Audit, Compliance and Risk Blog

The Toxic Substances Control Act (TSCA) was enacted in 1976 to develop adequate data regarding the effects of chemical substances and mixtures on human health and the environment, and to prevent unduly hazardous chemicals from entering commercial use. TSCA authorizes the US Environmental Protection Agency (EPA) to regulate chemical substances and mixtures that present an “unreasonable risk of injury to health or the environment,” and to take action with respect to chemical substances and mixtures that pose “imminent hazards.”

TSCA incorporated approaches from older, more targeted laws including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; which regulates pesticides) and the Federal Food, Drug, and Cosmetic Act. Its core provisions remain relatively unchanged nearly 40 years later, so it still reflects a much less intrusive approach to regulation than many later-amended laws governing air, water and waste. This blog summarizes requirements for chemical assessment; my next blog will discuss significant legislation introduced this month, seeking to address provisions widely seen as out-dated and inadequate.

Requirements For New Chemicals

TSCA’s broadest application is to review of new "chemical substances" proposed for manufacture or import, and to significant new uses of existing chemical substances. Would-be manufacturers and importers must provide EPA advance notice of their intentions, accompanied by information about the chemical. This allows the agency to evaluate chemicals before they are distributed commercially, and to determine if production and use should be restricted or even prohibited. Notification is made in a Premanufacture Notice (PMN) for chemicals that do not already appear in EPA’s TSCA Inventory—which identifies roughly 85,000 chemicals, including 62,000 chemicals already in commerce when TSCA was enacted. PMN information requirements distinguish chemical substances with distinct chemical structure (Class 1 substances); chemical substances that cannot be fully represented by a structural diagram (Class 2 substances); and polymers. The following key information is required:

• Chemical name, molecular formula, Chemical Abstracts Service (CAS) number, and chemical structure (plus CAS numbers of immediate chemical precursors to Class 2 substances)

• By-products

• For polymers, monomers and other reactants, by chemical name and CAS number, average polymer size, and amount of residual monomer 

• Any impurities anticipated (by name, CAS number, and percentage by weight) 

• Synonyms and trade names of the new chemical substance

• Estimated maximum quantity to be manufactured or imported during the first year of production, and during any 12-month period throughout the first three years of production

• Categories of use by function and application

• Where the new substance will be manufactured, processed, or used by the manufacturer; points of release of the new chemical substance; worker exposure information; and information on release to the environment

• Processing and use operations projected for the new chemical at facilities not controlled by the manufacturer

• Test data.

Each PMN must provide all available test data relating to the new chemical’s effects on health or the environment. These data must cover the processing, distribution, and use or disposal of the new chemical substance, or any mixture or article that will contain the new chemical substance.

If a planned application involves a chemical already in the inventory, the manufacturer or import must file a Significant New Use Notice (SNUN) with similar information. Manufacturers and importers can withhold information claimed to be confidential business information

EPA has 90 days to review the information, and can allow, reject, or add conditions to the proposed use. If EPA fails to act, the manufacturer or importer can begin distribution.

Requirements For Existing Chemicals

There is no blanket requirement to provide information about “existing” chemicals, including those that were already being distributed in commerce when TSCA was enacted four decades ago. For tens of thousands of chemicals, no further test data have been submitted since the chemical first entered the TSCA Inventory. However, the TSCA legislation and EPA rules do provide reporting requirements for several categories of chemicals, including:

• Preliminary Assessment Information Report (PAIR) for chemicals that may pose “an unreasonable risk of injury to health or the environment” – these call for information analogous to PMNs and SNUNs.

• Reporting on chemicals for which information reasonably supports a conclusion that the chemical poses a “substantial risk of injury to health or the environment” (Section 8(e) reports).

• Priority Testing for chemicals designated by the EPA-sponsored Interagency Testing Committee (Section 4(e)) Priority Testing).

• Chemical Data Reporting Rule, requiring most sites that manufacture 25,000 pounds or more of any chemical in the TSCA Inventory to report activities and volumes every 4 years. 

In general, if EPA determines that a chemical poses “unreasonable risks,” the agency must evaluate regulatory responses and choose the “least burdensome” option. In addition, EPA has created a TSCA Work Plan under which the agency identifies priorities for peer reviewed studies of chemical-specific information.

Uses For The Information

TSCA itself is designed to provide EPA with access to health and safety information about chemicals (“chemical substances”), and to empower EPA to take regulatory steps it deems appropriate. However, in the years since 1976 other regulatory and commercial activities have arisen that make use of this information – except for information claimed to be Confidential Business Information. Most broadly, elements of the information from PMNs and SNUNs appear on Safety Data Sheets (SDSs, and their longstanding predecessors Material Safety Data Sheets (MSDSs)), which the Occupational Safety and Health Administration (OSHA) requires employers to provide to employees who work with chemicals as part of the Hazard Communication Standard. (I blogged about HCS here) Note that HCS requires manufacturers to update SDSs/MSDSs when significant new information become available – for example, if new studies lead to different conclusions about chemical hazards.

Other environmental, health and safety (EH&S) programs also incorporate this information when regulators consider appropriate standards to protect public health, worker health, and the environment – using this chemical information to begin evaluation of possible Clean Air Act or Clean Water Act regulations, for example. In many cases, those EH&S programs require manufacturers and importers to conduct additional studies to expand and update available information – note that TSCA contains no blanket requirement that manufacturers to provide this updated information, so only those chemicals subject to one of the follow-on programs identified above (PAIR, Section 8(e), etc.) receives subsequent review under TSCA.

Self-Evaluation Checklist

Does the organization manufacture, import and/or process any “chemical substance” subject to TSCA?

• Did the organization meet PMN/SNUN requirements applicable to each chemical substance when it was introduced?

• Does the organization comply with any subsequent information requirements under TSCA programs (PAIR, Section 8(e), etc.)

• Does the organization incorporate chemical information, including information developed to meet TSCA requirements, into disclosures and compliance requirements under other applicable EH&S programs?

• Does the organization develop information about “chemical substances” that it withholds from disclosure under claim of confidential business information, trade secret, etc.?

Does the organization use any chemical substance?

• Has the organization compared its chemical inventory with chemicals in the TSCA Inventory?

• Has the organization determined which chemicals require a SDS/MSDS?

• Does the organization comply with applicable EH&S requirements governing use of each chemical?

Where Can I Go For More Information?

• EPA’s Office of Pollution Prevention and Toxics  

• OSHA’s Hazard Communication Standard webpage 

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