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S.697’s New Chemical Provisions: Will They Meaningfully Enhance the Current Program?

With the House and Senate moving on separate tracks to reform the Toxic Substances Control Act (TSCA), there has been growing debate about the merits of their differing approaches to new chemical review under section 5 of the law.

H.R. 2576, which passed the House on June 23, retains section 5 in its current form. S. 697, reported out of committee on April 28, would rewrite section 5. Once the Senate acts on TSCA reform, the process of reconciling the two bills will begin. How critical are the Senate’s new chemical provisions in enhancing TSCA’s public health protections? And how much weight should they receive in evaluating the strengths and weaknesses of the two bills?

Some observers have touted the Senate revisions as a major enhancement of the new chemicals program. This greatly overstates their value. While the revisions are generally not harmful (with the exception of changes to EPA’s SNUR authority not discussed here), their beneficial impact will be modest at best.

Many experts (and EPA itself) believe that the new chemicals program is one of the few functioning aspects of TSCA. Although not ideal in all respects, the program has made progress in screening all new chemicals, identifying those that raise health or environmental concerns, and addressing those concerns through a combination of restrictions on exposure and release and testing.

The new chemicals program stands in marked contrast to the existing chemicals program, which nearly all would agree is hopelessly broken and has a dismal record in reducing the risks of established chemical products. Fixing the existing chemicals program is far and away the highest priority for TSCA reform and the single most important challenge that Congress must meet.

Although a lower priority, improving the section 5 program might be worthwhile if it significantly strengthened the new chemical review process. But the changes in S. 697 would not measurably alter how the program operates today.

S.697 would leave intact the basic structure and principal features of section 5. As under current law, manufacturers and importers of new substances (i.e. those not listed on the TSCA Inventory) would be obligated to file premanufacture notices (PMNs) before beginning production or importation. EPA would have 90 days to review these notices, with the ability to extend the review period to 180 days. The information to be included in PMNs would be the same as now required in EPA regulations. Manufacturers would not be required to provide any more test data or information on exposure than they now submit.

As under current law, if EPA has no concerns about the chemical, it would allow the review period to expire, clearing the way for submission of a notice of intent to manufacture (NOCM) and listing on the TSCA Inventory. However, if EPA has concerns about the chemical, both current law and S. 697 authorize EPA to issue an order placing limitations on manufacture and processing and/or requiring testing. The range of requirements EPA can include in such orders under S. 697 is no broader (and in fact more limited in some areas) than those authorized in the current version of TSCA section 5.

The major changes in S.697 are in section 5(d)(3) which, as revised,  directs EPA to make one of three findings after reviewing the PMN: (1) the chemical is likely to meet the safety standard; (2) the chemical is not likely to meet the safety standard; or (3) additional information is needed to determine whether the chemical meets the safety standard. In the latter two situations but not the first, EPA can regulate the chemical and/or require testing.

Although current section 5(e) is worded differently from section 5(d)(3) in S. 697, the two are very similar in concept. Under section 5(e), EPA must assess whether the chemical is innocuous based on available information or whether there is either a potential concern about its health and environmental effects (“may present an unreasonable risk”)  or it has exposure potential (“will be produced in substantial quantities” and may result in “significant or substantial human exposure”). Where EPA makes these findings, it can restrict manufacture and use and, if available information is insufficient, require testing.

EPA has had fairly broad latitude under this framework to identify and restrict new chemicals of concern. To determine if a new chemical may be hazardous, EPA uses a combination of available data and structure-activity relationships (SAR) to determine if the chemical has molecular characteristics similar to those of chemical classes with known or suspected health or environmental effects. Its SAR methodology has advanced considerably since the inception of the program; the Agency has developed a long list of suspect chemical categories with which to screen and prioritize PMN chemicals based on their level of concern.

Even where SAR does not identify suspected adverse effects, EPA looks at whether the chemical’s proposed uses are indicative of potential high exposure and should be restricted under the exposure-based component of section 5(e). Chemicals with consumer product applications, wide distribution across a range of industrial facilities or expected releases to air, water or waste would be candidates for exposure-based restrictions and/or testing requirements.

Under the current law, a large portion of the PMNs submitted have been subject to close scrutiny by EPA. As of EPA’s most recent tabulation on September 30, 2010, 36,623 PMNs had been received by EPA since 1979. Of these, 4,441 resulted in some type of action by the Agency. This included section 5(e) consent orders (approximately 1500) and Significant New Use Rules (SNURs) (around 1550). The SNURs were equally divided between those codifying the restrictions in 5(e) and those applicable to non-5(e) chemicals (i.e. where the Agency did not regulate the activities of the PMN submitter but issued a SNUR to maintain control of additional uses after the chemical is added to the TSCA Inventory). In addition, 1848 PMNs were withdrawn in the face of likely 5(e) orders and over 300 voluntary testing actions were taken by industry in response to the threat of 5(e) requirements.

Since the first 5(e) order in 1979, there have been no industry challenges to any of EPA’s actions.

The Senate bill may seem to give EPA more leverage to impose restrictions because it requires such restrictions unless the Agency concludes that the new chemical is likely to meet the safety standard. In practice, however, this will not be a big hurdle. EPA can be expected to conclude — much as it does now — that chemicals lacking any toxicological concern or with very low exposure potential are likely to meet the safety standard and should be allowed to enter the marketplace without restriction. And again like current practice, chemicals that raise toxicological issues based on SAR or adverse test data, or are likely to have substantial exposure potential, will be restricted on the ground that they are unlikely to meet the safety standard or lack sufficient information to apply the standard. In short, the analysis EPA conducts will be very similar to what it does now.

The one arguable benefit of the Senate revisions is that they lower the burden of proof on EPA where it seeks to restrict a new chemical. This is because EPA could impose such restrictions merely because it lacks sufficient information to apply the safety standard, without necessarily demonstrating potential toxicity or substantial exposure. This may be an advantage in theory but not in practice given EPA’s success over 35 years in using its authority under the existing law without any challenge by industry.

Of course, if a new EPA management were to abandon EPA’s current approach to new chemical review and greatly pare back use of section 5(e), the Senate bill would give stakeholders more leverage to hold EPA accountable. This may be a good reason to include the Senate provisions in the conference bill sent to the President but it’s a far cry from meaningfully changing the program as it exists today.

What the Senate bill does not do is authorize EPA to require all PMN submitters to supply a minimum data set, without which the PMN will not be reviewed.   Such testing requirements have been called for by many stakeholders and have been incorporated in the chemical control laws of several other countries. They would address the biggest weakness of the current program – EPA’s heavy reliance on SAR – by greatly increasing the amount of data generated on new chemicals. In contrast to the Senate bill, mandatory testing requirements for new chemicals would meaningfully improve the new chemical program.

In sum, the Senate new chemical provisions may have modest benefits but they won’t produce the sea-change in the new chemical program some have claimed. In light of these provisions’ limited impact, comparisons between the House and Senate bills should be based not on how the bills approach section 5, but on whether they remedy the failures of the existing chemicals program, preserve the ability of states to address unsafe chemicals, clearly delineate the scope of EPA’s authority and minimize litigation, and avoid burdensome mandates on EPA that will divert resources away from health and environmental protection.