The Bioterrorism Preparedness and Response Act, which came into force at the end of last year, requires all facilities exporting foodstuffs, including ingredients, to the US to register with the FDA and food importers to give the agency advance notice before shipments arrive at ports or border crossings.
Nearly 20 per cent of all imports into the US are food and food products and the laws prompted accusations from some European firms that the country was putting up trade barriers.
However in an interview with NutraIngredients.com last year, Michael McGuffin, president of the trade organization the American Herbal Products Association, said the rule was not designed to disadvantage foreign firms.
"But I think it is important for foreign suppliers to evaluate this after three months or so. If they identify a loss of revenue then they need to communicate this," he said.
Now is the time to do so. The FDA this week called for comment on several aspects of the regulation, including how the regulations are affecting foreign companies (which need to hire a US agent for registration) and alternatives for prior notice submission on shipments.
The agency is planning to investigate the cost to foreign facilities of hiring and retaining their agents and whether any firms have stopped exports to the US as a result of the costs required. It will equally look at loss of business for domestic firms.
FDA has also published a plan along with the US Bureau of Customs detailing increased integration of customs and bioterrorism regulations. This could lead to better communications and reduced time requirements for processing shipment information.
Comments on the regulations will be received until 14 May and can be submitted online.