Toxic Substance Control Act

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Toxic Substance Control Act

• ENVIRONMENTAL RISK ASSESSMENT

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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
  EPAs regulations
• TSCA seeks to control hazardous inputs into
  commerce and industry rather than regulating
  by-products from manufacturing processes

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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 EPAs initial inventory was compiled from
  information submitted by chemical manufacturers

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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

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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

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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.

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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

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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

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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

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What is environmental risk assessment (ERA)?

• Qualitative and quantitative valuation of
  environmental status

• ERA is is comprised of
• human health risk assessment
• ecological risk assessment.

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Purposes in performing ERA

• to learn about the risks
• to reduce the risk

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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.

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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.

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Human health risk assessment (HHRA)
Involves

• hazard identification
• dose-response assessment
• exposure assessment
• risk characterization.

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Ecological risk assessment (ERA)

• Determines the likelihood of the
  occurrence/non-occurrence of adverse ecological
  effects as a result of exposure to hazard

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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).

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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 TSCAs 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

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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

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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

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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