Regulation of Toxic Substances

Regulation of Toxic Substances

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

July 2002 Environmental Law 2

TSCA


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


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


Toxic Substances Control Act


Became

&


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


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

http://www4.law.cornell.edu/uscode/15/ch53schII.html

http://www4.law.cornell.edu/uscode/15/ch53schIII.html

http://www4.law.cornell.edu/uscode/15/ch53schIV.html


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


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



• 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



• Key Sections (cont.)25. Studies 26. Administration 27. Development and evaluation of test

methods 28. State programs 29. Authorization of appropriations 31. Annual report


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


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


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


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.


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,


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


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


New Chemicals processed under the PMN rule

Application Complete?

No

Technical Review

Sufficient to Determine

Risk?No

Review by EPA

Yes

NoticeApprove?

No


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


What is required on PMN

• CAS number• Structure of chemical• Impurities• Health, environment and Safety Data

(sometimes)• Anticipated production data• MSDS


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.


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


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


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


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.

http://www.epa.gov/ttn/uatw/hlthef/asbestos.html


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


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


Friable/Nonfriable Asbestos


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


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


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


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


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


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


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


Title IV Lead Abatement

• Allows delegation to states for local certification

• EPA sets standards for testing laboratories

• Information clearing house• Lead pamphlet

Regulation of Toxic Substances

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