We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a monthly 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.
My definition of insanitary condition is not always my wife’s definition of insanitary condition. Not a problem. In our house, my wife’s opinion rules the day. The same should not be true in an official establishment. Something other than opinion should rule the day. Neither the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), nor the 9 Code of Federal Regulations (CFR) Chapter III define meaning for the terms “sanitary,” “insanitary,” or “insanitary condition.” That is concerning considering that these terms appear more than 200 times in 9 CFR Chapter III, and “insanitary condition” is a common justification given by FSIS in-plant personnel (IPP) when rejecting equipment or facilities, slowing or stopping production lines, or refusing to allow the processing of product. How is an establishment owner to objectively defend his/her establishment against allegations of noncompliance based on insanitary conditions?
FSIS Policy
FSIS Directive 5000.1 Verifying an Establishment Food Safety System instructs IPP on verification of sanitation compliance. The directive does not define “insanitary condition.” It does instruct IPP to consider that, “there can be conditions in the facility that are less than perfect but that would not represent noncompliance…because they are not creating insanitary conditions.”
The FSIS training module, FSIS as a Public Health Regulatory Agency: 5000.1 Walk Through, defines an insanitary condition as, “a state, condition or occurrence in which any edible meat or poultry products may become contaminated or adulterated through exposure, slaughter, processing, handling, and packaging or by any other means.” This is the standard FSIS trains IPP to enforce. It is problematic on its face for two good reasons.
One, it is policy, bureaucratic opinion, not the product of rulemaking. Enforcement of a standard not subject to rulemaking is a violation of the Administrative Procedures Act. Two, it is sufficiently broad so that the ordinary establishment owner cannot determine when and where it does and does not apply. Terms like “may” and “by any other means” allow application whenever and where ever IPP want the policy standard to apply. The training policy encompasses whatever is theoretically possible, rendering moot the Directive 5000.1 policy, “there can be conditions in the facility that are less than perfect but that would not represent noncompliance.”
FMIA and PPIA
The phrase “insanitary conditions” appears once in the statutes, in the definition of adulterated [21 USC 453(g)(4) and 21 USC 601(m)(4)]. An article is adulterated, “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
The statutes do not prohibit “insanitary conditions.” The statutes prohibit adulterated product in commerce [21 USC 458 and 21 USC 610]. Noncompliance exists because product is adulterated, not because less than perfect conditions exist. Condition-based adulteration requires that product (1) be “prepared, packed, or held” and (2) may have been “contaminated with filth” or “rendered injurious to health.” A “prepared, packed, or held” product can only be “contaminated with filth” or “rendered injurious to health” if the product shares the same physical space as the offending condition.
- The roof leaks. Rain water drips into a room where ground beef is prepared. Insanitary conditions exist.
- The roof leaks. Rain water drips into the boiler room where no product is prepared, packed, or held. Less than perfect conditions, not insanitary conditions, exist.
- A foul odor emanates from the inedible storage room and permeates the entire facility. Insanitary conditions exist in the room where ground beef is prepared. Less than perfect conditions exist in the boiler room where no product is prepared, packed, or held.
Conclusion
So, how do you objectively defend your establishment against allegations of noncompliance based on “insanitary conditions?”
1. Keep the conversation focused on the meaning of “adulterated” as defined in the FMIA and PPIA, not “insanitary condition” as defined in FSIS bureaucratic policy.
2. Demonstrate that product is sufficiently physically separated from the offending condition to prevent “filth” or substances “injurious to health” from contacting product.
3. Emphasize the FSIS verification instruction to consider that, “there can be conditions in the facility that are less than perfect but that would not represent noncompliance” to advantage.
4. If IPP issues a Noncompliance Record (NR) with which you disagree, take what action is necessary to prevent interruptions with production, but appeal the NR.
As always, if you have a question, please use the Contact Us link and ask.
Did you miss Dr. Fisher’s previous posts?
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