[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.30]
[Page 218-220]
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-
Subpart B Tolerances for Unavoidable Poisonous or Deleterious Substances
Sec. 109.30 Tolerances for polychlorinated biphenyls (PCB's).
(a) Polychlorinated biphenyls (PCB's) are toxic, industrial
chemicals. Because of their widespread, uncontrolled industrial
applications, PCB's have become a persistent and ubiquitous contaminant
in the environment. As a result, certain foods and animal feeds,
principally those of animal and marine origin, contain PCB's as
unavoidable, environmental contaminants. PCB's are transmitted to the
food portion (meat, milk, and eggs) of food-producing animals ingesting
PCB-contaminated animal feed. In addition, a significant percentage of
paper food-packaging materials contain PCB's which may migrate to the
packaged food. The source of PCB's in paper food-packaging materials is
primarily of certain types of carbonless copy paper (containing 3 to 5
percent PCB's) in waste paper stocks used for manufacturing recycled
paper. Therefore, temporary tolerances for residues of PCB's as
unavoidable environmental or industrial contaminants are established for
a sufficient period of time following the effective date of this
paragraph to permit the elimination of such contaminants at the earliest
practicable time. For the purposes of this paragraph, the term
``polychlorinated biphenyls (PCB's)'' is applicable to mixtures of
chlorinated biphenyl compounds, irrespective of which mixture of PCB's
is present as the residue. The temporary tolerances for residues of
PCB's are as follows:
(1) 1.5 parts per million in milk (fat basis).
(2) 1.5 parts per million in manufactured dairy products (fat
basis).
(3) 3 parts per million in poultry (fat basis).
(4) 0.3 parts per million in eggs.
(5) 0.2 parts per million in finished animal feed for food-producing
animals (except the following finished animal feeds: feed concentrates,
feed supplements, and feed premixes).
(6) 2 parts per million in animal feed components of animal origin,
including fishmeal and other by-products of marine origin and in
finished animal feed concentrates, supplements, and premixes intended
for food producing animals.
(7) 2 parts per million in fish and shellfish (edible portion). The
edible portion of fish excludes head, scales, viscera, and inedible
bones.
(8) 0.2 parts per million in infant and junior foods.
(9) 10 parts per million in paper food-packaging material intended
for or used with human food, finished animal feed and any components
intended for animal feeds. The tolerance shall not apply to paper food-
packaging material separated from the food therein by a functional
barrier which is impermeable to migration of PCB's.
(b) A compilation entitled ``Analytical Methodology for
Polychlorinated Biphenyls, June 1979'' for determining compliance with
the tolerances established in this section is available from the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(c) A barrier is functional for purposes of paragraph (a)(9) of this
section if the barrier limits migration of PCB's from the packaging
material to food to a level not exceeding the migration which occurs
under the same test conditions from packaging material containing 10
parts per million PCB without the use of a barrier. A class of barrier
material is functional for purposes of paragraph (a)(9) of this section
if a
[[Page 219]]
representative barrier of the class limits migration of PCB's from the
packaging material to food to a level not exceeding the migration which
occurs under the same test conditions from packaging material containing
10 parts per million PCB without the use of a barrier. Migration levels
shall be determined for purpose of this paragraph solely by use of
testing conditions described in ``Test Procedures for Determination of
PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised
May 1983'', which is incorporated by reference. Copies are available
from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. A
class of barrier material shall be deemed functional only if the
definition of the class and the designation of one or more
representative barriers has been approved by the Director, Center for
Food Safety and Applied Nutrition, Food and Drug Administration. In the
event that the Director, Center for Food Safety and Applied Nutrition,
does not approve a proposal made to the Center regarding the definition
of a class of barrier material or the designation of representative
barriers, the Director shall advise the person making the proposal of
the reasons for the Center's disapproval within 90 days of receipt of
the proposal. All proposals for definition of classes and determinations
of the Food and Drug Administration regarding such proposals shall be on
file with the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(d) Any person who asserts that a barrier or class of barriers is
functional shall submit the results of tests conducted to determine the
functionality of the barrier or class of barriers to Center for Food
Safety and Applied Nutrition (HFS-308), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. All barriers or classes
of barriers shall be tested with the four solid food receptors specified
in ``Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'', which is
incorporated by reference. The availability of this reference is given
in paragraph (c) of this section. The test results as to each barrier
shall be accompanied by (1) a description of the barrier's composition
adequate to enable identification; and (2) a specific definition of the
barrier by relevant technical characteristics. The Center for Food
Safety and Applied Nutrition shall review submitted test results
promptly. Within 60 days of the receipt of test results, the Director,
Center for Food Safety and Applied Nutrition, shall notify the person
submitting the test results whether the tests were conducted in
accordance with the ``Analytical Methodology for Polychlorinated
Biphenyls; June 1979'', which is incorporated by reference, or the
``Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'' and whether,
therefore, the barrier or class of barriers is deemed functional within
the meaning of paragraph (c) of this section. The test results and any
response of the Food and Drug Administration shall be placed on file
with the Division of Dockets Management, Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
[42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29, 1979;
46 FR 8459, Jan. 27, 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021, Aug.
16, 1983; 54 FR 24892, June 12, 1989; 59 FR 14364, Mar. 28, 1994; 61 FR
14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
Effective Date Note: At 38 FR 22794, Aug. 24, 1973, the following
appeared concerning Sec. 109.30(a)(9) (formerly 122.10(a)(9)):
* * * Sec. 109.30(a)(9) is hereby stayed pending full review of the
objections and requests for hearing. * * *
In the interim, as stated in the final order (38 FR 18098) the Food
and Drug Administration will enforce the temporary tolerance level
established by Sec. 109.30(a)(9) by seizing any paper food-packaging
material shipped in interstate commerce after September 4, 1973
containing higher than the specified
[[Page 220]]
level of PCB's as adulterated in violation of sec. 402 of the act.
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances
[Reserved]
Subpart D--Naturally Occurring Posionous or Deleterious Substances
[Reserved]
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