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By Pat Rizzuto
July 21 — Large chemical manufacturers may have a near-term advantage over smaller companies when filing requests to make new chemicals under the amended Toxic Substances Control Act, a policy analyst and attorneys said.
Over time, however, the chemical-specific data that large manufacturers will have more resources to provide should improve the agency's chemical assessments, Dan Newton, senior manager for government relations at the Society of Chemical Manufacturers and Affiliates (SOCMA), Jamie Conrad of Conrad Law & Policy Counsel and Herb Estreicher, a partner with Keller and Heckman LLP, told Bloomberg BNA July 20 and 21.
During webinars and subsequent e-mail exchanges with Bloomberg BNA, Newton, Conrad and Estreicher discussed changes to TSCA made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. Law No. 114–182), which the president signed into law June 22.
The Environmental Protection Agency “has more authority to get data” under the amended law, Newton told participants July 20 during a SOCMA webinar.
“You can expect greater emphasis on exposures and downstream uses,” he said. “It's very important to know how your customers are handling your chemicals. EPA likely will be looking for more data about foreseeable uses.”
Chemical manufacturers will “have to make the case up front that your chemical is safe or you may run into regulatory scrutiny,” Estreicher said July 21 during a webinar organized by the American National Standards Institute's Network on Chemical Regulation.
Smaller chemical manufacturers will find this more challenging than large manufacturers, because they have fewer resources to invest in finding, generating and analyzing data, Estreicher told Bloomberg BNA after the network's webinar.
As the amount of data submitted to EPA increases, however, the agency's ability to use “read across” methods will improve, and that will benefit small and large chemical manufacturers, Newton said during SOCMA's webinar. Read across refers to methods that allow analysts to apply toxicity and physico-chemical data from one chemical to a similar chemical that lacks that type of data.
As manufacturers submit data demonstrating their chemicals' safety, the EPA will get more “negative” data than it would typically find in scientific literature, Newton said. He referred to the tendency of scientific journals to publish studies with “positive” results, meaning a chemical caused some kind of problem.
Estreicher agreed that, over time, the body of data chemical manufacturers submit will improve the information the EPA has on chemicals generally, and that will improve the agency's assessments of both new chemicals and ones already in commerce.
The information the EPA needs most urgently is exposure data, he told Bloomberg BNA.
Conrad, from Conrad Law & Policy Counsel, had a slightly different take on the question of whether large chemical manufacturers would have an advantage over smaller ones when it comes to the data EPA can order to be submitted under the TSCA amendments of 2016.
In general, size gives an advantage when it comes to generating more information, Conrad told Bloomberg BNA after SOCMA's webinar.
Small manufacturers, however, are often inventing molecules for particular markets rather than trying to maximize sales broadly, he said. If a new chemical would likely have only a few applications, the EPA won't need as much information as it would for a new chemical with many different potential uses.
That means a small chemical manufacturer could get a large return on its investment in gathering the data it needs the EPA to assess about its particular chemical, Conrad said.
“I think smaller manufacturers may always have a bit of a market opportunity in that inventing a new molecule for somebody may not make the return for investment target that a big company has for any new project,” Conrad said. “It’s a bit like the niche that community banks have over the big money center banks.”
He and Newton offered some “good news” about the Lautenberg Act when they each made presentations during SOCMA's webinar.
The Lautenberg Act doesn't prescribe a minimum data requirement for new chemicals, they said.
“It’s a much better situation under the new law than would have been obtained under the `minimum data set' that non-governmental organizations had been pushing for initially,” Conrad said.
Chemical laws in other parts of the world, notably the European Union's registration, evaluation, authorization and restriction of chemicals (REACH) law, require companies to provide regulatory authorities with specific toxicity and other data—a “minimum data set”—before the companies can manufacture more than a specific small volume established under those laws.
Newton said other “good news,” in the Lautenberg Act is that it maintained TSCA's traditional 90-day review period for new chemicals. The term “new chemical” refers to a chemical that isn't on the TSCA inventory of chemicals that have already been made or sold in the United States.
Chemical manufacturers that would like to make or import a new chemical submit a pre-manufacture notice, or PMN, to the EPA. The agency has 90 days to review those notices. As under the original TSCA, the agency can extend that deadline for “good cause,” Newton said.
A beneficial change of the new law is that chemical manufacturers, which will have to pay a yet-to-be-determined fee for the agency to process their pre-manufacture notice, can get their money back if the EPA fails to make a decision within the 90 days or within the extended deadline that a company agrees to, Newton said.
Even if it gives the money back, the EPA has to make a decision about the new chemical, according to the Lautenberg Act (15 U.S.C. Ch. 53 §2604).
Neither Conrad nor Newton characterized any provisions of the Lautenberg Act as bad news for companies.
The effects of many provisions remain to be determined by the ways the EPA interprets them and implements the new law, they said.
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