EPA IG report: New Chemicals Program fails to assure protection

Richard Denison, Ph.D., is a Senior Scientist.

In a post to this blog nearly a year ago, I noted that many voices in the chemical industry were claiming that EPA’s New Chemicals Program (NCP) was robust and served as an excellent model for TSCA reform.  My post took considerable issue with that point of view, noting the many structural constraints TSCA imposes on EPA in its effort to review new chemicals:

• No data, no problem: No up-front testing requirement or minimum data set applies to new chemicals.
• Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.
• Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!
• One bite at the apple: EPA typically gets only a single opportunity to review a new chemical.
• Crystal-ball gazing: EPA has to try to anticipate a new chemical’s for-all-time future production and use.
• Black box: New chemical reviews lack transparency.
• Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates lack of evidence of harm with evidence of no harm.

Lately, I’ve been hearing chemical industry representatives trying to resuscitate the NCP-as-model-for-TSCA-reform mantra.  So it is especially timely that a new report from EPA’s Office of Inspector General (OIG) has just been released that again thoroughly dismantles that notion.  The new report’s critique of the NCP closely mirrors the appraisal I provided earlier.  And adding weight to its analysis is the fact that EPA’s senior management has fully concurred with the report’s conclusions and recommendations.

Let me first note that this new report covers more than just the NCP.  Among its other conclusions:

• “Oversight of regulatory actions designed to reduce known risks is a low priority,” reflected in the report’s documentation of the fact that compliance assurance and enforcement under TSCA is virtually nonexistent.
• “EPA’s procedures for handling confidential business information requests are predisposed to protect industry information rather than to provide public access to health and safety studies.”  (The report’s findings on CBI provide updated documentation for many of the conclusions of the 1992 EPA-commissioned report about which I recently blogged.)

With regard to the New Chemicals Program, as I’ve covered much of this critique in my earlier post, I won’t repeat it here but strongly suggest you read the new report for more detail.

Anti-precaution in practice

But I do want to note one especially compelling highlight of the OIG report that strongly reinforces my point that the NCP’s new chemical review process is actually anti-precautionary.

I had noted earlier how EPA’s presumption going in to a review of a new chemical is essentially that, unless it has good evidence indicating a potential risk, it effectively finds the chemical does not pose a risk.  (A great example of this came to light in a consent order EPA issued for a carbon nanotube it reviewed last year.)

This approach, which in part reflects TSCA’s placement of the burden of proof on EPA to show harm rather than on industry to show safety, is especially ironic given the lack of any upfront data requirement and the paucity of data available on new chemicals.

EPA’s OIG reached similar conclusions about the NCP:

• “EPA’s assurance that new chemicals introduced into commerce do not pose unreasonable risks to workers, consumers, or the environment is not supported by data or actual testing.”

and

• “In cases where full information does not exist or analyses are limited [which is the case for the great majority of new chemicals], EPA reports the new chemicals as not having risk.”

But the OIG report goes on to nicely illustrate the aggregate impact of EPA’s arithmetic that equates no data with no harm.

As a performance measure for the NCP, EPA annually reports to Congress the “percentage of new chemicals introduced into commerce that do not pose unreasonable risks to workers, consumers, or the environment” (emphasis added).

How is that measured?  Bear with me as I try to explain the convoluted process stepwise – I assure you the conclusion is startling enough to warrant following this through to the end.

1. As I’ve discussed previously, if a company develops or obtains data it believes indicate a chemical it produces poses a substantial risk, it is required to provide a notice to EPA summarizing the data.  The requirement to submit these so-called “substantial risk” notices is specified under TSCA section 8(e), but the information actually received is entirely based on self-disclosure by industry.
2. To measure NCP performance, EPA does a review of the notices received in a given year for chemicals that at some point in the past went through a new chemical review; about 30 such notices are received each year.
3. If EPA staff believe that the concern raised about a chemical in the substantial risk notice would have been flagged via a new chemical review of that same chemical had it been reviewed at the present time, EPA counts that as a chemical that does not pose an unreasonable risk.
4. In FY 2005 and 2006, EPA staff decided that for all (100%) of the small number of such chemicals reviewed, the concern would have been flagged in a new chemical review; in FY 2007, they concluded that all but one (96%) of the concerns would have been flagged.
5. Here’s the final leap:  Based on this analysis, EPA reported to Congress that 100% (for FY 2005 and 2006) and 96% (for FY 2007) of all of the chemicals introduced into commerce did not pose any unreasonable risk.

Still with me?

What’s wrong with this picture?

• Note that EPA reviews about 1,500 new chemical notices each year, and about half of those chemicals go on to actually enter commerce.  So the roughly 30 such chemicals for which substantial risk notices are received annually represent only about 4% of the number of new chemicals entering commerce.  Nothing comes in on the other 96% – and that’s good enough for EPA to maintain they do not present an unreasonable risk.
• Moreover, few if any of the notices received in a given year are for new chemicals that entered commerce in that same year; rather, they may have entered many years or even decades earlier.
• Substantial risk notices are not the outcome of any kind of systematic testing of chemicals in commerce – recall that under TSCA companies are not required to do any routine testing of their chemicals, and EPA has rarely required them to do any testing.  So the chances of a company stumbling on evidence on substantial risk for one of its chemicals are rather remote.
• Because there is no routine testing requirements and no specification of a set of data requirements for chemicals in commerce, even where a company does encounter evidence of substantial risk, it cannot be concluded that the resulting notice reflects all of the adverse outcomes that would have been found had the chemical been subject to testing for a robust set of health and environmental endpoints.
• Under this performance measure, no other data available on the chemical – whether in EPA’s files or in the literature – are considered.
• Hence, it cannot be concluded that the concern identified in the notice is the only concern that chemical would raise if thoroughly tested.  So how can EPA imply that its new chemical review would have flagged all potential concerns with a given chemical, and hence that the chemical does not present any unreasonable risk?
• Throughout the history of TSCA, EPA has raised concerns that industry compliance with the substantial risk notice requirement is incomplete; in 1991 it even offered a limited amnesty program in an effort to unearth additional substantial risk data.  And the OIG report notes that EPA enforcement of this and other TSCA requirements is exceedingly limited and therefore that “EPA does not have assurance that industry submits all Section 8(e) notices for identified risks.”
• The report further describes the high-profile case EPA brought against DuPont in 2004 for failure to submit substantial risk notice(s) – a very rare enforcement case that was widely regarded as a “shot across the bow” by EPA to try to spur greater compliance with this TSCA requirement (how successful it was is unclear).

All of this makes it pretty clear that EPA possesses only a tiny fraction of the tiles in the huge mosaic of the 23,000 chemicals that have passed through the New Chemicals Program review process.

It might be justifiable for EPA to conclude that it has not been made aware of unreasonable risks posed by many or most of the new chemicals it has at one point or another reviewed and allowed to enter commerce.  But for EPA to rely on such a flawed and spotty performance measure to affirmatively conclude that virtually all of those chemicals do not pose unreasonable risks to workers, consumers, or the environment – well, that vividly shows how under TSCA, EPA relies on the absence of evidence of harm instead of requiring evidence of absence of harm.