[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.15]

[Page 210-211]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 109_UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND 
FOOD-PACKAGING MATERIAL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  109.15  Use of polychlorinated biphenyls (PCB's) in establishments 
manufacturing food-packaging materials.

    (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, and 
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 caused the contamination of food 
products intended for human consumption (meat, milk and eggs). 
Investigations by the Food and Drug Administration have revealed that a 
significant percentage of paper food-packaging material contains PCB's 
which can migrate to the packaged food. The origin of PCB's in such 
material is not fully understood. Reclaimed fibers containing carbonless 
copy paper (contains 3 to 5 percent PCB's) have been identified as a 
primary source of PCB's in paper products. Some virgin paper products 
have also been found to contain PCB's, the source of which is generally 
attributed to direct contamination from industrial accidents from the 
use of PCB-containing equipment and machinery in food packaging 
manufacturing establishments. Since PCB's are toxic chemicals, the PCB 
contamination of food-packaging materials as a result of industrial 
accidents, which can cause the PCB contamination of food, represents a 
hazard to public health. It is therefore necessary to place certain 
restrictions on the industrial uses of PCB's in establishments 
manufacturing food-packaging materials.
    (b) The following special provisions are necessary to preclude the 
accidental PCB contamination of food-packaging materials:
    (1) New equipment or machinery for manufacturing food-packaging 
materials shall not contain or use PCB's.
    (2) On or before September 4, 1973, the management of establishments 
manufacturing food-packaging materials shall:
    (i) Have the heat exchange fluid used in existing equipment for 
manufacturing food-packaging materials sampled and tested to determine 
whether it contains PCB's or verify the absence of

[[Page 211]]

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 establishment any other 
PCB-containing equipment, machinery and materials wherever there is a 
reasonable expectation that such articles could cause food-packaging 
materials to become contaminated with PCB's either as a result of normal 
use or as a result of accident, breakage, or other mishap.
    (iii) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement is 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.; and (d) 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) The provisions of this section do not apply to electrical 
transformers and condensers containing PCB's in sealed containers.