FDA to Notify Companies Prior to Launching Biosecurity Records Search
Agency Issues Second Industry Q&A on Rule Implementation
The Food and Drug Administration (FDA) will notify food companies in writing before asking for their records in an emergency, FDA announced last week.
Under the recordkeeping provision (Section 306) of the Biosecurity Act of 2002, FDA inspectors have expanded access to an involved company's records if there is a reasonable belief that an adulterated food product has entered the marketplace that could cause "serious adverse health consequences or death to humans or animals" (known as a SAHCODHA threat). However, prior to last week's announcement, inspectors would not have had to inform companies why their records were being searched.
"We are extremely pleased that FDA will tell companies when a records search is due to a biosecurity concern," said Clay Detlefsen, IDFA vice president of regulatory affairs and counsel. "IDFA asked FDA to take this step in its comments submitted this May, since processors need to know the facts in order to be as helpful as possible during an emergency situation."
Once FDA has determined that a particular food product poses a serious health risk to the public, agency personnel will submit a written notice — entitled FDA Form 482c, "Notice of Inspection — Request for Records" — to the owner, operator or agent in charge of the involved food company to obtain the records that FDA needs.
Detlefsen noted that "this new request procedure will quickly indicate to a food company that this records review goes beyond a routine inspection and that inspectors likely need expanded records access in order to track down a public health threat."
To review FDA's announcement, which outlines the steps that agency personnel will take during such a situation, click here to visit FDA's website.
New Industry Guidance Announced In related news, FDA released last week a second guidance document regarding the implementation of its recordkeeping rule for the food industry. As a follow-up to its first guidance that was issued in September, this new Q&A answers more questions on compliance issues, including specific situations that dairy companies face. IDFA encourages its members to review the document in order to prepare for compliance.
Companies with 500 or more full-time employees have until December 9, 2005, to comply with the recordkeeping regulation. Small companies (11-499 full-time employees) must comply by June 9, 2006, while very small companies (10 or fewer full-time employees) will have until December 9, 2006, to comply.
As previously reported in News Update, IDFA hosts periodic conference calls for members to review and discuss issues that arise as the industry moves toward compliance. If you'd like to participate in these calls, contact Clay Detlefsen at email@example.com, 202/220-3554.
To review FDA's new Q&A document, click here to visit the agency's website.
FDA announced the recordkeeping final rule on December 9, 2004. The regulation requires manufacturers, processors, packers, distributors, receivers, holders and importers of food to keep specific records on their suppliers and customers, so that a questionable product can be traced one step forward and one step backward at each place in the distribution chain. The recordkeeping rule is the fourth of four food industry-related provisions in the Biosecurity Act, which was signed into law in June 2002 largely in response to the terrorist attacks on September 11, 2001.
For background information on the recordkeeping rule, members can click here.