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.
A prescribed, one-size-fits-all methodology for preparing a flow chart and identifying an intended use or consumer does not exist. The process for preparing product, and the intended use or consumer of that product, can vary between establishments. Each establishment exercises autonomy in how they prepare a flowchart and identify the intended use or consumer, provided the outcome achieves the 9 CFR 417.2(a)(2) performance standard.
The 9 CFR 417.2(a)(2) reads:
“A flow chart describing the steps of each process and product flow in the establishment shall be prepared and the intended use or consumers of the finished product shall be identified.”
The Flow Chart
The performance standard for a flow chart is to describe (1) the steps of each process and (2) the product flow in the establishment. Let’s break this down.
What are “the steps?”
Per an askFSIS FAQ titled “HACCP ‘step’ of a Flow Chart,” “The steps listed on the flow chart should accurately describe what occurs in producing the product […] including optional steps. Multiple activities can be incorporated into one step.” The flowchart exists to meet the need of the establishment, not FSIS inspection personnel. The establishment determines the level of detail necessary in the flowchart. It may be appropriate for a large slaughter establishment that employs many butchers, each performing a different sanitary dressing step, to describe sanitary dressing with numerous steps and for a very small establishment that employs a single butcher who performs all sanitary dressing steps, to describe sanitary dressing with fewer steps.
What is “each process?”
A “process” (noun) is a series of actions or operations (i.e. steps) conducted to an end; especially a continuous operation in manufacture. The establishment, not FSIS, determines what that end is; therefore, the establishment defines the process, with one caveat. Per an askFSIS FAQ titled “HACCP ‘step’ of a Flow Chart,” “The […] flow chart should accurately describe […] what occurs […] from receiving through final shipment.” FSIS considers “each process” as beginning with the receipt of some material and ending with the shipment of the finished product.
A 9 CFR 417.2(a)(2) process is not synonymous with a 9 CFR 417.2(b)(1) process category. The nine 9 CFR 417.2(b)(1) processing categories codify how FSIS assigns inspection tasks. An establishment may adopt this process classification scheme but is not required to do so.
What is product flow in the establishment?
Flow is limited to product. Product is any carcass, meat, meat by-product, or meat food product [9 CFR § 301.2], or any carcass or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof [9 CFR § 381.1], capable of use as human food. A livestock or poultry carcass or any part of a carcass that is inedible is not product. Non-meat and non-poultry ingredients prior to their addition to product are not product. Packaging materials are not product. The flowchart need not describe the flow of articles that are not product. Flow is further limited to “in the establishment.” The flow chart must describe product flow starting with the receipt of raw ingredient product through the shipment of the finished product.
The Intended Use or Consumer
The performance standard for identifying the “intended use or consumer” is limited to the “finished product.” Notice that the performance standard is “intended use or consumers;” not “intended use and consumers.” 9 CFR 417.2(a)(2) requires identification of one or the other, not both. Let’s break this down.
What is “intended use?”
“Intended use” identifies how the producing establishment intends to use the product, not how the producing establishment intends for the purchaser to use the product. The “intended use” options are limited. If the producing establishment intends to use the product as an ingredient to prepare a different product, then the intended use of the product is “for further processing.” If the producing establishment intends to sell the product, then the producing establishment will not “use” the product. No intended use exists. The producing establishment does not control how the purchaser intends to use the product.
What is “intended consumer?”
“Intended consumer” identifies the customer to whom the producing establishment sells the product. The regulations routinely use the term “consumer” in the context of household consumer; however, a consumer is anyone who utilizes economic goods as a customer; therefore, a consumer is not limited to household consumers. The intended customer options are limited. If the producing establishment sells the product to:
- a wholesale dealer, then the intended consumer is the wholesale dealer.
- a 9 CFR 303.1(d)(1) retail stores, restaurants or similar retail-type establishment, then the intended consumer is a retail store, restaurants or similar retail-type establishment.
- directly to household consumers, then the intended consumer is the household consumer.
A flow chart describing the process steps and product flow provides a framework for conducting a hazard analysis. Intended use or consumer of the finished product influences how the producing establishment prevents adulteration during handling, storage, and shipment of finished product.
Over the upcoming months we will discuss 9 CFR 417.2(a) requirements for each of the 9 CFR 417.2(b)(1) process categories. My goal is to provide a basic hazard analysis for every type of meat and poultry product prepared.
As always, if you have a question, please use the Contact Us link and ask.
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