US Approach to Regulation: TSCA and Public Health

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US Approach to Regulation TSCA and Public Health

• Lynn R. Goldman, MD, MPH
• Professor, Environmental Health Sciences
• Johns Hopkins Bloomberg School of Public Health
• October 13, 2004

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Talk will cover

• Public health and environmental goals of TSCA
  (Toxic Substances Control Act)
• Major features of TSCA
• Principles for TSCA reform

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Chemicals management media specific versus
cradle to grave approaches

• Media specific approach
• Focus is on engineering approaches to decrease or
  eliminate pollution/exposure from specific
  substances in specific media.
• Cradle to grave approach
• Focus is on pollution prevention via
  consideration of the entire lifecycle of a
  chemical or process including alternative
  processes

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Media Specific Statutes

• Media specific approaches
• Environmental
• Clean Air Act, Clean Water Act, Safe Drinking
  Water Act, Resources Conservation and Recovery
  Act, etc.
• Occupational
• Occupational Safety and Health Act, Mining Health
  and Safety Act, etc.
• Consumer
• Consumer Products Safety Act, Federal Food Drug
  and Cosmetics Act, etc.

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Cradle to Grave Approach

• Chemicals are managed throughout their lifecycle
• Research and development
• Commercialization and scaling up production
• Production
• Processing, formulation
• Product manufacture
• Transport of materials and goods
• Worker exposures (in production, formulation, use
  and disposal)
• Consumer exposures (in product use)
• Waste (emissions, disposal, recycling, reuse)
• Statutes TSCA and Federal Insecticide,
  Rodenticide and Fungicide Act

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Public health provisions in chemicals statutes

• Risk standard public health and environmental
  goals
• Protection of sensitive populations young,
  diseased, etc.
• Ability of other considerations (e.g., cost
  benefit) to trump public health
• New chemicals approvals
• Assessment of risks of existing chemicals
• Management of existing chemical hazards
• Chemical security
• Right to know access to information
• Pollution prevention
• Management of chemicals in trade

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Risk standard

• Food Quality Protection Act
• Food reasonable certainty of no harm
• FIFRA Avoid unreasonable risk to health or the
  environment
• TSCA
• Avoid unreasonable risk to health or the
  environment
• Conclusion
• Standard in TSCA is a least common denominator

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Protection of sensitive populations

• FQPA
• Specific provisions regarding examination of
  toxicity and exposure to children
• Assessment of aggregate risks from multiple
  uses of a pesticide
• Assessment of cumulative risks from multiple
  pesticides with same mode of action
• TSCA
• No such specific provisions but TSCA would not
  preclude EPA from doing so
• Conclusions
• TSCA does not give EPA clear direction for
  protection of sensitive populations (like
  children)
• TSCA does not require EPA to address
  environmental justice concerns (especially
  cumulative and aggregate risks)

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Role of other considerations (e.g., cost benefit)

• FQPA
• Costs and benefits a consideration for nonfood
  uses
• Public health considerations only for food uses
• Burden is on manufacturer to prove safety before
  a pesticide can be marketed or re-registered
• TSCA
• Same standard (cost-benefit balancing) for all
  circumstances
• Overly elaborate procedures (in law and court
  interpretation)
• Burden is on EPA to prove cost-benefit standard
  is met
• Conclusions
• TSCA does not provide a public health based
  standard for chemicals under any circumstance
• TSCA will never be effective unless the burden
  can be shfted onto industry to prove safety

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New chemicals approvals

• FIFRA
• Extensive database of testing required under
  FIFRA Part 151
• Emergency exemptions allowed
• Exemptions (by rulemaking) allowed (e.g., garlic,
  pheromones, genetic material)
• TSCA
• Only chemical structure and physical
  characteristics are supplied
• Agency uses Structure Activity Relationships and
  physicochemical properties for most decisions
• Conclusions
• A more robust data set (e.g., the OECD Screening
  Inventory DataSet) for initial determination
  would provide EPA with more risk information
• Rule making allowed to create exemptions
• Increased testing could be required for certain
  uses (e.g., food uses, consumer products, heavy
  worker exposures)

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Assessment of risks of existing chemicals

• FIFRA
• All pesticides on the market were approved at
  some time and have registrations
• 1988 law required reregistration, to update
  testing
• TSCA
• 70,000 existing chemicals grandfathered into use
  and placed on the inventory
• The inventory has numerous inaccuracies and is
  only partially updated
• To required testing EPA must write a test rule
  that contains a finding of unreasonable risk
  (can be based on exposure) EPA must meet a heavy
  burden to justify testing
• Voluntary high volume testing (but no clear
  pathway to more complete testing)
• Generation of data is not rewarded
• Conclusions
• TSCA does not give EPA clear expectation for
  testing of risks of existing chemicals
• TSCA does not provide for exposure monitoring
• Minus hazard and exposure data there is no
  risk assessment

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Need for Explicit Priority Setting and Tiered
Assessments

• FQPA
• Hundreds of pesticides on the market formulated
  into tens of thousands of commercial products
• TSCA
• Tens of thousands of chemicals on the market
  (15,000 at more than 10,000 lbs/year)
  manufactured into millions of products
• Conclusion
• EPA has not been given clear direction regarding
  which chemicals/classes of chemicals should be
  addressed first, (e.g., persistence
  bioaccumulation endocrine activity
  mutagenicity presence in home and school
  environments, in food, in drinking water, or in
  air or presence in humans, wildlife or the
  environment).
• Tiered assessment processes have not been
  established (e.g. where do you go beyond
  screening assessment?)

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Management of existing chemical hazards

• FQPA
• Occurs via pesticide reregistration processes
  and hundreds of individual actions every year
• TSCA
• TSCA Section 6 and has almost no regulatory
  actions each year
• 1992 Fifth Circuit Court decision on the 1989
  asbestos ban and phase out (corrosion fittings)
  set a precedent for a very high bar for EPA
• Substantial substitution analyses, for which EPA
  will never have adequate resources
• A preference for end-of-pipe solutions to meet
  the TSCA least burdensome language (rather than
  solutions involving source reduction such as use
  of safer substitutes)
• In consequence almost all risk management under
  TSCA is on a voluntary basis
• Conclusions
• We have paralysis by analysis analytic
  requirements are not within reason
• We do not reward/encourage pollution prevention
  approaches
• We do not provide a set of clear expectations to
  EPA about chemical management

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Managing risks to consumers, workers, and
communities

• FQPA
• Registration process considers all risk scenarios
• TSCA
• Fragmentation of responsibilities within EPA
  (air, water, waste offices) and among agencies
  (Occupational Safety and Health Administration,
  Consumer Products Safety Commission)
• TSCA referral process has been unproductive
• Conclusions
• A multimedia approach for chemicals management
  requires more engagement and coordination across
  all of EPA as well as OSHA, CPSC, the National
  Toxicology Program (NTP), the CDC in areas such
  as research, hazard assessment, exposure
  assessment, risk communication and risk management

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Chemical Security

• Numerous exceedingly hazardous chemicals can be
  purchased over the internet
• Chemical facilities are not secure from terrorist
  attacks (although some have taken action
  voluntarily)
• Chemical transport has not been secured .
• Policy Objective
• Chemicals management needs to recognize that we
  are in a new environment with threats of
  terrorist attacks

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Right to know access to information

• TSCA
• In 1998, more than 65 of the information
  filings directed to the Agency through TSCA were
  claimed as confidential.
• Submissions under the former Inventory Update
  Rule show that about 20 of facility identities
  were claimed as confidential.
• In 1998, 40 of Section 8(e) substantial risk
  notices had chemical identity claimed as
  confidential.
• States cannot receive CBI filings under the
  statute, yet many chemical risk management
  decisions in this country are done at the state
  and local level
• Conclusions
• TSCA should protect legitimate business
  interests, BUT
• States, scientists and the general public need
  more information (especially facility identities
  and chemical identities for states and health and
  environmental information for all parties!)

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Pollution prevention (P2)

• FQPA
• Incentives for safer pesticides
• TSCA
• No built-in incentives for greener chemistries
  TSCA bias against the development of new, greener
  processes
• Most chemical regulation is done in other program
  offices in a stovepipe fashion, decreasing
  opportunities for P2
• Conclusions
• TSCA does not reward efforts to develop new safer
  processes and for source reduction efforts
• TSCA does not enable EPA to replace burdensome
  media based regulations with more efficient and
  protective multimedia approaches

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Management of chemicals in trade

• TSCA should
• Ratify Stockholm Convention on Persistent Organic
  Pollutants (POPs)
• Ratify Rotterdam Convention on Prior Informed
  Consent (PIC)
• Put the US government in the center of
  international efforts for sound management of
  chemicals
• Current efforts in the House of Representatives
  to ratify the POPs and PIC convention would
  instead make it more difficult for the US to be
  full participants

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Conclusion

• To be successful, TSCA needs
• Clear expectations of EPA for action to protect
  health and the environment (and deadlines)
• Burden on industry to obtain approvals
• Participation by state (and sometimes local) govt
• Reward information
• Reward innovation
• Make information available to the public
• Involvement of other federal players
• Ratify chemicals conventions

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Role of Industry

• Move toward multimedia, pollution prevention
  approaches
• Participate in voluntary efforts, e.g., voluntary
  chemical testing and green chemistry efforts as
  well as full implementation of Responsible Care
• Establish more progressive and consistent
  approaches to public policy in this area
• Examples EU REACH effort, chemical plant
  security legislation, POPs ratification,
  chemicals reform