Overview of FDA Final Regulations for Preventive Controls

StopBy IWLA Washington Representative Pat O’Connor

The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final. Compliance dates for some businesses begin in September 2016.

Following is a preliminary review of how the rule addresses the exemption for facilities that are solely engaged in the storage of packaged products and the modified exemption for storage of foods that require time and temperature controls (TCS foods).

Food Safety Plan
Covered facilities must establish and implement a food-safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food-safety plan that includes hazard analysis, preventive controls, and oversight and management of preventive controls.

FDA limits the exemption to a facility solely engaged in the storage of packaged food that is not exposed to the environment. In the introductory text to the final rule, FDA says, “The plain meaning of ‘solely’ is only, completely, entirely; without another or others; singly; alone.” Further, FDA says that a facility is “any establishment, structure, or structures under one ownership at one general physical location …

However, FDA says in the introductory text that a facility “that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control associated with its food products would document that determination in its written hazard analysis but would not need to establish preventive controls and associated preventive control management components for its products.

Scenarios Where the Exemption will not Apply

  • A warehouse that handles packaged food and nonfood items, such as consumer goods, will have to have a written food-safety plan, which includes a hazard analysis. Although the introductory text does not address this specific issue, it’s clear from the discussion of “solely” that the exemption would not 1
  • A warehouse that handles both packaged food and conducts other food processing activities will have to have a written food-safety plan. In the introductory text, FDA says, “We disagree that a designated storage area in an establishment that conducts manufacturing, processing, or packing in addition to storage can fall within the exemption for facilities ‘solely engaged in … storage.’” 2

Grading and Sampling
FDA discusses in the text the situation where a facility that only stores packaged food, but where sampling food (such as sugar) for grading or quality- control purposes occurs. FDA says: “We consider that sampling food in the manner described by this comment is a practical necessity for the distribution of the food within the definition of ‘holding,’ and that the exemption still applies to a facility that conducts such sampling. Importantly, the sampling must be in done in accordance with CGMPs such that the exposure does not result in contamination of the food.”

Modified Exemption for TCS Foods
The rule adopts a modified exemption for facilities that handle packaged foods that require time/temperature controls. The facility must establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxic production by, microorganisms of public health significance.

Responsibility for Determining Proper Temperature
With respect to temperature controls, IWLA said in its written comments on the proposed rule that it is the responsibility of the product owners to determine optimal conditions for storage of their products, including the appropriate temperature, and communicate those requirements to the warehouse. In response, FDA says that it is appropriate for the manufacturer of the food to share the responsibility with the warehouse for the proper storage of food. FDA says in the text.

“It is not necessary to specify this joint responsibility for determining storage conditions in the rule, because the rule already clearly specifies that its provisions apply to persons who manufacture/process food, as well as to persons who hold food. Both the warehouse and the manufacturer have flexibility in determining how to comply with the rule, including the specific mechanism whereby the warehouse would receive information about storage of a food product from the manufacturer or owner of the product.”

Decision Whether to Ship
Also in comments, IWLA said that the responsibility for determining any corrective actions for a TCS food when there is a loss of temperature control falls to the product owner rather than to the warehouse. IWLA also said that a warehouse is a third-party who is not legally empowered to make independent decisions about when and where to ship a product, or to ship at all. FDA limits its response to suggesting that returning food to the manufacturer “is one way to satisfy the requirement to prevent food from entering commerce, if the owner, operator, or agent in charge of a warehouse cannot ensure the affected food is not adulterated under section 402 of the FD&C Act, either on its own or after consultation with the manufacturer or processor of the food affected.”



1 However, if the only food products in the facility are unexposed package food (not subject to temperature control), the hazard analysis may well conclude that no preventive controls are necessary. Similarly, if there are unexposed TCS foods, the hazard analysis may determine that the modified requirements outlined in section 117.206 of the regulation are appropriate and the food-safety plan would build on those provisions.

2 In this example, preventive controls would be required for the food processing activities. By contrast, for the packaged food, the hazard analysis would likely conclude that no preventive controls are necessary.


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