In the last several weeks, there’s been some back and forth between researchers and regulators on how REACH legislation will affect costs and loss of animal lives. In a study published on August 26 in the journal Nature, the researchers reported that toxicity testing required by REACH will cost $13.6 billion, or six times more than estimated, and require 54 million research animals, or 20 times higher than the previous estimate. The study reports that the European Union’s cost estimate was based on preregistration of 29,000 substances which was well below the actual preregistration total of 140,000 substances. Accounting for redundancies and mistakes in preregistration, the study estimated that a conservative estimate puts preregistration at about 68,000 substances. Using this number as the basis for its analysis, the study determined that REACH’s costs are likely to be substantially higher, largely because of a requirement to test chemicals’ effects on reproductive systems in two generations of animals -- a test that requires a large number of test subjects. But the study’s results have been challenged by the regulators.
The European Union Chemicals Agency, which administers REACH, has since issued two press releases on the matter. It maintains that it expects the final costs and number of animals used to remain close to original estimates. The regulators claim that the study well overestimated the number of substances that will require a full set of testing data and that the testing costs were grossly overestimated.
In a related development, the Organization for Economic Co-operation and Development (OECD) is drawing up guidance for an extended one-generation reproductive toxicity test. Under the guidance, tests beyond the first generation would be conducted only if a specific cause for concern arose in the first-generation offspring. The OECD will hold a meeting in October to discuss outstanding technical issues, including what would be considered as a trigger for additional tests. Draft guidelines are expected to be submitted for approval in March 2010. If approved, the guidelines would be published and in place before testing begins in December 2010.