2.109 New drugs; exemption from section 505 of the act. [Revised]

§ 2.109 New drugs; exemption from section 505 of the act. A new drug shall not be deemed to be subject to section 505 of the act if it is a drug which is licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682; 42 U.S.C. Sup. V 201 et seq.), or under the animal virus-serum-toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq.). (Sec. 701 (a), 52 Stat. 1055; 21 U.S.C. 371) [Reg., Jan. 16, 1947, effective Jan. 21, 1947, 12 F.R. 408]

PART 3-STATEMENTS OF GENERAL POLICY OR INTERPRETATION [ADDED]

Sec.

3.1 Notice to packers of canned oysters. 3.2 Notice to packers and shippers of shelled peanuts.

§ 3.1 Notice to packers of canned oysters. Regulations fixing a standard of fill of container for canned oysters were promulgated on November 25, 1944 (21 CFR, 1944 Supp., 36.6). This standard requires that the drained weight of oysters, when the drained weight of such oysters in the can averages less than

1⁄2 ounce per oyster, shall be not less than 68 percent of the water capacity of the can in which packed. For the No. 1 can, often referred to as the No. 1 eastern oyster can, having outside dimensions of diameter 2 11/16 inches and height 4.0 inches, a drained weight of about 7.5 ounces of oysters is required.

At the hearing which resulted in the promulgation of this standard, there was insufficient evidence to warrant findings of fact on which to base a standard of fill of container when the drained weight of oysters in a particular can averages 1⁄2 ounce or more per oyster. No standard for oysters of such size was established at that time.

It has recently come to our attention that some packers of canned oysters are now putting up large oysters, not subject to the requirements of the fill of container standard, so that the drained weight in many instances is 5 ounces or even less for the No. 1 can. Although such canned oysters are not subject to the provisions of the fill of container standard they are subject to the substantive provisions of the Federal Food, Drug, and Cosmetic Act. Section 402 (b) (2) of this act states that a food shall be deemed to be adulterated if any substance has been substituted wholly or in part therefor. Section 403 (d) of the act provides that a food shall be deemed to be misbranded if its container is so made, formed or filled as to be misleading. It is our opinion that these sections apply to canned oysters if water, brine, or liquid draining from oysters during processing, replaces a quantity of oysters which should be added to fill the

can.

It is the intention of this agency to call a hearing as soon as practicable on proposals to adopt definitions and standards of identity and standards for fill of container for all canned oysters. In the meantime the Food and Drug Administration will apply the substantive provisions of the act to canned oysters where the container is not as full of oysters as is practicable without injury to the quality or appearance of the product. (Secs. 3, 12, 60 Stat. 238, 244; 5 U.S.C. 1002, 1011) [Statement, Feb. 3, 1947, 12 F.R. 8831

§ 3.2 Notice to packers and shippers of shelled peanuts. Investigations by the Food and Drug Administration have shown that a number of interstate shipments of shelled peanuts in bags hold

ing from approximately 100 to 125 pounds each have failed to bear labeling as required by the terms of the Federal Food, Drug, and Cosmetic Act.

Shelled peanuts in sacks, whether or not shipped in carload lots, should bear the following information required by the law on food in package form:

(a) The name of the product.

(b) An accurate statement of net weight.

(c) The name and place of business of the packer or distributor.

This information should be conspicuously set forth. It may be printed or stenciled on each bag or, if desired, placed on tags which are securely attached to each bag.

The net weight marked on the bags must be the correct net weight of the peanuts at the time they are delivered to the carrier for interstate shipment. The tare weight of the bag should not be included in the weight declaration. (Sec. [State3, 60 Stat. 238; 5 U.S.C. 1002) ment, June 2, 1947, 12 F.R. 36891

PART 15-CEREAL FLOURS AND RELATED PRODUCTS; DEFINITIONS AND STANDARDS OF IDENTITY

CODIFICATION: The heading of Part 15 was amended to read as set forth above, and the text of §§ 15.00 to 15.150, inclusive (21 CFR, Cum. Supp., 15.00 to 15.150), was designated "Subpart A-Wheat Flour and Related Products", and Subpart B was added, by Docket No. FDC-44, Acting Administrator, May 7, 1947, effective on the ninetieth day following May 13, 1947, 12 F.R. 3107.

Sec.

Sec.

15.514 Enriched corn grits; identity. Appendix-Findings of fact and conclusions.

AUTHORITY: §§ 15.500 to 15.514, inclusive, issued under secs. 401, 701, 52 Stat. 1046, 1055; 21 U. S. C. 341, 371.

SOURCE: §§ 15.500 to 15.514, inclusive, contained in Docket No. FDC-44, Acting Administrator, May 7, 1947, effective on the ninetieth day following May 13, 1947, 12 F.R. 3110.

NOTE: For findings of fact and conclusions re Docket No. FDC-44, see Appendix, infra.

§ 15.500 White corn meal; identity. (a) White corn meal is the food prepared by so grinding cleaned white corn that when tested by the method prescribed in paragraph (b) (2) of this section not less than 35 percent passes through a No. 12 sieve, not less than 45 percent through a No. 25 sieve, but not more than 35 percent through a No. 72 grits gauze. Its moisture content is not more than 15 percent. In its preparation coarse particles of the ground corn may be separated and discarded, or reground and recombined with all or part of the material from which they were separated, but in any such case the crude fiber content of the finished corn meal is not less than 1.2 percent and not more than that of the cleaned corn from which it was ground, and its fat content does not differ more than 0.3 percent from that of such corn. The contents of crude fiber and fat in all the foregoing provisions relating thereto are on a moisture free basis.

(b) (1) For the purposes of this section moisture is determined by the method prescribed in "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 6th edition, page 259, sections 20.70 and 20.71; fat is determined by the method prescribed on pages 259 and 260, sections 20.70 and 20.73; and crude fiber determined by the method prescribed on pages 259 and 260, sections 20.70 and 20.74.

(2) The method referred to in paragraph (a) of this section is as follows:

Use No. 12 and No. 25 sieves, having standard 8-inch diameter, full height frames, complying with the specifications for wire cloth and sieve frames in "Standard Specifications for Sieves," published March 1, 1940, in L. C. 584 of the Bureau of Standards, U. S. Department of Commerce. A sieve with frame

are

of the same dimensions as the Nos. 12 and 25 and fitted with 72 XXX grits gauze is used as the third sieve. It is referred to hereafter as the No. 72 sieve. The 72 XXX grits gauze has openings equivalent in size with those of No. 70 woven wire cloth, complying with specifications for such cloth contained in such "Standard Specifications for Sieves." Attach bottom pan to No. 72 sieve. Fit the No. 25 sieve into the No. 72 sieve and the No. 12 sieve into the No. 25 sieve. Pour 100 grams of sample into the No. 12 sieve, attach cover and hold the assembly in a slightly inclined position and shake the assembly of sieves by striking the sides against one hand with an upward stroke, at the rate of about 150 times per minute. Turn the assembly of sieves about % of a revolution, each time in the same direction, after each 25 strokes. Continue shaking for 2 minutes. Weigh separately the material remaining on each sieve and in the pan, and calculate each weight as percent of sample. Sometimes when meals tested, fine particles clog the sieve openings. If any sieve is clogged by fine material smaller than its openings, empty the contents onto a piece of paper. Remove the entrapped material on the bottom of the sieve by a hair brush and add to the sieve below. In like manner, clean the adhering material from inside the sieve and add to the material on the paper. Return mixture on the paper to the sieve, reassemble the sieves, and shake in the same manner as before for 1 minute. Repeat cleaning procedure if necessary until a 5 gram or less loss in weight occurs in any sieve during a 1 minute shaking. The percent of sample passing through No. 12 sieve shall be determined by subtracting from 100 percent, the percent of material remaining on the No. 12 sieve. The percent passing through a No. 25 sieve shall be determined by adding the percents remaining on the No. 72 sieve and the percent in pan. The percent in the pan shall be considered as the percent passing through a No. 72 XXX grits gauze.

§ 15.501 Yellow corn meal; identity. Yellow corn meal conforms to the definition and standard of identity prescribed by 15.500 for white corn meal except that cleaned yellow corn is used instead of cleaned white corn.

§ 15.502 Bolted white corn meal; identity. (a) Bolted white corn meal is

the food prepared by so grinding and sifting cleaned white corn that:

(1) Its crude fiber content is less than 1.2 percent but its fat content is not less than 2.25 percent, and

(2) When tested by the method prescribed in § 15.500 (b) (2), except that a No. 20 standard sieve is used instead of the No. 12 sieve, not less than 95 percent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent through No. 72 XXX grits gauze. Its moisture content is not more than 15 percent. In its preparation particles of ground corn which contain germ may be separated, reground, and recombined with all or part of the material from which it was separated, but in any such case the fat content of the finished bolted white corn meal does not exceed by more than 0.3 percent the fat content of the cleaned corn from which it was ground. The contents of crude fiber and fat in all the foregoing provisions relating thereto are on a moisture free basis.

(b) For the purposes of this section, moisture, fat and crude fiber are determined by the methods therefor referred to in § 15.500 (b) (1).

§ 15.503 Bolted yellow corn meal; identity. Bolted yellow corn meal conforms to the definition and standard of identity prescribed by § 15.502 for bolted white corn meal except that cleaned yellow corn is used instead of cleaned white corn.

§ 15.504 Degerminated white corn meal, degermed white corn meal; identity. (a) Degerminated white corn meal, degermed white corn meal, is the food prepared by grinding cleaned white corn and removing bran and germ so that:

(1) On a moisture free basis, its crude fiber content is less than 1.2 percent and its fat content is less than 2.25 percent; and

(2) When tested by the method prescribed in § 15.500 (b) (2), except that a No. 20 standard sieve is used instead of a No. 12 sieve, not less than 95 percent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent through No. 72 XXX grits gauze. Its moisture content is not more than 15 percent.

(b) For the purpose of this section, moisture, fat and crude fiber are deter

wire cloth. Its moisture content is not more than 15 percent. In its preparation part of the ground corn may be removed, but in any such case, the content (on a moisture free basis) of neither the crude fiber nor fat in the finished white corn flour exceeds the content (on a moisture free basis) of such substance in the cleaned corn from which it was ground.

(b) (1) For the purpose of this section, moisture, fat and crude fiber are determined by methods therefor referred to in § 15.500 (b) (1).

(2) The method referred to in paragraph (a) of this section is as follows:

Weigh 5 grams of sample into a tared truncated metal cone (top diameter 5 centimeters, bottom diameter 2 centimeters, height 4 centimeters), fitted at bottom with 70-mesh wire cloth complying with the specifications for No. 70 wire cloth in "Standard Specifications for Sieves", published March 1, 1940 in L. C. 584 of the Bureau of Standards, U. S. Department of Commerce. Attach cone to a suction flask. Wash with 150 ml. of petroleum ether applied in a small stream without suction, while gently stirring the sample with a small glass rod. Apply suction for 2 minutes after washing is completed, then shake the cone for 2 minutes with a vigorous horizontal motion; striking the side against the hand, and then weigh. The decrease in weight of sample, calculated as percent by weight of sample shall be considered the percent passing through No. 70 wire cloth. Transfer the residue from cone to a No. 50 sieve having a standard 8inch diameter full height frame, complying with the specifications for wire cloth and sieve frame in said "Standard Specifications for Sieves." Shake for 2 minutes with a vigorous horizontal motion, striking the side against the hand; remove and weigh the residue; calculate the weight of residue as percent by weight of sample, and subtract from 100 percent to obtain the percent of sample passing through the No. 50 sieve.

§ 15.509 Yellow corn flour; identity. Yellow corn flour conforms to the definition and standard of identity prescribed by § 15.508 for white corn flour except that cleaned yellow corn is used instead of cleaned white corn.

§ 15.510 Grits, corn grits, hominy grits; identity. (a) Grits, corn grits, hominy grits, is the food prepared by so grinding and sifting cleaned white corn,

with removal of corn bran and germ, that:

(1) On a moisture free basis its crude fiber content is not more than 1.2 percent and its fat content is not more than 2.25 percent; and

(2) When tested by the method prescribed in paragraph (b) (2) of this section not less than 95 percent passes through a No. 10 sieve but not more than 20 percent through a No. 25 sieve.

(b) (1) For the purposes of this section moisture, fat and crude fiber are determined by methods therefor referred to in § 15.500 (b) (1).

(2) The method referred to in paragraph (a) of this section is as follows:

Use No. 10 and No. 25 sieves, having standard 8-inch diameter full height frames, complying with the specifications for wire cloth and sieve frames in "Standard Specifications for Sieves", published March 1, 1940, in L. C. 584 of the Bureau of Standards, U. S. Department of Commerce. Attach bottom pan to No. 25 sieve. Fit the No. 10 sieve into the No. 25 sieve. Pour 100 grams of sample into the No. 10 sieve, attach cover and hold assembly in a slightly inclined position, shake the sieves by striking the sides against one hand with an upward stroke, at the rate of about 150 times per minute. Turn the sieves about % of a revolution each time in the same direction after each 25 strokes. Continue shaking for 2 minutes. Weigh separately the material remaining on the No. 10 sieve and in the pan, and calculate each weight as percent of sample. The percent of sample passing through a No. 10 sieve shall be determined by subtracting from 100 percent, the percent remaining on the No. 10 sieve. The percent of material in the pan shall be considered as the percent passing through a No. 25 sieve.

§ 15.511 Yellow grits, yellow corn grits, yellow hominy grits; identity. Yellow grits, yellow corn grits, yellow hominy grits, conforms to the definition and standard of identity prescribed by § 15.510 for grits except that cleaned yellow corn is used instead of cleaned white corn.

§ 15.512 Quick grits, quick cooking grits; identity. (a) Quick grits, quick cooking grits are the foods, each of which conforms to the definition and standard prescribed for a kind of grits by §§ 15.510 or 15.511, except that in