SOCMA is advocating for members to improve the TSCA – EPA’s has a proposed rule on procedural changes to TSCA, and while SOCMA does not believe the proposed changes will lead to EPA meeting the legally required 30 day review period for LVEs or 90 day PMN reviews, SOCMA, in working with SOCMA’s Chemical Regulatory Committee provided insight to EPA.

SOCMA filed its comments to EPA. Download Comments.

  • Use of best available science– EPA must incorporate TSCA Section 26 science standards into the proposed rule instead of relying on conservative defaults.
  • New upfront data requirements– If EPA is going to codify data requirements, it must be required to use PMN submitter data and not apply conservative assumptions or use modeling unless EPA can show that its data is more scientifically accurate.
  • Reasonably foreseen uses– Consistent with TSCA, EPA must modify its approach to reviewing intended, known, or reasonably foreseen conditions of use. Additionally, TSCA does not require EPA to review reasonably foreseen uses at the same time as the intended and known uses identified by a submitter. 
  • Refunds– To encourage accountability with statutory timelines, EPA should issue refunds to PMN submitters if EPA asks the submitter to suspend the review period for reasons other than legitimate scientific reasons.
  • Extensions of the review period– EPA should not extend its ability to request suspensions of the review period from 15 days to 30 days, as this would result in more delays and uncertainty in the program.
  • Pre-submission meetings– EPA should codify procedures for pre-submission meetings with PMN submitters and ensure that appropriate experts from EPA attend.
  • Potentially exposed or susceptible subpopulations (PESS)– EPA should align the proposed definition with the TSCA statutory definition for PESS.
  • Restarting “90-day clock” if submitter later provides information that EPA believes was “known to or reasonably ascertainable by” the company– We urge EPA not to finalize this requirement because this will result in even longer new chemicals reviews, and, in practice, submitters provide such data to EPA typically after EPA unnecessarily applies its own conservative assumptions, causing the submitter to have to provide more information to rebut EPA’s assumptions.  
  • Perfluoroalkyl and polyfluoroalkyl substance (PFAS) and persistent, bioaccumulative, and toxic (PCB) exclusion from LVEs and Low Releases and Exposure Exemptions (LoREXs)– EPA should not categorically classify large groups of substances as ineligible for LVEs or LoREXs. EPA already has authority to deny LVE or LoREX applications if it is unable to find that manufacture, processing, distribution in commerce, use, and disposal of the exempted substance will not present an unreasonable risk of injury to human health or the environment.
  • Transparency– EPA should provide more information to submitters about the status of their new chemical notices.
  • Review of EPA determinations– EPA should provide submitters with the opportunity to administratively challenge an EPA determination on a new chemical notice rather than having to resort to federal court action.
  • Sector-specific approaches– EPA should clarify procedures for and consideration of sector-specific approaches to new chemicals reviews if requested by a specific industry sector or based on other scientifically valid criteria.
  • Use of check boxes in the PMN form– EPA should not modify the PMN form to require check boxes on every screen.
  • EPA must implement a risk, not hazard based approach for new chemical reviews-TSCA requires that EPA evaluate new chemicals to ensure they do not present an unreasonable risk of injury to health or the environment under the conditions of use. EPA should not be making hazard-based determinations on new chemicals.

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