Chemicals Policy & Science Initiative LCSP
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Toxic Substances Control Act (TSCA)

The Toxic Substances Control Act (TSCA) is the primary federal regulations of chemicals. TSCA established the principle of public interest in the marketing of chemicals. The Congressional intent, described in Section 2 of TSCA (15 U.S.C. 2601-2692), is for industry to have the responsibility to understand chemical risks, and government to have authority to control unreasonable risks in a way that does not hinder innovation.  Under TSCA a "new chemical substance" is defined as "any chemical substance which is not included in the chemical substance list compiled and published under TSCA section 8(b)." This list, called the "TSCA Inventory," is a list of all chemical substances in commerce prior to December, 1979. All chemicals on the market prior to this date (about 60,000 substances, more than 99% by volume of what is on the market today), are considered existing chemical substances.

TSCA contains a number of key provisions that address data collection and risk management for new and existing substances.  These include: 

  • Section 4: Compels the EPA Administrator to require the testing of chemical substances or mixtures, new or existing, if 1) there are insufficient data to make an unreasonable risk determination and testing is therefore necessary; and 2) the chemical substance or mixture may present an unreasonable risk or the chemical will be produced in substantial quantities and either may enter the environment in substantial quantities or lead to significant or substantial human exposure.
  • Section 5:  Prohibits the manufacture, processing, or import of a “new chemical substance” or “significant new use” of an existing substance unless a premanufacture notification (PMN) is submitted to EPA at least 90 days before the commencement of manufacture or processing. The PMN contains information on the chemical identity, physical characteristics, processing and use, and available toxicity data. During this 90-day period, EPA reviews the chemical’s human and environmental risks and exposures, examining the data submitted in addition to other information. EPA can then request more data, prohibit or limit manufacture, or halt the review process.  EPA can also issue Significant New Use Rules for new and existing chemicals that may have uses or volume increases that were not previously predicted.
  • Section 6: Authorizes the EPA to issue regulations to address the risks of existing substances that present an unreasonable risk to health.  Such regulations can be issued immediately when a threat of harm is imminent.
  • Section 8: Authorizes EPA to promulgate rules that require chemical manufacturers, processors, and distributors to maintain records and make reports on chemicals and mixtures. This includes requirements to submit health and safety studies, provide immediate notice of “substantial risks,” and maintain records of adverse health effects for 30 years.  This section allows EPA to issue rules to collect production and use information as well as information on disposal and byproducts.  This includes the Inventory Update Rule, which generates an inventory every four years of all of the non-polymer chemicals produced in or imported into the United States.

The EPA’s TSCA Inventory currently contains over 70,000 existing chemicals, many of which are produced or imported at low or negligible volumes, while others are polymers. If one excludes low volume chemicals (~25,000 chemicals produced or imported in amounts less than 10,000 pounds per year) and polymers (which tend to be poorly absorbed by organisms and therefore generally exhibit low toxicity), one finds that there are about 15,000 non-polymeric chemicals produced/imported at levels above 10,000 pounds per year in the U.S. These 15,000 have been identified as being within the scope of EPA’s Office of Pollution Prevention and Toxics’ (OPPT) programs for existing chemicals (those grandfathered onto the TSCA Inventory in 1976) with the primary focus being on the 3,000-4,000 High Production Volume (HPV) chemicals (those used or produced in the US at 1 million pounds per year or more). 

The success of TSCA has been limited by several factors including a lack of data on chemicals in commerce; high burdens for agency action; a focus on review of new chemicals without adequate attention to existing chemicals; and a chemical-by-chemical approach to chemicals management.  There has also been relatively little attention paid to chemicals in products. Due to these limitations, many EPA efforts to reduce and substitute chemicals are largely voluntary and dependent on the willingness of industry to participate.

For more information on TSCA see the following resources:

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