Unavoidable contaminants in food for human consumption and food-packaging material (21 CFR 109.3-109.30)

210 21 CFR Ch. I (4–1–11 Edition) Pt. 109 provision is available for public disclo sure. (3) Quantitative or semiquantitative formulas. [42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] PART 109—UNAVOIDABLE CON TAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL Subpart A—General Provisions Sec. 109.3 Definitions and interpretations. 109.4 Establishment of tolerances, regu latory limits, and action levels. 109.6 Added poisonous or deleterious sub stances. 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. Subpart A—General Provisions § 109.3 Definitions and interpretations. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) The definitions of terms con tained in section 201 of the act are ap plicable to such terms when used in this part unless modified in this sec tion. (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inher ent natural constituent of a food and is not the result of environmental, agri cultural, industrial, or other contami nation. (d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally oc curring poisonous or deleterious sub stance. 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 in crease. (e) Food includes human food and substances migrating to food from food-contact articles. § 109.4 Establishment of tolerances, regulatory limits, and action levels. (a) When appropriate under the cri teria 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 sec tion 406 of the act. A tolerance may prohibit any detectable amount of the substance in food. (b) When appropriate under the cri teria 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 addi tive, may be established by regulation in subpart C of this part under the pro visions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may pro hibit any detectable amount of the sub stance in food. The regulatory limit es tablished 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 cri teria of § 109.6, an action level for an added poisonous or deleterious sub stance, 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 estab lished or changed, a notice shall be published in the FEDERAL REGISTER as soon as practicable thereafter. The no tice shall call attention to the mate rial supporting the action level which shall be on file with the Division of Dockets Management before the notice VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 211 Food and Drug Administration, HHS § 109.6 is 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 com plete list of such foods. [42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990] § 109.6 Added poisonous or deleterious substances. (a) Use of an added poisonous or dele terious substance, other than a pes ticide chemical, that is also a food ad ditive, will be controlled by a regula tion issued under section 409 of the act when possible. When such a use cannot be approved under the criteria of sec tion 409 of the act, or when the added poisonous or deleterious substance is not a food additive, a tolerance, regu latory limit, or action level may be es tablished pursuant to the criteria in paragraphs (b), (c), or (d) of this sec tion. Residues resulting from the use of an added poisonous or deleterious sub stance that is also a pesticide chemical will ordinarily be controlled by a toler ance 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 sub stance 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 pur suant to the criteria established in paragraph (d) of this section. (b) A tolerance for an added poi sonous or deleterious substance in any food may be established when the fol lowing criteria are met: (1) The substance cannot be avoided by good manufacturing practice. (2) The tolerance established is suffi cient 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 appro priateness of the tolerance include an ticipated improvements in good manu facturing practice that would change the extent to which use of the sub stance 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 prac tices. (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 estab lished for the substance under section 406 of the act or technological changes appear reasonably possible that may affect the appropriateness of a toler ance. The regulatory limit established represents the level at which food is adulterated within the meaning of sec tion 402(a)(1) of the act. (d) An action level for an added poi sonous or deleterious substance in any food may be established when the cri teria in paragraph (b) of this section are met, except that technological or other changes that might affect the ap propriateness of the tolerance are fore seeable in the near future. An action level for an added poisonous or delete rious substance in any food may be es tablished 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 para graph (b) of this section or in section 406 of the act. An action level will be withdrawn when a tolerance or regu latory 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 toler ances (sections 406 and 701 of the act). VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 212 21 CFR Ch. I (4–1–11 Edition) § 109.7 In the event the effectiveness of a tol erance 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 objec tion. [42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990] § 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, regu latory 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 condi tions or the other requirements in this chapter that food manufacturers must observe current good manufacturing practices. Evidence obtained through factory inspection or otherwise indi cating such a violation renders the food unlawful, even though the amounts of poisonous or deleterious substances are lower than the cur rently established tolerances, regu latory 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] § 109.15 Use of polychlorinated biphenyls (PCB’s) in establishments manufacturing food-packaging ma terials. (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 sta ble, heat resistant, and nonflammable chemicals. Industrial uses of PCB’s in clude, or did include in the past, their use as electrical transformer and ca pacitor fluids, heat transfer fluids, hy draulic 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 en vironment, causing the contamination of certain foods. In addition, incidents have occurred in which PCB’s have di rectly 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 prod ucts intended for human consumption (meat, milk and eggs). Investigations by the Food and Drug Administration have revealed that a significant per centage of paper food-packaging mate rial contains PCB’s which can migrate to the packaged food. The origin of PCB’s in such material is not fully un derstood. 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 attrib uted to direct contamination from in dustrial accidents from the use of PCB containing equipment and machinery in food packaging manufacturing es tablishments. 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, rep resents a hazard to public health. It is therefore necessary to place certain re strictions on the industrial uses of PCB’s in establishments manufac turing food-packaging materials. (b) The following special provisions are necessary to preclude the acci dental PCB contamination of food packaging materials: (1) New equipment or machinery for manufacturing food-packaging mate rials shall not contain or use PCB’s. (2) On or before September 4, 1973, the management of establishments manu facturing food-packaging materials shall: (i) Have the heat exchange fluid used in existing equipment for manufac turing food-packaging materials sam pled and tested to determine whether it contains PCB’s or verify the absence of VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 213 Food and Drug Administration, HHS § 109.16 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 pos sible 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-con taining equipment, machinery and ma terials wherever there is a reasonable expectation that such articles could cause food-packaging materials to be come 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 charac teristics of fluids selected as PCB re placements must be adequately deter mined so that the least potentially hazardous replacement is used. In mak ing this determination with respect to a given fluid, consideration should be given to (a) its toxicity; (b) the max imum 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 environ mental stability and tendency to sur vive and be concentrated through the food chain. The judgment as to wheth er a replacement fluid is sufficiently non-hazardous is to be made on an indi vidual installation and operation basis. (c) The provisions of this section do not apply to electrical transformers and condensers containing PCB’s in sealed containers. § 109.16 Ornamental and decorative ceramicware. (a) Lead is a toxic metal that is used as a component of glazes and decora tive 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 deco ration into the food. The provisions of paragraph (b) of this section are nec essary 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 Poi soning,’’ and ‘‘Not for Food Use—Food Consumed from this Vessel May be Harmful,’’ and (ii) A conspicuous and legible perma nent statement of the message selected from paragraph (b)(1)(i) of this section molded or fired onto the exterior sur face of the base or, when the ceramicware is not fired after decora tion, permanently painted onto the ex terior surface of the base. This perma nent 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 poten tial food-contact surface. (c) In addition to steps required under paragraphs (b)(1) and (b)(2) of this section, the following optional in formation 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 state ment shall be placed after the required statement. (2) A symbol may be used to advise that a piece of ornamental or decora tive ceramicware is not to be used with food, as illustrated below. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 214 21 CFR Ch. I (4–1–11 Edition) § 109.30 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] Subpart B—Tolerances for Un avoidable Poisonous or Dele terious Substances § 109.30 Tolerances for polychlorinated biphenyls (PCB’s). (a) Polychlorinated biphenyls (PCB’s) are toxic, industrial chemicals. Be cause of their widespread, uncontrolled industrial applications, PCB’s have be come a persistent and ubiquitous con taminant in the environment. As a re sult, 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-pro ducing animals ingesting PCB-con taminated 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 manu facturing recycled paper. Therefore, temporary tolerances for residues of PCB’s as unavoidable environmental or industrial contaminants are estab lished for a sufficient period of time following the effective date of this paragraph to permit the elimination of such contaminants at the earliest prac ticable time. For the purposes of this paragraph, the term ‘‘polychlorinated biphenyls (PCB’s)’’ is applicable to mixtures of chlorinated biphenyl com pounds, 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 manufac tured 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 supple ments, and feed premixes). (6) 2 parts per million in animal feed components of animal origin, including fishmeal and other by-products of ma rine origin and in finished animal feed concentrates, supplements, and pre mixes intended for food producing ani mals. (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 imper meable to migration of PCB’s. (b) A compilation entitled ‘‘Analyt ical Methodology for Polychlorinated Biphenyls, June 1979’’ for determining compliance with the tolerances estab lished in this section is available from the Division of Dockets Management (HFA–305), Food and Drug Administra tion, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. (c) A barrier is functional for pur poses 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 con ditions from packaging material con taining 10 parts per million PCB with out the use of a barrier. A class of bar rier material is functional for purposes of paragraph (a)(9) of this section if a VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066 ER 0 1 JA 9 3 .3 6 8 < /G P H > W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 215 Food and Drug Administration, HHS § 109.30 representative barrier of the class lim its migration of PCB’s from the pack aging 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 deter mined for purpose of this paragraph solely by use of testing conditions de scribed in ‘‘Test Procedures for Deter mination of PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised May 1983’’, which is incor porated by reference. Copies are avail able from the Division of Dockets Man agement (HFA–305), Food and Drug Ad ministration, 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/ federallregister/ codeloflfederallregulations/ ibrllocations.html. A class of barrier material shall be deemed functional only if the definition of the class and the designation of one or more rep resentative 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 ma terial or the designation of representa tive 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 pro posal. 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 Administra tion, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. (d) Any person who asserts that a barrier or class of barriers is functional shall submit the results of tests con ducted to determine the functionality of the barrier or class of barriers to Center for Food Safety and Applied Nu trition (HFS–308), Food and Drug Ad ministration, 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 Pack aging, Inner-Wraps, September 1976, re vised 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 Ap plied Nutrition shall review submitted test results promptly. Within 60 days of the receipt of test results, the Director, Center for Food Safety and Applied Nu trition, shall notify the person submit ting the test results whether the tests were conducted in accordance with the ‘‘Analytical Methodology for Poly chlorinated Biphenyls; June 1979’’, which is incorporated by reference, or the ‘‘Test Procedures for Determina tion of PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised May 1983’’ and whether, therefore, the barrier or class of bar riers is deemed functional within the meaning of paragraph (c) of this sec tion. 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 § 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 Administra tion 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 VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 216 21 CFR Ch. I (4–1–11 Edition) Pt. 110 level of PCB’s as adulterated in violation of sec. 402 of the act. Subpart C—Regulatory Limits for Added Poisonous or Delete rious Substances [Reserved] Subpart D—Naturally Occurring Posionous or Deleterious Sub stances [Reserved] PART 110—CURRENT GOOD MAN UFACTURING PRACTICE IN MAN UFACTURING, PACKING, OR HOLDING HUMAN FOOD Subpart A—General Provisions Sec. 110.3 Definitions. 110.5 Current good manufacturing practice. 110.10 Personnel. 110.19 Exclusions. Subpart B—Buildings and Facilities 110.20 Plant and grounds. 110.35 Sanitary operations. 110.37 Sanitary facilities and controls. Subpart C—Equipment 110.40 Equipment and utensils. Subpart D [Reserved] Subpart E—Production and Process Controls 110.80 Processes and controls. 110.93 Warehousing and distribution. Subpart F [Reserved] Subpart G—Defect Action Levels 110.110 Natural or unavoidable defects in food for human use that present no health hazard. AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264. SOURCE: 51 FR 24475, June 19, 1986, unless otherwise noted. Subpart A—General Provisions § 110.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following definitions shall also apply: (a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below. (b) Adequate means that which is needed to accomplish the intended pur pose in keeping with good public health practice. (c) Batter means a semifluid sub stance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. (d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a suffi cient time and at a sufficient tempera ture to partially or completely inac tivate the naturally occurring enzymes and to effect other physical or bio chemical changes in the food. (e) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decompo sition of the final food. (f) Food means food as defined in sec tion 201(f) of the act and includes raw materials and ingredients. (g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs dur ing the normal course of operations. ‘‘Food-contact surfaces’’ includes uten sils and food-contact surfaces of equip ment. (h) Lot means the food produced dur ing a period of time indicated by a spe cific code. (i) Microorganisms means yeasts, molds, bacteria, and viruses and in cludes, but is not limited to, species having public health significance. The term ‘‘undesirable microorganisms’’ in cludes those microorganisms that are of public health significance, that sub ject food to decomposition, that indi cate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regu lations, FDA used the adjective ‘‘mi crobial’’ instead of using an adjectival VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R