Commission response to GMO Petition is "complacent and evasive"
THE BACKGROUND
Petitions One of the fundamental rights of European citizens: Any citizen, acting individually or jointly with others, may at any time exercise his right of petition to the European Parliament under Article 194 of the EC Treaty.
Any citizen of the European Union, or resident in a Member State, may, individually or in association with others, submit a petition to the European Parliament on a subject which comes within the European Union's fields of activity and which affects them directly. Any company, organisation or association with its headquarters in the European Union may also exercise this right of petition, which is guaranteed by the Treaty.
A petition may take the form of a complaint or a request and may relate to issues of public or private interest.
The petition may present an individual request, a complaint or observation concerning the application of EU law or an appeal to the European Parliament to adopt a position on a specific matter. Such petitions give the European Parliament the opportunity of calling attention to any infringement of a European citizen's rights by a Member State or local authorities or other institution.
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What action is taken in the case of admissible petitions?
http://www.europarl.europa.eu/parliament/public/staticDisplay.do?id=49&pageRank=4&language=EN
If the subject of your petition concerns an area of activity of the European Union it will normally be declared admissible by the Committee on Petitions, which will then decide what type of action should be taken, according to the Rules of Procedure.
Whatever is decided, the Committee on Petitions will inform you as soon as possible after the decision has been reached.
Depending on the circumstances, the Committee on Petitions may:
• ask the European Commission to conduct a preliminary investigation and provide information regarding compliance with relevant Community legislation or contact SOLVIT, • refer the petition to other European Parliament committees for information or further action (a committee might, for example, take account of a petition in its legislative activities), • in some exceptional cases prepare and submit a full report to Parliament to be voted upon in plenary ; or conduct a fact-finding visit to the country or region concerned and issue a Committee report containing its observations and recommendations; • or take any other action considered appropriate to try to resolve an issue or deliver a suitable response to the petitioner. Meetings of the Committee on Petitions take place every month, as a rule, except during the month of August when Parliament is in recess. The Committee is assisted in its work by a permanent secretariat which manages the petitions process, has an advisory role and which prepares meetings of the Committee.
The Petitions Committee of the European Parliament may seek to cooperate with national or local authorities in Member States to resolve an issue raised by a petitioner. Details of petitions may therefore be shared with such authorities unless the petitioner specifically objects.
The Petitions Committee cannot, however, override decisions taken by competent authorities within Member States. As the European Parliament is not a judicial authority: it can neither pass judgement on, nor revoke decisions taken by, the Courts of law in Member States. Petitions seeking such courses of action are inadmissible.
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That's the theory -- now for the reality......(1) Petition, (2) EC Response, and (3) Rejoinder.
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(1) THE PETITION
Name: Brian John Postal Address: Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN, Wales, UK Nationality: Welsh Hosting MEP: Kathy Sinnott, MEP Ireland South Title of Petition: The importance of impartiality within EFSA & the food safety rights of EU citizens
Text of Petition (No. 0813/2008):
The European Food and Safety Agency (EFSA) was designed to improve food safety in the EU, to restore the faith of EU citizens in EU food and guarantee consumer protection. As such, EFSA claims to provide "independent scientific advice [which] underpins the European food safety system"[1]. As citizens who should be served by this remit of EFSA we petition the European Parliament today because we see that the modus operandi of EFSA means it cannot be neutral or independent and thus violates the rights of all EU consumers to clean, safe and healthy food.
It is our assertion that EFSA does not operate according to EU law, namely Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. In addition principles of European Consumer Law are being disregarded, and priorities laid down in the Sixth Framework Programme (2000-2006): food quality and safety (2002/835/EC).
As an independent risk assessor, EFSA should not base its assessments of GM foods and crops on "advocacy science" submitted by applicants, which is by definition partial, selective and biased. Yet it continues to do so, despite the fact that some such science may also be fraudulent, since the application dossiers from GM corporations and patent owners cannot be examined in full by members of the public and by independent scientists and thus cannot be subjected to a proper process of peer review. Thus when dossiers are assembled, companies can simply omit "inconvenient" findings; they can also "manufacture" favourable results by the aggregation of data with a view to masking effects, by the use of insensitive testing techniques, by statistical manipulation, and by careful experimental design. Such practices are fraudulent, and they place Europeans at risk since GM crops and foods cleared as "safe" on the basis of dossier evidence may in fact be dangerous.
Furthermore, and more importantly, the science which is assessed by EFSA is for the most part non-replicable science which should never be admitted as valid, let alone considered in detail and acted upon. It is a fundamental principle of science that all experiments must be replicable if scientific fraud is to be avoided -- and yet EFSA never asks for replicability. (It has occasionally asked for supplementary evidence, but never for full independent replication of experiments.) Those who apply for approvals for GM crops and foods systematically block research by refusing to supply GM seeds, reference materials and chow for animal feeding experiments by independent scientists or institutions; this means that the dossier experiments cannot be replicated or improved, and that results cannot be verified or questioned. In Hungary, for example, Monsanto refused to supply MON810 seed to Professor Darvas and colleagues as soon as their research started to throw up negative environmental effects. Another example is in France, where Monsanto refused to supply MON863 materials for experiments designed to replicate or test the results reported in the MON863 dossier. Both examples clearly violate the terms under which EFSA operates namely Article 38 (concerning Transparency) of Regulation 178/2002 Section 4.
These concerns lead us to ask that the Parliament instruct EFSA to enforce the highest standards of scientific ethics in its own GMO Panel and in the dossiers of GM applicants, thereby safeguarding the health of citizens as per its original remit. We ask that EFSA be instructed to insist on full and early release of all scientific data contained in dossiers, and to insist on signed declarations from applicants relating to replicability, so as to enable a full and independent verification (or falsification) of apparent findings.
As EU citizens with rights we are being discriminated against by EFSA who, rather than protecting us, are supporting the commercial ambitions of the GM companies and "enabling" their approvals. We wish to emphasize the fact that there are no benefits to consumers in terms of taste, quality, shelf-life, price, and nutritional value of GM crops and foods -- the only benefits are to farmers wishing to reduce labour costs and spend less by using chemicals, and to the companies that own the seed and sell the herbicides / pesticides. It is valid for certain EU institutions, such as those involved in trade and agriculture, to support these corporate ambitions but EFSA should represent citizens and not business interests. EFSA exists to provide a service to EU citizens and the European institutions, and it must therefore treat consumers as its number one priority. It is our view that the current modus operandi of EFSA fails to do this, implying that EFSA has breached its responsibility to European consumers and to Regulation 178/2002 Section 4: Article 37-40 on Independence, Transparency, Confidentiality and Communication.
Kathy Sinnott MEP will be the hosting MEP for this petition.
[1] http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htm
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(2) COMMISSION RESPONSE
EUROPEAN PARLIAMENT
www.europarl.europa.eu/meetdocs/2004_2009/.../777624en.pdf
Committee on Petitions 20.03.2009
NOTICE TO MEMBERS
Subject: Petition 0813/2008 by Mr. John Brian (British), on alleged breaches of the general principles governing the activity of the European Food Safety Agency (EFSA) in connection with the examination of the applications for Genetically Modified foods
1. Summary of petition The petitioner alleges that, in carrying out its activity, the European Food Safety Agency (EFSA) would have failed to protect the interests of the European citizens, to guarantee consumer protection and to provide independent scientific advice. The petitioner argues that in examining the applications for Genetically Modified food or crops, EFSA would base its assessment on data provided by the applicants, which would be selective and biased. The petitioner also criticizes the non-transparent way in which EFSA assesses the files and considers that data in such application should be put to public scrutiny. The petitioner asks the European Parliament to have EFSA enforce the highest standards of scientific ethics in its Genetically Modified Organisms (GMO) Panel and in examining GMO applications.
2. Admissibility Declared admissible on 24 October 2008. Information requested from Commission under Rule 192(4).
3. Commission reply, received on 20 March 2009.
The European Food Safety Authority (EFSA) as established by Regulation (EC) No. 178/2002 is a scientific body, independent from the Union Institutions (1) with the main mission to provide scientific advice for the Community's legislation and policies in all fields that have a direct or indirect impact on food and feed safety.
The legislation establishing EFSA provides for a Scientific Committee and ten Scientific Panels which are responsible for providing scientific opinions in the various specialised areas relating to the remit of EFSA, one of which is the GMO Panel. Their members are independent experts, identified following a public call for expression of interest and nominated by EFSA’s Management Board. Internal rules and guidance on declarations of interests, the establishment of Scientific Committee and Panels and implementing measures on transparency and confidentiality requirements and on declarations of interests are published on the EFSA website. The Scientific Panels may involve ad hoc experts in expert working groups who contribute to the preparatory work of the Panels and are covered by the same internal rules as the Panel members.
Members of the scientific panels and ad hoc experts are obliged to complete an annual declaration of interests mentioning possible interests which could impact on the work of the panel. These declarations are published on the EFSA website. Similarly, the declarations of interests for members of working group are also published. In addition, for each meeting, experts are required to declare any interest which may constitute a conflict of interest with respect to the agenda of the meeting. This is reported in the minutes of the meeting which are again published on the website. Due to the fact that all scientists involved in the Scientific Committee and Panels have various interests in the respect of their area of work, it is necessary to differentiate between interests and conflict of interest.
The EFSA GMO Panel evaluates the studies submitted by the applicants. The environmental risk assessment takes place in accordance with the thorough criteria established by the principles of Annex II of Directive 2001/18/EC. The study types to be submitted are defined on the basis of the provisions of Directive 2001/18/EC and Regulation 1829/2003 which require a detailed set of information (2) to be provided in accordance with the published EFSA guidance documents for the risk assessment of GMOs. In the context of its evaluation, the Authority is also entitled to request supplementary data and it may always ask to be assisted by a food assessment body of a Member State. Moreover the EFSA GMO Panel always checks the quality of the tests which in principle must be performed by accredited laboratories respecting Good Laboratory Practice protocols and using internationally recognised OECD standards. Against this background the duration of the studies needed to assess the safety of a product is defined on a case by case basis.
It is also worth mentioning that EFSA's evaluation of studies submitted by applicants reflects normal practice for the risk assessment of authorisation dossiers. This is not only the case for other areas covered by EFSA but is the practice for agencies responsible for the assessment of authorisation dossiers in other areas, such as, the European Medicines Agency (EMEA) and also reflects the situation internationally. Furthermore, it should also be recognised that EFSA's opinions on GMOs are not restricted to the provided data alone, such as applicant dossiers, but also takes into account studies carried out by independent researchers and published in peer review scientific journals. These are systematically identified and referenced in each scientific opinion.
The results of the EFSA assessment, together with other relevant factors, are taken into account in the subsequent risk management decision, proposed by the Commission and taken under a regulatory procedure ensuring close co-operation between the Commission and the Member States.
It must be stressed that these steps are taken with full transparency and active involvement of not only the competent national authority of Member States (3) but also the public at large. Directive 2001/18/EC and Regulation (EC) No 1829/2003 both provide for a public access to the information and data received during the authorisation process and offer the public the possibility to forward comments to the Commission further to the risk assessment and before the adoption of the authorisation decision.
In conclusion, the Commission considers the protection of human and animal health and the environment as a top priority and is committed to ensure that genetically modified seed, food and feed are authorised only when they do not have adverse effects on human health, animal health or the environment. In this context the Commission is confident in the work carried out by EFSA, a judgment which has been shared even recently by the vast majority of Member States and the European Parliament. The Commission will continue to fulfil its responsibilities in the implementation of this framework which is probably the strictest in the world and which we constantly monitor for possible improvements.
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(1) Regulation (EC) No 178/2002 of the Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002
(2) See Annex III of Directive 2001/18/EC outlining information required in the notification
(3) See Articles 6(4)/18(4) of Regulation(EC) No 1829/2003
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(3) REJOINDER from Petitioner, dated 1st May 2009
Regarding the Commission's response to my Petition, I find it to be complacent and evasive, in that it does not address any of the key concerns raised in the Petition. It fails to address the issue of "selective advocacy science" which is quite likely to be flawed or even fraudulent; it does not address the issue of non-replicable science and the blocking of independent research into GM varieties; and it does not address the ongoing attempts by EFSA to frustrate or prevent full public disclosure of the contents of GMO dossiers. It simply falls back on platitudes and pretends that EFSA's work is independent and impartial, whereas it patently is not -- which is why there is such disquiet about EFSA throughout the voluntary sector.
I therefore ask the Parliament and the Petitions Committee to reject the Commission response on the following grounds:
1. With reference to this paragraph: "The EFSA GMO Panel evaluates the studies submitted by the applicants. The environmental risk assessment takes place in accordance with the thorough criteria established by the principles of Annex II of Directive 2001/18/ EC............" The whole point is that these criteria are not thorough at all. They allow applicants a huge amount of discretion and even permit scientific fraud. Many of the tests reported upon in dossiers refer to "surrogate proteins" or to GM constructs simply assumed to be stable and uniform in the GM varieties considered. For composite materials like food and feed, reductionist approaches testing single components in vitro or in vivo are highly unsatisfactory and cannot clarify important safety issues. In spite of the obvious need, very few studies designed to investigate putative effects of GE nucleic acids or food/feed on potential animal or human consumers have been published in peer- reviewed journals (Domingo, J. L., 2000). A consensus has emerged that the effects observed in some published studies (Fares, N. H. & El- Sayed, A. K., 1998; Ewen, S. W. B. & Pusztai, A., 1999) must be experimentally followed up. To this day, this has not been done by EFSA, nor has EFSA insisted on such work by the applicants for GMO consents. Most of the animal feeding studies conducted so far have been designed exclusively to reveal husbandry production or nutritional differences between GMOs and their unmodified counterparts. Studies designed to reveal physiological or pathological effects are extremely few, and they demonstrate a quite worrisome trend (Pryme, I. F. & Lembcke, R., 2003): Studies performed by the industry find no problems, while studies from independent research groups often reveal effects that should have merited immediate follow- up, confirmation and extension. Such follow-up studies have not been performed or insisted upon by EFSA. There are two main factors accounting for this situation: The lack of funds for independent research, and the reluctance of producers to deliver GM materials for analysis.
Supporting documentation:
Domingo, J. L. (2000). Health Risks of GM Foods: Many Opinions but Few Data. Science 288, 1748-1749.
Ewen, S. W. B. & Pusztai, A. (1999). Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet 354, 1353-1354.
Fares, N. H. & El-Sayed, A. K. (1998). Fine Structural Changes in the Ileum of Mice Fed on d Endotoxin-Treated Potatoes and Transgenic Potatoes. Nat. Toxins 6, 219-233.
Freese, W. & Schubert, D. (2004). Safety testing and regulation of genetically engineered foods. Biotechnol. Genet. Eng. Rev. 21, 299-324.
Mayer, S. & Stirling, A. (2004). GM crops: good or bad? EMBO Rep. 5, 1021.
Pryme, I. F. & Lembcke, R. (2003). In vivo studies on possible health consequences of genetically modified food and feed—with particular regard to ingredients consisting of genetically modified plant materials. Nutr Health 17, 1-8.
Pusztai, A. (2002). Can science give us the tools for recognizing possible public health risks for GM food?. Nutr Health 16.
2. With reference to this sentence: " ........ it should also be recognised that EFSA's opinions on GMOs are not restricted to the provided data alone, such as applicant dossiers, but also takes into account studies carried out by independent researchers and published in peer review scientific journals." We are intrigued by the fact that the EFSA GMO Panel does in theory take into account "independent" studies which may be brought to its attention in the assessment of GMO varieties, but it tends to be dismissive of independent studies critical of GMOs that may not appear in peer- reviewed journals, while being perfectly prepared to accept non- assessed and highly selective and manipulated research from the companies assembling their GM application dossiers. The approach of EFSA is far from being even-handed; it applies a high level of scepticism when considering independent research, and a high level of acceptance when considering industry-led research (Mueller, 2008). This is one of the reasons why EFSA is so mistrusted by NGOs and consumer groups. On a related matter, EFSA appears quite unconcerned about the fact that much of the research reported upon in applicant dossiers is NON-REPLICABLE for the simple reason that the GM patent holders / applicants simply refuse, as a matter of course, to allow their GM plant materials, seeds or reference materials to be used for independent analysis. Since non-replicable science should never be accepted as valid by any reputable scientific committee, we have made the point repeatedly to EFSA that no dossier material should be taken at face value unless it is accompanied by a statement from the applicant specifically committing to the provision of requested GM materials for independent repeat experiments or follow-up studies. In the absence of such cooperation by applicants, it should be assumed that their studies are fraudulent. EFSA has refused to address this issue, and the Commission reply to our petition also omits to mention it. That is simply not acceptable, and we insist that as a result of this connivance in poor or fraudulent research, the health of EU consumers is being put at risk. In 2005, at a GM meeting at FOA headquarters in Rome, Dr Harry Kuiper, chair of the GMO panel of EFSA, stood against the consensus among the 12 invited scientist and refused to consider independent feeding studies as a means of settling the rising controversy over the safety of GM foods. That neatly summarises EFSA's real position.
Supporting documentation:
Mueller, W. (2008) EFSA misleads the European Commission and the public over GMOs Eco-risk, Vienna, May 2008, 4 pp.
Pollack, A. (2009). Crop scientists say biotechnology seed companies are thwarting research. New York Times. CheckBiotech, Friday, February 20, 2009 http://greenbio.checkbiotech.org/news/crop_scientists_say_biotechnology_seed_companies_are_
thwarting_research
GM Free Cymru (2007) PERVERTED SCIENCE -- THE MANIPULATION OF GM RESEARCH. How "inconvenient" GM research is stifled, starved, marginalized and patronized. http://www.gmfreecymru.org/pivotal_papers/manipulation.htm
Fatka, J. (2009) Biotech companies limiting independent GM analysis. Farm Weekly, 16 March 2009
3. With reference to this statement: "Directive 2001/18/EC and Regulation (EC) No 1829/2003 both provide for a public access to the information and data received during the authorisation process and offer the public the possibility to forward comments to the Commission further to the risk assessment and before the adoption of the authorisation decision." This is fine in theory, but in practice EFSA puts major obstacles in the way of those who wish to peruse full dossiers or even selected parts of a dossier. It misuses "commercial in confidence" rules to prohibit or restrict access to documents. For example, in the case of MON863 EFSA hid important research information just because Monsanto asked it to, until it was forced by a German court ruling to accept that the public interest and the "right to know" must override the commercial interests of a seed owner. When independent analysis of the MON863 data showed up serious statistical flaws and possible data manipulation, EFSA refused to revise its good opinion of MON863, preferring instead to criticise the independent researchers for perceived flaws in their work. In 2006, in the case of LLRice601, EFSA withheld 30 pages of diagrams and data from perusal, simply because Bayer asked it to, and with no sound scientific or economic justification. It has a track record of protecting the interests of commercial GMO developers and blocking truly independent analysis of data and full public access.
Supporting documentation:
Greenpeace (2005) Preliminary report by Criigen on the “First public investigation of the crude data in Mon 863 toxicity tests on rats”. http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/
gentechnik/MON_863_French_report_statistics.pdf
GeneWatch (2005) Response of GeneWatch UK to questionnaire for Member States on the implementation of Regulation (EC) 1829/2003 of the European Parliament and of the Council on genetically modified food and feed. (February 2005) http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/
Consultation_on_implementation_of_1829_2003.pdf
Ho, Mae-wan. (2007) French scientists find signs of toxicity to liver and kidney in Monsanto’s study on its controversial GM maize. ISIS Report 03/05/07. GM Maize MON 863 Toxic.
Séralini G-E, Cellier D, Spiroux de Vendomois J. (2007) New analysis of a rat feeding study with genetically modified maize reveals signs of hepatorenal toxicity. Arch Environmental Contamination and Toxicology 2007, published online 13 March 2007.
Séralini G-E, Cellier D, Spiroux de Vendomois J. Crii-Gen Letter to EFSA, 20 April 2007, http://www.criigen.org Bt maize MON863: EFSA stands by its opinion: No concerns. GMO Safety (2007)
http://www.gmo-safety.eu/en/news/576.docu.html
John, B.S. (2006) OPEN LETTER: Protest re EFSA's refusal of full disclosure of information on LLRICE601. 16th September 2006 http://www.gmfreecymru.org/open_letters/Open_letter16Sept2006.htm
Smith, J.M. (2005) Cause For Concern. The Ecologist, October 2005. http://www.theecologist.org/PAGES/archive_detail.asp?content_id=2318
Thus there are very substantial reasons why this Petition should be "kept open" for further detailed consideration -- and I will provide further evidence relating to my concerns if the Committee wishes.
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Since May 1st 2009, there has been total silence on this matter from the Commission and the Parliament..........