EPA’s review of premanufacture notices (PMNs) for new chemical substances under the Toxic Substances Control Act (TSCA) has continued to suffer from significant delays. These delays in the PMN review process have been exacerbated by the federal government shutdown beginning in late December 2018 as the backlog has grown. EPA issuance of significant new use rules (SNUR) for new chemicals has also been delayed. 

Manufacturers and importers of new chemicals should continue to anticipate delays in the PMN review process and plan for additional time before the manufacture or import of a chemical substance can commence. Manufacturers and importers should also consider the prospect of negotiating a TSCA section 5(e) order that imposes controls or restrictions on the use of the new chemical and/or requires testing.

Growing Pains After Enactment of the LCSA

Upon enactment of the Frank A. Lautenberg Chemical Safety for the 21st Century Act (LCSA) on June 22, 2019, EPA had to revamp its PMN review process to reflect changes to the new chemical review framework. As part of this process, EPA also restarted the 90-day clock for 331 PMNs that were pending at the time of enactment of the LCSA. Within the first year after enactment, the backlog exceeded 600 “new chemical” applications according to EPA. Former EPA Administrator Scott Pruitt committed to eliminating the backlog of new chemical reviews that were stuck in EPA’s PMN review processes when he was confirmed.

On August 7, 2017, EPA announced that the new chemical backlog had been eliminated. EPA reported that it had only 382 open new chemical cases (which likely included PMNs, microbial commercial activity notices (MCANs), significant new use notices (SNUNs), and exemption applications). According to EPA, that caseload had returned to the baseline and was in line with a typical workload for the TSCA New Chemicals Program. EPA also highlighted its efforts to continuously improve EPA’s TSCA New Chemicals Program by redeploying full-time staff to work on new chemicals, initiating streamlined work processes around new chemicals, and institutionalizing a voluntary pre-PMN submission process so that submitters understand what information is most useful to EPA and what they can expect from EPA during the review process.

Despite EPA’s announcement in 2017 and efforts to improve the PMN review process, the PMN backlog has ballooned again, and EPA’s shutdown beginning in December 2018 compounded this already growing problem. 

The Effects of the Federal Government Shutdown

The recent federal government shutdown that began on December 29, 2018 resulted in another setback for EPA and the TSCA New Chemicals Program. During the shutdown, EPA’s New Chemicals Review Program, which includes the PMN review process, ground to a complete halt. EPA did not fully resume its work on the PMN program until January 31, 2019, 33 days after the shutdown began. 

As a result of the shutdown, EPA issued an extension to the review periods for all PMNs, MCANs, SNUNs, and exemption applications that were pending as of December 29, 2018. 84 Fed. Reg. 2851 (Feb. 8, 2019). EPA extended the review period for these applications by 33 days – the equivalent time period from the date of the shutdown until EPA fully resumed operations of the TSCA New Chemicals Program. EPA issues this extension under TSCA section 5(c), which allows the Agency to extend the PMN review process by up to 90 days for good cause. 

In addition to freezing review of all pending new chemical applications, the shutdown postponed the review of all incoming new chemical applications submitted during the shutdown. EPA did not receive notifications or process any submissions during the shutdown, and EPA did not begin its review of TSCA section 5 notices submitted during the shutdown until the TSCA New Chemicals Program resumed operations. In other words, the 90-day review clock for PMNs did not start until January 31, 2019 for all new chemical applications. 

Current Backlog of PMN Reviews

According to EPA, there are currently 542 cases under review as of February 19, 2018. These include PMNs, MCANs, SNUNs, and other exemption applications. The current backlog is approaching the previous total of over 600 cases that EPA reported shortly after enactment in 2017. The current EPA statistics show over a 40% increase in EPA’s caseload since EPA’s announcement in 2017 that the backlog had been eliminated. See Statistics for the New Chemicals Review Program under TSCA. 

EPA’s review of PMNs in the past year highlights the significant backlog and delays experienced by PMN submitters. Manufacturers and imports have submitted 324 PMNs to EPA since February 1, 2018 (this number does not include PMN submissions deemed invalid or withdrawn). Of these, EPA has only completed its review and made final determinations regarding 30 chemical substances, or less than 10% of the total number. In these cases, EPA has determined that 23 chemical substances are not likely to present an unreasonable risk, and has issued a 5(e) order for the other 7 chemical substances based on insufficient information or its finding that the chemical substance may present an unreasonable risk. The remaining 294 PMNs submitted in the past year are still under review. See EPA PMNs and SNUNs Table.

Most PMNs Subject to Some Restriction

Since enactment of the LCSA on June 22, 2016, EPA has issued 564 total determinations allowing manufacturers to commence manufacture of new chemical substances. Since June 22, 2016, EPA has:

• Issued a section 5(e) order for 439 chemical substances.
• Issued a section 5(f) order for 2 chemical substances.
• Made a “not likely to present an unreasonable risk” determination for 123 chemical substances are. 

This is based on a review of EPA's PMNs and SNUNs Table (current as of February 14, 2019).

A total of 78% of the final determinations have resulted in a section 5(e) or a section 5(f) order. About 22% have resulted in a “not likely to present” determination. This demonstrates that EPA has imposed controls or restrictions on chemical substances for a majority of the PMNs it has reviewed since enactment of the LCSA. PMN submitters should consider the likelihood of having to negotiate and comply with a section 5(e) order, and the associated delays with doing so. 

Delays for Significant New Use Rules

EPA’s issuance of SNURs following a section 5(e) order has also been delayed. TSCA section 5(f)(4) requires EPA to initiate a SNUR rulemaking within 90 days of issuing a section 5(e) order or, by that time, explain why it is not doing so. EPA has not published any explanations.

EPA is not meeting that 90-day deadline (as indicated by publication of a direct final SNUR or a proposed SNUR), but the Agency is closing the gap. EPA has initiated SNUR rulemaking for 378 PMN chemicals with section 5(e) or section 5(f) orders effective after the date of enactment. This represents approximately 85% of the total number of section 5(e) and section 5(f) orders issued since enactment. The issuance of a SNUR has typically lagged between seven to 12 months after the effective dates of the respective 5(e) orders, with some SNURs being issued as much as two years later. 

EPA is clearly struggling to meet its deadline to issue SNURs within 90 days, but manufacturers and processors of new chemical substances should monitor the situation as EPA seeks to catch up and promulgate SNURs for outstanding chemical substances subject to section 5(e) orders.

Recommendations

Manufacturers and importers of new chemicals should anticipate and plan for significant delays for PMN reviews as EPA continues to work through the backlog of PMNs. Manufacturers and importers should also consider the prospect of a TSCA section 5(e) order that imposes controls or restrictions on the use of the new chemical or requires testing, and should be prepared to negotiate this 5(e) order. PMN submitters should consider options to increase the likelihood of a favorable (or at least faster) determination. Please see our previous article, Ten Things PMN Submitters Need to Know, for a discussion of possible options.

Beveridge & Diamond’s Chemicals Regulation practice group and Chemicals industry group provide strategic, business-focused advice to the global chemicals industry. We work with large and small chemical companies whose products and activities are subject to EPA’s broad chemical regulatory authority under TSCA and state chemical restrictions. For more information, please contact the authors.