FDA Amends FSMA FAQs, Says Food Defense is a Shift for Agency
The Food and Drug Administration has added a new section on food defense to its frequently asked questions on the Food Safety Modernization Act (FSMA). FDA states that food defense involves the effort to protect the food supply against intentional (as opposed to accidental) contamination due to sabotage, terrorism, counterfeiting, etc.
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(FDA also added new FAQs on food tracing and high-risk food recordkeeping requirements. See ITT’s Online Archives or 09/08/11 news, 11090811, for BP summary of these aspects of the FAQs.)
The following are highlights of the five new FAQs on food defense:
FDA Must Issue “Food Defense” Regs on Measures to Protect Supply Chain
FSMA requires FDA to issue “food defense” regulations to protect against the intentional adulteration of food. For example, FDA is required to issue regulations specifying appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain from intentional adulteration at specific vulnerable points, as appropriate.
In addition, FSMA requires FDA to issue regulations regarding hazards related to food, including those hazards that may be intentionally introduced, to establish standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of preventive controls.
Further, FSMA requires FDA to issue regulations to establish science-based minimum standards for the safe production and harvesting and those types of fruits and vegetables that are raw agricultural commodities for which FDA has determined that such standards minimize the risk of serious adverse health consequences or death, including from hazards that may be intentionally introduced.
Consulting on Cost/Benefit as Food Defense Regs Are Shift from Current System
FDA states that issuance of regulations to protect against intentional contamination will mark a shift from the current system. This shift presents a number of challenges to the agency and its stakeholders. Substantive information gathering and analysis is underway as the FDA works to analyze available data and engage stakeholders to better understand the benefits and costs of such regulation.
So Far, FDA Has Focused on Identifying Vulnerable Supply Chain Points
The agency’s efforts to date to have focused on identifying points within the supply chain, specifically process steps that are vulnerable to intentional contamination. The agency has collaborated with government partners and stakeholders to assess the food supply and identify effective mitigation strategies.
Likely to Seek Public Input on Food Defense Regulations in Early 2012
Regarding its timeline for implementing regulations, FDA states that it is prioritizing its efforts to implement the FSMA based on public health needs, but that it is targeting early 2012 to issue a public call for information and input on food defense issues.