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By Pat Rizzuto
Sept. 27 —
Chemical manufacturers are getting heartburn with the ways the Environmental Protection Agency is handling the new chemicals in commerce provisions of the amended chemicals law, according to attorneys who spoke with Bloomberg BNA.
John Dubeck, a chemical engineer and attorney in Keller & Heckman’s Washington office, said: “Business plans are being threatened and upended, all without any notice that the changes to EPA’s new chemical review process would be so significant.”
Many more stumbling blocks may emerge as the Environmental Protection Agency prepares four regulatory proposals and other materials needed to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182), which amended the Toxic Substances Control Act June 22.
The Lautenberg Act’s initial implementation is causing discomfort, according to Richard Denison, senior scientist with the Environmental Defense Fund in Washington, and Mike Walls, from the American Chemistry Council. Both men—whose organizations pushed for TSCA reform—urged all parties at a Sept. 22 forum held by the George Washington University to continue the cooperation that led to the Lautenberg Act’s passage.
Sen. Tom Udall (D-N.M.), who introduced the Lautenberg Act with Sen. David Vitter (R-La.), said: “I’m very hopeful that all sides of this will stay on their best behavior to make sure we can implement the law effectively.”
So far the EPA is off to a good start and continuing to involve a broad array of stakeholders as it carries out its responsibilities under the new law, Udall said at the forum.
“We cannot let this effort fall apart like it did after TSCA passed in 1976,” Udall said.
Sept. 19 marked the first milestone of EPA’s implementation of the new law. Ninety days had passed since President Barack Obama signed the Lautenberg Act into law.
The date is a milestone, because both the original and amended TSCA give the EPA 90 days to review new chemicals. That means by Sept. 19 the agency had to make calls on the 334 new chemicals it said it was reviewing when the law went into effect.
Since Sept. 19, attorneys and other industry representatives have shared their experiences with the changes the Lautenberg Act has brought to the EPA’s new chemicals program in conversations and e-mails with Bloomberg BNA.
As of Sept. 21, the agency had announced on its website that 24 new chemicals and new microorganisms could enter the U.S. market, because they would not be likely to present an unreasonable risk. That’s the most favorable finding for companies that the agency can make under the law. Less public were the letters that companies began to receive.
“EPA has affirmatively approved only a handful of PMNs [premanufacture notices] and is requesting additional review time and/or is seeking additional toxicological or ecotoxicological data on numerous other PMN cases,” Tom Berger, an attorney focused on rulemakings with Keller and Heckman’s LLP Indianapolis office, told Bloomberg BNA.
Chemical manufacturers must submit PMNs 90 days prior to wanting to introduce a new chemical into U.S. commerce. The same requirement applies for new microorganisms, although that notice requires manufacturers to submit a microbial commercial activity notice, or MCAN.
The agency had been planning—prior to the Lautenberg Act—to allow a number of new chemicals to enter commerce and now it is requesting more toxicity data, Berger said.
Dan Newton, senior government relations manager at the Society of Chemical Manufacturers and Affiliates, said the small chemical makers his trade association represented also had received EPA requests to extend the time the agency has to review the new chemicals they submitted. The society relies on timely responses to its members’ notices from EPA so they can produce customized batches of often unique chemistries.
Richard Engler, a former EPA chemist now working with the Bergeson & Campbell, P.C., said that law firm already has voluntarily agreed to extend the EPA’s review time for new chemicals it was evaluating.
He said he also anticipates agency requests for more data, and he expects the agency will restrict uses of new chemicals more often than it did before the Lautenberg Act became law. The agency can impose restrictions through consent orders it develops with the original manufacture of a substance and through various types of significant new use rules, or SNURs, that it can issue. Typically SNURs bind other chemical manufacturers to restrictions the original maker of a chemical agreed to.
“TSCA reform,” Berger said, “has not put an end to protracted, sometimes multi-year, PMN review periods.”
Chemical makers can choose not to voluntarily extend the EPA’s 90-day review period, Berger said. Doing so, however, triggers a process that can lead to use and other restrictions of the new chemical, he said.
Those restrictions also will be crafted using worst case assumptions the agency makes unless it receives scientific data that would refine those presumptions, Berger said.
Chemical manufacturers are reporting other early effects under the amended TSCA as well as decisions the agency appears to have made even prior to the Lautenberg Act becoming law, other Keller and Heckman attorneys told Bloomberg BNA.
Martha Marrapese, an attorney at that law firm, pointed to a four-page list of questions she said the EPA is now asking companies to answer to substantiate any claims they assert that certain information should not be released to the public because it is a trade secret.
She described the agency’s requirements for confidential business information claim as a “hard line” interpretation of the Lautenberg Act’s substantiation requirements.
David Sarvadi, a partner at Keller and Heckman’s Washington office who focuses on chemical management, described a change he said occurred shortly before the Lautenberg Act.
The agency has long allowed some chemicals to be made or imported without requiring premanufacture notices provided the chemicals meet specific criteria, such as production levels of 10,000 kilograms a year or less.
“EPA apparently decided that no substances that triggered concerns for PBT classification—even if solely on the basis of EPA’s computer structure activity relationship analysis—would be eligible for low-volume exemptions,” Sarvadi said. PBTs are persistent, bioaccumulative and toxic chemicals.
“This decision was made without notice to the regulated community, as are many of the decisions now affecting PMNs,” Sarvadi said.
Attorney Dubeck summarized what his law firm’s team is seeing with respect to the EPA’s new chemicals oversight.
“The fact that these consequences were never identified during the long legislative process strongly suggests they are neither necessary nor intended. Indeed, throughout the legislative process there was a general recognition that the new chemicals program was working well,” he said.
Denison, from the Environmental Defense Fund, said the new law revised how new chemicals get evaluated and required the agency—for the first time—to make a specific finding about the risks a new chemical would pose before that substance could enter the market.
Previously, if the EPA took no action, a new chemical could be put on the market 90 days after its manufacturer filed its premanufacture notice.
When the agency took action, such as requiring additional data prior to manufacture or to limiting production methods in some way, the concerns the agency had that prompted those actions and the specific restrictions were frequently kept confidential, outside of public view.
The Lautenberg Act requires the EPA to use specific new criteria, such as potential risks to workers or children, to evaluate new chemicals, and it requires the agency to release its findings to the public, Denison said. The 90-day time frame the agency has to review new chemicals didn’t change, he said.
There was no time cushion between the law’s passage and its effective date, Denison said. “That’s going to pose significant growing pains for everyone.”
Walls, from the American Chemistry Council, told Bloomberg BNA he agrees the lack of a transition between the Lautenberg Act’s passage and its effective date is a challenge for the agency and regulated parties.
Yet Walls said he heard a positive signal from the agency during the university forum discussion when Wendy Cleland-Hamnett, director of the EPA’s Office of Pollution Prevention and Toxics, said her office is open to revising some of the new procedures it is implementing.
The office that regulates chemicals, had to “hit the ground running” and figure out how to make the findings required by the Lautenberg Act, how to implement its requirements that companies substantiate confidential business information claims, how to keep track of claims it substantiates, and figure out what to tell companies about their new chemicals 90 days after the law was enacted, Cleland-Hamnett said.
It has developed procedures to accomplish those tasks, but “we’ll be continuing to refine those procedures,” she said.
The agency’s workload won’t slacken anytime soon.
By December, the agency plans to propose risk management actions to control excess risks for three chemicals, Cleland Hamnett said. The proposed rules would address worker and consumer risks for certain narrow uses of trichloroethylene (TCE), n-methylpyrrolidone (NMP) and methylene chloride.
The agency also is working on four Lautenberg Act implementation rules that it also aims to propose by the end of December. Several related tasks also have December deadlines.
The agency invited early comments on three of the four implementation rules. Those three the agency has accepted comment on would: describe how the agency will select high-priority chemicals that must have their risks evaluated; describe how the agency will evaluate chemical risks; and propose fees industry would pay to help it recoup some of its expenditures required to review their products.
Trade associations and law firms also have been submitting comments on the fourth implementation rule: the process the EPA will use to divide the TSCA inventory into two parts: an active inventory of chemicals in commerce and inactive inventory of those that were, but no longer are. The rule will describe the process chemical manufacturers would have to use to move a chemical from the inactive to the active list.
The agency’s fall workload is “a pretty heavy lift,” Cleland-Hamnett said and the agency is lifting that load without additional resources. The agency’s chemicals management budget is about $56 million in fiscal year 2016, which ends Oct. 1.
Staff from other offices have been temporarily detailed to the pollution prevention and toxics office, but new staff and contractors are needed, Cleland-Hamnett said.
With less than a week before the fiscal year ends, Congress has yet to agree on next year’s appropriations.
Udall said a continuing resolution could be a straitjacket for the agency as it works to implement the Lautenberg Act. However, Senate Majority Leader Mitch McConnell (R-Ky.) Sept. 22 sent a signal showing his commitment to supporting $3 million in new funding for EPA’s chemicals work during discussion of a continuing budget resolution, Udall said. The White House had requested $4 million for that purpose.
Cleland-Hamnett said the agency wants to finish crafting its regulatory proposals, so that the team the next administration brings in can read public comments and issue final rules, she said.
Three of the Lautenberg Act’s implementation rules must be issued as final rules by June 2017.
Blake Morant, dean of the George Washington University Law School, said a new administration poses a particular challenge for the EPA’s implementation of the new law.
“How do you get new administrators to treat this as a very important part of their agenda?,” Morant asked, before he and Udall offered some suggestions.
Organizations with access to the candidates’ inner circles can discuss reasons the new chemicals law is important, Morant said. He urged them to highlight the law’s bipartisan development and passage.
Udall said interested parties can put forward names of individuals to serve at the EPA and its chemicals office that could be accepted by the regulated community and environmental health advocates.
EPA’s staff will continue to implement the amended law during the next administration’s initial months in office, said Lynn Goldman, dean of George Washington University’s School of Public Health.
It seems to take the Senate twice as long to clear political appointees as it did in the 1990s, said Goldman, who served as assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention from 1993 to 1998 under President Bill Clinton.
Walls, from the American Chemistry Council, said litigation of final decisions the EPA will make under the Lautenberg Act is likely.
Litigation results because people have different interpretations of the law, it is not an indication of failure, he said.
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