FDA, USDA, EPA & Government Scientists

(Information courtesy of Mothers for Natural Law of the Natural Law Party)

The quotes below were extracted from documents obtained by the Alliance for Bio-Integrity during the preparation for their law suit against the FDA. Please visit the website of the Alliance for the complete documents and details of the case against the FDA.

“The process of genetic engineering and traditional breeding are different, and according to the technical experts in the agency [FDA], they lead to different risks.”

“I wonder if part of the problems associated with this approach – using scientific issues to set the stage for the policy statement – are due to the fact that the scope of technical experts assigned to the project did not include any whose usual job is risk analysis.”

Dr. Linda Kahl, FDA compliance officer, to Dr. James Maryanski, FDA’s Biotechnology Coordinator, about the Federal Register document “Statement of Policy: Foods from Genetically Modified Plants”. Dated January 8, 1992

“A genetically engineered plant may contain an identical profile of expected plant toxicant levels (i.e. expected toxicants) as is normally found in a closely related, natural plant. However, genetically modified plants could also contain unexpected high concentrations of plant toxicants. The presence of high levels of toxicants in the bioengineered food plant could occur by two or more mechanisms. For example, normal levels of toxicants could be amplified through enhancement of toxicant gene transcription and translation. This might occur as a result of up-stream or down-stream promotion of gene activities in the modified plant DNA. In addition, plant toxicant genes which were normally inactive could be expressed in the modified plant gene as a result of insertion of the new genetic material (i.e. positional mutagenesis). Thus, the task of analysis of all major toxins in genetically engineered plant food includes the assessment of both expected toxicants and unexpected toxicants that could occur in the modified plant food.”

Edwin J. Mathews, Ph.D., in a memorandum to the Toxicology Section of the Biotechnology Working Group. Subject: Analysis of the Major Plant Toxicants.

“At this time it is unlikely that molecular and compositional analysis can reasonably detect or predict all possible changes in toxicant levels or the development of new toxic metabolites as a result of genetic modifications introduced by the new methods of biotechnology.”

“We cannot assume that all gene products, particularly those encoded by genes from non-food sources, will be digestible. For example, there is evidence that certain types of proteins (e.g., plant lectins and protein allergens) are resistant to digestion and can be absorbed in biologically active form.”

Samuel I. Shibko, in a memorandum to Dr. James Maryansksi, FDA Biotechnology Coordinator. Subject: Revision of Toxicology Section of the Statement of Policy: Foods Derived from Genetically Modified Plants..

“Unexpected Effects – This is the industry’s pet idea, namely that there are no unintended effects that will raise the FDA’s level of concern. But time and time again, there is no data to backup [sic] their contention, while the scientific literature does contain many examples of naturally occurring pleiotropic effects. When the introduction of genes into plant’s genome randomly occurs, as is the case with the current technology (but not traditional breeding), it seems apparent that many pleiotropic effects will occur. Many of these effects might not be seen by the breeder because of the more or less similar growing conditions in the limited trials that are performed. Until more of these experimental plants have a wider environmental distribution, it would be premature for the FDA to summarily dismiss pleiotropy as is done here.”

“Chart IV, box that reads – “Newly introduced protein present in food from the plant?” This does not take into account, nor does the document as a whole, those introduced proteins (enzymes) that while acting on one specific, intended substrate to produce a desired effect, will also affect other cellular molecules, either as substrates, or by swamping the plant’s regulatory/metabolic system and depriving the plant of resources needed for other things. It is not prudent to rely on plant breeders always finding these types of changes (especially when they are under pressure to get a product out). Nowhere is such an issue discussed or examined in this document.”

Dr. Louis J. Pribyl, in comments on the “Biotechnology Draft Document, 2/27/92”.

“Lines 9-17 appear to provide justification for the use of tox[icology] studies in safety assessment, citing as an example the inability of analytical or molecular methods to detect the presence of a [sic] unknown toxin produced by activation of a previously cryptic gene. However, lines 8-end of paragraph say that the tox[icology] studies will not be needed if DNA insertion is limited to only a single site of known genomic location. This discussion implies that pleiotropy (i.e., production of a [sic] unknown toxin due to activation of a previously cryptic gene) will disappear or be negligible if gene insertions are limited to a single copy at a known genomic location. Evidence should be provided to support this position.”

“It is my understanding that pleiotropic effects are unpredictable, and may be triggered by gene insertion at a single site, as well as at multiple sites, the plant genome.”

Carl B. Johnson, in comments on the “draft statement of policy 12/12/91”.

“As I know you are aware, there are a number of specific issues addressed in the document for which a scientific consensus does not exist currently, especially the need for specific toxicology tests. Also, the quantity and quality of data that would be required is not addressed and is difficult to specify at this time. I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.”

Dr. Jams Maryanski, FDA Biotechnology Coordinator, in a letter to Dr. Bill Murray, Chairman of the Food Directorate, Canada. Subject: the safety assessment of foods and food ingredients developed through new biotechnology.

“In response to your question on how the agency should regulate genetically modified food plants, I and other scientists at CVM have concluded that there is ample scientific justification to support a pre-market review of these products. As you state in the Notice, the new methods of genetic modification permit the introduction of genes from a wider range of sources than possible by traditional breeding. The FDA will be confronted with new plant constituents that could be of a toxicological or environmental concern. The Notice further describes unintended or pleiotropic effects that pose unknown safety concern. It has always been our position that the sponsor needs to generate the appropriate scientific information to demonstrate product safety to humans, animals and the environment.

“A marked-up copy of the Notice with our comments will be provided to you directly by the Center’s scientists. Generally, I would urge you to eliminate statements that suggest that the lack of information can be used as evidence for no regulatory concern.”

“Residues of plant constituents or toxicants in meat and milk products may pose human food safety problems. For example, increased levels of glucosinolates or erusic acid in rapeseed may produce a residue problem in edible products.”

Gerald B. Guest, DVM, Director of the Center for Veterinary Medicine, in a memorandum to Dr. James Maryanski, Biotechnology Coordinator. Subject: “Regulation of Transgenic Plants – FDA Draft Federal Register Notice on Food Biotechnology”.

“The insertion of any DNA into the plant genome may result in various phenotypic changes (desirable or undesirable) referred to as pleiotropic effects. Undesirable phenotypes may include, for example, poor growth, reduced levels of nutrients, increased levels of natural toxicants, etc. Pleiotropic effects occur in genetically engineered plants obtained with Agrobacterium-mediated transformation at frequencies up to 30% (Ref. )[sic]. Most of these effects can be managed by the subsequent breeding and selection procedures. Nevertheless, some undesirable effects such as increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals), and undesirable alterations in the levbels of nutrients may escape breeders’ attention unless genetically engineered plants are evaluated specifically for these changes. Such evaluations should be performed on a case-by-case basis, i.e., every transformant should be evaluated before it enters the marketplace. (A similar approach was recommended by the International Food Biotechnology Council (Ref. )[sic]).

“To address unrecognized toxic substances that may unexpectedly appear in transgenic plants or to evaluate plants that normally contain many toxic substances at very low levels, toxicological evaluation of the edible plant tissue may be more appropriate than using chemical identification and quantification procedures.”

Division of Food Chemistry and Technology and Division of Contaminants Chemistry. Subject: “Points to Consider for Safety Evaluation of Genetically Modified Foods. Supplemental Information.”

“Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible.”

Phil Angell, Director of Corporate Communications, Monsanto. (The New York Times of 10/25/98)

“Except for a handful of new “food additives” such as artificial sweeteners, which must receive premarket approval from FDA before entering the marketplace, most new foods are introduced under the “postmarket” authority of the Food, Drug, and Cosmetic Act. Under this authority, foods made up of proteins, fats and carbohydrates with a history of safe use in food can be sold once companies are satisfied the new product is safe without first getting FDA permission.

These concerns were expressed in light of a policy proposal by the Food and Drug Administration. In fact, the FDA implemented policies which conflict directly with the recomendations of these government scientists. Naturally enough, other scientists, being free to take a broader look at genetic engineering, have also raised concerns.