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Regulation of Toxic Substances
Toxic Substances Control Act 15 U.S.C. § 2601 et seq. (1976)
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July 2002 Environmental Law 2
TSCA
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July 2002 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
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July 2002 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
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July 2002 Environmental Law 5
Toxic Substances Control Act
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July 2002 Environmental Law 6
Became
&
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July 2002 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
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July 2002 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
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July 2002 Environmental Law 9
SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES
• Key Sections4. Testing of chemical substances and
mixtures5. Manufacturing and processing notices6. Regulations of hazardous chemical
substances and mixtures 7. Reporting and retention
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July 2002 Environmental Law 10
SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES (cont.)
• Key Sections (continued)10. Research, Development, collection
and dissemination, and utilization of data
11. Inspections and subpoenas12. Exports13. Entry into customs territory of the
United States14. Disclosure of data
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July 2002 Environmental Law 11
SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES
• Key Sections (cont.)15. Prohibited acts 16. Penalties 17. Specific enforcement and seizure 18. Preemption 19. Judicial review 20. Citizens civil actions21. Citizen’s petitions22. Employee protection
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July 2002 Environmental Law 12
SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES
• Key Sections (cont.)25. Studies 26. Administration 27. Development and evaluation of test
methods 28. State programs 29. Authorization of appropriations 31. Annual report
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July 2002 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
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July 2002 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
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July 2002 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
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July 2002 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.
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July 2002 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,
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July 2002 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
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July 2002 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
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July 2002 Environmental Law 20
New Chemicals processed under the PMN rule
Application Complete?
No
Technical Review
Sufficient to Determine
Risk?No
Review by EPA
Yes
NoticeApprove?
No
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July 2002 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
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July 2002 Environmental Law 22
What is required on PMN
• CAS number• Structure of chemical• Impurities• Health, environment and Safety Data
(sometimes)• Anticipated production data• MSDS
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July 2002 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.
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July 2002 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
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July 2002 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
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July 2002 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
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July 2002 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.
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July 2002 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
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July 2002 Environmental Law 29
School Districts
• Develop a plan for:A. Chrysotile (serpentine)B. Crocidolite (ruebeckite)C. Amosite (cummingtonite-grunerite),D. AnthophylliteE. TemoliteF. Actinolite
• Implement and complete plan in specified time
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July 2002 Environmental Law 30
Friable/Nonfriable Asbestos
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July 2002 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
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July 2002 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
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July 2002 Environmental Law 33
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July 2002 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
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July 2002 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
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July 2002 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
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July 2002 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
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July 2002 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
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July 2002 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