Toxic Substances Control Act TSCA

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Toxic Substances Control ActTSCA

• EVEN 6354Environmental Regulations Policy

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TSCA Objectives

• The general purpose of TSCA is to regulate the
  manufacture, processing, distribution in
  commerce, use, or disposal of chemical substances
  and mixtures which may present an unreasonable
  risk of injury to health or the environment.

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Background

• Congress was concerned with toxic substances that
  no one seemed to have studied enough to determine
  whether they could create problems or not.
• Particular concern at that time were PCBs used in
  electric transformers and capacitors that tended
  to break open dispersing the chemical
• A contractor at Corpus Christi Naval Air Station,
  who was hired to change capacitors and
  transformers dropped them to the ground from the
  poles and spread PCBs over a large area

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Introduction

• The Toxic Substances Control Act (TSCA) of 1976
  give EPA the ability to track the 75,000
  industrial chemicals currently produced or
  imported into the United States, and thousands of
  new chemicals introduced by industry.
• EPA repeatedly screens these chemicals and can
  require reporting or testing of those that may
  pose an environmental or human-health hazard.
• EPA can ban the manufacture and import of
  chemicals that pose unreasonable risks.

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TSCA Content

• Title I Control of Toxic Substances
• Title II Asbestos Hazard Emergency Response Act
• Title III Indoor Radon Abatement Act
• Title IV Lead-Based Paint Reduction Act

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Regulatory Approach

• Toxics List TSCA Chemical Substance Inventory
• A new Chemical is any substance not in the list
• New Chemicals subject to Pre-manufacture Review
• EPA has authority to require testing, which is
  sponsored by manufacturers
• EPA has authority to limit or prohibit
  manufacture. PCBs are prohibited
• Record keeping and Reporting required
• Export Notice and Import Certification Required

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The Inventory Contents

• Common or trade name, chemical identity and
  molecular identity
• Categories or proposed categories of use
• Total manufactured or processed for each use
• Byproducts resulting from manufacture,
  processing, use, or disposal
• All existing data on the environmental and health
  effects of the substance or mixture
• Number of individuals exposed in the workplace,
  and the length of time of exposure
• Method of disposal.

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New Chemicals

• Pre Manufacture Notice (PMN)
• Exclusions (no PMN, regulated Elsewhere)
  Pesticides, Fungicides, Food, Food Additives,
  Cosmetics and Drugs
• PMN Exemptions Test Market (No Risk) RD
  (Responsible Firms/Individuals) Polymers
  Polaroid Chemicals in Articles
• Minimizing Delays demonstrating minimum Risk
• Risk Hazard x Exposure
• Hazard f(Human Toxicity)
• Exposure f(Production Volume Use)

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Pre-Manufacture Notification

• The pre-manufacture notification (or SNUN) must
  be accompanied by the test results, if there is a
  requirement for test results.
• If no testing is required by rule, then the
  pre-manufacture notification must be accompanied
  by data that shows that the new chemical
  substance or the significant new use will not
  present an unreasonable risk of injury to health
  or the environment.

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Resolutions on New Chemicals

• Should come 90 days limit after PMN, but can be
  extended
• Result can be Limit Production or Prohibition
  based on Risk
• Significant New Use Rule (SNUR) of a Listed
  Substance applies if new use increments Exposure
  and consequently Risk

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Prohibition or Limitation

• If the data submitted with the PMN is not
  adequate for EPA to evaluate the health and
  environmental effects
• If the proposed activities may present an
  unreasonable risk of injury to health or the
  environment
• If the substance is or will be produced in
  substantial quantities and the substance may
  enter the environment in substantial quantities
• If there may be significant or substantial human
  exposure.
• If the respondent files objections to the order,
  then the order does not take effect, however, EPA
  is then required to request an injunction in
  federal District Court.

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Possible Rules on New Substances (1)

• Prohibit or limit the amount that may be used for
  manufacture, processing, or commerce.
• Prohibit or limit the amount or concentration for
  a particular use
• Require specific labeling, including clear and
  adequate warnings and instructions.
• Require the making and retention of records of
  the processes used to manufacture or process
• Monitor or conduct tests to assure compliance
  with the requirements of any applicable TSCA rule.

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Possible Rules on New Substances (2)

• Prohibit or otherwise regulate any manner or
  method of commercial use.
• Prohibit or otherwise regulate any manner or
  method of disposal.
• Require the giving of notice of unreasonable risk
  of injury to distributors in commerce and other
  persons in possession, giving public notice of
  risk, or replace or repurchase the substance or
  mixture at the option of the person in
  possession.

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Confidential Information

• Trade secrets or commercial information submitted
  under TSCA cannot be released by EPA
• Release of this information is very sensitive
  because competitors, may use it in their
  advantage
• Disclosure is punishable by a fine of up to 5000
  and a year in jail, under TSCA.
• Certain health and safety studies, however, may
  be released.

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Testing

• Objective Generate Data on Health and
  Environmental Risk of Products
• Interagency Testing Committee (ITC) recommends
  Chemicals for testing Carcinogenic, Mutagenic or
  Teratogenic
• Follow Good Laboratory Testing Standards
• Significant Risk gt Rule Making

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Reasons for Testing

• To determine whether the manufacture,
  distribution, processing, use, or disposal may
  present an unreasonable risk of injury to health
  or the environment (Risk basis)
• To establish if a chemical substance or mixture
  is or will be produced in substantial quantities
  and either it will enter the environment in
  substantial quantities or there will be
  significant or substantial human exposure
  (Exposure basis)
• To collect data and experience upon which effects
  on health or the environment can reasonably be
  determined or predicted

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Chemicals Grouping

• EPA has grouped new chemical substances with
  similar structural and toxicological properties
  into working categories
• Groupings enable to use accumulated data and
  decisional precedents on similar substances
• This has streamlined the process for Agency
  review and regulatory follow-up on new chemicals
• EPA is developing a category of persistent,
  bioaccumulative, and toxic (PBT) chemical
  substances.

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Microbial Products of Biotechnology, 1997

• Intergeneric microorganisms are those that
  contain genetic material from organisms in more
  than one taxonomic genera having a high
  likelihood of expressing new traits
• Subject to this rule are new microorganisms
  used commercially for such purposes as production
  of industrial enzymes and other specialty
  chemicals agricultural practices (e.g.,
  biofertilizers) and break-down of chemical
  pollutants in the environment (bioremediation).
• Microorganisms that are not intergeneric are not
  subject to Section 5 of TSCA.

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Objectives of Microbial Products of Biotechnology

• Provide significant regulatory relief to those
  wishing to use certain products of microbial
  biotechnology.
• Ensure that EPA can identify and regulate risk
  associated with microbial products of
  biotechnology without unnecessarily hampering
  this important new industry
• Those microorganisms are considered New
  Chemicals, thus they fall under TSCA Section 5

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Specific Chemicals Regulations

• EPA can regulate under TSCA specific chemicals
  that present unreasonable risks to health and the
  environment
• To regulate the specific chemicals EPA must
  consider
• The effects on health and environment
• The Exposure to humans and environment
• The benefits and availability of substitutes
• The economic consequences of the rule

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Chemicals Regulated

• Asbestos
• Chlorofluorocarbons (CFCs) The Montreal Protocol
• Tetrachlorodibenzo-P-dioxin (TCDD, dioxins and
  furans) Under RCRA
• Exavalent chromium (Cr6) On Cooling Water
  Towers
• Metal Working Fluids (that create
  N-nitrosodiethanolamine)
• Polychlorinated Biphenyls (PCBs) Ban Disposal

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Asbestos Ban

• 1989 Ban on manufacture, import, processing and
  distribution of asbestos products
• Asbestos is associated with lung cancer
• The US Fifth Court of Appeals overturned the ban
  in 1991
• The ban still applies to asbestos in corrugated
  paper, rollboard, commercial and specialty paper,
  flooring felt and any other new uses of asbestos.
  
• The CAAA bans it from fireproofing, insulating,
  decorative and most spray applied surfacing uses

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Asbestos Products not banned

• Asbestos-cement corrugated sheet, asbestos-cement
  flat sheet, asbestos clothing, pipeline wrap,
• Roofing felt, vinyl-asbestos floor tile,
  asbestos-cement shingle, millboard,
  asbestos-cement pipe,
• Automatic transmission components, clutch
  facings, friction materials, disc brake pads,
  drum
• Brake linings, brake blocks, gaskets, non-roofing
  coatings, and roof coatings.

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Chlorofluorocarbons (CFCs)

• 1973 ban of CFCs as propellants
• Implementation of the Montreal Protocol under the
  CAA

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Tetrachlorodibenzo-P-dioxin (TCDD)

• Also includes many of the dioxins and furans
• Regulated under RCRA

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Exavalent chromium (Cr6)

• Use in air conditioning and refrigeration systems
  as corrosion inhibitor is banned
• Still permitted in Cooling Water Towers, but
  several cases tried in courts (Erin Brockovich
  actions)

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Metal Working Fluids

• Metalworking fluids are used in metal machining
  for cooling or lubricating
• Nitrosating agent is a substance that has the
  potential to transfer a nitrosyl group (-NO) to a
  secondary or tertiary amine to form the
  corresponding nitrosamine
• The regulation prohibits the addition of any
  nitrosating agent, including nitrites, to the
  triethanolamine salt of tricarboxylic acid, when
  the substance is or could be used in metalworking
  fluids
• The addition of nitrites or other nitrosating
  agents to this substance leads to formation of
  N-nitrosodiethanolamine a substance known to
  cause cancer in laboratory animals

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Polychlorinated Biphenyls (PCBs)

• 1979 Ban on the manufacture of PCBs and phase out
  of its uses, rules on disposal
• 1994 Modified rule for disposal
• 1998 Final modified rule on disposal, maximum
  emissions and decontamination standards. Also
  established a manifesting system

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TSCA and other Laws

• Pesticides regulated under the Federal
  Insecticide, Fungicide,and Rodenticide Act
  (FIFRA)
• Food, Food Additives and Cosmetics regulated
  under the Federal Food, Drug and Cosmetic Act
  (FDCA)

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Inspections

• For New Chemicals activities
• For record keeping compliance
• For verification

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Enforcement and Civil Penalties

• Civil penalties imposed for violations of TSCA
• Civil penalties based on nature, extent and
  circumstances of the violation
• To assess the penalty the gravity of the
  violation is determined
• Culpability determined by the persons knowledge
  of TISCA provisions
• And the persons degree of control over the
  violation
• Civil actions can be initiated by any person
  against a violator of TSCA

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Import Export

• Importers subject to the same rules as a domestic
  manufacturer
• Customs to refuse imports non complying with TSCA
• First export to a country requires notification