with any applicable specifications prescribed by such regulation.

[42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR 55455, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999]

§ 178.3930 Terpene resins.

The terpene resins identified in paragraph (a) of this section may be safely used as components of polypropylene film intended for use in contact with food, and the terpene resins identified in paragraph (b) of this section may be safely used as components of polyolefin film intended for use in contact with food;

(a) Terpene resins consisting of the hydrogenated polymers of terpene hydrocarbons obtainable from sulfate turpentine and meeting the following specifications: Drop-softening point of 118°-138 °C; iodine value less than 20.

(b) Terpene resins consisting of polymers of beta-pinene and meeting the following specifications: Acid value less than 1; saponification number less than 1; color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution.

§ 178.3940 Tetraethylene glycol di-(2ethylhexoate).

glycol

di-(2

Tetraethylene ethylhexoate) containing not more than 22 parts per million ethylene and/ or diethylene glycols may be used at a level not to exceed 0.7 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with §177.1500 of this chapter.

§ 178.3950 Tetrahydrofuran.

Tetrahydrofuran may be safely used in the fabrication of articles intended for packaging, transporting, or storing foods, subject to the provisions of this section.

(a) It is used as a solvent in the casting of film from a solution of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene chloride that have been polymerized singly or copolym

(1) X-ray tubes producing X-radiation from operation of the tube source at a voltage of 500 kilovolt peak or lower.

(2) Sealed units producing radiations at energy levels of not more than 2.2 million electron volts from one of the following isotopes: Americium-241, cesium-137, cobalt-60, iodine-125, krypton85, radium-226, and strontium-90.

(3) Sealed units producing neutron radiation from the isotope Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.

(4) Machine sources producing X-radiation at energies no greater than 10 million electron volts (MeV).

(b) To assure safe use of these radiation sources:

(1) The label of the sources shall bear, in addition to the other information required by the Act:

(i) Appropriate and accurate information identifying the source of radiation.

(ii) The maximum energy of radiation emitted by X-ray tube sources.

(iii) The maximum energy of X-radiation emitted by machine source.

(2) The label or accompanying labeling shall bear:

(i) Adequate directions for installation and use.

(ii) A statement that no food shall be exposed to radiation sources listed in paragraph (a) (1) and (2) of this section so as to receive an absorbed dose in excess of 10 grays.

(iii) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(3) of this section so as to receive an absorbed dose in excess of 2 milligrays.

(iv) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(4) of this section so as to receive a dose in excess of 0.5 gray (Gy).

[42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, Apr. 10, 2001]

§ 179.25 General provisions for food irradiation.

For the purposes of §179.26, current good manufacturing practice is defined to include the following restrictions:

(a) Any firm that treats foods with ionizing radiation shall comply with

the requirements of part 110 of this chapter and other applicable regulations.

(b) Food treated with ionizing radiation shall receive the minimum radiation dose reasonably required to accomplish its intended technical effect and not more than the maximum dose specified by the applicable regulation for that use.

(c) Packaging materials subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods shall comply with § 179.45.

(d) Radiation treatment of food shall conform to a scheduled process. A scheduled process for food irradiation is a written procedure that ensures that the radiation dose range selected by the food irradiation processor is adequate under commercial processing conditions (including atmosphere and temperature) for the radiation to achieve its intended effect on a specific product and in a specific facility. A food irradiation processor shall operate with a scheduled process established by qualified persons having expert knowledge in radiation processing requirements of food and specific for that food and for that irradiation processor's treatment facility.

(e) A food irradiation processor shall maintain records as specified in this section for a period of time that exIceeds the shelf life of the irradiated food product by 1 year, up to a maximum of 3 years, whichever period is shorter, and shall make these records available for inspection and copy by authorized employees of the Food and Drug Administration. Such records shall include the food treated, lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation.

[51 FR 13399, Apr. 18, 1986, as amended at 67 FR 9585, Mar. 4, 2002]

2. For growth and maturation inhibition Not to exceed 1 of fresh foods.

3. For disinfestation of arthropod pests in food.

4. For microbial disinfection of dry or dehydrated enzyme preparations (including immobilized enzymes).

5. For microbial disinfection of the following dry or dehydrated aromatic vegetable substances when used as ingredients in small amounts solely for flavoring or aroma: culinary herbs, seeds, spices, vegetable seasonings that are used to impart flavor but that are not either represented as, or appear to be, a vegetable that is eaten for its own sake, and blends of these aromatic vegetable substances. Turmeric and paprika may also be irradiated when they are to be used as color additives. The blends may contain sodium chloride and minor amounts of dry food ingredients ordinarily used in such blends.

kGy (100 krad). Do.

Not to exceed 10 kGy (1 megarad (Mrad)).

Not to exceed 30 kGy (3 Mrad).

Use

6. For control of food-borne pathogens in fresh or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions of such carcasses that are "ready-to-cook poultry" within the meaning of 9 CFR 381.1(b)(44), or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses). 7. For the sterilization of frozen, packaged meats used solely in the National Aeronautics and Space Administration space flight programs.

Limitations

Not to exceed 3 kGy (300 krad); any packaging used shall not exclude oxygen.

Minimum dose 44 kGy (4.4 Mrad). Packaging materials used need not comply with § 179.25(c) provided that their use is otherwise permitted by applicable regulations in parts 174 through 186 of this chapter. Not to exceed 4.5 kGy maximum for refrigerated products; not to exceed 7.0 kGy maximum for frozen products.

"Treated with radiation" or the statement "Treated by irradiation" in addition to information required by other regulations. The logo shall be placed prominently and conspicuously in conjunction with the required statement. The radiation disclosure statement is not required to be more prominent than the declaration of ingredients required under § 101.4 of this chapter. As used in this provision, the term “radiation disclosure statement" means the written statement that discloses that a food has been intentionally subject to irradiation.

(2) For irradiated foods not in package form, the required logo and phrase "Treated with radiation" or "Treated by irradiation" shall be displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alternative, each item of food may be individually labeled. In either case, the information must be prominently and conspicuously displayed to purchasers. The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irradiated ingredient but that has not itself been irradiated.

(3) For a food, any portion of which is irradiated in conformance with paragraph (b) of this section, the label and labeling and invoices or bills of lading shall bear either the statement "Treated with radiation-do not irradiate again" or the statement "Treated by irradiation-do not irradiate again”

Irradiated food

Food and food products

Potable water

Juice products

when shipped to a food manufacturer or processor for further processing, labeling, or packing.

[51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, 2000; 65 FR 64607, Oct. 30, 2000]

§ 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies.

Radiofrequency radiation, including microwave frequencies, may be safely used for heating food under the following conditions:

(a) The radiation source consists of electronic equipment producing radio waves with specific frequencies for this purpose authorized by the Federal Communications Commission.

(b) The radiation is used or intended for use in the production of heat in food wherever heat is necessary and effective in the treatment or processing of food.

$179.39 Ultraviolet radiation for the processing and treatment of food. Ultraviolet radiation for the processing and treatment of food may be safely used under the following conditions:

(a) The radiation sources consist of low pressure mercury lamps emitting 90 percent of the emission at a wavelength of 253.7 nanometers (2,537 Angstroms).

(b) The ultraviolet radiation is used or intended for use as follows:

trol.

Use

Sterilization of water used in food production.

gens and other microorga

nisms.

[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]

$179.41 Pulsed light for the treatment of food.

Pulsed light may be safely used for treatment of foods under the following conditions:

(a) The radiation sources consist of xenon flashlamps designed to emit broadband radiation consisting of wavelengths covering the range of 200 to 1,100 nanometers (nm), and operated so that the pulse duration is no longer than 2 milliseconds (msec);

(b) The treatment is used for surface microorganism control;

(c) Foods treated with pulsed light shall receive the minimum treatment reasonably required to accomplish the intended technical effect; and

(d) The total cumulative treatment shall not exceed 12.0 Joules/square centimeter (J/cm2.)

[61 FR 42383, Aug. 15, 1996]

Subpart C-Packaging Materials for Irradiated Foods

$179.45 Packaging materials for use during the irradiation of prepackaged foods.

The packaging materials identified in this section may be safely subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods, subject to the provisions of this section and to the requirement that no induced radioactivity is detectable in the packaging material itself:

(a) The radiation of the food itself shall comply with regulations in this part.

(b) The following packaging materials may be subjected to a dose of radiation, not to exceed 10 kilograys, unless otherwise indicated, incidental to the use of gamma, electron beam, or Xradiation in the radiation treatment of prepackaged foods:

(1) Nitrocellulose-coated or vinylidene chloride copolymer-coated cellophane complying with §177.1200 of this chapter.

(2) Glassine paper complying with § 176.170 of this chapter.

(3) Wax-coated paperboard complying with § 176.170 of this chapter.

(4) Polyolefin film prepared from one or more of the basic olefin polymers complying with §177.1520 of this chapter. The finished film may contain:

(i) Adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, polyvinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section.

(ii) Coatings comprising a vinylidene chloride copolymer containing a minimum of 85 percent vinylidene chloride with one or more of the following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate.

(5) Kraft paper prepared from unbleached sulfate pulp to which rosin, complying with §178.3870 of this chapter, and alum may be added. The kraft paper is used only as a container for flour and is irradiated with a dose not exceeding 500 grays.

(6) Polyethylene terephthalate film prepared from the basic polymer as described in §177.1630(e)(4)(i) and (ii) of this chapter. The finished film may contain:

(i) Adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, polyvinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section.

(ii) Coatings comprising a vinylidene chloride copolymer containing a minimum of 85 percent vinylidene chloride with one or more of the following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate.

(iii) Coatings consisting of polyethylene conforming to § 177.1520 of this chapter.

(7) Polystyrene film prepared from styrene basic polymer. The finished film may contain adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter.

(8) Rubber hydrochloride film prepared from rubber hydrochloride basic polymer having a chlorine content of 30-32 weight percent and having a maximum extractable fraction of 2 weight percent when extracted with n-hexane at reflux temperature for 2 hours. The finished film may contain adjuvant substances used in compliance with