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By Pat Rizzuto
July 15 — Manufacturers of new chemicals should give the Environmental Protection Agency strategic, detailed notices about exposures and properties to boost their market chances following changes to the U.S. chemicals law, industry advisors say.
Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed,” Lynn Bergeson, managing partner of Bergeson & Campbell PC, said during a July 14 webinar the firm organized.
Ernie Rosenberg, president and chief executive officer of the American Cleaning Institute, told Bloomberg BNA July 15 that new chemical manufacturers are asking for trouble if they submit a notification without first checking how analogous chemicals are regulated in Australia, Canada, the European Union and elsewhere.
Richard Dension, lead senior scientist with the Environmental Defense Fund, said the changes the amended law makes to EPA's new chemicals program “are not trivial.”
The changes will make it easier for the public to understand why EPA concludes that new chemicals may or may not enter commerce; what restrictions it may impose on the uses of those chemicals and why, he said during the Bergeson & Campbell webinar.
Martha Marrapese, an attorney with Keller and Heckman LLP, said the amended Toxic Substances Control Act makes it easier for the EPA to ask manufacturers to provide more information.
The amended law also makes it easier for the EPA to impose restrictions on the potential uses of a new chemical, Marrapese said during a July 13 Keller and Heckman webinar.
The good news is that companies that provide the EPA with sufficient exposure, toxicity or physical-chemical information to convince the agency the new chemical would meet the law's safety standard can make or import their new chemical before the 90-day review period is over, Marrapese said.
Under the previous version of TSCA, chemical manufacturers had to wait 90 days to make a new chemical, even if it raised no concerns for the EPA, she said.
As amended June 22 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. Law No. 114-182), TSCA now allows companies to commence manufacture of a new chemical as soon as they receive a letter or other notification from EPA stating it has concluded the compound is not likely to present an unreasonable risk, Marrapese said.
She referred to one of the explicit decisions the Lautenberg Act requires the EPA to make as it reviews new chemicals.
For example, the agency's risk evaluation must focus on the chemicals “conditions of use.”
The EPA also must determine whether the new chemical would pose an unreasonable risk to “potentially exposed or susceptible subpopulations.”
Bergeson, Marrapese and Rosenberg discussed the implications of these new decisions and criteria and the impact they may have on the chemical industry's ability to innovate new products.
Both the old and newly amended TSCA say the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson said, referring to Section 2601(b)(3).
The new law makes “very consequential changes” to the new chemicals provisions of TSCA as the EPA will have to carefully balance the requirements imposed by different sections of the law, she said.
Rosenberg, who years ago helped manage the agency's new chemicals program, said the EPA has always been sensitive to the importance of innovation as it reviews new chemicals.
The amended law does impose additional decision-making criteria on the EPA, he said.
The new criteria in the law mean chemical manufacturers will have to use evidence to back their assumptions, Rosenberg said.
Many of the EPA's potential concerns may be addressed by citing exposure data, such as information that would show a compound's molecular structure would not migrate from a car bumper or baby's teething ring, he said.
Manufacturers may need to search for data on similar chemicals, and will have to tap chemical databases from around the world, Rosenberg said.
Manufacturers also should check whether an analogous chemical has had its uses restricted in another country, he said.
“Everyone will be looking much more carefully. They'll want EPA to make the finding that their chemical is likely to meet the safety standard,” Rosenberg said.
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