Last week FDA issued a final rule on FSMA’s provision on FDA Records Access Authority. Having received only two comments on the interim final rule, issued Feb. 23, 2012, FDA issued the final regulation adopting “without change, the interim final rule.” Probably the most notable aspect of the rule is that access to records has been reduced from credible evidence to reasonable probability of a serious adverse health consequences or death (SAHCD), giving FDA easier access to records with a lower bar for requesting them.
Despite the lack of addition, deletion or change, the final rule and its published guidance documents include some interesting points of which domestic and foreign persons – including domestic and foreign human food, animal food and dietary supplement facilities that manufacture, process, pack, transport, distribute, receive, hold and import– should be aware. The first is the repercussion of denying access to the records, a second is FDA’s response to one of the two comments, and a third is those records that may and may not be accessed and copied by the FDA.
Of equal importance to FDA easier records access is the fact that providing access is not to be taken lightly, as refusal to do so “is a prohibited act,” applying to both domestic and foreign persons – with the preference that the records be provided in English. In the Q&A section of its Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the FD&C Act, FDA asks “What action may FDA take when a firm refuses to permit access to records?” The answer: Because the refusal to permit access to or copying of the required records, “FDA may initiate civil or criminal action, as necessary.”
It should be noted, however, that the rule states that FDA can request the records “upon presentation of appropriate credentials and a written notice.” So you should always make sure to check an inspector’s credentials, and know that you have 24 hours to turn in the records after the official written request is made. Refusal to provide records or the finding of cause within the records can also lead to additional administrative, judicial, or other action, as appropriated, including:
- Suspension of the food facility’s registration, thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce
- Administrative detention of the food to control its movement
- Seizure of the food
- Issuance of a mandatory recall order for the food
- Injunction against the firm.
This leads us into the second point: FDA’s response to a comment requesting that the Agency clarify the meaning of the new records access authority, and, in particular, the phrases “reasonably believes is likely to be affected in a similar manner” and “reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequences or death.” While stating in the Federal Register document that such determination will be made on a case-by-case basis because such decisions are fact-specific, the Agency did add some Guidance examples of situations in which food may cause SAHCD, including:
- Peanut butter contaminated with Salmonella or Smoked salmon contaminated with Listeria monocytogenes
- Under-processed canned chili that contains Clostridium botulinum toxin
- Cake mix containing milk that is not declared in the ingredient statement on the label
- Candy contaminated with peanuts because of cross-contact with peanut-containing food
- Baby food that poses a choking hazard
- Animal feed contaminated with elevated levels of monensin, copper, or selenium
- Pet food contaminated with elevated levels of melamine and cyanuric acid.
In the same Guidance, examples of situations in which food is “likely to be affected in a similar manner” were given as:
- Salmonella outbreak in which, based on epidemiological data, multiple foods are initially implicated as potential sources
- Articles of food prepared or packed on an identical processing line or in in shared-use equipment as another article of food which may cause SAHCD
- Articles of food that were prepared, packed or held under similar conditions as an article of food which may cause SAHCD.
Records That May be Accessed and Copied
The Guidance explains that FDA records access extends to all records required to be kept under Section 414(b) of the FDCA and any other record related to the “manufacture, processing, packing, transporting, distribution, receipt, holding, or importation” of food. The records may be in any format and may be located at a facility other than where the covered activities take place. It is advisable that these records can be accessed quickly to meet the 24-hour required timeframe. The FDA may access records including:
- Manufacturing records
- Raw materials (ingredients and packaging) receipt records
- Product distribution records
- Product inventory records
- Test records
- Recall records
- Reportable food records
- Customer distribution lists
- Complaint and adverse event records.
Records That May Not be Accessed or Copied
Specifically, the Guidance explains that FDA records access authority does not extend to the following:
- Records from farms
- Records from restaurants
- Records relating to food within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. § 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. § 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. § 1031 et seq.)
- Financial and pricing data
- Personnel data
- Research and sales data other than shipment data regarding sales.
So as previously stated, despite the lack of addition, deletion or change, the Records Access final rule, although unchanged, and its published guidance documents include some interesting points of which food facilities and transporters should be aware. Make sure to obtain FDA Officials’ credentials, and provide them the records requested in the 24-hour timeframe to avoid potential subsequent action.
TAGged for you!
Record Access Final Rule – No Changes but Plenty of Critical Points by David Acheson is licensed under a Creative Commons Attribution 4.0 International License.