Mixing biotechnology and agriculture is controversial to many, which has led several states to consider passing laws requiring the labeling of several or all types of foods containing ingredients produced from genetically modified organisms, or GMOs. It has also led to a widely unfavorable view of biotech seed companies such as Monsanto (NYSE:MON) and Dow Chemical (NYSE:DOW), while friction is brewing between the public and food companies such as Kellogg (NYSE:K), General Mills, and Coca-Cola that oppose state-by-state GMO labeling.
At the heart of the issue is a widespread fear that GMO foods are or could somehow pose a risk to human health. Controversy persists despite overwhelming scientific evidence that demonstrates GMO foods are just as safe as traditionally produced foods. In fact, all engineered products must go through comprehensive testing to prove substantial equivalence compared with products produced through traditional means. There are certainly differences, but there are actually many regulatory similarities between GMO foods and pharmaceutical compounds, which tend to generate much less of an uproar before getting tossed into our bodies. How do the two types of products compare from a regulatory standpoint?
The value of time and population
In the United States, each pharmaceutical compound is tested for effectiveness and safety in clinical trials conducted under the watchful eye of the Food and Drug Administration. Similarly, each GMO food must undergo a range of tests mandated by specific regulatory agencies. The United States Department of Agriculture and the Environmental Protection Agency oversee livestock and environmental safety, while the FDA is tasked with ensuring substantial equivalence for new food products for human and animal consumption. Foods and pharmaceuticals go through different regulatory channels before gaining marketing approval, but each progresses through a robust, multi-year process.
That hasn't stopped many people from pointing to the fact that GMO foods have "only" been available for two decades. Ironically, when a pharmaceutical compound is approved after one decade of testing people tend to associate the time it took to get to market with words such as "finally" and phrases similar to "wow, that took a mighty long time." It's useful to consider how widespread biotech crops have become in "only" 20 years:
That map illustrates that many people worldwide alive today have safely consumed GMO foods. Indirectly, the map shows the robustness of the international regulatory environment (link opens a PDF) that has approved biotech products multiple times for multiple uses through independent analysis. How specifically do pharmaceuticals and biotech crops compare?
The pharmaceutical regulatory process
Pharmaceutical compounds must run through a staggering amount of preclinical and clinical work to demonstrate that they are effective, safe, and that the benefits gained from treatment outweigh the risks or improve upon the accepted standard of care. The number of people enrolled and the allowable range of toxicity depend on the disease being treated and the size of the company conducting the trials but generally fit to the following guidelines.
Preclinical work consists of cell culture and animal testing that demonstrate feasibility and collect general safety data. Companies or organizations can then move to human testing, also known as clinical trials. Phase 1 trials enroll up to 100 people to determine safety, establish a dosing range, and determine possible side effects. If a compound is well tolerated and side effects aren't too cumbersome, it moves into a phase 2 trial, which enrolls up to 500 people. In mid-stage trials, the safety and effectiveness of a compound is tested against a placebo. Data are also collected that help determine how to design the final stage of clinical testing to best demonstrate that a compound is worthy of FDA approval.
A compound that successfully enters into a phase 3 trial will be tested against the standard of care or a competing therapy in several thousand people. Disease-specific endpoints are established with the FDA before a late-stage trial is initiated, but unforeseen safety complications can still lead to failure, no matter how effective.
It could take up to a decade or longer to collect sufficient data to gain marketing approval. Even after initial approval, the FDA may require further long-term safety studies before approving a compound for broader use. It's an expensive and rigorous process -- and it isn't perfect -- but it does a great job of ensuring consumer safety nonetheless.
The biotech crop regulatory process
Companies or organizations developing biotech products must go through thorough regulatory processes, too. They must complete testing before gaining marketing approval for specific use as energy crops, animal feed, human food, imports, and commercial cultivation in general. Not all regulatory approvals are mandatory, but it is within the best interest of developers to complete all voluntary submissions given the legal ramifications if problems arise. All GMO foods on the market today have undergone full review.
Tests evaluating the environmental and human health impacts of the traits of pesticide (herbicides, insecticides, fungicides, and the like) introduced into biotech crops are submitted to the EPA. Crops containing Bt toxins (Cry proteins) to ward off insect pests fall under this jurisdiction, although not all crops contain pesticide traits.
Information about how and where biotech crops are grown during field tests is submitted to the USDA. The agency is responsible for ensuring that tests are conducted under controlled conditions and evaluating the environmental consequences of planting biotech crops. In addition, the USDA keeps track of where engineered crops are commercially grown and harvested.
Recently, the largest concern for consumers has been the perceived health risks posed by GMO foods. Luckily, a detailed analysis is conducted for each product. Data from health and safety assessments are submitted to the FDA for regulatory approval, which largely focuses on proving substantial equivalence, or that a new food or ingredient is similar to existing foods and ingredients. That requires analysis that shows comparable fat, protein, amino acid, vitamin, mineral, and starch content compared with similar foods.
GMO foods or ingredients that are substantially equivalent to existing foods but have other unique characteristics are subject to further testing, as are foods not deemed substantially equivalent. Similarly, the toxicity and allergenicity of foods are studied in animal testing, which must meet regulatory guidelines for approval.
The FDA requires a label if a food contains an unusual amount of a nutrient that a consumer would otherwise not expect, or if elevated levels of allergens are detected. Otherwise, no label is necessary, because the process in which a product is created conveys no meaningful information to the consumer. Not every GMO food will be required to pass through all three regulatory agencies, but each body has the legal power to seek immediate removal from the market should concerns under their jurisdiction arise.
Foolish bottom line
While no regulatory process is foolproof and recalls for pharmaceutical compounds and GMO foods have occurred, I get the feeling most people aren't aware of just how difficult it is to get a product to the market. Scientists at Monsanto and its peers aren't bursting out of labs, throwing seeds into the ground, and grabbing the nearest hose to irrigate their new creation. I hope that illustrating the regulatory process GMO products must go through helps quell any fears you may have about the safety of such products.
Fool contributor Maxx Chatsko has no position in any stocks mentioned. Check out his personal portfolio or his CAPS page, or follow him on Twitter, @BlacknGoldFool, to keep up with his writing on biopharmaceuticals, industrial biotech, and the bioeconomy.
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