Government Shutdown Impact on TSCA and FIFRA Actions at EPA
January 24, 2019
The Environmental Protection Agency (EPA) has been closed due to the partial government shutdown since December 28, 2018.  This closure will have wide ranging effects on EPA regulatory activities associated with Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) regulated products, even once the Agency re-opens.

TSCA

As of December 31, 2018, the review of all TSCA Pre-Manufacture Notice (PMN) and Low Volume Exemption (LVE) submissions was suspended and will remain so until EPA funding is restored. The shutdown will likely cause the backlog of TSCA new chemicals under review to sharply increase, voiding EPA efforts of the last year in bringing the caseload back to historical levels. Delays in review of TSCA submissions can be expected to continue for months after the agency resumes operation.

Under the TSCA Inventory Notification (Active-Inactive) Rule, the final TSCA Inventory listing of Inactive substances was scheduled to be published in the Federal Register in January 2019. The government shutdown is likely to delay the publication until at least February 2019. The effective date of the rule is 90 days after publication.

The manufacturer/importer of any substance for which a polymer exemption is claimed must submit a report of manufacture to EPA by January 31 of the year following the year in which the substance was first manufactured. This reporting obligation remains even if the government shutdown continues through this date.

FIFRA

All regulatory actions under FIFRA are also suspended.  For pending FIFRA actions, we anticipate that the Agency will add additional time to the current PRIA due dates at least equal to the amount of time the Agency is closed.  Registrants should expect that PRIA deadlines within at least the first six months of 2019 may not be met. The process for renegotiation of PRIA deadlines is unknown at this time.

Although EPA’s CDX submission portal appears to be accepting new submissions, we understand that submissions will not be acknowledged and new regulatory actions will have to be re-submitted once the Agency re-opens. Therefore, we do not recommend making any electronic submissions via CDX, until the Agency reopens.

In addition to the shutdown, the Pesticide Registration Improvement Act (PRIA 3) expired on December 21, 2018.  Any new submissions received after that date will not be subject to PRIA time frames and the registration service fee will be reduced by 70% from the current levels.  While there are plans to extend PRIA 3 through September 30, 2019, until this is completed, Exponent does not recommend making submissions that are typically subject to PRIA since they will not have assigned timelines.

There is also the potential for State actions that are dependent on EPA review or input to also be delayed. Examples include but are not limited to State-issued documents that require or typically rely on EPA peer review.

How Can Exponent Help?

Exponent is prepared to help clients navigate the complexities associated with responding to the current fluid regulatory environment. We continue to support clients through the shutdown, working to obtain the best outcome for their needs and strategic planning for actions companies should take upon the re-opening of the EPA.

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