Farm Bureau Wants A Second Draft Of FSMA Rules
By Sam Lewis
With the belief that FSMA’s rules will need to be altered significantly, Farm Bureau is insisting second drafts be made for public comment
Farm Bureau’s primary worry with the proposed animal feed rule is that the rule has grown to be more burdensome than Congress envisioned when it was approved. The bureau cites concern specifically with the definition of what a farm is defined as, exemptions for low-risk activities tied to raw agricultural commodities, besides produce, and requirements for preventative controls.
“Given the complexity of the proposed rules, the current process of responding to comments on this draft rule with a final rule as a next step does not allow FDA to craft a sound and operable food safety framework. An interim step, such as a second draft rule or interim final rule, is needed to work through the regulatory process with adequate stakeholder input,” Farm Bureau wrote in recent comments.
The bureau says it values the FDA’s recognition of farms as exempt entities from registration, but Farm Bureau feels the definition of a farm is very limited and doesn’t include many activities, such as feed manufacturing. "In geographically isolated areas or locations where only a small number of farms are present, it is not unusual for a farm to add value to grains and other feedstuffs grown on its operation by mixing animal feed that can then be sold to neighboring farms,” the agency says. Farm Bureau also notes its agreement with the FDA on the agency's intentions to exempt facilities that store raw agricultural commodities from obligations that would be created in the current proposed good manufacturing practices (GMP) and preventative controls regulations.
Farm Bureau believes these exemptions should also be applicable to grain elevators. While these facilities store raw agricultural commodities, they are currently not exempt from proposed regulations as they lie outside of the FDA’s definition of what holding means. “The FDA has chosen a very tight and unrealistic interpretation within this context. Any post-harvest activities — even those inherently associated with storage of raw agricultural commodities, such as drying, screening, cleaning, conditioning, fumigating, and blending — effectively negate the exemption for facilities. This is impractical and counterproductive to the overall goal of risk-based feed safety for the animal and the public,” according to Farm Bureau.
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The proposed rule on preventative controls requirement is another place where Farm Bureau thinks the FDA is going too far. Here, the rule would require all implemented preventative controls for hazards to be branded “reasonably likely to occur” and conducted as a critical control point established within a hazard analysis and critical control point (HACCP) plan. This would make the rule very similar to the preventative controls for human food rule, which Farm Bureau says was never Congress’ intention. Lawmakers gave the FDA authority under FSMA to create separate HACCP and risk-based preventative controls rules for human and animal food as they recognized the risks with each type of food are very different.
According to Farm Bureau, the FDA has ignored the intentions of Congress by proposing an onerous, difficult structure to prevent and control dangers that may never occur in animal food manufacturing. The organization says the proposal is impractical and deters resources from proven practices ensuring the safety of animal feed.