By Pat Rizzuto
It is March madness in the chemicals arena as chemical makers, trade associations, lawyers and environmentalists scramble to shape how the EPA exercises new oversight over chemicals in commerce.
The continued availability of some commercial products, consumer confidence in chemical safety, and public health impacts hang in the balance as the Environmental Protection Agency shapes its review and control of chemicals, attorneys and environmental groups told Bloomberg BNA.
A wide swath of businesses and associations, along with environmental health groups, are preparing comments on 17 topics to help update the agency’s new mandate to more comprehensively identify and manage the risks posed by chemicals used by businesses and consumers.
EPA’s response to the comments will shape the implementation of a law passed last June that would overhaul what environmentalists have bemoaned as a lax national approach to tens of thousands of toxics in commerce and the environment.
The law may also tamp down a patchwork of state chemical labeling, disclosure rules and controls, which industry representatives said are difficult for national firms to comply with and may wrongly ban needed chemicals.
Given that chemical oversight before the new law passed has been limited, many companies and trade associations are for the first time grappling with a potentially confusing set of new government requirements and rules.
Thirteen of the 17 dockets the EPA has opened seek comments on proposed rules and risk reviews mandated by the Lautenberg Chemical Safety Act (LCSA), which overhauled the Toxic Substances Control Act. Another three dockets address proposed rules authorized by the amended law to restrict uses of three solvents.
“It’s not typical for an agency to be involved in this many rulemakings for the same statute at the same time. It’s an extraordinary burden on industry and EPA,” said Heidi McAuliffe, vice president for government affairs with the American Coatings Association, which is preparing comments for up to seven dockets.
“Every single one of those dockets addresses actions that will have a significant impact on our manufacturing processes,” McAuliffe said.
Four law firms contacted by Bloomberg BNA say they are able to file the comments they are preparing without hiring additional staff or contractors. Others say other aspects of TSCA’s implementation has prompted them to seek new hires. Lynn Bergeson, managing partner of Bergeson & Campbell PC in Washington, said that the firm may hire additional staff to address the backlog of hundreds of new chemical applications, called “premanufacture notices,” pending at the EPA.
The EPA’s implementation efforts are “the biggest thing to hit U.S. chemical regulations since the TSCA inventory was established” in the late 1970s, Irene Hantman, an attorney with Verdant Law PLLC told Bloomberg BNA. An existing or new potential client calls nearly every day to learn more and decide whether it too wants Verdant’s help submitting comments, Hantman said.
Three of the 17 dockets, known as the “framework rules,” address chemicals in commerce. These three rules would determine how the EPA would:
Retailers too are focusing on the framework rules because many of them make, distribute and sell house brands of chemical-intensive consumer products, said Peter Hsiao, an attorney with Morrison & Foerster LLP’s Los Angeles office. Hsiao heads his office’s Environment and Energy Group and its Green Products and Chemicals team.
Retailers—like other companies that purchase chemicals to make goods—want to make sure they will have access to needed chemicals, yet they also want to assure their customers the chemicals in their products are safe, he said.
Three dockets are open for comments about proposed restrictions on the use of three solvents—trichloroethylene, methylene chloride and n-methylpyrrolidone—based on risk assessments the agency completed prior to the new law’s passage. These proposed rules are the agency’s first attempt to use Section 6 of TSCA to restrict or ban a chemical in commerce since a pivotal legal decision in 1991, when the U.S. Court of Appeals for the Fifth Circuit overturned the agency’s 1989 effort to ban most uses of asbestos ( Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 33 ERC 1961 (5th Cir. 1991)). That case was widely perceived to undercut EPA’s nonpesticide chemical authorities.
The 17th docket addresses three new, generically named chemicals. The agency is proposing “significant new use rules” that would require companies making, or processors working with, any of the three chemicals to notify the EPA before they make or use the chemicals in a new way. All three chemicals entered commerce in 2015, before the most recent amendments.
McAuliffe said the American Coatings Association plans to ask the EPA to clarify how it will separate high or low priority compounds for risk reviews, among other issues.
The agency’s proposed prioritization rule appears to allow a chemical to remain indefinitely in limbo while the agency seeks more toxicity, exposure or other data without making a decision on whether it is a high or low priority, she said. Companies aren’t comfortable with a chemical staying indefinitely in the pre-prioritization phase, McAuliffe said.
The association’s members also want to know which tools and authorities the EPA will use to secure data during the pre-prioritization stage, she said.
The amended statute authorizes the EPA to obtain data through orders, consent agreements and rules. Members would like to know whether the agency plans to issue data collection rules, authorized by Section 8 of TSCA, or inspections and subpoenas authorized under Section 11, McAuliffe said.
Hantman said processors—companies that mix chemicals into products such as paints, waxes, glues, and cleaners without causing chemical reactions—need to focus on the inventory rule which will separate commercially active from dormant compounds.
“They must make sure all the chemicals that make up their raw materials are on the active inventory,” she said. Companies that make or use a chemical that would end up on the inactive inventory, would have to notify the EPA and get the chemical activated before they could work with the chemical.
The challenge, Hantman said, is that many processors haven’t paid much attention to their responsibilities under that proposed rule, because they don’t routinely focus on chemical regulations.
Environmental health, public health, labor and other organizations also are actively developing strategies to influence the EPA’s implementation of the amended chemicals law, in part by urging the agency to protect vulnerable groups such as children, the elderly and workers.
“We’re trying to cover as many dockets as we can,” Liz Hitchcock, legislative director for the Safer Chemicals, Healthy Families coalition told Bloomberg BNA. The coalition consists of about 450 organizations and businesses across the country.
Hitchcock said she is a “traffic cop” helping to coordinate a nationwide effort to urge strict new public health and environmental protections. Environmental health organizations also want the EPA to consider impacts chemicals have throughout their life cycle, including once they are disposed, Hitchcock said. They are urging the EPA to carefully weigh health and environmental concerns for vulnerable and exposed populations, Hitchcock wrote in a recent blog.
The Adhesive and Sealant Council—which also represents processors—is encouraging its members to submit comments and working with the American Chemistry Council (ACC) to submit joint comments, Mark Collatz, director of regulatory affairs for the adhesive council told Bloomberg BNA.
None of the risk evaluation dockets address impending rules, but it is “absolutely important” for processors to let the EPA know whether or not their product contains any of the 10 chemicals, he said.
The EPA has published “Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal” documents for each of the 10 chemicals with information it collected from databases, web searches and other sources. The EPA names companies that make—and products that contain—the chemicals based on the agency’s preliminary searches.
It’s a big data dump in which EPA is saying “here’s everything we found,” Collatz said.
Some companies may not make the listed product any more or may make it using a different formulation that no longer contains one of the 10 chemicals the agency is analyzing, he said. The council is urging its members to let the EPA know that, he said.
Conversely, if a company makes a formulation that contains one or more of the 10 chemicals, that company also should report the information to the agency even if the amount of the chemical is very small, Collatz said.
If companies don’t tell the EPA and the agency finds out the product contains the chemical, that could lead to increased scrutiny and perhaps a new use regulation, he said. Companies may have to go through some kind of evaluation, and that EPA evaluation could lead to strict new manufacturing or use controls, Collatz said.
Compiling use information is not easy, because companies often purchase chemical mixtures that perform some type of function in a final product. Paint and coatings manufacturers may not know what chemicals are in those mixtures because that’s another company’s proprietary information, McAuliffe said.
“The number of open dockets shows EPA’s substantial effort to stay on schedule while soliciting stakeholder participation and comment. ACC is committed to the effective implementation of the LCSA, and we are working hard to develop and offer industry comments for these dockets,” the council said.
Charles Franklin, an attorney working in the Washington office of Akin Gump Strauss Hauer & Feld LLP, said: “I do not recall an equivalent clustering of framework rulemaking proposals during the past 25 years, including the periods after passage of the 1992 Lead-Based Paint Hazard Reduction Act and the 1996 Food Quality Protection Act (FQPA)" that governs pesticides.
“The post-FQPA period is probably the closest analogy but, even then, the actions were more spread out—and EPA had significantly more staff and resources to meet its obligations,” Franklin told Bloomberg BNA by email.
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