Wednesday, August 24, 2016

FDA Issues Draft Guidance for Facilities Sending By-Products for Use in Animal Feed

FDA issued a draft guidance for food processing facilities that send their by-products for animal feed. For example, a company sending peels or rinds after processing produce, or a company sending over baked cookies to a hog farmer.  The following is the important sections from this draft guidance.

First, these foods need to be safe for animal consumption. It may be wise to get the AAFCO manual to understand what ingredients can be fed to animals. The example used - propylene glycol is considered GRAS as an anti-caking agent for human food when used as specified in the regulation (21 CFR 184.1666), but is prohibited in or on cat food (21 CFR 589.1001). " Human food facilities that are distributing a by-product should know whether their by-product can or will be used for animal food and whether it is suitable for use in animal food. Human food facilities that do not intend for their human food by-products to be used as animal food should make it clear during distribution that the by-products are not for use as animal food. For example, this can be done by stating that the by-product is "Not for Animal Food Use" on the invoice, bill of lading, or other documentation accompanying the by-product during distribution."

BY-PRODUCTS FROM HUMAN FOOD FACILITIES THAT MEET THE V.REQUIREMENTS IN § 507.12 ARE NOT SUBJECT TO THE FULL REQUIREMENTS OF PART 507
Most human food processing facilities will fall under this category. These facilities must meet these two conditions:

"The first condition that must be met is that the human food facility must be subject to and in compliance with applicable human food safety regulations. Specifically, the human food facility must be: (1) subject to and in compliance with the CGMPs for human food and in compliance with all other applicable human food safety requirements of the FD&C Act and implementing regulations for human food, or (2) subject to and in compliance with the requirements of § 117.8 and in compliance with all other applicable human food safety requirements of the FD&C Act and implementing regulations for the off-farm packing and holding of produce."  [117.8 - off-farm packing and holding of raw agricultural commodities]

"The second condition that must be met is that the human food facility must not further manufacture or process the human food by-products for use as animal food (§ 507.12(a)(2)). Manufacturing/processing is defined as making animal food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating animal food, including food crops or ingredients."

If the facility meets those two conditions, then once the by-product for use as animal food is separated from the human food, the human food by-product for use as animal food is only subject to the limited requirements found in § 507.28 for its holding and distribution.

"Holding requirements (§ 507.28(a)) - When human food by-products for use as animal food are held for distribution, they must be held under conditions that will protect them from contamination. (§ 507.28(a)). Contamination may be caused by physical, chemical, or biological contaminants." The facility must protect it from someone adding trash to it. The facility must choose proper containers and how often those containers must be cleaned.

The containers must be adequately identified through proper labeling which could be done on the invoice or bill of lading.

Shipping containers and bulk vehicles (§ 507.28(c)) - When the facility is responsible for transporting the human food by-products for use as animal food itself or arranges with a third-party to transport the animal food, the shipping containers (for example, totes, drums, and tubs) and bulk vehicles used to distribute the animal food must be examined prior to use to protect against the contamination of animal food from the container or vehicle. (§ 507.28(c)).

"We expect facility personnel involved in the process of loading the product into the shipping container or vehicle to be aware of the condition of the shipping container or vehicle, and consider whether its condition would contaminate the human food by-products for use as animal food. Depending on the circumstances, this examination could include looking at the shipping container or vehicle to observe whether there are any residues in it that may contaminate the human food by-product for use as animal food. When a visual inspection is not practical, we would expect the facility to know what the shipping container or vehicle had previously been used for and because of that, whether the container needed to be cleaned prior to use to protect the human food by-product for use as animal food from contamination. This does not mean that the shipping container must be cleaned prior to each use in all situations. The regulations do not require the facility to examine the shipping container or bulk vehicle when the customer arranges for the transportation of the animal food, including when the customer arranges for a third-party to pick up the animal food." 

HUMAN FOOD FACILITIES SUBJECT TO THE FULL REQUIREMENTS OF VI.PART 507 FOR HUMAN FOOD BY-PRODUCTS FOR USE AS ANIMAL FOOD
Details conditions for when human food companies must meet all aspects of the Animal Food Regulation.

HUMAN FOOD AND HUMAN FOOD BY-PRODUCTS WITH A FOOD SAFETY VII.CONCERN (DIVERSION TO ANIMAL FOOD USE)
Addresses rejected food because of a food safety hazard.

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