Under the leadership of Scott Gottlieb, the U.S. Food and Drug Administration (FDA) has the potential to embrace innovation and shed its reputation of being a slow-moving, politically manipulated agency. But there are problems that need to be addressed. For example, the Government Accountability Office (GAO) says the FDA can’t enforce its own rule on produce designed to combat food borne illnesses because it doesn’t know which farms produce which commodities.
The FDA’s Produce Safety Rule established requirements for such factors as water quality, employee hygiene, and compost makeup to establish science-based standards for growing, harvesting, packing, and holding produce. The rule is part of the Food Safety Modernization Act designed to increase food safety standards.
While the FDA touted that the rule would “reduce the risk of harmful contaminations while also allowing appropriate flexibility for farmers and producers” when it was announced in 2015, many questions abound in its wake.
Which farms produce what is a critical question and seems to be at the top of the list.
The GAO notes that while the produce rule specifies the commodities subject to it, the “FDA does not have an inventory of farms producing those commodities and therefore does not know which businesses are subject to the rule.”
That’s largely because the FDA’s business inventory data are collected from information provided by businesses required to register with the administration, but farms don’t face that requirement.
“FDA officials we interviewed said that not having data regarding farms can make it difficult for FDA to connect businesses with the educational and technical assistance resources to help them comply with the rule,” the GAO wrote.
Representatives of the produce industry told the GAO that the FDA is open to their concerns, but expressed frustration at the lack of information they need to comply with the produce rule, according to the report.
Food Quality News reported that water testing is a major concern of the new rule, with producers expressing concern about increased costs. They note the rule requires new testing standards, so finding laboratories that implement the proper practices is difficult.
The FDA also hasn’t been quickly answering queries from an industry trying to determine how to implement the produce rule.
A previous GAO report on the issue in 2016 found that the industry was “struggling to cope” with the rule and one member of the produce industry complained it took four months to get an answer from the FDA to a question about the rule. The November report found that the current median response time is 48 days.
FDA officials told the GAO that the administration’s State Produce Implementation Cooperative Agreement Program will help address the challenge of identifying produce-producing farms. That program includes funding for states to develop and maintain an inventory of businesses subject to the produce rule. But not all states are participating in the program, and the FDA must develop farm inventories in those locations.
Its response to the new produce rule is just one of several issues the FDA could improve upon as new Trump-appointed commissioner Scott Gottlieb settles into the post.
A coalition of groups, that includes the Taxpayers Protection Alliance, sent a letter to Gottlieb in May that urged him to foster innovations in sectors where the FDA plays a meaningful role.
Namely, that coalition implored Gottlieb to delay a deeming rule by two years to allow the creation of an environment that encourages smokers to switch from cigarettes to less harmful products such as electronic cigarettes and heat-not-burn products. The deeming rule that took effect in 2016 requires e-vapor product manufacturers to endure a lengthy and expensive pre-market application process.
The FDA estimates that a single application will take 5,000 hours and cost $330,000, which the coalition says is killing innovation — not to mention those people who might be more apt to switch away from tobacco with the availability of more e-vapor products.
As it heads into 2018 and its first full year under Gottlieb, the FDA needs to reconsider some heavy-handed rules while also making it easier for industry actors to comply with the rules it keeps in place.