§ 111.50 21 CFR Ch. I (4±1±99 Edition) SOURCE: 62 FR 2249, Jan. 15, 1997, unless Subpart B [Reserved] otherwise noted. Subpart CÐEquipment § 111.50 Packaging of iron-containing dietary supplements. 113.40 Equipment and procedures. (a) The use of iron and iron salts as Subpart DÐControl of Components, Food iron sources in dietary supplements of- Product Containers, Closures, and In- fered in solid oral dosage form (e.g., Process Material tablets or capsules), and containing 30 113.60 Containers. milligrams or more of iron per dosage unit, is safe and in accordance with Subpart EÐProduction and Process current good manufacturing practice Controls only when such supplements are pack- 113.81 Product preparation. aged in unit-dose packaging. ``Unit- 113.83 Establishing scheduled processes. dose packaging'' means a method of 113.87 Operations in the thermal processing packaging a product into a nonreusable room. container designed to hold a single dos- 113.89 Deviations in processing, venting, or age unit intended for administration control of critical factors. directly from that container, irrespec- Subpart FÐRecords and Reports tive of whether the recommended dose is one or more than one of these units. 113.100 Processing and production records. The term ``dosage unit'' means the in- AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. dividual physical unit of the product 264. (e.g., tablets or capsules). Iron-con- SOURCE: 44 FR 16215, Mar. 16, 1979, unless taining dietary supplements that are otherwise noted. subject to this regulation are also sub- ject to child-resistant special pack- Subpart AÐGeneral Provisions aging requirements in 16 CFR parts 1700, 1701, and 1702. § 113.3 Definitions. (b)(1) Dietary supplements offered in For the purposes of this part, the fol- solid oral dosage form (e.g., tablets or lowing definitions apply: capsules), and containing 30 milligrams (a) Aseptic processing and packaging or more of iron per dosage unit, are ex- means the filling of a commercially empt from the provisions of paragraph sterilized cooled product into pre- (a) of this section until January 15, sterilized containers, followed by asep- 1998, if the sole source of iron in the di- tic hermetical sealing, with a etary supplement is carbonyl iron that presterilized closure, in an atmosphere meets the specifications of § 184.1375 of free of microorganisms. this chapter. (b) Bleeders means openings used to (2) If the temporary exemption is not remove air that enters with steam extended or made permanent, such die- from retorts and steam chambers and to promote circulation of steam in tary supplements shall be in compli- such retorts and steam chambers. ance with the provisions of paragraph Bleeders may serve as a means of re- (a) of this section on or before July 15, moving condensate. 1998. (c) Come-up-time means the time which elapses between the introduction PART 113ÐTHERMALLY PROCESSED of steam into the closed retort and the LOW-ACID FOODS PACKAGED time when the retort reaches the re- IN HERMETICALLY SEALED CON- quired processing temperature. TAINERS (d) Commercial processor includes any person engaged in commercial, custom, or institutional (church, school, penal, Subpart AÐGeneral Provisions or other organization) processing of Sec. food, including pet food. Persons en- 113.3 Definitions. gaged in the production of foods that 113.5 Current good manufacturing practice. are to be used in market or consumer 113.10 Personnel. tests are also included. 216 VerDate 26<APR>99 13:34 Apr 27, 1999 Jkt 183063 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Y:\SGML\183063T.XXX pfrm04 PsN: 183063T Food and Drug Administration, HHS § 113.3 (e) Commercial sterility: (1) ``Commer- tended to be secure against the entry cial sterility'' of thermally processed of microorganisms and thereby to food means the condition achievedÐ maintain the commercial sterility of (i) By the application of heat which its contents after processing. renders the food free ofÐ (k) Incubation means the holding of a (a) Microorganisms capable of repro- sample(s) at a specified temperature ducing in the food under normal non- for a specified period of time for the refrigerated conditions of storage and purpose of permitting or stimulating distribution; and the growth of microorganisms. (b) Viable microorganisms (including (l) Initial temperature means the aver- spores) of public health significance; or age temperature of the contents of the (ii) By the control of water activity coldest container to be processed at the and the application of heat, which ren- time the thermal processing cycle be- ders the food free of microorganisms gins, as determined after thorough stir- capable of reproducing in the food under normal nonrefrigerated condi- ring or shaking of the filled and sealed tions of storage and distribution. container. (2) ``Commercial sterility'' of equip- (m) Lot means that amount of a prod- ment and containers used for aseptic uct produced during a period of time processing and packaging of food indicated by a specific code. means the condition achieved by appli- (n) Low-acid foods means any foods, cation of heat, chemical sterilant(s), or other than alcoholic beverages, with a other appropriate treatment that ren- finished equilibrium pH greater than ders the equipment and containers free 4.6 and a water activity (aw) greater of viable microorganisms having public than 0.85. Tomatoes and tomato prod- health significance, as well as micro- ucts having a finished equilibrium pH organisms of nonhealth significance, less than 4.7 are not classed as low-acid capable of reproducing in the food foods. under normal nonrefrigerated condi- (o) Minimum thermal process means tions of storage and distribution. the application of heat to food, either (f) Critical factor means any property, before or after sealing in a hermeti- characteristic, condition, aspect, or cally sealed container, for a period of other parameter, variation of which time and at a temperature scientif- may affect the scheduled process and ically determined to be adequate to en- the attainment of commercial ste- sure destruction of microorganisms of rility. public health significance. (g) Flame sterilizer means an appa- (p) Operating process means the proc- ratus in which hermetically sealed con- ess selected by the processor that tainers are agitated at atmospheric equals or exceeds the minimum re- pressure, by either continuous, dis- quirements set forth in the scheduled continuous, or reciprocating move- process. ment, with impinging gas flames to (q) Retort means any closed vessel or achieve sterilization temperatures. A other equipment used for the thermal holding period in a heated section may processing of foods. follow the initial heating period. (h) Headspace, gross is the vertical (r) Scheduled process means the proc- distance between the level of the prod- ess selected by the processor as ade- uct (generally the liquid surface) in an quate under the conditions of manufac- upright rigid container and the top ture for a given product to achieve edge of the container (the top of the commercial sterility. This process may double seam of a can or the top edge of be in excess of that necessary to ensure a glass jar). destruction of microorganisms of pub- (i) Headspace, net of a container is the lic health significance, and shall be at vertical distance between the level of least equivalent to the process estab- the product (generally the liquid sur- lished by a competent processing au- face) in the upright rigid container and thority to achieve commercial ste- the inside surface of the lid. rility. (j) Hermetically sealed container means (s) Shall is used to state mandatory a container that is designed and in- requirements. 217 VerDate 26<APR>99 13:34 Apr 27, 1999 Jkt 183063 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Y:\SGML\183063T.XXX pfrm04 PsN: 183063T § 113.5 21 CFR Ch. I (4±1±99 Edition) (t) Should is used to state rec- Subpart B [Reserved] ommended or advisory procedures or to identify recommended equipment. Subpart CÐEquipment (u) Vacuum-packed products means those products that are sealed in a con- § 113.40 Equipment and procedures. tainer under the vacuum specified in (a) Equipment and procedures for pres- the scheduled process, the maintenance sure processing in steam in still retortsÐ of which vacuum is critical to the ade- (1) Indicating mercury-in-glass thermom- quacy of the scheduled process. eter. Each retort shall be equipped with (v) Vents means openings through the at least one mercury-in-glass ther- retort shell, controlled by gate, plug mometer whose divisions are easily cock, or other adequate valves used for readable to 1 °F and whose temperature the elimination of air during the vent- range does not exceed 17 °F per inch of ing period. graduated scale. Thermometers shall (w) Water activity (aw) is a measure of be tested for accuracy against a known the free moisture in a product and is accurate standard thermometer upon the quotient of the water vapor pres- installation and at least once a year sure of the substance divided by the thereafter, or more frequently if nec- vapor pressure of pure water at the essary, to ensure their accuracy. same temperature. Records of thermometer accuracy checks that specify date, standard § 113.5 Current good manufacturing used, method used, and person per- practice. forming the test should be maintained. Each thermometer should have a tag, The criteria in §§ 113.10, 113.40, 113.60, seal, or other means of identity that 113.81, 113.83, 113.87, 113.89, and 113.100 includes the date on which it was last shall apply in determining whether the tested for accuracy. A thermometer facilities, methods, practices, and con- that has a divided mercury column or trols used by the commercial processor that cannot be adjusted to the stand- in the manufacture, processing, or ard shall be repaired or replaced before packing of low-acid foods in hermeti- further use of the retort.