The UK's Health and Safety Executive (HSE) has released guidance in the form of a leaflet to help REACH registrants minimize the use of animal testing as they prepare their final documents for submission this fall. Between 5,000 and 10,000 registrations expected by the November 30th, 2010 deadline. Each of those, without any attempt to minimize the number of animal tests, could require over 5000 animals according to HSE. The animal rights group, British Union of Anti-Vivisectionists (BUAV) predicts even more animals will be used, all told they say that over 75,000 chemicals may need new testing, which could mean 16-54 million animals over the next ten years. I think this number is highly unlikely, but nevertheless there will be significant animal testing proposed under REACH.
The guide recommends that wherever possible registrants should employ the basic principles of the "3Rs," that is, reduction, refinement and replacement, in order to reduce the number of animals used.
Besides some specific suggestions for particular endpoints, the guidance strongly suggests that registrants use the techniques listed in Annex XI of the REACH regulation, including:
- Use of all existing data: Search for previous studies done on the chemical
- Weight of evidence: Use information from multiple sources to avoid having to do new tests
- QSARs: Use computer modeling wherever validated and supportable for a particular chemical
- Grouping and Read Across: Maximize the value of data for similar chemicals that can be used to estimate the values for your chemical
- In Vitro: Use in vitro methods rather than methods that require animals; also use new Ex Vivo methods
- Waive Data Requirements if Not Technically Possible to Test: Some endpoints cannot be measured or are not appropriate to measure for certain substances
- Exposure-Based Waiving: Don't do animal testing in cases where there will be no exposure to humans or the environment
More specifics can be found in the UK guidance.
These considerations and the strong actions of the animal welfare organizations will most certainly need to be part of the "new TSCA" that is expected to be introduced shortly in the United States.
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