supplement, feed additive concentrate, feed additive premix, or complete feed prepared therefrom shall bear, in addition to the other information required by the act, the following:

(c) To assure safe use, the label and labeling of the additive, any combination of additives, and any feed additive (1) The name of the additive or additives.

(2) A statement of the quantity or quantities contained therein.

(3) Adequate directions and warnings for use.

[33 F.R. 2774, Feb. 9, 1968]

The food additive calcium periodate may be safely used in accordance with the following prescribed conditions:

(a) The additive is produced by reacting calcium iodate with calcium hydroxide or calcium oxide to form a substance consisting of not less than 60 percent by weight of penta calcium orthoperiodate containing 28 to 31 percent by weight of iodine.

(b) It is used or intended for use in salt for livestock as a source of iodine. [33 F.R. 4408, Mar. 12, 1968, as amended at 33 F.R. 19172, Dec. 24, 1968]

§ 121.314 Sodium penicillin (penicillin sodium, penicillin sodium salt), calcium penicillin (penicillin calcium, penicillin calcium salt), crystalline penicillin (crystalline penicillin sodium, crystalline penicillin sodium salt, crystalline penicillin potassium, crystalline penicillin potassium salt, crystalline penicillin G sodium, crystalline penicillin G sodium salt, crystalline penicillin G potassium, crystalline penicillin G potassium salt, crystalline penicillin O sodium, crystalline penicillin O sodium salt, crystalline penicillin O potassium, crystalline penicillin O potassium salt). (a) Sodium penicillin (penicillin sodium, penicillin sodium salt), calcium penicillin (penicillin calcium, penicillin calcium salt), crystalline penicillin (crys

66-042-72-9

talline penicillin sodium, crystalline penicillin sodium salt, crystalline penicillin potassium, crystalline penicillin potassium salt, crystalline penicillin G sodium, crystalline penicillin G sodium salt, crystalline penicillin G potassium, crystalline penicillin G potassium salt, crystalline penicillin O sodium, crystalline penicillin O sodium salt, crystalline penicillin O potassium, crystalline penicillin O potassium salt) comply with the requirements of § 146a.24 of this chapter.

(b) Each such additive is used or intended for use as an intramammary infusion in food-producing animals in an amount not to exceed 100,000 units per dose. Its labeling shall comply with the requirements prescribed in § 135b.24 (c) (2) of this chapter.

[34 F.R. 7850, May 17, 1969, as amended at 36 F.R. 7647, Apr. 23, 1971]

NOTE: An amendment appearing at 36 F.R. 22828, Dec. 1, 1971 revoked § 121.314 effective 40 days after publication in the FEDERAL REGISTER.

(a) Procaine penicillin for aqueous injection complies with the requirements of § 146a.47 of this chapter.

(b) It is used or intended for use as an intramammary infusion in foodproducing animals in an amount not to exceed 100,000 units per dose. Its labeling shall comply with requirements prescribed in § 135b.25 (c) (2) of this chapter. [34 F.R. 7850, May 17, 1969, as amended at 36 F.R. 7647, Apr. 23, 1971]

NOTE: An amendment appearing at 36 F.R. 22828, Dec. 1, 1971 revoked § 121.315 effective 40 days after publication in the FEDERAL REGISTER.

§ 121.316 Procaine penicillin and buffered crystalline penicillin for aqueous injection.

(a) Procaine penicillin and buffered crystalline penicillin for aqueous injection comply with the requirements of § 146a.50 of this chapter.

(b) It is used or intended for use as an intramammary infusion in food-producing animals in an amount not to exceed 100,000 units per dose. Its labeling shall comply with the requirements prescribed in § 135b.26 (c) (2) of this chapter.

[34 F.R. 7850, May 17, 1969, as amended at 36 F.R. 7647, Apr. 23, 1971]

NOTE: An amendment appearing at 36 F.R. 22828, Dec. 1, 1971 revoked § 121.316 effective 40 days after publication in the FEDERAL REGISTER.

§ 121.317 1-Ephenamine penicillin G for aqueous injection.

(a) l-Ephenamine penicillin G for aqueous injection complies with the requirements of § 146a.66 of this chapter.

(b) It is used or intended for use as an intramammary infusion in foodproducing animals in an amount not to exceed 100,000 units per dose. Its labeling shall comply with the requirements prescribed in § 135b.27 (c) (2) of this chapter.

[34 F.R. 7850, May 17, 1969, as amended at 36 F.R. 7647, Apr. 23, 1971]

NOTE: An amendment appearing at 36 F.R. 22828, Dec. 1, 1971 revoked § 121.317 effective 40 days after publication in the FEDERAL REGISTER.

§ 121.319 Ammoniated cottonseed meal. The food additive ammoniated cottonseed meal may be safely used in accordance with the following conditions:

(a) The food additive is the product obtained by the treatment of cottonseed meal with anhydrous ammonia until a pressure of 50 pounds per square inch gauge is reached.

(b) It is used or intended for use in the feed of ruminants as a source of protein and/or as the sole source of nonprotein nitrogen in an amount not to exceed 20 percent of the total ration.

(c) To assure safe use, the label and labeling of the additive and of any feed additive supplement, concentrate, or premix prepared therefrom shall bear, in addition to the other information required by the act, the following:

(1) The name of the additive. (2) The maximum percentage of equivalent crude protein from the nonprotein nitrogen.

(3) Directions for use to provide not more than 20 percent of the additive in the total ration.

(4) A statement:

(i) That not more than one-third of the total protein in the feed should come from nonprotein nitrogen sources.

(ii) That the additive is not to be given to debilitated or starved animals.

(iii) "Warning-This feed should be used only in accordance with directions furnished on the label."

[33 F.R. 11077, Aug. 3, 1968]

§ 121.320 Polyethylene glycol (400) mono- and dioleate.

(a) The food additive polyethylene glycol (400) mono- and dioleate meets the following specifications: Saponification number, 80-88; acid number, 5.0 maximum; and average molecular weight range, 640-680.

(b) It is used as a processing aid in the production of animal feeds when present as a result of its addition to molasses in an amount not to exceed 250 parts per million of the molasses. [33 F.R. 10845, July 31, 1968]

§ 121.322 Diatomaceous earth.

(a) Identity. The additive consists of siliceous skeletal material derived from various species of diatoms.

(b) Specifications. The additive shall conform to the following specifications: Lead, not more than 15 parts per million. Arsenic, not more than 1.5 parts per million as As.

Fluorine, not more than 600 parts per million.

(c) Uses. It is used or intended for use as an inert carrier or anticaking agent in animal feeds in an amount not to exceed 2 percent by weight of the total ration.

[33 F.R. 12041, Aug. 24, 1968]

§ 121.323 Famphur (0,0-dimethyl 0-p(dimethylsulfamoyl) phenyl phosphorothioate).

The food additive famphur may be safely used in accordance with the following prescribed conditions:

(a) The additive is the chemical O,O-dimethyl O-p-(dimethylsulfamoyl) phenyl phosphorothioate (C10H16NOS2P). It has a melting point range of 52.5° C.

(b) The additive is used or intended for use as the sole medication as prescribed in the following table:

Amount

1. Famphur... 1.1 mg. per pound body weight per day.

2. Famphur... 2.3 mg. per pound body weight per day.

Limitations

(c) To assure safe use, the label and labeling of the additive, any feed additive supplement, feed additive concentrate, feed additive premix, or complete feed or other dosage form prepared therefrom, shall bear in addition to the other information required by the act the following: (1) The name of the additive.

(2) A statement of the quantity of the additive contained therein.

(3) Adequate directions and warnings for use which shall include a statement that famphur is a cholinesterase inhibitor and that animals being treated with famphur should not be exposed durIng or within a few days before or after treatment to any other cholinesteraseinhibiting chemicals.

(d) Tolerance limitations for residues of famphur in edible products from treated animals are established in 40 CFR 180.233 under the chemical name.

[33 F.R. 15996, Oct. 31, 1968] § 121.326

Dimethoate including its oxy

gen analog.

Indications for use

Control of grubs and aid in control of sucking lice.

Control of grubs.

(b) The antibiotic activity is expressed in this section in terms of the appropriate antibiotic standard.

(c) The additive is used or intended for use in swine feed for improvement of weight gain and feed efficiency in the presence of growth-suppressing bacteria in an amount not less than 5 grams nor more than 11.25 grams per ton of complete feed.

(d) To assure safe use, the label and labeling of the additive, feed additive premix, feed additive concentrate, feed additive supplement, or complete feed prepared therefrom shall bear, in addition to the other information required by the act, the following:

(1) The name of the additive.

(2) A statement of the quantity contained therein.

(3) Adequate directions and warnings for use, including the statement, "Not to be fed to breeding swine."

[33 F.R. 19801, Dec. 27, 1968]

§ 121.328 Feed grade biuret.

The food additive feed grade biuret may be safely used in ruminant feed in accordance with the following prescribed conditions:

(a) The food additive is the product resulting from the controlled pyrolysis of urea conforming to the following specifications:

tion to other information required by the Act, the following:

of

(i) The name of the additive. (ii) The maximum percentage equivalent crude protein from nonprotein nitrogen.

(iii) The statement "Do not feed to animals producing milk for human consumption."

(2) The label shall recommend that the diet be balanced to provide adequate nutrients when equivalent crude protein from all forms of nonprotein nitrogen exceed one-third of the total crude protein in the total daily ration.

[34 F.R. 1826, Feb. 7, 1969; 34 F.R. 2307, Feb. 18, 1969]

§ 121.330 Aldicarb.

A tolerance of 0.3 part per million is established for residues of the insecticide and nematocide aldicarb (2methyl-2-(methylthio) propionaldehyde O-(methylcarbamoyl) oxime) and its cholinesterase-inhibiting metabolites 2methyl-2-(methylsulfinyl) propionaldehyde O-(methylcarbamoyl)oxime and 2-methyl-2-(methylsulfonyl) propionaldehyde O-(methylcarbamoyl)oxime in or on cottonseed hulls. Such residues may be present therein only as a result of application of the pesticide chemical to the growing raw agricultural commodity cotton.

[34 F.R. 14652, Sept. 20, 1969] § 121.331 Fluometuron.

A tolerance of 0.2 part per million is established for residues of the herbicide fluometuron (1,1-dimethyl-3-(a,a,a-trifluoro-m-tolyl) urea) in or on sugarcane bagasse resulting from application of the herbicide to the growing raw agricultural commodity sugarcane.

[34 F.R. 14169, Sept. 9, 1969, as amended at 34 F.R. 20272, Dec. 25, 1969]

§ 121.332 S,S,S-Tributyl phosphorotrithioate.

A tolerance of 6 parts per million is established for residues of the defoliant S,S,S-tributyl phosphorotrithioate in or on cottonseed hulls. Such residue may be present only as a result of application of the defoliant to the growing cotton crop. [34 F.R. 17106, Oct. 22, 1969]

§ 121.334 Methanearsonic acid.

A tolerance of 0.9 part per million (expressed as As2O3) is established for resi

dues of the herbicide methanearsonic acid in, or on cottonseed hulls, from application of the disodium and monosodium salts of methanearsonic acid in the production of cotton.

[35 F.R. 18370, Dec. 3, 1970]

§ 121.335 Succinic acid 2,2-dimethylhydrazide.

A tolerance of 90 parts per million is established for residues of the plant regulator succinic acid 2,2-dimethylhydrazide in peanut meal resulting from application of the plant regulator to the growing raw agricultural commodity peanuts. [36 F.R. 12692, July 3, 1971]

§ 121.337 Formetanate hydrochloride.

A tolerance of 10 parts per million is established for residues of the insecticide formetanate hydrochloride (m-[[(dimethylamino) methylene l amino] phenyl methylcarbamate hydrochloride) in citrus molasses resulting from application of the insecticide to the growing raw agricultural commodities grapefruit, lemons, limes, oranges, and tangerines. [36 F.R. 22900, Dec. 2, 1971]

Subpart D-Food Additives Permitted in Food for Human Consumption

AUTHORITY: The provisions of this Subpart D issued under sec. 409, 72 Stat. 1785; 21 U.S.C. 348.

§ 121.1000 General provisions applicable to this subpart.

(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this subpart, good manufacturing practice shall be defined to include the following restrictions.

(1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food.

(2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.

(b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the act.

(a) Ethoxyquin oxy-2,2,4-trimethylquinoline)

(1,2-dihydro-6-ethmay be safely used as an antioxidant for preservation of color in the production of chili powder, paprika, and ground chili at levels not in excess of 100 parts per million.

(b) In order to provide for the safe use of the additive in feed prepared in accordance with §§ 121.201 and 121.202, tolerances are established for residues of ethoxyquin in or on edible products of animals as follows:

5 parts per million in or on the uncooked fat of meat from animals except poultry.

3 parts per million in or on the uncooked liver and fat of poultry.

0.5 part per million in or on the uncooked muscle meat of animals.

0.5 part per million in poultry eggs.
Zero in milk.

§ 121.1004 Glyceryl-lacto esters of fatty acids.

Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono- and diglycerides) may be safely used in food in accordance with the following prescribed conditions:

(a) They are manufactured from glycerin, lactic acid, and fatty acids conforming with § 121.1070 and/or oleic acid derived from tall oil fatty acids conforming with § 121.1237 and/or edible fats and oils.

(b) They are used in amounts not in excess of those reasonably required to accomplish their intended physical or technical effect as emulsifiers and plasticizers in food.

[30 F.R. 15845, Dec. 23, 1965, as amended at 36 F.R. 9628, May 27, 1971]

§ 121.1006 Maleic hydrazide.

A food additive known as maleic hydrazide (1,2-dihydro-3,6-pyridazinedione) may be present in potato chips when used in accordance with the following conditions:

(a) The food additive is present as a result of the application of a pesticide

formulation containing maleic hydrazide to the growing potato plant in accordance with directions registered by the United States Department of Agriculture.

(b) The label of the pesticide formulation containing the food additive conforms to labeling registered by the United States Department of Agriculture.

(c) The food additive is present in an amount not to exceed 160 parts per million by weight of the finished food.

§ 121.1008 Polysorbate 65.

The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed stearic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 15 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

(b) The food additive meets the following specifications:

Saponification number 88-98.
Acid number 0-2.

Hydroxyl number 44-60.

Oxyethylene content 46 percent-50 percent. (c) The additive is used, or intended for use, as follows:

(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet, and nonstandardized frozen desserts, when used alone or in combination with polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

(i) Sorbitan monostearate.
(ii) Polysorbate 60.

When used alone, the maximum amount of polysorbate 65 shall not exceed 0.32 percent of the cake or cake mix, on a dry-weight basis. When used with sorbitan monostearate and/or polysorbate 60, it shall not exceed 0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or the polysorbate 60 exceed 0.46 percent, and no combination of these