[pullquote]In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching. It is especially common around the holidays or in August when many people, especially those in Congress are on vacation. On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline[/pullquote]
Tom Neltner, J.D., is Chemicals Policy Director
On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).
The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge. The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.
Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole.
Six years ago, the Government Accountability Office, the Congressional watchdog, reviewed FDA’s GRAS program and declared, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations.” GAO continued, “FDA is not systematically ensuring the continued safety of current GRAS substances.”
FDA’s final rule does little to address those shortcomings.
The announcement finalizes a proposed rule that the agency first published in 1997. For the next 19 years, the FDA operated under the proposed rule, while public health advocates and others offered extensive comments about the lax regulatory program. But the rule was never finalized, so no legal challenges have followed. In 2014, the Center for Food Safety sued FDA to force the agency to issue a final rule.
The final rule does nothing to fix the fundamental flaws raised by the public. It remains to be seen how the program’s many critics will address the issue.
Even when presented with an opportunity to improve the proposed rule, the agency made only minor tweaks. For example, the rule binds FDA to making a final decision on the voluntary notice within 270 days of the filing. In addition, it allows “general recognition” to be based on unpublished exposure or toxicology data as long as the “scientific data, information, or methods, which ordinarily are published,” even if they are in fact unpublished. There is no requirement to have an actual published study. The only type of data that the agency says cannot be used are “confidential industry files.”
The agency summarily dismissed a detailed legal analysis making clear that the current approval process – one that is little changed in the final rule – violates the law because it lets novel chemicals into the food supply without FDA safety review. FDA cites as authority for the rule several provisions of the Federal Food, Drug and Cosmetic Act including Section 701. This section gives the agency broad authority to promulgate regulations for the efficient enforcement of the Act. Despite this authority, FDA rejected making notice mandatory as GAO suggested because the food additives provision of the law is silent on the issue. If the agency is unaware of what chemicals are being added to food, it cannot efficiently ensure that these additives – and the food that contains them – are safe.
Over the years, it has become increasingly clear to consumers that FDA is unable or unwilling to ensure food is safe. According to a 2016 industry survey, 38% of consumers rate chemicals in food as their most important food safety concern, up from 9% in 2009. Since many of these GRAS chemicals do not need to appear in the label’s ingredient list, consumers have little choice but to rely on food retailers and manufacturers to ensure the agency has reviewed all additives. Until this loophole is finally closed, EDF will continue working with companies to fill the void left by FDA’s action.