Are Affygility Solutions' toxicologists certified?

Here at Affygility Solutions we often get asked the question,"Is our company or our toxicologists certified? To answer this question, it is important to ascertain exactly what is the question that you are trying to answer.

First, there is no independent organization or regulatory body in the world that "certifies" on a company-wide basis as being qualified to prepare OEL/ADE/PDE monographs. Certifications such as ISO 9001, ISO 14001, OHSAS 18001, etc are management system certifications - not toxicology certifications; therefore, ISO or OHSAS certifications are meaningless in regards to the preparation of health-based exposure limit monographs (ADE, PDE, HBEL). These three certifications have little to no applicability to the field of toxicology.

Second, there are two organizations in the world that "certify" individuals as toxicologists. These organizations are as follows:

American Board of Toxicology; and

European Registry of Toxicology.

Individuals that are certified by the American Board of Toxicology are considered Diplomate American Board of Toxicology (DABT) or those listed in the European Registry of Toxicology are considered European Registry of Toxicology (ERT). These certifications are not company-specific and follow the specific individual when they change employers.

While both organizations are globally recognized, it does appear, that based on the certification criteria, that a DABT is more rigorous to obtain (see below chart) than an ERT.

Finally, there is no requirement in the European Medicines Agency's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" that toxicologist are certified. The PIC/S and WHO guidance is nearly identical to the EMA, so we can assume they are equivalent. What it does say in Section 6 of the guidance document is as follows:

However, in the recently released ASTM standard on "Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)" it does say the following:

IMPORTANT NOTE

As is common practice in all toxicology consulting companies, not everyone that is involved in the preparation of a monograph needs to be "certified." Typically, consulting organizations will have junior-level staff perform many of the tasks that required less experience. These tasks could include data and information gathering literature searches, preparing citations lists, preparing the draft document, and QC activities. At Affygility Solutions, the final report is then reviewed and approved by the certified toxicologists.

Please be assured that the toxicologists at Affygility Solutions are EXPERTS in their field. Copies of the CVs for Affygility Solutions' toxicologists can be found here: https://affygility.com/cv/