Food Safety Proposed Rules Overhauled to be More Flexible and Targeted
Responding to criticism that its original proposals were too burdensome, the Food and Drug Administration has substantively revised a slate of proposed regulatory changes designed to implement provisions of the FDA Food Safety Modernization Act concerning produce safety, preventive controls for human and animal food, and the foreign supplier verification program. The FDA states that these changes are intended to ensure a more flexible and targeted means to ensure food safety. Comments on the supplemental proposed rules are due no later than Dec. 15 and the FDA is planning to hold a public meeting on them Nov. 13 in College Park, Md.
Foreign Supplier Verification Program
The FSVP proposed rule would, for the first time, place responsibility for ensuring the safety of imported food squarely on the shoulders of the importer (or, if foreign, the importer’s agent). Importers who fail to meet this responsibility would face denial of entry and/or eligibility to participate in the FDA’s voluntary qualified importer program for expedited review and entry of food, which is currently in development.
Under the revised proposed rule, importers would have to conduct a more comprehensive analysis of potential risks associated with foods and foreign suppliers, taking into account factors such as the nature of hazards in food; the entity that will be applying hazard controls (e.g., the foreign supplier or its ingredient supplier); the foreign supplier’s procedures, processes and practices related to food safety; applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations; and the foreign supplier’s food safety performance history. The FDA is asking for input on whether this analysis should also include consideration of hazards that may be intentionally introduced for purposes of economic gain.
On the other hand, importers would have more flexibility to determine appropriate supplier verification measures based on food and supplier risks. When there is reason to believe that a hazard will cause serious injuries or deaths, a clear, rigorous verification standard would be required in the form of annual on-site auditing of the supplier. Importers would be allowed to use a different approach (possibly including less frequent auditing) only if they can establish that it will provide adequate assurance that the hazard is controlled.
Other changes include changing the definitions of “very small importer” and “very small foreign supplier” to those having no more than $1 million in annual food sales (up from $500,000), deeming importers that operate food facilities in compliance with any potential supplier verification provisions included in the preventive controls rules to be in compliance with any parallel FSVP requirements, and generally requiring compliance 18 months after publication of the final rule.
Preventive Controls for Human and Animal Food
The original proposed rules would require foreign and domestic facilities that manufacture, process, pack or hold human or animal food to be sold in the U.S. to develop written plans to identify potential food safety hazards and put in place risk-based controls to mitigate those hazards. Facilities would also be required to monitor their controls, verify that they are effective, take appropriate actions to correct any problems that arise, and maintain records documenting these actions.
The updated proposals would require each human and animal food facility, when appropriate, to conduct (a) product testing to verify the implementation and effectiveness of preventive controls and (b) environmental monitoring to verify the implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard. Facilities would also have to implement supplier controls when their hazard analysis identifies a significant hazard for a raw material or ingredient and that hazard is controlled before the facility receives the raw material or ingredient from a supplier. The FDA states that these provisions would provide facilities with the flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans. In that instance, an annual onsite audit of the supplier would be required unless the facility can show that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.
A farm would no longer be required to register as a food facility subject to the proposed rule on human food merely because it packs or holds raw agricultural commodities grown on another farm under a different ownership, activities that would instead be subject to the produce safety rule. However, farms that conduct additional processing or manufacturing may be subject to preventive controls rule for those activities.
The FDA is providing additional flexibility for human food processors that create byproducts used as animal food and are already complying with FDA human food safety requirements. Such entities would not need to implement additional preventive controls or current good manufacturing practice regulations when supplying a byproduct (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed CGMPs to prevent physical and chemical contamination when holding and distributing the byproduct (e.g., ensuring the by-product isn’t co-mingled with garbage). However, further processing a byproduct for use as animal food (e.g., drying, pelleting, heat treatment) would require compliance with the preventive controls for animal food rule.
This rule proposes enforceable science- and risk-based safety standards for growing, harvesting, packing and holding fruits and vegetables on foreign and domestic farms. It would cover all fruits and vegetables except those rarely consumed raw, produced for personal consumption or (with certain documentation) destined for commercial processing that will reduce microorganisms of public health concern. The rule focuses on areas of risk such as agricultural water, biological soil amendments, health and hygiene, domesticated and wild animals, and equipment, tools and buildings.
To account for natural variations in water sources, the FDA is now proposing a tiered and more targeted approach to testing each source of untreated water that would reduce how often the water is tested and base the frequency of testing on the water source and the results of prior tests.
In addition, this rule would not apply to farms or farm mixed-type facilities with an average annual monetary value of produce sales (not sales of all foods produced on the farm, as originally proposed) of $25,000 or less.
For more information on these supplemental proposed rules, please contact Shelly Garg at (305) 894-1043.