Print

1. Action Alert! FDA & Labeling of GE Foods - foodfirst
2. EU AND US NEW GMO FOOD LEGISLATION - BRIDGES Weekly Trade News
3. GM-contaminated seed allowed under UK and EU proposal
---

Action Alert! FDA Fails To Require Labeling of GE Foods
originated: Anuradha Mittal <This email address is being protected from spambots. You need JavaScript enabled to view it.>

Last week, in the final days of the Clinton administration, the FDA  submitted its long awaited policy on genetically engineered foods.  The  policy, which was originally proposed in May of 2000, will not require  labeling of genetically engineered food, nor will it require mandatory  pre-market safety testing of genetically engineered products.  Instead,  the FDA encouraged voluntary labeling of biotech products, requiring  only that biotech food producers engage in "consultations" with the FDA  in which they submit information on their products.   The information  must be submitted to the FDA within 120 days of marketing, and will be  made available to the public.

"This is a major disappointment for consumers, farmers and  environmentalists who were hoping that our regulatory agencies would  finally take a real stand," said Dr. Peter Rosset, Co-director of Food  First/The Institute for Food and Development Policy, based in Oakland,  CA.

"Despite a PR offensive claiming that government regulators are finally  taking GE foods seriously, closer examination reveals this to be a  hollow claim," said Rosset. "These rules, if they can be called that,  are not nearly as tough as those for food additives. In reality the FDA  is providing industry with a thinly disguised whitewash."

The FDA's new rules ignore not only the concerns of environmental,  family farm and consumer groups, but also overlook the recommendations  made by the Biotechnology Consultative Forum.  In a report released in  December of 2000, the BCF, an international panel of experts who  represent both sides of the biotech debate, advised the Clinton  administration to require mandatory labeling of GE foods in order to  protect consumers' right to informed choices about what they eat.

"The proposed rules appear to provide a security blanket to the biotech  industry at the expense of public health, the environment, and the few  businesses that choose not to use GE foods," said Ms. Anuradha Mittal,  also Co Director at Food First. Companies that label their foods as  GE-free must bear the cost of labeling, and must verify their claims  through chain of custody documentation, test results, or be certified  organic, while who do use GE ingredients face no such hurdles.

"It is critical that informed citizens make their voices heard at the  FDA," said Ms. Mittal.  "In the past we reversed poor organic standards  from the USDA," she added.  "Now it is time to let the FDA know what we  think," she said, in reference to the highly successful letter writing  campaign during the USDA public comment period which reversed that  agency's position.

 Take Action!

The FDA is allowing for an open commentary period until April 3, 2001.  Write to FDA Commissioner Jane Henney and tell her that the new policy  is insufficient.  Tell her you are disappointed that the FDA continues  to ignore the safety concerns of consumers and chooses instead to help  the companies developing biotech products.  Demand that she change the  policy on GMO food to one that protects the rights of the consumer.  A  sample letter follows.

Send your e-mails to This email address is being protected from spambots. You need JavaScript enabled to view it., subject re: dockets .  00N-1396 and 00D-1598, or write to:

FDA Commissioner Jane Henney Dockets Management Branch (HFA 305) Food  and Drug Administration 5630 FisherÇs Lane, rm. 1061 Rockville MD 20852

For the full text of the FDA rules, visit:  http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm

For more information about issues surrounding biotechnology, see Food  First's website at: http://www.foodfirst.org/progs/global/biotech

Sample Letter:

Dear Commissioner Henney,

The proposed Food and Drug Administration (FDA) regulations fail to  require labels or safety tests on genetically engineered (GE) food. The  new rules continue to deny Americans the right to know what is in our  food, while protecting the economic interests of biotech corporations.

Labeling GE foods would protect the public from potential health effects  that could only be traced if GE foods can be identified. By refusing to  require both labeling and mandatory safety testing of foods, the FDA  puts consumer's health at risk, and ignores the recommendations of the  Biotechnology Consultative Forum, who in December urged the US to  require mandatory labeling of GE foods.

I urge you to reconsider this proposal and insure that GE foods are  subject to pre-market testing and labeling.  Americans have a right to  make informed decisions about the food we consume.

Sincerely,

Join the fight against hunger. For more information contact  This email address is being protected from spambots. You need JavaScript enabled to view it..
---

2. EU AND US DEVELOPING NEW GMO FOOD LEGISLATION
FDA rules on premarket notice and labelling for GM foods

The US Food and Drug Administration (FDA) last week released its proposed rule on premarket notice and draft guidance on labelling of bioengineered foods (see BRIDGES Weekly, 16 Jan 01, http://www.ictsd.org/html/weekly/story4.16-01-01.htm). Despite receiving a flood of comments supporting mandatory labelling of GMOs, the FDA opted for voluntary rather than mandatory guidelines for labelling of genetically modified organisms (GMOs). The US move, which follows the recently completed conciliation process between the European Parliament and Council regarding amendments to Directive 90/220/EEC, will do little to mend the transatlantic rift between the EU and US regarding the EU's de facto moratorium on the approval of new GMOs.

The FDA's proposed rule on "Premarket Notice Concerning Bioengineered Foods" would require GM food producers to notify the FDA at least 120 days prior to the commercial distribution of plant-derived bioengineered foods intended for human or animal consumption. The notification would need to be accompanied by information on, inter alia, the method of development; any newly inserted antibiotic resistance marker gene (ARMG); and the substances introduced into or modified in the food, including safety considerations associated with them. Information submitted to the FDA and its response would be posted in the agency's electronic reading room (http://www.fda.gov/foi/electrr.htm) unless deemed confidential. The FDA has also issued a draft guidance document to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering or the use of bioengineered ingredients in order to ensure that labelling is truthful and not misleading.

The proposed rules have come under heavy criticism from consumer and environmental groups who claim that the provisions fail to adequately protect human health and the environment. In particular, many have expressed their anger that the FDA did not accommodate the widespread public demand for GM food labelling. Others have criticised the FDA rule for not requiring any mandatory testing of GM foods, but rather placing the burden of proof largely on those companies that wish to market their products as "GM free".

EU REVISION OF DIRECTIVE 90/220/EEC

Efforts to reform regulations related to GM foods are also underway within the EU, in particular with regard to the EU "Council Directive on the deliberate release into the environment of genetically modified organisms" (90/220/EEC). In December 2000, the European Parliament and Council concluded a conciliation procedure on GMOs that had been initiated after the Council refused to accept the Parliament's 29 amendments to the Directive in April. This agreement will now be submitted to the plenary for ratification in February. It is unclear, however, whether the new directive will end the de facto moratorium that currently exists in the EU on the approval of new GMOs.

Amongst other provisions, the revised Directive calls for the phasing out of antibiotic resistance marker genes for GMOs placed on the market by 31 December 2004 and for experimental GMOs possibly by 31 December 2008. The EU action is seen to be a precautionary approach to ARMGs, since no clear evidence regarding their health impacts currently exists. The FDA, in contrast, does not provide for the phase-out of ARMGs, but only proposes that newly inserted ARMGs are specified. According to the FDA draft guidelines on the use of ARMGs released in 1998, "the presence in food of proteins encoded by antibiotic resistance genes is not of great concern", nor does the potential transfer of antibiotic resistance to cells lining the gastrointestinal tract "raise a safety concern". It remains to be seen if the US will challenge any EU provisions that mandate the phase-out of ARMGs.

EU working paper on traceability and labelling

The European Commission has recently issued a working document on traceability and labelling of GMOs and products derived from GMOs. The document reiterates the Council's Common Position on amending Directive 90/220/EEC, and proposes that Member States should take measures to ensure traceability at all stages of the placing on the market of GMOs. These provisions would also apply to imports, in that products containing and/or consisting of GMOs cannot be imported into the Community if they do not comply. Regarding labelling, the Position requires that GMOs placed on the market or in products must specify that they contain GMOs, either on the label or in an accompanying document. The Commission's document then outlines various options regarding traceability and labelling, and invites Member States to provide their views and experience.

To view the proposed FDA rules on bioengineered foods visit: http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm? yr=2001&mn=1&dy=18. The FDA draft guidance on ARMGs is available at: http://vm.cfsan.fda.gov/~dms/opa-armg.html. The European Commission Document on traceability and labelling is available at: http://europa.eu.int/comm/food/fs/biotech/biotech01_en.pdf.

   "Biotech Foods Rule Fails to Protect American Public," ENVIRONMENT NEWS SERVICE, 18 January 2001;

   "EU close to agreement on new genetic crop law," REUTERS 13 December 2000;

   "GMO conciliation nears end," NEWS REPORT EUROPARL, 13 December 2000; ICTSD Internal Files.
---

3. GM-contaminated seed to be allowed under UK Government and EU proposal
Press Release from http://www.gmfoodnews.com/
18 January 2001, London, UK

Proposals released on 17 January 2001 by the Ministry of Agriculture Fisheries and Foods (MAFF) indicate that the UK Government is intending to allow up to  0.50% contamination of seeds by Genetically Modified (GM) varieties.

Marcus Williamson of www.gmfoodnews.com comments :

"Consumers will not tolerate 0.50% contamination by, for example, glass or  benzene, in their food. Why should we tolerate contamination of our food  crops by the presence of GM seeds?"

Also proposed is new labelling for seeds, so that they carry the wording :

"EU-unauthorised genetically modified organisms not present"

or

"Genetically modified variety"

Marcus Williamson adds :

"This is a further step towards preparing the way for the introduction  of GM foods which are not wanted by the consumer, are untested and are  damaging to the environment.

These crops are only of benefit to the agrochemical companies which  produce them and have no advantages at all for the consumer or for the environment.

The consumer demands 0.00% (ZERO) presence of genetically modified varieties in seeds, food ingredients and derivatives."

The MAFF seed purity proposals news release can be found at :

http://www.maff.gov.uk/inf/newsrel/2001/010116a.htm

Anyone who wishes to comment on the seed purity proposals may do so before 10 April 2001, by writing to :

George Saunders
Ministry of Agriculture
Fisheries and Food PVRO and Seeds Division
Room 21
White House Lane
Huntingdon Road
Cambridge
CB3 OLF
UK
Fax : 01223 342386
E-mail : This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the dangers of GM foods contact :
Marcus Williamson
http://www.gmfoodnews.com/
This email address is being protected from spambots. You need JavaScript enabled to view it.
ENDS