The Washington Post ran a front-page article Saturday, written by Spencer Hsu, which reported the auction sale by FEMA of most of the 120,000 notorious formaldehyde-tainted trailers it had purchased five years ago to house the victims of Hurricane Katrina.

The article cites FEMA as saying that “wholesale buyers from the auction must sign contracts attesting that trailers will not be used, sold or advertised as housing, and that trailers will carry a sticker saying, ‘Not to be used for housing’.”

Think that’s likely to be enough? 

Think again.  Consider this excerpt from a consumer alert issued by the Attorney General of Arkansas, Dustin McDaniel:  “Proceed with caution, extreme caution, if you are tempted to respond to what appears to be an attractive offer for a travel trailer or manufactured home.”  He and others pointed to the high likelihood that the trailers will now enter a market where they may be sold and resold repeatedly and the warning label removed or ignored.

Hsu cites one woman who several years ago purchased a trailer for her son – days before all the publicity broke about dangerous levels of formaldehyde.  Now she’s worried about him keeping the trailer, but also has qualms about selling it to someone else.  “This is like history repeating itself," she said. "People are all going to buy them, move into them and then start getting sick."

Some buyers appear to have fewer qualms:  The highest bidder for the FEMA trailers says he already has buyers – retailers who intend to resell the trailers – for the 15,000 units he bought at auction, adding that formaldehyde is a “non-topic” that his buyers don’t even ask about.

This story vividly illustrates just how enduring the lifecycles of dangerous chemicals can be when our policies let chemicals get so deeply embedded into commerce without requiring they be shown to be safe.

It’s not an isolated incident.  In another recent front page Washington Post article, Lyndsay Layton documented the difficulties faced by the food industry in trying to replace a chemical used to make the lining used inside virtually every food can sold in America.  That chemical is bisphenol A (BPA) – a hormone-like compound which is found in the bodies of 93% of the American public, and is now suspected of interfering with human reproduction and early development.  Some 6 billion pounds of BPA are produced annually.

But back to formaldehyde, an estimated 46 billion pounds of which are made annually.

TSCA shares the blame

A year ago, in the House of Representatives’ first oversight hearing on the Toxic Substances Control Act (TSCA) in decades, I testified about how the structural flaws in this 34-year-old law played a key role in allowing those FEMA trailers to be built and to deliver a second knock-out blow to Katrina victims.

The FEMA trailers were made using plywood imported from China.  That plywood is made using adhesives that release high levels of formaldehyde, a known human carcinogen.  China makes a low-formaldehyde product for export to Europe and Japan, and even for domestic use in China, because in those markets there are regulatory limits in place.  But they have a ready market here in the U.S. for the cheaper, more dangerous plywood because we have no such restrictions.  That plywood ended up in the FEMA trailers – and continues to be sold into countless other markets across the country.

In 2008, the U.S. Environmental Protection Agency (EPA) was petitioned under TSCA to regulate this use of formaldehyde.  It denied the petition, citing its insufficient legal authority under TSCA and saying that further study is needed. 

Meanwhile, the tainted trailers live on and are now slated to expose yet another group of unwitting victims as they descend to the next sad stage in their lifecycle.

Ironically, unique among all federal environmental laws, TSCA is supposed to give EPA the ability to reduce risk along the entire lifecycle of a chemical, from its production and distribution, through its use and all the way to disposal of products containing it.  But TSCA made actually exercising any of that authority dependent on EPA proving a chemical presents an “unreasonable risk,” something it was unable to do even for asbestos back in 1991, and which it has never tried again.

It’s long past time we had a federal law that gives EPA the power to protect Americans from dangerous chemicals already on the market – and to prevent future repeats of episodes like the FEMA trailer debacle.  That will only happen when producers are compelled to prove their chemicals are safe as a condition for entering or remaining in commerce.

I urge you to join the Safer Chemicals, Healthy Families campaign in pressing for real reform of TSCA that will serve the next generation of Americans far better than it did the last.  And tell your members of Congress to do the same.

Sara Goodman of Greenwire/E&E News had a great piece picked up by the New York Times yesterday about state governments pressing for meaningful TSCA reform.  I blogged earlier about the states’ reform principles, quoting Ted Sturdevant, Director of the Washington State Department of Ecology, urging that “[w]e need a federal law that prevents contamination from happening in the first place, and phases out the harmful chemicals that are already in widespread use.”

Goodman’s piece yesterday focused more on the need for fundamental reform of confidential business information (CBI) claim allowances under TSCA.  Recall that, under TSCA, state governments as well as the public are denied access to any CBI EPA receives.  Judging by their quotes in Goodman’s piece, they’re not happy about it: 

• "It doesn't seem right that we have to go elsewhere to get information, it seems like the role of the federal government [should be] to help support us," said Ken Zarker, pollution prevention manager with Washington state's Department of Ecology.
• Added Ginger Jordan-Hilliard, public health coordinator for Maine's Environmental Protection Department, "We're talking about a very basic right to know, which is needed by consumers, regulators, workers. … If [a chemical] is in products we're going to use, we feel like people ought to have access to robust information."

I got what I thought was a nice quote in there, too, pointing out that under TSCA, "[t]he presumption is against disclosure, even for information that nobody would argue is legitimate CBI.  That culture has permeated the agency and its practices so deeply it's just second nature at this point."

But the other half of the equation, in addition to EPA leniency, is the chemical industry’s profligacy in making claims.  Remarkably, that’s a view apparently shared by at least the National Petrochemical & Refiners Association.  Here’s my favorite quote from Goodman’s piece:

“The trade group's vice president, [Jim] Cooper, said confidentiality claims have run amok because there is no easy EPA mechanism to switch off claims.  ‘EPA has to figure out a way to provide companies with a mechanism where they can recategorize the confidentiality of chemicals,’ Cooper said. ‘It's got to be efficient, then it will be used.’”

Well, they always say that admitting one has a problem of excess is the first step toward recovery.

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.

I recently obtained – not without some effort on both EPA’s and my part – a scanned copy of a 1992 report commissioned by EPA innocuously titled “Influence of CBI Requirements on TSCA Implementation,” authored by the now-defunct Hampshire Research Associates.  I subsequently found a copy in an old EPA docket, located here (6 MB PDF file).

This understated yet remarkable report is a veritable treasure trove of information that painstakingly documents the rampant rise in illegitimate confidential business information (CBI) claims made by the chemical industry in the first decade after passage of the Toxic Substances Control Act (TSCA) – and the very limited options available to EPA to stop such activity (despite recent admirable efforts on its part).

Now, some of you may be saying:  “Wow, that report is old, surely things have improved since then.”  To which I respond there is absolutely no reason to believe that is the case (see this earlier blog post for just one indication of the continuing excess of CBI claims under TSCA).  I would welcome any evidence to the contrary, but as you’ll see, the underlying reasons for this problem are structural to TSCA and EPA’s implementing regulations.

I have been a squeaky wheel on this CBI issue for some time, of course.  But this report elucidates several new dimensions of the nature and extent of the problem.  And it documents them:  Because the authors were contracted by EPA, they had access to internal databases and records of submissions EPA had received under TSCA during the period of 1979-1990.

In this post, I’ll summarize 10 key findings from the report that document the problem.  In a subsequent post, I’ll look at what the report had to say about solutions.

Key findings (I’ll list them all here so you can take them in all at once, and then elaborate on each one below):

1. Half or more of all information submitted to EPA under TSCA was claimed as CBI.
2. The fraction of information claimed CBI under TSCA was initially low and then rose, often dramatically, over time.
3. When EPA reversed a policy it had in place until 1982 that required up-front substantiation of CBI claims for new chemicals, the number of such claims shot up.
4. When examined by EPA, a large fraction of CBI claims were found to be illegitimate – the information so claimed was not eligible under TSCA or EPA regulations.
5. However, the vast majority of CBI claims have never been reviewed by EPA.  And EPA has accepted without challenge CBI claims for information which TSCA does not allow to be so claimed.
6. Industry faces no penalty for making a false or erroneous CBI claim under TSCA; in contrast, EPA personnel face criminal penalties for wrongful disclosure of CBI – even if the information is not eligible for CBI protection.
7. Claiming information CBI under TSCA is simple and facilitated by EPA procedures; in contrast, challenging such claims is highly cumbersome and resource-intensive.
8. Processing and protecting CBI imposes heavy direct and indirect costs on EPA; in contrast, there is virtually no cost to industry to assert a CBI claim.
9. EPA has routinely failed to disclose the extent of CBI claims asserted overall, or what types of information it receives have been claimed CBI, to what extent and by whom.
10. The extent of CBI claims asserted under TSCA exceeds by orders of magnitude that under other federal laws – most notably the Toxics Release Inventory (TRI) – even for very similar types of information submitted by companies.

Elaboration of findings (quotes below are taken from the report):

 1.      Half or more of all information submitted to EPA under TSCA was claimed as CBI.

While the extent varies by submission type and information element, CBI claims were made for:

• more than 25% of all “substantial risk” notices received under Section 8(e) of TSCA (80% of these claimed the chemical identity CBI);
• more than 20% of all health and safety studies;
• about half of all EPA-requested records of significant adverse reactions (required to be kept under TSCA Section 8(c)); and
• more than 90% of all new chemical notices.

Submissions for all of the first three categories, and for quite a few of the fourth category, constitute or contain what EPA defines to be “health and safety studies.”  These CBI claims were made, therefore, in direct contravention of the plain language of TSCA, which expressly precludes such studies from CBI protection (see discussion of this issue in earlier posts).

2.      The fraction of information claimed CBI was initially low and then rose, often dramatically, over time.

The report examined trends over time in CBI claims, and revealed a “learning curve” that appears to have been followed: companies increased the frequency of such claims as they learned there was little or no consequence to their asserting them, even for information clearly off-limits for CBI protection under TSCA or EPA regulations.  For example:

• About 70% of premanufacture notification (PMN) submissions for new chemicals submitted to EPA during the first 4 years of the PMN program (1979-1982) claimed the chemical identity as CBI.  That number rose considerably thereafter, reaching 92% by 1990, the last year of data covered by the report.  (Note that this high rate of CBI claims for PMNs has if anything increased further since 1990:  EPA indicated in 2007 that about 95% of PMNs contain information, including chemical identity, designated by the submitter as CBI; see p. 10 of this report).
• Very few “substantial risk” notices were submitted until 1983 (fewer than 15 per year).  From that year onward, the number of such submissions increased – but so did the fraction of them claiming CBI, rising from a mere 15-18% in 1983-85 to a whopping 48% by 1990.

3.      When EPA reversed a policy it had in place until 1982 that required up-front substantiation of CBI claims for new chemicals, the number of such claims shot up.

One contributing factor to the jump in CBI claims accompanying PMNs starting in 1983 appears to have been EPA’s reversal of a policy in place prior to that year that required up-front substantiation of CBI claims to be provided at the time the claims were asserted.  This is one of several factors the report identifies clearly indicating that the lower the “cost” or effort required to assert CBI claims, the more claims are made – regardless of whether or not the claims are warranted.

4.      When examined by EPA, a large fraction of CBI claims were found to be illegitimate – the information so claimed was not eligible under TSCA or EPA regulations.

These facts and trends apparently aroused sufficient suspicion about CBI claim validity to finally lead EPA in 1990 to initiate a pilot program to review and challenge CBI claims.  Specifically, EPA challenged all CBI claims made in association with a significant number of the submissions of health and safety data it received over a limited period under either Section 8(d) or 8(e) of TSCA.  Remember that TSCA expressly excludes health and safety studies from eligibility for CBI protection, and EPA regulations expressly define chemical identity as an integral part of a health and safety study; for a refresher on these points, click here).

So what happened?

In every case in which EPA challenged a claim, the submitter agreed to remove or reduce the scope of the claim.  The report states that this result “indicates that EPA is correct in challenging the validity of these CBI claims.”  This high frequency of questionable or invalid claims appears to have continued:  It was reconfirmed by an EPA official cited in a 2005 report by the Government Accountability Office (see page 33), who indicated that, while only about 14 CBI claims are reviewed per year, nearly all challenged claims were withdrawn.

The report provides numerous examples of spurious claims and justifications uncovered by this review, concluding that “they illustrate an apparent reliance on CBI claims to avoid embarrassment or adverse public reaction, rather than to protect trade secret information,” and “an effort to prevent disclosure of precisely the sort of information that the framers of TSCA sought to make available to the public.”

The examples make for entertaining reading; I’ll cite just one here:  A submitter of a “substantial risk” notice claimed both its own identity and the identity of the chemical in question as CBI.  When asked to justify the claim, the submitter said the health effect identified in the study was “highly unusual” and that it sought to avoid public release of this information until it could conduct further research, so as to avoid “premature and possibly unnecessary concern” about its chemical.

Seeking in this manner to use TSCA’s CBI provisions for a purpose for which a company might otherwise hire a public relations firm is not, of course, what Congress had in mind when it mandated immediate disclosure of such information.  Nor does it come close to a justification that the information constitutes a trade secret, which is the sole legitimate basis for CBI assertions.

Unfortunately, to the best of my knowledge, that review program at EPA was short-lived and has not been repeated.

5.      The vast majority of CBI claims have never been reviewed by EPA.  And EPA has accepted without challenge CBI claims for information which TSCA does not allow to be so claimed.

TSCA allows companies submitting information to claim any information they want confidential, whether or not it actually meets statutory or regulatory descriptions of eligible information.  The onus then shifts to EPA to challenge a claim it considers invalid (more on the process EPA must follow is below).

Because the resources required to conduct such case-by-case challenges are lacking, the report found that “the vast majority of claims submitted are not reviewed” and substantiation is rarely even requested.  Substantiation is requested and claims are challenged typically only when a Freedom of Information Act (FOIA) request is filed for the information (but see finding 8 below on the limitations of this as a trigger for review).

Lest you think things might have improved, all indications are that this minute rate of review of CBI claims continues to the present day.  As noted earlier, EPA confirmed in the 2005 GAO report (see page 33) that only about 14 CBI claims are reviewed per year.

Another key conclusion of the Hampshire report is that “Agency practice in accepting CBI claims has, in fact, been more lenient than the statute (or its implementing regulations) requires.”

For example, EPA routinely allows PMN submissions to be claimed CBI in their entirety – even when they contain health and safety studies.  (Elsewhere I have noted how few PMNs actually contain any such studies; for example, 85% of PMNs contain no health data.  But 15% of the roughly 1,500 PMNs filed annually is still a good number of PMNs with health data – which should, but are not being, released by EPA.)

All of this contributes to quite a vicious circle:  The more CBI claims are made, the fewer EPA can review; the fewer EPA reviews, the greater the incentive to make unwarranted claims.

Ah, but we’re not nearly done yet:  There are still more factors that contribute to this perverse downward spiral that serves to reduce disclosure of chemical information that Congress meant for the public to see; read on.

6.      Industry faces no penalty for making a false or erroneous CBI claim under TSCA; in contrast, EPA personnel face criminal penalties for wrongful disclosure of CBI – even if the information is not eligible for CBI protection.

The report calls out this remarkable imbalance, noting that it has contributed to the proliferation of CBI claims.  It has also led EPA to create a level of protection for CBI equivalent to that granted top-secret national security information elsewhere in government, and has engendered an “institutional culture” at EPA that invariably tilts far to the side of nondisclosure over public right to know.

7.      Claiming information CBI under TSCA is simple and facilitated by EPA procedures; in contrast, challenging such claims is highly cumbersome and resource-intensive.

Further lowering the transaction costs for asserting CBI claims and raising those for challenging them are the procedures EPA has developed.

In many cases, merely checking a box is all that is required to designate part or all of a submission as CBI.  Until and unless a specific claim is challenged, the confidentiality of that information must be protected by EPA.

In contrast, EPA policy specifies that, for each CBI claim it wishes to scrutinize, it must typically first contact the submitter to request substantiation of a CBI claim, then review the substantiation, then again contact the submitter if it believes the claim is unwarranted to seek its consent to release the information.  If unsuccessful, EPA must then convince its Office of General Counsel the case warrants issuance of a notice of denial, which must be sent by certified mail.  Disclosure must then still await a 30-day period during which the submitter can challenge the impending disclosure in court and halt it pending judicial review and decision.

8.      Processing and protecting CBI imposes heavy direct and indirect costs on EPA; in contrast, there is virtually no cost to industry to assert a CBI claim.

The report describes a range of substantial costs CBI protection imposes on EPA, ranging from direct costs to establish and maintain the needed security infrastructure, to indirect costs associated with limiting or complicating the ability of EPA staff to access information critical to performance of their jobs.  While these costs may be legitimate for information that truly warrants CBI protection, they clearly are excessive in light of the large number of unwarranted claims made.

In contrast, under TSCA there is not even a processing fee associated making a CBI claim.  The report points out that such a fee would serve a dual function, based on experience under other laws:  It could reduce the number of claims made merely by imposing a cost on doing so.  And it would provide EPA with resources sufficient to cover its costs of processing, reviewing, and where necessary challenging such claims.

9.      EPA has routinely failed to disclose the extent of CBI claims asserted overall, or what types of information it receives have been claimed CBI, to what extent and by whom.

In protecting information claimed as CBI, EPA practice has gone beyond merely protecting that information, to shielding from the public even the fact that such information was claimed CBI.  As a result, the report concludes, “there is no way for outside users to know whether or not EPA is in possession of data relevant to their interests.” 

Yet TSCA provides no basis for EPA to hide from the public the fact that a company has claimed certain information to be CBI.  Nor can EPA legitimately hide the extent to which certain types of data are claimed CBI.

Surely the public has a right to know that a certain company claims all of the information it submits to be CBI, while another company claims little or none of what it submits.  And the public should be able to know how often companies claim health and safety data they submit to be CBI – despite and in direct contravention to TSCA’s prohibition on doing so.

How else can we know what we don’t know?

One bright spot of late was EPA’s effort to tally and publicize the extent of CBI claims made for data elements required to be reported under its most recent TSCA Inventory Update Reporting (IUR) cycle.  EPA’s summary report of the information submitted under the 2006 IUR has a nifty table (see Exhibit 3 in that report) indicating the – often large – extent to which certain types of information were claimed CBI by companies.

But it needs to go the next step:  For each submission it receives, it should either make public each information element in the submission – or clearly indicate that the element is claimed by the submitter to be CBI.  That is in addition to providing (as it did in that latest IUR report) aggregated statistics characterizing the frequency and extent of CBI claims both for individual information elements and overall for a given submission type.

10.  The extent of CBI claims asserted under TSCA exceeds by orders of magnitude that under other federal laws – most notably the Toxics Release Inventory (TRI) – even for very similar types of information submitted by companies.

This finding falls under the category of “clearly, there is a better way.”  The report highlights CBI policy and practice under the Emergency Planning and Community Right-to-Know Act (EPCRA), which established the Toxics Release Inventory (TRI). 

The report notes that, in 1988, only 23 trade secret claims were made under TRI – out of more than 70,000 forms submitted.  That’s 0.03%.  Contrast that with TSCA, under which the report estimates 50% or more of the submitted information was subject to CBI claims.

The report’s conclusion:  “CBI claims under TSCA are far in excess of what is needed to protect true trade secrets.”

What accounts for the radical disparity in the CBI experience under these two laws?  The report identifies five key differences.  EPCRA (Section 322) and its associated regulations:

• require up-front substantiation of all CBI claims at the time they are made;
• mandate claims to be certified by a senior company official;
• provide civil and criminal penalties for false claims;
• limit CBI claims to a narrow set of information elements; and
• require that each submission be made available – with each information element claimed CBI clearly identified so the public understands what is being withheld.

These EPCRA provisions help to inform the report’s excellent assessment of solutions to excessive CBI claims under TSCA – which I will delve into in another post in the near future.  So stay tuned – or just read the report!

Interesting exchange this afternoon between Joe Householder, Executive Director of the Coalition for Chemical Safety, and myself in comments on my last blog post.  See Mr. Householder's comment here, and my reply here.

The chemical industry’s fake grassroots group formed to feign broad support for its version of reform of the Toxic Substances Control Act (TSCA) – the Coalition for Chemical Safety, issued a press release today touting that it’s surpassed 150 members. 

I blogged earlier about how some of the small businesses it has enlisted apparently weren’t told about the Coalition backers’ actual positions on toxic chemicals.

Now a review of the 150 members that have allowed the Coalition to meet its latest “milestone” reveals it has supplemented unwitting small businesses with dozens of agriculture-related companies and associations – despite the fact that TSCA doesn’t regulate ag chemicals!

Who knew that growing astroturf requires pesticides??

At least 40 of the Coalition’s members are clearly in the farm, landscaping or seed business – begging the question of whether they’ve been attracted to sign up by the Coalition backers wrongly claiming TSCA reform might lead to bans on pesticides.

More generally, the Coalition’s release makes clear it’s more than willing to play the “chemical ban” card to scare up members.  One choice quote:  “The Virginia State Police Association (VSPA) joined the Virginia Coalition for Chemical Safety to help ensure that our troopers have access to the very best safety equipment available,” says VSPA’s Executive Director.

Of course, real TSCA reform is not about halting the use of chemicals – it’s about driving the replacement of dangerous chemicals with safe ones.  It’s about integrating the heretofore largely missing ingredient of health and environmental safety – alongside traditional considerations of performance, cost and consumer needs – into all decisions made about which chemicals and products our nation makes, uses and sells.  It’s about ensuring the market has robust information needed to inform those decisions, and government has the authority to distinguish between safe and unsafe chemicals.

If the Coalition is serious about TSCA reform, it ought to embrace all aspects of the platform of a real grassroots coalition calling for comprehensive reform – Safer Chemicals, Healthy Families – which doesn’t depend on misleading or scaring potential members to get them to sign up.

After EPA announced yesterday that it will deny certain confidential business information (CBI) claims that have masked the identity of risky chemicals, two chemical industry trade associations responded favorably, saying they “welcome” the move as “the right thing to do.” 

Entirely missing from their responses, however, was any acknowledgment of the fact that the EPA policy shift would not have been necessary but for the huge number of illegitimate CBI claims made by none other than the member companies of those same trade associations.  In a classic case of industry-speak, the companies who have been effectively stealing information from the public about their chemicals try to obscure their nefarious role by now saying they welcome the new alarm system they have forced EPA to install.

As I noted in a post to this blog on Wednesday, EPA’s new policy states that EPA will in general now deny any CBI claim intended to hide the identity of a chemical for which a company is submitting information, as required by law, indicating the chemical poses a substantial risk, if that chemical is already identified on the public version of the Toxic Substances Control Act (TSCA) Inventory.  (My post also noted that further changes are needed if this problem is truly to be solved.)

So what does the chemical industry think of this move by EPA?

In an article in Chemical Week, Charles Drevna, the president of the National Petrochemical & Refiners Association is quoted as saying:

"We support EPA’s action because it is the right thing do with regard to addressing health and safety concerns.  We applaud the Obama Administration for taking this step that, frankly, previous administrations would have been wise to consider.  In the case of health and safety information, it makes little sense to protect the identity of a chemical that is already publicly available on the TSCA inventory."

And Chemical Watch (subscription required) quotes Mike Walls, the American Chemistry Council’s (ACC) vice president regulatory and technical affairs, as saying:

“EPA’s announcement of a general policy on confidentiality claims associated with certain filings under TSCA is a welcome indication of the agency’s ability to apply its statutory authority to promote transparency. While ACC is still assessing the full impact of the policy on filings made under Section 8(e), in general the announced policy is consistent with ACC’s position that EPA and chemical companies should work together to enhance public access to chemical health and safety information.”

Rhetoric versus deeds

This new-found industry enthusiasm for transparency and working to enhance public access to chemical information is quite a reversal from its practice for decades of pressing every opportunity to claim information it submits to EPA as CBI, thereby denying public access to it.  Indeed, it has learned that by flooding the agency with such claims, it can overwhelm EPA’s only defense mechanism:  a time- and resource-intensive, case-by-case challenge process.

The results?  As reported by the Government Accountability Office (see pages 32-34):

• EPA receives extensive illegitimate CBI claims, which must be honored until and unless challenged by EPA.
• EPA is able to challenge only about 14 CBI claims out of thousands made each year, because it simply can’t afford to do more.

Lest you think all this is in the past, consider the very latest posting by EPA of the “substantial risk” notices it receives, those posted for the month of November 2009:

• 41 submissions covering 54 chemical substances were received.
• For 32 of the chemicals, the chemical’s identity was claimed CBI by the submitter.
• For at least 25 of these chemicals, the submitter is a member of the American Chemistry Council.
• For an additional four of these chemicals, the company’s identity as well as that of the chemical were claimed CBI by its mystery submitter.

It remains to be seen how the chemical industry’s rhetoric will stand up when the tougher needed changes are pursued, whether by EPA in efforts to use its existing TSCA authorities, or by Congress in seeking to rein in CBI abuses when amending TSCA.

That will be the real test of whether or not we’re dealing with a truly reformed offender.

The Safer Chemicals Healthy Families campaign, of which EDF is a founding member, is releasing an important report today:  "The Health Case for Reforming the Toxic Substances Control Act."  This report connects the growing number of dots linking chemical exposures to a number of serious chronic diseases that are rising in incidence.  These include certain types of cancer, including childhood cancers; learning and developmental disabilities; Alzheimer's and Parkinson's Disease; reproductive health and fertility problems in both women and men; and asthma.

The report provides a succinct review of the state of the science in each of these areas, and argues that the U.S. has an opportunity to help ameliorate both the rise in these chronic diseases and their associated health care costs — by enacting comprehensive reform of our nation's policies addressing the safety of chemicals.

Check out the report and news release.

Tomorrow's Federal Register will contain a short notice from EPA that partially corrects a decades-old Agency practice that has denied the public access to the identity of chemicals that present substantial risks.

This welcome action begins to pull back the curtain on the chemical secrecy that has been a hallmark of life for the public under the Toxic Substances Control Act (TSCA).  As I noted in a previous post, this action is one of a host of changes needed to remedy the major excesses and abuses of confidentiality under TSCA.  EPA's action makes clear that some things can be done even as we await TSCA reform.

Here's what EPA's notice outlines as the new policy and practice, to take effect immediately:

If, in submitting a "notice of substantial risk" as required under Section 8(e) of TSCA, a company claims the identity of the chemical in question to be confidential business information (CBI), EPA will:

1. review the claim at the time of submission;
2. generally deny the claim if the chemical is on the public portion of the TSCA Inventory (i.e., was not claimed CBI in that context); and
3. inform the submitter of that decision in a manner that constitutes a final EPA action and hence is not challengeable except via judicial review.

What's changing?

All three of these steps represent significant departures from the status quo:

First, EPA will actually review such claims as they come in, to determine whether they are consistent with the new policy or not.  In the past, EPA has rarely reviewed such claims ever, let alone at the time of submission, with the result being that virtually all such claims were by default allowed to persist in perpetuity.

The Federal Register notice forthrightly acknowledges this past practice: 

"Previously, EPA's general practice had been to redact chemical identity from TSCA section 8(e) postings where the identity was claimed CBI even when the chemical identity was listed on the public portion of the TSCA Chemical Substances Inventory."

Second, EPA is putting prospective claimants on notice that, when reviewing such claims, "EPA expects to find that the chemical identity clearly is not entitled to confidential treatment."  This effectively reverses prior policy and practice, under which such claims were presumed to be legitimate even without actual review of them.

Third, EPA's decisions will be communicated to the claimant via a "determination letter" that represents a final Agency action. In the past, EPA has often had to engage in a prolonged song-and-dance exchange of letters with claimants as a prelude to making a final decision – chewing up precious Agency resources and hence drastically curbing the number of EPA challenges of CBI claims.

What's the basis for the change?

EPA's new policy is based on the common-sense notion that the identity of a chemical that is already known to the public – by virtue of it being listed on the public part of the TSCA Inventory – has already been disclosed, and hence cannot be claimed CBI in a different context.

EPA also notes that, by the way, this new policy is consistent with a core part of its mission:  "To promote public understanding of the potential risks posed by chemicals in commerce."

Why this is only a first step towards what's needed

EPA's action is a great first step, but it's only that.  Unless EPA goes further, its new policy will still deny the public access to the identity of many other chemicals posing substantial risk – but whose identities have been masked as CBI and hence don't appear on the public portion of the TSCA Inventory.

(Indeed, I suspect that most of the chemicals with identities claimed CBI in Section 8(e) notices are also claimed CBI on the TSCA Inventory.  EPA did not but should provide such statistics, so that the magnitude of the change it's making – and of the larger problem – can be better gauged.)

Here's why EPA must go further:

First, public interest must trump private interest.

While TSCA provides wide latitude for companies submitting information to EPA to claim it CBI, one bright spot – in theory – is that TSCA prohibits granting CBI status to data from health and safety studies (see section 14(b)).

Why would Congress, when drafting TSCA, have gone out of its way to carve out an exemption from CBI eligibility for data from health and safety studies – effectively establishing the public's right to know such information – only to render impotent that right by denying the public the right to know to which chemical the data apply?  That makes no sense.

In its regulations, EPA itself has defined the identity of a chemical to be an integral part of a health and safety study (see here and here).

EPA's regulations also acknowledge the primacy of public over private interest.  Part 2 of Title 40 of the Code of Federal Regulations lays out EPA's regulatory provisions governing "public information," including procedures to be followed under the Freedom of Information Act (FOIA).  Look at this interesting provision found in Section 2.202(d):

"If two or more of the sections containing special rules apply to the particular information in question, and the applicable sections prescribe conflicting special rules for the treatment of the information, the rule which provides greater or wider availability to the public of the information shall govern." (emphasis added)

But as is so often the case under TSCA, what TSCA giveth with one hand it taketh away with the other.

TSCA provides an exception to the exception for health and safety data:  In disclosing such data, EPA cannot make public data that discloses either:

• "processes used in the manufacturing or processing of a chemical substance or mixture" or
• in the case of a mixture, "the portion of the mixture comprised by any of the chemical substances in the mixture."

Based presumably on this provision of TSCA, EPA regulations provide certain conditions under which a company may assert a confidentiality claim for the identity of a chemical – even when associated with a health and safety study.  It should be noted, however, that these regulations only apply to new, not existing, chemicals.  Moreover, they state that EPA will deny such a claim unless the claimant demonstrates that "the specific chemical identity is not necessary to interpret a health and safety study." See 40 CFR §720.90(c)(3).

I ask you:  How on earth could it not be essential to know the identity of a chemical in order to understand health and safety information about that chemical?

Finally, the astute reader will notice that nothing in TSCA's exception to the rule that health and safety data must be made public speaks to chemical identity.  Only the divulgence of information describing how a chemical is made or processed, or revealing how much of a given chemical is in a mixture, is excepted.

I suspect that some talented chemical industry lawyers have racked up many billable hours devising arguments as to why EPA must interpret such a limited provision so broadly as to extend it all the way to including something never mentioned at all in the provision:  chemical identity.

I would argue that such an interpretation flies in the face of:

• the express words of TSCA,
• the clear intent of Congress to provide public access to health and safety information,
• the core principles of right-to-know and the primacy of public over private interest,
• sound public policy, and
• last but not least, plain old common sense.

So I welcome EPA's action as a good first step in correcting a particularly egregious example of chemical secrecy under TSCA.  It appears that EPA sees it as a first step toward addressing this problem as well:  Its Federal Register notice describes the new policy as "part of a broader effort to increase transparency and provide more valuable information to the public."  Other recent actions announced by EPA fit this mold.  For example, its disclosure of the identities of 530 chemicals on the TSCA Inventory previously exclude as CBI; and its proposal to require disclosure of the identities of inert ingredients in pesticide formulations.

I also look forward to the next installment in EPA's effort.

In recent days, two compelling cases have surfaced of so-called “regrettable substitutions” – industry responding to concerns about the use of one dangerous chemical by replacing it with another that is less well-studied, or at least not currently in the crosshairs.

Case 1:  Chinese manufacturers of children’s jewelry, responding to concerns and restrictions on the use of lead in such products produced for export to the U.S., have replaced it with cadmium, a known human carcinogen and developmental toxicant that, if anything is even more toxic to kids than lead – but is not subject to any restrictions in such kids’ products. 

Case 2:  American food product manufacturers, responding to concerns about the devastating effects on the lungs of workers exposed to diacetyl – an artificial butter flavoring used in many products, most notably microwave popcorn – have begun to replace it with closely related chemicals likely to break down into diacetyl or otherwise have similar effects.

Are we destined forever to play this dangerous variant on the game of whack-a-mole, or can something be done?

Investigative journalism to the rescue

An interesting side-note to both cases:  Journalists have played the major role in exposing these debacles. 

In case 1, it was not our government, but rather Justin Pritchard at the Associated Press, that brought the lead-to-cadmium bait-and-switch to light.  AP commissioned its own product testing, testing 103 items – charm bracelets, pendants and the like — bought in New York, Ohio, Texas and California in November or December 2009.  It found that 12 percent of the items contained at least 10 percent cadmium, with the highest containing 91 percent!

In case 2, while the National Institute for Occupational Health and Safety (NIOSH) has been hot on the trail of diacetyl and substitutes, it was Andrew Schneider, a longtime investigative reporter writing for the AOL news outlet Sphere, who has most recently publicized the quiet replacement of diacetyl with closely related chemicals.  [Note added 1/13:  I was remiss in not realizing and noting the extensive coverage of this issue going back many months that has been going on at The Pump Handle blog.]

Isn’t it obvious that such substitutions should be avoided?

One might think that the chemicals considered as substitutes for a known danger would get scrutinized a little more closely than usual, in order to avoid repeating unwanted history.  But a combination of incomplete or inadequate regulations, resource-strapped government agencies and entrenched political resistance to market intervention work to perpetuate a lethally flawed system of chemicals management in this country.

From a scientific standpoint, avoiding the use of any toxic metal in making kids’ products would seem to be a no-brainer.  The AP story points out that virtually nontoxic zinc is a suitable substitute metal for use in children’s jewelry.  But this case apparently was driven down the path of least resistance:  Cadmium has been used domestically in China for kids’ jewelry and related products for many years, which likely explains the rapid transition to using it for exports in the face of newly-enacted U.S. restrictions on lead.

The diacetyl case is equally hard to fathom from a purely logical – dare I say naïve? – standpoint.

Inhalation of diacetyl leads to a wholly debilitative lung condition whose name speaks for itself: obliterative bronchiolitis.  Previously known to affect workers exposed to certain types of fumes in heavy industry, its association with diacetyl in butter flavorings began to be recognized only in 2000, when the first cases of what is now known as “popcorn workers lung” were identified at a microwave popcorn plant in Missouri.

First thought to be confined to industrial workers (albeit in the food industry), cases of this disease traced to diacetyl exposure have now been found in service industry workers and even in an individual consumer who reportedly ate two bags of microwave popcorn a day and enjoyed inhaling their aroma (who doesn’t?). 

Andrew Schneider reports on the case of a Blockbuster Video employee who contracted the condition after microwaving many bags of popcorn on a nightly basis to fill the old-fashioned popcorn machine in the store.  She is the third known case among of non-factory workers.

In response to the horrible publicity surrounding diacetyl, a number of major food companies – General Mills and ConAgra (owner of Orville Redenbacher’s) among them – announced they would no longer use it.

So what have they moved to instead?  As noted by Andrew Schneider, some companies have shifted to “natural materials” known variously as starter distillates and diacetyl trimmers.  [Note added 1/13:  An astute reader has posted a comment noting that the reference in the original Sphere article to "diacetyl trimmer" is likely a typo, and should actually be "diacetyl trimer."  This chemical is essentially comprised of three linked diacetyl molecules.   Indeed, meeting notes posted on the website of the Division of Occupational Safety and Health of the California Department of Industrial Relations cite John Hallagan, general counsel for the Flavor and Extract Manufacturers Association, indicating that a trimer of diacetyl is one substitute for diacetyl now being used.]

Schneider notes that these “substitutes” either contain diacetyl or release it upon contact with heat and moisture (gee, how likely is that to happen?).  He cites NIOSH physicians who describe these materials as not representing any real substitution at all.  He also cites a trade association representative saying this shift is occurring so that companies can label their newly-formulated products as “natural.”  [Note added 1/13:  Thanks to another very interesting post from last week on this subject of diacetyl substitutes by Celeste Monforton at The Pump Handle, I have learned that NIOSH and OSHA have both stated in writing their concern about the lack of safety data on substitutes and the concern that they break down into diacetyl.  NIOSH did so in a recent letter sent to new OSHA Administrator David Michaels.  OSHA did so in a January 2009 Federal Register notice, stating:  "Both diacetyl trimer and the sulfite adduct of diacetyl have a low vapor pressure in their basic form, and are thus less likely to evaporate and result in employee inhalation exposures during the production process. However, both are converted to diacetyl during consumer food preparation, so that the foods when consumed will contain diacetyl. For example, if placed on popcorn, both convert to diacetyl when the popcorn is popped."]

To describe another substitute, I need to provide a short chemistry lesson.  Diacetyl is a nickname for the chemical, 2,3-butanedione.  It looks like this:

Some companies who tout their move away from diacetyl have replaced it with flavorings containing this chemical:

This chemical is named 2,3-pentanedione.  As you can see, even if you’re not a chemist, the only difference is the addition of a single carbon atom, from a total of four (to which the “buta”prefix refers) to five (to which the “penta” prefix refers).

They should know better

You also don’t have to be a toxicologist to have the following thought pop into your head faster than you could make a bag of microwave popcorn:  If these chemicals look so similar, might not they affect people’s lungs in a similar manner?  And might not a company want to thoroughly test the second chemical before claiming it to be a safe replacement for diacetyl?

This past November, NIOSH did an inspection of a General Mills “bakery mix production facility” located in Los Angeles.  In the resulting inspection report, termed a Health Hazard Evaluation, NIOSH reported that the company had replaced most, but not all, diacetyl-containing flavorings with ones containing 2,3-pentanedione.  Detectable levels of this chemical were found in the air in the plant and could be measured especially where workers bagged the powdered bakery mixes.

NIOSH also reported that a number of plant workers exhibited respiratory symptoms while at work.  And lung function tests performed by NIOSH found “higher than expected” evidence and incidence of respiratory problems, compared to the U.S. adult population; for example, 18% of the workers had “restrictive patterns” indicative of possible lung disease.  None of the workers exhibited popcorn worker lung-like symptoms, however.

None of this proves 2,3-pentanedione is risky, of course.  But it certainly begs the question.

Noting in its report that “a ‘safe’ level of diacetyl has not been established, and even low levels of diacetyl are potentially hazardous,” NIOSH goes on to state:

The toxicology of diacetyl substitutes is only now being studied.  Because 2,3-pentanedione, 2,3-hexanedione, and 2,3-heptanedione all share the same functional alpha-diketone group as diacetyl, these compounds may also share diacetyl’s mechanism of toxicity.

In other words, the operative presumption should be that 2,3-pentanedione and related chemicals affect people the same way diacetyl does.

Indeed, NIOSH’s report recommends to General Mills that “Until more is known about 2,3-pentanedione and similar alpha-diketone compounds, do not assume these compounds are safe.” (emphasis added) 

Yet these chemicals continue to be used as substitutes for diacetyl.

What can be done to avoid “regrettable substitutions”?

The two examples above may strike you as no-brainers, but there are many more cases that are not so obvious or where there aren’t such clear red flags.

I can sympathize with companies caught unawares when a chemical they use crashes onto the radar screen.  Nor is it hard for me to imagine they might leap at the first available alternative that is identified, based on nothing more than the fact that it is not, at least technically, the chemical of concern.

But these impulses can be downright dangerous in the context of our current policy and regulatory climate that has allowed most chemicals in or entering commerce to escape adequate testing or safety assessment.  That failing makes it all the more likely that a chemical chosen as a substitute for a known bad actor is either no better or untested and unstudied.

As readers of this blog know, the poster child for this failed policy is the 1976 Toxic Substances Control Act (TSCA).  TSCA “grandfathered in” the more than 60,000 chemicals on the market at the time, without requiring any testing or demonstration of their safety.  Measured by tonnage, the vast majority of chemicals on the market today – 34 years later – is comprised of those same chemicals.

What changes to TSCA could lessen the likelihood of further regrettable substitutions?

Here are a few suggestions, each of which is a featured plank in the platform of the Safer Chemicals, Healthy Families campaign with which EDF is closely working.

1.      Adopt a comprehensive approach to testing and assessing the safety of chemicals in commerce:

First, we simply must bite the bullet and start the process of digging ourselves out of the hole created by TSCA.  While it will require considerable time and expense, TSCA reform must include a requirement that all chemicals be shown to be safe as a condition to enter or remain on the market, based on robust information developed on the uses, hazards of and exposures to those chemicals.

Some, especially in the chemical industry, would have us skip this altogether.  As I noted in previous posts (here and here), they suggest we simply identify the usual top suspects, maybe require further testing and study of them, and then maybe even regulate a handful of those – and be done with it.  Their estimates of how many chemicals might “rise to the top” range from “50-100” (subscription required) to “5%” of chemicals in use today.

As I've argued before, there's an inherent contradiction here.  The chemical industry is among the first to cry "regrettable substitution" when insufficient attention is given to what will replace a chemical targeted by state or federal authorities for restrictions.  But how are we ever to compare alternatives and select safer ones with confidence unless we have good information about them?

2.      Maximize public and market availability of chemical information:

Companies and institutions that use chemicals to make products, or that sell, buy or use those products, as well as individual consumers, make decisions involving chemical choices every day.  Those choices are often ill-informed today, based on assumption instead of data, or incomplete or biased information.

Companies need to know what chemicals are in the products they’re making, buying, selling or using, what is known about those chemicals’ hazards, and what the potential alternatives to such chemicals are.  They also need to know when government has identified a chemical to be of concern and is considering initiating regulatory action.

Only by requiring the development and broad sharing of sound and complete information about chemicals can we hope to address what amounts to a major market failure perpetuated by our current chemicals policies.

3.      Drive companies as well as government to prioritize efforts to develop, identify and assess the safety of alternatives to chemicals of concern:

Government needs to have the authority to direct both its own resources and attention and those of companies toward developing and identifying safer alternatives to chemicals of concern.  Doing so will require that both carrots and sticks are embodied in the range of tools available to government.  For example, government needs:

• ample authority to clearly identify and restrict the use of dangerous chemicals;
• the ability to require companies to seek out safer alternatives, as one of the available regulatory actions it can take;
• resources to investigate and identify safer alternatives, and to develop and provide to companies the tools and data they need to do the same; and
• programs to incentivize and reward those companies that do develop and implement safer alternatives.

Adopting these kinds of changes just might yield a future chemicals management system about which we can truly say, “No regrets!”