Toxic Substance Control Act

1. Toxic Substance Control Act ENVIRONMENTAL RISK ASSESSMENT

2. Toxic Substances Control Act • History of the Act • The primary purpose of TSCA is to regulate chemical substances and mixtures • It does so by regulating both the distribution of existing chemicals and the manufacture of new chemicals based on their risks to health and the environment • The scope of the term “new chemical substances and mixtures” is defined in the statute and in EPA’s regulations • TSCA seeks to control hazardous inputs into commerce and industry rather than regulating by-products from manufacturing processes

3. Toxic Substances Control Act • The TSCA Inventory • Under TSCA any person who manufactures, processes or imports a new chemical substance or mixture for commercial purposes must submit a “notice of intent” (known as a Premanufacture Notice or PMN) to the EPA at least 90 days before they begin manufacturing or processing • The person must submit test data for the substance • The EPA subsequently determines if the new chemical or mixture presents an unreasonable risk to health and environment or if testing on the new chemical must be performed • The EPA’s initial inventory was compiled from information submitted by chemical manufacturers

4. Toxic Substances Control Act • The original inventory is periodically updated to add new chemicals for which PMNs are filed • There are currently over 75,000 chemicals on the database • Premanufacture Notices (PMNs) • If a company plans to import, manufacture or process a new chemical substance, it must give the EPA at least 90 days’ notice • Before a company can give notice, it must decide whether its proposed substance is in fact “new”

5. Toxic Substances Control Act • The EPA takes action to control potential risks to health or the environment on approximately 10% of the PMNs submitted • Only 2-3% of these currently undergo a more stringent standard review • TSCA regulations exempt from PMN requirements “substances manufactured or imported only in small quantities solely for research and development” • The regulations also exempt substances manufactured or imported for test-marketing and for export • Also exempt are certain by-products, impurities formed ancillary to a chemical reaction or production process and certain polymers

6. Toxic Substances Control Act • EPA Review of Premanufacture Notices • Once the EPA receives a PMN, the Agency publishes a notice in the Federal Register • When the PMN is complete the EPA has 90 days (in some circumstances, 180 days) to decide whether to prohibit or regulate manufacture of the new chemical • The EPA reviews PMNs in six stages. These stages include: • prenotice communication, process start-up, initial review, detailed review, regulatory response, and closeout.

7. Toxic Substances Control Act • If the EPA takes no action on the notice within 90 days, the manufacturer may begin production -- the manufacturer must supply the EPA with further notice that manufacture will commence • At that point the EPA adds the chemical to the TSCA Inventory • TSCA Testing Provisions • The EPA can require a manufacturer to test its chemical if the substance may pose an unreasonable risk or if potential exposure to humans and the environment is substantial

8. Toxic Substances Control Act • If the EPA requires testing, it must devise a test rule • Significant New Use Rules (SNURs) • Under TSCA EPA has authority to issue a Significant New Use Rule or SNUR if the EPA determines that a use of a chemical substance is a significant new use • Once a SNUR is issued, a PMN is required for the specified new uses of the existing chemical

9. Toxic Substances Control Act • Regulation of Unreasonable Risk • If the EPA decides that a chemical presents an unreasonable risk, it can do a variety of things including: • Completely prohibit manufacture • Prohibit or limit certain use • Prescribe quantity and concentration limits in manufacture • Specify quality control measures that must be used by the manufacturer or processor • Require tests that are reasonable and necessary to assure compliance with regulations issued under § 6 • Establish recordkeeping requirements • Control disposal • Impose labeling and other public disclosure requirements

10. What is environmental risk assessment (ERA)? • ERA is is comprised of: • human health risk assessment; • ecological risk assessment. • Qualitative and quantitative valuation of environmental status

11. Purposes in performing ERA • to learn about the risks • to reduce the risk

12. Risk comparison • Probability of frequency of events causing one or more immediate fatalities. • Chance of death for an individual within a specified population in each year. • Number of deaths from lifetime exposure. • Loss of life expectancy considers the age at which death occurs. • Deaths per tone of product, or per facility.

13. Risk management: • Risk analysis and assessment: identification of hazards to people and the environment, the determination of the probability of occurrence of these hazards, and the magnitude of the events. • Risk limits - entails defining the acceptability of the risk, which can be classified as acceptable or in need of reduction. • Risk reduction: design and implementation of risk-reducing measures and controls.

14. Human health risk assessment (HHRA) • hazard identification; • dose-response assessment; • exposure assessment; • risk characterization. Involves:

15. Ecological risk assessment (ERA) • Determines the likelihood of the occurrence/non-occurrence of adverse ecological effects as a result of exposure to hazard

17. Hazards • chemicals toxic to humans, animals, and plants; • materials that are highly flammable or explosive; • mechanical equipment, the failure of which would endanger persons and property; • structural failure (e.g., dam or containment vessel); • natural disasters that exacerbate technological hazards; • ecosystem damage (e.g., soil erosion).

18. Toxic Substances Control Act • Regulation of PCBs under TSCA • Polychlorinated Biphenyls (PCBs) are a group of highly stable chemicals that achieved widespread industrial use by the time of TSCA’s enactment • PCBs are synthetic chemicals that fall within the group known as chlorinated hydrocarbons • PCBs were specifically included in the TSCA legislation due to growing concern about their environmental effects and due to evidence that PCBs are highly toxic in animals • Tests on laboratory animals showed that PCBs could cause cancers, tumors, birth defects and reproductive failures

19. Toxic Substances Control Act • The EPA issued regulations on use and retirement of PCB-containing transformers in or near commercial buildings • The Agency also regulates the unintended by-product manufacture of PCBs • The PCB regulations also include certain recordkeeping requirements • Regulation of Asbestos under TSCA • In 1989 the EPA issued a final rule under TSCA to phase out the use of asbestos in commercial products

20. Toxic Substances Control Act • The asbestos rule was designed to ban the use of asbestos in new products by 1997 • Section 8(e) requires manufacturers, importers, processors and distributors who obtain information “which reasonably supports the conclusion that [a] substance or mixture presents a substantial risk of injury to health or the environment” to inform the EPA immediately • Section 8(c) requires the manufacturer and processors of chemical substances to “maintain records of significant adverse reactions to health or the environment … alleged to have been caused by the substance or mixture”

21. Toxic Substances Control Act • Enforcement and Penalties under TSCA • TSCA allows EPA to inspect any facility where chemical substances are manufactured, processed, or stored • TSCA allows the EPA to pursue civil penalties of up to $25,000 per day for each violation of the statute • The Agency can also seek criminal fines of up to $25,000 per day and imprisonment of up to one year