FOOD & BEVERAGE
The United States Gets Serious About
Food Safety
Recent, highly publicized food incidents and drug recalls have eroded public confidence in the
FDA’s ability to protect consumers from harm. The goal of the new Commissioner of the Food
and Drug Administration, Dr. Margaret A. Hamburg, is to restore public confidence in the
process. To do so, she is enacting new procedures designed to enforce existing laws.
—Paula Hollywood, senior analyst, ARC Advisory Group
n September 8, 2009, the FDA launched the
Reportable Food Registry, an electronic portal
through which food facilities report the reasonable probability that use of, or exposure to, a
food will cause serious adverse health consequences or death to
humans or animals.
The FDA’s goal is to prevent harm to consumers by having all
regulated companies commit to compliance. Strengthening
enforcement will enable the agency to quickly intercept unsafe
or fraudulent products to contain injury.
Procedural actions instituted to mitigate risk and improve the
effectiveness of the FDA’s enforcement system include a new
close-out procedure that adds a more effective and fairer procedure to the regulatory process.
Post-inspection deadlines: Once the FDA provides inspection findings identifying a serious problem, the firm will generally
have no more than 15 working days in which to respond before the
FDA proceeds with a warning letter or enforcement action.
Speed issuance of warning letters: The process of issuing
warning letters will be streamlined by limiting warning-letter
review to significant legal issues.
Collaborate with regulatory partners: To develop effective risk control and enforcement strategies, local, state and international officials will have greater authority to act quickly to
protect food safety. The FDA will have responsibility for alerting
O
Prioritize followup: After issuing a warning letter or a major
product recall occurs, the agency will make it a priority to follow
up promptly with appropriate action.
Act swiftly and aggressively: The FDA will discontinue the
practice of issuing multiple warning letters to non-compliant
firms before taking enforcement action.
Close-out Process: If the FDA can determine, usually based on
a re-inspection, that a firm has fully corrected the violations raised in
a warning letter, the agency will provide a close-out letter. This indicates that the firm has successfully addressed the issues in question.
The Outlook
Several pieces of legislation currently under consideration by the
U.S. Congress have potential implications for any concern that
supplies food, including impact on their supply chain operations.
Comprehensive food safety reform mandating that firms have
food safety plans in place and granting the agency greater
authority to initiate mandatory recalls has bipartisan support and
backing from food industry leaders and consumer advocacy
groups. Regardless of the pending legislation, the agency head is
proceeding with plans to hire 350 new employees for food
safety, 125 of which will be dedicated field inspectors. With these
additional resources, the agency plans to increase the total number of inspections to 9000 in 2010.
