Yesterday 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 will get inspected. As a reminder, FSMA requires FDA to inspect HR facilities at least every three years and NHR facilities ever seven years (after the initial post-FSMA cycle). The system announced today 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:
- Known risky foods (leafy greens, sprouts, baked goods, spices, eggs, etc.), as defined through outbreak and Class I recall data;
- Compliance history of a facility (one Official Action Indicated (OAI), or three or more Voluntary Action Indicated (VAI) in the last five years);
- Establishment type (processor vs. warehouse, etc.); and
- 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 for high risk definition for foreign facilities, for import certifications, for “high risk” foods for which additional recordkeeping will be required, and for 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 5 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 5 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 at this time.
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.
For more information, see FDA’s guidance and decision tree, or contact Faegre Baker Daniels attorneys Sarah Brew or Steve Toeniskoetter.
National Feed and Grain Association has learned that FDA is planning to issue four separate sets of proposed regulations on the one-year anniversary of President Obama’s signing into law the Food Safety Modernization Act (FSMA). Those four regulations are:
(1) Preventive controls for human food
(2) Preventive controls for feed, feed ingredients, and pet food
(3) Foreign Supplier Verification Program (FSVP)
(4) Regulations requiring produce growers to implement preventive controls and product tracing systems for certain types of produce
FDA is also expected to release a “fact sheet” for each of the proposed regulations summarizing the major requirements, as well as schedule public meetings to provide opportunity for comment. Full article from NGFA.
Faegre Baker Daniels and FaegreBD Consulting will provide more analysis and guidance on the proposed rules later this week.
Leavitt Partners, Faegre & Benson LLP and B&D Consulting are joining forces to provide companies involved in the global food supply chain with a collaborative solution to food safety management. This joint effort will provide guidance for companies seeking to navigate the shifting food safety challenges of today’s systems and those required to comply with new regulations resulting from the passage of the 2011 Food and Drug Administration Food Safety Modernization Act. Read more.
The FDA recently announced new fees, related to the Food Safety Modernization Act (FSMA). The fees in question will go into effect October 1 and will be effective until September 30, 2012. The announced fees apply when a facility is reinspected, if a facility fails to comply with a recall order, and for importer reinspections. FDA derives its authority to assess these fees from FSMA.
FDA will bill companies $224 per hour for work of FDA staff. If the work requires travel to a foreign country, the rate rises to $335 per hour. Neither rate includes travel costs for foreign inspections.
Under “limited circumstances” FDA indicates it may be willing to waive applicable charges for certain small businesses, based upon factors such as economic hardship, the type of violation in question, and other factors. FDA is currently gathering information related to the impact of fees on small businesses, and there will not be a separate fee schedule for 2012. However, it is expected that one will be in effect for later years.
FDA is accepting comments regarding the burden of the proposed fees on small businesses through October 31, 2011. Comments submitted through that date will be considered as FDA begins the process of determining fees for 2013. Comments can be submitted online through the regulations.gov portal.
FDA continues to focus on the safety of imported products that fall under its jurisdiction. The safety of imported foods has been an issue of national attention lately, as it is one of the key areas highlighted in the recent Food Safety Modernization Act (FSMA). As part of this overall concern related to imported items, FDA recently released a strategy highlighting key steps the agency needs to take to improve the safety of imported products within its jurisdiction, including food products.
FDA’s strategy was released as part of a report entitled “Pathway to Global Product Quality and Safety. The report notes that food imports have dramatically increased over the past decade, quadrupling from 6 million to 24 million over just the past decade, growing at an average pace of 10 percent per year. With this rise in imports though, the U.S. has also seen a rise in the number of food safety concerns in imported foods. These past events, coupled with the changing global food marketplace, prompted FDA to develop strategies to move from the historical focus on reacting to food safety events to a more proactive prevention approach.
To move towards improving the safety of imported foods and working to prevent unsafe food from entering the U.S., FDA has identified what it refers to as four “building blocks” of needed action:
- Assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
- Develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
- Expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
- Effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.
The strategies outlined in the report are ambitious, and as FDA notes, will require cooperation with federal, state and international agencies and governments to implement. In addition, FDA indicates it will continue to ask Congress to update FDA’s authorities to ensure they are effective in a global marketplace. However, the report also focuses on several areas that may prove challenging to the agency. Increased reliance on third party certifications and audits bring its own series of challenges, both domestically and internationally, and many of these initiatives have the potential to be expensive…and right now funding is a major uncertainty for FDA.
In the short term, FDA indicates that it plans to create a global network of inspectors over the next 12 months through cooperation with foreign governments. More importantly, for food industry stakeholders, FDA indicated that it would be engaging stakeholders to help FDA meet their goals, a process that may take several years.
The full report is available on the FDA website. We will continue to see further information regarding the development of import-related food safety programs as FDA continues to work on implementing the FSMA. A number of workshops have already been held, summaries of which are available here .