ngin - Norfolk Genetic Information Network

10 January 2003

LACK OF U.S. SAFETY STANDARDS FOR GM CROPS REVEALED  IN BRUSSELS

1.US Government's lack of safety standards for GM crops revealed by consumer representative in Brussels
2.Media briefing

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1.Press Release from Consumers International

US Government's lack of safety standards for GM crops revealed by consumer representative in Brussels

Brussels - Friday - 10 January 2003 - Documentation showing that the US government allows the biotechnology industry to police itself on safety testing of GM crops will be presented today at a meeting hosted by the German Marshall Fund in Brussels on GM crops, by Consumers International representative, Dr. Michael Hansen.

Dr. Hansen will provide letters written by the US Food and Drug Administration (FDA) to Monsanto accepting at face value Monsanto's own conclusions regarding the safety of their GM corn variety (see attached media briefing for excerpts of the letters)

Dr. Hansen also states that, contrary to the impression given by US ambassadors in Europe and elsewhere, the US government does not have rigorous standards for safety assessments on GM crops, does not thoroughly review company data, and has never formally approved any of the GM corn varieties grown in the US.

These allegations come at a critical time as the US government is making every effort to persuade both European and African governments that GM crops are thoroughly reviewed and that anyone raising questions about safety is ignorant and acting immorally.

"Consumers worldwide and especially in the US are outraged that the US government is threatening the EU with WTO challenges for refusing to accept GM corn  until comprehensive labelling and traceability systems are in place, when they themselves do not formally review and approve the safety of the GM corn varieties grown in the US"  said Dr. Hansen.

Dr. Hansen further criticised the FDA for failing to follow through on regulatory improvements proposed in 2001.  "Back in 1992, the FDA claimed that GM technology is similar to traditional breeding and would therefore be regulated in the same way (see attached media briefing for excerpts from FDA's policy document).  Then, in 2001, the FDA admitted that there is a difference between traditional breeding and GM technology and proposed that there should be mandatory notification of GM food marketing and a mandatory FDA data review.  However, they have still not issued any such regulation"

Consumers Union (CU) in the US and Consumers International (CI) worldwide are calling on the US government to stop pressurising the EU and Africa to accept its GM corn and instead get its own house in order by conducting mandatory safety reviews of data provided by the biotechnology industry and prohibiting the marketing of GM crops unless they have been approved by the FDA.   CU and CI point out that Africa's food needs could be met with non-GMO foods.  They note that 70 % of the corn grown in the US is not genetically modified.

ENDs.

For further information or to arrange an interview, please contact MayaVaughan, Consumers International on tel. +44 (0) 20 7226 6663 ext. 219or mobile: +44 (0)7931 798 086 or email: mvaughan@consint.org

Notes to Editors

1)      Media Briefing attached (will be on CI website later today)

2)       Michael Hansen, Ph.D. is a Senior Research Associate focussing on biotechnology for the Consumers Policy Institute, a division of Consumers Union, the largest consumer organization in the United States.  He represents Consumers International at UN bodies that establish international standards on genetically modified food, including the Codex Committee on Food Labelling and the Codex Ad Hoc Task Force on Foods Derived from Modern Biotechnology.  For more information, seewww.consumersunion.org.

3)      Consumers International is a federation of consumer organisations dedicated to the protection and promotion of consumers' rights worldwide through empowering national consumer groups and campaigning at the international level. It currently represents over 250organisations in 115 countries. For more information, see: www.consumersinternational.org

4)      The German Marshall Fund Meeting takes place between January10-12. The focus of the meeting is on how the transatlantic dynamics regarding agricultural biotechnology are affecting developing countries in Africa as they confront issues associated with the importing and growing of GM crops and products.

5)      Consumers International position on the issue of GM food aid to Africa can be seen in the attached letter to James Morris, Director of the World Food Programme. Click here to see full letter: http://www.consumersinternational.org/documents_asp/ViewADocument.asp?regid=135&ID=503&categoryid=463&langID=1
For further information on the African consumer movement's position on GM crops, please click here: http://www.consumersinternational.org/News/display.asp?id=175&regionid=135&tag=X&type=news&langid=1

6)      The German Marshall Fund of the United States (GMF) is an American institution that stimulates the exchange of ideas and promotes cooperation between the United States and Europe in the spirit of the post war Marshall Plan. GMF was created in 1972 by a gift from Germany as a permanent memorial to Marshall Plan aid.

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MEDIA BRIEFING

(to go with media release: US Government lack of safety standards for GM crops revealed)

Strictly embargoed until 01.00hrs (GMT) Friday 10th January 2003

Brussels, February 10th January 2003

The information contained in this media briefing will be presented by Michael Hansen, Ph.D., representing Consumers International,  at todays meeting in Brussels, hosted by the German Marshall Fund on GM crops and the implications for the import and production of these crops in the developing world.

MEDIA BRIEFING

The Food and Drug Administration (FDA) does not require safety testing for genetically engineered (GE) plants and has not formally approved any of the GE corn (maize) varieties being grown in the United States:

The FDAs original policy on GE/GM plants was introduced at a press conference at an industry gathering on May 28, 1992 by then Vice-President Dan Quayle as a de-regulatory initiative. The policy was based on the notion "that the new techniques [e.g. genetic engineering] are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding" (57 FR 22991, May 29, 1992), and therefore should be regulated in the same way.   In other words, no requirement for human safety testing.  But FDA will conduct "voluntary safety consultations" with companies.

The fact that FDA does not approve GE/GM crops can be seen in the letter FDA sends to the company after completion of a "safety consultation:"

For example, the letter sent to Monsanto on September 25, 1996 about its MON810 Bt maize states, "Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn grain and forage derived from the new variety are not materially different in composition, safety, or other relevant parameters from corn grain and forage currently on the market, and that they do not raise issues that would require premarket review or approval by FDA" bold added (www.cfsan.fda.gov/~acrobat2/bnfL034.pdf). Note that FDA does not state its own opinion about the safety of this crop; it only states what the company believes.  The letters for all 52 "safety consultations" done since the Flavr Savr tomato contain basically the same language.

FDA has recently admitted that it should require mandatory notification of GE/GM food marketing, but has not issued such a regulation:

 In 2001, the FDA made a proposal requiring companies to notify the government at least 120 days before commercializing a transgenic plant variety.  As part of that proposed rule, the FDA asked for data on each separate transformation event: "[B]ecause some rDNA-induced unintended changes are specific to a transformational event (e.g. those resulting from insertional mutagenesis), FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended trait and has had no questions about such foods. In contrast, the agency does not believe that it needs to receive information about foods from plants derived through narrow crosses [e.g. traditional breeding]" italics added (FR 66(12), pg. 4711).  In other words, FDA finally admits that differences exist between GE and traditional breeding, that companies should inform and provide basic data before putting a GE/GM food on the market.  Unfortunately, although the FDA received over 85,000 comments from the public overwhelmingly supporting mandatory notification, and although industry also supported it as well, the Bush Administration has not implemented this change and says it cannot predict when it will have time to consider it.

For GE/GM plants that produce a newly introduced pesticide, the Environmental Protection Agency (EPA) reviews and approves the safety of the pesticide, but not other plant characteristics.  The safety of other changes in the food are not reviewed and approved, as they come under the jurisdiction of the FDA.

A major food safety concern for GE plants is allergenicity, which is not adequately addressed in the U.S:

Last year, the report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, held at FAO headquarters in Rome, laid out a detailed protocol (a decision tree) for evaluating the allergenicity of GM foods (FAO,  2001).  None of the GE/GM crops, including GM maize, on the market in the U.S. have been assessed, either by the EPA or the FDA, using such a protocol.

Various types of scientific evidence suggest that Bt maize may contain a transgenic allergen:

Bt maize contains various modified endotoxins from the soil bacterium Bacillus thuringiensis (Bt).  These d-endotoxins are called Cry proteins, in particular Cry1Ab or Cry1Ac.  A study of farmworkers who worked in onion fields where foliar Bt sprays were used found that 2 of them contained antibodies to the d-endotoxins, Cry1Ab and/or Cry1Ac, consistent with an allergy (Bernstein et al., 1999).  One of the first steps in assessing the allergic potential of a protein (most allergens are proteins) is to determine if it has similarity in amino acid sequence to a known allergen.  A paper published in 1998 by the head of FDAs own biotechnology studies branch, Dr. Steven Gendel, found significant amino acid sequence similarity between Cry1Ab and Cry1Ac (found in Bt maize and Bt cotton) and vitellogenin, the main precursor to egg yolk protein and a known allergen, as well as between Cry3A (Bt potatoes) and b-lactoglobulin, a major milk allergen (Gendel, 1998).

Global agreement has been reached on what constitutes proper safety assessment of foods derived from GE/GM plants, yet such suggested studies have not been carried out on GM Bt maize (or any other GE/GM crop approved in the US):

Earlier this year, the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology reached agreement on a "Draft guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants" (ALINORM 03/34, Appendix V, pp. 61-73).  This document is at Step 8 of the Codex procedure, which means that all 35 countries, including the U.S., at the meeting in Yokahama, Japan agreed on this document and recommended that it be adopted by the full Codex Alimentarius Commission.  This is important because in the case of trade disputes, the World Trade Organization considers that, in terms of food safety, the standards or guidelines of Codex Alimentarius are deemed the global science-based standard and, thus, immune to trade challenges, i.e. they are not considered to be a "non-tariff trade barrier."  At present, the U.S. has not subjected GE/GM maize to the complete safety assessment laid out in this document.
 


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