(5) Further Rejoinder from BSJ to the Commission, dated 23rd March 2010
With reference to the Commission's observations dated 1st September 2009
I have to say that I am still very disappointed and dissatisfied with the Commission's response, which fails to recognize that the basis of my complaint is that there is a good deal of difference between what EFSA does in theory, and what it does in practice. I am not the first individual to protest about this; it is a common complaint from NGOs and consumer groups, and even the Environment Council (4th December 2008) appeared fully aware that EFSA is widely mistrusted across Europe, and for good reasons (1).
The Commission has still not addressed my detailed points. With reference to the observations of 1st September 2009:
1. The Commission says that prior to authorisation any GMO "has to undergo a safety assessment of high standards". The standards are certainly higher than those of the USA, but the safety assessments insisted upon by EFSA are by no means adequate to pick up chronic or long-term health effects associated with GMOs, as has been pointed out by independent scientists (2). Furthermore, the assessments are currently being loosened up -- and the Draft Implementing Regulation currently under consideration (based upon EFSA's own internal "guidelines") contains a number of derogations and dispensations which will allow applicants, with the connivance of EFSA, to simplify safety study requirements or to omit them altogether (3). Once that Regulation is adopted, I predict that the quality of safety assessments will fall dramatically.
2. The Commission says that EFSA is "a scientific agency independent of the Commission" with a GMO Panel made up of "renowned scientists chosen for their competence in the relevant fields." The so-called independence of EFSA has been, and remains, under close scrutiny, and I for one do not believe it (4). The Commission works closely with EFSA on the appointment of GMO Panel members, and there has been a close and even incestuous relationship between the Panel and DG-SANCO from the beginning. For example, in the drafting of the Implementing Regulation sent to the WTO on 12th January 2010 EFSA was heavily engaged right from the beginning, in the expert panel considering various drafts, and in the Standing Committee which finally approved the draft. Individual Panel members almost all have strong links with the biotechnology industry or have academic careers which depend upon the continuing success of the "GM enterprise." There are no truly independent scientists on the Panel who are likely to question the cosy relationship which EFSA has with industry; and the manner in which Suzy Renckens was allowed to slip straight from EFSA to a commercial role promoting GM applications for Syngenta has caused great anger among NGOs.
3. The Commission says that the GMO Panel " is assisted by ad hoc experts......" Those experts are of course carefully chosen by EFSA to reinforce the "opinions" already arrived at. I am aware of at least one occasion when the advice of an ad hoc expert consulted by one of the national competent authorities was not acceptable to EFSA, since it did not accord with its own opinion; so it went off and found another "ad hoc expert" whose opinion could be counted on........
4. The Commission says that "applicants are obliged to provide studies, including independent peer-reviewed studies, to demonstrate that the GMOs do not have adverse effects on human or animal health or the environment." That is not true. In the Draft Implementing Regulations currently being considered, the requirement for fully independent peer-reviewed studies appears to have been dropped, and replaced by some vague statements suggesting that independent studies might in some circumstances be a good idea (3). There has been a barrage of criticism from the media in recent months about the manner in which GMO applicants / patent holders do not just discourage but actually prevent genuinely independent studies from taking place. EFSA knows about this, and has chosen to do nothing about it (5).
5. With respect to the test methods used for risk assessment. the Commission says: "The petitioner does not say that the system is flawed but that some science submitted by applicant is so." The system was a reasonably good one, and I have indeed pointed out (more than once) that seriously defective safety assessments have slipped through the EFSA net without comment. I am also complaining about the manner in which EFSA applies its own guidelines, in that it does not properly scrutinize the relationship between data sets and "safety conclusions" and permits, for example, the use of surrogate proteins instead of insisting on the use of actual proteins isolated from the GM product under consideration (3).
6. The Commission says that in finalising the new GMO Implementing Regulation it will "further specify the requirements for applications submitted...." the wording implies that the requirements will be tightened up. Unfortunately, the reverse is true. A close examination, clause by clause, indicates to me that the requirements will be dramatically loosened up, giving EFSA derogated powers to decide, for example, that complex stacked events (which need even closer scrutiny than single events) may not need new safety studies if the individual "events" have already been tested in the past (2).
7. The Commission says that in the development of the new Implementing Regulation "stakeholders have also been consulted." That may be technically true, but the process was so complex and secretive that (having participated in it) I have to say that it was designed to discourage comments and to drive away all but the most persistent (6). Furthermore, the documents which arose from the consultation are written in such a way as to make it impossible to see who made which comments, and which comments were acted upon. It appears to me and to others who contributed that all comments considered to be "inconvenient" were simply dismissed out of hand. Then EFSA said "All comments received were carefully considered." If the Commission believes that, it will believe anything.
8. Public access to data and information submitted in the application process. The Commission says that the Directive and the Regulation provide for " extensive public access to the information and data received during the authorisation process and offers the public the possibility to comment on the application in the light of the risk assessment and before the adoption of the authorisation decision." That may well be the theory. But in practice, as I have pointed out, it is incredibly difficult to get at this material. A password may be issued by EFSA in response to a request for information, and more than once in the past I have had to resort to the Freedom of Information rules in order to obtain sight of material which EFSA seemed to want to protect on behalf of the GMO applicant. Access is then time- limited. And the data which is made available is -- in my experience and others -- heavily selected and censored (7). Some sections which have nothing to do with commercial confidentiality are blacked out. The EFSA instinct for secrecy, and for shutting off genuine peer review, is very strong indeed. And if it is the Commission that makes "ad hoc" decisions as to what information may be viewed, and what may not, the Commission itself deserved heavy criticism for conniving with the GM multinationals who are seeking consents.
9. Finally, the Commission says this: "The procedure does not block independent research as is apparent by the considerable non- proprietary literature cited by EFSA in its opinions on GMOs." Again, I do not accept this. It may be that the PROCEDURE does not block independent research, but everybody knows that this is what happens, and we have complained about it on behalf of independent scientists for years. The media have recently picked up on this issue too (5). I am in touch with many independent scientists who have tried to obtain GM wholefoods and reference materials for food safety and environmental research, and who have been refused all cooperation by the GM patent holders. Time and again, their planned research has had to be abandoned. That is a scandal, and as long as it continues, we can have no assurance that the so-called rigorous safety studies assessed by EFSA are not all fraudulent. The Commission and EFSA have consistently refused to address this issue. They could have done so years ago by insisting that all research submitted MUST be replicable, and that all submitted in-house research (and research done by "approved" scientists under the control of the applicants) MUST be accompanied by a written commitment to allow follow-up repeat or improved research by national or independent scientists WITHOUT HINDRANCE. When the Commission says: "Neither the European Commission nor EFSA have any influence on how companies award contracts for carrying out independent research, a situation similar to other areas of endeavour" it is being disingenuous and even dishonest. Of course it has influence, and it is absurd to call such contracted research "independent" since it is subject to a wide range of constraints, including the power for the contractor to withhold the test results and to block publication. For example, who knows how many Monsanto feeding studies have been hidden away, simply because they came up with "inconvenient" results?
In conclusion, the Commission in its answer has once again failed to give any assurances that it places the safety of the consumer above the commercial aspirations of the GMO applicants; and I maintain my position that both EFSA and the Commission are allowing potentially fraudulent research to determine GMO policy and to harm public health and the environment.
Brian John
(1) http://www.gmfreecymru.org/news/Press_Notice05Dec2008.htm
(2) How Subchronic and Chronic Health Effects can be Neglected for GMOs, Pesticides or Chemicals. Int J Biol Sci 2009; 5:438-443. http://www.biolsci.org/v05p0438.htm
(3) http://www.gmfreecymru.org/open_letters/Open_letter28Feb2010.html Urgent Scientific and Policy concerns about the new Draft GMO Regulation
(4) EFSA is not fit for purpose http://www.gmfreecymru.org/open_letters/Open_letter10Dec2007.htm
(5) http://www.gmfreecymru.org/documents/complain.htm http://www.nature.com/news/2009/090902/full/461027a.html?s=news_rss http://www.globalresearch.ca/index.php?context=va&aid=14570 http://www.scientificamerican.com/article.cfm?id=do-seed-companies-control-gm-crop-research
(6) http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902010430.htm
(7) http://www.gmfreecymru.org/news/Press_Notice24May2005.htm GM MAIZE CONSPIRACY REVEALED