Not ’Til the Fat Lady Sings: TSCA’s Next Act

The newly enacted revision to the failed chemical safety law marks a rare recent example of bipartisanship, but whether it will lead to improved environmental protection remains to be seen.

When President Obama signed the new chemical safety legislation into law on June 22, 2016, he formally ended decades of stalemate and conflict over whether and how to fix a broken system. He was also inaugurating an era—perhaps equally long—of sparring over how to ensure that the new statute actually does improve the regulation of chemicals.

The bill the president enacted, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, was the product of three years of tortuous, and often tortured, negotiations. Even its name was controversial. Advocates for and against the bill disagreed over whether the measure was a fitting legacy for Senator Lautenberg, who had long fought for greater environmental protection. (The senator’s widow was a dogged advocate for the bill, mostly behind the scenes.)

It was Sen. Lautenberg who, in 2013, jump-started the talks that led to the new law, which amends the 1976 Toxic Substances Control Act (TSCA). TSCA had been widely viewed as a broken statute for many years—the one foundational environmental law from the 1970s that had not worked. The Environmental Protection Agency (EPA) had reviewed just a few of the 80,000 or so chemicals that were already in use when TSCA was passed and had regulated only about a half dozen.

EPA’s glacially slow review of chemicals that were on the market before 1976—and even today that’s most chemicals—came to a virtually complete halt in 1991 when a federal appellate court overturned EPA’s proposed ban on asbestos, a well-known carcinogen. That ruling, never appealed by EPA, left much of TSCA a dead letter because the court interpreted the law in a way that made it just about impossible to ever successfully defend a chemical regulation when the agency was (inevitably) sued.

Efforts to revise TSCA had run aground because of profound differences between the chemical industry and environmental and health groups, but by 2013, elements of the chemical industry were feeling pressure to get some kind of federal system in place. States and large retailers were taking action to limit the sale of particular chemicals, and citizen groups and the media were drawing more attention to the dangers of commonly used toxic chemicals, such as flame retardants in furniture. The industry had no official national arbiter it could point to when challenged, the way the pharmaceutical industry, say, could use the Food and Drug Administration. A hamstrung EPA no longer looked like an unalloyed good to companies with products under attack, especially if the industry could shape whatever new regulatory system was put in place.

Unicorn sausage

That was the context when discussions began between Sen. Lautenberg and an unlikely interlocutor, Sen. David Vitter (R-LA), a hard-edged conservative and defender of the chemical industry, especially the petroleum companies in his home state. The history of those discussions remains to be written, and much about them continues to be unclear, including exactly how they were initiated and who knew what about their content when. But they resulted in a draft bill that was publicly released in the spring of 2013, a few weeks before Sen. Lautenberg passed away.

That draft became the template for altering TSCA, and set the parameters for the three years of negotiation that led to the new law that President Obama signed. The Lautenberg-Vitter bill’s fatal flaws are the origin of many of the fundamental problems with the new law. To begin with, the original bill was demonstrably weaker than the 1976 TSCA law—no mean feat. It would have enabled EPA to make unchallengeable determinations that chemicals were safe with virtually no scientific review while taking away much of the authority states have to regulate chemicals. An industry-oriented EPA (as was the case, for example, in the early years of the Reagan presidency) could have used the law to declare chemicals safe with impunity. And the bill failed to correct some of the most basic failings in TSCA, such as the lack of any enforceable deadlines to get EPA to act.

But the Lautenberg-Vitter bill did raise the possibility (and the specter) that a bipartisan agreement on TSCA was feasible, and it made progress on a few key issues. Most notably, it attempted to prevent EPA from taking cost into account in making safety determinations—albeit as part of an overall bill that would have been a step backward. And in today’s polarized Congress, any bipartisan effort is noteworthy enough to have some momentum; many in the press and in Congress assume anything bipartisan must be a thoughtful compromise no matter what its actual content. A bipartisan bill these days is seen as a kind of miracle; if you criticize a bipartisan bill, you’re treated as if you killed the last unicorn.

So the Lautenberg-Vitter bill did end up being the start of serious talks on TSCA, despite its severe tilt toward industry’s interests. Sen. Tom Udall (D-NM) took over the Lautenberg role as the lead Democrat after Sen. Lautenberg’s death. The primary bloc of environmental and health groups, the Safer Chemicals, Healthy Families Coalition, panned the bill, but expressed willingness to enter into talks. One environmental group, the Environmental Defense Fund, expressed support for the measure. And EPA, which had earlier released general principles it said should guide a TSCA rewrite, made clear privately that it was eager to have work on TSCA continue.

The serpentine path from that moment to the White House signing ceremony should truly be the subject of a book. It would offer not only a case study of legislating on a complex issue in a deeply divided Congress, but also enough personality conflict, high emotion, melodrama, and cliff-hanger moments to live up to TSCA’s operatic acronym. But the process was prologue; the law will likely govern how chemicals are regulated for many years to come. So where did things end up?

It’s a mixed bag, and the actual results will, even more than with most statutes, depend largely on agency implementation decisions and future court rulings. The law leaves a lot of critical decisions to EPA, sometimes in cloudy or unprecedented language.

The bill calls for making decisions based on the “weight of the evidence”—a term that a National Academy of Sciences report has said is so ambiguous it should be avoided.

A new hope

In some important ways, the new law sets the stage for real advances. It sets an enforceable schedule—albeit not a particularly aggressive one—for EPA to review existing chemicals. (The schedule is complicated, but EPA has to have 30 risk assessments under way within three and a half years of enactment.) The law requires that EPA determine whether chemicals are safe solely on the basis of health impacts without taking cost into account. It makes it easier and faster for EPA to require industry to submit more test data about chemicals that are in the marketplace. It requires that EPA consider the risks to vulnerable populations—those facing greater exposure or with greater susceptibility, such as children and pregnant women—when determining the risk a chemical may pose. These provisions make the amended TSCA more similar to effective environmental statutes such as the Clean Air Act.

The law imposes (limited) fees on the chemical industry to help pay for the new work EPA will have to undertake, and it makes it harder for industry to withhold information from the public by misusing the “Confidential Business Information” designation.

The law also fixes provisions in TSCA that led to the court decision blocking asbestos regulation. The original TSCA required EPA to impose the “least burdensome” regulation to achieve its goal—a seemingly sensible requirement that, in practice, meant that EPA had to cost out and formally consider any conceivable approach to risk abatement and perhaps some inconceivable ones for a regulation to be upheld—an impossible task. The new law says that EPA need only review a finite number of alternatives of its own choosing; one can suffice. EPA can (but is not required to) choose among the options on the basis of cost, but the regulation has to eliminate the risk the agency has determined the chemical poses.

And the new law ameliorates some of the worst features of the Lautenberg-Vitter proposal. For example, that bill would have enabled EPA to declare a chemical a “low priority”—basically, giving it a clean bill of health—with virtually no scientific review. The designation could not have been challenged and would have pre-empted any future state action on the chemical. The new law, unfortunately, retains the low-priority category, but it provides some limits on when EPA can use the designation (it cannot, for example, assume that a lack of information means the chemical presents a low risk), allows low-priority designations to be challenged in court, and eliminates the pre-emptive effect.

Whether these provisions will turn out to be actual advances that increase public protection remains to be determined. For example, the legal formula the law uses to describe unacceptable risk and to keep cost considerations out of safety determinations, which originated in the Lautenberg-Vitter measure, has never been used this way before, and its precise meaning will first be determined by EPA and then likely challenged in court. The chemical industry was adamant that the law use the “unreasonable risk” language that has previously been associated with cost considerations rather than formulations that have been tried in other statutes. EPA will also need to decide which vulnerable populations to consider when reviewing a chemical and how to determine their level of risk.

The agency will have to determine when to label a chemical low-priority, and its decisions may be challenged in court. Current EPA officials have said they view the low-priority label as applying only to chemicals that are virtually free of risk, but it remains to be seen whether they will act accordingly, given industry pressure. And in any event, a future EPA could still try to apply the category more broadly.

Courts may also be asked to rule on the language that replaced the “least burdensome” requirement, which inartfully combines wording from several different versions of the bill. A case could arise if, for example, industry challenges a regulation by claiming that EPA should have selected a cheaper alternative, especially one reviewed by the agency.

EPA will also have to determine and describe what scientific methods it will use to evaluate chemicals and how it will evaluate the results. Most of the language in Lautenberg-Vitter that sought to dictate scientific procedures has been removed, but the bill still calls for making decisions based on the “weight of the evidence”—a term that a National Academy of Sciences report has said is so ambiguous it should be avoided.

This list only begins to hint at the number of questions that will arise during implementation—some arcane, yet all consequential—and many are complicated by drafting defects that originated in Lautenberg-Vitter, even though the final law cleans up most of the (sometimes purposeful) ambiguities presented by almost every line of that initial proposal.

Now for the bad news

And these are only some of the matters raised by the positive aspects of the new law. Then, there are its significant shortcomings. Most notable is the extent to which the new law pre-empts state authority—the most volatile issue during the negotiations over the bill and the last to be settled. Industry was seeking broad pre-emption from state regulation as the quid pro quo for a functional federal regulatory system, and although negotiations narrowed pre-emption, state action will now be much more circumscribed than it was under the 1976 TSCA. For example, under the original TSCA, states retained the capacity to ban chemicals even after the federal government acted, and states were never pre-empted by EPA finding a chemical to be safe. The newly amended law blocks most state actions (including bans) on a chemical once EPA has either declared it safe or imposed federal regulations.

Most troubling is that the law takes the apparently unprecedented step of blocking state actions before the federal government has decided whether to regulate a chemical. Pre-emption is triggered simply by EPA deciding to review a chemical, a multiyear process. The period of that pre-emption was reduced in the final bill from prior versions—it now covers only some of the period when EPA is examining a chemical and it can’t be extended if EPA delays a decision—but there is no legitimate rationale in principle or practice to prevent states from protecting their citizens when the federal government has not made a decision. Indeed, the law is perverse—a federal statement that a chemical should be reviewed because it could present a serious risk is what blocks a state from taking action.

The pre-emption provisions are complex, and disputes may arise over exactly which actions states are still allowed to take and when.

The new law also allows industry to determine up to half the list of existing chemicals for EPA to review, if it pays for those reviews. Formally allowing a regulated entity to hijack the priority-setting of a federal agency is a dangerous precedent that offers no public benefit. This was simply a political bargain that originated in an even more damaging form in a House bill.

The new law also weakens EPA’s ability to acquire information on the use of chemicals in imported products—disturbing when imported products such as toys from China and elsewhere have caused so much concern. Much of the language on imports is murkily crafted, but its source was quite clear. It came from a business coalition dominated by aircraft and automotive manufacturers, which had concerns about having to keep track of chemicals in numerous component parts their products use. But the bill does not target that problem or even those industries. Instead, it creates barriers to regulating imported goods generally. Those industries also were granted an exemption from regulation for any replacement part “designed” before an applicable standard is imposed—a giant loophole—when earlier versions of the bill exempted only those parts that had already been manufactured, allowing current inventories to be drawn down (even though the product presented a danger).

Uncertainty ahead

Ben Franklin famously said after the Constitutional Convention that Americans now had a republic “if you can keep it.” With far greater skepticism and uncertainty, it can be said that Americans now have a functional chemical safety law, if EPA can properly implement it. “Properly” will, of course, be in the eye of the beholder and vehemently disputed as EPA makes its decisions and courts decide if they pass muster. For now, the extent of public protection still hangs in the balance. The TSCA law is an opera that is about to spawn many sequels.

David Goldston is director of government affairs at the Natural Resources Defense Council in Washington, DC.

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Cite this Article

Goldston, David. “Not ’Til the Fat Lady Sings: TSCA’s Next Act.” Issues in Science and Technology 33, no. 1 (Fall 2016).

Vol. XXXIII, No. 1, Fall 2016