FDA PUBLISHES RECORDS ACCESS INTERIM FINAL RULE
On Thursday, February 23, 2012, the FDA published an Interim Final Rule related to its authority to access records. Section 101 of the Food Safety Modernization Act expands FDA’s ability to access records beyond those relating to the specific suspect article of food to records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. FDA may also access records if FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.
- FDA access to records applies to each of the following:
- Both foreign and domestic facilities that manufacture, process, pack, transport, distribute, receive, hold, or import articles of food.
- Copies of the records needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
- Copies of records needed to assist FDA in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.
- Examples of records that FDA can access and copy include:
- Manufacturing records
- Raw materials (ingredients and packaging) receipt records
- Product distribution records
- Product inventory records
- Test records
- Recall records
- Reportable food/feed records
- Customer distribution lists
- Complaint and adverse event records
Access to records and other information must be made available within 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. The Interim Rule is effective March 1, 2012. Comments on the Interim Final Rule must be submitted by May 23, 2012. View the Interim Final Rule here.
For more information or assistance in developing a strategy to avoid or reduce exposure to user fees, please contact David P. Graham or Ranelle Leier.
This alert is a copyrighted publication produced by Oppenheimer Wolff & Donnelly LLP. The information contained in this alert is of a general nature and is subject to change. Readers should not act without further inquiry and/or consultation with legal counsel.