[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109]
 
[Page 209]
 
                        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.
109.3  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.
 
     Subpart B--Tolerances for Unavoidable Poisonous or Deleterious 
                               Substances
 
109.30  Tolerances for polychlorinated biphenyls (PCB's).
 
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]
 
Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]
 
    Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.
 
    Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.3]
 
[Page 209]
 
                        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. 109.3  Definitions and interpretations.
 
 
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms contained in section 201 of the act are 
applicable to such terms when used in this part unless modified in this 
section.
    (c) A naturally occurring poisonous or deleterious substance is a 
poisonous or deleterious substance that is an inherent natural 
constituent of a food and is not the result of environmental, 
agricultural, industrial, or other contamination.
    (d) An added poisonous or deleterious substance is a poisonous or 
deleterious substance that is not a naturally occurring poisonous or 
deleterious substance. When a naturally occurring poisonous or 
deleterious substance is increased to abnormal levels through 
mishandling or other intervening acts, it is an added poisonous or 
deleterious substance to the extent of such increase.
    (e) Food includes human food and substances migrating to food from 
food-contact articles.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.4]
 
[Page 209-210]
 
                        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. 109.4  Establishment of tolerances, regulatory limits, and action levels.
 
    (a) When appropriate under the criteria of Sec. 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 Sec. 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 Sec. 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.
    (2) Whenever an action level is established or changed, a notice 
shall be published in the Federal Register as soon as practicable 
thereafter. The notice shall call attention to the material supporting 
the action level which shall be on file with the Dockets Management 
Branch before the notice is
 
[[Page 210]]
 
published. The notice shall invite public comment on the action level.
    (d) A regulation may be established in subpart D of this part to 
identify a food containing a naturally occurring poisonous or 
deleterious substance which will be deemed to be adulterated under 
section 402(a)(1) of the act. These regulations do not constitute a 
complete list of such foods.
 
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.6]
 
[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. 109.6  Added poisonous or deleterious substances.
 
    (a) Use of an added poisonous or deleterious substance, other than a 
pesticide chemical, that is also a food additive, will be controlled by 
a regulation issued under section 409 of the act when possible. When 
such a use cannot be approved under the criteria of section 409 of the 
act, or when the added poisonous or deleterious substance is not a food 
additive, a tolerance, regulatory limit, or action level may be 
established pursuant to the criteria in paragraphs (b), (c), or (d) of 
this section. Residues resulting from the use of an added poisonous or 
deleterious substance that is also a pesticide chemical will ordinarily 
be controlled by a tolerance established in a regulation issued under 
sections 406, 408, or 409 of the act by the U.S. Environmental 
Protection Agency (EPA). When such a regulation has not been issued, an 
action level for an added poisonous or deleterious substance that is 
also a pesticide chemical may be established by the Food and Drug 
Administration. The Food and Drug Administration will request EPA to 
recommend such an action level pursuant to the criteria established in 
paragraph (d) of this section.
    (b) A tolerance for an added poisonous or deleterious substance in 
any food may be established when the following criteria are met:
    (1) The substance cannot be avoided by good manufacturing practice.
    (2) The tolerance established is sufficient for the protection of 
the public health, taking into account the extent to which the presence 
of the substance cannot be avoided and the other ways in which the 
consumer may be affected by the same or related poisonous or deleterious 
substances.
    (3) No technological or other changes are foreseeable in the near 
future that might affect the appropriateness of the tolerance 
established. Examples of changes that might affect the appropriateness 
of the tolerance include anticipated improvements in good manufacturing 
practice that would change the extent to which use of the substance is 
unavoidable and anticipated studies expected to provide significant new 
toxicological or use data.
    (c) A regulatory limit for an added poisonous or deleterious 
substance in any food may be established when each of the following 
criteria is met:
    (1) The substance cannot be avoided by current good manufacturing 
practices.
    (2) There is no tolerance established for the substance in the 
particular food under sections 406, 408, or 409 of the act.
    (3) There is insufficient information by which a tolerance may be 
established for the substance under section 406 of the act or 
technological changes appear reasonably possible that may affect the 
appropriateness of a tolerance. The regulatory limit established 
represents the level at which food is adulterated within the meaning of 
section 402(a)(1) of the act.
    (d) An action level for an added poisonous or deleterious substance 
in any food may be established when the criteria in paragraph (b) of 
this section are met, except that technological or other changes that 
might affect the appropriateness of the tolerance are foreseeable in the 
near future. An action level for an added poisonous or deleterious 
substance in any food may be established at a level at which the Food 
and Drug Administration may regard the food as adulterated within the 
meaning of section 402(a)(1) of the act, without regard to the criteria 
in paragraph (b) of this section or in section 406 of the act. An action 
level will be withdrawn when a tolerance or regulatory limit for the 
same substance and use has been established.
    (e) Tolerances will be established under authority appropriate for 
action levels (sections 306, 402(a), and 701(a) of the act, together 
with section 408 or 409 of the act, if appropriate) as well as under 
authority appropriate for tolerances (sections 406 and 701 of the act).
 
[[Page 211]]
 
In the event the effectiveness of a tolerance is stayed pursuant to 
section 701(e)(2) of the act by the filing of an objection, the order 
establishing the tolerance shall be deemed to be an order establishing 
an action level until final action is taken upon such objection.
 
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.7]
 
[Page 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. 109.7  Unavoidability.
 
    (a) Tolerances and action levels in this part are established at 
levels based on the unavoidability of the poisonous or deleterious 
substance concerned and do not establish a permissible level of 
contamination where it is avoidable.
    (b) Compliance with tolerances, regulatory limits, and action levels 
does not excuse failure to observe either the requirement in section 
402(a)(4) of the act that food may not be prepared, packed, or held 
under insanitary conditions or the other requirements in this chapter 
that food manufacturers must observe current good manufacturing 
practices. Evidence obtained through factory inspection or otherwise 
indicating such a violation renders the food unlawful, even though the 
amounts of poisonous or deleterious substances are lower than the 
currently established tolerances, regulatory limits, or action levels. 
The manufacturer of food must at all times utilize quality control 
procedures which will reduce contamination to the lowest level currently 
feasible.
 
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.15]
 
[Page 211-212]
 
                        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 212]]
 
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.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.16]
 
[Page 212-213]
 
                        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. 109.16  Ornamental and decorative ceramicware.
 
    (a) Lead is a toxic metal that is used as a component of glazes and 
decorative decals on ceramics, including some ornamental and decorative 
ceramicware. The use of ornamental or decorative ceramicware to prepare, 
serve, or hold food may result in the leaching of lead from the glaze or 
decoration into the food. The provisions of paragraph (b) of this 
section are necessary to ensure that ornamental or decorative 
ceramicware bear adequate indications that they are not to be used for 
food-handling purposes.
    (b) Ornamental or decorative ceramicware initially introduced or 
initially delivered for introduction into interstate commerce on or 
after July 13, 1994 appears to be suitable for food use will be 
considered to be for food use unless:
    (1) It bears:
    (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
    (ii) A conspicuous and legible permanent statement of the message 
selected from paragraph (b)(1)(i) of this section molded or fired onto 
the exterior surface of the base or, when the ceramicware is not fired 
after decoration, permanently painted onto the exterior surface of the 
base. This permanent statement shall be in letters at least 3.2 
millimeters (0.125 inch) in height, except that if insufficient space 
exists for the permanent statement in letters of such height, the 
statement shall be in the largest letters that will allow it to fit on 
the base of the piece, provided that the letters are at least 1.6 
millimeters (0.062 inch) in height; or
    (2) A hole is bored through the potential food-contact surface.
    (c) In addition to steps required under paragraphs (b)(1) and (b)(2) 
of this section, the following optional information may be provided on 
the ware:
    (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.
    (2) A symbol may be used to advise that a piece of ornamental or 
decorative ceramicware is not to be used with food, as illustrated 
below.
 
[[Page 213]]
 
[GRAPHIC] [TIFF OMITTED] TR01JA93.368
 
 
The circle of the above symbol should be at least 2.54 centimeters (1 
inch) in diameter. The symbol may be used on the temporary label or 
applied to the base of the piece in the same manner as the permanent 
statement.
 
[59 FR 1641, Jan. 12, 1994]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR109.30]
 
[Page 213-215]
 
                        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 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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    (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 214]]
 
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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (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 Dockets Management Branch, Food and Drug Administration, rm. 1-
23, 12420 Parklawn Dr., Rockville, MD 20857.
 
[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 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]
 
[[Page 215]]
 
Subpart D--Naturally Occurring Posionous or Deleterious Substances 
[Reserved]