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WASHINGTON — The Environmental Protection Agency is shifting course under the Trump administration on how it assesses new chemicals for health and environmental hazards, streamlining a safety review process that industry leaders say is too slow and cumbersome.
But some former EPA officials, as well as experts and advocates, say the agency is skipping vital steps that protect the public from hazardous chemicals that consumers have never used before, undermining new laws and regulations that Congress passed with overwhelming bipartisan support in 2016.
According to these critics, that could mean that manufacturers might get approval to introduce a new chemical for one purpose, without getting a thorough, timely review of the chemical’s safety if it is later used for a different purpose. Asbestos, for example, was commonly used in building insulation before the EPA cracked down on its use, but the carcinogenic chemical is still found in brake pads for automobiles — posing hazards for garage mechanics — and is widely used to manufacture chlorine.
In recent months, the EPA has quietly overhauled its process for determining whether new chemicals — used in everything from household cleaners and industrial manufacturing to children’s toys — pose a serious risk to human health or the environment. Among other changes, the agency will no longer require that manufacturers who want to produce new, potentially hazardous chemicals sign legal agreements that restrict their use under certain conditions.
Such agreements, known as consent orders, will still be required if the EPA believes that the manufacturer’s intended use for a new chemical poses a risk to the public health and the environment. But the agency won’t require consent orders when it believes there are risks associated with “reasonably foreseen” uses of the new chemical — ones that go beyond what a manufacturer says it’s intending to do, but which the agency believes are reasonable to anticipate in the future.
Instead the EPA will rely on a broader measure, known as significant new-use rules, to regulate chemicals that are likely to pose a risk if they're used for a different purpose. The agency typically has to issue these rules whenever they want to restrict the broad use of potentially hazardous chemicals, since consent orders apply only to a single manufacturer.
Eliminating consent orders in these cases would be “more efficient,” said Jeff Morris, director of the EPA’s toxics program. He laid out the agency’s shift to significant new use rules at a public meeting in early December: “It’s our belief that they could be equally protective but eliminate this one step.”
Chemical industry lobbyists had pushed for the change, arguing that the EPA’s rising use of consent orders was unwarranted. Chemical manufacturers “are burdened by the delay of waiting for EPA to draft the orders, negotiating them with EPA, and then waiting for EPA to issue the orders,” the American Chemistry Council, the industry’s largest trade association, told the agency days before President Donald Trump took office.
But consumer advocates, along with some former agency officials and research experts, believe that EPA’s moves are sabotaging a safety review process that Congress had taken great pains to bolster. Richard Denison of the Environmental Defense Fund, an advocacy group, points out that the 2016 law requires the EPA to assess the broad use of chemicals because manufacturers frequently find different uses for hazardous substances over time, as in the use of asbestos.
“EPA is explicitly disavowing and downplaying a tool that’s really been a cornerstone of new chemical regulation,” said Bob Sussman, a former EPA attorney under Obama and counsel for the Safer Chemicals, Healthy Families coalition, which represents environmental and public health advocates. “We believe EPA is taking a big step backward in the protection of health and the environment without an offsetting benefit.”
'Playing a dangerous game'
Under EPA administrator Scott Pruitt’s leadership, the agency has taken major industry-friendly steps to loosen its regulation of legacy chemicals. Last year, the EPA delayed bans on chemicals already in widespread use, including a lethal substance in paint strippers and a pesticide linked to developmental disabilities in children.
But the agency is also overhauling its process of reviewing new, unproven chemicals that have yet to hit the marketplace. The changes come in the wake of intense lobbying by the chemical industry, which complained that the EPA was taking too long to clear innovative new products for commercial use that the industry considered safe.
"We were very concerned as an industry — that was one of our top priorities when I talked to the administration," said Robert Helminiak, a lobbyist for the Society of Chemical Manufacturers and Affiliates, who met with Pruitt last year.
When the Trump administration took office, the EPA was facing a serious backlog of new chemicals awaiting safety reviews. About 600 cases had piled up after Congress approved the sweeping reforms to the 1976 Toxic Substances Control Act (TSCA), which passed in June 2016 after decades of deliberation and was called the Frank R. Lautenberg Chemical Safety for the 21st Century Act, after the Democratic senator from New Jersey.
For the first time, the EPA under the act was required to make an explicit determination that a new chemical was safe before it could be sold to consumers, using stricter criteria to evaluate their health and environmental risks. The new law also required the EPA to evaluate the risks of chemicals already in commercial use, by specific deadlines.
At the urging of industry, Pruitt promised to expedite the post-Lautenberg review process for new chemicals “to make the process faster and more efficient, while ensuring chemical safety." With great fanfare, he announced the EPA had cleared its backlog in August and unveiled its early reforms to the safety review process.
But some public-health experts and former officials say that the EPA's efforts to streamline the program are undermining its newly expanded authority to require testing when it believes there is insufficient data, or when future uses may pose a risk.
“What I’m observing is an effort by the agency and also some in the industry to turn back the clock and behave as though the Lautenberg Act was never passed in the first place,” said Lynn Goldman, dean of George Washington University’s school of public health and a former EPA official under Clinton. “The agency has been granted more authority to do testing, then it put hands in its pockets and said it doesn’t want to use this authority.”
Critics say there’s a big difference between the consent orders they want the EPA to issue and the agency’s proposed alternative. Consent orders often include mandatory testing of new chemicals for potential health and environmental hazards. By contrast, significant new-use rules typically don’t require testing, though they can recommend that it should happen in the future if a manufacturer wants to use a restricted chemical.
At that point, however, the harm may have already been done, says Veena Singla, an environmental health researcher at the University of California, San Francisco. “Chemicals do end up being used for many different applications than what the manufacturer originally thought or intended,” she said. “After the fact, we’ve seen what the problem is: The chemical is out there.”
The Trump administration says that its safety reviews will be just as robust under its changes to the program. If a manufacturer wants to use a chemical for a new purpose that might be risky — say, by putting the substance in water — it’s still legally required to seek the EPA’s approval if there are significant new-use restrictions in place. The EPA can then mandate more testing at that point, said Morris: “The end result is that there would be the same amount of testing.”
But public-health advocates say there’s no guarantee that the EPA will require the same testing further down the line, arguing that consent orders provide far more assurance that the agency is properly scrutinizing toxic substances. They now fear that the EPA will go even further to relax the law: The agency is currently deciding whether it will allow manufacturers to commercialize new chemicals while it is still hammering out the rules restricting future, reasonably foreseen uses — something that industry groups are currently pushing for.
If the EPA lets these chemicals on the marketplace early, then it will be “blatantly violating the law” that Congress passed to tighten these safety reviews, said Sen. Tom Udall, D-N.M., who co-authored the Lautenberg Act and help push it into law after Lautenberg’s death in 2013.
The new law requires the EPA “to review the safety of all uses of a new, and potentially dangerous, chemical before allowing it to be sold to consumers, not just selective uses,” said Sen. Tom Carper, D-Del., the top-ranking Democrat on the Senate Environment and Public Works Committee. If the agency allows a chemical to be sold before putting all its restrictions into place, that “contradicts the spirit and letter of the law,” he added.
“This may please Pruitt’s corporate allies, but it is playing a dangerous game, with the safety of millions of Americans at stake,” Udall said.
Consumer advocates say that it’s critical for the EPA to be aggressive about putting the 2016 law into effect, given the agency's past failures to protect the public from toxic chemicals.
Older flame retardants linked to cancer were phased out in the 1970s, only to be replaced by new flame retardants that were also linked to cancer, hormone disruption and development problems, despite passing the EPA’s safety review process.
Other “regrettable substitutions” include bisphenol-S, which was intended to be a safe replacement for BPA; and GenX, a substitute for a carcinogenic substance used to make Teflon, only to be later linked to cancer as well. Right before Trump took office, the federal government agreed to pay more than $2 billion to veterans who developed leukemia, liver cancer and Parkinson’s disease after exposure to water contaminated with trichloroethylene and other chemicals at a North Carolina military base.
Such horror stories helped build broad bipartisan support for the 2016 overhaul, which Congress passed on a nearly unanimous vote. Under the old regime, the EPA didn’t have to sign off on new chemicals if it concluded that they were likely to be safe. If the manufacturer never heard anything from the agency within 90 days, it could go ahead and start making its new product. Under the new law, the EPA has to make an affirmative decision that a new chemical is safe before it can be commercialized — the crux of its new safety review process.
Getting to market sooner
The chemical industry, however, insists that the 2016 overhaul was never intended to make radical reforms across the board. The new law “really doesn’t do very much for new chemicals — the process was the part of TSCA that was really working pretty well,” Helminiak said.
Before the EPA had unveiled its Trump-era changes, industry groups argued that the agency was taking a needlessly draconian approach toward new chemicals reviews, requiring consent orders where none were necessary. When a manufacturer wants the EPA to approve a new chemical, it describes its intended use for the substance. So the EPA “accomplishes nothing useful” by subjecting them to consent orders for other purposes they have no intention of pursuing, the American Chemistry Council (ACC) said in January. Instead, it would simply burden manufacturers with onerous testing requirements and other conditions that make it harder for them to sell innovative new products, industry groups said.
The EPA’s new approach is likely to reduce the testing that manufacturers who first bring these new chemicals to market are required to do. Using significant new-use rules (SNURs) “reduces the testing that the EPA is seeking to impose, because testing is rarely required in a SNUR,” said Richard Engler, a former EPA scientist who now works for Bergeson & Campbell, a law firm that represents chemical manufacturers. “If someone is of the view that every consent order should have testing in it, then yes, switching to SNURs is going to produce less data,” Engler said, though he believes EPA’s new approach will be just as protective.
But industry groups say the agency still hasn’t gone far enough to speed up the safety review process, warning that the latest reforms could bring their own delays.
Significant new-use rules can take far longer to finalize than consent orders, since they are regulations subject to a public notice and comment period. If the EPA determines that a new chemical is safe for its intended use, a manufacturer should be able to start making and selling that product immediately, without waiting for the EPA to finalize its new rules for separate, reasonably foreseeable uses, said the ACC’s Michael Walls: “There’s got to be a way to get to market earlier.”
Denison of the Environmental Defense Fund warns the EPA against giving the green light too early. Even if a company sticks to the use of a chemical that the agency has deemed safe, it can’t predict what other parties might do with it once it’s on the market, said Denison: “Companies say they can’t control how chemicals are being used.”
‘This EPA has worked very well with industry’
The EPA says that it’s still deliberating how long manufacturers will have to wait to bring their new chemicals to market. “This is an area that we are discussing,” Morris said in December.
Consumer advocates fear the EPA will ultimately heed industry's call. Under the new administration, industry heavyweights have been able to appeal directly to their former colleagues: Trump appointee Nancy Beck, a former senior executive at the ACC, is now a top deputy for the EPA’s chemical safety office. Trump’s nominee to lead the office, Michael Dourson, spent decades conducting industry-friendly research for the ACC and Dow Chemical, among others. He worked as a senior EPA adviser for months before withdrawing his nomination in December, under fire for his industry ties.
In recent months, the agency has worked closely with the ACC to revamp the paperwork that manufacturers must submit to get new chemicals approved. With the group's help, the EPA consulted three industry giants — Dow Chemical, Procter & Gamble, and the BASF Corporation — to revise its new chemical application process.
“It’s always important to get feedback from companies using the document,” David Tobias, an EPA scientist, said at the agency’s December meeting. “We’ve already made some changes based on this consultation.” (The EPA declined to specify the changes it's made and said it is working with “a variety of stakeholders” on the new chemicals program.)
Industry groups say they’re hardly getting a free pass: From their perspective, the EPA hasn’t hesitated to tighten its scrutiny of new chemicals, placing more stringent restrictions on their use and expanding the scope of their reviews. But they acknowledge that Pruitt’s EPA has been receptive to their concerns.
“This EPA has worked very well with industry,” Helminiak said. “They really have certainly listened to what the specialty chemical industry has to say.”
CORRECTION (11:30 a.m., Jan. 17, 2018): An earlier version of this article misstated a chemical that was considered a "regrettable substitution" for another chemical by advocates. It was bisphenol-S that replaced BPA, not the other way around. The article also misstated the chemical that contaminated a North Carolina military base. It was trichloroethylene, not GenX.