FDA Continues FSMA Implementation For User Fees and Suspension of Registration

The Food and Drug Administration (FDA) is continuing its efforts to implement the FDA Food Safety Modernization Act in accordance with required deadlines. On Monday, August 1, FDA published a Federal Register Notice[1] announcing the fiscal year (FY) 2012 fee schedule for certain domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections, as well as a revised Frequently Asked Questions (FAQ) document[2] with information on the fees. FDA has also recently published FAQ on the implementation of the suspension of food facility registration and Federal/State integration.

User Fees

Section 107 of FSMA grants FDA the authority to assess and collect fees related to (1) certain domestic food facility, foreign food facility, and importer reinspections; (2) failure to comply with recall orders; (3) administrative costs of the voluntary qualified importer program; (4) costs associated with issuing food export certifications; and (5) costs to establish and administer the third-party accreditation program. Section 107 requires FDA to publish the fees in a Federal Register notice not later than 60 days before the start of each fiscal year. On August 1, FDA announced the 2012 fee schedule for items (1) and (2).

For facility and importer reinspections, the fees apply when FDA needs to conduct a follow up inspection of a facility or imported food due to food safety violation(s) found on a prior inspection, to ensure that the facility or imported food is in compliance. Recall user fees can be imposed for FDA's activities associated with a recall order, when a domestic food facility or importer does not comply with such order.

The FY 2012 fees rates are as follows: $224 an hour if no foreign travel is required and $335 an hour if foreign travel is required. The fees are effective October 1, 2011 through September 30, 2012. The responsible party will be invoiced for the direct hours spent to perform the reinspection or recall activities at the appropriate hourly rate, and payment must be made within 30 days of the invoice date.

Recognizing that user fees may cause difficulties for small businesses, during FY 2012 FDA will consider waiving, in limited cases, some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors. In this regard, FDA has established a public docket[3] to obtain information that will be used to

formulate a proposed set of guidelines regarding the burden of fee amounts on small businesses.

Suspension of Food Facility Registration

Section 102 of FSMA authorizes FDA to suspend the registration of a facility registered under section 415 of the Federal Food, Drug and Cosmetic Act in certain circumstances. The suspension order (or order to vacate suspension) may be issued only by the Secretary of the Department of Health and Human Services, or the FDA Commissioner. This authority became effective on July 4, 2011, although FDA is required to issue implementing regulations. On July 14, FDA announced new FAQ relating to its implementation of this section.

As detailed in FSMA, FDA may suspend the registration of a facility if FDA determines that food manufactured, processed, packed, received, or held by a facility has reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility:

- Created, caused or was otherwise responsible for such reasonable probability;

OR

- Knew of or had reason to know of such reasonable probability AND packed, received or held such food

If the registration of a facility is suspended, no person shall import or export food into the United States, offer to import or export food into the United States, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility.

A facility that has its registration suspended is entitled to an informal hearing within 2 days of suspension. If adequate grounds for suspension do not exist, the registration will be reinstated at the hearing. If suspension is still necessary after the hearing, the food facility must develop a corrective action plan that outlines how to correct the conditions causing the suspension.

Federal/State Integration

Various sections of FSMA provide for better coordination of activities between FDA, state, and local authorities. FDA has updated its FAQ to provide information on the Agency's activities in this regard. Specifically, FDA discusses the Partnership for Food Protection (PFP), which consists of workgroups with representatives from Federal, State, and local governments with roles in protecting the food supply and public health, and the Integrated Food Safety System (IFSS), which is a mechanism to develop strengthened inspection, laboratory, and response capacity nationwide.

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Please contact Deborah C. Attwood (attwood@khlaw.com) (202-434-4279) or Melvin S. Drozen (drozen@khlaw.com) (202-434-4222) if you have any questions about these provisions of FSMA, or would like more information about FSMA generally.