Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants

On this page:

• Rule Summary
• Rule History
• Compliance

Rule Summary

This final rule, issued pursuant to the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule, requires manufacturers (including importers) of 50 specified chemicals to report certain lists and copies  of unpublished health and safety studies to EPA.

The chemicals subject to this rule are (1) 20 chemicals designated by EPA as high-priority substances for risk evaluation and (2) 30 organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA).

EPA is taking this action because the TSCA Interagency Testing Committee (ITC) added these chemicals to the Priority Testing List through its 69^th and 74^th Reports and EPA will use this information to inform the risk evaluations currently underway for 20 High-Priority Substances and for future prioritization.

Read the final rule, including which chemicals are being added to the Health and Safety Data Reporting Rule. EXIT

EPA is making available, for reference purposes, a historical document entitled “ 1989 Reporting Guide for TSCA 8(d) (pdf) (11.17 MB, 2/16/1989, N/A) ”  The agency is not  reissuing the guidance.

Rule History

Background

1. High-Priority Substances:

Twenty chemicals identified in this rule have been designated high-priority substances for risk evaluation under TSCA section 6(b). EPA is seeking unpublished health and safety studies to ensure that such studies are available to EPA to inform its risk evaluation findings of whether any of these chemicals present an unreasonable risk to health or the environment under their conditions of use. Further, this information will be considered, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals.  

2. Organohalogen Flame Retardants:

EPA requests this information to help support prioritization and evaluation activities under TSCA. Further, this information will be considered, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals. Additionally, CPSC, a representative member of the ITC, needs information on a group of organohalogen flame retardants because the Commission voted to grant a petition to begin rulemaking for this class of chemicals under the Federal Hazardous Substances Act (FHSA).

Compliance

Submission Timeline

The original deadline for submissions to the TSCA Health and Safety Data Reporting rule was September 27, 2021. EPA filed a Federal Register Notice , amending the deadline to December 1, 2021 for 20 of the 50 chemical substances (High Priority Chemicals), and to January 25, 2022 for 30 of the 50 chemical substances (organohalogen flame retardants) as listed below. 

https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0474-0010

Questions and Answers

Who must submit studies and lists of studies? 

Under section 8(d), any person “who manufactures, processes, or distributes in commerce or who proposes to manufacture, process, or distribute in commerce” any chemical listed at 40 C.F.R. § 716.120 is required to submit or list health and safety studies. 

Manufacturer means a person who produces or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance. 

Except as provided in paragraphs (b) and (c) of this section, only those persons described in this section are required to report under this part. Persons who must report include manufacturers (including importers) who fall within the North American Industry Classification System (NAICS) (in effect as of January 1, 1997) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries), who:  

(1) In the 10 years preceding the effective date on which a substance or mixture is added to C.F.R. § 716.120, either had proposed to manufacture (including import), or had manufactured (including imported) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in C.F.R. § 716.65.  

(2) As of the effective date on which a substance or mixture is added to C.F.R. § 716.120, and who propose to manufacture (including import), or who are manufacturing (including importing) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in C.F.R. § 716.65.  

(3) After the effective date on which a substance or mixture is added to C.F.R. § 716.120, and who propose to manufacture (including import) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in C.F.R. § 716.65.  

(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may require that any person who does not fall within NAICS (in effect as of January 1, 1997) Subsector 325 or Industry Group 32411, and who had proposed to manufacture (including import) or process, had manufactured (including imported) or processed, proposes to manufacture (including import) or process, or is manufacturing (including importing) or processing a substance or mixture listed in C.F.R. § 716.120 must report under this part.  

(c) Processors and persons who propose to process a substance or mixture otherwise subject to the reporting requirements imposed by this part are not subject to this part unless EPA specifically states otherwise in a particular notice or rule promulgated under the authority of 15 U.S.C. 2607(d). 

Are chemical substances as byproducts exempt from reporting?  

Manufacturers of listed chemical substances as byproducts are expressly covered. 40 C.F.R. § 716.5(a). 

 Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s). 

What Studies Should be Submitted? 

Health and safety study or study means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA. 

40 C.F.R. § 716.3. 

(1) It is intended that the term health and safety study be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included. Chemical identity is part of, or underlying data to, a health and safety study. 

(2) Examples are: 

(i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects. 

(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies. 

(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility. 

(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture. 

Are studies where a listed chemical was manufactured only as an impurity exempt from reporting? 

Studies where a listed chemical was manufactured only as an impurity are not required to be reported to EPA for this amendment of the 8(d) rule. 40 C.F.R. § 716.10(a)(3), § 716.20(a)(9).  

There are categories of studies exempt from the copy and list requirement of § 716.30 and § 716.35. Studies “published in scientific literature”, are exempt from reporting requirements. How does EPA interpret this exemption with respect to other government agency websites? 

Data that is available on a government agency’s website (whether the website is provided by a state, federal, or international agency) does not meet the 40 CFR 716.20(a)(1) exception of having been “published in scientific literature,” even if available online. Scientific literature generally refers to journals and similar publications, including summaries of such literature and various other technical and analytical documents. Such literature is often peer reviewed and is typically made available to the scientific community for purposes of sharing and furthering empirical and theoretical discussion.  

Unlike published journals, among other differences, the chemical effects and exposure assessment webpages and generally available content of government agencies are not as consistently detected/collected using certain internet search and aggregator tools designed for accessing scientific literature.  Further, there is less certainty surrounding the online permanence of materials on these websites due to agency site updates and removals. Generally, publications on government agencies, unless they are specifically focused on the scientific discussion of a chemical (e.g., a Report on Carcinogens report by the National Toxicology Program), are not considered to have been “published in scientific literature.” 

If an entity is aware of an unpublished study or other information required by a TSCA Section 8(d) rule, but does not possess it, EPA recommends that the entity submit the list of the information in accordance with 40 CFR § 716.35. 

For a complete list of studies not subject to the reporting requirements refer to 40 CFR § 716.20.  

Is a poster presentation or presentation at a scientific conference (e.g., a power-point) considered to be “published in the scientific literature?” 

Regarding scientific conference presentations or poster presentations, EPA does not consider conference materials to fit the 40 CFR § 716.20(a)(1) exception of having been “published in scientific literature,” even if available online.   Scientific literature generally refers to journals and similar publications, including summaries of such literature and various other technical and analytical documents.   Such literature is often peer reviewed and is typically made available to the scientific community for purposes of sharing and furthering empirical and theoretical discussion.  

EPA also considers scientific conference presentations as informal sources, where there is less certainty surrounding the online permanence of such materials due to conference website updates and removals. 

If an entity is aware of an unpublished study due to a conference poster or similar, EPA would not be expected to know of that conference poster – despite its (perhaps temporary) existence online.   EPA recommends that the entity submit the list of the information in accordance with 40 CFR § 716.35. 

For a complete list of studies not subject to the reporting requirements refer to 40 CFR § 716.20. 

If an entity does not have any copies or lists of data and or studies for the 50 defined chemical substances, are they required to negatively affirm with the EPA in the CDX portal?   

No, an entity is not required to affirm with EPA that they have no copies or lists of data or studies for the 50 defined chemical substances into the CDX platform. However, if it is the entity’s preference, a “Not Applicable” submission type can be provided to EPA via CDX. 

How does a respondent submit data? 

Entities are required to use EPA’s CDX reporting system Module 8(d) for purposes of reporting under TSCA 8(d).  Please DO NOT use the General Correspondence and or Communication submission type, as that will cause delays. 

The following are points of contact for CDX, also available on the CDX website. 

By Telephone: 
Person-to-person telephone support is available from 8:00 am to 6:00 pm (ET). Call our toll-free line at 888-890-1995. (970) 494-5500 for International callers. 

By E-mail: 
Send e-mail to Technical Support at helpdesk@epacdx.net. 

Please refer to the Guide for Using the CDX reporting Application: “How to Submit Data for this Rule (pdf).”  TSCA Section 8(d) Health Safety Data Reporting (pdf) (224.29 KB)