Will FDA’s New Budget Cover Food Safety Costs?

Under FSMA, firms are required to renew and update their registration information every two years. In addition, all “high-risk” domestic facilities must be inspected by 2016 and no less than every three years afterwards. The law directs FDA to inspect at least 600 foreign facilities annually and double those inspections every year for the next five years. Despite deficiencies in its database systems, FDA had been aiming to inspect all foreign and domestic high-risk facilities within three years, two years earlier than directed by FSMA, and is attempting to inspect all non-high-risk facilities within seven years, according to the agency’s “2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices” released last November.

The new food facility registration fee would be used to upgrade FDA’s inspection system “by increasing the effectiveness of inspections through adoption of preventive controls, training of personnel to inspect against the new prevention standards, and developing new ways to educate and inform industry,” the agency says. The fee would also support improvements in food and feed safety science and risk analysis, “so that knowledge of the methods of food and feed contamination can better prevent outbreaks and ensure that resources are better focused on areas of greatest risk.”

Authorization to impose the new user fees will require passage of new legislation, something that is far from certain. The FDA’s Fiscal 2014 budget request had also proposed the facility registration and import user fees. In his February congressional testimony, Taylor said the registration fee would allow FDA to increase its capacity to establish an integrated national food safety system “and further strengthen food safety inspection, research, and import review.” The proposed import user fee would assess a “minimal amount (approximately $20)” per line entry, defined as each portion of an imported shipment that is listed as a separate item on an entry document. “The improvements to the import process with not only facilitate the entry of safe products, but also improve public health by enabling FDA to focus its attention on higher-risk products,” Taylor said.

If the new user fees are approved and enacted next year, FDA will use the funds for comprehensive retraining of federal and state inspectors to ensure inspection quality and consistency; training and technical assistance for small and mid-size growers and processors; and building the import oversight system mandated by FSMA. “A central theme of these investments is supporting and leveraging the food safety efforts of both public and private partners to make the most effective use of available resources,” the agency says in its congressional justification.

But Dr. Acheson is skeptical that Congress will give FDA the green light. “Once again the FDA has asked for user fees, and they did not get them the last several times, and they will not likely get them this time, either,” he says. “The last several budgets have also had amounts for re-inspection fees, but as far as I am aware the FDA

has not put the system in place to collect any of those. Maybe that is a ‘Catch-22’ in that they don’t have the resources to put the system in place to collect the resources they so desperately need,” Dr. Acheson says.

Indeed, the current year’s $15 million food reinspection user fee would be cut to $6 million in Fiscal 2015, while a current $13 million food recall fee would drop to $1 million. The already authorized Voluntary Qualified Importer Program, which is intended to expedite imports from certified foreign suppliers and importers, would collect $5 million in new user fees starting next fiscal year. In addition, FDA is requesting a new $5 million food contact notification user fee “to better position FDA to reduce microbial food contamination through premarket notification to ensure the safety of food contact substances.”