Regulation of Toxic Substances

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Regulation of Toxic Substances

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

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TSCA
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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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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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Toxic Substances Control Act
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Became

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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 productswhen
  necessary
• Risk-based statute

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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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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

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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

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SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

• Key Sections (cont.)
• Prohibited acts
• Penalties
• Specific enforcement and seizure
• Preemption
• Judicial review
• Citizens civil actions
• Citizens petitions
• Employee protection

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SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

• Key Sections (cont.)
• Studies
• Administration
• Development and evaluation of test methods
• State programs
• Authorization of appropriations
• Annual report

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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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Least Known by Public

• Requires an inventory of chemicals75,000
  chemicals in the inventory
• Approximately 3,000 are high-volume chemicals
• Most information on chemicals is based on a
  risk-assessment based on Structural Activitylt6
  data

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

• Has been a problemDow 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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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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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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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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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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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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School Districts

• Develop a plan for
• Chrysotile (serpentine)
• Crocidolite (ruebeckite)
• Amosite (cummingtonite-grunerite),
• Anthophyllite
• Temolite
• Actinolite
• Implement and complete plan in specified time

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Friable/Nonfriable Asbestos
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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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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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(No Transcript)
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Indoor Radon Abatement

• Requires EPA to publish a citizens 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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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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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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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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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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Title IV Lead Abatement

• Allows delegation to states for local
  certification
• EPA sets standards for testing laboratories
• Information clearing house
• Lead pamphlet