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Assessing and Managing Chemicals under TSCA

Highlights of Key Provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act

The following provides a brief overview of the key provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act for:

  • Existing chemicals;
  • New chemicals;
  • Confidential business information;
  • Source of sustained funding;
  • Federal-state partnership; and
  • Mercury export and disposal.

Read the full text of the bill.

Learn more about the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Existing Chemicals

  • Chemical Assessments
    • Prioritization
      • EPA must establish a risk-based process to determine which chemicals it will prioritize for assessment, identifying them as either “high” or low” priority substances.     
        • High priority – the chemical may present an unreasonable risk of injury to health or the environment due to potential hazard and route of exposure, including to susceptible subpopulations
        • Low priority – the chemical use does  not meet the standard for high-priority
    • Risk Evaluations
      • High priority designation triggers a requirement and deadline for EPA to complete a risk evaluation on that chemical to determine its safety
      • Low priority designation does not require further action, although the chemical can move to high-priority based on new information
      • Assessment pipeline
        • First 180 days – EPA must have 10 ongoing risk evaluations
        • Within 3.5 years – EPA must have 20 ongoing risk evaluations
    • New Risk-Based Safety Standard
      • Chemicals are evaluated against a new risk-based safety standard to determine whether a chemical use poses an “unreasonable risk”
        • Risk evaluation excludes consideration of costs or non-risk factors 
        • Must consider risks to susceptible and highly exposed populations
    • Action to address unreasonable risks
      • When unreasonable risks are identified, EPA must take final risk management action within two years, or four years if extension needed
      • Costs and availability of alternatives considered when determining appropriate action to address risks
      • Action, including bans and phaseouts, must begin as quickly as possible but no later than five years after the final regulation
    • Manufacturer-requested assessments
      • Manufacturers can request that EPA evaluate specific chemicals, and pay the associated costs as follows:
        • If on the TSCA Workplan, manufacturers pay 50% of costs
        • If not on the TSCA Workplan, manufacturers pay 100% of costs
      • These assessments must account for between 25-50% of the number of ongoing risk evaluations for high-priority chemicals, but do not count towards the minimum 20 ongoing risk evaluation requirement
  • Chemical Testing Authority
    • Expands authority to obtain testing information for prioritizing or conducting risk evaluations on a chemical, and expedites the process with new order and consent agreement authorities
    • Promotes the use of non-animal alternative testing methodologies
  • Persistent, Bioaccumulative, and Toxic (PBT) Chemicals
    • New fast-track process to address certain PBT chemicals on the TSCA Workplan
      • Risk evaluation not needed, only use and exposure to chemical needed
      • Action to reduce exposure to extent practicable must be proposed no later than three years after the new law and finalized 18 months later.
      • Additional requirements for PBTs in the prioritization process for assessments

New Chemicals

  • Pre-Market Review of New Chemicals
    • New requirement that EPA must make an affirmative finding on the safety of a new chemical or significant new use of an existing chemical before it is allowed into the marketplace
      • EPA can still take a range of actions to address potential concerns including ban, limitations, and additional testing on the chemical

Confidential Business Information

  • Establishes new substantiation requirements for certain types of confidentiality claims from companies 
  • Requires that EPA review and make determinations on all new confidentiality claims for the identity of chemicals and a subset of other types of confidentiality claims
  • EPA must review past confidentiality claims for chemical identity to determine if still warranted

Source of Sustained Funding

  • Allows EPA to collect up to $25 million annually in user fees from chemical manufacturers and processors when they:
    • Submit test data for EPA review
    • Submit a premanufacture notice for a new chemicals or a notice of new use
    • Manufacture or process a chemical substance that is the subject of a risk evaluation; or
    • Request that EPA conduct a chemical risk evaluation
  • New fees will defray costs for new chemical reviews and a range of TSCA implementation activities for existing chemicals

Federal-State Partnership

  • Preservation of State Laws
    • States can continue to act on any chemical, or particular uses or risks from a chemical, that EPA has not yet addressed
    • Existing state requirements (prior to April 22, 2016) are grandfathered
    • Existing and new state requirements under state laws in effect on August 31, 2003, are preserved
    • Preserves states environmental authorities related to air, water, waste disposal and treatment
    • States and federal government can co-enforce identical regulations
  • Preemption of State Laws
    • State action on a chemical is preempted when:
      • EPA finds (through a risk evaluation) that the chemical is safe, or
      • EPA takes final action to address the chemical’s risks
    • State action on a chemical is temporarily “paused” when EPA’s risk evaluation on the chemical is underway, but lifted when EPA:
      • completes the risk evaluation, or
      • misses the deadline to complete the risk evaluation
  • Exemptions
    • States can apply for waivers from both general and “pause” preemption
    • If certain conditions are met, EPA MAY grant an exemption from general preemption, and MUST grant an exemption from pause preemption

Mercury Export and Disposal

  • Amends requirements of the Mercury Export Ban Act (MEBA) and addresses Dept. of Energy’s (DOE) responsibility to designate a long-term storage facility
    • If the facility is not operational by 1/1/2020, DOE must accept title to and pay for permitting and storage costs for mercury accumulated in accordance with MEBA prior to that date
  • Requires that EPA create an inventory of supply, use, and trade of mercury and mercury compounds; and prohibits export of certain mercury compounds