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Protecting the safety net for new chemicals under TSCA

Over two years ago, Congress strengthened the 1976 Toxic Substances Control Act (TSCA), a well-intentioned but flawed law that had made little progress in addressing the many toxic chemicals that pervade our homes, workplaces, schools and outdoor environment. The new law was not perfect, but our groups hoped that with proper implementation it would result in a stronger federal toxics program. Unfortunately, the Trump EPA – led by former industry insiders who continue to take their cues from the nation’s chemical manufacturers — has retreated from the goals of Congress and undermined the new law at every turn.

Few aspects of the new law have been at more risk than the section 5 premanufacture notice (PMN) program, which provides critical safeguards against unsafe new chemicals entering commerce. The amended law put considerably more teeth in this program, but from day one, the chemical industry has sought to block EPA from implementing the tougher review process that the law required. We have persistently pushed back on EPA’s efforts to weaken the program. In January of this year, NRDC sued EPA to block implementation of the so-called “PMN Framework,” a decision-making roadmap that EPA announced in November 2017 and that we argued bypassed the clear requirements of the law. SCHF later intervened in the case.

We’re now withdrawing our case because, despite the statements of agency officials last December, EPA has not in fact gone ahead with the Framework and seems unlikely to do so. As a result, the PMN program has dodged a bullet that would have had destructive consequences for public health.

We’re not celebrating, however: the chemical industry still has the PMN program in its sights, and the Trump administration hasn’t given up on finding ways to cut corners on the review and regulation of new chemicals. There are troubling signs that EPA is now employing new, hard-to-track strategies for allowing new chemicals raising health or environmental concerns to slip through the section 5 safety net. The persistence of the chemical industry and the Trump administration in trying to dismantle the new protections under TSCA requires heightened vigilance in monitoring decisions on individual new chemicals so that EPA is held accountable for questionable legal and scientific judgments that stray from the requirements of the law.

Why the New Chemicals Program Is Important

The new chemicals program originated in a recognition by Congress that many chemicals causing widespread harm had been introduced into commerce without any review and testing. As explained by the House of Representatives in 1976, “we have become literally surrounded by a man-made chemical environment” and “[t]his vast volume of chemicals have, for the most part, been released into the environment with little or no knowledge of their long-term health or environmental effects.” H.R. Rep. No. 94-1341, at 3 (1976). According to the Senate report on the 1976 law, “[t]he most effective and efficient time to prevent unreasonable risks to public health or the environment is prior to first manufacture. It is at this point that the costs of regulation in terms of human suffering, jobs lost, wasted capital expenditures, and other costs are lowest.” Senate Rep. No. 94-698, (1976) at 5.

How Congress Strengthened PMN Review in 2016

Regrettably, the 1976 law contained limitations that hampered the effectiveness of the new chemicals program.  Between 1979 and mid-2016, EPA received 40,151 pre-manufacture notices. But only 4 percent of these notices were subject to orders under TSCA section 5(e), the tool in the law that authorized EPA to restrict new chemicals that may present unreasonable risks of injury to health or the environment. Congress deemed this situation unacceptable when it overhauled TSCA in 2016. Several Democratic sponsors of the new law noted at the time of enactment that “[w]hile existing TSCA does not preclude EPA from reviewing new chemicals . . . following notification by the manufacturer or processor, it does not require EPA to do so or to reach conclusions on the potential risks of all such chemicals before they enter the marketplace.” To change this “passive approach,” they explained that, “[f]or the first time, EPA will be required to review all new chemicals . . . and make an affirmative finding regarding the chemical’s . . . potential risks as a condition for commencement of manufacture for commercial purposes and, in the absence of a finding that the chemical . . . is not likely to present an unreasonable risk, manufacture will not be allowed to occur.”

This approach is reflected in section 5(a)(3) of the new law. This provision directs EPA to determine the safety of every new chemical and to regulate it under section 5(e) if the Agency finds that it “may present an unreasonable risk,” lacks “sufficient information” to determine its risks or will be produced in substantial quantities and may have significant or substantial human exposure or environmental release. EPA is only allowed to authorize manufacture of the new chemical without restriction where it makes a determination under section 5(a)(3)(C) that the chemical “is not likely to present an unreasonable risk.”

During the eighteen months following enactment of the new law, EPA seemed to follow its requirements. As of December 2017, EPA had issued section 5(e) orders for around 80 percent of all the chemicals completing PMN review. The EPA orders addressed a broad range of health and environmental concerns, provided protection to workers, consumers and the general population, required enforceable reductions in exposure and environmental release and called for testing.

How the PMN Framework Dismantled the 2016 Amendments

Almost from the day TSCA took effect, however, the chemical industry pushed back hard on EPA’s heightened use of section 5(e), making one dubious argument after another – that Congress only envisioned minor changes in the PMN program, that the length of PMN reviews was creating a “backlog” and stifling innovation, and that EPA’s 5(e) orders were based on speculative changes in use that were not “intended” by the PMN submitter. The pressure by industry to roll back the program was exerted not just in public statements but undoubtedly in private discussions with senior EPA political appointees, including a weekend meeting at a fancy resort between former Administrator Scott Pruitt and the chemical manufacturers’ trade association, the American Chemistry Council.

The industry campaign was rewarded on November 7, 2017, when EPA released its New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA. Closely resembling recommendations in industry comments, the Framework would substitute a weak and largely voluntary new chemical review process for the strong regulatory regime established by Congress. Its impact would be to limit reliance on enforceable orders under section 5(e), the focus of industry unhappiness with EPA‘s initial approach to implementing the law. As the first step in curtailing these orders, EPA would evaluate the PMN substance based only on the “intended” use conditions identified in the PMN. Where these activities raised human health or environmental concerns that may present an unreasonable risk of injury, EPA would recommend changes to the PMN and encourage the submitter to amend its PMN to incorporate them. Although these controls would be strictly voluntary, EPA would then rely on the amended PMN to make a determination that the chemical is “unlikely to present an unreasonable risk” under section 5(a)(3)(B). Even where the PMN lacked test data, EPA would presume that the available information on the PMN substance is “sufficient” for a determination of risk and an order requiring testing is unnecessary.

TSCA requires EPA safety determinations under section 5(a)(3) to be based on the new chemical’s “conditions of use,” a term covering not just “intended” uses but those that are “known” or “reasonably foreseen.” However, the Framework would address potential risks presented by “reasonably foreseen” uses of the new chemical not with section 5(e) orders but with significant new use rules (SNURs) under section 5(a)(2). The Framework provided no assurance that these SNURs would in fact be issued or would be timely and, by their nature, any SNUR would be less protective than a section 5(e) order. Nowhere does the law allow EPA to base a determination that a chemical “is unlikely to present an unreasonable risk” under section 5(a)(3)(C) on the possibility of a future SNUR of uncertain value in protecting health and the environment.

EPA Did Not Implement the PMN Framework After We Filed Suit

EPA requested comment on the Framework but, at its December 7, 2017 public meeting, Jeff Morris, Director of the EPA office overseeing the new chemicals program, emphasized that “we are going to move forward; we are acting on this framework now . . . and governing ourselves by the framework.” Our groups protested against immediate implementation of the Framework and asked that it be delayed but EPA never responded. Faced with EPA’s seeming resolve to immediately make major weakening changes in the PMN program that lacked any basis in the law, NRDC filed for judicial review of the Framework on January 5, 2018. SCHF later was granted intervention.

The brief EPA filed on July 31 informed the court of appeals that – contrary to the previous explicit statements of Dr. Morris — it had not in fact implemented the Framework, was still reviewing public comments and did not know when, if ever, it would take further action on the Framework. This surprising announcement was supported by a declaration from Dr. Morris stating that EPA had issued no SNURs in accordance with the Framework and that section 5(e) orders remained the principal tool used in the new chemicals program. He explained that, since posting the Framework on November 6, 2017, EPA had issued 150 section 5(a)(3) safety determinations regarding PMNs; that 131 (or 87 percent) resulted in orders under section 5(e); and that only 19 determinations (or 13 percent) concluded that the chemical was “unlikely to present an unreasonable risk” under section 5(a)(3)(C). Dr. Morris further asserted that “reasonably foreseen” future uses were, in fact, the basis for several section 5(e) actions and were considered in all determinations of PMN safety during this period.

In short, EPA has backed off on Dr. Morris’ statements in December that PMN reviews were “being governed” by the Framework, put the Framework on the back burner and seemingly continued to follow the general approach to PMN review that the law required.

The Need for Continued Vigilance

While EPA’s announced decision to back off of the Framework is good news, it does not ensure that EPA is following the law’s requirements, or that the public is being protected from the introduction of new chemicals of concern into the marketplace. There are troubling indications that EPA is still trying to achieve the goal of the Framework – to curtail the use of section 5(e) orders – by other means. Even more disturbing, recent reports suggest that EPA’s career staff are being instructed orally on how to implement the new program, to avoid putting any instructions in writing.

EPA recently issued an eyebrow-raising “not likely” determination for a polymer intended for use as “a deodorizer in industrial, commercial, and household consumer products such as floor cleaners, cat litters, fabric refresher sprays, etc.” The polymer is part of two chemical classes known by EPA to have serious adverse health effects and EPA’s determination recognized its potential to cause “mutagenicity, developmental/reproductive toxicity, neurotoxicity, and carcinogenicity.” In its determination, EPA assumed that the polymer would only be present in consumer products at levels of 2% or below but provided no assurance that the PMN submitter or other companies would not increase its concentration to higher levels and placed no limit on the types of products in which the chemical might be used.

The decision document also failed to identify any “reasonably foreseen” uses of the polymer. This marks a departure from previous determinations (which identify reasonably foreseen uses in almost all cases) and suggests that EPA may be setting a higher – and illegal — bar for classifying future uses as reasonably foreseen. Reinforcing this possibility is new wording in footnote 1 in the EPA decision document. This footnote, which discusses how EPA defines a PMN substance’s conditions of use, states that “[r]easonably foreseen conditions of use are future circumstances, distinct from known or intended conditions of use, under which the Administrator expects the chemical substance to be manufactured, processed, distributed, used, or disposed of” (emphasis added).  The word “expects” indicates that EPA now seeks to redefine “reasonably foreseen” as “highly likely” (a standard that would be impossible to meet given the inherent uncertainty in predicting how a chemical will be used in the future). A definition of reasonably foreseen as “highly likely” is inconsistent with the letter and intent of the revised TSCA and would be vulnerable to legal challenge.

We have many questions about EPA’s failure to issue a section 5(e) order for this polymer. Among them: Why did the agency conclude that an unreasonable risk to human health was not likely despite the wide range of products with consumer uses that might result in significant exposure and the polymer’s acknowledged potential for serious health effects? Why wasn’t an enforceable limit placed on the concentration of the polymer that could be present in products? Was there a risk to workers handling the PMN substance and why were no enforceable workplace protections required? Why didn’t EPA issue an order requiring testing of the polymer under section 5(e) based on a finding under section 5(a)(3)(B)(i) that the available data were insufficient in light of its similarities to substances with known adverse health effects? Did EPA do a search for “reasonably foreseen” uses of the polymer and what possibilities did it examine?

We don’t know the answers to these questions because the decision document is painfully short on details and EPA has not made available the underlying technical analyses that form the basis for its “not likely” determinations. The Agency also doesn’t post PMNs and follow-up submissions on its Website; these are obtainable with some effort but are frequently unhelpful because of the large amount of information commonly withheld as Confidential Business Information (CBI), although there are new limits on the extent of information that can be claimed as CBI under the revised TSCA. Thus, the public cannot meaningfully decipher the basis for EPA’s decisions on specific new chemicals and must – to a considerable extent — accept these decisions “on faith.” But how much faith can the public have in decisions by EPA’s Toxics Office while it is under the direction of a former chemical industry official? If EPA is using individual PMN reviews to make major legal or policy changes in the PMN program (a definite possibility in light of the August 1 “not likely” determination), the public will have no notice of these changes and no ability to respond. Which, of course, is exactly what the chemical manufacturers want.

It is remarkable that, as communities across the country are grappling with the legacy contamination of drinking water and food by cancer-causing fluorinated chemicals that some in the chemical industry have for years insisted are “safe”, the Trump administration appears to be determined to let new potential carcinogens on the market, and into our homes, with as little review or public disclosure as possible.

We’re calling on EPA to open up the new chemicals program to public scrutiny and review and to greatly increase the information it posts on individual chemical reviews. We can’t let the Trump administration and the chemical industry continue to collaborate behind closed doors to weaken the law and allow new unsafe chemicals to enter the marketplace. To encourage this step and maintain pressure on the agency, we will be filing FOIA requests for all available information on “not likely” determinations and challenging the unjustified withholding of information as CBI. Our goal is to shine light on individual new chemical decisions so that EPA can be held accountable if it is failing to comply with the law.