EPA's ability to require testing, EPA does
not currently see the need for testing to complete these risk evaluations.
Obtain: EPA conducted extensive and varied data gathering activities for each of the first 10
chemicals, including:
(1) Conducted extensive and transparent searches of public databases and sources of scientific
literature, government and/or industry sector or other reports, etc. [See supplemental file,
Strategy for Conducting Literature Searches, associated with each of the ten chemicals on
the chemical's webpage],
(2) Searched EPA TSCA 8(e) and CBI submission holdings for data on the first ten chemicals.
(3) Consulted a variety of sources to identify conditions of use of the initial ten chemicals.
These sources included information reported to EPA (including Chemical Data Reporting and
the Toxics Release Inventory), literature searches, proprietary reports, trade publications,
and reports developed for prior EPA and international assessments. To identify formulated
products containing , EPA searched for safety data sheets (SDS, formerly referred
to as material safety data sheets (MSDS)) using internet searches, EPA Chemical and Product
Categories (CPCat) data, the National Institute for Health's (NIH) Household Product
Database, and other resources in which SDS could be found. Each SDS was then cross-
checked with company websites to make sure that each product SDS was current. EPA also
communicated with companies, industry groups, international regulatory agencies, and non-
governmental organizations, to make sure the list of uses was correct, complete, and up-to-
date. A preliminary list of uses was presented to the public for comment ahead of a public
meeting as part of a use document for . Those public comments as well as
information from other engagements with stakeholders were integrated into this scoping
document.
(4) Conducted a market analysis of conditions of use using proprietary databases and
repositories.
(5) Conducted many outreach meetings with chemical manufacturers, processors, chemical
users, non-governmental organizations, trade organizations, and other experts, including
other State and Federal Agencies (e.g., Dept of Defense, NASA, OSHA, NIOSH, FDA and CPSC)
for each of the initial ten chemicals [See Docket(s)
https://www.epa.gov/assessing-and-rnanaging-chernicals-under-tsca/risk-evaluations-
existing-chemicals-under-tsca#ten ] to support development of conditions of use documents
[see Dockets
https://www.epa.gov/assessing-and-rnanaging-chernicals-under-tsca/risk-evaluations-
existing-chemicals-under-tsca#ten1 and scope documents
(6) Published conditions of use documents, solicited public comment/input on conditions of use
of the initial ten chemicals, convened a public meeting and opened dockets to receive
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written public comments. See the following link for additional information:
(7) Solicited public input on Scope documents and encouraged submission of additional
data/information regarding the scope for each of the initial ten chemicals
(8) Consulted existing systematic review approaches and methods to inform development of
data evaluation step of systematic review under TSCA
(9) Worked with chemical manufacturers, industry associations, other federal agencies, state
governments, unions, non-governmental organizations, and international regulatory
partners to discuss additional data/information that would inform risk evaluations and
scenarios where people could be exposed to the initial ten chemicals. As a result, EPA
received additional study reports regarding hazard information, (e.g. PV29), occupational
monitoring data from DoD, data from OSHA on worker exposures, and a variety of
information from a wide swath or stakeholders on how chemicals are used in specific
industries.
(10) Published Problem Formulation documents and solicited public input to obtain further
information useful for developing the draft risk evaluation
Synthesize: EPA has synthesized reasonably available information in several phases during the
risk evaluation process for the first chemicals, as follows:
(1) Developed conditions of use documents that synthesize the data/information obtained from
searches and meetings with stakeholders for each the initial ten chemicals.
(2) Conducted title and abstract screening on all references obtained from the literature
searches, synthesizing this information into 'on topic' and 'off topic' bins for all ten
chemicals [see supplemental file, Bibliography, for each of the ten chemicals on the
chemical's webpage],
(3) Developed Scope documents that synthesize conditions of use and lifecycle information for
each chemical to describe the hazards, exposures, conditions of use, and the potentially
exposed or susceptible subpopulations the Administrator expects to consider in the risk
evaluation and link them to the plan for the analyses to be included in the risk evaluation.
(4) Synthesized existing methods/approaches to systematic review to develop the evaluation
strategies to assess data/information quality as described in the supplemental document,
Application of Systematic Review in TSCA Risk Evaluations
(5) Synthesized additional input/data/information received on scope documents in developing
problem formulation documents that synthesize conditions of use and lifecycle information
for each chemical to describe the hazards, exposures, conditions of use, and the potentially
exposed or susceptible subpopulations the Administrator expects to consider in the risk
evaluation and link them to the plan for the analyses to be included in the risk evaluation.
(6) Consulted within EPA, across major media programs, to integrate and synthesize (cross-
walk) the nexus between TSCA and other major media statutes and regulatory programs
(e.g., CAA, CWA, SDWA, RCRA).
EPA agrees that it makes sense to view information that can be obtained through testing as
"reasonably available" in some instances - especially information that can be obtained through
short-term testing, where it can be obtained within the relevant statutory deadlines and the
information would be of sufficient value to merit the testing. EPA will consider use of its
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information gathering authorities under section 8 on a similar basis - i.e., considering the
statutory deadlines and the value the additional information would likely have in reducing
uncertainty in its fit-for-purpose evaluations. As discussed in the prioritization rulemaking, EPA
will seek to generally ensure that sufficient information to complete a risk evaluation exists and
is available to the Agency prior to initiating the evaluation. For these first ten risk evaluations,
EPA believes that these are generally data-rich chemicals, and the use of our data gathering
authority is not warranted at this time. However, EPA also recognizes that there may be
circumstances where additional information may need to be developed within the time frames
of the risk evaluation process. This may include information developed through the use of novel
and advancing chemical assessment procedures, measures, methods, protocols, methodologies,
or models (e.g., high-throughput chemical assessment techniques). EPA will tailor its
information gathering efforts as appropriate.
"Problem formulations should highlight aspects of use and exposure where available information is
insufficient and request or require submission of this information by industry and other interested
parties." (0741-0060)
Response: To date, EPA has gathered extensive use and exposure data for these ten chemicals
and believe we have adequate use and exposure info. In fact, some additional information on
uses and exposure were submitted during the comment period on the Scope documents and
this information was used to refine the problem formulations. We will seek to obtain more if we
find we need it.
"Absence of data does not equal no risk, and efforts to obtain data should occur immediately"
(0741-0029).
Response: OPPT does not believe that absence of data equals no risk. However, when OPPT
does find existing data are not adequate, OPPT will use all available authorities to fill data gaps
necessary to conduct fit-for-purpose assessments. As discussed previously, due to the deadlines
mandated in TSCA, information must be reasonably available within the constraints of the
timeframes imposed.
"When EPA relies on prior assessments, EPA must provide a short analysis indicating why they are
sufficiently reliable to ensure that EPA is not overlooking reasonably available information" (0741-
0059).
Response: EPA will re-evaluate the quality of the key/supporting data/information sources used
in previous assessments by applying standards and guidance under amended TSCA.
"EPA has provided no sound reasoning for relying solely on voluntary requests for information, and
doing so may result in limited, biased, inaccurate, or incomplete information on the chemicals, and
this does not constitute all "reasonably available" information. By contrast, If EPA acts under TSCA
§§ 8(a), (c), and (d), the regulations impose some requirements that will help ensure the accuracy
and completeness of the information." (0741-0059)
Response: EPA has not indicated it would rely solely on voluntary requests for information.
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"EPA should use section 4, 8(a), 8(c), 11 and 26(a) to fill data gaps, as the information obtained
would constitute 'reasonably available information." (0071-0061)
Response: EPA will use available authorities to fill data gaps as appropriate. However, EPA must
adhere to the timeframes imposed by TSCA. In the risk evaluation rule, EPA defined reasonably
available information to mean information that EPA possesses, or can reasonably obtain and
synthesize for use in risk evaluations, considering the deadlines for completing the evaluation.
And, consistent with the risk evaluation rule preamble, EPA will consider the value of the
information that would be obtained through its information collection authorities in judging
whether the information is reasonably available.
Alternative Assessment
14. One commenter strongly urged EPA to conduct comprehensive alternative assessments with a
priority on hazard assessment for of each of the ten chemicals under consideration. Four of the ten
chemicals currently selected by EPA as priority chemicals for risk evaluation have been previously
listed by EPA as "acceptable substitutes" under the Significant New Alternatives Policy (SNAP)
program that reviews substitutes for ozone-depleting substances within a comparative risk
framework. The need now to reevaluate these chemicals will require millions of additional taxpayer
dollars for the evaluation itself, as well as potentially millions of dollars in private resources as
companies move a second time to replace what EPA deems a hazardous chemical with an
acceptable substitute. By using a comprehensive alternatives assessment framework that prioritizes
hazard, EPA will be able to reach conclusions about each of the ten chemicals that are far less likely
to result in the need for reassessment in a few years (0741-0058).
Response: In the prioritization rule, EPA stated that an alternative assessment of substitute
chemicals is more appropriate during the risk management phase.
Ongoing Section 6(a) rule makings
15. Two commenters included comments regarding the on-going section 6(a) rulemakings that may
impact trichloroethylene, methylene chloride, and N-Methylpyrrolidone. One commenter
specifically questions EPA's decision not to examine uses addressed by its planned 6(a) rules
governing certain uses of TCE, DCM, and NMP, and furthers states that this is only justified if EPA
plans to move forward with risk management rules that ban these uses and thereby eliminate the
unreasonable risks previously identified for these uses. "By definition, EPA has already found these
uses to be "conditions of use" as "the circumstances, as determined by the Administrator, under
which a chemical substance is known to be manufactured, processed, distributed in commerce,
used, or disposed of." 15 U.S.C. § 2605(b)(4)(A), 2602(4). In addition, EPA has already found that
these uses present unreasonable risks. It would be absurd for EPA to exclude these uses unless EPA
has already banned these uses to eliminate the unreasonable risks and ensure that such uses no
longer present any residual risk which would otherwise need to be included in the present risk
evaluations for those chemicals" (0741-0059).
Another commenter adds that EPA risk evaluations should not reassess uses of trichloroethylene
(TCE), methylene chloride (MC) and N-Methylpyrrolidone (NMP) that were fully assessed in its
proposed section 6(a) rules, although these exposure pathways should be included in its
determinations of aggregate exposure to these chemicals (0741-0060).
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Response: Although EPA indicated in the TCE, NMP and MeCI scope documents that EPA did not
expect to evaluate the uses assessed in the 2014 or 2015 risk assessment in the TCE, NMP or
MeCI risk evaluation, respectively, EPA has decided to evaluate these conditions of use for TCE
and NMP in the risk evaluation. EPA is including these conditions of use so that they are part of
EPA's determination of whether TCE and NMP presents an unreasonable risk "under the
conditions of use," TSCA 6(b)(4)(A). EPA has concluded that the Agency's assessment of the
potential risks from these widely used chemicals will be more robust if the potential risks from
these conditions of use are evaluated by applying standards and guidance under amended TSCA.
In particular, this includes ensuring the evaluations are consistent with the scientific standards in
Section 26 of TSCA, the Procedures for Chemical Risk Evaluation under the Amended Toxic
Substances Control Act (40 CFR Part 702) and EPA's supplemental document, Application of
Systematic Review in TSCA Risk Evaluations. EPA also expects to consider other available hazard
and exposure data to ensure that all reasonably available information is taken into
consideration. It is important to note that conducting these evaluations does not preclude EPA
from finalizing the proposed TCE and NMP regulation. On May 10th, 2018 EPA announced it
intends to finalize the methylene chloride rulemaking proposed in January 2017. Therefore, EPA
will not re-evaluate the paint stripping uses of methylene chloride and will be relying on the
previous assessment.
Other
16. One commenters shared information on the "Beyond Science and Decisions" project, a risk methods
compendium as a resource for regulators and scientists on key considerations for applying selected
dose-response techniques for various problem formulations, with suggested techniques and
resources (0741-0057).
Response: Thank you for this comment and for the suggested resources.
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