While it includes measures which will improve its response capabilities, in essence the Food Safety Modernization Act (FSMA) is aimed at changing the Food and Drug Administration’s food safety function from a predominantly reactive to a preventive one.
In that overall aim, it is generally deemed to have been successful. However, a major caveat remains: passing the legislation and implementing it are two entirely different matters.
Phased introduction, consultation and pilot projects
Lobbying in Washington played a role in the development of the FSMA and the FDA will continue to consult with stakeholders as it finalises some of the regulations it calls for.
The FSMA was passed into law on 4 January, and some of its powers came into effect immediately. For example, powers to mandate recalls and suspend registration of a facility if the agency determines that the food poses a reasonable probability of serious adverse health consequences or death, are already in place.
Indeed, the FDA has ordered a number of product seizures during the year, most recently this month from a warehouse owned by Chetak Chicago LLC in Illinois.
However, many of its measures will come into force on a phased basis. Large companies have until 4 July 2012 to implement the requirements for companies enshrined in the act, for example relating to food safety plans, while smaller companies will have a further 18 months
In addition, the precise stipulations of certain new regulatory powers granted to the FDA remain to be finalised. The FDA opened a comment period in May which ran until August, and further consultation with industry, along with initiatives such as meetings and briefings for food companies, will follow.
“The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety,” deputy FDA commissioner Michael Taylor said at the beginning of the comment period. “It’s imperative that we get information, data and feedback from industry and other stakeholders.”
The rhetoric from trade associations such as the GMA and FMI underlines the expectation that industry expects to be involved in the continuing development of the FSMA’s measures.
With regard to the response to outbreaks, the FSMA required the FDA to establish at least two pilot projects, one for produce and one for processed foods, aimed at enhancing the agency’s and industry’s ability to trace products responsible for food-borne illness outbreaks. In September, it announced it had briefed the Institute of Food Technologists to carry out two pilot schemes.
So while the FSMA technically became law in January, it represents a framework of food safety measures, comprising some which were immediately in force, some which are self-executing and will come into operation as a matter of course, and other stipulations which remain to be fully fleshed out.
The funding question
While some key details of the FDA’s new powers are yet to be finalised, arguably the most critical imponderable of all is the question of whether the FDA will be granted sufficient funding to implement the extensive provisions of the FSMA.
Since the legislation was passed, the debate has switched from the scope and coverage of the reforms to the issue of Congressional appropriations. The fact that in its finalised form the FSMA includes measures which on paper look fairly costly, such as the controls on imported food, has only heightened that debate, and many are concerned that the intentions behind the bill will be compromised through lack of financial support.
“It’s a real concern,” says CSPI’s David Plunkett. “With food safety laws traditionally, the authorising legislation comes out and is very strong and says what we’re going to do, but a lot of times Congress falls down on the appropriations side, and so the funding never comes through. A lot of the promise of the legislation is lost simply because the agency doesn’t have the resources to implement it.”
This concern is echoed by Professor Mike Doyle, director of the Center for Food Safety at the University of Georgia, who describes the funding issue as the FSMA’s “major Achilles heel”.
Doyle expresses doubts as to whether there will be sufficient funding to provide effectively the inspection and certification systems envisaged under the FSMA. He is also sceptical that the FDA will be able to meet the challenges the FSMA sets regarding oversight of imported food. “It all sounds good when you say it fast,” says Doyle. “When the rubber meets the road, that’s a whole other matter. It’s going to be a lot more challenging than meets the eye I think”
However, on the positive side, Doyle adds: “There are many things in the act that will be incumbent on industry to employ and that’s going to take industry dollars and not necessarily government dollars, such as developing food safety plans.”
Doyle also observes that sometimes legislation is put in place but not adequately funded until a crisis occurs that turns political and public attention towards the issue. In the case of food safety, sadly such events are always a possibility.
It should also be borne in mind that the law does not impact on the food safety jurisdictions of the US Department of Agriculture (USDA).
Integration: an opportunity missed?
For all the enthusiastic support for the FSMA, some stakeholders, including CSPI, believe an opportunity was missed for the integration of the FDA’s food safety functions with those that come under the USDA’s jurisdiction, governing meat, poultry and eggs.
Indeed, it is a specific stipulation in the FSMA that the existing USDA jurisdictions are not affected. As a rough estimate, USDA regulations cover around 20% of the US food supply. So in essence while the US does indeed have a substantially revamped regulatory apparatus for food safety, a significant proportion of the supply chain is not covered by its provisions.
This is not quite the omission it first appears. The regulatory procedures at the USDA were generally acknowledged to be better than those in place at the FDA, particularly from a preventive standpoint. Indeed, arguably the primary pillar of the USDA system is its inspection infrastructure. However, as David Plunkett of CSPI suggests, “it still has problems”.
At the early stages of discussion of a wholesale review of food safety – after this was endorsed by the incoming President Obama – the idea of integrating the two systems was extensively discussed.
However, Doyle believes a legislative package including the substantial task of integration simply would not have got through Congress, not least because the inspectoral function of the USDA is highly unionised.
Interestingly, while the creation of an inspections infrastructure has been generally viewed as one of the strengths of the FSMA from a preventive standpoint, some suggest the track record of the USDA system, which relies heavily on its highly developed inspections process, underlines that this in itself cannot be viewed as a panacea.
In a blog in January, Shaun Kennedy, director of the National Center for Food Protection and Defense (NCFPD), wrote: “While inspection does a great job of identifying issues within firms and, in some cases, identifying firms that need to have significant action taken against them, inspection is not a cure-all. If the presence of inspectors meant dramatically reducing or eliminating unintentional food contamination, we would not have any foodborne illness outbreaks associated with USDA-regulated products, since they have inspectors present at all times.”
Integration of the USDA and FDA functions certainly appears to have been abandoned relatively early. But there are now moves in progress to reform the USDA’s food safety system. So in addition to the duplication of administrative resources inherent in running two separate systems, the legislature now faces a further period of debate, involving considerable resource in its own right, which could conceivably have been conducted in parallel with the debate over the FDA reforms. To the outsider, this is certainly a puzzling state of affairs and perhaps says as much about the nature of bureaucracies as it does about the approach to food safety in the US.