RCI Safety Analysis: Food Safety Modernization Act Review, Part 3
Date Posted: December 13, 2012
This article is reprinted by permission from RCI Safety.
As I mentioned in Article 1, we will cover FSMA in bite-size pieces; thus, the idea behind brief, weekly articles.
However, even at this pace sometimes you need to take a step back and give a topic a little more time.
We had many interesting calls and emails in response to the last article.
I thought it would be helpful to share some of these in FAQ format in a follow-up to Article 2 – Registration Mandates.
QS 1: “Do grain elevators need to register?”
Yes. All establishments at which food is manufactured/processed, packed, or held are required to be registered, unless otherwise exempt. FDA understands the term "collecting facilities" to refer to facilities that store or hold food, such as silos or grain elevators. Such a facility must be registered with FDA because food (grain) is held by the facility (21 CFR 1.225; 1.227(b)(5)).
QS 2: “Can RCI check the registration status for a client?”
No. Neither the list of registered facilities nor any information derived from FDA registration is public. Be sure to file completed forms (3537) with registration and PIN numbers for future reference. Registration records are not subject to disclosure under the Freedom of Information Act (FOIA) either.
QS 3: “Do facilities that distribute wild bird seed or wild animal feed need to register?”
Yes. All facilities which warehouse, distribute, or process feed for domestic or wild animals must register with the FDA. Feed is food regardless of what animal consumes it.
QS 4: “When registering a grain elevator or feed mill, do I need to list ‘snack food items’ or ‘soft drinks or water’ as a General Product Category in Section 10a of Form 3537 for the soft drinks and snack items we sell in vending machines or from countertop displays?”
No. By definition vending machine locations are considered “Retail Food Establishments” and are exempt from registration (21 CFR 1.227(b)(11)).
QS 5: “When registering a grain elevator, do I need to list ‘pet food’ or ‘minerals or mineral products’ as a General Product Category in Section 10b of Form 3537 for dog food and livestock mineral we sell directly to the end user or consumer?”
No. Since you do not manufacture/process, pack, or hold the dog food or livestock mineral they are considered “Retail” items (even though you are a Food Establishment for grain) and do not need to be listed on your 3537. There is some confusion over the term “hold.” Holding means storage of food for future processing, packaging or business to business transactions such as warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
QS 6: “Do farmers need to register?”
No . . . maybe. Currently, farms are defined as a facility devoted to the growing and harvesting of crops for food and/or the raising of animals for food (including seafood). This definition also includes farms that pack, hold, process, or manufacture food, if all of the food is consumed on that farm or another farm under the same ownership. If; however, food/feed goes beyond what is considered harvesting, the facility would be considered a food facility and be required to register with FDA. This is subject to change as FDA is redefining what constitutes on-farm packing, holding, manufacturing, and processing.
QS 7: “Are any food related businesses exempt from registration with FDA?”
Yes. Under the current definition, farms, restaurants, and retail facilities are exempt from the registration requirement.
Preview to Article 4 – Inspection and Compliance (next week)
In developing a food safety program, 90% of your time will be spent on prevention; however, before we delve into hazard analysis and risk based controls, I’d like to discuss some of the authority FSMA places in the FDA.
It’s been said that federal agencies utilize the carrot and stick approach - the carrot is a fine and the stick is bigger fine.
In Article 4 - Inspection and Compliance, we’ll discuss inspections, suspensions, recalls and detentions.
The “stick” just got a whole lot bigger.
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