Sep 3, 2009
Implementing Europe’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program will require a massive increase in animal testing and cost six times more than previously estimated. The findings come from an analysis conducted by researchers at the John Hopkins Bloomberg School of Public Health (Baltimore, MD).
"REACH expected that 27,000 companies would submit 180,000 preregistrations on 30,000 chemicals,” Thomas Hartung, a Doerenkamp-Zbinden professor, chair for evidence-based toxicology, and director of the Center for Alternatives to Animal Testing at the Bloomberg School of Public Health, explained to Pharmaceutical Technology Europe (PTE). “The big surprise, however, was that at the end of December 2008, 65,000 companies had submitted 2.7 million preregistrations on 143,000 chemicals." Hartung co-chaired the 7th World Congress on Alternatives & Animal Use held in Rome earlier this week.
In a press statement, Hartung described REACH as the "biggest investment ever into consumer safety." However, he also believes that the scale of the challenge may have been underestimated. REACH could require 54 million research animals and EUR 9.5 billion ($13.5 billion) during the next 10 years. Approximately 90% of the projected animal use and 70% of the projected cost would come from research into reproductive toxicity testing. Usually, data must be collected from two generations of two species of animals.
Hartung explained to PTE that the second species is rarely used when testing chemicals because few new chemicals are produced at quantities high enough to trigger testing. "This is now different with REACH where the high-production chemicals are tested; so while only 70 two-generation studies were conducted over 25 years for industrial chemicals in the EU, we calculated 14,000 for REACH if the guidance to industry is followed," he said.
He added that, "European regulators need to understand that this is not only about animal numbers, but mainly about feasibility. It is not possible to create the test facilities. We do not have the toxicologists—a two-generation study assesses 80 endpoints, including complex histopathology. Our analysis should not be misread as a pure ethical or financial concern—it is about a bottleneck identified for a program we want to happen."
So what are the alternatives? Hartung suggests testing only suspicious chemicals. "Currently, the main trigger is production volume; at least prioritize the suspicious substances and leave the others for later when high-throughput strategies are developed," he says. He offered additional options, including the use of an extended one-generation study and in vitro approaches.
"We hope that our study helps to gain momentum for a revision of current practices in regulatory toxicology," Hartung told PTE. He also explained that Europe could benefit from a development similar to the US Environmental Protection Agency toxicity testing strategy, which came into force in March 2009.
Insiders Mulling Over ImpactsThe insiders, BNA and ChemicalWatch, are both reporting that EPA has released an announcement on the end of CHAMP. But even industry professionals are left in the dark, as no announcement has been made publicly available at the websites of CHAMP, the EPA, nor the White House blog.
Major organizations have responded cautiously to the announcement. Some statements published in Chemical & Engineering News:
"We are confident that any changes to ChAMP do not signal a reversal of the U.S. government's commitment, but rather further strengthen the program." -American Chemistry Council.
"It is extremely disheartening that the administration would abandon its priority-setting chemicals management process before it is even given the opportunity to work." -National Petrochemicals and Refiners Association
"We urge EPA to not delay the forward progress it has been making under ChAMP." - Society of Chemical Manufacturers.
CHAMP for Better or WorseCHAMP represents a largely "voluntary" effort by the chemical industry to provide information on High Production Volume (HPV) chemicals. "Voluntary" in quotations, because such programs have become the preferred way for industry to avoid the burden of regulation by stepping up to the plate first. So the response of industry can be understood in the context of fears that the program which succeeds CHAMP may very well require a bit more -- meaning more cost and more bureaucracy in the pursuit of more protection of American citizens.
The Environmental Defense Fund and others have criticized CHAMP for an insufficient standard of protection, pointing out that the data submitted voluntarily by industry shows large gaps in knowledge about the chemicals currently on the market. Worse, according to EDF, is the process EPA applies to the incomplete data. CHAMP throws chemicals with no evidence of a high hazard into the "don't worry" or "don't worry too much" boxes. EDF argues that in the face of incomplete data, EPA should flag chemicals for priority research whenever the data is incomplete.
As is often the case in the complexity of the real world, both sides are right. The chemicals which have incomplete data are most often the ones that industry knows are not too bad, based on years of handling these chemicals without observing any clusters of illness related to them. So the assumption that these chemicals are "safe" is not groundless in spite of a lack of specific animal studies. Perhaps hiding behind the PETA issues, industry makes a strong case that testing should not be done simply so that check-boxes can be ticked.
What Comes After CHAMP?
And no matter who is right, the key fact is that the US EPA has to do something. Clearly the Obama Administration is committed to environmental protection. So the message behind the suspension of the Bush era CHAMP program can only imply a finding or anticipated finding, perhaps under cost-benefit analysis, that CHAMP is grossly, indefensibly ineffective. Subtext: US citizens have been inadequately protected for years in spite of money being thrown at the problem (EPA requested a hefty increase in its 2010 budget for more hiring in CHAMP).
The anticipated successor to CHAMP is the Lautenberg Kids Safe Chemical Act. This law would update the decades old Toxic Substances Control Act (TSCA). In the wake of European REACH, EPA will be under pressure to expect more, much more, from industry. A battle looms. Will industry be able to maintain its stance that "responsible care" can protect people and the environment most cost-effectively? Or will they face an era of regulatory control championed by a public confused and fearful as they confront daily a chemical soup.
While TSCA reform has yet to solidify into real legislative proposals in the current Congress, Senator Lautenberg has indicated that he will reintroduce the Kids Safe Chemicals Act in 2009. This legislation would inject the "precautionary principle" into the chemicals management process and shift the burden of proof away from the government and to the chemical company. Critics say this approach is like altering our judicial system toward the philosophy that a defendant is "guilty until proven innocent."
Meanwhile, on February 26, 2009 the House Subcommittee on Commerce, Trade, and Consumer Protection held the first of what is expected to be a series of hearings on the potential overhaul of TSCA. Committee Members and their witnesses expressed a strong desire to explore the possibility of REACH as an appropriate model for the U.S. while industry witnesses criticized REACH and similar programs, favoring instead a "true risk-based system" to align economic and regulatory regimes. However, even the chemical industry has indicated it is not opposed to updating or modernizing TSCA. American Chemistry Council (ACC) and Society of Chemical Manufacturers and Affiliates (SOCMA) testimony echoed this point but were very clear on the principle that the U.S. should not go the route of Europe and completely change its philosophy regarding chemicals management.
In considering TSCA reform, NACD urges Congress to support approaches like ChAMP, which has the potential to quickly test and provide public information on more chemicals than a REACH type of framework. NACD is concerned with approaches such as REACH which follow the "precautionary principle," create a cumbersome bureaucracy, and stifle innovation. In addition, NACD believes that there should be one uniform federal system for chemicals management rather than a patchwork of 50 different state standards.
NACD members are committed to the distribution of products that can be used safely and without harm to the environment as well as meeting or exceeding governmental safety requirements. Any evaluation of TSCA must recognize that the chemical industry’s innovation has played an integral role in the U.S. economy, and that sweeping revisions could prove highly detrimental to Americans’ way of life with no measurable benefit.
NACD Government Affairs staff will continue to participate in the discussions with industry groups as well as Capitol Hill and Committee staff as this issue continues to develop in the 111th Congress with an eye toward chemicals management policies based on sound scientific data and an adherence to the risk-based approach which has served the public well.
Published: Monday 18 July 2005
US Senator Frank R. Lautenberg introduced draft legislation aiming at better protecting children, mothers and workers against potentially hazardous chemicals.
The bill is sponsored by Democrat political heavyweights including 2004 Presidential candidate John Kerry and Hillary Clinton.