MEC&F Expert Engineers : EPA Moves Swiftly (aka, turtle moves) to Carry Out New Chemical Reform Legislation

Thursday, September 1, 2016

EPA Moves Swiftly (aka, turtle moves) to Carry Out New Chemical Reform Legislation

EPA Moves Swiftly to Carry Out New Chemical Reform Legislation

Agency tackles new legislative mandates set forth in first major update to environmental statute in 20 years

09/01/2016
Contact Information: 
Robert Daguillard (daguillard.robert@epa.gov)
(202) 564-6618
WASHINGTON— U.S. Environmental Protection Agency (EPA) is taking action to ensure that the Frank R. Lautenberg Chemical Safety for the 21st Century Act signed this June 22, 2016, delivers on the promise of better protecting the environment and public health. This bipartisan bill to reform the Toxic Substances Control Act (TSCA) outlines a number of responsibilities for EPA that must be completed within a tight timeframe.

The milestones accomplished by the agency include:

•A plan released on June 29, 2016, that outlines activities for the first year of implementing the new law;

•The first determinations completed on seven premanufacture notices under TSCA in July, 2016. The new law requires the agency to make affirmative determinations on new chemical substances before they can enter the marketplace. Additional determinations will be released as they are completed;

•A series of public meetings held from August 9-12, 2016, to obtain comments and feedback from stakeholders on the processes that will be used to establish fees and prioritize and evaluate chemicals under the new law;

•A list of five mercury compounds released on August 26, 2016, that will be prohibited from export as of January 1, 2020. This action will prevent the ability to convert these compounds to elemental mercury after export from the United States.

Additionally, the agency is establishing the Science Advisory Committee on Chemicals (SACC) to provide independent advice and expert consultation on scientific and technical aspects on risk evaluations, methodologies, and pollution prevention measures or approaches. The call for nominations to serve on this committee was issued on August 26, 2016.

The new amendments to TSCA will help bring significant improvements to public health as EPA continues to take the steps necessary for its successful implementation.

More about the Frank R. Lautenberg Chemical Safety for the 21st Century Act and EPA’s implementation activities and to sign up for updates, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act

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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.

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
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