The EPA says that it is cutting into the backlog of new chemical reviews required under the Toxic Substances Control Act (TSCA) and expects to have the number of ongoing cases down to its “typical baseline” of about 300 by the end of July 2017.
The 2016 amendments to TSCA added a significant requirement to how the EPA conducts these reviews without giving the Agency any additional time to complete the work. As a result, the number of active cases ballooned to about 600 in January 2017. The Agency says it retained temporary staff to help handle the extra work. As of May 30, 2017, there were 443 cases under review.
Before the Amendments
The EPA reviews about 1,000 new chemical submissions (premanufacture notices [PMNs] or significant new use notices [SNUNs]) per year and has no more than 90 days to complete each review. If the Agency flags a concern within this time frame, the review period could be suspended to allow the agency and the submitter to address the concern and allow the new substance onto the market, enter into a non-Section 5(e) Significant New Use Rule (SNUR), negotiate a TSCA Section 5(e) SNUR, or withdraw the PMN. But before the amendments, the Agency did not have to issue a finding on these submissions. If 90 days passed without such an issuance, the manufacturer could begin commercializing the chemical substance.
Affirmative Determination
The amendments changed this by requiring the Agency to make an affirmative determination on PMNs for new chemicals or SNUNs for existing chemicals before manufacturing can commence. Three types of affirmative determinations can be made:
- The new chemical or significant new use presents an unreasonable risk.
- Available information is insufficient, or the new chemical or significant new use may present an unreasonable risk, or it has substantial production and exposure.
- The new chemical or significant new use is not likely to present an unreasonable risk.
Expeditious Action
For companies that submitted PMNs before enactment of the amendments, which are currently undergoing review, the new law reset the 90-day review period. However, the EPA said it would attempt to complete the reviews within the original 90-day time frame. Expeditious action under TSCA is clearly a priority for EPA Administrator Scott Pruitt.
“We are committed to working with companies to gather all the relevant information early in the process, to inform safety reviews for new chemicals,” said Pruitt. “Reviewing new chemicals quickly will enable those deemed safe to enter the marketplace to support jobs and our economy.”
In addition to retaining temporary staff, the EPA says it has reduced the backlog by prioritizing and implementing process efficiencies by, for example, grouping the review of similar chemicals. The EPA adds that it will continue to work with all stakeholders to identify additional changes to improve the quality, efficiency, and transparency of the new chemical review program.
No Substances Banned
The Agency notes that between June 22, 2016, and May 30, 2017, it has completed 373 reviews of PMNs, SNUNs, and microbial commercial activity notices (MCANs) with the following results:
- Allowed to commercialize without restrictions—81
- Allowed to commercialize with restrictions—178
- Not allowed to commercialize pending development of information—3
- Banned—0
- Cases withdrawn—111
The EPA statistics for the new chemical review program are summarized here.