We have mentioned in previous issues that the U.S. Food and Drug Administration (FDA) depends on user fees for a significant percentage of its funding each year. Currently, the FDA is asking Congress to back the current level of user fees that have been proposed by the agency. Michael Taylor, an FDA official, appeared before a House Energy & Commerce Committee panel on Feb. 4 to make the request.
The panel was told by Taylor that the agency needs the projected $225 million the fees would provide to increase the number of foreign inspections and audits under the Food Safety Modernization Act (FSMA). Although the agency has enough funding for some aspects of the overhaul, including issuing regulations and increasing domestic inspections, it does not have the resources to fully implement other portions of the law, including the mandate to prevent the importation of contaminated food.
The user fee proposal, part of President Barack Obama’s budget for fiscal year 2014, included a food importer fee that was projected to generate an estimated $166 million in 2014. Also included was a facility fee that would generate an estimated $59 million. So far Congress hasn’t enacted those proposals. Taylor said in his appearance before the panel:
FSMA will only be as effective as its implementation. We have adequate resources to issue required regulations … but, simply put, we cannot achieve FDA’s vision without a significant increase in resources.
It should be noted that the FDA received $900 million to go toward the agency’s food safety work in the last budget. It was reported that a number of lawmakers were skeptical about the agency’s proposed fees. Rep. Michael C. Burgess, R-Texas, asked Taylor to account for how the agency has been spending the $900 million it received before trying to seek additional funding. Taylor responded by pointing out that, although some of the $900 million is being used toward the FSMA, lots of those funds also go toward the agency’s other food-related activities, including food additive regulations and the scrutiny of dietary supplements.
In his response before the panel to questions and comments, Taylor said it would take “several years” to fully implement the FSMA. He says that he expects it to be completed in the next decade. The U.S. imports roughly half of its fresh fruit and 20 percent of its vegetables, according to Taylor. He said the import fees would help toward auditing complex supply chain management systems overseas. Taylor added that the facility registration fees would also help support federal state partnerships under the FSMA.
The FSMA, according to Taylor, also needs funding to retrain the FDA and state inspectors on modern prevention systems, as well as to provide technical assistance to small and medium farms. Food industry groups are opposing additional user fees and urged the FDA to seek more Congressional funding instead of imposing fees on food producers. A letter from a coalition of some 50 food industry groups stated:
As consumers continue to cope with a period of prolonged economic recovery and food makers and retailers struggle with fluctuating commodity prices, the creation of new food taxes or regulatory fees would mean higher costs for food makers and lead to higher retail food prices for struggling consumers.
I have always believed that Congress should adequately fund the FDA and not make the agency dependent on funding from the very industry it has to regulate.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.