REACH in the EU: Model for TSCA?
Governments regulate chemicals to help keep citizens safe from toxicants that would otherwise pollute their food, drink, and air. But such regulations are difficult to pass because of course some parties will always claim that the regulation will cost taxpayers, will cost jobs, and will inflict mortal wounds to the economy. In this challenging environment, EU and US agencies are now working to strengthen historically weak chemical oversight. The popular press recently covered a Nature article that projected much higher costs for the EU's oversight plan and predicted the necessity of extraordinary numbers of lab animals for toxicity tests. Nature is a respected science journal, not predictably partisan venue like, say, the Wall Street Journal editorial page or the Socialist Worker. But critics including an EU agency and the Environmental Defense Fund point out flawed reasoning and familiar marks of bias in this Nature paper, flaws not highlighted in the popular press. 1
As we wrote in our last post, efforts to regulate bisphenol A may be in process, but a larger issue persists in the number of chemicals with unknown safety profiles that citizens are subjected to. In the US, some chemicals can enter the market with minimal government testing and 60,000 chemicals were grandfathered in under the US Environmental Protection Agency's Toxic Substances Control Act (TSCA) of 1976. To be clear, not all of these grandfathered chemicals are on the market, and some are safe -- but some aren't -- which ones?
Toxicologists have long argued for an overhaul of TSCA, known in some circles as the "Toxic Substances Conversation Act" by those who think it serves the needs of the chemical industry all too well. Asbestos, for instance, remains on the market because the EPA can not use TSCA (.doc download) to ban most asbestos products, regardless of documented health risks.
On the European front, a newer regime for testing chemicals called REACH (registration, evaluation,authorization and restriction of chemical substances) promises more complete oversight of chemicals in the EU than TSCA in the US. But REACH has its own complex goals and challenges, as we described here and here. And like TSCA in the US, the European program has its foes.
REACH: Smelling A Rat in the EU?
REACH underwent significant changes in the face of the chemical industry pressure before its implementation. Companies continue to agitate about the costs of REACH and the European Chemical Agency (ECHA) and the European Commission continues to reassure the public by reiterating their cost estimates.
Recently, toxicologists introduced a new wrinkle. Thomas Hartung, from John Hopkins Bloomberg School of Public Health, and chemistry consultant Costanza Rovida caused a stir by estimating not only huge unpredicted costs for REACH, but for predicting that REACH regulations would require millions more lab animals than the EU had calculated. Their Nature article referred to their analysis in the less well known journal ALTEX. They claim most REACH overruns would stem from reproductive testing, and said the program would use:
"54 million vertebrate animals and cost 9.5 billion... This is 20 times more animals and 6 times the costs of the official estimates. By comparison, some 90,000 animals are currently used every year for testing new chemicals in Europe, costing the industry some 60 million per year."
You don't need to be an animal activist to recoil at costly regulations that might waste every last vertebrate lab animal in Europe and more -- a reaction that their study could provoke. But suppose the authors didn't calculate correctly?
The Environmental Defense Fund's Richard Denison et al. comb through the Nature and ALTEX calculations and dispute pretty much every the calculation Hartung and Rovida make, starting with the estimates of the number of chemicals in use, moving on to the numbers for chemicals pre-registered, likely to be registered, the numbers of rats needed, and the associated costs. Denison concludes:
"As noted at the start, this study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved."
ECHA comes to basically the same conclusion, and notes that "the real figures are more likely to be the ones assessed and published when the new chemicals legislation (REACH) was prepared and negotiated."
The Opportunities of Lax Oversight?
Given that Denison's estimates and the numbers originally estimated by ECHA were a fraction of Hartung's estimates, the reader may ask -- "Which is it? Are there hundreds of thousands of unknown chemicals that need to be tested? Tens of thousands? Thousands? Why don't scientists know?" Well exactly, that's the point. As REACH progresses EU citizens will get better grip on which chemicals they're being exposed to and in what quantities. The current level of public ambiguity indicates the extent to which the risks to citizens are now unknown. But ECHA estimates that about 16,000 chemicals will be be registered by the first two deadlines, and that less than 6,000 of these will need full testing. The picture will get clearer as the chemical registrations are assessed through REACH.
In the meantime, the years of lax oversight provide the authors the opportunity to shock everyone. 54 million animals, some might ask (gasping)? The Nature article prompts that loaded question -- to which organizations like ECHA and EDF, dedicated to protecting people from say, being blinded by eyelash dyes, must reply with the uncomfortable answer: "No, actually it's only 9 million animals, not 54 million".
In truth, REACH is already committed to alternative testing like cell-based assays, and cheaper toxicology testing methods such as high-throughput screening. Decreasing the number of animals used in testing is a goal shared by all -- by the EU, by EDF, the EPA, etc.
When Chemical Companies Ally with The Humane Society, It Means?
Based on their estimates, Hartung and Rovida conclude that REACH is unfeasible and recommend halting aspects of it. They also recommend increased funding, especially in the US, for non-animal testing methods. While it's impossible to discern any motive for their study other than science progress and animal welfare, it's nevertheless interesting to look at some background.
Hartung runs John Hopkin's Center for Alternatives to Animal Testing (CAAT), which aims to develop methods to replace animals testing. He left his position at the European Centre for the Validation of Alternative Methods (ECVAM) saying, among other things, that chemical companies weren't involved enough (via Alttox.com). He moved to John's Hopkins in 2008.
Chemical companies are involved now. EDF's Denison points out that although the ALTEX study claims to have been peer reviewed, 5 of the 6 "peers" were actually industry representatives. Also of note, ALTEX is a publication of John's Hopkins'. Co-author Hartung sits on the journal's board and was assigned the position of North American editor in February. ALTEX is not exactly a neutral publication venue for Hartung.3
Chemical companies have historically argued that chemicals are safe without testing, that REACH is unnecessary, and that TSCA is good as is. But their cooperation is important to the success of toxicology programs, so in this case we'd hope that they've come around, that their concern for animals is genuine, and that their commitment to REACH steadfast.
But Denison thinks otherwise. He points out that the chemicals targeted by REACH effect animals in the wild too. So why the huge concern for lab rats, but not for eagles? Denison also notes "a strongly shared interest between the chemical industry and animal welfare advocates in undercutting chemical testing programs".
EDF has a long history of working with companies to achieve market friendly environmental compromises. Denison himself has substantial history with chemical companies who have been less than cooperative (.pdf) in collaborations with the EPA. There may well be a need for increased funding of alternative toxicology testing methods. But given the background of EDF and Denison it's hard to ignore their criticism, despite Hartung's excellent credentials and expressed support for REACH.
1Nature 460, 1080-1081 (27 August 2009) | doi:10.1038/4601080a; Published online 26 August 2009, Chemical regulators have overreached, Thomas Hartung & Costanza Rovida
2 Even the chemical, pharmaceutical and personal products industries are dedicated to reducing animal testing.Alttox, an on-line forum for alternatives to animal testing, is cosponsored by the Humane Society, Proctor and Gamble, and the American Chemical Council.
3 We previously criticized the journal "Risk Analysis" which we called vanity press for Sciences International Inc..