GM Free Cymru

Urgent Scientific and Policy concerns about the new Draft GMO Regulation

OPEN LETTER 27th February 2010

European Commissioner for Health and Consumer Policy
European Commission
B - 1049 Brussels


cc President Manuel Barroso

Dear Commissioner Dalli,

Commission Regulation on Implementing Rules for GM applications and  assessments

As you will be aware, on 12th January a Draft GM Regulation (1) was  placed onto the WTO website under its conformity assessment procedure,  and is due to be brought into law in May of this year.  Because of the  complex procedures within the EU, this has been done without any  consultation with the public, NGOs or consumer groups, and even  without discussion among the "competent authorities" who are  responsible for GMO risk management in the various countries of the  EU.  We do not think there has been any discussion within the  Parliament either.  That causes us very great concern, even though the  Commission might have used comitology rules and followed the correct  procedures for bringing in an "Implementing Regulation".

We are a group of scientists with long experience in the GM field, and  we are so worried about the content of this Draft Regulation that we  have brought our concerns to the attention of Professor Buzek, the  President of the Parliament, and Mr Van Rompuy, President of the  European Council.  We are now also raising these concerns with you and  President Barroso, and we respectfully urge you to hold back the Draft  Regulation for careful scrutiny by individuals other than the national  representatives and EFSA staff who have drafted them.  The drafting  process has been too tightly controlled, and we believe that if the  safety and health of the people of Europe are to be safeguarded, much  of the text needs to be modified.

The grounds for our protest are as follows:

1.  We understand that the Commission and EFSA staff who have done the  drafting work have promoted the draft regulation as "tightening up" or  strengthening the precedures for the assessment of GM applications.   With all due respect, if you read the Regulation for yourself you will  see that it does nothing of the sort.  In fact, it waters down the  application requirements and assessment procedures to such an extent  that some applications can now go through under a simplified procedure  with virtually no scientific scrutiny or risk assessment along the way.

2. There are a number of scientific grounds for concern, which we have  already spelled out for Professor Buzek and Mr Van Rompuy, and which  we also append below.  These are very serious matters, and it appears  to us that EFSA and Commission civil servants have -- for whatever  reason -- slipped from the high scientific standards which we have a  right to expect of them, and  have in the process placed the safety of  the people of the EU at risk. We will appreciate it if you will  examine our points very carefully -- and we will welcome the  opportunity to discuss these further with you and your staff.

3.  We believe that another reason for the "slippage of standards" in  this Draft Regulation is the desire -- on the part of your civil  servants -- to put in place a "fast track approvals process" for  political or diplomatic reasons, in order to appease the United States  government and the WTO.  The motive is, no doubt, to demonstrate that  in the EU there is no GM-related "restraint of trade."  That is  understandable, given the outcome of the famous GM ruling of a few  years ago!  However, in seeking to achieve this political objective,  the careful regulatory regime for which Europe is justly renowned has  been dismantled and undermined -- and this cannot have been the intent  of the Commission.

4.  What we see over and again in the clauses of the Draft Regulation  are subtle -- and sometimes blatant -- changes of POLICY relating to  GMOs.  Again, this might not have been the Commission's intention, but  those who have drafted the text have not restricted themselves to  "implementing rules".  They have gone far beyond that, and that is why  we have claimed in our letters to Professor Buzek and Mr Van Rompuy  that the Commission -- which has to take responsibility for this --  has exceeded its powers.  You need to read the text carefully in order  to appreciate this -- and if you wish we will be happy to itemise for  you nine distinct and discernible policy changes.

5.  Finally, we consider that this Draft Regulation goes dramatically  against the letter and the spirit of the decisions made by the  Environment Council at its meeting on 8th December 2008.  That meeting  stressed the need for greater transparency, greater accountability,  less secrecy, more cooperation between EFSA and member states and  competent authorities, and an enhanced role for independent science  and peer review. On every one of those issues, the Draft Regulation  goes in the opposite direction, greatly enhancing the power of EFSA to  treat applications more or less as it wishes and to make deals with  the applicants for GM approvals.  That is a dangerous and even  sinister trend, and we trust that the Commission will not wish to be  associated with it.

Please, therefore, withdraw this Draft Regulation for a period of calm  reflection and careful scrutiny.  We and many NGOs and consumer groups  will, we are sure, be prepared to contribute constructively to this  process.

We look forward to hearing from you on these matters.

Yours sincerely,

Dr Brian John, Dr Jose Ramon Olarieta, Prof Brian Wynne, Dr Mae-wan  Ho, Prof Jose L. Domingo, Prof Bob Orskov, Prof. Enric Tello, Dr Eva  Novotny, Dr Irina Ermakova, Dr Arpad Pusztai, Prof Marcello Buiatti,  Dr Susan Bardocz, Dr. Christian Vélot, Prof. G-E Seralini, Dr Carlo  Leifert, Prof Philip Bereano



1. REDUCED VIGILANCE. There is a noticeable lessening of vigilance on  GM safety issues. With respect to feeding studies, we see an  increasing emphasis on the nutritional equivalence of GM food/feed and  a pretence that this can give guidance on health and safety. We know  already that the majority of feeding studies submitted in application  dossiers are not safety studies at all, but are concerned primarily  with nutrition and productivity. In several places the Draft Reg text  suggests that for nearly all GM food and feed varieties, "sufficient  experience is available" for assumptions to be made about safety and  to suggest that further studies are unnecessary. We dispute that  contention. Elsewhere there is the comment that experimental testing  "may be necessary" involving laboratory animals. That allows  applicants to avoid lab tests if they can claim that a new variety  coming forward is "substantially equivalent" to something already  tested in the past. Since substantial equivalence is nothing more than  a myth, proper laboratory studies must be insisted upon, in all cases..

2. DEROGATIONS AND DEALS. By watering down the regulatory requirements  for animal testing, toxicology studies etc, there is a distinct  possibility that EFSA can in future make convenient "deals" with  applicants to bypass almost all of the studies that should be done.  For example: "By way of derogation from paragraph 1, an application  may be accepted even if it does not satisfy all the requirements set  out in that paragraph, provided that the applicant submits verifiable  justification for each element not complying with those requirements."  Again: "........when studies have been already submitted for the  purposes of an application to EFSA, a reference to such studies and  the results of the evaluation may, with the agreement of the  Authority, be made in the framework of another application...." Under  "Toxicology" there is a paragraph which allows the applicant to "state  reasons" why he does not need to submit required or recommended  studies in order for a sound ruling to be made on safety and risk. We  fear that, on its past record, EFSA will be very accommodating in this  matter........

3. STACKED EVENTS. We have particular concerns about the method  proposed for dealing with "stacked event" applications. "Second  generation" GM crops, including those with supposedly enhanced  nutritional value, are likely to be non-uniform and unstable because  they have complex introduced traits. If two or more GM lines are  hybridized to introduce "stacked" GM traits, the potential dangers  become even greater because of synergistic effects. And yet it seems  to us from a reading of the Draft Reg that applications for these  complex varieties can be pushed through along a "fast track" process  with simplified requirements, as indicated above. Applicants can  simply provide a "scientific rationale justifying that there is no  need for experimental data" for the relevant "sub-combinations." On  the contrary, "stacked event" varieties should in our considered view  NEVER be approved for cultivation or use unless thy have been through  a MORE onerous safety testing regime than the "single trait" varieties  from which they are bred. There is a further, quite deliberate,  muddying of the water. If it can be claimed that the stacking was done  by conventional breeding (even if the lines used are GM lines) all  that is needed is an "assessment" of nutritional or compositional  changes, and "no further studies shall be recommended." (1.6)

4. RESEARCH STANDARDS AND PROTOCOLS. There is a distinct lack of  clarity about the precise safety testing regime that should be  employed with respect to new GM varieties. For example, applicants are  simply urged to take into account relevant international standards,  such as the guidelines of the Codex Alimentarius and the OECD for the  conduct of food safety assessments on GM plants. Again, the text  indicates that studies presented in applications "should" be carried  out in accordance with "this Regulation", internationally agreed  protocols and the test methods described by the OECD when available.  What we have here are vague recommendations, with frequent use of the  word "should" and hardly any use of the word "must." We know from past  experience that EFSA does not actually insist on the highest Codex  Alimentarius standards anyway, for example by accepting evidence based  on the use of surrogate proteins, and not insisting on tests on cooked  or uncooked whole GM foods.

5. CHOICE OF COMPARATORS. It is fully accepted in the Codex  Alimentarius and OECD Guidance documents that all tests of GM  materials MUST involve comparisons with non-GM counterparts or  isolines. Otherwise the results will be meaningless with respect to GM  effects. We are greatly concerned that under "Comparative analysis" in  the Draft Reg there now appears to be leeway in the choice of "the  conventional counterpart" and additional comparators. Our reading is  that a GM counterpart or "original event" can now be used -- rather  than the isoline or variety from which the GM plant was bred. This  would be in clear breach of international protocols.

6. SURROGATE PROTEINS. Under "Toxicology" it is proposed to allow  "testing of newly expressed proteins" without any instruction or  
requirement that they have to be isolated or derived from the GM plant  itself. Under "testing of newly expressed proteins" (1.4.1) the Draft  Regulation says that the tested protein "shall be equivalent to the  newly expressed protein as it is expressed in the GM plant." The use  of "surrogate proteins" in past research has been a major cause of  scientific dispute, and applicants have been allowed to get away with  it over and again. This is in our view poor science, and scientific  manipulation and distortion is inevitable -- with potentially dramatic  consequences for public health.

7. INSERTIONAL MUTAGENESIS. We can find no mention of this in the  Draft Reg, although it is predicted on theoretical grounds and  demonstrated in GM plants already in cultivation. Under "molecular  characterization" there is no requirement for information on the  effect of the GM process on the genome of the recipient plant  (insertional mutagenesis.) There is no request or instruction for  applicants to LOOK FOR insertional mutagenesis, and we do not  understand why EFSA appears to be blind on this issue. This is a major  defect in the Regulation, again with safety and health implications.

8. ANTIBIOTIC RESISTANCE MARKER GENES. In the text, we can see no  requirement that ARMs (antibiotic resistance marker genes) MUST be  removed after initial plant breeding. All the EC appears to insist  upon is this: "The risk assessment may be facilitated if the presence  of inserted DNA not essential to achieve the desired trait is  minimised." (See also Annex II, 2.1) That is hardly a tough statement  of policy or intent, and by common scientific consent there are  serious public health implications.

9. MOLECULAR CHARACTERIZATION. There are a number of major  deficiencies in the Draft Reg. Under "Hazard Identification" there is  no requirement for information on the donor organism, its safety or  health effects, allergenicity and so forth. As indicated above, the  effect of the GM process on the genome of the recipient plant  (insertional mutagenesis) MUST be demonstrated. Relating to DNA,  applicants can submit a sequence as it was "intended to be inserted"  -- which may of course turn out to be quite unlike the sequence  actually contained within the commercialised GM plant. And when it  comes to the expression of inserts, the text says that where tissue- specific promoters have been used, information "may" be requested on  the expression of target genes in other plant parts relevant for risk  assessment. That means that such information may also NOT be  requested......... with potential public health consequences.

10. SUBSTANTIAL EQUIVALENCE. Under (Description of the  protocols for the experimental design, (a) Principles of experimental  design) there is a fascinating and protracted discussion on how an  applicant is supposed to demonstrate that a GM variety is  substantially different and substantially equivalent to its  "counterpart", all at the same time. Please forgive us for saying so,  but this is more than a little absurd!  In any case, there is now  overwhelming evidence that GM varieties are substantially different  from their isolines, and the authors of this Regulation have neglected  to take this evidence into account.

11. SAFETY STUDIES INVOLVING ANIMALS. The Draft Regs appear to accept  that 90-day rodent feeding studies need not be designed "to detect  effects on reproduction or development, other than effects on adult  reproductive organ weights and histopathology." Why not? Reproductive  effects are of massive potential significance, and the effects of  reproductional toxicity should be looked for during and after the  first generation. Applicants are given the option to test the whole  food and feed beyond a 90-day rodent feeding study, "where  appropriate." It is beyond belief that any applicants will ever do  this, if they are given the option not to. Given what we already know  about toxic effects arising from the consumption of GM feed, full  lifetime studies on rats should be mandatory. There is also no  requirement even for short-term livestock feeding studies (  Interpretation of relevance of animal studies) -- although the Draft  Regs say they may be considered, on a case-by-case basis and be  hypothesis-driven. Again, there is no chance whatsoever that any such  studies will be done voluntarily. There should be a clear requirement  for lifelong feeding studies on "target animals" -- ie those which  will consume GM materials for the whole of their lives. (1.6.2) Also  there is very little in the document about the indirect effects of  herbicide residues arising from the planting of RR or other herbicide  tolerant GM crops, although by law these effects must be identified  and revealed. This is another major defect. Again, there is no  requirement placed on applicants to look for the synergistic or  combined effects of herbicide treatment and transgenes on either  nutritional value or toxicology. We already know, for example, that  certain transgenic rice varieties have reduced nutritional value in  addition to other defects.

12. DEPENDENCE ON INDUSTRY STUDIES. Under 1.4.5. (Conclusion of the  toxicological assessment) there is mention of various "adverse  effects" that might be identified in feeding and other studies. But it  is extraordinary that the EC proposes that all of the assessment of  the safety studies should be done by the applicant, with no  independent involvement or verification studies. Does the EC really  think that an applicant is going to point out potential adverse  effects in his own toxicology studies? The invitation in 1829/2003  (and repeated in the Environment Council on 4 December 2008) for  independent reviews of the raw data, or for peer-reviewed studies to  be submitted, has now been ditched. There are two problems here. The  first is that EFSA and the EC assume the honesty of Monsanto, Syngenta  and other corporations which are renowned for their expertise in  manipulating their scientific results. The second is that the research  which the regulators accept as honest is almost always non-replicable,  since the seed and feed owners will not permit truly independent  research teams to use their materials for repeat or improved  experiments. In spite of frequent invitations from us and from other  scientists , the Commission has consistently refused to address this  issue, although it was invited to do so by the Environment Council on  4th December 2008. In our view all industry-sponsored research on GM  safety must be assumed as designed to produce "convenient" results,  until it is independently verified.

13. ANALYSES OF RAW DATA. There is no requirement in the Draft Regs  for an applicant to release or reveal his test data for peer group or  public review -- he is only asked to "justify his conclusions" or to  "consider" or "evaluate" his data. That is a nonsensical state of  affairs. This is a very controversial area, given that EFSA assists in  the "protection" of data and experiment information if applicants  claim it under the "commercial in confidence" rules. There is secrecy  and censorship on a scale that is entirely inappropriate, and where  there is no threat whatsoever to intellectual property rights. It is  unacceptable that interested parties have to resort to the courts in  order to achieve public access to experimental data and to facilitate  peer review by independent scientists. Under (Information of  variation of constituents from databases) we find the following:  "Based upon the considerations above, the applicant shall establish  whether the differences and/or lack of equivalence observed are to be  considered relevant for further consideration in the risk assessment  process or if the difference and/or lack of equivalence does not raise  safety concerns". This allows applicants to argue that observed  differences between test animal groups are "not biologically  significant" even if they are statistically significant. We therefore  ask for the following to be added: "Statistically significant  differences shall always raise safety concerns." Furthermore, we  condemn the common practice of EFSA in accepting without question the  data analyses conducted by applicants, while subjecting independent  analyses of the same data to sceptical and even hostile scrutiny. This  can only lead to accusations of complacency, connivance in defective  science, and lack of objectivity in the "facilitation" of GM approvals.

14. POST-MARKET MONITORING. "When necessary, a proposal for post-  market monitoring regarding the use of food for human consumption and/ or the use of feed for animal consumption shall be submitted in  accordance with Annex III." The Annex allows the applicant and EFSA to  say "we have monitored past crops that have now been combined into a  stacked event -- so monitoring of the stacked event in the field and  in the food chain is unnecessary." That is unacceptable to us, for the  reasons outlined above. Annex III also implies that, as long as a Post- Marketing Proposal is submitted, it is permitted to market a product  even if "it is not possible to address remaining uncertainties", if  "the relevance and intensity of effects and side-effects ... are  difficult to predict", and if "potential side-effects are identified  but cannot be studied in ... the safety assessment". In other words,  the company need not bother to test safety thoroughly, as long as it  will continue to collect some data (unspecified) about the general  public and any animals that are given the GM food / feed, in order to  see whether people or animals are becoming ill in large numbers. This  again is irresponsible, and completely unacceptable.

15. HEALTH IMPLICATIONS. We see many signs in the Draft Regs that the  Commission and EFSA are making unjustified assumptions about the  safety of GM crops and foods. For example, on the matter of  allergenicity, there is a watering down of long-established  requirements to show that GM plants are not harmful. Now we see the  use of vague terms such as "depending on the available  information"...... with no requirement for studies to demonstrate  safety in use. Also, there seems to be a conflation of Nutritional  assessment and Exposure assessment. The Draft Regs say: "If possible,  the applicant shall identify and consider particular sections of the  population with an expected high exposure and shall within the risk  assessment (stet)." There is a drafting error here -- but in our view  there should be a strict requirement for a written analysis of  sections of the population that might be at increased risk from the  consumption of GM food or animal products from GM-fed animals -- for  example, vegetarians or those with coeliac disease might be subjected  to high levels of GM soy intake.

16. RESEARCH BLOCKING. In Annex IV we find these words: Applicants  shall provide "samples of the food and feed and their control samples  of a type and amount to be specified by the CRL for the specific  application for authorisation." Also: "The applicant shall provide  information as regards the place where the reference material can be  accessed. This shall be accompanied by adequate information  demonstrating that the availability of the reference material will be  maintained throughout the period of validity of the authorisation." We  have checked this carefully, and have found that CRL only requires  enough reference material for verification of the GM event, and for  confirming the efficacy of test methods etc. There is NO requirement  for applicants to provide adequate quantities (of GM varieties and  their isolines) for independent verification or repeats of their  safety experiments and feeding trials. So effectively the applicants  retain full control of their reference materials and have to make no  commitment to provide extra material either for the EC or for anybody  else. As indicated in (12) above, this means that all of their  experiments are NON- REPLICABLE -- and on that basis alone they should  not even be considered by the regulators as valid "science." What do  the Commission and EFSA propose to do about this blatant and on-going  abuse of scientific ethics?


(1) Draft COMMISSION REGULATION on implementing rules concerning  applications for authorisation of genetically modified food and feed  in accordance with Regulation (EC) No 1829/2003 of the European  Parliament and of the Council and amending Regulations No (EC)  641/2004 and (EC) No 1981/2006 (Text with EEA relevance)