§§ 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 §§ 178.3740 and 181.22 through 181.30 of this chapter.

(10) Nylon 11 conforming to §177.1500 of this chapter.

(c) Ethylene-vinyl acetate copolymers complying with $177.1350 of this chapter. The ethylene-vinyl acetate

Substances

Amides of erucic, linoleic, oleic, palmitic, and stearic acid BHA as described in § 172.110 of this chapter

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 Xradiation 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 § 177.1520(a) of this chapter. The finished film may contain one or more of the following added substances:

Limitations

Not to exceed 1 pct by weight of the polymer.

Calcium and sodium propionates

BHT as described in § 172.115 of this chapter

Petroleum wax as described in § 178.3710 of this chapter

Do.

Do.

Do.

Do.

Do.

Do.

(ii) Polyethylene terephthalate film prepared from the basic polymer as described in §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 § 177.1500(a)(6) of this chapter and meeting the specifications of item 6.1 of the table in §177.1500(b) of this chapter. The finished film may contain one or 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 °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

197-064 D-15

(a) Substances having a history of use in food for human consumption or in food contact surfaces may at any time have their safety or functionality brought into question by new information that in itself is not conclusive. An interim food additive regulation for the use of any such substance may be promulgated in this subpart when new information raises a substantial question about the safety or functionality of the substance but there is a reasonable certainty that the substance is not harmful and that no harm to the public health will result from the continued use of the substance for a limited period of time while the question raised is being resolved by further study.

(b) No interim food additive regulation may be promulgated if the new information is conclusive with respect to the question raised or if there is a reasonable likelihood that the substance

is harmful or that continued use of the substance will result in harm to the public health.

(c) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose an interim food additive regulation. A final order promulgating an interim food additive regulation shall provide that continued use of the substance in food is subject to each of the following conditions:

(1) Use of the substance in food or food contact surfaces must comply with whatever limitations the Commissioner deems to be appropriate under the circumstances.

(2) Within 60 days following the effective date of the regulation, an interested person shall satisfy the Commissioner in writing that studies adequate and appropriate to resolve the questions raised about the substance have been undertaken, or the Food and Drug Administration may undertake the studies. The Commissioner may extend this 60-day period if necessary to review and act on proposed protocols. If no such commitment is made, or adequate and appropriate studies are not undertaken, an order shall immediately be published in the FEDERAL REGISTER revoking the interim food additive regulation effective upon publication.

(3) A progress report shall be filed on the studies every January 1 and July 1 until completion. If the progress report is inadequate or if the Commissioner concludes that the studies are not being pursued promptly and diligently or if interim results indicate a reasonable likelihood that a health hazard exists, an order will promptly be published in the FEDERAL REGISTER revoking the interim food additive regulation effective upon publication.

(4) If nonclinical laboratory studies are involved, studies filed with the Commissioner shall include, with respect to each study, either a statement that the study has been or will be conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(5) [Reserved]

(6) If clinical investigations involving human subjects are involved, such investigations filed with the Commissioner shall include, with respect to each investigation, a statement that the investigation either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with §§ 56.104 or 56.105, and that it has been or will be conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.

(d) Promptly upon completion of the studies undertaken on the substance, the Commissioner will review all available data, will terminate the interim food additive regulation, and will either issue a food additive regulation or will require elimination of the substance from the food supply.

(e) The Commissioner may consult with advisory committees, professional organizations, or other experts in the field, in evaluating:

(1) Whether an interim food additive regulation is justified,

(2) The type of studies necessary and appropriate to resolve questions raised about a substance,

(3) Whether interim results indicate the reasonable likelihood that a health hazard exists, or

(4) Whether the data available at the conclusion of those studies justify a food additive regulation.

(f) Where appropriate, an emergency action level may be issued for a substance subject to paragraph (a) of this section that is not an approved food additive, pending the issuance of a final interim food additive regulation. Such an action level shall be issued pursuant to sections 306 and 402(a) of the act to identify, based upon available data, a safe level of use for the substance. Such an action level shall be issued in a notice published in the FEDERAL REGISTER and shall be followed as soon as practicable by a proposed interim food additive regulation. Where the available data do not permit establishing an action level for the safe use of a substance, use of the substance may be prohibited. The identification of a pro

hibited substance may be made in part 189 of this chapter when appropriate.

[42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR 39634, Sept. 27, 1989]

Subpart B-Specific Requirements for Certain Food Additives

§ 180.22 Acrylonitrile copolymers. Acrylonitrile copolymers may be safely used on an interim basis as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions:

(a) Limitations for acrylonitrile monomer extraction for finished foodcontact articles, determined by a method of analysis titled "Gas-Solid Chromatographic Procedure for Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and Food Simulating Solvents,' which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408, are as follows:

(1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food contact surface-0.003 milligram/ square inch when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use.

(2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food contact surface-0.3 part per million calculated on the basis of the volume of the container when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use.

(3) In the case of repeated-use articles-0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of

use.

The food-simulating solvents shall include, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either nheptane or an appropriate oil or fat.

(b) Where necessary, current regulations permitting the use of acrylonitrile copolymers shall be revised to specify limitations on acrylonitrile/ mercaptan complexes utilized in the production of acrylonitrile copolymers. Such copolymers, if they contain reversible acrylonitrile/mercaptan complexes and are used in other than repeated-use conditions, shall be tested to determine the identity of the complex and the level of the complex present in the food-contact article. Such testing shall include determination of the rate of decomposition of the complex at temperatures of 100 °F, 160 °F, and 212 °F using 3 percent acetic acid as the hydrolic agent. Acrylonitrile monomer levels, acrylonitrile/ mercaptan complex levels, acrylonitrile oligomer levels, descriptions of the analytical methods used to determine the complex and the acrylonitrile migration, and validation studies of these analytical methods shall be submitted by June 9, 1977, to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, unless an extension is granted by the Food and Drug Administration for good cause shown. Analytical methods for the determination of acrylonitrile complexes with ndodecyl-mercaptan, n-octyl mercaptan, and 2-mercaptoethanol, titled "Determination B-Dodecylmercaptopropionitrile in NR-16R Aqueous Extracts" and "Measurement of B(2-Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating Solvent," are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

of

(c) The following data shall be provided for finished food-contact articles intended for repeated use:

(1) Qualitative and quantitative migration values at a time equivalent to initial batch usage, utilizing solvents and temperatures appropriate to the intended conditions of use.

(2) Qualitative and quantitative migration values at the time of equilibrium extractions, utilizing solvents and temperatures appropriate to the intended conditions of use.

(3) Data on the volume and/or weight of food handled during the initial batch time period(s), during the equilibrium test period, and over the estimated life of the food-contact surface.

(d) Where acrylonitrile copolymers represent only a minor component of a polymer system, calculations based on 100 percent migration of the acrylonitrile component may be submitted in lieu of the requirements of paragraphs (a), (b), and (c) of this section in support of the continued safe use of acrylonitrile copolymers.

(e) On or before September 13, 1976, any interested person shall satisfy the Commissioner of Food and Drugs that toxicological feeding studies adequate and appropriate to establish safe conditions for the use of acrylonitrile copolymers have been, or soon will be, undertaken. Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime feeding studies with a mammalian species, preferably with animals exposed in utero to the chemical, (2) studies of multigeneration reproduction with oral administration of the test material, (3) assessment of teratogenic and mutagenic potentials, (4) subchronic oral administration in a nonrodent mammal, (5) tests to determine any synergistic toxic effects between acrylonitrile monomer and cyanide ion, and (6) a literature search on the effects of chronic ingestion of hydrogen cyanide. Data on levels of acrylamide extractable from acrylonitrile copolymers shall also be submitted. Protocols of testing should be submitted for review to the Center for Food Safety and Applied Nutrition (HFS-200, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

(f) Acrylonitrile copolymers may be used in contact with food only if authorized in parts 174 through 179 or § 181.32 of this chapter, except that

other uses of acrylonitrile copolymers in use prior to June 14, 1976, may continue under the following conditions:

(1) On or before August 13, 1976, each use of acrylonitrile copolymers in a manner not authorized by §181.32 of this chapter or parts 174 through 179 of this chapter shall be the subject of a notice to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Such notice shall be accompanied by a statement of the basis, including any articles and correspondence, on which the user in good faith believed the use to be prior-sanctioned. The Commissioner of Food and Drugs shall, by notice in the FEDERAL REGISTER, identify any use of acrylonitrile copolymers not in accordance with this paragraph. Those uses are thereafter unapproved food additives and consequently unlawful.

(2) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall be the subject of a petition submitted on or before December 13, 1976, in accordance with §171.1 of this chapter, unless an extension of time is granted by the Food and Drug Administration for good cause shown. Any application for extension shall be by petition submitted in accordance with the requirements of part 10 of this chapter. If a petition is denied, in whole or in part, those uses subject to the denial are thereafter unapproved food additives and consequently unlawful.

(3) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall meet the acrylonitrile monomer extraction limitation set forth in paragraph (a) of this section and shall be subject to the requirements of paragraph (b) of this section.

(g) In addition to the requirements of this section, the use of acrylonitrile copolymers shall comply with all applicable requirements in other regulations in this part.

[42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996]

hexahydric alcohol, differing from sorbitol principally by having a different optical rotation. Mannitol is produced by one of the following processes:

(1) The electrolytic reduction or transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose.

(2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii.

(b) The ingredient meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 188-190, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(c) The ingredient is used as an anticaking agent and free-flow agent as defined in §170.3(0)(1) of this chapter, formulation aid as defined in §170.3(0) (14) of this chapter, firming agent as defined in §170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in §170.3(0)(12) of this chapter, lubricant and release agent as defined in §170.3(0)(18) of this chapter, nutritive sweetener as defined in §170.3(0)(21) of this chapter, processing aid as defined in $170.3(0)(24) of this chapter, stabilizer and thickener as defined in § 170.3(0)(28) of this chapter, surface-finishing agent as defined in §170.3(0)(30) of this chapter, and texturizer as defined in § 170.3(o)(32) of this chapter.

(d) The ingredient is used in food at levels not to exceed 98 percent in pressed mints and 5 percent in all other hard candy and cough drops as defined in § 170.3(n)(25) of this chapter, 31 percent in chewing gum as defined in § 170.3(n)(6) of this chapter, 40 percent in soft candy as defined in §170.3(n)(38) of this chapter, 8 percent in confections and frostings as defined in §170.3(n)(9) of this chapter, 15 percent in nonstandardized jams and jellies, commercial, as defined in §170.3(n)(28) of this chapter, and at levels less than 2.5 percent in all other foods.

(e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 20 grams of mannitol shall bear the