Food Safety and Inspection Serv. (Meat, Poultry), USDA § 318.7
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Food Safety and Inspection Serv. (Meat, Poultry), USDA § 318.7 (3) Hog and sheep casings intended (other than shell eggs) which have not for use as containers of product may be been so inspected and passed for whole- treated by soaking in or applying someness shall not be used in the prep- thereto sound, fresh pineapple juice or aration of such meat food products. papain or bromelin or pancreatic ex- (10) Dry milk products which are in- tract to permit the enzymes contained tended for use as ingredients of meat in these substances to act on the cas- food products shall be considered ac- ings to make them less resistant. The ceptable for such use only when pro- casings shall be handled in a clean and duced in a plant approved by the De- sanitary manner throughout and the partment under the regulations in 7 treatment shall be followed by washing CFR part 58, and when found to be and flushing the casings with water sound and otherwise acceptable when sufficiently to effectively remove the presented for use. Dry milk products substance used and terminate the enzy- prepared in a plant not so approved matic action. shall not be used in the preparation of (4) On account of the invariable pres- such meat food products. ence of bone splinters, detached spinal (11) [Reserved] cords shall not be used in the prepara- (12) Ingredients for use in any prod- tion of edible product other than for uct may not bear or contain any pes- rendering where they constitute a suit- ticide chemical or other residues in ex- able raw material. cess of level permitted in § 318.16. (5) Testicles if handled as an edible (13) Use of ``Mechanically Separated product may be shipped from the offi- (Kind of Poultry),'' as defined in cial establishment as such, but they § 381.173 of this chapter, in the prepara- shall not be used as an ingredient of a tion of meat food products shall accord meat food product. with § 381.174 and all other applicable (6) Tonsils shall be removed and shall provisions of this subchapter. not be used as ingredients of meat food products. [35 FR 15586, Oct. 3, 1970, as amended at 38 FR (7) Blood from livestock prepared in 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; accordance with § 310.20 of this sub- 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, chapter may be used as an ingredient 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, Nov. 3, 1995] of a meat food product for which a standard is prescribed in part 319 of § 318.7 Approval of substances for use this subchapter, if permitted by such in the preparation of products. standard, and may be used in any meat food product for which no such stand- (a)(1) No substance may be used in ard is prescribed in part 319 of this sub- the preparation of any product unless chapter if it is a common and usual in- it is approved in paragraph (c)(4) of this gredient of such product. section or elsewhere in part 318 or in (8) Intestines shall not be used as in- part 319 of this subchapter, or by the gredients in any meat food product for Administrator in specific cases. which a standard is prescribed in part (2) Approval of new substances or 319 of this subchapter and shall not be new uses or new levels of use of ap- used in other products unless the prod- proved substances may be granted by ucts are labeled in accordance with the Administrator if: § 317.8(b)(3) of this subchapter. (i) The substance has been previously (9) Poultry products and egg products approved by the Food and Drug Admin- (other than shell eggs) which are in- istration (FDA) for use in meat or tended for use as ingredients of meat meat food products as a food additive, food products shall be considered ac- color additive, or as a substance gen- ceptable for such use only when identi- erally recognized as safe and is listed fied as having been inspected and in title 21 of the Code of Federal Regu- passed for wholesomeness by the De- lations, parts 73, 74, 81, 172, 173, 179, 182 partment under the regulations in 7 or 184. CFR part 59 or 9 CFR part 362 or 381 (ii) Its use is in compliance with ap- and when found to be sound and other- plicable FDA requirements; and wise acceptable when presented for use. (iii) The Administrator has deter- Poultry products and egg products mined that: 241 VerDate 20<JAN>98 08:22 Feb 09, 1998 Jkt 179031 PO 00000 Frm 00237 Fmt 8010 Sfmt 8010 Y:\SGML\179031.TXT 179031-3 § 318.7 9 CFR Ch. III (1±1±98 Edition) (A) The use of the substance will not spectrometry before being considered render the product in which it is used positive. If, during the interval re- adulterated or misbranded or otherwise quired for the Department to analyze not in compliance with the require- the confirmatory samples by gas ments of the Act; and chromotography and mass spectrom- (B) Its use is functional and suitable etry, changes are made in processing for the product and it is permitted for procedures which are expected to result use at the lowest level necessary to ac- in no confirmable levels of complish the stated technical effect as nitrosamines in pumped bacon pro- determined in specific cases. duced by these new procedures, an es- (3) Whenever the Administrator de- tablishment may submit samples to termines that approval of a new sub- USDA for analysis upon prior notifica- stance or new use or new level of use of tion and arrangements with USDA. If, an approved substance should be grant- however, an establishment furnishes ed in accordance with paragraph (a)(2) USDA with laboratory results from of this section, the Administrator shall testing five consecutive lots of pumped issue a final rule amending the chart of bacon produced under the new proce- substances in paragraph (c)(4) of this dures and the testing is performed by section to include the additional sub- the USDA methodology and proce- stance or new use of the substance, and dures, those results will be utilized in any technical effect or change in level making the determination concerning of use of the substance. the product produced under the new (4) No product shall bear or contain procedures. Should the results of these any substance which would render it tests reveal that confirmable levels of adulterated or misbranded, or which is nitorosamines are not indicated in any not approved in part 318 or part 319 of of the five consecutive lots, the con- this subchapter, or by the Adminis- firmation analysis by USDA shall be trator in specific cases. terminated and the establishment shall (b) Requirements for the use of ni- revert to normal monitoring status. In trite and sodium ascorbate or sodium the event the test results continue to erythorbate (isoascorbate) in bacon. indicate nitrosamines, however, USDA Nitrates shall not be used in curing shall proceed in its confirmation anal- bacon. ysis on the original samples taken for (1) Pumped bacon. With respect to confirmation. If any one of the original bacon injected with curing ingredients samples collected by USDA for con- and massaged bacon: sodium nitrite firmation if found to contain confirm- shall be used at 120 parts per million able levels of nitrosamines, all pumped (PPM) ingoing or an equivalent bacon in the producing establishment amount of potassium nitrite shall be and all future production will be re- used (148 PPM ingoing); and 550 PPM of tained. The Department shall sample sodium ascorbate or sodium and analyze such retained pumped erythorbate (isoascorbate) shall be bacon for nitrosamines on a lot by lot used. Sodium ascorbate or sodium basis. A production lot shall be that erythorbate have a molecular weight of pumped bacon produced by the estab- approximately 198. Hydrated forms of lishment in any single shift. Samples these substances shall be adjusted to from any lot of pumped bacon under re- attain the equivalent of 550 PPM of so- tention found to contain nitrosamines dium ascorbate or sodium erythorbate. at a confirmable level shall cause the (2) The Department shall collect lot of pumped bacon to be disposed of samples of pumped bacon from produc- in a manner to assure it will not form ing plants and analyze them for the nitrosamines when cooked. Such dis- level of nitrosamines by the Thermal posal may include incorporation of the Energy Analyzer (TEA). In the event uncooked pumped bacon as an ingredi- that a TEA analysis indicates that a ent of another meat food product pro- confirmable level of nitrosamines vided it is processed for eating without might be present, additional samples further preparation in a manner to pre- shall be collected and analyzed by gas clude the formation of nitrosamines. chromatography. Presumptive positive Bacon subsequently produced shall not results must be confirmed by mass be retained because of nitrosamines if 242 VerDate 20<JAN>98 08:22 Feb 09, 1998 Jkt 179031 PO 00000 Frm 00238 Fmt 8010 Sfmt 8010 Y:\SGML\179031.TXT 179031-3 Food Safety and Inspection Serv. (Meat, Poultry), USDA § 318.7 the operator of the establishment (4) The Department shall collect makesadjustments in the processing of samples of bacon from plants producing the product and laboratory results ob- under paragraph (b)(3) of this section tained by TEA analysis of samples and analyze them for the level of from five consecutive normal sized lots nitrosamines.