Science and Law
9th May 2013

GMO Litigation – A very real threat, but empty science

Advances in molecular biology over past few decades have been astounding. One of the hallmark stories has been the successful genetic manipulation of organisms, which is used for basic research as well as applied science such as genetically modified organisms (GMOs). 

GMO Litigation – A very real threat, but empty science

Advances in molecular biology over past few decades have been astounding. One of the hallmark stories has been the successful genetic manipulation of organisms, which is used for basic research as well as applied science such as genetically modified organisms (GMOs).  We have all heard about it. However, amazing scientific advances have their critics.  Recently there has been an outcry for stricter regulatory oversight for these products, which some have alleged a link to detrimental environmental and health effects.

    

In this post we review some of the basics on GMOs, including a review of what they are, how they are regulated, how they are covered in the media, and what science says about their effects. Following the GMO controversy will be critical to environmental defense lawyers defending everything from large food manufacturers to pesticide and herbicide manufacturers.

What are GMOs?

GMOs are organisms with a genetic makeup that has been altered by inserting a “foreign” genetic sequence into the host genome.  The so-called foreign insert contains all of the regulatory elements of a gene, allowing it to encode for the protein of interest.  Although GMO technology is widely used in animals, more recent concerns and controversy entail genetically engineered (GE) crops which face a different level of regulatory oversight.

GE crops have realized a rather speedy agricultural integration.  Their utilization quickly expanded, and their commercialization experienced a 94-fold increase from 1996 to 2011, making biotech crops the fastest adopted crop technology in the history of modern agriculture (Broeders, 2012). In the United States, the introduction of GE crops into the food supply began in 1994 when the FDA approved the first whole GE food for commercialization: the Flavr Savr tomato (Morin, 2008).  It didn’t take long for this technology to be quickly disseminated to other crops such as rice, potato, sugar-beet, cotton, corn, soybean, and canola.  With such rapid development, some have claimed that GMOs severely lack adequate regulatory oversight. Let’s take a closer look.

How are GMOs regulated in the US?

Garnering increased attention, the safety of GE crops has been called into question, largely by the media and the activist communities.  As noted by Morin:

The arguments against GM [genetically modified] food range from the ethical and      religious to concerns over inherent or potential risks to health and safety, and the environmental impact such technologies may have.

Recently, the current state of affairs has political personnel and laymen pointing their fingers at the FDA – particularly their regulatory procedure with respect to lack of GE food labeling to start.

GMOs are regulated by three bodies which all regulate transgenic crops from a different perspective: EPA evaluates environmental safety, USDA evaluates whether the plant is safe to grow, and the FDA evaluates food safety (which likely include GMOs).

The Federation of American Scientists, an independent, nonpartisan and registered non-profit membership organization, which provides rigorous, objective, evidence-based analysis and practical policy recommendations on national and international security issues connected to applied science and technology, take the position that there is no real concern here:

According to a policy established in 1992, FDA considers most GM crops as “substantially equivalent” to non-GM crops. In such cases, GM crops are designated as “Generally Recognized as Safe” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and do not require pre-market approval. If, however, the insertion of a transgene into a food crop results in the expression of foreign proteins that differ significantly in structure, function, or quality from natural plant proteins and are potentially harmful to human health, FDA reserves the authority to apply more stringent provisions of FFDCA requiring the mandatory pre-market approval of food additives, whether or not they are the products of biotechnology.

Furthermore, in 1997 the “FDA established a voluntary consultation process with GM crop developers to review the determination of ‘substantial equivalence’ before the crop is marketed, such as assessing the toxicity and allergenicity of the gene product and the plant itself” (emphasis added).

The Growing Media Storm

Despite the apparent consensus that there is substantial equivalence between traditional crops and GMO crops, recent news portrays the current FDA framework as lacking.

For example, protests have been plentiful in Hawaii on this issue, given its ideal geographical location, climate, and natural resources for testing GE crops. Indeed, five of the world’s largest agricultural companies have established a presence in Hawaii including figurehead Monsanto, Syngenta, Dow AgroSciences, Dupont Pioneer, and BASF.

A recent news article summarized the current state of affairs:

In the past 20 years, these chemical companies have performed over 5,000 open-field-test experiments of pesticide-resistant crops on an estimated 40,000 to 60,000 acres of Hawaiian land without any disclosure, making the place and its people a guinea pig for biotech engineering.

More recently, in an effort to facilitate GMO consumer awareness, west coast Senator Boxer and Representative Defazio introduced legislation that would require the FDA to “clearly label” all GE foods (Food Safety News).  These sentiments were reiterated on the east coast (article here), which additionally addressed the lack of transparency in GMO research hindering individuals to make their best personal consumer choices.  This position was articulated by former state representative Richard Roy of Milford: “All the studies have been done by the industry and they don’t allow independent examinations.  They have patents on their products.”

Despite the growing concern called for in the media, the activists, and the legislature, there doesn’t appear to be a great deal of evidence.

The Scientific Evidence

The science related to GMOs can be summarized quite succinctly: overall the data and the scientific community conclude that GMOs are safe and no new safety concerns have been raised about  marketed GE cultivars (for example, see articles here and here).

Scientific opponents of GMOs argue that there is a lack of public research on the issue and the alleged paucity of data argues for more research.  For example in the Journal of Toxicology and Environmental Health, Bakshi states:

…the review of available literature indicates that the genetically modified crops available in the market that are intended for human consumption are generally safe; their consumption is not associated with serious health problems. However, because of potential for exposure of a large segment of human population to genetically modified foods, more research is needed to ensure that the genetically modified foods are safe for human consumption.

Overall, the number of GMOs cultivated for commercial, or research purposes continues to increase (Broeders, 2012). More scientific evidence will emerge, helping scientist and policy-makers elucidate the real, if any, health and environmental hazards of GMOs.

The Future

As litigation begins to surface on GMO issues, we should certainly continue to be prudent.

We envision that lawsuits to come may be personal injury cases (individuals claiming they have been harmed by GMOs), consumer fraud cases (personal injury cases hiding in consumer fraud statute), and potentially, municipalities suing large corporations over contaminated issues.

ISS has a great deal of experience supporting these types of litigation.  ISS is well connected with the expert community in vast scientific disciplines, and we provide rigorous scientific assessments of plaintiff theories as well as the appropriate response.

Assessing the safety of GMOs (like many other exposures), requires a meticulous and grounded scientific context – a context with which experienced scientists are deeply familiar.

At the end of the day, the absence of incontrovertible safety data does not mean that GMOs pose any adverse health risk to exposed populations.

-Above Image courtesy of Grant Cochrane / FreeDigitalPhotos.net-

Did you like this post? We are here to help! Schedule a consult with one of our experts.

Just fill out the form bellow and we will contact you with more information.

  • This field is for validation purposes and should be left unchanged.

Recent Related Articles

Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]
15 July 2020
Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]

On Wednesday July 8, 2020, Dr. David Schwartz of Innovative Science Solutions presented at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. A complimentary copy of the panel presentation is now available for download. Read more

The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting
02 July 2020
The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting

Dr. David Schwartz of Innovative Science Solutions will be presenting at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. Read more

WEBINAR ANNOUNCEMENT: What’s in Those Genes?
12 June 2020
WEBINAR ANNOUNCEMENT: What’s in Those Genes?

Genetic Evidence Concerning Causation for Mesothelioma 16 June 2020 at 2pm Eastern Daylight Time. Read more

Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes
28 April 2020
Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes

Plaintiff experts having been asserting for decades that all mesotheliomas must be linked to some asbestos exposure. Indeed, this has led to the erroneous (but widespread) view that mesothelioma is a signature disease, only caused by asbestos exposure. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us