Food Safety Modernization Act (FSMA) Update, October 4, 2011
October 4, 2011
Dear International Colleague:
As part of the U.S. Food and Drug Administration’s (FDA) implementation of the Food Safety Modernization Act (FSMA) and as an update to our last letter dated July 5, 2011, I want to inform you of FDA’s obligations to develop and assess user fees under the new law, and to clarify certain aspects of FDA’s proposal to implement the user-fee provisions having reached the October 1st implementation deadline as specified in FSMA. Also, this and related issues were discussed during the most recent FDA Embassy Seminar with Dr. Margaret Hamburg, Commissioner of Food and Drugs.
First, FDA has decided to use its enforcement discretion to delay the assessment of user fees for importer re-inspections. FDA is in the process of considering legal, policy and technical issues associated with the assessment and collection of import reinspection fees. Recognizing the complexities involved in this undertaking, FDA is deferring implementation until these issues are resolved. This decision means that importers will not be charged fees for any reinspections undertaken by FDA due to adverse findings. However, the reinspection fees for both domestic and foreign facilities and non-compliance with FDA recall orders will still go into effect on October 1, 2011 as announced in FDA’s August World Trade Organization (WTO) notification.
Second, I would like to highlight the circumstances that will trigger FDA’s assessment of a re-inspection user fee for foreign (and domestic) facilities. A re-inspection is defined as “one or more inspections conducted…subsequent to…an inspection which identified non-compliance materially related to a food safety requirement of the Food Drug and Cosmetic Act…” Only non-compliant facility inspections taking place after October 1, 2011 will have the potential to trigger re-inspection fees.
To assist both domestic and foreign industry with complying with the implementation of the fee provisions under section 107 of the FSMA, FDA has published a new “Guidance for Industry” in the form of questions and answers to provide answers to common questions that might arise about the new fee provisions and FDA’s plans for their implementation in Fiscal Year 2012. This guidance can be found on FDA’s website at:
Please be assured that FDA remains committed to implementing FSMA in a transparent manner and will continue to update our international counterparts on a regular basis. All interested parties wanting to submit their comments directly to FDA in response to FDA’s August 11, 2011 notification to the WTO’s Committee on Sanitary and Phytosanitary (SPS) Measures of two Federal Register Notices on user fee rates (G/SPS/N/USA/2156/Add. 2 and Add. 3) must submit their comments by Monday, October 31, 2011 to FSMAWTO@fda.hhs.gov or by fax to +1.301.436.2618.
You may also monitor FDA’s FSMA website at http://www.fda.gov/fsma for details on how our Agency is implementing the law or sign up for our subscription service to receive the latest FSMA updates as they are downloaded on our website.
I look forward to our continued cooperation in making FSMA effective and efficient in protecting public health and in the production of safe foods.
Mary Lou Valdez, MSM
Associate Commissioner for International Programs