Modified Requirements for Qualified Facilities (Preventive Controls Rule)

NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.

Background

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  Congress also stipulated that qualified facilities could have their status withdrawn under certain circumstances (see below).

Modified Requirements for Qualified Facilities

In its proposed Preventive Controls Rule, FDA outlines the modified requirements for qualified facilities.  A facility is eligible for modified requirements if it either:

  • Is a “very small business,” defined as less than $1 million in annual sales of human food, OR
  • Has less than $500,000 in annual gross sales (adjusted for inflation) over a previous three-year period AND sells the majority of the food directly to a “qualified end-user” (i.e., a consumer, or a restaurant or retail food establishment (e.g., a grocery store) that is located in the same state as the facility or not more than 275 miles from the facility).

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.

What the Proposed Standards Require

Under the proposed Preventive Controls Rule, qualified facilities are subject to five parts of the regulations:

  • General provisions,
  • Current Good Manufacturing Practices,
  • Modified requirements that apply to a qualified facilities,
  • Certain recordkeeping requirements, and
  • Withdrawal of modified requirements that apply to qualified facilities.

Under pre-existing law, a qualified facility has to register with FDA like other food facilities.

General Provisions

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.

Current Good Manufacturing Practices

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).

Modified Requirements that Apply to Qualified Facilities

The proposed rule sets forth modified requirements for qualified facilities to the hazard analysis and risk-based preventive controls (“HARPC”) requirements (“Subpart C” of the proposed rule).

Under the modified requirements, qualified facilities must submit two types of documentation to FDA:

  1. A statement from the qualified facility certifying that it is a qualified facility; and
  2. Either:
    1. Documentation showing that the facility has identified hazards, is implementing preventive controls, and is monitoring to ensure the effectiveness of the preventive controls; OR
    2. Documentation that the facility is complying with applicable non-Federal food safety law (e.g., state, local, or county).

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.

Certain Recordkeeping Requirements

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.

Withdrawal of Modified Requirements that Apply to a Qualified Facility

FDA can withdraw a qualified exemption under certain broad circumstances:

  1. In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility; or
  2. If FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the facility that are material to the safety of the food processed, manufactured, packed, or held by the facility.  (Also known as the “material conditions” clause.)

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:

  1. FDA may consider alternative actions before withdrawing a qualified exemption, including a warning letter, recall, administrative detention, suspension of registration, seizure, and injunction; and
  2. Before FDA can withdraw a qualified exemption, FDA must first provide notice in writing of the circumstances that may lead FDA to withdraw the exemption; provide the facility with an opportunity to respond to the notification; and consider the actions taken by the facility to address the circumstances that may lead FDA to withdraw the exemption.

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:

  1. The withdrawal resulted from the facility being directly linked to an ongoing foodborne illness investigation and the investigation concludes and determines that there was no direct link; or
  2. The facility resolves the conditions or conduct that caused FDA to issue the withdrawal, and withdrawal is no longer necessary to protect public health or prevent or mitigate a foodborne illness outbreak.

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.

FDA Needs to Hear from YOU About Modified Requirements for Qualified Facilities

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:

  • How can the withdrawal process be improved?
  • What type of evidence of a problem should FDA include in a withdrawal order?
  • What information should should FDA include in the initial notice of intent to withdraw a qualified exemption?
  • Should the process for withdrawing a qualified exemption be the same across the Produce and Preventive Controls rules?
  • Are the timelines outlined in the withdrawal process feasible?
  • What type of documentation do you regularly keep that could be used to appeal a withdrawal order?
  • If you are happy with FDA’s decision to allow a withdrawn qualified exemption to be reinstated, be sure to say so in your comments!

How do I submit a comment to FDA?

Our step-by-step instructions show you how.

Additional Resources

 

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