This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179]
[Page 439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart A [Reserved]
Subpart B--Radiation and Radiation Sources
Sec.
179.21 Sources of radiation used for inspection of food, for inspection
of packaged food, and for controlling food processing.
179.25 General provisions for food irradiation.
179.26 Ionizing radiation for the treatment of food.
179.30 Radiofrequency radiation for the heating of food, including
microwave frequencies.
179.39 Ultraviolet radiation for the processing and treatment of food.
179.41 Pulsed light for the treatment of food.
Subpart C--Packaging Materials for Irradiated Foods
179.45 Packaging materials for use during the irradiation of
prepackaged foods.
Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.
Source: 42 FR 14635, Mar. 15, 1977, unless otherwise noted.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.21]
[Page 439-440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.
Sources of radiation for the purposes of inspection of foods, for
inspection of packaged food, and for controlling food processing may be
safely used under the following conditions:
(a) The radiation source is one of the following:
[[Page 440]]
(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, krypton-85, 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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.25]
[Page 440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 179.25 General provisions for food irradiation.
For the purposes of Sec. 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 food shall be in
compliance with Sec. 179.45, shall be the subject of an exemption for
such use under Sec. 170.39 of this chapter, or shall be the subject of
an effective premarket notification for a food contact substance for
such use submitted under Sec. 170.100 of this chapter.
(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 exceeds 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; 67
FR 35731, May 21, 2002]
[[Page 441]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.26]
[Page 441-442]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 179.26 Ionizing radiation for the treatment of food.
Ionizing radiation for treatment of foods may be safely used under
the following conditions:
(a) Energy sources. Ionizing radiation is limited to:
(1) Gamma rays from sealed units of the radionuclides cobalt-60 or
cesium-137.
(2) Electrons generated from machine sources at energies not to
exceed 10 million electron volts.
(3) X-rays generated from machine sources at energies not to exceed
5 million electron volts.
(b) Limitations.
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
1. For control of Trichinella spiralis in Minimum dose 0.3 kiloGray
pork carcasses or fresh, non-heat- (kGy) (30 kilorad (krad));
processed cuts of pork carcasses. maximum dose not to exceed
1 kGy (100 krad).
2. For growth and maturation inhibition of Not to exceed 1 kGy (100
fresh foods. krad).
3. For disinfestation of arthropod pests Do.
in food.
4. For microbial disinfection of dry or Not to exceed 10 kGy (1
dehydrated enzyme preparations (including megarad (Mrad)).
immobilized enzymes).
5. For microbial disinfection of the Not to exceed 30 kGy (3
following dry or dehydrated aromatic Mrad).
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.
6. For control of food-borne pathogens in Not to exceed 3 kGy (300
fresh or frozen, uncooked poultry krad); any packaging used
products that are: (1) Whole carcasses or shall not exclude oxygen.
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, Minimum dose 44 kGy (4.4
packaged meats used solely in the Mrad). Packaging materials
National Aeronautics and Space used need not comply with
Administration space flight programs. Sec. 179.25(c) provided
that their use is otherwise
permitted by applicable
regulations in parts 174
through 186 of this
chapter.
8. For control of foodborne pathogens in, Not to exceed 4.5 kGy
and extension of the shelf-life of, maximum for refrigerated
refrigerated or frozen, uncooked products products; not to exceed 7.0
that are meat within the meaning of 9 CFR kGy maximum for frozen
301.2(rr), meat byproducts within the products.
meaning of 9 CFR 301.2(tt), or meat food
products within the meaning of 9 CFR
301.2(uu), with or without nonfluid
seasoning, that are otherwise composed
solely of intact or ground meat, meat
byproducts, or both meat and meat
byproducts.
9. For control of Salmonella in fresh Not to exceed 3.0 kGy.
shell eggs..
10. For control of microbial pathogens on Not to exceed 8.0 kGy.
seeds for sprouting..
------------------------------------------------------------------------
(c) Labeling. (1) The label and labeling of retail packages of foods
irradiated in conformance with paragraph (b) of this section shall bear
the following logo along with either the statement
[[Page 442]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.000
"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 Sec. 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" 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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.30]
[Page 442]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.39]
[Page 442-443]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 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:
[[Page 443]]
----------------------------------------------------------------------------------------------------------------
Irradiated food Limitations Use
----------------------------------------------------------------------------------------------------------------
Food and food products................... Without ozone production: high fat- Surface microorganism
content food irradiated in vacuum or in control.
an inert atmosphere; intensity of
radiation, 1 W (of 2,537 A. radiation)
per 5 to 10 ft.2.
Potable water............................ Without ozone production; coefficient of Sterilization of water used
absorption, 0.19 per cm or less; flow in food production.
rate, 100 gal/h per watt of 2,537 A.
radiation; water depth, 1 cm or less;
lamp-operating temperature, 36 to 46
deg.C..
Juice products........................... Turbulent flow through tubes with a Reduction of human
minimum Reynolds number of 2,200.. pathogens and other
microorganisms.
----------------------------------------------------------------------------------------------------------------
[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.41]
[Page 443]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart B--Radiation and Radiation Sources
Sec. 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/cm\2\.)
[61 FR 42383, Aug. 15, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.45]
[Page 443-445]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
Subpart C--Packaging Materials for Irradiated Foods
Sec. 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 X-radiation in the
radiation treatment of prepackaged foods:
(1) Nitrocellulose-coated or vinylidene chloride copolymer-coated
cellophane complying with Sec. 177.1200 of this chapter.
(2) Glassine paper complying with Sec. 176.170 of this chapter.
(3) Wax-coated paperboard complying with Sec. 176.170 of this
chapter.
(4) Polyolefin film prepared from one or more of the basic olefin
polymers complying with Sec. 177.1520 of this chapter. The finished film
may contain:
(i) Adjuvant substances used in compliance with Secs. 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 Sec. 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 Sec. 177.1630(e)(4)(i) and (ii) of this chapter. The
finished film may contain:
(i) Adjuvant substances used in compliance with Secs. 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.
[[Page 444]]
(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
Sec. 177.1520 of this chapter.
(7) Polystyrene film prepared from styrene basic polymer. The
finished film may contain adjuvant substances used in compliance with
Secs. 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 Secs. 178.3740 and
181.22 through 181.30 of this chapter.
(9) Vinylidene chloride-vinyl chloride copolymer film prepared from
vinylidene chloride-vinyl chloride basic copolymers containing not less
than 70 weight percent of vinylidene chloride and having a viscosity of
0.50-1.50 centipoises as determined by ASTM method D729-81, "Standard
Specification for Vinylidene Chloride Molding Compounds," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408. The finished film may
contain adjuvant substances used in compliance with Secs. 178.3740 and
181.22 through 181.30 of this chapter.
(10) Nylon 11 conforming to Sec. 177.1500 of this chapter.
(c) Ethylene-vinyl acetate copolymers complying with Sec. 177.1350
of this chapter. The ethylene-vinyl acetate packaging materials may be
subjected to a dose of radiation, not to exceed 30 kilogray (3
megarads), incidental to the use of gamma, electron beam, or X-radiation
in the radiation treatment of packaged foods.
(d) The following packaging materials may be subjected to a dose of
radiation, not to exceed 60 kilograys incidental to the use of gamma,
electron beam, or X-radiation in the radiation processing of prepackaged
foods:
(1) Vegetable parchments, consisting of a cellulose material made
from waterleaf paper (unsized) treated with concentrated sulfuric acid,
neutralized, and thoroughly washed with distilled water.
(2) Films prepared from basic polymers and with or without
adjuvants, as follows:
(i) Polyethylene film prepared from the basic polymer as described
in Sec. 177.1520(a) of this chapter. The finished film may contain one
or more of the following added substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Amides of erucic, linoleic, oleic, Not to exceed 1 pct by weight
palmitic, and stearic acid. of the polymer.
BHA as described in Sec. 172.110 of Do.
this chapter.
BHT as described in Sec. 172.115 of Do.
this chapter.
Calcium and sodium propionates......... Do.
Petroleum wax as described in Sec. Do.
178.3710 of this chapter.
Polypropylene, noncrystalline, as Not to exceed 2 pct by weight
described in Sec. 177.1520(c) of this of the polymer.
chapter.
Stearates of aluminum, calcium, Not to exceed 1 pct by weight
magnesium, potassium, and sodium as of the polymer.
described in Sec. 172.863(a) of this
chapter.
Triethylene glycol as described in Sec. Do.
178.3740(b) of this chapter.
Mineral oil as described in Sec. Do.
178.3620 (a) or (b) of this chapter.
------------------------------------------------------------------------
(ii) Polyethylene terephthalate film prepared from the basic polymer
as described in Sec. 177.1630(e)(4)(ii) of this chapter. The finished
film may contain one or more of the added substances listed in paragraph
(d)(2)(i) of this section.
(iii) Nylon 6 films prepared from the nylon 6 basic polymer as
described in Sec. 177.1500(a)(6) of this chapter and meeting the
specifications of item 6.1 of the table in Sec. 177.1500(b) of this
chapter. The finished film may contain one or
[[Page 445]]
more of the added substances listed in paragraph (d)(2)(i) of this
section.
(iv) Vinyl chloride-vinyl acetate copolymer film prepared from the
basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride
with 10.0 to 11.5 weight percent of vinyl acetate and having a maximum
volatility of not over 3.0 percent (1 hour at 105 deg.C) and viscosity
not less than 0.30 determined by ASTM method D1243-79, "Standard Test
Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,"
Method A, which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(9) of this section.
The finished film may contain one or more of the added substances listed
in paragraph (d)(2)(i) of this section.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984;
54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, Mar.
29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR 10575, Feb. 16, 2001]
