August 30, 2007 The Pump Handle 3Comment

By Liz Borkowski 

Here in the U.S., people seem to like the idea of our government ensuring that we’ve got clean air, clean water, and healthy workplaces, and that our exposure to toxic substances is limited. However, we also keep electing politicians who make it hard for federal agencies to ensure these things.

We’ve written before about problems at OSHA, where workers suffer from preventable harm while officials emphasize voluntary compliance at the expense of standard-setting, and at FDA, where a rush to review new drug applications leaves post-market drug safety under-resourced. While presidential appointees heading these agencies deserve a share of the blame (a hefty share, in the case of OSHA’s Edwin Foulke), the legislation governing agency activities often erects hurdles that can slow progress to a crawl. A new report from Environmental Defense shows how this is happening at EPA with toxic chemical legislation.

The Toxic Substances Control Act of 1976 allows EPA to collect or require the development of information about the toxicity of particular chemicals used and produced in the U.S. If it wants to require companies to test their chemicals, though, it has to make certain statutory findings about the substance involved, and that can be a cumbersome process. In High Hopes, Low Marks: A Final Report Card on the High Production Volume Chemical Challenge (via ES&T), Environmental Defense Senior Scientist Richard Denison reports that in the 30+ years since TSCA’s enactment, “EPA has succeeded in compelling hazard testing for about 200 of the tens of thousands of chemicals in US commerce.”

After a series of studies documented major gaps in knowledge about hazards associated with some of the highest-volume chemicals in use, EPA established a voluntary program to try and fill these holes. The High Production Volume Chemical Challenge, launched in 1998, asked chemical manufacturers and importers to “sponsor,” or provide a basic set of hazard data for, HPV chemicals – a list that at the time consisted of 2,782 substances produced or imported into the US in amounts of one million pounds or more annually.

High Hopes, Low Marks applauds the program for what it’s trying to do and recognizes that it would be extremely difficult for EPA to force companies to develop data on this many chemicals. It finds, though, that the agency has “limited recourse to ensure full participation of manufacturers or the timely submission and high quality of hazard data sets developed for HPV chemicals.” The chemical industry was supposed to have submitted its final data sets by 2004, and EPA was supposed to have made it available to the public in 2005. As of July 6, 2007, Dennison reports that the status of the 2,782 HPV chemicals breaks down as follows:

• 15% exempted or removed from the list
• 10% never sponsored
• 15% lack a test plan
• 20% test plan pending
• 40% final data sets completed

Data on forty percent of HPV chemicals is better than nothing, but the quality of those data sets is also an issue. Dennison explains, “The average quality of initial submissions of test plans and robust study summaries, while originally quite good, has declined considerably over the course of the Challenge, especially in the past 18 months.” Since participation is voluntary, it will be hard for the EPA to demand that the companies improve the quality of their work.

The quality of EPA’s work isn’t as high as we might hope, either. It’s been slow to develop test rules for the unsponsored (or “orphan”) chemicals, and when it comes to the HPV database, “much work remains to fully populate it and make it functional and user-friendly.”

In short, the Challenge isn’t going so well. The ED report summarizes some “lessons learned” that might improve the program in the future, but it seems that a better solution might be to amend TSCA to give EPA more authority. That’s what the GAO recommended, anyway, in its 2005 report on EPA chemical regulation:

To improve EPA’s ability to assess the health and environmental risks of chemicals, the Congress should consider amending TSCA to

• provide explicit authority for EPA to enter into enforceable consent agreements under which chemical companies are required to conduct testing;

• give EPA, in addition to its current authorities under section 4 of TSCA, the authority to require chemical substance manufacturers and processors to develop test data based on substantial production volume and the necessity for testing; and

• authorize EPA to share with the states and foreign governments the confidential business information that chemical companies provide to EPA, subject to regulations to be established by EPA in consultation with the chemical industry and other interested parties, that would set forth the procedures to be followed by all recipients of the information in order to protect the information from unauthorized disclosures.

Actually, this sounds kind of like what Lynn R. Goldman, EPA Assistant Administrator For Prevention, Pesticides And Toxic Substances said back in 1998, when the HPV Challenge got its start. In ICIS News, Glenn Hess reported on discussion at an industry-sponsored forum on TSCA:

Dr. Goldman insists changes are need for reviewing new chemicals (TSCA Section V) and managing extremely hazardous substances (TSCA Section VI).

She recommends adopting a modified version of the European approach to evaluating the safety of new industrial chemicals prior to marketing, in which a “base set of health and environmental effects data” is required.

Under TSCA, US chemical manufacturers do not have to provide EPA with toxicological data or information about a chemical’s basic physical characteristics. Dr. Goldman notes that more than half of pre-manufacture notifications are submitted with no toxicity data at all. The US is the only industrialized nation that does not require the submission of such data as part of its new chemical review process. …

“Volunteerism is great, but it only goes so far,” she says. “There will be situations, and industry knows this, where people will not voluntarily come forward [to take risk reduction actions]. And for some in industry, it is less expensive to hire lawyers and fight EPA” than to voluntarily halt the use of an extremely hazardous substance.

Nine years later, we have additional evidence that industry volunteerism does not go far enough. Will legislators heed the call to amend TSCA, or will we be stuck knowing too little about the risks that high-production volume chemicals?

Liz Borkowski works for the Project on Scientific Knowledge and Public Policy (SKAPP) at George Washington University’s School of Public Health and Health Services.

3 thoughts on “Low Grades for Voluntary Chemical Reporting

  1. Hello,

    I am a food science student at The Ohio State University majoring in Food Business Management and I thought I would add some perspective to your story.

    Diacetyl isn’t just a ‘food chemical’ . The reason the dfood industry uses it as a butter flavoring is because it is the chemical found in butter that gives butter it’s flavor. That’s right, if you want immediate action taken against diacetyl, then you will also be ridding the country of butter, buttermilk, sour cream, and some cheeses. Diacetyl is a natural byproduct of certain dairy foods.

    Does diacetyl become an airborne chemical once heated in a microwave? I really don’t know.

    The patient in this case reportedly ate microwaved popcorn several times a day. Does that seem like a lot to anybody else? I only eat popcorn several times a year, so I guess I’m on the other end of the spectrum. Do we regulate an additive based on the most casual consumer? No. Do we regulate an additive based on the consumer with the highest levels of consumption? No. The cancer patient and I are examples of the extremes of consumption for a particular product.

    There are other things that can be done that are more effective towards stemming the possible illness of those on the extremes of consumption. Diacetyl is an additive, and as an additive, the FDA lists the specific amounts that can be used whil still being GRAS. All the FDA would need to do is reduce the amount that can be used. That way, crazy popcorn cancer guy would have to eat several more bags of popcorn a day for several more years before anything would be a problem.

    Before that can be done though, the FDA need more scientific study done on this phenomena. Saying that there isn’t any other possibility isn’t good enough for science. Data must be reproducible under different studies by different people. Variables must be eliminated. Does this only occur with popcorn in a microwave? Does the packaging play a role? Could melting or heating butter on a stove (for non-microwave popcorn) carry the same effect?

    More questions need answered and more proof given before anything rational can be done.

  2. I see a need here for other ethically and legally messy changes, which science and biomedicine alone cannot address, privately or with force of law.

    Some of these issues are ones which require functionally literate people acting responsibly, and a choice between approaches which are oppressive and trample civil rights, or approaches which respect a Darwinian view that people have a right to harm themselves but not others. I lean strongly towards the latter, but also view “lack of candor” in nondisclosure of information (even if people use it recklessly or ignore it) as equivalent to active frauds.

    Since most people lack biomedical backgrounds, there’s also a need for education in terms of simple daily life practices. That ties into religion and subcultures for most people, when only a tiny fraction do original research or study, and then interpret that information in realistic ways. The ethical and legal issues of how to tamper with traditions which are also individual rights requires reaching community leaders who approach different audiences using a wide range of techniques depending on local and group needs or abilities.

    If we had strongarm regulation restricting all chemicals which if concentrated and used to extreme levels could cause medical disability or death, green vegetables and water would make that list. In effect, the only way to fully protect the clueless and reckless is to kill them. An alternative to that is to also use education and information channels to leaders, to help more people recognize religion rooted world views which indoctrinate binary good-bad, good-evil black and white ideologies as fundamentally dysfunctional and pathological, while also looking for ways to simplify issues of great complexity into functional mechanisms for people who’d likely never visit a site like this.

    When 9 of 10 people approached on the street who agree to look at a petition have been proven willing to sign a demand to ban dihydrogen oxide as dangerous based on a scientifically accurate list of harmful effects, and only a tiny minority do a double take and recognize that as water, our society offers some serious challenges in how to make information useful.

    What if building codes required outside ventilation, mechanical or passive window based, for kitchens as they do for bathrooms? That in concert with economic pressures and energy efficiency improvements might be as much of the popcorn issue as actual food safety. Did the home cancer guy, with a nearly certain incredibly unhealthy overall diet if he used massive amounts of microwave popcorn, live in a small apartment or condo with a poorly ventilated interior kitchen?

    Even an MSDS for a structural steel beam warns of the hazards of it burning, or dropping on a foot, or from eating or inhaling it. Should anyone who needs that MSDS information really be trusted with a grinder, cutoff saw, torch, or crane? At some point Sam’s suggestions might well point to some humans really being most qualified to remove themselves from the gene pool as a public health improvement. Drunk drivers are perhaps the most extreme example of that, of a safe substance often used by reckless people in unsafe ways.

    Shhh…. DC public policy officials aren’t allowed to honestly discuss such issues though.

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