for milk production
We feel CI should refer to this drug as rBST rather than BST.
We strongly agree with CIs opinion that JECFA has made some very major mistakes in the way it has reviewed the rBST safety. We feel CI may want to emphasise even stronger that it cannot be accepted that the full JECFA report is still not published. We agree that the JECFA review was flawed. We would urge CI to demand a new set of tests to be conducted by independent scientists, as the original data are now over twelve years old. For data to be scientific, one factor is that it must be possible for other scientists to conduct the same experiments, to verify the data. We feel CI should propose this as a constructive way out of the current rather scandalous situation.
We support that you mention the FDA 1990 Juskevich and Guyer article. This paper contains a summary of data that comes from Monsanto Corporation, one of the makers of rBST. However, requests to see the raw data from one of the main studies that this FDA article refers to have been denied. The reason has been given by FDA and by Monsanto that this raw data is "trade secret". As this data is quoted quite a lot in the 1990 paper, especially in the tables, we doubt the role of the FDA in reviewing rBST. The information in tables 1 - 7 are from unpublished studies (ref. 42). Without the raw data, independent statistical analysis of the results are not possible. Again, we feel CI should propose that other scientists conduct the same experiments and the analysis of the data as a way to regain consumer confidence in the rBST review process.
We agree strongly that FDA seems to have committed itself to the safety of rBST, and that to change its position now might be equal to a political disaster. This leads us to urge CI to demand that the JECFA and Codex review must be conducted by other people than FDA officials. Even though the current officials may be individuals of integrity, they must step down in order for others to take over the review process. FDA officials with more or less obvious ties to one of the producers of this controversial drug should not be allowed to jeopardize the health of consumers world wide.
Finally we must strongly emphasise that the unprecedented CCRVDF decision in October 1998 to move up MRLs for rBST from step 7 to step 8 is unacceptable. We feel CI must use this term, as "grave reservations" is not sufficient to express our outrage. We agree with CIs conclusion that a consesus approach must be the solution to this "knotty" problem. The Codex Committee will lose all credibility at a very crucial point in time - just before renewed WTO agricultural negotiations - if no solution is found that takes into account normal Codex procedure. Perhaps CI would want to put this section earlier in the paper in light of the fact that CCRVDF was so deeply split on this issue.
Martin J. Frid