Toxic Substances Regulation

A key component of everyday life in industrial-urban society in the 21st century is the use of large quantities of chemicals. About 83,000 chemicals are listed for commercial use in the United States. Some are highly hazardous and pose a range of toxicities; many are human-made and xenobiotic (foreign) to life on our planet. In 1976, the U.S. Congress, in an effort to control unreasonable risks to human health and adverse impacts on the environment associated with hazardous chemicals, passed the Toxic Substances Control Act (TSCA) authorizing the Environmental Protection Agency (EPA) to control these chemicals. TSCA places the burden of proof on the EPA to demonstrate that a chemical poses a risk to human health or the environment and provides the agency with two different authorities for controlling chemicals:

• For new chemicals, defined as any of about 21,000 chemicals introduced in 1979 or later, if the agency determines that insufficient information exists to reasonably evaluate the effects, then EPA can restrict production and use until the information is available. TSCA does not require the chemical industry to supply negative information about new chemicals, however. Instead, TSCA requires that EPA must first prove that a substance could pose a hazard before requesting information from chemical companies.
• For existing chemicals, defined as 62,000 chemicals in production before 1979, EPA may regulate a chemical if there is a reasonable basis to conclude that the chemical presents an [Page 902]unreasonable risk. EPA must prove that a chemical poses risks and then develop regulatory actions that will be least burdensome to the chemical industry. This requirement is so difficult that only in rare cases has EPA acted on existing chemicals. Thus, TSCA mainly regulates the introduction of new chemicals.

TSCA gave EPA an enormous burden of responsibility. Most daunting is the burden of proof that TSCA placed on the agency. Of the 62,000 existing chemicals listed for commercial use in the United States before 1979, only 200 have been evaluated for safety. Of those evaluated, 8 chemicals, or 4%, were banned from further commercial use. If the same rate of toxicity exists for all 83,000 chemicals, then another 3,320 chemicals could be excluded. This will not happen because the EPA lacks resources and is hampered by numerous legal requirements. Our industrial society originally developed without either self-governance or regulatory oversight, and this has resulted in old toxic substances, even those banned many years ago, appearing in places they should not be found, including the blood and urine of newborn children.

TSCA created a confrontational relationship between the chemical industry and the regulatory agency. Many of the environmental stories in the news are about chemical substances that the EPA is authorized to control under TSCA regulations.