FDA reform proposals spark more debate
In the wake of numerous food contamination scares, the effectiveness of the Food and Drug Administration in protecting food safety in the US has been a subject of fierce debate. Last month, the US Congress put forward proposals for extensive reform of the agency. Ben Cooper assesses how they have been received by industry representatives, consumer advocates and other stakeholders.
The long-running debate over the effectiveness of the Food and Drug Administration (FDA) in protecting food safety in the US stepped up a gear last month as the House Energy and Commerce Committee Chair John Dingell released draft proposals for broad regulatory changes to how the FDA regulates the food supply.
The proposals would allow the FDA to order the recall of contaminated foods - currently it can only request recalls - and would establish a group of inspectors to monitor manufacturers every four years. The legislation would establish a new system of fees to finance the additional oversight, while a comprehensive registry of all food facilities operating in the US or importing food would be created.
Under the new proposals, food companies would pay an annual registration fee of US$2,000 per facility, while importers also would have to register and pay a fee. There will also be re-inspection fees for transgressing companies. The legislation would require food companies to list the country of origin of their products on labels. Among other measures, the committee also proposed to strengthen fines imposed on food companies that fail to comply with safety regulations.
The proposals are a discussion draft, with the House Energy and Commerce Committee inviting comments from all stakeholders as part of an ongoing consultative process.
In view of the number of high-profile food contamination scares seen in the US in recent years, it is the move from a reactive to a more proactive and preventive approach that has most pleased consumer advocates.
"One of the biggest problems we have seen with the FDA is that it is not orientated towards prevention; they are more reactionary," says Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America. "One of things these draft proposals do is refocus the FDA on a preventative mission. So that is something we are really happy to see."
Waldrop also welcomes the proposed introduction of safety standards for fresh produce. The FDA currently just issues guidance for companies in this area. "This provision could go a lot further but at least it's a start," he adds.
Above all, it is the more regular monitoring of facilities which Waldrop sees as the key development. While he feels that inspections every four years still to be insufficient, it is once again a step in the right direction. "It hasn't gone far enough. We would like to see inspection frequency increased."
The issue of how the additional oversight should be financed has also sparked debate. While the Grocery Manufacturers Association (GMA) is concerned about the extension of the FDA's regulatory powers, which it says create "unnecessary regulatory burdens" and "over-broad enforcement power", it was particularly concerned about the system of user fees being proposed, which it said would act as an additional tax on a food industry already struggling with cost inflation.
There had been a degree of unanimity between campaigners and the industry over the issue of fees, as both maintained that public money should be used to finance food safety provisions. However, refinements to the Dingell proposals have made this element of the proposals more acceptable to consumer advocates. Crucially, Waldrop believes the new proposals are more acceptable as they represent a method of recouping money from industry without linking the fees specifically to inspection services. However, the pressure group, the Center For Science in the Public Interest (CSPI), has asked for the fees to be graduated so that smaller companies would pay less than larger producers.
On the issue of funding, there remains a strong consensus that the FDA needs more funds to carry out its work effectively, however its activities are structured.
Last week, the GMA welcomed a proposal by Senator Herb Kohl to boost the FDA's 2009 budget by $275m, which would include $100m for food safety. Along with other stakeholders, the GMA has called for the FDA's budget to be doubled, and said the Kohl proposal provides a "significant down-payment" towards this end.
Waldrop agrees. "It is a good start but the FDA budget has got to be sustained and increased over the next five years. It is a much better step forward than we have seen from this administration. The goal is to double the budget in five years."
Indeed, in spite of the heated debate over the role of the FDA, there is widespread consensus over the need for action to strengthen the agency. The Alliance for a Stronger FDA, which is campaigning for reform and better funding, is an extremely broad church, including public health organisations, consumer pressure groups, industry associations and former FDA officials among its membership.
But, in spite of the broad acknowledgement of a need for change, the coming months are likely to see much further debate over the Dingell proposals. As Waldrop points out, there are a lot of variables, not least the fact that all this is happening in an election year.
Interestingly, another food safety bill was proposed only a few days after the publication of the Dingell discussion draft by Jim Costa, a Democrat Congressman from California, and Adam Putnam, a Republican representing Florida. The Costa-Putnam bill includes fewer regulatory stipulations and follows voluntary guidelines advocated by the GMA.
Neither Costa nor Putnam sits on the Energy and Commerce Committee but Costa said in a news conference that he would work with Dingell "in a collaborative fashion".
In addition to some political opposition and industry concerns about over-regulation and costs, there has also been a suggestion that measures in the Dingell bill aimed at improving the regulation of imported foods could run counter to international trade agreements.
The European Commission has questioned whether the draft bill would comply with US World Trade Organization (WTO) obligations, according to a report in Inside US Trade. The concerns, raised in a letter to the House Energy and Commerce Committee, relate to new fees that would be imposed and the requirement that food facilities be certified by third parties in order to avoid certain restrictions.
The commission questioned whether the fees - the draft proposals stipulate an annual registration fee of US$10,000 for an importer - complied with the specific WTO obligation that any fee should not be higher than the cost of services. In the EU, inspection fees are levied in proportion to the size of an import shipment.
However, the European Commission also pointed out that the bill would bring the US regulatory system closer to that of the EU, notably in its stipulation that every food plant should have some form of Hazard Analysis and Critical Control Point (HACCP) quality control system in place. The fact that the Dingell proposals might be bringing the US closer to an EU style of governance may not sit well with those holding a more sceptical view of regulation, who would likely characterise the EU as being over-regulated.
The international trade implications, the question of how additional funds are raised through fees and the thorny issue of the FDA budget as a whole are therefore likely to be much discussed in Washington DC during the coming months.
Companies: Grocery Manufacturers Association
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