Back to listing

Date: Fri, 14 Nov 2003 08:50:56 -0500
Reply-To: PSA Forum
Sender: PSA Forum
From: Bob Livingston
Subject: E Forum
Content-Type: multipart/mixed;
[multipart/alternative]

My name is Bob Livingston. I retired from the Food and Drug Administration where my duties involved the regulation of food additives and veterinary drugs. Presently I work for the Animal Health Institute. I have participated in several JECFA meetings dealing solely with veterinary drugs and have attended numerous other Codex meetings.

General Comments
Many of the suggestions in this e-forum have some merit but would be costly to implement. Translational costs at the expert meetings and the translation of all the material would add enormously to the expense of these meetings. Who would bear the cost of translating submissions into several languages? Some of the submissions to JECFA have been measured in linear feet of shelf space, not just number of volumes. This could discourage the submission of valuable information. Opening up the expert meetings to non-scientists would also involve added expense to the meetings; how would the secretariat limit the number of individuals wanting to attend expert meetings? I believe that the transparency issue should be addressed in the Codex Committees where attendance is already open. Transparency of the scientific decision making should be addressed by clear instructions to the risk assessors and well documented reports to the Codex Committees.

The creation of a Scientific Steering Committee would increase both the costs and bureaucracy of Codex. Additional funds should be used to staff the Codex Secretariat as well as the Secretariats of the expert committees. In my opinion risk assessment policy should be handled by the Codex Committees and consultations.

Paper 1.b
Data confidentiality is important to the sponsors of veterinary drugs that submit data to JECFA. Dr. Shaffner comments that he has never seen data he would consider confidential for a food additive. However, veterinary drugs are regulated differently in many countries than food additives and the full reports submitted in a dossier are of great value to a competitor. These reports can be used to register the veterinary drug in some countries. Also, the information provides a road map for a competitor to develop a competing drug of the same class or a pro-drug. For example, the information in a metabolism study and all the chemistry developed to separate and identify metabolites is of enormous commercial advantage. FAO/WHO needs to develop guidelines for handling confidential data.

FAO/WHO has an additional responsibility concerning the rights of the sponsors that submit data for a veterinary drug to JECFA. The sponsor that submits data to support an ADI should be able to develop the uses of the drug and use up the ADI as it sees fit. Codex has permitted other sponsors to submit data supporting other uses of the drug and use up the remaining portions of the ADI without it even consulting the original sponsor. Although Codex is not responsible for protecting intellectual property rights, it does have a responsibility to handle proprietary data in an appropriate manner.
Paper 1.c The declaration of any potential conflict of interest has merit; however, the inclusion of a declaration of strongly held beliefs and/or opinions would not add significantly to the transparency of the scientific advice. Any "bias" of an expert would be apparent from his/her publications and affiliations. Presumably, these would be included in the roster of experts and be considered by FAO/WHO in the selection process. It is extremely important to have differing scientific perspectives represented to ensure transparency. While industry experts might be precluded from some expert committees because of confidentiality, the inclusion of these experts should be a high priority for workshops and consultations concerning such issues as contaminants, microbiological risks and antimicrobial resistance.

To some extent, JECFA already uses risk assessments by other countries or regions. Frequently, the experts selected for JECFA have extensive experience regulating the same chemicals that are being reviewed by JECFA. In fact, the reviews within countries and regions have resulted in better data submissions to JECFA. I would hope that these reviewers would not be considered to have a conflict of interest.

Robert C. Livingston, Ph.D. Director, International Affairs and Regulatory Policy Animal Health Institute 1325 G Street, NW Suite 700 Washington, DC 20005-3104 202-637-2440 rlivingston@ahi.org