Another recent Alert noted that the Food Safety Modernization
Act (FSMA), signed by President Obama in January 2011, imposes some
new and stricter record-keeping requirements on companies in the
food supply chain. The FSMA also expanded the FDA's authority
to inspect such records any time the FDA "has a reasonable
belief that an article of food is adulterated and presents a threat
of serious adverse health consequences or death to humans or
animals." The FDA recently updated a Guidance document on food
records to incorporate this expanded authority to access records,
"Questions and Answers Regarding Establishment and Maintenance
of Records By Persons Who Manufacture, Process, Pack, Transport,
Distribute, Receive, Hold, or Import Food (Edition 5)." At the
same time, the FDA issued a draft Guidance on the issue titled,
"Draft Guidance for Industry: FDA Records Access Authority
Under Sections 414 and 704 of the Federal Food, Drug, &
Cosmetic Act."
Both the updated Guidance and the new draft Guidance incorporate
the "reasonable belief" standard for authorizing the FDA
to demand copies of a firm's records on 24 hours notice. This
standard has also been incorporated into the applicable regulation
at 21 C.F.R. § 1.361. The practical effect of this change is
that it will be more difficult than it was under prior law to
challenge successfully an FDA request for records.
These recent developments also provide a good opportunity to remind
companies of the surprising breadth of some food record-keeping
requirements. Does your company furnish bottled water, coffee, tea,
or other beverages to employees? If so, it is subject to
regulations requiring it to maintain certain records of the source
of those beverages. In fact, as far as bottled water is concerned,
this example is taken directly from the Q&A Guidance (Edition
5) described above. The requirement would apply equally to any type
of food provided to employees. This example highlights the need for
any company that operates at any point in the food supply chain
(except certain expressly excluded firms, such as farms and
restaurants) to become familiar and begin complying with the
record-keeping regulations if they are not already doing so.
A pdf copy of the Q&A Guidance is available here and the draft Guidance is available here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
