By George Kimbrell, legal director and Ryan Talbott, staff attorney for Center for Food Safety
Especially these days, it can feel like nobody in government is looking out for the public’s welfare, which is supposed to be its main job. And when it comes to food and agriculture’s effects on public health and the environment, the story is much the same. For these reasons, public interest organizations are even more needed than ever.
At Center for Food Safety (CFS), our mission is to protect food, farms, and the environment on behalf of all Americans. For over two decades, CFS has spearheaded the food movement, fighting the industrial model of food production, and safeguarding organic, ecological, and sustainable alternatives. We have many program areas, but a key aspect of all our work is ensuring that laws intended to protect the safety of the U.S. food supply are implemented and enforced.
CFS recently sued the U.S. Food and Drug Administration (FDA) for its failure to implement vital provisions of the Food Safety Modernization Act (FSMA) intended to identify foods at “high-risk” for foodborne illness. Foodborne illness is an ongoing epidemic in our country. According to the Centers for Disease Control and Prevention (CDC), every year, 47.8 million people, or one in six Americans, are sickened as a result of foodborne illness. Tragically, 3,000 die and nearly 128,000 are hospitalized every year. Many suffer serious long-term effects such as kidney failure, chronic arthritis, and nerve and brain damage. The annual cost to the U.S. economy in medical bills and productivity losses alone is over $93 billion.
To help stem this tide, Congress required FDA to classify these “high-risk” foods and establish special recordkeeping requirements for them, which were both supposed to be done over 5 years ago. These requirements are meant to enable FDA to identify the source of contamination rapidly, while an outbreak is still occurring, and then swiftly implement the recall process to reduce the potential for illnesses, hospitalizations, and death. Because FDA has fallen down on the job, CFS’s lawsuit will simply force the agency to do what it should have done years ago.
The need to complete the “high-risk” food designations is glaring. Earlier this year, an E. coli outbreak linked to romaine lettuce sickened hundreds in 36 states. While the first illnesses were detected on March 13, 2018, it wasn’t until April 13, 2018 that government officials traced the contamination to the “Yuma, Arizona growing region.” That is one month in which the public was completely in the dark about whether the romaine lettuce in their grocery store was safe to eat. Even though investigators narrowed the contamination source to the “Yuma, Arizona growing region,” a specific source was never identified. This is unacceptable since recent technological advances, such as Blockchain, allow retailers to identify the origin of certain produce shipments in seconds.
Unfortunately, this is not the first time CFS has had to sue FDA for failing to do what FSMA requires. From 2012–2014 CFS successfully litigated over FDA’s failure to comply with FSMA’s timelines for issuing seven major rules implementing FSMA in vital areas such as preventing contaminated food imports, contamination in transportation, and field and factory preventative controls and hazard analysis requirements. That case resulted in FDA’s enactment of those regulations based on new Court-set deadlines. Without CFS, FDA, almost certainly, would still have not completed these critical food safety rules to this day.
The safety of ubiquitous food additives is another area where CFS has been holding FDA accountable. The short story is this: In the U.S., food additives must undergo premarket reviews by FDA, and are approved or rejected based on scientific evidence. There is an exception, for some food ingredients that are “generally recognized as safe” (GRAS), based on a history of their safe use, like sugar or gelatin. Manufacturers can also file a formal petition to FDA requesting that it approve a food additive as “GRAS” based on published studies.
However, way back in 1997, FDA proposed a change to its regulation of food additives: to replace the GRAS petition process with a mere “notification” process. That is, manufacturers could unilaterally determine if a food additive was GRAS, and then just notify FDA. Because FDA review under the notification process is so cursory, FDA itself does not confirm whether or not an additive is GRAS. Instead, it just relies on manufacturers’ assertions about the safety of their own products. CFS and others filed objections to the proposed change.
Here’s the catch: even though FDA never officially made the new rule into law, it operated as if it had been. For over 15 years, FDA used this fast-track “notification” process to allow potentially unsafe food additives into the food supply. The notification process is the loophole that has swallowed the food additive rule, completely replacing the old petition process.
In 2014, CFS sued FDA for failing to finalize the 1997 rule and continuing to operate under the inadequate and illegal notification process. FDA subsequently agreed to a settlement in which it was required to finalize the GRAS rule by August 2016. Unfortunately, when FDA finalized the rule, it simply rubberstamped its 1997 practice where manufacturers simply tell FDA they are using a substance that they believe is safe, without any safety review by FDA.
Thus in 2017 CFS went back to court, this time to challenge FDA’s new GRAS rule. FDA sought to have the case dismissed but in September 2018, the court rejected FDA’s motion. We now are progressing to the merits stage, where we’ll ask the court to hold FDA accountable and order the agency to promulgate a new GRAS rule; one that protects public health.
Finally, earlier this year, CFS joined a coalition of groups in filing a legal action aimed at forcing FDA to decide whether to prohibit seven cancer-causing artificial chemicals from use in food as flavorings. The seven chemicals are benzophenone (a.k.a. diphenylketone), ethyl acrylate, eugenyl methyl ether (a.k.a. 4-allylveratrole or methyl eugenol), myrcene (a.k.a. 7-methyl-3-methylene-1,6-octadiene), pulegone (a.k.a. p-menth-4(8)-en-3-one), pyridine, and styrene. Though these seven chemicals are used to flavor a wide variety of processed foods, they are likely unfamiliar to consumers because, under food labeling rules, they would all appear only as “artificial flavor” on food ingredient lists. In response, FDA agreed to withdraw its approval of six of the seven flavors and granted the industry’s request to abandon the seventh flavor (styrene), which is no longer approved for use in food.
Keeping our food supply safe and healthy requires an ongoing commitment. And we’re on the front lines every day, trench by trench, fighting for a safe food system. But it’s not all bad news. With your help, we will continue to move to a better food future, one bite at a time.