Controversy Continues on EPA's Stance on New Chemicals

In implementing the amended TSCA, the EPA has apparently turned its default assumption toward new chemicals upside down, interpreting it as requiring the agency to block manufacture in the absence of definitive evidence that a substance is safe rather than allowing it to proceed unless there is evidence of potential risk.

In opinion pieces in this month's Global Business Briefing, advocates on opposite sides of the issue agree on that, but clash on whether this was what Congress intended and on whether it's a positive development.

Attorney Jamie Conrad, formerly an assistant general counsel at the American Chemistry Council, argues that the 2016 Lautenberg Act did not intend to shift the EPA's "null hypothesis," and the new regime is slowing the approval process to a crawl and stifling innovation. Meanwhile, Richard Denison, lead senior scientist at NGO the Environmental Defense Fund, contends that the agency is implementing the new TSCA correctly, and it is a long overdue change needed to restore public confidence.

The key TSCA provisions require the EPA to publish an affirmative "determination" that a new chemical is unlikely to pose an unreasonable risk before it can be manufactured commercially and that the agency consider the "reasonably foreseen" uses of a new chemical. The latter provision has essentially eliminated the use of "non-5(e) Snurs," which the EPA used to issue when it determined that the specific conditions of use and precautions described in a PMN would not pose an unreasonable risk, but for which additional uses may be concerning. In these cases, the agency would ‘drop’ the PMN, allowing the substance to be marketed. The new requirement of an affirmative finding has changed EPA's policy to impose consent orders on the original submitter to address potentially foreseen uses, even if they are not named in the PMN.

While "it must now 'determine' that a new chemical is unlikely to pose an unreasonable risk before it can allow unrestricted manufacture," Mr Conrad writes, "the EPA was effectively making that determination whenever it ‘dropped’ its review of a PMN, or lifted an order after submission of needed information. The agency probably gives these determinations more attention now that it has to publish them. But it is not required to make them any differently."

When EPA 'lacks evidence'

Mr Conrad contends that when EPA lacks the evidence to determine that a substance is definitively safe or unsafe under all conceivable circumstances, the agency can "make these determinations on the basis of the weight of the best available scientific evidence."

He argues that impeding the marketing of new chemicals will prevent improved, possibly more environmentally friendly, substances from replacing older ones and could give nations like China an economic and technological advantage.

Dr Denison, however, concludes that "the EPA’s implementation to date of the changes to new chemical reviews is not only consistent with the new law, but is mandated by it." Moreover, he contends that the current slowdown in approvals will abate once new procedures are established within the EPA and manufacturers adapt by providing more risk data along with PMNs.

Chemicals