Chemical Companies, Processors, and Importers (Which includes Importers of Content) Have to Supply Opinions on Significant Alterations to EPA’s TSCA Reporting Specifications | Wiley Rein LLP

The Environmental Security Agency (EPA or Company) recently hosted a webinar to introduce the Agency’s intent to suggest a groundbreaking new reporting and recordkeeping rule pursuant to Toxic Substances Control Act (TSCA) Sections 8(a), (c), and (d). If you manufacture, method, import, or distribute—or even suggest to manufacture (which include import), procedure, or distribute—chemical substances or mixtures, which includes article content and byproducts, you should really carefully abide by this impending rulemaking and supply EPA opinions on the basic framework explained in the Agency’s webinar presentation by August 16, 2021.

This unforeseen addition to the existing chemical review framework will probable introduce a sea transform in TSCA reporting and recordkeeping requirements that could impose substantial yearly burdens on suppliers, processers, and distributors, which includes little entities and importers of article content. If the Agency’s proposed PFAS reporting rule is any indication of how EPA intends to use its TSCA Section 8 authorities, the reporting necessities may well be in depth.

What Will Be Demanded

EPA refers to the future new rule as the Tiered Info Reporting Rule (TDR Rule). As described by EPA, facts will be expected for three distinctive phases of the agency’s procedure for reviewing existing substances:

  • Problems of Use Facts (COU). At the outset, reporting would be essential for chemical substances that the Company may well take into consideration for prioritization—a “pre-prioritization” move not necessary by TSCA. EPA would use the info that it collects to determine regardless of whether the chemical should (a) enter prioritization or (b) “return” to the general pool of chemical substances authorized under TSCA. Throughout final month’s webinar, EPA indicated that the reporting prerequisites would start when the Agency “lists” the chemical as a prospect for prioritization beneath the TSCA danger evaluation framework (only all those chemical substances that EPA establishes as “high priority” finally undertake TSCA hazard evaluations). Impacted businesses would require to submit the essential details to EPA only 3 months immediately after the “listing” and per year thereafter.
  • Prioritization Information Set. This second set of knowledge would apply to chemical substances formally incorporated in the TSCA prioritization step and would enable EPA figure out which chemicals need to be regarded as a “high priority” and thus go through a chance evaluation. Companies once more would be necessary to submit facts to EPA only three months right after initiation of prioritization and annually thereafter. The 2016 adjustments to TSCA put guideposts on EPA when it seeks knowledge at this point in the process that EPA will need to have to abide by.
  • Danger Analysis/Risk Management Information Set. This final established of data would give info for EPA’s danger evaluation and threat administration activities, utilize when the chemical is formally classified by way of the TSCA process as a higher-precedence chemical, and be thanks 4-6 months soon after the commencement of the threat analysis (yet again, with yearly reporting requirements).

Through any and all of these ways, corporations may possibly need to have to post the adhering to facts and information to EPA: industrial, business, or purchaser employs product and short article info discontinued or phased-out makes use of health and safety details, these kinds of as toxicity facts, publicity checking data, employee exposures, and engineering controls to minimize publicity bodily-chemical attributes federal and condition regulatory actions and information on substitute substances that are safe and sound and powerful options.

Suppliers (like importers) would be demanded to submit facts for the COU and prioritization data sets. The risk evaluation/threat management reporting requirements would use to both equally manufacturers (which include importers), processors, and distributors.

What to Enjoy For

Of specific take note, EPA’s new TDR strategy alerts the re-introduction of a “pre-prioritization” step in the TSCA Segment 6 assessment method. EPA proposed and subsequently dropped pre-prioritization in the Final Prioritization Rule thanks to “widely differing, and usually irreconcilable views by commenters.” It appears that pre-prioritization is back—and deserves considerable stakeholder engagement. Getting your chemical or use on the pre-prioritization or “candidate” list could have unintended penalties for your company—without the means to offer EPA with details on why these kinds of a listing lacks advantage.

Businesses will also want to present feed-back on EPA’s strategy to use its TSCA Section 8(c) authority as part of the TDR Rule. This provision and its implementing laws involve producers (including importers), processors, and distributors to maintain data on and, on ask for, deliver to the Agency the pursuing sort of data:

  • Considerable adverse health results
  • Buyer allegations
  • Occupational ailment or harm and
  • Grievances of harm to the environment.

Most likely impacted stakeholders ought to interact with EPA now and share their experiences with complying with the latest Portion 8(c) recordkeeping obligations.


In accordance to EPA’s Federal Sign-up see, stakeholders will have to submit composed reviews on this possible rulemaking by August 15, 2021. Supplied that this day falls on a Sunday, on the other hand, reviews are because of on Monday, August 16, 2021 (which is consistent with the date indicated in EPA’s webinar slides).

EPA has not mentioned when it plans to challenge the precise proposed TDR Rule. In these predicaments, dependent on our practical experience, it is vital to have interaction EPA early in the rule improvement method and primarily in reaction to an invitation for general public opinions. Quite often, EPA will adhere to its proposed framework in situations like this when the Agency seeks time-sensitive information and facts to inform present and long term mandated functions. Consequently, it is specially essential to scrutinize diligently this early framework now and present EPA with constructive responses for shaping equally the proposed and the last TDR Rule. 

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