[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.45]

[Page 8-9]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec.  500.45  Use of polychlorinated biphenyls (PCB's) in the production, handling, and storage of animal feed.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their use as electrical transformer and 
capacitor fluids, heat transfer fluids, hydraulic fluids, plasticizers, 
and in formulations of lubricants, coatings, and inks. Their unique 
physical and chemical properties and widespread, uncontrolled industrial 
applications have caused PCB's to be a persistent and ubiquitous 
contaminant in the environment, causing the contamination of certain 
foods. In addition, incidents have occurred in which PCB's have directly 
contaminated animal feeds as a result of industrial accidents (leakage 
or spillage of PCB fluids from plant equipment). These accidents in turn 
cause the contamination of food intended for human consumption (meat, 
milk, and eggs). Investigations by the Food and Drug Administration have 
revealed that heat exchange fluids for certain pasteurization equipment 
used in processing animal feed contain PCB's. Although heat exchange 
fluids in such equipment are considered to be in closed systems, leakage 
has occurred that resulted in direct contamination of animal feed with 
PCB's and subsequently resulted in the transfer of PCB's to human food 
produced by animals consuming the contaminated feed. The use of PCB-
containing coatings on the inner walls of silos has resulted in the 
contamination of silage which has in turn caused PCB residues in the 
milk of dairy cows consuming the contaminated silage. Since PCB's are 
toxic chemicals, the PCB contamination of food as a result of these and 
other incidents represent a hazard to public health. It is therefore 
necessary to place certain restrictions on the industrial uses of PCB's 
in the production, handling, and storage of animal feed.
    (b) The following special provisions are necessary to preclude 
accidental PCB contamination of animal feed:
    (1) Coatings or paints for use on the contact surfaces of feed 
storage areas may not contain PCB's or any other harmful or deleterious 
substances likely to contaminate feed.
    (2) New equipment or machinery for handling or processing feed in or 
around an establishment producing animal feed shall not contain PCB's.
    (3) On or before Sept. 4, 1973, the management of establishments 
producing animal feed shall:
    (i) Have the heat exchange fluid used in existing equipment or 
machinery for handling and processing feed sampled and tested to 
determine whether it contains PCB's, or verify the absence of PCB's in 
such formulations by other appropriate means. On or before Sept. 4, 
1973, any such fluid formulated with PCB's must to the fullest extent 
possible commensurate with current good manufacturing practices, be 
replaced with a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any PCB-containing lubricants for equipment or machinery 
used for handling or processing animal feed.

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    (iii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any other PCB-containing materials, whenever there is a 
reasonable expectation that such materials could cause animal feed to 
become contaminated with PCB's either as a result of normal use or as a 
result of accident, breakage, or other mishap.
    (iv) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement should be used. In making this 
determination with respect to a given fluid, consideration should be 
given to (a) its toxicity; (b) the maximum quantity that could be 
spilled onto a given quantity of food before it would be noticed, taking 
into account its color and odor; (c) possible signaling devices in the 
equipment to indicate a loss of fluid, etc.; (d) and its environmental 
stability and tendency to survive and be concentrated through the food 
chain. The judgment as to whether a replacement fluid is sufficiently 
non-hazardous is to be made on an individual installation and operation 
basis.
    (c) For the purpose of this section, the provisions do not apply to 
electrical transformers and condensers containing PCB's in sealed 
containers.
    (d) For the purpose of this section, the term animal feed includes 
all articles used for food or drink for animals other than man.