Key Provisions of the Amended Toxic Substance Control Act

Source: epa.gov, June 23, 2016

The following provides a brief overview of the key provisions in the amended TSCA, including: existing chemicals; new chemicals; confidential business information; source of sustained funding; federal-state partnership; and mercury export and disposal.

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
• Chemical Testing Authority
  • Expands EPA’s 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 pre-manufacture 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.
• Requires that EPA create an inventory of supply, use, and trade of mercury and mercury compounds; and prohibits export of certain mercury compounds.

For more information, including details of the EPA’s first year implementation plan, go here.