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 The issue at stake here is whether the FDA and USDA will comply with the GMO regulation or seek to have it rescinded so as to be in compliance with Trump’s EO, and that outcome is likely to affect the extent to which FSMA preventive controls guidance is issued on time by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...

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…