Regulation of Toxic Substances

1. Regulation of Toxic Substances Toxic Substances Control Act 15 U.S.C. § 2601 et seq. (1976)

2. TSCA Environmental Law

3. Cause for Legislation • Vinyl Chloride (angiosarcoma) • OSHA set emergency level in factories of 50 ppm vinyl chloride 4/5/74 • Final regulations effective October 3 reduced this level to one ppm TWA and 5 ppm STEL January 1, 1976 • Additional data linked vinyl chloride with other liver, blood, respiratory, brain, and genetic abnormalities Environmental Law

4. Other Pressures • Asbestos • Black Lung • other pneumoconioses • Minerals (asbestos, silica) • Organic materials (flour) • Hypersensitivity (cadmium, beryllium, chlorine, and fluorine) • Polychlorinated biphenyls • In fish • Accidental Japanese Poisoning Environmental Law

5. Toxic Substances Control Act Environmental Law

6. Became & Environmental Law

7. Intent • To close loopholes in other environmental statutes • Protect public from exposure to hazardous materials before they enter the commerce stream • Protect confidentiality for new products—when necessary • Risk-based statute Environmental Law

8. Title 15 CHAPTER 53 - TOXIC SUBSTANCES CONTROL • SUBCHAPTER 1 CONTROL OF TOXIC SUBSTANCES • SUBCHAPTER II ASBESTOS HAZARD EMERGENCY RESPONSE • SUBCHAPTER III INDOOR RADON ABATEMENT • SUBCHAPTER IV LEAD EXPOSURE REDUCTION Environmental Law

9. SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES • Key Sections • Testing of chemical substances and mixtures • Manufacturing and processing notices • Regulations of hazardous chemical substances and mixtures • Reporting and retention Environmental Law

10. SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES (cont.) • Key Sections (continued) • Research, Development, collection and dissemination, and utilization of data • Inspections and subpoenas • Exports • Entry into customs territory of the United States • Disclosure of data Environmental Law

11. SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES • Key Sections (cont.) • Prohibited acts • Penalties • Specific enforcement and seizure • Preemption • Judicial review • Citizens civil actions • Citizen’s petitions • Employee protection Environmental Law

12. SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES • Key Sections (cont.) • Studies • Administration • Development and evaluation of test methods • State programs • Authorization of appropriations • Annual report Environmental Law

13. Exclusions • Those Chemicals already covered by the: • already covered by the Federal Insecticide, Fungicide and Rodenticide Act • Any source material, special nuclear fuel material, or by product covered under Atomic Energy Act • Tobacco or any tobacco product • Articles of sale subject to tax imposed by section 4182 or 4221 of the IRS Code • Anything defined under §201 of the Federal Food Drug and Cosmetic Act Environmental Law

14. Least Known by Public • Requires an inventory of chemicals—75,000 chemicals in the inventory • Approximately 3,000 are high-volume chemicals • Most information on chemicals is based on a risk-assessment based on Structural Activity—<6% data Environmental Law

15. Testing of chemical substances and mixtures • The administrator may require testing if a material or mixture: • May present unreasonable risk in manufacture, transit, storage, use or disposal • Insufficient data or experience exist to assess risk Environmental Law

16. Testing Requirement Rule • Identification of material • Standards for test data • Requirements for health data such as: • carcinogenesis, • mutagenesis, • teratogenesis, • behavioral disorders, • cumulative or synergistic effects, and • any other effect which may present an unreasonable risk of injury to health or the environment. Environmental Law

17. Priority List for Testing • Develop a priority list for testing of materials • An interagency committee is appointed to develop and review this list • EPA, DOL, CEQ, NIOSH, NIEHS, NCI, DOC, Environmental Law

18. Priority List Basis • Quantities of substance/mixture: • Manufactured • Enters the environment • Number of individuals exposed and duration in the workplace • Extent that humans will receive exposure in the environment • Extent of relationship to other chemicals/mixtures that cause injury to health/environment • Extent of existing data regarding health/environment Environmental Law

19. Manufacture Notices • No one may manufacture a new chemical substance after 30 days after a §8(e) test rule • No one may manufacture a material if subject to a Significant New Use (SNUR) unless PMN processed • No one may import a substance not in the inventory unless PMN granted Environmental Law

20. New Chemicals processed under the PMN rule Sufficient to Determine Risk? Complete? Technical Review Application No No Yes Approve? Review by EPA Notice No Environmental Law

21. Most Information is Confidential • Manufacturers can justify secrecy for information • Most advocates are frustrated by lack of access to information • Some manufacturers have people who monitor the new listing to follow new products Environmental Law

22. What is required on PMN • CAS number • Structure of chemical • Impurities • Health, environment and Safety Data (sometimes) • Anticipated production data • MSDS Environmental Law

23. Confidentiality • Has been a problem—Dow Chemical found a photograph of one of their facilities on a bulletin board at EPA with a drawn missile headed for the smokestack. This was submitted as confidential information, and competitors seeing this could back-engineer the process. Environmental Law

24. Summary of Major Provisions • Inventory of Existing Chemicals • Premanufacturing Notification • Must be submitted 90 days prior to manufacture or import • Export notification • Can ban • Can ask for more data Section 4 Test Rules Environmental Law

25. Title II Asbestos • Problem with Asbestos identified by Dr. Irving Selikoff, Mount Sinai School of Medicine alerted Union Workers of the risk of sewing asbestos clothing in 1971 • Tobacco use much greater influence than asbestos alone • Concern for asbestos in schools Environmental Law

26. History • Title II added by the Asbestos Hazard Emergency Response Act of 1986 (PL99-518, Oct. 22, 1986) • Concern for training and protection of workers removing asbestos from schools to protect children from exposure • Determine extent of risk Environmental Law

27. For Health Data • http://www.epa.gov/ttn/uatw/hlthef/asbestos.html • EPA estimates that, if an individual were to breathe air containing asbestos at 0.000004 fibers/mL over his or her entire lifetime, that person would theoretically have no more than a one-in-a-million increased chance of developing cancer as a direct result of breathing air containing this chemical. Similarly, EPA estimates that breathing air containing 0.00004 fibers/mL would result in not greater than a one-in-a-hundred thousand increased chance of developing cancer, and air containing 0.0004 fibers/mL would result in not greater than a one-in-ten-thousand increased chance of developing cancer. Environmental Law

28. EPA Responsibilities • Public education about risks • Regulations about: • Inspection • Response action • Post response actions • Transportation and disposal • Management plan requirements for local school districts • Laboratory accreditation program Environmental Law

29. School Districts • Develop a plan for: • Chrysotile (serpentine) • Crocidolite (ruebeckite) • Amosite (cummingtonite-grunerite), • Anthophyllite • Temolite • Actinolite • Implement and complete plan in specified time Environmental Law

30. Friable/Nonfriable Asbestos Environmental Law

31. Ambient Standard • The ambient exterior concentration after extraction: • Less than 0.003 fibers per cubic centimeter if using scanning EM • Less than 0.005 fibers per cubic centimeter if using transmission EM Environmental Law

32. Indoor Radon Abatement • Title III of the Toxic Substances Control Act • Added by PL-100-551 (October 28, 1988 • Goal: to have all indoor building air at the same Radon level as outdoor air Environmental Law

33. Environmental Law

34. Indoor Radon Abatement • Requires EPA to publish a citizen’s guide with action levels • Approximately two-thirds (66%) of Americans are generally aware of radon, and • of those, three-quarters (75%, on average) understand that radon is a health hazard. • Since the mid-1980s, about 18 million homes have been tested for radon and • about 500,000 of them have been mitigated. • Approximately 1.8 million new homes have been built with radon-resistant features since 1990 Environmental Law

35. EPA Responsibility • Develop construction standards and techniques • Provide technical assistance to the states • Establish a clearinghouse • Voluntary proficiency program for rating effectiveness of radon measuring devices and methods • Training seminars Environmental Law

36. EPA Responsibility (cont.) • Publication of public information about risks and mitigation • Demonstrate radon mitigation methods in various structures • Establish national data base by state with location and amounts of radiation • Study of Radon in schools • Regional Radon training centers Environmental Law

37. Title IV Lead Abatement • Intent to remove or encapsulate lead-based paint in older buildings. • Lead-based paint — lead in excess of 1.0 mg cm² or 0.5% by weight • Target Housing — any housing constructed before 1978 Environmental Law

38. Requirements • All individuals working with removal, risk assessment must be accredited and trained to perform work safely • Develop regulations to: • Set minimum requirements to accredit trainers • Minimum curriculum requirements • Minimum train hours • Minimum hands-on training requirements • Minimum trainee competency and proficiency requirements • Minimum requirements for training quality control Environmental Law

39. Title IV Lead Abatement • Allows delegation to states for local certification • EPA sets standards for testing laboratories • Information clearing house • Lead pamphlet Environmental Law