When the GLP’s were introduced in the 70’s researchers were confronted with the need to know what contaminants, which may confound study results, were in the feeds that were being fed to their animals. This would require that the animal care group purchase feeds, take representative samples, analyze the sample for contaminants and then decide whether the food was suitable for use based on the analysis results. This represented a logistical nightmare as most facilities did not (and still do not) have the luxury of space to store 4-5 weeks supply of feed while the analyses were being performed. In reality an additional back-up of 4-5 weeks supply needed to be stored in the event that the first lot was found to be unacceptable. So now the needed storage space had to hold 8-10 weeks of feed. And, what does one do with a two months supply of diet if it is found to be contaminated?
This scenario was the impetus for the introduction of Certified Diets by Purina in the 70’s. After polling toxicologists around the country, a list of contaminants was developed with maximum allowable concentrations determined for each contaminant. After a lot of diet was milled and identified, a representative sample was collected and sent to an independent lab for analyses while the lot was stored at the mill. After the analysis report was received, the results were checked against the maximum allowable level of each contaminant. If each of the 30 contaminants were found to be below the threshold limits, the diet was released for distribution as a Certified Diet. The key was that each analytical report represented a specific, uniquely identified lot and was checked against a standard of allowable limits prior to release. Diets that met GLP requirements could then be fed immediately after arrival at the facility.
Other feed manufactures followed suit with near identical programs.
As animals do consume varying amounts of bedding, beddings became available that offered the same programs. Again, the key is that each analytical report represented a specific, uniquely identified lot and the results were checked against a standard of allowable limits prior to release.
There are many enrichment manipulanda items that are marketed as “Certified” but they do not meet the standards described above. Most are contaminant screened which the supplier has described as subjecting a random sample on an intermittent basis to analysis. No attempt is made connect the analytical results to the actual product by lot number. The analytical results are not subjected to a pass:fail comparison to maximum allowable levels prior to shipping. A semiannual analysis of a sample from an unidentified lot, whose analytical results are not held to a standard, is not “certified” in the sense that we understand as meeting the GLP requirements.
ASAP offers two levels of monitoring products for environmental contaminants.
We do offer lot specific analysis of enrichment items but since we do not perform the check against the standards we do not present them as “certified”. These items are offered as “profiled” so as not to obscure the fact that they do not meet GLP requirements as received by the buyer. Of course the buyer should review the analytical results and decide whether they are acceptable for use within their protocol covering GLP studies.
ASAP’s I Chews are the only truly certified environmental enrichment product specifically designed for laboratory rodents. The product is accompanied by a lot specific certificate of analysis and that has been checked against a standard. To ship to your facility I Chews have to meet the same environmental contaminant standards as your Certified LabDiets® and certified beddings. We sample and analyze the raw material and document the lot identification from the raw material supplier, through the manufacturing process, through our packing procedure, and into your laboratory.