My first experience with a scientific experiment came in 7th grade for my middle school science fair project. I tested four different types of starches — corn, potato, arrowroot, and tapioca — to find which starch was the strongest. I had to state my problem, hypothesis, methods, and conclusion and present the data I had found. I artfully placed all of this information on a trifold foam board and wrote a five-minute speech about what I had done. At the science fair, judges rated my understanding of the process, the choices I made about how to execute the experiment, and my overall delivery of the project. I was very proud of myself when I received 3rd place at the Iowa State Science Fair. I thought that I had done something really amazing.
Now, with the knowledge I have, however, I’m not so sure. The holes and inaccuracies in my experiment were cringe-worthy and my shaky results hardly supported my stretched conclusion. The procedures I did to test starch strength were incredibly subjective and the instruments I borrowed from my father’s farm tool shop were in no way capable of the precision I claimed I had.
For many of us non-scientist folks, a middle school science fair project or a chemistry lab in college is about the extent of our knowledge on how an actual scientific experiment is conducted. Our entire understanding of how amazing innovations and ground-breaking technology is developed is based on our own often unwilling misadventures into the field. For my experiment, there was absolutely no oversight on my processes and “eh, that’s good enough” was good enough. It is easy to assume that science done in industry is the same way. Fortunately, for us who benefit from this science but aren’t involved in it, that is far from the case.
I knew coming to Monsanto, that GMOs and crop protection products were regulated by the government. In the United States, it is done by the EPA, FDA, and USDA. What I didn’t realize, however, were the strict rules in place by these and other international regulatory authorities that Monsanto and industry must follow to prove that their products are safe.
The two main legal protocols that all biotechnology and crop protection companies must follow are Good Laboratory Practices (GLPs) and OECD Testing Guidelines. Both of these were created by the intergovernmental Organization for Economic Cooperation and Development (OECD) to set standards for safety tests so that global regulators are assured of the quality and integrity of the data and results.
The two main legal protocols that all biotechnology and crop protection companies must follow are Good Laboratory Practices (GLPs) and OECD Testing Guidelines.
Essentially, GLPs determine how safety tests are planned, performed, monitored, recorded, archived, and reported to ensure that submitted data is reliable and a true reflection of results. It also ensures that every safety test is reproducible and retrievable. This means that all data collected in a study is kept for the lifetime of the product on the market. Additionally, under no circumstances is data collected from a safety study allowed to be discarded, even if it is rejected, not applicable to the study, a mistake, or part of an unfinished study. This means that Monsanto has reports from over 20,000 studies conducted over the past 54 years. GLPs also makes sure that all researchers are trained and qualified and that their equipment is properly maintained and calibrated.
The OECD Testing Guidelines are internationally-accepted methods for conducting experimental tests performed in laboratories. They are like recipes for individual tests or procedures. For example, one is how to find the boiling point of a substance. It states the steps, instruments, and equations required to perform the experiment. There are many more OECD Testing Guidelines for a variety of tests, including how a product may affect specific animals or if it could be harmful in meat, milk, or eggs. Both the OECD Testing Guidelines and GLPs were created with the public safety of humans and the environment in mind.
When Monsanto wants to bring a product to market, regulatory authorities not only check to make sure that the product has been verified safe, but they also make sure that the tests were conducted according to GLPs and the OECD Testing Guidelines. Additionally, as a part of GLPs, the EPA also regularly visits the laboratories in person to inspect facilities, perform data reviews, and detect any violations. If it is found that something is not compliant, Monsanto could face legal penalties in the form of fines or, in serious cases, criminal prosecution.
Ultimately, all of these requirements ensure that the safety tests submitted to regulatory authorities around the world are reliable and accurate. Unlike my crude starch strength experiment, the studies done at Monsanto aren’t submitted to judges in the form of a five-minute presentation, but instead to government regulators with a document that is literally hundreds of pages long and 6–9 years in the making. Scientists are not asked two minutes of questions at the end of their presentation like I was, but instead regulatory authorities spend years asking questions about submissions. Instead of simply relying on the honor system, companies have to prove that their products are safe by following government-mandated regulations which dictate required processes and procedures. And, most importantly, instead of being a 7th grader recklessly attempting her first scientific experiment, the researchers at Monsanto are real-live scientists who have advanced degrees, years of experience, and a love for the beauty of impartial, fact-based, rule-following science.