Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt21.2.109&rgn=div5
Timestamp: 2020-02-25 22:41:27
Document Index: 378916125

Matched Legal Cases: ['art 109', '§109', '§109', '§109', '§109', '§109', '§109', '§109', 'art 109', '§109', '§109', '§109', '§109', '§109', '§109']

Title 21 → Chapter I → Subchapter B → Part 109
§109.3 Definitions and interpretations.
§109.4 Establishment of tolerances, regulatory limits, and action levels.
§109.6 Added poisonous or deleterious substances.
§109.7 Unavoidability.
§109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.
§109.16 Ornamental and decorative ceramicware.
§109.30 Tolerances for polychlorinated biphenyls (PCB's).
Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 109 appear at 81 FR 49896, July 29, 2016.
(a) When appropriate under the criteria of §109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food.
(b) When appropriate under the criteria of §109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart C of this part under the provisions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act.
(c)(1) When appropriate under the criteria of §109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated.
(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.
(i) A conspicuous stick-on label on a surface clearly visible to consumers that states in legible script in letters at least 3.2 millimeters (0.125 inch) in height one of the following messages: “Not for Food Use. May Poison Food,” “Not for Food Use. Glaze contains lead. Food Use May Result in Lead Poisoning,” and “Not for Food Use—Food Consumed from this Vessel May be Harmful,” and
(1) A further explanatory statement concerning the decorative nature of the piece, such as “Decorative” or “For Decorative Purposes Only,” may be used; however, such additional statement shall be placed after the required statement.
(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:
(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 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, 5001 Campus Dr., 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.
Effective Date Note: At 38 FR 22794, Aug. 24, 1973, the following appeared concerning §109.30(a)(9) (formerly 122.10(a)(9)):
* * * §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 §109.30(a)(9) by seizing any paper food-packaging material shipped in interstate commerce after September 4, 1973 containing higher than the specified level of PCB's as adulterated in violation of sec. 402 of the act.