FDA opens new comment period on bioterrorism regs

The US recently implemented two pieces of legislation - currently at the interim final rule stage - designed to safeguard the country's food supply against bioterrorism. The first requires all food facilities to register with the FDA, while the second requires prior notice to US customs of any imported food shipments.

The relevance for the pharmaceuticals industry is that there are a number of food ingredients - such as gelatine and glycerine - that are widely used as excipients. But customs in the US have no mechanism to separate shipments intended for pharma use from those for food, and so excipients will be subject to the same legal requirements.

At a meeting organised by the International Pharmaceutical Excipients Council earlier this year, European excipient suppliers drew attention to a number of teething troubles with the legislation, such as the difficulties of complying with prior notice requirements, confidentiality of facility registration numbers and issues relating to the retention of a US agent.

The FDA appears to have responded to these concerns, and is asking for information on the impact of registration process on importers, as well as small US businesses.

For foreign facilities, the agency wants to receive comments on the cost of hiring and maintaining a US agent; the number of foreign facilities that have hired a new US agent or which have obtained additional services from someone with whom they already have a relationship; the number of foreign facilities which have stopped exporting to the US as a result of the new requirements; and the distribution of costs between submission of registrations and other services offered by the US agent.

The FDA said it is also working on its own costings of the process of hiring and maintaining a US agent.

Meanwhile, from US small businesses, the agency is seeking information on the effects, if any, when foreign facilities stop exporting to the US due to the new requirements; the number of small businesses that have been adversely affected by trading partners that have ceased exporting to the US; and the costs incurred by these small businesses due to the loss of these partners.

Notice period​

The notice period that US Customs requires will also come under scrutiny in the latest comment period. At the IPEC meeting earlier this year, it was pointed out that for example, the legislation requires notice of import to be served no more than five days prior to shipment and no less than eight hours before arrival by ship. This would be difficult to comply with if your shipment is on a ship leaving Singapore and bound for the Eastern seaboard.

The agency is considering whether to reduce the notice period for shipments, and to see whether electronic advance notification systems used by the US Customs for certain shipments can be extended to include products regulated by the FDA under food law.

The prior notice requirements will be discussed by the FDA and Customs later this year, and a final rule is scheduled to be published in March 2005.

IPEC estimates that up to 90 per cent of imported excipients are affected by the regulations.