From the American Farm Bureau Federation:
With the understanding that significant changes will have to be made to the Food and Drug Administration's Food Safety Modernization Act proposed rule for animal feed, Farm Bureau is again urging officials to put a second draft of the proposed rule out for public comment.
"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.
Further, the second draft of all the FSMA-related proposed rules should be made available for thorough review as to how they are intended to work together, according to Farm Bureau.
"FDA says that five rules comprise the core of its risk-based framework-produce safety, the Foreign Supplier Verification Program, third-party audit certification and preventative controls for human food and for animal feed. Because all five rules contain overlapping provisions that together affect our members both directly and indirectly, it is critical that they be evaluated in context as a complete package," Farm Bureau said.
The organization also submitted detailed comments on the specifics of the animal feed rule.
Farm Bureau's central concern with parts of the proposed animal feed rule (and the other proposed FSMA rules) is that they are significantly more onerous than Congress intended when it approved the underlying law establishing a risk-based food and feed safety system. Among the feed safety issues Farm Bureau addressed are the definition of "farm," exemptions for low-risk activities associated with raw agricultural commodities (RACs) other than produce, and preventive controls requirements.
While the organization appreciates FDA's recognition of farms as appropriately exempt from facility registration in general and in regard to this rule specifically, the farm definition is too limited to encompass other normal farm activities, including feed manufacturing on a limited scale.
"Particularly 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," Farm Bureau said. In a handful of areas that don't have sufficient retail feed distribution, like Alaska, for example, purchasing feed from a neighboring farm might be the only way for a farmer to feed his livestock.
Farm Bureau noted its agreement with FDA on the agency's intent to exempt facilities that store RACs other than fruits and vegetables from requirements that would be established within its proposed current good manufacturing practices regulation and its proposed preventative controls regulation.
These exemptions should also apply to facilities like grain elevators, which, although they engage in activities customarily performed for the safe or effective storage of RACs other than fruits and vegetables, are not exempt from these proposed regulations because their activities fall outside FDA's unreasonably narrow proposed definition for "holding."
"Since FDA has chosen a very tight and unrealistic interpretation within this context, any post-harvest activities-even those inherently associated with storage of RACs, 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.
The proposed animal feed rule's preventative controls requirements is another area in which the FDA is overstepping. The core aspects of FDA's proposed regulation would essentially require that all preventative controls implemented for hazards identified as being "reasonably likely to occur" be handled like a "critical control point" that has been established within a formal hazard analysis and critical control point plan, similar to the preventive controls regulation for processed foods for humans. This approach is not consistent with Congress' intent when lawmakers gave FDA authority under FSMA to create a separate hazard analysis and risk-based preventative controls rule specific to animal feed, Farm Bureau said. Congress recognized that the potential safety hazards and commensurate risk associated with animal feed are vastly different than those involved in processing human food.
FDA ignored Congressional intent and instead proposed an extremely burdensome, complex framework to prevent and control hazards that may not be prevalent in feed manufacturing. In addition to being impractical, the unnecessary requirements proposed by FDA divert limited resources away from industry practices that actually have been proven to ensure the safety of animal feed.
The organization is urging FDA to follow more closely the legal framework laid out in FSMA and provide flexibility for the management of hazards and preventative controls that are tailored to each facility's operation and commensurate with the nature of animal feed/pet food safety risk that may be present.