Monday 29 May 2017

FSMA Proposed Rule for Preventive Controls for Animal Feed/Food; Hazard Analysis

Food Court continues its series on the newly announced rule for preventive controls for animal feed and food under the Food Safety Modernization Act (FSMA). The rule was released late on Friday October 25; earlier posts on the rule can be found here and here.

The rule resembles the proposed rule for preventive controls for human food released earlier this year. Both rules require a food safety plan, which identifies hazards reasonably likely to occur and corresponding corrective actions. The components of the food safety plan are also similar along with the requirements around who can write the plan. It’s clear both rules draw from the same basic blueprint. Still there are fundamental differences in the hazards addressed by the two rules.

The hazard analysis set out in the preventive controls rule for animal feed is broader in scope. The rule is unique in setting out standards to address a wide range of species. Proposed § 507.33(a) would require that the identification and evaluation of hazards be done “for each type of animal food manufactured, processed, packed, or held at the facility.” For example, a facility may need to conduct multiple hazard analyses if it uses an animal protein blend as an ingredient in the manufacture of food intended for swine, poultry, dogs and cats. The hazard analysis required by proposed § 507.33 would be to identify the Salmonella serotypes to which swine, poultry, dogs, and cats are each susceptible. Animals are not the only consideration. The rule requires the hazard analysis to hazards reasonably likely to occur related to the  health of human handlers (e.g., pet owners) who are likely to come in contact with the finished food products.

The hazard analysis in the preventive controls rule for animal feed emphasizes chemical adulteration. The preventive controls rule for animal feed/food and human food share the same basic structure when identifying the categories of hazards – microbiological, chemical, physical, and radiological. The preventive controls rule for humans, however, strong emphasizes microbiological contamination while the preventive controls rule for animal feed/food emphasizes chemical adulteration motivated by economics (i.e. economic adulteration). The rule contains a unique section dedicated to examples of animal food safety incidents. Nearly every example involves the addition of a chemical compound due to economic considerations. The examples include melamine to bolster protein counts, mycotoxins, and dioxin in ball clay used in poultry feed. The FDA believes economically driven chemical adulteration pervasive enough to consider recognizing intentional economic adulteration as a required component of a hazard analysis. From the rule: “…[the Agency] recognizes that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in animal foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. The Agency requests comment on whether to include potential hazards that may be intentionally introduced for economic reasons. The Agency also requests comment on when an economically motivated adulterant can be considered reasonably likely to occur.”

The hazard analysis component is crucial component of the preventive controls rule. Based on the brief overview above it should be clear the hazard analysis proposed by the rule is unique from traditional HACCP hazard analysis and distinct from the proposed preventive controls rule for human food. The animal industry will experience the first serious regulation in the history of the FDA. Both the GMP and the preventive controls provisions require thoughtful consideration and planning.

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