Development of Tiered Data Reporting To Inform TSCA Prioritization, Risk Evaluation, and Risk Management; Notice of Public Meeting and Opportunity To Comment, 37152-37154 [2021-14928]

Download as PDF 37152 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER21–2293–000] lotter on DSK11XQN23PROD with NOTICES1 Fish Springs Ranch Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization This is a supplemental notice in the above-referenced proceeding of Fish Springs Ranch Solar, LLC’s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability. Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission’s Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. Notice is hereby given that the deadline for filing protests with regard to the applicant’s request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is July 21, 2021. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at https:// www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission’s Home Page (https:// www.ferc.gov) using the ‘‘eLibrary’’ link. Enter the docket number excluding the VerDate Sep<11>2014 17:49 Jul 13, 2021 Jkt 253001 last three digits in the docket number field to access the document. At this time, the Commission has suspended access to the Commission’s Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID–19), issued by the President on March 13, 2020. For assistance, contact the Federal Energy Regulatory Commission at FERCOnlineSupport@ferc.gov or call toll-free, (886) 208–3676 or TYY, (202) 502–8659. Dated: July 1, 2021. Debbie-Anne A. Reese, Deputy Secretary. [FR Doc. 2021–14922 Filed 7–13–21; 8:45 am] BILLING CODE 6717–01–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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-epatirered-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 https:// 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. E:\FR\FM\14JYN1.SGM 14JYN1 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 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: D Chemical manufacturing (NAICS code 325); and D 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. lotter on DSK11XQN23PROD with NOTICES1 B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through https:// 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 VerDate Sep<11>2014 17:49 Jul 13, 2021 Jkt 253001 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-managingchemicals-under-tsca/how-epaevaluates-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 exposurerelated needs of the existing chemicals program. EPA needs data targeted to specific analyses at each stage of the existing chemicals program. Such data PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 37153 include exposure, health, and ecotoxicity 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 exposurerelated 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 3month 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-managingchemicals-under-tsca/prioritizingexisting-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 E:\FR\FM\14JYN1.SGM 14JYN1 lotter on DSK11XQN23PROD with NOTICES1 37154 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 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-chemicalsunder-tsca/risk-evaluations-existingchemicals-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-chemicalsunder-tsca/risk-management-existingchemicals-under-tsca. VerDate Sep<11>2014 17:49 Jul 13, 2021 Jkt 253001 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 FEDERAL COMMUNICATIONS COMMISSION [OMB 3060–0355; FR ID 37519] Information Collection Being Reviewed by the Federal Communications Commission Federal Communications Commission. ACTION: Notice and request for comments. AGENCY: As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission’s burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number. DATES: Written PRA comments should be submitted on or before September 13, 2021. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicole Ongele, FCC, via email PRA@ fcc.gov and to Nicole.Ongele@fcc.gov. FOR FURTHER INFORMATION CONTACT: For additional information about the information collection, contact Nicole Ongele, (202) 418–2991. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060–0355. Title: Rate-of-Return Monitoring Reports. SUMMARY: E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[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.

-----------------------------------------------------------------------

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 
https://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: [email protected].
    For meeting logistics or registration assistance contact: Sarah 
Swenson; telephone number: (202) 566-0279; 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].

[[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 
https://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]
BILLING CODE 6560-50-P
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