EPA Developing Guidance for New Chemical Submissions 

JUNE 15, 2017

EPA’s Director for the Office of Pollution Prevention and Toxics (OPPT) Jeffrey Morris told participants on a recent webinar that the Agency is developing guidance for new chemical, pre-manufacture notification (PMN) submissions and hopes to release it this fall.

The guidance is intended to streamline the review process by instructing chemical manufacturers what specific data sets and information are necessary for a quick resolution and determination that the chemical presents or does not present an unreasonable risk to human health and/or the environment.

EPA hopes the guidance documents will virtually eliminate the well-publicized backlog of pending new chemical applications.

Morris previously stated the Agency is working to clear that backlog of PMNs by this July that it is largely attributable to the June 2016 TSCA amendments that mandate the Agency must make an affirmative safety finding before approving a new chemical.

Under the “old” TSCA, EPA could simply allow the 90-day review period for a PMN to run out and then the manufacturer would be allowed to commercialize the substance.

Under the “new” TSCA, EPA must make a determination that the chemical presents an unreasonable risk of injury to human health or the environment, that the Agency has insufficient information to make such a determination, or that the chemical is not likely to present an unreasonable risk.

EPA said the affirmative determination mandate requires more resources and has created the backlog of PMNs. There were 600 PMNs pending at the end of 2016, but the number has dropped to 150 in May.

While there is still a significant number of pending PMNs, it is welcome news for manufacturers and processors, including ILMA members, that the Agency is working through the process more quickly than before.

Despite cuts called for in President Trump’s 2018 budget proposal for most EPA offices, OPPT is slated for a nearly $7 million increase in funds to further assist with implementation of the TSCA amendments.