Lynn L. Bergeson and Richard E. Engler, Ph.D., Quoted By Bloomberg BNA Daily Environment Report Regarding EPA Review Process For New Chemicals
On April 3, 2018, Lynn L. Bergeson, President, The Acta Group (Acta®), and Richard E. Engler, Ph.D., Senior Chemist with Acta, were quoted by the Bloomberg BNA Daily Environment Report in the article “EPA Aims for Predictable Chemical Reviews, Director Says.”
Richard Engler—a senior chemist with Bergeson & Campbell, P.C.—and Lynn L. Bergeson, managing partner of that same law firm, described some specific types of problems they would like the agency to address.
Since 2016, the agency has encouraged companies to meet with EPA officials before they submit their pre-manufacture requests (PMNs) to make new chemicals.
The new chemicals program uses computer models to predict toxicity and exposures, and its analyses depend on presumptions—for example, conclusions about the extent to which a worker may be exposed to a chemical during various tasks— and mathematical analyses about ways chemicals move through the environment, said Engler, who formerly reviewed new chemicals during his 17 years at the agency.
Agency contractors do a lot of the initial analyses, and mistakes occur, he said. The initial analysis, for example, may inaccurately estimate how quickly or slowly a new chemical could move in air or water, Engler said.
“There are always going to be errors,” he said. “The question is: When do you catch them?”
Since TSCA was amended, the chemical office’s workload exploded, and many career staff retired or moved on, opening up the program to less experienced staff, some of whom have been detailed just for a few months, Engler said.
With less time, less experience, and new responsibilities, the EPA staff that oversee the contractors’ work fail to catch mistakes, he said.
Product managers with the chemical maker or agency officials eventually find them, but that delays and complicates the review, Engler said.
Resolving divergent scientific perspectives on whether or not something is an error is made harder because company scientists are typically not allowed to speak with agency scientists, he said. Instead, most exchanges are filtered through a program manager who is familiar with the process, but may not understand the specific science at issue.
The result can be rounds of telephone tag with repeated written requests, miscommunications, and misunderstandings, he added.
If the company and agency scientists were allowed to talk directly to each other that could save time, Engler said.
The EPA in December released two draft documents that could help resolve challenges if they were finalized, Bergeson said. They are New Chemicals Decision-Making Framework and New Chemicals Decision Guidelines Manual—Detailed Outline.
Final documents that clearly lay out what is needed, why, and how the office will consider the information could be useful in promoting predictability, she said.
See – http://news.bna.com/deln/display/split_display.adp?fedfid=131056908&vname=dennotallissues&wsn=499922000&scm=DELNWB (subscription required)