[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR424.22]



[Page 658-661]

 

                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS

 

     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 424_PREPARATION AND PROCESSING OPERATIONS--Table of Contents

 

           Subpart C_Food Ingredients and Sources of Radiation

 

Sec. 424.22  Certain other permitted uses.



    (a) Under appropriate declaration as required in parts 316 and 317 

of this chapter, the following substances may be added to meat:

    (1) General. Common salt, approved sugars (sucrose, cane or beet 

sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids 

(corn syrup, glucose syrup and fructose), wood smoke, vinegar, 

flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, 

potassium nitrite, and other food and color additives specified in the 

chart in paragraph (c) of this section may be added to meat under 

conditions, if any, specified in this part or in part 317 of this 

chapter.

    (2) Artificial flavorings. Other harmless artificial flavorings may 

be added to meat, with the approval of the Administrator in specific 

cases.

    (3) Coloring matter and dyes. Coloring matter and dyes, other than 

those specified in a regulation permitting that use in this chapter or 

in 21 CFR Chapter I, Subchapter A and Subchapter B, may be applied to 

meat mixed with rendered fat, applied to natural and artificial casings, 

and applied to such casings enclosing products, if approved by the 

Administrator in specific cases. When any coloring matter or dye is 

applied to casings, there shall be no penetration of coloring into the 

product.

    (b) Use of nitrite and sodium ascorbate or sodium erythorbate 

(isoascorbate) in bacon.

    (1) Pumped bacon. With respect to bacon injected with curing 

ingredients and massaged bacon, sodium nitrite shall be used at 120 

parts per million (ppm) ingoing or an equivalent amount of potassium 

nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate 

or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or 

sodium erythorbate have a molecular weight of approximately 198. 

Hydrated forms of these substances shall be adjusted to attain the 

equivalent of 550 ppm of sodium ascorbate or sodium erythorbate.

    (i) The Department shall collect samples of pumped bacon from 

producing plants and analyze them for the level of nitrosamines by the 

Thermal Energy Analyzer (TEA). In the event that a TEA analysis 

indicates that a confirmable level of nitrosamines might be present, 

additional samples shall be collected and analyzed by gas 

chromatography. Presumptive positive results



[[Page 659]]



must be confirmed by mass spectrometry before being considered positive. 

If during the interval required for the Department to analyze the 

confirmatory samples by gas chromatography and mass spectrometry, 

changes are made in processing procedures which are expected to result 

in no confirmable levels of nitrosamines in pumped bacon produced by 

these new procedures, an establishment may submit samples to USDA for 

analysis upon prior notification and arrangements with USDA. If, 

however, an establishment furnishes USDA with laboratory results from 

testing five consecutive lots of pumped bacon produced under the new 

procedures and the testing is performed by the USDA methodology and 

procedures, those results will be utilized in making the determination 

concerning the product produced under the new procedures. Should the 

results of these tests reveal that confirmable levels of nitrosamines 

are not indicated in any of the five consecutive lots, the confirmation 

analysis by USDA shall be terminated and the establishment shall revert 

to normal monitoring status. In the event the test results continue to 

indicate nitrosamines, however, USDA shall proceed in its confirmation 

analysis on the original samples taken for confirmation. If any one of 

the original samples collected by USDA for confirmation is found to 

contain confirmable levels of nitrosamines, all pumped bacon in the 

producing establishment and all future production will be retained. The 

Department shall sample and analyze such retained pumped bacon for 

nitrosamines on a lot by lot basis. A production lot shall be that 

pumped bacon produced by the establishment in any single shift. Samples 

from any lot of pumped bacon under retention found to contain 

nitrosamines at a confirmable level shall cause the lot of pumped bacon 

to be disposed of in a manner to ensure it will not form nitrosamines 

when cooked. Such disposal may include incorporation of the uncooked 

pumped bacon as an ingredient of another meat provided it is processed 

for eating without further preparation in a manner to preclude the 

formation of nitrosamines. Bacon subsequently produced shall not be 

retained because of nitrosamines if the operator of the establishment 

makes adjustments in the processing of the product and laboratory 

results obtained by TEA analysis of samples from five consecutive normal 

sized lots of pumped bacon indicates that the product being produced 

contains no confirmable levels of nitrosamines. These tests from five 

consecutive normal sized lots of pumped bacon shall be conducted by the 

Department. However, if the establishment furnishes the Department with 

the results of tests conducted under the methodology and procedures used 

by the Department, such test results will be utilized in making the 

determination concerning the nitrosamine content of the product. All 

tests of pumped bacon for nitrosamines under this paragraph (b)(1)(i) 

shall be made on pumped bacon cooked at 340 degrees F. for 3 minutes on 

each side. In order to determine that no confirmable levels of 

nitrosamines are present in a sample tested, the testing must be 

performed by methodology and procedures that would detect the presence 

of any nitrosamines at 10 ppb.

    (ii) Notwithstanding the provisions of paragraph (b)(1)(i) of this 

section, sodium nitrite may be used at:

    (A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550 

ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; 

or

    (B) A predetermined level between 40 and 80 ppm (potassium nitrite 

at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium 

erythorbate (isoascorbate); and additional sucrose or other similar 

fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of 

lactic acid producing bacteria such as Pediococcus acetolactii or other 

bacteria demonstrated to be equally effective in preventing the 

production of botulinum toxin at a level sufficient for the purpose of 

preventing the production of botulinum toxin.

    (C) The Department shall collect samples of bacon from 

establishments producing under paragraph (b)(1)(ii) of this section and 

analyze them for the level of nitrosamines. Samples shall be randomly 

selected throughout the production of a lot. The actual sampling



[[Page 660]]



plans and methods of analysis that are used will result in approximately 

the same likelihood as under paragraph (b)(1)(i) of this section of 

having a presumptive positive result when the true mean level of 

nitrosamines in a production lot is 10 ppb. In the event of a 

presumptive positive result, the establishment shall become subject to 

the provisions of paragraph (b)(1)(i) of this section.

    (2) Immersion cured bacon. Immersion cured bacon may be placed in a 

brine solution containing salt, nitrite and flavoring material or in a 

container with salt, nitrite and flavoring material. Sodium nitrite 

shall not exceed 120 ppm ingoing or an equivalent amount of potassium 

nitrite (148 ppm ingoing) based on the actual or estimated skin-free 

green weight of the bacon bellies.

    (3) Bacon made with dry curing materials. With respect to bacon made 

with dry curing materials, the product shall be cured by applying a 

premeasured amount of cure mixture to the bacon belly surfaces, 

completely covering the surfaces. Sodium nitrite shall not exceed 200 

ppm ingoing or an equivalent amount of potassium nitrite (246 ppm 

ingoing) in dry cured bacon based on the actual or estimated skin-free 

green weight of the bacon belly.

    (c) Irradiation of meat food and poultry products.

    (1) General requirements. Meat food and poultry products may be 

treated to reduce foodborne pathogens and to extend product shelf-life 

by the use of sources of ionizing radiation as identified in 21 CFR 

179.26(a). Official establishments must irradiate meat food and poultry 

products in accordance with 21 CFR 179.26(b), the Hazard Analysis and 

Critical Control Point (HACCP) system requirements in part 417 of this 

chapter, and the provisions of this section.

    (2) Dosimetry. Official establishments that irradiate meat food and 

poultry products must have the following procedures in place:

    (i) Laboratory operation procedures for determining the absorbed 

dose value from the dosimeter.

    (ii) Calibration criteria for verifying the accuracy and consistency 

of any means of measurement (e.g., time clocks and weight scales).

    (iii) Calibration and accountability criteria for verifying the 

traceability and accuracy of dosimeters for the intended purpose, and 

the verification of calibration at least every 12 months. To confirm 

traceability, establishments must relate, through documentation, the end 

point measurement of a dosimeter to recognized standards.

    (iv) Procedures for ensuring that the product unit is dose mapped to 

identify the regions of minimum and maximum absorbed dose and such 

regions are consistent from one product unit to another of like product.

    (v) Procedures for accounting for the total absorbed dose received 

by the product unit (e.g., partial applications of the absorbed dose 

within one production lot).

    (vi) Procedures for verifying routine dosimetry, i.e., assuring each 

production lot receives the total absorbed dose. Establishments may 

either position one dosimeter at the regions of minimum and maximum 

absorbed dose (or at one region verified to represent such) on at least 

the first, middle, and last product unit in each production lot or use 

statistically based validation and dose mapping to determine the number 

and placement of dosimeters in each production lot.

    (vii) Procedures for verifying the relationship of absorbed dose as 

measured by the dosimeter to time exposure of the product unit to the 

radiation source.

    (viii) Procedures for verifying the integrity of the radiation 

source and processing procedure. Aside from expected and verified 

radiation source activity decay for radionuclide sources, the radiation 

source or processing procedure must not be altered, modified, 

replenished, or adjusted without repeating dose mapping of product units 

to redefine the regions of minimum and maximum absorbed dose.

    (3) Documentation. Official establishments that irradiate meat food 

or poultry products must have the following documentation on premises, 

available to FSIS:

    (i) Documentation that the irradiation facility is licensed or 

possesses gamma radiation sources registered



[[Page 661]]



with the Nuclear Regulatory Commission (NRC) or the appropriate State 

government acting under authority granted by the NRC.

    (ii) Documentation that the machine radiation source irradiation 

facility is registered with the appropriate State government, if 

applicable.

    (iii) Documentation that a worker safety program addressing OSHA 

regulations (29 CFR chapter XVII) is in place.

    (iv) Citations or other documents that relate to incidences in which 

the establishment was found not to comply with Federal or State agency 

requirements for irradiation facilities.

    (v) A certification by the operator that the irradiation facility 

personnel will only operate under supervision of a person who has 

successfully completed a course of instruction for operators of food 

irradiation facilities.

    (vi) A certification by the operator that the key irradiation 

personnel, who monitor or control daily operations, have been trained in 

food technology, irradiation processing, and radiation health and 

safety.

    (vii) Guarantees from the suppliers of all food-contact packaging 

materials that may be subject to irradiation that those materials comply 

with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

    (4) Labeling. (i) The labels on packages of meat food and poultry 

products irradiated in their entirety, in conformance with this section 

and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end 

of this paragraph (c)(4)(i). Unless the word ``Irradiated'' is part of 

the product name, labels also must bear a statement such as ``Treated 

with radiation'' or ``Treated by irradiation.'' The logo must be placed 

in conjunction with the required statement, if the statement is used. 

The statement is not required to be more prominent than the declaration 

of ingredients required under Sec. 317.2(c)(2). Any label bearing the 

logo or any wording of explanation with respect to this logo must be 

approved as required by Section 317.4. of this chapter or subparts M and 

N of part 381.

[GRAPHIC] [TIFF OMITTED] TR23DE99.000



    (ii) For meat food or poultry products that have been irradiated in 

their entirety, but that are not sold in packages, the required logo 

must be displayed to the purchaser with either the labeling of the bulk 

container plainly in view or a counter sign, card, or other appropriate 

device bearing the information that the product has been treated with 

radiation. In either case, the information must be prominently and 

conspicuously displayed to purchasers. Unless the word ``Irradiated'' is 

part of the product name, the labeling counter sign, card, or other 

device also must bear a statement such as ``Treated with radiation'' or 

``Treated by irradiation.'' The logo must be placed in conjunction with 

the required statement, if the statement is used.

    (iii) The inclusion of an irradiated meat food or poultry product 

ingredient in any multi-ingredient meat food or poultry product must be 

reflected in the ingredient statement on the finished product labeling.

    (iv) Optional labeling statements about the purpose for radiation 

processing may be included on the product label in addition to the 

stated requirements elsewhere in this section, provided that such 

statements are not false or misleading. Statements that there has been a 

specific reduction in microbial pathogens must be substantiated by 

processing documentation.



[64 FR 72175, Dec. 23, 1999, as amended at 64 FR 72165, Dec. 23, 1999; 

65 FR 34391, May 30, 2000]