The US is tightening up rules to thwart bioterrorists. From this August all companies exporting food to the United States will have to give prior notice of shipments. All the facilities from which the food comes have to be registered. After 9/11 the American public wants protection, but some fear trade flows will be disrupted. Chris Lyddon reports.

A spokesman for the United States Food and Drug Administration, who spoke on condition of anonymity, told that the FDA had worked hard to avoid creating any problems with trade. “When we were designing the regulations we conducted outreach and solicited comment from the industry,” he said. “We met with representatives of other countries and worked with the WTO. We wanted to be sure that we weren’t blocking trade.”

He admitted that the new rules would require some adjustment in business practices. “It’s a change in the market place dynamic, but it’s not a prohibition,” he said. “There’s a change in the time to submit paperwork and you need to register with the FDA, but that’s not very time consuming. It’s free and once you’ve done it you’re set, unless you change something, like open a new facility.”

The prior notice rule would also make little difference. “It only takes a small amount of time and it will allow us to increase the security of the food supply,” he said. “It is our goal to keep trade flowing as freely as possible.” It would create some initial disruption. “Any time you introduce something new, it takes time so there’s a small cost,” he said, but there would be little real change. “You can still bring in what you used to bring in. Much of the information was already being provided to US customs,” he said.

There had been examples of bioterrorism in the past, although he did not have full details. “Some years ago there was a group which sprayed a salad bar with a pathogen,” he said.

Food “could be used as a mechanism for attack”

The new rules were a way of avoiding possible problems. “What we wanted to do in putting forth these rules is look at possible vulnerabilities,” he said. “We know food could be used as a mechanism for an attack and we know there are people out there who don’t like us.”

An attack on food would have direct effects, by causing illness, or even death, but it would also have an economic effect, if it were to hit public confidence in the food supply. “We wanted to take precautions and have the flexibility to respond to new things which are unplanned,” he said. “It’s a precautionary measure.”

The new rules would help the industry achieve greater food safety. “This is going to allow us to increase the security of the food supply and it will allow us to increase its safety,” he said. “We don’t believe it will disrupt trade.”

The European Food Industry Association, CIAA, was one of the organisations which had responded when the FDA asked for input, Evelyne Dollet, economic affairs manager told “It’s not yet clear how it will work, because we are still in a transitional period,” she said.

“Clear non-tariff barrier”

The CIAA told the FDA that it considered the underlying aim, to protect consumers against risks, as legitimate. “However the CIAA is very concerned about the disproportionate character of the law,” CIAA director general Raymond Destin told the FDA in a letter last year. The CIAA did not believe that the measures would not be effective in eliminating the risk of contamination or adulteration. “CIAA considers that the measures envisaged to be applied to food imports will impose heavy and costly burdens upon EU exporters and will act as a clear non-tariff barrier,” Destin wrote.

The CIAA’s Dollet identified potential problems for small companies, particularly where they have not exported to the US before. “In particular there are difficulties with samples,” she said. If a company had exported to the US before it would not have needed to register. But the new rules mean a company would  have to go through the whole process before even a small sample could be sent to a potential customer.

The European food industry has not been the only one to complain. In June, John R Cady of the US National Food Processors Association, as part of testimony before a sub-committee of the US House of Representatives, called on the FDA to address remaining key issues. Like Dollet he highlighted samples as a big problem. “The major problem posed by FDA’s interim final rule for prior notice of imported food shipments concerns the inability of industry to import research and development samples,” he said. “Without a means for meeting the prior notice requirements in this area, research and development samples will be denied entry to the United States, eliminating a valuable tool for evaluating products and for new product development.”

Keeping an eye on it

By mid-July, NFPA urged FDA to extend its discretionary enforcement period, due to run out on 12 August, until 12 December 2004. “Industry remains concerned about what could be avoidable ‘surprises’ on 12 August (when the discretionary enforcement period ends) that result in detention of products at the border or disruption of trade due to non-compliance by other importers,” Cady noted.

The NFPA also called on the FDA to recognise the systems already in place to identify low-risk shippers, pointing out that many companies were already participating in Customs Trade Partnership Against Terrorism (CTPAT) and using the Free and Secure Trade (FAST) carrier transport across the Northern borders. The CIAA’s Dollet made a similar point. “They need to link the FDA measures with the customs measures like CTPAT and FAST,” she said.

Peter Van den Heuvel, analyst at Food From Britain North America, felt that the FDA had made the registration process reasonably straightforward. “It’s online and it’s automated,” he told But the prior notice rules were perhaps a bigger challenge, particularly for food companies trying to clinch a sale. “A lot of times you get a buyer interested and you need to move fast,” he said.

The initial signs were that the FDA was prepared to review the rules to deal with any teething problems, he said. There was a need to make sure customs agents were checking details given against a proper database, to flag up potential problems.

The British food industry organisation, the Food and Drink Federation, is watching to see what the effect of the rules will be as they are more closely applied, its spokeswoman Christine Fisk told “We haven’t had any of our members raise it as an issue,” she said. “At the moment it isn’t yet being strictly applied. We’re keeping an eye on it.”