FDA Defines "High Risk" Facilities for Increased Inspections Under FSMA

On March 9, 2012, FDA released long-awaited information on how it will categorize food facilities as either high-risk (HR) or non-high risk (NHR) for purposes of determining how often they will get inspected. As a reminder, FSMA requires FDA to inspect HR facilities at least every three years and NHR facilities every seven years (after the initial post-FSMA cycle). The system announced March 9, 2012, will apply through FY2014. While FSMA identifies six different factors, several of those cannot be used yet or do not apply to domestic facilities (rigor of food safety plan, high risk imported foods, import certification and VQIP). In essence, FDA will be looking at the following factors for the next two years:

1. Known risky foods (leafy greens, sprouts, baked goods, spices, eggs, etc.) as defined through outbreak and Class I recall data
2. Compliance history of a facility — one Official Action Indicated (OAI) or three or more Voluntary Actions Indicated (VAI) in the last five years
3. Establishment type (processor vs. warehouse, etc.)
4. Years since last inspection

Some important issues to note:

• This "high risk" guidance only applies with respect to domestic food manufacturing, processing, packing or storage facilities. We are still waiting on high risk definition for foreign facilities, import certifications, "high risk" foods for which additional recordkeeping will be required and foods at "high risk" for intentional adulteration.
• These "high risk" factors are not all equal. Some will put your facility automatically in the "high risk" category, per FDA's decision tree. Examples: A facility with an OAI or more than three VAI indications within five years is automatically "high risk." So is a facility that manufactures a food type associated with both outbreaks and Class I recalls within the past five years.
• FDA also identifies "the rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls" as a relevant factor but, because the agency has limited facility-specific data, that factor is not included in the assessment model or decision tree.

Some final thoughts: First, recall classifications will be more important going forward (fight for Class II or III, rather than I). Second, avoiding VAI and especially OAI indications on FDA Form 483s is going to be key. That means being prepared for inspections and strong advocacy during inspections and in response to 483s to avoid VAI/OAI status. Finally, FDA retains the authority to inspect a facility at any time or with any frequency when responding to emerging public health information or following up on violative inspections and/or samples.