IMPORTANT: This text was last updated in November 2013. It does not reflect changes made to the proposed FSMA rules in 2014. We will update this header when the text has been updated to reflect the re-proposed rules!
No food facility is exempt from the responsibility to produce safe food, but different scales and types of supply chains pose varying levels of risk to public health. A food facility that produces peanut butter on a large scale that is shipped across the country and served to thousands of people in institutional cafeterias poses a different level of risk to public health than a farm that produces jam on a small scale to sell directly to a consumer at a farmers market. The scale of production and consumption, and complexity of the supply chain are all risk factors that can influence the safety of a food product and how many people get sick if the product is contaminated.
In writing the Food Safety Modernization Act (FSMA), Congress recognized that different scales of facilities and different types of supply chains pose different risks to the safety of the food supply. Congress required FDA to take a risk-based approach to the new regulations and to provide sufficient flexibility in the regulations to be applicable to a wide range of facilities, including small businesses and facilities co-located on farms. Instead of a “one-size-fits-all” approach to food safety, Congress required the Food and Drug Administration (FDA) to take into account differences due to scale and supply chain when writing the new food safety regulations.
One of the parts of this risk-based, scale-sensitive approach was a provision that set forth modified requirements for facilities that both gross less than $500,000 in all food sales annually and sell the majority of their food directly to consumers or to grocery stores, institutions, or restaurants in-state or within a 275-mile radius. The law allows for these facilities – which FDA calls “qualified facilities” – to comply with less burdensome, modified requirements instead of with the full set of preventive controls regulations. Congress also stipulated that qualified facilities could have their status withdrawn under certain circumstances (see below).
In its proposed Preventive Controls Rule, FDA outlines the modified requirements for qualified facilities. A facility is eligible for modified requirements if it either:
The sales thresholds apply to the value of human food sales, not just sales of processed product, but excluding sales of animal feed. This includes sales of produce, hay, commodities like corn and soybeans, dairy, livestock, and processed foods. The baseline year for calculating any changes due to inflation is 2011. However, the re-proposed definition of very small business ($1 million dollars) means that all facilities with less than $1 million dollars in sale qualify for modified requirements, simplifying a facilities determination that it qualifies for modified requirements without having to track the percentage of sales to qualified end users.
For the full list of out-right exemptions and modified requirements in the proposed Preventive Controls Rule, click here.
Under the proposed Preventive Controls Rule, qualified facilities are subject to five parts of the regulations:
Under pre-existing law, a qualified facility has to register with FDA like other food facilities.
Regardless of their status under FSMA, all facilities – including qualified facilities – are prohibited through pre-existing law from selling adulterated food. Food is considered to be adulterated under a number of circumstances, including if it has been “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
It is extremely unclear in the proposed Preventive Controls Rule whether FDA is expanding the definition of when and how a food is considered adulterated, and whether, in doing so, FDA is also negating the option for a facility to be compliance with the regulations through the modified requirements. If FDA is negating that option, then FDA’s change is a huge issue that contradicts FSMA. We will provide more clarification on this issue once we receive more information.
The proposed requirements also state that failing to comply with the Preventive Controls Rule is a “prohibited act” subject to penalties and enforcement actions laid out in pre-existing law, the Federal Food, Drug, and Cosmetic Act.
The Preventive Controls Rule makes revisions to existing Current Good Manufacturing requirements. If a facility is subject to Current Good Manufacturing requirements, then that facility will continue to be. To review the Current Good Manufacturing requirements with the proposed revisions, click here (entire “Subpart B” of the proposed rule).
Under the modified requirements, qualified facilities must submit two types of documentation to FDA:
A qualified facility that does not submit documentation in 2(a) above must also include its name and complete business address on either a food packaging label on the food, on a sign that is displayed at the point of sale with the food, on documents delivered with the food in the normal course of business, or an electronic notice in an internet sale.
A qualified facility must submit that documentation to FDA electronically or by mail 90 days after the rules go into effect, and then must resubmit at least every two years or whenever there is a change in the information included in the documentation.
A qualified facility must maintain records that support the documentation required (see above). These records must be accurate and legible, and must be retained at the facility for at least two years after the date they were prepared. Records that are more than 6 months old may be stored offsite if they can be retrieved and provided onsite within 24 hours.
FDA can withdraw a qualified exemption under certain broad circumstances:
FDA did not establish a strong evidentiary standard for issuing a withdrawal order. FDA also did not define key terms in the “material conditions” clause to clarify the situations that would lead to a withdrawal. FDA has again declined to define these terms in the re-proposed Preventive Controls rule, stating that it is not necessary to define these terms and still provide a fair process.
The proposed rule lays out a procedure for withdrawal that includes issuing an order to withdraw the exemption. FDA specifies the type of information the order must contain, including a statement that the facility must comply with the full hazard analysis and risk-based preventive controls requirements within 60 days after the date of the order. The re-proposed Preventive Controls rule, however, changes this to 120 days. The facility owner, operator, or agent receiving the withdrawal order must then either come into compliance within 120 days or appeal the order within 10 days of receiving the order.
The preamble of the revised proposed rule explains that FDA views the withdrawal as a rare event, and now provides explicitly in the regulations that:
The revised proposed rule also establishes a process whereby a facility can have a qualified exemption reinstated. This is a significant improvement from the original proposed rule, which took a “one strike you’re out” approach. Now, a qualified exemption can be reinstated if:
In the case of (1) above, FDA will reinstate the qualified exemption at its own initiative and notify the facility in writing that the exemption was reinstated. In the case of (2) above, FDA will reinstate the exemption at its own initiative or at the request of the facility. If both (1) and (2) apply, then the facility must request the reinstatement.
If a facility decides to appeal a withdrawal order, FDA outlines a procedure for submitting an appeal, which can include a request for an informal hearing. FDA provides additional detail on the process for requesting an informal hearing and on the requirements applicable to that hearing. FDA establishes a timeframe for a decision on an appeal.
Finally, FDA provides information about when a withdrawal order would be revoked.\
If you will be eligible for modified requirements, FDA needs to hear from you about how to improve the modified requirements and the withdrawal provisions. FDA is requesting comment on the proposed requirements, on additional specific issues, and on information to include in additional guidance documents.
Here are some questions to guide your comments on this part of the proposed Preventive Controls Rule if you are eligible to be a qualified facility:
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