Data Development and Information Collection to Assess Risks
Under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has broad authority to issue regulations designed to:
- Require manufacturers (including importers) or processors to test chemical substances and mixtures and report their findings to EPA (TSCA section 4 Test Requirements, 15 U.S.C. 2603)) ;
- Gather information on chemical manufacturing, processing and use (TSCA section 8(a) Reporting Requirements, 15 U.S.C. 2607));
- Gather unpublished chemical health and safety information from manufacturers (including importers), processors or distributors (TSCA section 8(d) Reporting Requirements, 15 U.S.C. 2607);
- Gather information on chemical exports (TSCA section 12(b) Export Notification Requirements, 15 U.S.C. 2611).
In addition, TSCA section 8(e) Substantial Risk Reporting (15 U.S.C. 2607) requires manufacturers (including importers), processors and distributors to notify EPA immediately of information that reasonably supports the conclusion that their substances or mixtures present a substantial risk to health or the environment.
This hazard and exposure data is important information that enables the Agency to better identify, prioritize, and assess potential risks to human health and the environment. On this page you will learn more about:
- What type of information does EPA collect?
- What does EPA do with the information it collects?
Test Rules -- Section 4 of TSCA gives EPA the authority to require chemical manufacturers and processors to test existing chemicals and report the results to EPA. Under section 4, EPA can by rule require testing after making “data inadequacy” and “testing is necessary” findings. Testing required by EPA must be conducted via EPA-approved test methods and guidelines.
Enforceable Consent Agreements/Voluntary Testing Agreements -- EPA also works with members of the U.S. chemical industry to develop needed data via TSCA section 4 Enforceable Consent Agreements (ECAs) and Voluntary Testing Agreements (VTAs). ECAs and VTAs are usually less resource intensive than formal TSCA rule-making and allow EPA to consider agreed-upon pollution prevention and other types of product stewardship initiatives by the chemical industry as a possible substitute for or adjunct to certain types of needed testing.
- ECA on Octamethylcyclotetrasiloxane (D4)
- EPA has entered into an Enforceable Consent Agreement with five manufacturers of octamethylcyclotetrasiloxane (CAS Rn: 556-67-2), which is widely used as a chemical intermediate and component of personal care products. The EPA will require testing for the chemical’s presence in several environmental media.
- Under the terms of the ECA, the signatory companies have agreed to collect and analyze samples from environmental media around wastewater treatment plants (WWTP) that treat D4. WWTP influent, WWTP effluent, and WWTP biosolids. In addition, downstream surface water, sediment, and biota will be tested. The testing program will be conducted over a one year period. The information gathered by the ECA will be used in conjunction with other available data to assess exposures and risks due to environmental releases from D4. Read the Federal Register notice.
- Materials related to this ECA can be found in the docket: EPA-HQ-OPPT-2012-0209-0068.
- High Production Volume Voluntary Testing Program
In 1998 EPA, Environmental Defense (ED), American Petroleum Institute (API), and American Chemistry Council (ACC) launched the High Production Volume (HPV) Challenge Program, a voluntary program intended to collect health and environmental effects data to provide the public with basic hazard information regarding HPV chemicals. As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.
Access HPV data through the High Production Volume Information System (HPVIS) a database which consists of basic hazard (toxicity) and environmental fate information on HPV chemicals that can be used by environmental managers, public decision-makers, and others in their own health and environmental protection activities.
- Interagency Testing Committee (ITC)
- The TSCA Interagency Testing Committee (ITC), created under section 4(e) of TSCA is an an independent advisory committee to the Administrator of the U.S. EPA. The ITC was created to make recommendations to the EPA Administrator on prioritizing and selecting chemicals for testing or information reporting to meet the coordinated data needs of its member U.S. Government organizations. Learn more about the ITC.
- View test data submitted to EPA in ChemView
- View Federal Register notices on receipt of test data issued under TSCA section 4
- Read the EPA regulations governing testing
- Read about electronic reporting requirements under TSCA
- For industry: View reporting obligations and sunset dates of chemicals subject to final TSCA section 4 Test Rules and ECAs
Chemical Data Reporting – EPA collects manufacturing (including import), processing, and use information about chemicals in commerce in the United States under the Chemical Data Reporting (CDR) rule under TSCA section 8.
Toxics Release Inventory Reporting – Facilities in certain industry sectors that employ more than 10 full time employees and manufacture (including import) or process more than 25,000 of a TRI-listed chemical or otherwise use more than 10,000 lbs of a listed chemical in a given year are required to report their releases to EPA pursuant to the Emergency Planning and Community Right-to-Know Act.
Under TSCA section 8(d), EPA has the authority to promulgate rules to require producers, importers, and (if specified) processors of a chemical substance or mixture to submit lists and/or copies of ongoing and completed, unpublished health and safety studies. EPA has also used its TSCA section 8(d) authority to gather information needed by other EPA Program Offices and other Federal Agencies. Chemicals that are designated or recommended for testing by the TSCA Interagency Testing Committee (ITC) may be added to the rule via immediate final rulemaking (up to 50 substances/year). Non-ITC chemicals can be added to the section 8(d) rule via notice and comment rulemaking.
The term "health and safety study" is intended to be interpreted broadly and means "any study of any effect of a chemical substance or mixture on health or the environment or on both," including but not limited to:
- Epidemiological or clinical studies;
- Studies of occupational exposure;
- In vivo and in vitro toxicological studies; and
- Ecotoxicological studies.
- View health and safety data submitted to EPA in ChemView
- Read the EPA health and safety data reporting regulations available at 40 CFR Part 716
Substantial Risk Notifications -- Section 8(e) of the Toxic Substances Control Act (TSCA) requires U.S. chemical manufacturers (including importers), processors, and distributors to notify EPA immediately of information that reasonably supports the conclusion that their substances or mixtures presents a substantial risk of injury to health or the environment.
Anyone subject to the TSCA section 8(e) reporting requirement should submit a report to EPA within 30 calendar days of obtaining the information. This information may be toxicity or exposure data and need not be complete or definitive. Full reports or summarized results may be submitted. Limited studies (e.g., range-finding studies), preliminary results and draft reports may constitute sufficient evidence for TSCA section 8(e) reporting. Information that has been published or submitted to EPA under other authorities is exempt from TSCA section 8(e) reporting.
- View substantial risk notifications submitted to EPA in ChemView or CDAT.
- Reporting a TSCA Chemical Substantial Risk Notice.
- For industry: How do I file substantial risk notifications and FYI submissions under TSCA section 8(e)?
- View TSCA section 8(e) frequent questions.
For Your Information (FYI) submissions -- EPA established a classification system to distinguish voluntary “For Your Information” (FYI) submissions from Substantial Risk Notifications submitted formally to EPA under TSCA section 8(e), discussed above. The FYI classification was created by EPA to capture chemical risk submissions by persons or organizations not subject to the TSCA section 8(e) reporting requirements.
Since 1977, EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies as well as similar organizations and agencies in foreign countries. These substantial risk notices contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment.
Data collected pursuant to EPA’s TSCA information collection authorities is used for a variety of purposes, including to enhance the Agency’s understanding of chemical hazards and exposures in order to better assess risks to human health and the environment; to support risk reduction efforts; and to inform efforts to encourage industry to switch to safer chemicals. EPA also seeks to increase public access to non-confidential data on chemicals where possible.
- Learn about EPA’s TSCA Risk Evaluation for chemicals under TSCA.
- Learn about Current Chemical Risk Reduction Activities
- Learn about EPA’s Safer Choice and Green Chemistry Programs.
- Learn about EPA’s ChemView and its transparency efforts.
EPA's TSCA section 8(c) rule requires producers, importers, and certain processors of chemical substances and mixtures to keep records concerning significant adverse reaction allegations and report those records to EPA upon notice in the Federal Register or upon notice by letter. The TSCA section 8(c) rule also provides a mechanism to identify previously unknown chemical hazards in that it may reveal patterns of adverse effects which otherwise may not be otherwise noticed or detected.