Proposed Rules: Procedures for Prioritization and Risk Evaluation of Substances under the Amended Toxic Substances Control Act

24 January, 2017

What’s Happening?

The Environmental Protection Agency (EPA) has released two prepublications of proposed rules describing how it will prioritize and conduct risk evaluations of existing substances on the TSCA Inventory under the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (aka LCSA).  Once the official version of the document publishes in the Federal Register comments will be accepted.

When the original TSCA Inventory was collated there were more than 60,000 substances in commerce at that time.  These chemical substances were included with no requirement for EPA to evaluate their risks to health or the environment (“existing” substances). LCSA mandates the EPA to systematically prioritize and assess existing chemical substances, and manage identified risks.  Two components of the proposed process (Prioritization and Risk Evaluation) are the subject of this alert.

How Could it Impact Me?

The proposed rules could impact you if you manufacture, import, process or use chemical substances listed on the TSCA Inventory.

Quick Summary

The proposed process to assess existing chemicals effectively creates a continuously refreshed "pipeline" of substances that will be subject to risk review and potential management.  It includes well defined deadlines with prioritization being the initial step. The proposal for prioritization includes four stages:
 

  • pre-prioritization
  • initiation - subject to a 90 day comment period
  • proposed designation - including the basis for the designation also subject to a 90 day comment period
  • final designation - High-Priority (initiating  risk evaluation) or Low-Priority (no risk evaluation)
     

Preference for High-Priority designation will be given to substances:
 

  • listed in the 2014 Update of the TSCA Work Plan
  • that have persistence and bioaccumulation scores of 3
  • that are known human carcinogens and have high acute and chronic toxicity
     

Further, 50% of all ongoing risk evaluations must be substances from the 2014 Update to the TSCA Work Plan.

The "risk-based" screening criteria in pre-prioritization include but are not limited to:
 

  • hazard and exposure potential of the chemical substance (e.g., persistence and bioaccumulation, potentially exposed or susceptible subpopulations, and storage near significant sources of drinking water)
  • conditions of use or significant changes in the conditions of use[1] of the chemical substance, and
  • production volume or significant changes in the volume of the chemical substance manufactured or processed
     

TSCA limits the prioritization process duration to between nine and twelve months. Due to the statutory deadlines triggered at the initiation step, in cases where insufficient information exists to make a final determination designation, “High-Priority” will be the default.  Given that this designation immediately triggers risk evaluation, EPA expects to pursue significant data gathering[2] before initiating prioritization to minimize the number of cases where there is “insufficient information”.  In addition, unlike the TSCA Work Plan paradigm, this assessment will address all conditions of use.

For each risk evaluation, EPA must publish a document outlining the scope of the risk evaluation that includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations expected to be considered no later than six months after the initiation of the risk evaluation.  Each risk evaluation must also:
 

  • integrate and assess available information on hazards and exposure for the conditions of use of the chemical substance, including information on specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations
  • describe whether aggregate or sentinel exposures were considered and the basis for that consideration
  • take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use
  • describe the weight of scientific evidence for the identified hazards and exposure
     

In addition, the risk evaluation must not consider costs or other non-risk factors.

The statute requires that the risk evaluation process last no longer than three years with one possible six-month extension, and that the Agency allow for at least one 30 day public comment period on the draft prior to publishing a final risk evaluation.

Risk Evaluation is to initially encompass:
 

  • ten chemical substances from the 2014 update to the TSCA Work Plan
  • chemical substances designated as High-Priority from prioritization
  • substances submitted by manufacturers that have met the criteria for EPA to conduct a risk evaluation
     

Other than those requested by a manufacturer on completion of a risk evaluation EPA must designate at least one additional High-Priority Substance to take its place, and must designate at least twenty additional chemical substances as High-Priority by three an one half years after enactment, effectively doubling the number of chemical substances in the "pipeline".

Bottom Line

For all manufacturers, importers, processors and users of existing chemicals in the US it would be prudent to:
 

  • Evaluate all purchased and manufactured substances to determine if any may be subject to this process
  • Identify and review any data in your possession that may be pertinent to a risk assessment and subject to a data call-in, including substantiation for confidential business protection, if warranted
  • Make sure the details of all uses (including human exposure and environmental release) are well documented along with any mitigation to the exposure or release.  The level of detail likely to be required increases greatly for consumer and sensitive population (e.g., child) uses
     

[1] EPA interprets "significant changes in" conditions of use to have relevance primarily in the context of revising a priority designation in the future.

[2] Using available TSCA sections 4 and 8 authority.
 

Contact Us

Critical Path Services can help you determine what your company’s vulnerabilities may be under the new TSCA regulation. We can also provide your company with periodic TSCA updates and assist you in positioning your company to address future regulatory requirements. Critical Path Services can provide representatives of your company with a free consultation to talk you through the major changes enacted by the new law and how these changes could affect your business.

References and Related Documents

Proposed Rule - Prioritization of Chemicals for Risk Evaluation

Proposed Rule - Chemical Risk Evaluation

Business Units: 
Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail