The Produce Marketing Association submitted comments to the FDA on the FDA's proposed user fees for domestic and foreign facility reinspections, recall, and importer reinspection user fee rates for fiscal year 2012.
PMA "gets after" FDA on the issue of reinspection fees on import agents....
PMA's comment to FDA:
Re: FSMA Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012, Docket No. FDA-2011-N-0528
To Whom It May Concern:
On behalf of our members, the Produce Marketing Association submits the following comments to the Federal Register notice setting fees for re-inspections, both domestic and foreign.
PMA is the largest trade association representing companies that market fresh fruits and vegetables. We represent 2,700 companies from grower-shippers and supermarket retailers, to foodservice operators and importers. PMA members handle more than 90 percent of fresh produce sold to consumers in the United States.
Section 107 of the Food Safety Modernization Act (FSMA) limited FDA’s authority to collect fees to certain discrete areas. Under the new law, FDA may charge fees to re-inspect a domestic or foreign facility or an importer after the initial inspection identified noncompliance with requirements related to food safety. The FSMA also authorizes fees for the costs related to food recall.
The FDA, in publishing the notice for the 2012 fees, defined a re-inspection more broadly than the law allows or than Congress intended. PMA understands that when FDA returns to a facility that failed its initial inspection, that is an activity that generates a user fee. However, the notice includes other activities, particularly with reference to imports, in which the fees are inappropriate. After all, the statute has three distinct requirements: the activity must be an (1) inspection or examination that occurs after (2) an FDA inspection that identified noncompliance, (3) that is materially related to food safety.
In several instances, FDA claims activities trigger a fee in cases where those activities are not re-inspections. FDA proposes to charge a fee when an importer produces evidence to overcome an FDA action to detain food. For example, an importer may produce laboratory analysis that disproves the FDA assumption that a product may be adulterated and the notice would charge an importer for FDA’s time in reviewing the information. As written, the fee serves as a penalty to importers who challenge FDA’s rule and discourages the submission of information that proves the safety of the food. Similarly, food ordered destroyed is not a re-inspection but simply part of the original inspection activity. FDA should narrowly construe what is meant by a re-inspection.
PMA also urges the agency to carefully distinguish between re-inspections related to a food safety requirement and other errors that may generate re-inspections. We applaud the agency for recognizing that many labeling requirements, such as font size, do not affect food safety. While the notice states that FDA may issue guidance on this point, PMA suggests that this should be subject to rulemaking in advance of collecting fees, or at least in advance of collecting any fees relating to a misbranding. Without diminishing the importance of the FDA labeling rules, we note that nearly all have nothing to do with food safety.
FDA goes beyond its statutory authority by including fixed costs in its computation of the fee rates. Under the FSMA, fees are to cover only the costs of re-inspection-related activities, including administrative expenses, incurred in connection with arranging, conducting, and evaluating the results of re-inspections or in collecting those fees. Although Congress mandated that the agency recover 100 percent of the costs, those costs must be associated with the re-inspection-related activity. The notice includes costs not related to inspection-related activities. FDA’s computation includes operating costs the agency will incur whether or not any re-inspections occur. Given that, it is difficult to see how apportioning the agency’s overall costs to user fees is a cost associated with an inspection-related activity. We question FDA’s methodology in arriving at the fee and suggest that the fee cover the direct costs of the inspector’s time while performing the re-inspection.
With insufficient discussion or debate, this docket proposes a dramatic change in the responsibilities for someone acting as the agent for a foreign facility. Under the notice, the agent may be responsible for the payment of re-inspection fees. Under the Bioterrorism Act, foreign facilities required to register with the FDA had to list contact information for a U.S. agent. While the FSMA expanded the responsibilities of the U.S. agent by making them responsible for the fee, this is a change with enormous practical implications. The FDA’s own regulations explain that the U.S. agent “acts as a communications link between FDA and the foreign facility for both emergency and routine communications.” Such a dramatic change should be subject to notice-and-comment rulemaking. Until that careful consideration occurs, U.S. agents should not be made liable for the fees charged to foreign facilities.
Thank you for the opportunity to provide comments on the issue of re-inspection fees.
Very truly yours,
Dr. Robert J. Whitaker
Chief Science and Technology Officer
Produce Marketing Association
Vice President, Government Relations & Public Affairs
Produce Marketing Association