Regarding FDA Failure to Respond to Citizens Petition to Label and Safety Test GE Food
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PHYSICIANS STATEMENT CALLING ON FDA TO URGENTLY RESPOND TO 2011
CITIZENS’ PETITION BY CENTER FOR FOOD SAFETY SEEKING FDA REVISION OF
CURRENT FDA POLICY REGARDING
GENETICALLY ENGINEERED FOODS
NOVEMBER 7, 2014
We, the undersigned, as concerned physicians or physicians organizations, declare our intent to inform and request the US FDA to urgently respond to a formal citizens petition[i] filed in October 2011 by the Center for Food Safety and 22 supporting organizations and businesses by: 1) advocating thorough, science- based safety testing of GE products prior to marketing; 2) cultivation of GE crops in a manner minimizing risk of contamination of conventional food supplies and the environment ; and 3) providing consumers with a means of identifying GE foods through mandatory product labeling.
On October 12, 2011, the Center for Food Safety filed in good faith a formal Citizens Petition in compliance with federal law, contained in 21 CFR Code of Federal Regulations, 10.30, Citizen Petition,[xii] requesting, in conjunction with 22 other concerned organizations and businesses, to request mandatory safety testing and labeling of genetically engineered foods.
The major basis of the Center for Food Safety petition is “Genetic engineering makes silent but fundamental changes to our food at the molecular level, the full human health and environmental consequences of which are still being discovered. Unlabeled genetically engineered foods are misleading to consumers who, in the absence of labeling, overwhelmingly purchase based on the reasonable assumption that their food is produced conventionally. Mandatory labeling for GE foods is necessary in order to prevent consumer deception and economic fraud.”
Organizations signing the 2011 CFS petition include the following:
Although 21 CFR Code of Federal Regulations required response by the FDA within a maximum of 180 days, no response from FDA has yet been received in spite of lapse of a three year period.
Note to Signers of the above Physician Statement
Please complete this form to support the above statement.
[i] “Citizens Petition Before the United States Food and Drug Administration, October 12, 2011, Petition Seeking Mandatory Labeling of GE Foods, Center for Food Safety, http://www.regulations.gov/#!documentDetail;D=FDA-2011-P-0723-0001
[ii]Public Health Focus: FDA, USDA, NOAA Statements on Food Safety, 3/23/2011, http://www.fda.gov/newsevents/publichealthfocus/ucm248257.htm
[iii]How U.S. FDA’s GRAS Notification Process Works, December 2005/January 2006, US Food and Drug Administration,http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.htm
[iv]Alliance for Bio-Integrity, Letter dated 10/23/91, from James H. Maryanski, Ph.D., Biotechnology Coordinator, Center for Food Safety and Applied Nutrition (FDA); Page 1: http://biointegrity.org/FDAdocs/06/view1.html and Page 2: http://biointegrity.org/FDAdocs/06/view2.html For additional letters from FDA Scientists expressing safety concerns, seehttp://www.biointegrity.org/list.htm
[v]Cimons, Marlene and Walters, Donna K. H., “Stage Set for ‘Biotech” Debut at Grocery Store: U.S. Policy to be unveiled today regulates foods created by genetic engineering like other varieties,” Los Angeles Times, May 26, 1992. http://articles.latimes.com/print/1992-05-26/news/mn-144_1_genetic-engineering
[vi]Caplan, Richard and Spitzer, Skip, “Regulation of Genetically Engineered Crops and Foods in the United States,” US Public Interest Research Group and Pesticide Action Network North America, March 2001, https://nativeseeds.org/pdf/GERegulations.pdf
[vii]FDA Statement of Policy: Foods Derived from New Plant Varieties, Federal Register Vol. 57-1992, 5/29/92http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm
[viii]Overview of FDA Consultations, U.S. Food and Drug Administration, Specialty Crop Regulatory Assistance Workshop, 12/6-12/8,2011, http://www.specialtycropassistance.org/uploads/ckeditor/files/SCRA%202011%20Workshop%20Presentations/SCRA2011%20FDA%20Overview%20Merker.pdf
[ix]FDA Statement of Policy: Foods Derived from New Plant Varieties, 5/29/92, Federal Register Vol. 7, No. 104 at 22991http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm
[xi] “May 26, 1992: FDA Rules that Genetically Modified Food Is ‘Substantially Equivalent’ to Conventionally Grown Food,” Creative Commons,http://www.historycommons.org/context.jsp?item=FDAScResponseTo526Ruling
[xiv]American Academy of Environmental Medicine (AAEM Press Release, May 19, 2009), http://www.aaemonline.org/gmopressrelease.html
[xv] “Statement: No Scientific Consensus on GMO Safety,” European Network of Scientists for Social and Environmental Responsibility, October, 2013, See: http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/
[xvi] “Genetically Modified Foods Position Paper: The American Academy of Environmental Medicine,” containing a statement by World Health Organization citing “…several animal studies indicate serious health risks associated with GM food consumption including infertility, immune dysregulation, accelerated aging, dysregulation of genes associated with cholesterol synthesis, insulin regulation, cell signaling, and protein formation and changes in liver, kidney, spleen and gastrointestinal system.” (See: http://www.aaemonline.org/gmopost.html )