September 21, 2015
Testimony submitted by Martin E. Levin to the Joint Committee on Environment, Natural Resources, and Agriculture of the Massachusetts State Legislature
I have been practicing law in Massachusetts, in the public and private sectors, for over thirty years. I am writing in support of House bill No. 3242, “An Act Establishing the Genetic Engineering Transparency Food and Seed Labeling Act” (“House 3242”). The current regulatory system leaves Massachusetts families without reason to rely on regulatory judgments about or protection against possible health risks associated with certain genetically engineered (“GE”) foods, and yet denies Massachusetts families the information necessary to make those judgments for themselves.
As explained in greater detail below, the principle GE food products that have been made commercially available are composed of plants that have been engineered for pesticide-related traits, and there is sound scientific evidence indicating that this technology has increased incidence of pesticides in the plants that are being introduced into our foods. The present regulatory system puts pre-market review and judgments about the potential health effects of these GE plants largely in the hands of the developers of the plants, who have a significant economic incentive to insure that the products are brought to market. Government assurances regarding the safety and wholesomeness of the foods derived from those plants are premised on the fact that food producers have a legal duty to assure the quality of the food they bring to market. However, there is virtually no government monitoring of whether that duty is being fulfilled. As a result, individual consumers must make judgments about the possible risks and relative benefits of purchasing those foods on their own. Without mandatory labeling of genetically engineered foods, consumers are denied the most basic information necessary to make those judgments. I urge the Legislature to fill this information gap by passing House 3242.
1) Most GMO-derived Foods on the market today have been genetically engineered for use with, and/or generation of, pesticides.
Today, when we speak of foods known to be derived from genetically modified organisms (“GMO-derived Foods”), we are speaking of foods that consist of, or include ingredients made from, genetically modified plants. Since the introduction of GMO-derived Foods into the U.S. market, the primary genetically engineered crops made commercially available are corn, cotton, and soybeans, each of which constitutes approximately 90% of such crops, respectively, grown in the U.S. Other commercially available crops that are now primarily genetically engineered are canola (87%) and sugarbeets (95%). These crops are used in a wide variety of processed foods, in the form of, e.g., meal, flour, starches, sweeteners, and vegetable oils. It is estimated that some 80% of conventional processed foods contain genetically engineered ingredients. Processed foods reported to contain genetically engineered ingredients include infant formula, baby foods, baking ingredients, cereals, salad dressings, soups, chips, and sweetened beverages.
Corn, cotton, soybeans, canola, and sugar beets have been engineered to express one or both of two traits: herbicide tolerance (“HT crops”), and insect resistance (“Bt crops”). HT crops can withstand application of glyphosate-based weed killers. Hence, farmers can apply such weed killers to eliminate weeds from cropland even during a crop’s growing season without also killing the crop. Bt crops have been engineered to produce certain forms of Bacillus thuringiensis (“Bt”) which have insecticidal properties on select insects known to feed on the crops. Hence, certain insects that can damage the crop are killed after feeding on the Bt crop.
2) Under the existing federal regulatory system, the safety and wholesomeness of today’s GMO-derived Foods receive limited pre-market review.
The Federal Food and Drug Administration (“FDA”) is the agency with primary responsibility for assuring the safety and wholesomeness of the foods Massachusetts citizens and all other Americans consume (except meat and poultry), including GMO-derived Foods. In exercising this responsibility, the FDA still adheres to the policy it published in 1992. At that time, the FDA announced its determination that genetic material transferred to plants can be presumed to be “Generally Recognized as Safe” (“GRAS”).
This presumption had considerable legal consequence, because it forms the basis for FDA’s position that GMO-derived Foods are not ordinarily subject to the mandatory FDA review and approval processes that apply to food additives pursuant to the Federal Food, Drug, and Cosmetics Act (“FFDCA”), 21 U.S.C. § 301 et seq. Rather, GMO-derived Foods are subject to a wholly voluntary “consultation process.” Under that process, GMO developers make their own determination, based on the scientific studies and data they choose to conduct and consider, that the genetic modification being made is in fact GRAS, and that the resulting modified plant is not materially different from its unmodified precursor.
The voluntary consultation process established by the FDA in 1992 involves the GMO developer’s submittal of a summary of the results of the developer’s own research in support of the developer’s conclusion that the plant or food is safe. FDA is relegated to review of the summary and expression of any questions or reservations concerning the developer’s conclusion based on the summary submitted. The FDA does not independently reach its own determination whether the food is safe or unsafe. Nor does the FDA have authority to require that all research conducted by the developer be submitted, in its complete form. Nor is there public input into the review process. And, since the consultation process is voluntary, a GMO developer can legally introduce the food into the market without going through the process at all.
Since most GMO-derived Foods are comprised of plants modified to permit use with and/or production of pesticides, the U.S. Environmental Protection Agency (“EPA”) also plays a role in the pre-market government review of the safety of GMO-derived Foods. Pursuant to the FFDCA, it is the EPA’s role to evaluate the risks posed by pesticide residues in food. Based on its risk assessment of the pesticide in question, the EPA sets “tolerances,” or maximum allowable amounts, for the presence of pesticides in foods. In addition, under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), a pesticidal trait that a plant is genetically modified to express must be registered with the EPA.
3) The primary legal responsibility for assuring that GMO-derived Foods are safe to consume rests with the food producer, but the government does little to monitor whether the food brought to market by the producer is in fact safe or even comports with the pre-market understanding of the conditions of the Foods’ safety.
In its 1992 policy statement, the FDA stated that it is the food producer’s “clear legal duty…to assure the safety of foods they offer to consumers…,” and that this duty “is backed up by [FDA’s] strong enforcement powers….” Where, as with GMO-derived Foods, the food is not subject to FDA’s pre-market mandatory safety review and approval process, FDA’s food safety regulatory authority is basically limited to its “post-market authority of section 402(a)(1) of the [FFDCA] (21 U.S.C. 342(a)(1)).” Under this section, which defines as “adulterated” any food that contains a poisonous or deleterious substance in such quantity as to make the food injurious to health, the FDA can remove unsafe foods from the market. Food producers can also be subject to criminal sanctions and civil liability for having marketed such unsafe foods. Hence, the food producer theoretically has strong legal and economic incentives to assure the safety of the food brought to market.
The problem with this model of food system safety is that there is virtually no government post-market monitoring to determine whether the producer of GMO-derived Foods is complying with its duty, even where that compliance can be easily determined. The federal government does little or no post-market food safety monitoring of the HT and Bt crops that constitute the overwhelming majority of genetically engineered plants and GMO-derived Food.
a. The government does not monitor the foods produced with HT crops for presence and concentration of the pesticide with which it is intended to be used, and for dietary intake of such pesticide.
The government’s failure to conduct any meaningful monitoring of GMO-derived Foods is most glaringly illustrated by its approach to HT crops. EPA has set tolerances for residues of glyphosate, which is the application for which these crops were engineered.
HT crops, the most prevalent constituent of GMO-derived Foods, are engineered to be tolerant to, and used with, glyphosate-based herbicide. The outcome of twenty years of cultivation of HT crops in the U.S. has been that glyphosate has become the “most commonly used agricultural pesticide” in the country, and glyphosate and its related degradation product now occur widely in the environment. Unsurprisingly, a study published last year in the peer-reviewed journal, Food Chemistry, found that genetically engineered soybeans contain high glyphosate and related residues, while conventionally and organically grown soybeans had none.
Although it is the FDA’s responsibility to monitor for violations of the EPA-set pesticide tolerances in food, the FDA is not legally required to select any particular food commodity for testing, and is not required to sample for any particular pesticide. And, in fact, the FDA has not been doing any post-market monitoring for glyphosate in food.
The U.S. Department of Agriculture (“USDA”) also samples for some pesticides in food commodities. Like FDA, USDA’s monitoring activities are discretionary and, in only one year – 2011—did the USDA reportedly sample for glyphosate. In that year, the USDA analyzed 300 soybean samples, and found glyphosate present in over 90% of the samples, at levels up to 18.5 ppm. The EPA tolerance for glyphosate in soybeans is 20 ppm. Despite the fact that USDA found glyphosate residues on soybeans at levels just shy of the allowed tolerance, the USDA did not sample for glyphosate in any of the succeeding years for which reports are available.
HT crop developers have long taken the position that glyphosate is a relatively safe pesticide, and certainly not carcinogenic. Doubtless that was their position at the time the FDA reviewed the developers’ conclusions that their genetic manipulations for herbicide tolerance should be considered GRAS, and the resulting plant not materially different from the unmodified precursor. Doubtless that was also the developers’ position at the time they went through the EPA registration process for the glyphosate pesticides for which the HT crops were being engineered. However, independent scientific research and reviews have recently concluded that glyphosate is a probable human carcinogen, and that glyphosate-based herbicides promote antibiotic resistance.
As noted, there has been absolutely no meaningful monitoring of GMO-derived Foods made with HT crops. Hence, it will be difficult for the government, no less the people who have been consuming these Foods, to draw conclusions about the possible health impacts of foods containing HT crops legally sufficient to impose on the food producers any post-market accountability for possible detrimental health impacts from these GMO-derived Foods. Without such accountability, there is no meaningful incentive for developers and producers of genetically engineered foods to assure that their products are not compromising food safety.
b. The government does not monitor the foods produced with Bt crops for presence and concentration of the pesticide which is incorporated into such crops, and for dietary intake of such pesticide.
Such concerns also exist with respect to the Bt crops. Bt, as it occurs naturally, is a soil bacterium. It has been used in agriculture as an insecticide for many years, but the production of Bt crops differs significantly from the conventional use of Bt in agriculture. Organic and other non-GMO farmers can limit the use of conventional forms of Bt to times when the target pests are present, thus both limiting the quantities used and avoiding the evolution of insect populations resistant to Bt’s effects. Moreover, the conventional Bt insecticide degrades within days due to environmental exposure, and any remaining residues can be washed off the crop prior to use or consumption. In contrast, Bt use in genetic engineering involves a synthesized form of Bt that is incorporated into and expressed by the plant itself—i.e., it is generated by, and persistently present in, the Bt plant.
Bt is generally considered to have low toxicity to people and other mammals. EPA has exercised its authority to grant an exemption from tolerance limits for the forms of Bt most commonly used in Bt crops. However, Bt has been known to cause allergic reactions in some people. Indeed, one form of a Bt toxin developed for use with the genetically engineered StarLink (TM) corn was approved by EPA only for sale as animal feed or for industrial purposes, because EPA could not rule it out as a potential human allergen. Despite this limitation on use, residues from StarLink(TM) corn were later found to have entered the human food supply, with subsequent reports of allergic reactions and determination by EPA scientists that no tolerance could be set that would be adequately protective of the public health.
Bt is also considered to be subject to normal digestive processes and expelled from the body within days. Nonetheless, a 2010 study conducted in Canada found a Bt toxin consistent with that expressed by Bt crops circulating in women’s blood, including the blood of pregnant women and their fetuses.
I am aware of no government post-market food monitoring of Bt crops to determine the actual concentrations of resulting residue of Bt that makes it into the U.S. food system, or the amounts that are regularly consumed by the public. Hence, its incidence and concentration in the foods consumed are unknown. Once again, it will be difficult for the government, no less the people who have been consuming these Foods, to draw conclusions about the possible health impacts of foods containing BT crops, particularly if those impacts consist of allergic reactions suffered by a small percentage of the population. Again, this undermines the theoretical accountability that food producers have for marketing foods with possible detrimental health impacts. And, without such accountability, there is no meaningful incentive for developers and producers of genetically engineered foods to assure that their products are not compromising food safety.
c. The government does not monitor GMO-derived Foods for possible health or nutritional issues created by unintended effects of genetic modification.
There remains significant controversy among reputable scientists and health professionals about the safety of consuming the products of genetic engineering as food. Safety concerns include the possible health effects of the intended modification of the food in question, such as the above pesticide-related traits for which most commercially available GMO-derived Foods have been engineered. In addition, concerns extend beyond those raised by the intended effects of genetic engineering, to encompass the unknown and unintended effects on the modified organism caused by (i) the modification technologies themselves, and (ii) the interaction between the altered gene, the entire genome of the organism, and the larger environment, all of which may affect how the modified gene expresses itself and how the modification affects the entire organism.
Even the FDA has allowed that the processes of genetic engineering can create unintended effects that draw into question the presumption that the resulting food product is not materially different from its unmodified precursor. In January, 2001, FDA proposed a rule that would have, for the first time, legally required pre-market notification and data submission to FDA with respect to new plant-derived bioengineered foods. In explaining its rationale for proposing to alter the voluntary consultation process in effect since 1992, FDA stated, in part:
…[B]y increasing the range of proteins that can be introduced into food over that possible by traditional breeding, there is an increased potential for introducing an allergen into a food developed using rDNA [Recombinant DNA] technology. Also, rDNA technology can be used to express proteins at higher concentrations than they would otherwise be expressed; these higher concentrations may increase the potential for such proteins to be allergenic….
…[rDNA] technology] shares with mutagenesis techniques a potential for introducing unintended effects through mutations. In part, this is because rDNA technology involves growing plants from tissue culture, which can exhibit somaclonal variation, and, more significantly, because breeders using this technology generally cannot control the location in the plant genome at which genetic material will insert when introduced into a plant. Thus, with rDNA technology, the introduced genetic segment may insert into a genetically active chromosomal location. Such insertion may disrupt or inactivate an important gene or a regulatory sequence that affects the expression of one or several genes, thereby potentially affecting adversely the safety of the food or raising other regulatory issues. Such an occurrence is referred to as an insertional mutation.
Because 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 new trait and has had no questions about such foods. Similarly, the agency believes that it needs to be provided with information about foods from rDNA-modified plants whose intended change is the introduction of a pesticidal protein subject to oversight by the Environmental Protection Agency (EPA) rather than FDA, because the transformational event that is used to introduce the pesticidal trait may also cause unintended changes to the food that would raise adulteration or misbranding questions subject to FDA jurisdiction.
In sum, almost fifteen years ago the FDA had concluded that the very processes of genetic engineering could result in unintended effects of sufficient concern with respect to the safety and wholesomeness of foods derived from genetically engineered plants that at least notice must be given to FDA of the proposed introduction of such foods into the market. The proposed rule was never enacted.
It goes without saying that if the government is not conducting post-market monitoring of the presence, dietary intake, and potential health effects of intended genetically engineered traits, it certainly is not conducting such monitoring of unintended effects of genetically engineered foods. Indeed, without mandated pre-market notification of proposed introduction of such foods, or labeling of such foods once on the market, where would the government begin?
There is little regulation in place to assure independent safety evaluations prior to placing GMO-derived Foods into the stream of commerce. There has never been an independent structure in place to monitor for the presence, dietary intake, and potential health effects of the food products of this new and still changing technology—no monitoring of actual concentrations of the traits and characteristics for which such foods were engineered; no monitoring of possible unintended effects resulting from genetic engineering; no monitoring of the age or health status of populations most exposed to those traits, characteristics, and possible effects; no monitoring of human physiological changes over time that might correlate with consumption of GMO-derived Foods, no less be caused by such consumption.
What we have, in essence, is a privatized, largely opaque, assessment system, in which the Massachusetts citizens most affected (consumers) are not even informed which products are GMO-derived Foods. Mandatory labeling to provide notice to consumers of which foods on the grocery store shelves contain GMOs is the least the government can do to provide some degree of protection to the public, and to make a first step in permitting consumers to make knowledgeable choices about the purchase of such Foods for themselves and their children. I respectfully urge the Joint Committee to vote favorably on House 3242.