Title of Petition 436-10: Formal protest from scientists against the Commission's draft regulation on implementing rules concerning the applications for authorisation of GM food and feed.
Name: Brian JohnPostal Address: Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN, Wales, UKNationality: Welsh
VERBAL PRESENTATION16th March 2011
On behalf of the 13 scientists who originally submitted this Formal Protest last year (1), and the many more who have subsequently expressed support for it, I thank the Committee for the opportunity to present our case. My previous Petition relates to the current GM assessment and approvals system; this one deals with some of the Commission's proposals for future reform.
As you will be aware, there has been great concern about both the contents of the Draft Implementing Regulation and about the manner of its introduction (2). It appeared to us, at the outset, that this document was designed to speed up the regulatory / approvals process, in response to blatant pressure from the US administration and the WTO.
It also appeared to represent a step along the way towards "harmonisation" or "synchronisation" of the approvals process on both sides of the Atlantic, by building in a whole range of measures which will ease the way for "simpler" and cheaper applications to come forward (3). This is to the benefit of the multinational corporations -- while placing at risk both the European environment and the health and safety of the people of Europe.
We also object to the key role played by EFSA in the drafting of this Regulation -- in contravention of the long-standing tradition that the executive arm should not draft the laws and rules that it must later implement. What are essentially internal guidelines are being turned into soft law and then into hard law, and it seems to us that EFSA has also been playing an improper role in the formulation of EU policy (4).
Our Key Concerns are itemised below (Appendix 1) and were laid out in more detail in our letter from February 2010 and our later submission in April 2010. In spite of responses from the Commission, and a detailed "defence" of its position from EFSA, we have to say that our concerns (like those of many other NGOs) are unchanged (5).
Over and again in its own defence, EFSA admits to the high degree of discretion it will exercise if the new regulation is adopted. This discretion can, and will, be used along with many assumptions, extrapolations and interpolations relating to the supposed"equivalence" of GM and non-GM plants. When that degree of discretion is enshrined in law, and the law is then enforced -- or not enforced -- by a body like EFSA with a known bias towards industry and a predisposition to consider GM crops and foods as inherentlysafe, then the citizens of Europe have a right to object.
FOUR VITAL POINTS:
- 1. EFSA has embraced the concept of Comparative Assessment just as it has accepted the concept of "substantial equivalence", the "concept of familiarity" and the use of theterm "generally accepted as safe" (GRAS). These terms are in our view all scientiﬁcally nonsensical (6). We are very concerned that they now underpin something as important as the risk assessment of GM crops and foods. The Commission has also twisted the deﬁnition of the word "adventitious" as it relates to GM contamination in ﬁeld crops andfood and feed products. The Commission has apparently taken EFSA advice with a view to softening the burden of regulation on the GM industry. We therefore think that the Commission has comprehensively abandoned the Precautionary Principle, in deﬁance ofDirective 2001/18, and that it has adopted the Anti-Precautionary Principle instead.
- 2. We ask the Committee to look very carefully at recent research, including that reported by Bristol University (which identiﬁes a new mechanism for horizontal gene transfer) andthat reported by Prof Andres Carrasco which brings into focus the dramatic ecological, health and socio-economic consequences of growing GM soy in South America and elsewhere (7). EFSA and the Commission appear oblivious to the manner in which GM soy is produced in non-EU countries. In recommending GM soy import approvals for food and feed use, EFSA fails even to consider the direct and indirect effects in the regions where cultivation is taking place. We believe that this "don't look, don't see" approach is both unethical and faulty in law.
- 3. With regard to the recent Commission proposal to allow Member States to restrict orprohibit speciﬁc GM crops within their territory (8), we consider that it is entirely impracticalto suggest that such bans could be based upon political, socio-economic or religiousjustiﬁcations. The Commission appears to have fallen into the trap of believing that once EFSA has issued its "scientiﬁc advice" on something, then that is the end of the matter. Nothing could be further from the truth. Science is not like that, and in any case EFSA's science is widely mistrusted. We therefore support the arguments presented by Corinne Lepage and her colleagues, namely that there are always scientiﬁc uncertainties, and thatMember States may invoke "supplementary" or conﬂicting science, or even demonstrate alack of a convincing safety case, in support of National GM restrictions or prohibitions.
- 4. We are deeply concerned that the decisions by Environment Council on 4th December 2008 (Appendix 2) have still not been fully implemented by either EFSA or the Commission. Indeed, it appears to us that the Commission, assisted by EFSA, is simply seeking to subvert or undermine those decisions (9), which have the utmost importance forhuman, animal and environmental health.
I am very grateful to the Committee for allowing me to bring this Petition forward on behalfof my colleagues from other parts of Europe, and I respectfully ask for carefulconsideration of the points I have raised.
Dr Brian John GM-Free Wales
- (1) http://www.gmfreecymru.org/open_letters/Open_letter23Feb2010.htmlFormal Protest from Scientists: Commission Regulation on Implementing Rules for GM applications and assessmentsDr 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 Michael Antoniou, Dr Arpad Pusztai, Prof Marcello Buiatti, Dr Susan Bardocz, Dr. Rafael HachikyanOPEN LETTER 23rd February 2010Urgent Scientiﬁc and Policy concerns about the new Draft GMO RegulationOPEN LETTER 27th February 2010 to John DALLI
- (2) EU Commission (2010): Draft Commission Regulation on implementing rulesconcerning applications for authorisation of genetically modiﬁed food and feed inaccordance with Regulation (EC) No 1829/2003 of the European Parliament and of theCouncil and amending Regulations No (EC) 641/2004 and (EC) No 1981/2006 (66 pages,in English).
Testbiotech opinion on EFSAʼs draft guidance on the environmental risk assessment ofgenetically modiﬁed plantsEFSA (2010) Panel on Genetically Modiﬁed Organisms (GMO); Guidance on the environmental risk assessment of genetically modiﬁed plants. EFSA Journal 20xx; volume(issue):xxxx. [100 pp.]. doi:10.2903/j.efsa.20NN.NNNN.Available online: www.efsa.europa.eu WARNING OVER "HIDDEN AGENDA" IN OVERHAUL OF GM APPROVALS SYSTEM
Wednesday, 03 March 2010 Comment: The Draft Regulation was submitted to the WTO under its conformity assessment procedure, and was due to be brought into law in May 2010 without anyconsultation with the public, NGOs or consumer groups, and even without discussionamong the "competent authorities." It was sold by the Commission as a "tightening up" ofthe rules relating to GMO assessment and approvals, but it does precisely the opposite.
(3) http://www.gmo-compass.org/eng/news/ 337.approval_gmo_crops_us_eu_seek_agreement.html
Approval of GMO crops: US and EU seek agreement, EU farmersʼ associations press forspeedhttp://www.theparliament.com/latest-news/article/newsarticle/eu-defends-balanced-and- pragmatic-gm-policy/
- (4) European Commission's illegal policy change
- (5) Letter from Elisabeth Waigmann of EFSA to Dorothee Andree of DG SANCO, containing Annex 1 -- EFSA responses to all of the points raised.
- (6) http://www.gmwatch.org/latest-listing/1-news-items/12816-more-gm-trickery-from-efsa- environmental-risk-assessment-guidelines-are-deeply-ﬂawed
More GM trickery from EFSA: Environmental risk assessment guidelines are deeply ﬂawedThursday, 20 January 2011, GM Watch Legal Opinion of Paul Lasok QC and Rebecca Haynes“In the Matter of the Proposed Regulation to Amend Directive 2001/18” GM Freeze
(7) Knight CJ, Bailey AM, Foster GD. Investigating Agrobacterium-mediated transformation of Verticillium albo-atrum on plant surfaces. PLOS ONE 2010, 5(10): e13684. Doi:10.1371/journal.pone.0013684
Paganelli, A., Gnazzo, V., Acosta, H., López, S.L., Carrasco, A.E. 2010. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signalling. Chem. Res. Toxicol., August 9. http://pubs.acs.org/doi/abs/10.1021/tx1001749 http://www.gmfreecymru.org.uk/pivotal_papers/health.html
Health Effects of GlyphosateHealth risks of GM Foods and Crops
(8) http://www.gmfreecymru.org/open_letters/Open_letter06July2010.htmlCommission proposals for national GM bans are deeply ﬂawedhttp://www.gmfreecymru.org/open_letters/Open_letter10Sept2010.html
Commission denial of evidence of harm from GM crops and foodshttp://www.greenpeace.org/eu-unit/press-centre/press-releases2/commission-plans-to-relax-rule www.gmfreeze.org/uploads/lasok_cultivation_summary_ﬁnal.pdf
EU States to discuss reasons for national GMO bans
We do of course welcome recent moves to ensure that socio-economic (cost/beneﬁt) factors are to be incorporated into the future GM approvals process.http://www.biosafety-info.net/article.php?aid=751
(9) Commissioner Dalli admits EU food safety regime must change
Council Conclusions on Genetically Modiﬁed Organisms 2912th Environment Councilmeeting Brussels, 4 December 2008 at www.consilium.europa.eu/uedocs/cms_Data/docs/ pressdata/en/envir/104509.pdf
Key concerns expressed in this Petition:
SIGNIFICANT SCIENTIFIC AND SAFETY CONCERNS
For more details see here:
- 1. REDUCED VIGILANCE. There is a noticeable lessening of vigilance on GM safety issues.
- 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 bedone.
- 3. STACKED EVENTS. We have particular concerns about the method proposed for dealing with "stacked event" applications, which involves a "fast track" process withsimpliﬁed requirements.
- 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 GMvarieties, which seems to fall far short of Codex Alimentarius standards.
- 5. CHOICE OF COMPARATORS. There now appears to be too much leeway in the choice of "the conventional counterpart" and additional comparators.
- 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 orderived from the GM plant itself.
- 7. INSERTIONAL MUTAGENESIS. The Draft Regulation is vague and complacent on this matter.
- 8. ANTIBIOTIC RESISTANCE MARKER GENES. We can see no requirement that ARMs (antibiotic resistance marker genes) MUST be removed after initial plant breeding.
- 9. MOLECULAR CHARACTERIZATION. There is lack of clarity in the Draft Regulation, with EFSA retaining the right to request -- or not request -- speciﬁc information.
- 10. SUBSTANTIAL EQUIVALENCE. The myth of substantial equivalence is maintained, in spite of the fact that there is now overwhelming evidence that GM varieties aresubstantially different from their isolines.
- 11. SAFETY STUDIES INVOLVING ANIMALS. The Draft Regs appear to accept the fantasy that short-term nutritional studies are adequate for identifying chronic healtheffects in mammals.
- 12. DEPENDENCE ON INDUSTRY STUDIES. In our view all industry-sponsoredresearch 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.
- 14. POST-MARKET MONITORING. The arrangements proposed for post-marketingmonitoring allow far too much discretion on the part of EFSA and the consent holders.
- 15. HEALTH IMPLICATIONS. There is no requirement for studies to demonstrate safety in use.
- 16. RESEARCH BLOCKING. EFSA and the Commission are still conniving in the use of non-replicable science and the blatant blocking of independent research.
Conclusions (unanimous) of Environment Council, 4th December 2008See also: Council Conclusions on Genetically Modiﬁed Organisms 2912th Environment Councilmeeting Brussels, 4 December 2008
- 1. There was a re-statement of the precautionary principle as a guiding principle in GMOassessments, on the basis that it has been inadequately used -- or disregarded -- in pastdecisions.
- 2. There was a commitment to a strengthening of the environmental impact assessmentfor GMOs and a strengthening of monitoring requirements.
- 3. There was a commitment that pesticide-producing GM crops (such as Bt11, 1507 and MON810) should be treated (in the assessment and approval process) in the same way aschemical pesticides.
- 4. Member states, competent authorities and EFSA were assured that they would from now on have the right to make speciﬁc assessments of the impacts of GMOs in speciﬁcgeographical areas / ecological niches.
- 5. Responding to the new research on damaging health effects associated with GM varieties, Ministers demanded that if new information becomes available with regard to therisk of the GMOs to human health, the competent authority must prepare an assessmentreport and indicate how the conditions of the consent should be revised or the consentterminated.
- 6. For the ﬁrst time, Ministers speciﬁed a role for independent scientists, scientiﬁcorganizations and NGOs in the GMO assessment process. An important role was
- accepted for organizations expert in ecological issues. Ministers also asked for effective coordination and cooperation between scientists.
- 7. For the ﬁrst time, socio-economic effects arising from the cultivation and / or marketing of GMOs must now be considered as relevant to the assessment process.
- 8. It was implicit in the drafted document that EFSA'a powers were to be substantiallyreduced, and EFSA was instructed to revise its GMO assessment procedures by 2010. Henceforth there was a commitment to a key role for member states, including states otherthan the applicant state.
- 9. There must now be greater protection from GMOs for special areas -- National Parksand other protected or designated areas. There was an acceptance that GM Free Zones coinciding with these protected areas could be declared and would be respected by theEC as valid.
- 10. The Ministers insisted on a reform of the secretive and defective assessment processthat has until now been operated by EFSA. Member States and the Commission musthenceforth ensure that systematic and independent research is conducted on the potentialrisks involved in the marketing and growing of GMOs. The necessary resources must be secured for such research by the Community and Member States. Most importantly, independent researchers must be given access to all relevant dossier material, whilerespecting intellectual property rights. Finally, Member States and the Commission must collect and exchange information on this research.
- 11. Finally, regions and local communities will henceforth have the right to declare GM-Free zones.