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.
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.
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.
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.
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.
Does the organization use any chemical substance?