GMOs and Food Safety Regulation

FSMA Preventative Controls Rule and GMO Labeling
Introduction
During his campaign Donald Trump pledged to roll back regulations. Upon entering the White House, President Trump made good on that promise with the January 30, 2017, Executive Order (EO) entitled “Reducing Regulation and Controlling Regulatory Costs.” The EO directed federal agencies to abolish two regulations for every new regulation implemented (PMA, 2017). In terms of the FDA Food Safety Modernization Act (FSMA), food safety advocates are concerned that producers may look forward to rolling back the current labeling law that requires produces to label products that contain genetically modified organisms (GMOs) as such on their Nutrition Facts Panel. This issue is important because the Food and Drug Administration (FDA) implemented new Nutrition Facts Panel requirements most recently in 2016 so that consumers could feel more confident about making purchases. The Vermont GMO mandatory labeling law went into effect in July of that year (PMA, 2016) and it requires the U.S. Department of Agriculture (USDA) to have governing regulations in place by 2018 regarding the “disclosure of genetically modified ingredients on food labels” (PMA, 2017). The issue at stake here is whether the FDA and USDA will comply with the GMO regulation or seek to have it rescinded so as to be in compliance with Trump’s EO, and that outcome is likely to affect the extent to which FSMA preventive controls guidance is issued on time by small businesses. As the FDA (2017) notes, FSMA compliance is staggered among sectors and most deadlines are not until 2018. The FSMA Final Rule for Preventive Controls for Human Food, “which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards” (FDA, 2017). If Trump’s EO gains traction among the FDA and USDA with respect to nutrition labeling, compliance with the FSMA Preventative Controls Rule could also be at jeopardy.
Background
The FSMA was signed into law by President Obama in 2010. However, several agencies have taken issue with the Act because so many industries are impacted by it—from farms to factories—and so many processes, from buying to selling domestically and abroad, must be overhauled to be in compliance with the many aspects of the Act, which have a wide-ranging focus to ensure food safety management in the food industry.
Section 1 of the FSMA provides regulation on inspections, registration of food facilities, hazard analysis and risk-based preventive controls, performance standards and standards for produce safety and protection against intentional adulteration. Section 106 states specifically that the Secretary shall “determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.” The FDA commenting on the FSMA (2017) states that “food defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment.” By enacting mitigating strategies that would protect food from intentional adulteration, the FSMA would inevitably be responsible for addressing the GMO controversy. The issue of GMO is a sensitive one because many people believe this is an unhealthy adulteration that should be classified as such—and the fight to have products labeled as containing GMOs is an important one for the public. As McGeary (2014) notes,  the FSMA “directed FDA to address the threat that the U.S. food supply is vulnerable to intentional actions, whether by terrorists or economic interests seeking to disrupt the food supply.” The inclusion of “economic interests” is an important one because it includes GMO proponents, like Monsanto, which is a major producer of GMO products in the U.S. and also around the world. A study by Seralini, Clair, Mesnage et al. (2012) showed that Monsanto’s GMO products were deadly when encountered over a long period of time. Though the products are economically profitable, their impact the environment and on human health has been viewed negatively. Dealing with this issue in the light of the FSMA and the Trump Administration’s call for rolling back regulations is important because many people are concerned that rollbacks will lead to a victory for GMO producers over anti-GMO activists, who saw the FSMA as a step in the right direction towards regulating this new burgeoning but still controversial GMO industry.
Analysis
The problem exists because there is a conflict of interest among the business side of the food industry and the security side of the food industry. The business side, from the perspective of a firm like Monsanto, sees the use of GMO as positive and having a good economic benefit. The security side sees or at least should see the GMO usage as at least suspect, due to the studies that have been done on the effects of GMO to the environment and to biological health. The current laws that apply are related to nutritional labeling of products that contain GMO so that consumers can be aware of what is in the products they are purchasing. However, this legislation, as described above has not yet been complied with by the food industry as a whole, for the deadline is not until 2018. The proposal by Trump to rollback regulations for every new regulation enacted puts the GMO labeling legislation at risk. The FSMA should be able to inspect products and ensure that GMO food is properly labeled as such so that safety concerns are addressed and consumers are protected. The FSMA was not designed to protect food simply from terrorist acts but also from any type of intentional adulteration, which many advocates of food safety believe GMO to be.
The laws create this issue because they commonly conflict with one another: Trump’s EO conflicts with the spirit of the FSMA in terms of providing more regulation to protect the public. The Trump Administration wants to provide protection to businesses so that they are not as hampered by regulations as they have been in the past. The issue is one of public safety versus private interest—and that is the whole nature of the conflict.
Solution
  The solution is simple as McGeary (2014) has stated: the “FSMA directed FDA to address the threat that the U.S. food supply is vulnerable to intentional actions, whether by terrorists or economic interests seeking to disrupt the food supply. Sadly, both Congress and the FDA continue to ignore the true solution to this problem: decentralizing and re-localizing our food system.” De-centralizing and re-localizing the food system would greatly help to reduce the bottleneck caused by continuous legislative activity, compliance extensions, and political turnover. Every time a new or different administration comes to power, sweeping changes are effected at the federal level. By cutting out the ability of the federal government to oversee the food industry and restoring that power to local producers and regulators would help to reduce the stalling, the in-fighting, and the ability for big producers like Monsanto to influence legislation through lobbying. Local authorities would have greater ability to affect the outcome of food safety issues that are discussed by the public. Since the public ultimately is who is at the heart of this issue, the public at a grassroots level should have the ability to influence the issue.
Thus, the FSMA Preventive Controls Rule should be modified to provide local regulators with the power granted the Secretary to oversee food safety issues so that firms must be in compliance with the local legislation regarding food security. This would impact businesses that are multinational and international as well as their supply chains because regulation would have to be complied with all along the way. Instead of easily circumventing federal law through stall tactics or a change of administration, firms whose product threatens the health of the public would be much more restricted by the local level regulators acting on behalf and with the full authority of the Secretary mandated by the FSMA to regulate the food industry.
Conclusion
The problem of rolling back regulations according to Trump’s January 30, 2017, Executive Order is that it threatens to reverse the progress made by President Obama and the FSMA with regard to the regulation of the food industry. One aspect of this that is important to the public is the issue of GMO and food safety. Advocates of food safety want to see products appropriately labeled and GMO production stopped or at least better regulated. If the FSMA granted authority to local level regulators, it would be much harder for big businesses like Monsanto to have their way, as they tend to do at the federal level.

References
FDA. (2017). FSMA Final Rule for Preventive Controls for Human Food. Retrieved
from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
FSMA. (2017). Frequently asked questions on FSMA. Retrieved from
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#Intentional_Adulteration
McGeary, J. (2014). Progress in the continuing FSMA saga and GMOs heat up for
2014. Retrieved from https://www.westonaprice.org/progress-in-the-continuing-fsma-saga-and-gmos-heat-up-for-2014/
PMA. (2016). GMO labeling negotiations near final. Retrieved from
https://www.pma.com/content/articles/2016/07/gmo-labeling-negotiations-near-final
PMA. (2017). U.S. in transition: FSMA and nutrition labeling. Retrieved from
https://www.pma.com/content/articles/2017/03/us-in-transition-fsma-and-nutrition-labeling
Seralini, G., Clair, E., Mesnage, R., et al. (2012). Long term toxicity of a
Roundup herbicide and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology, 50(11), 4221-4231.