We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a regular contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
9 CFR 416.2(b): Construction
As a kid, I picked cherries from the cherry tree in our backyard. Another form of cherry-picking occurs when FSIS inspectors base an allegation of noncompliance on isolated regulatory text and ignore the qualifying regulatory text. 9 Code of Federal Regulations (CFR) 416.2(b) is often cherry-picked.
According to 9 CFR 416.2(b): Construction:
(1) Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good repair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.
(2) Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.
(3) Walls, floors, ceilings, doors, windows, and other outside openings must be constructed and maintained to prevent the entrance of vermin, such as flies, rats, and mice.
(4) Rooms or compartments in which edible product is processed, handled, or stored must be separate and distinct from rooms or compartments in which inedible product is processed, handled, or stored, to the extent necessary to prevent product adulteration and the creation of insanitary conditions.
Scenarios
Consider these illustrative scenarios, each number corresponding to those listed above in 9 CFR 416.2(b).
1. A crumbling concrete floor in the raw ground processing room versus a crumbling concrete floor in the locker room. Neither floor is “kept in good repair” but “adulteration of product” is only possible in the raw ground processing room. Cherry-picking applies the “kept in good repair” performance standard to both circumstances and ignores “a manner that does not result in…” Noncompliance exists with §416.2(b)(1) only in the raw ground processing room.
2. A ceiling leak in an edible product storage cooler versus a ceiling leak in an inedible product storage cooler. Neither ceiling is “impervious to moisture” but “adulteration of product” is only possible in the product storage cooler. Cherry-picking applies the “impervious to moisture” performance standard to both circumstances and ignores “as necessary to prevent…” Noncompliance exists with §416.2(b)(2) only in the edible product storage cooler.
3. Flies are entering the building through holes in the door screen versus flies entering the building when the door is opened and closed by an entering/exiting employee. Neither door “prevents the entrance” of flies, but only the door with a hole in the screen is not “maintained to prevent” the entrance of flies. Cherry-picking applies the “entrance of” performance standard to both circumstances and ignores “constructed and maintained to…” Noncompliance exists with §416.2(b)(3) only for the door with a hole in the screen.
4. Edible and inedible product, in the same room, in close proximity, in open containers versus edible and inedible product, in the same room, physically separated, in sealed containers. In neither case are the rooms “separate and distinct,” but “product adulteration” is only reasonably likely to occur in the first case. Cherry-picking applies the “separate and distinct” performance standard to both circumstances and ignores “to the extent necessary to…” Noncompliance exists with §416.2(b)(4) only for edible and inedible product in close proximity, in open containers.
Compliance
If FSIS issues a noncompliance record alleging §416.2(b) noncompliance that accurately describes a failure to meet the entire performance standard, the noncompliance record is valid; fix the problem. If the noncompliance record and you meet the performance standards described, appeal the noncompliance. If the noncompliance record cherry-picks and ignores the qualifying text, appeal the noncompliance record. Don’t be surprised if FSIS denies your appeal. In the opinion of many FSIS inspection personnel, any building construction shortfall is synonymous with insanitary conditions and the adulteration of product. Cherry pie anyone?
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