Notice2021-14928
Development of Tiered Data Reporting To Inform TSCA Prioritization, Risk Evaluation, and Risk Management; Notice of Public Meeting and Opportunity To Comment
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Published
July 14, 2021
Issuing agencies
Environmental Protection Agency
Abstract
On July 27, 2021, EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform the Agency's prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). Currently, EPA primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to better meet the Agency's basic chemical data needs, such as information related to exposure, health, and eco- toxicity. To this end, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: Identifying a pool of substances as potential candidates for prioritization, Selecting candidate chemicals for and completing the prioritization process, and Assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). Feedback from the public meeting and comments received will help inform the Agency's development of a proposed rule.
Full Text
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<title>Federal Register, Volume 86 Issue 132 (Wednesday, July 14, 2021)</title>
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[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37152-37154]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14928]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0436; FRL-7732-03-OCSPP]
Development of Tiered Data Reporting To Inform TSCA
Prioritization, Risk Evaluation, and Risk Management; Notice of Public
Meeting and Opportunity To Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: On July 27, 2021, EPA's Office of Chemical Safety and
Pollution Prevention (OCSPP) will hold a public meeting to engage with
interested stakeholders on the development of a proposed rule for
implementing a tiered data collection strategy to help inform the
Agency's prioritization, risk evaluation, and risk management
activities for chemical substances or mixtures under the Toxic
Substances Control Act (TSCA). Currently, EPA primarily collects
exposure-related data through the TSCA Chemical Data Reporting (CDR)
process. EPA is interested in ensuring that data collection strategies
provide information to better meet the Agency's basic chemical data
needs, such as information related to exposure, health, and eco-
toxicity. To this end, EPA is exploring a data reporting rule that is
tiered to specific stages of the TSCA existing chemicals program:
Identifying a pool of substances as potential candidates for
prioritization, Selecting candidate chemicals for and completing the
prioritization process, and Assessing high-priority substances through
a robust risk evaluation, which may be followed by risk management
actions (depending on the outcome of the risk evaluation). Feedback
from the public meeting and comments received will help inform the
Agency's development of a proposed rule.
DATES:
Meeting: The meeting will be held virtually via WebEx on July 27,
2021, from 1:00 to 3:00 EDT.
Register by: Those who would like to make a comment during the
meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who
would like to participate in listen-only mode must register by 6:00
p.m. EDT on July 26, 2021.
Comments: Written comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0436, must be received on or before August
15, 2021.
Accommodations: To request accommodation of a disability, please
contact the meeting contact listed under FOR FURTHER INFORMATION
CONTACT, preferably at least 10 days prior to the meeting, to give EPA
as much time as possible to process your request.
ADDRESSES: Register to attend this virtual public meeting at <a href="https://us-epa-tirered-data-reporting.eventbrite.com">https://us-epa-tirered-data-reporting.eventbrite.com</a>.
Submit written comments to the docket for this action, identified
by docket identification (ID) number EPA-HQ-OPPT-2021-0436, online at
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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.
Please note that due to the public health concerns related to
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to
visitors with limited exceptions. The staff continues to provide remote
customer service via email, phone, and webform. For the latest status
information on the EPA/DC and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Susan Sharkey, Data Gathering
and Analysis Division (7410M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency; telephone number: (202) 564-
8789; email address: <a href="/cdn-cgi/l/email-protection#13607b726178766a3d606660727d537663723d747c65"><span class="__cf_email__" data-cfemail="aeddc6cfdcc5cbd780dddbddcfc0eecbdecf80c9c1d8">[email protected]</span></a>.
For meeting logistics or registration assistance contact: Sarah
Swenson; telephone number: (202) 566-0279; email address:
<a href="/cdn-cgi/l/email-protection#b9cacedcd7cad6d797cad8cbd8d1f9dcc9d897ded6cf"><span class="__cf_email__" data-cfemail="a6d5d1c3c8d5c9c888d5c7d4c7cee6c3d6c788c1c9d0">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#52060111137f1a3d263e3b3c37123722337c353d24"><span class="__cf_email__" data-cfemail="095d5a4a482441667d6560676c496c7968276e667f">[email protected]</span></a>.
[[Page 37153]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, or distribute or propose to manufacture
(including import), process, or distribute chemical substances or
mixtures that can be regulated under TSCA. Any use of the term
``manufacture'' in this document will encompass ``import,'' the term
``manufacturer'' will encompass ``importer,'' and the term ``chemical
substance'' will encompass ``byproduct chemical substance,'' unless
otherwise stated.
This action may be of interest to other stakeholders, including
non-profit organizations in the environmental and public health sectors
and members of the public interested in the safety of chemical
substances used in industrial, commercial, and consumer settings. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them,
and is based on the Agency's previous experience with TSCA section 8(a)
collections:
[ssquf] Chemical manufacturing (NAICS code 325); and
[ssquf] Petroleum and coal product manufacturing (NAICS code 324).
In addition to these anticipated respondents, the potentially
regulated community consists of manufacturers of byproducts that are
required to report under certain TSCA section 8(a) rules, including
CDR. Byproduct manufacturers may be listed under a different primary
NAICS activity code for a site, such as NAICS codes 22, 322, 327310,
331 and 3344, representing utilities, paper manufacturing, cement
manufacturing, primary metal manufacturing, and semiconductor and other
electronic component manufacturing, respectively.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
TSCA requires EPA to evaluate the safety of existing chemical
substances via a three-stage process comprised of prioritization, risk
evaluation, and risk management. EPA's website (<a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals</a>) provides a detailed overview of these three stages.
Under TSCA, EPA is required to have at least 20 chemical risk
evaluations being conducted at any given time on substances designated
as high-priority substances. Therefore, EPA needs to maintain a pool of
potential candidate chemical substances to ensure that there are a
sufficient number of substances ready to be prioritized and, if
designated a high-priority substance, to be evaluated for risk under
TSCA.
Currently, EPA relies on CDR for exposure-related information which
is used, along with data from other sources, to identify the potential
candidate chemicals. CDR requires submission of information to EPA by
manufacturers (including importers) every four years on the production
and use of chemicals in commerce. These basic exposure-related data
include information on the types, quantities and uses of chemical
substances produced domestically and imported into the United States.
EPA uses CDR data to support risk screening, chemical prioritization,
risk evaluation, and risk management activities, among other
activities. This information allows EPA to develop an understanding of
the types, amount, end uses, and possible exposure to chemicals in
commerce. The CDR database constitutes the most comprehensive source of
basic screening-level, exposure-related information on chemicals
available to EPA.
CDR data, however, could be enhanced to provide more specific or
relevant data to meet the exposure-related needs of the existing
chemicals program. EPA needs data targeted to specific analyses at each
stage of the existing chemicals program. Such data include exposure,
health, and eco-toxicity information.
A. Stages of the Existing Chemicals Prioritization, Risk Evaluation,
and Risk Management Program
Identification of Potential Candidates and Selection for
Prioritization: TSCA requires the systematic prioritization of tens of
thousands of existing chemicals for risk evaluation. EPA is required to
select a certain percentage of candidates for prioritization from
chemical substances listed on the 2014 Update of the TSCA Work Plan,
giving preference to chemicals with certain hazard characteristics.
Aside from the statutory preferences and requirements, EPA has broad
discretion to select which other chemical substances to prioritize. EPA
is interested in ensuring that exposure-related information collected
through CDR provides sufficient basic data to inform the potential
candidate selection process. Once a chemical substance is identified as
a potential candidate, EPA needs additional information to inform which
of the potential candidates should be selected to enter the
prioritization stage.
Prioritization: EPA formally announces when a chemical substance is
to begin 9 to 12-month long prioritization stage and provides a 3-month
period for the public to submit relevant information for the subject
chemicals. EPA needs sufficient information to understand the use and
other exposure-related scenarios in order to inform the decision of
whether the chemical should be designated as high-priority substance
and, therefore, enter the risk evaluation process.
Therefore, EPA is considering requiring certain necessary data be
reported by chemical manufacturers (including importers) and is
considering either notifying or collecting information from processors.
Additional information about the candidate selection and prioritization
processes is available on EPA's website, at <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/prioritizing-existing-chemicals-risk-evaluation">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/prioritizing-existing-chemicals-risk-evaluation</a>.
Risk evaluation: Once a chemical is designated as a high-priority
substance, EPA begins to evaluate the risk of the chemical. The purpose
of risk evaluation is to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, exclude consideration of costs or other non-
risk factors, use scientific
[[Page 37154]]
information and approaches in a manner that is consistent with the
requirements in TSCA for the best available science, and ensure
decisions are based on the weight of scientific evidence. EPA needs to
ensure that sufficient information is available to inform the risk
evaluation, including the development of the scope of the evaluation.
Information is needed in a timely manner. For example, the scope is
generally published as a draft within three months of a chemical being
designated as a high-priority substance, and the scope must be
finalized no later than six months after the initiation of the risk
evaluation process. Information is also needed to inform exposure and
hazard assessments. EPA is considering requiring chemical manufacturers
(including importers), processors, and distributors to submit
information to EPA to support these risk evaluation activities.
Additional information about the risk evaluation process is
available on EPA's website, at <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca</a>.
Risk management: Following risk evaluation, TSCA mandates that EPA
take action if the Agency determines that there are unreasonable risks
to public health or the environment from chemicals currently on the
market. If at the end of the risk evaluation process EPA determines
that a chemical substance presents an unreasonable risk of injury to
health or the environment, the Agency must immediately start the risk
management rulemaking process to address the unreasonable risk. EPA
needs to ensure that sufficient information is available to develop
risk management plans and actions. For chemicals in the risk management
stage, the Agency is considering requiring manufacturers (including
importers), processors, and distributors to report the same type of
information reported during the risk evaluation stage to ensure that
EPA has the most up-to-date information to inform risk management
actions. For example, if a company reported using a chemical in a
particular manner at the beginning of the existing chemical process,
but changes occurred in some way during the stages of the existing
chemical process, the company would report on those data elements that
have changed.
Additional information about the risk management process is
available on EPA's website, at <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca</a>.
B. TSCA Data Reporting Authorities
Under TSCA section 8, EPA is authorized to collect certain
information about chemical substances. EPA is considering using the
authorities under TSCA sections 8(a), 8(c), and 8(d) to develop a model
rule that can be used to trigger the need to report information for
each stage of the existing chemicals program.
TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate
rules under which manufacturers and processors of chemical substances
must maintain such records, and submit such information, as the EPA
Administrator may reasonably require. The information includes, to the
extent that it is known or reasonably ascertainable: Chemical identity
and related information; manufacturing and importing exposure-related
information including byproducts; processing and use exposure-related
information; and existing environmental and health effects information.
CDR, described previously, is an example of a TSCA section 8(a) rule.
TSCA section 8(c) requires manufacturers, processors, and
distributors to maintain and, upon request, submit to EPA information
such as: Significant adverse health effects, consumer allegations,
occupational disease or injury, and complaints of injury to the
environment.
TSCA section 8(d) requires manufacturers, processors, and
distributors to submit to EPA study information that is known or
reasonably ascertainable, including lists of health and safety studies
and, upon request, copies of such studies. The studies do not need to
be published to be included in the submission.
III. How can I request to participate in this meeting?
You may submit a request to participate in this meeting by
following the information listed under DATES and ADDRESSES. If you have
questions about the meeting, you may contact the technical person for
meeting content questions or the meeting contact for logistics and
participation questions, as listed under FOR FURTHER INFORMATION
CONTACT. Do not submit any information in your request that is
considered CBI.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 8, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-14928 Filed 7-13-21; 8:45 am]
BILLING CODE 6560-50-P
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