Document ID: EPA-HQ-OPPT-2021-0436-0001
Agency: epa
Document Type: Notice
Title: Development of Tiered Data Reporting To Inform TSCA Prioritization, Risk Evaluation, and Risk Management; Notice of Public Meeting and Opportunity To Comment
Posted Date: 2021-07-14T04:00Z

[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37152-37154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://us-epa-tirered-data-reporting.eventbrite.com.
    Submit written comments to the docket for this action, identified 
by docket identification (ID) number EPA-HQ-OPPT-2021-0436, online at 
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.
    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 https://www.epa.gov/dockets.

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: sharkey.susan@epa.gov.
    For meeting logistics or registration assistance contact: Sarah 
Swenson; telephone number: (202) 566-0279; email address: 
swenson.sarah@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

[[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 
http://www.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 https://www.epa.gov/dockets/commenting-epa-dockets.

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 (https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals) 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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/prioritizing-existing-chemicals-risk-evaluation.
    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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
    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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.

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]
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