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PART 1-ORGANIZATION AND 12 ounce per oyster, shall be not less than PROCEDURES

68 percent of the water capacity of the Sec.

can in which packed. For the No. 1 can, 1.2 Delegations of authority. (Amended] often referred to as the No. 1 eastern § 1.2 Delegations of authority.

oyster can, having outside dimensions of diameter 2 11/16 inches and height 4.0

inches, a drained weight of about 7.5 (3) To Charles W. Crawford, Louis D. ounces of oysters is required. Elliott, George P. Larrick, Henry Welch,

At the hearing which resulted in the Donald C. Grove, and William R. Jester, promulgation of this standard, there was to act in behalf of the Commissioner for insufficient evidence to warrant findings the purposes of the regulations promul- of fact on which to base a standard of gated under section 507 of the Federal fill of container when the drained weight Food, Drug, and Cosmetic Act as amend- of oysters in a particular can averages ed, governing certification of batches of 1/2 ounce or more per oyster. No standpenicillin- and streptomycin-containing ard for oysters of such size was estabdrugs.

lished at that time.

It has recently come to our attention CODIFICATION: In $ 1.2 (b), subparagraphs

that some packers of canned oysters are (3) and (4) were revoked, a new subpara

now putting up large oysters, not subgraph (3) added as set forth above, and subparagraph (5) redesignated (4), by Delega

ject to the requirements of the fill of tion of Authority, Commissioner for Special

container standard, so that the drained Services, approved by the Federal Security Ad- weight in many instances is 5 ounces or ministrator Nov. 12, 1947, 12 F.R. 7629.

even less for the No. 1 can. Although

such canned oysters are not subject to PART 2-REGULATIONS FOR THE the provisions of the fill of container ENFORCEMENT OF THE FEDERAL

standard they are subject to the sub

stantive provisions of the Federal Food, FOOD, DRUG, AND COSMETIC ACT

Drug, and Cosmetic Act. Section 402 NEW DRUGS AND DEVICES

(b) (2) of this act states that a food Sec.

shall be deemed to be adulterated if any 2.109 New drugs; exemption from section substance has been substituted wholly 505 of the act. (Revised]

or in part therefor. Section 403 (d) of $ 2.109 New drugs; exemption from the act provides that a food shall be section 505 of the act. A new drug shall

deemed to be misbranded if its container not be deemed to be subject to section is so made, formed or filled as to be mis505 of the act if it is a drug which is leading. It is our opinion that these licensed under the Public Health Service sections apply to canned oysters if water, Act of July 1, 1944 (58 Stat. 682; 42 brine, or liquid draining from oysters U.S.C. Sup. V 201 et seq.), or under the during processing, replaces a quantity of animal virus-serum-toxin law of March oyster which should be added to fill the 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et can. seq.). (Sec. 701 (a), 52 Stat. 1055; 21 It is the intention of this agency to call U.S.C. 371) [Reg., Jan. 16, 1947, effec- a hearing as soon as practicable on protive Jan, 21, 1947, 12 F.R. 408)

posals to adopt definitions and standards

of identity and standards for fill of conPART 3-STATEMENTS OF GENERAL

tainer for all canned oysters. In the POLICY OR INTERPRETATION meantime the Food and Drug Adminis(ADDED]

tration will apply the substantive pro

visions of the act to canned oysters where Sec. 3.1 Notice to packers of canned oysters.

the container is not as full of oysters as 3.2 Notice to packers and shippers of shelled

is practicable without injury to the qualpeanuts.

ity or appearance of the product. (Secs. $ 3.1 Notice to packers of canned

3, 12, 60 Stat. 238, 244; 5 U.S.C. 1002,

1011) oysters. Regulations fixing a standard

(Statement, Feb. 3, 1947, 12 F.R. of fill of container for canned oysters

883] were promulgated on November 25, 1944 $ 3.2 Notice to packers and shippers (21 CFR, 1944 Supp., 36.6). This stand- of shelled peanuts. Investigations by the ard requires that the drained weight of Food and Drug Administration have oysters, when the drained weight of such shown that a number of interstate shipoysters in the can averages less than ments of shelled peanuts in bags holdSubpart B-Corn Flour and Related

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. 3, 60 Stat. 238; 5 U.S.C. 1002) [Statement, June 2, 1947, 12 F.R. 3689]

PART 15-CEREAL FLOURS AND RE

LATED 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.
15.514 Enriched corn grits; identity.

Appendix-Findings of fact and con

clusions. 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 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 46 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 are 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.

Products [Added] Sec. 15.500 White corn meal; identity. 15.501 Yellow corn meal; identity. 15.502 Bolted white corn meal; Identity. 15.503 Bolted yellow corn meal; identity. 15.504 Degerminated white corn meal, de

germed white corn meal; identity. 15.505 Degerminated yellow corn meal, de

germed yellow corn meal; identity. 15.506 Self-rising white corn meal; identity. 15.507 Self-rising yellow corn meal; identity. 15.508 White corn flour; identity. 15.509 Yellow corn flour; identity. 15.510 Grits, corn grits, hominy grits; iden

tity. 15.511 Yellow grits, yellow corn grits, yellow

hominy grits; identity. 15.512 Quick grits, quick cooking grits;

identity. 15.513 Enriched corn meals; identity.

15.501 Yellow corn meal; identity. Yellow corn meal conforms to the defini. tion 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

mined by methods therefor referred to gas-measuring tube. Rotate and then in $ 15.500 (b) (1).

vigorously agitate the decomposition

flask for three minutes to mix the con$ 15.505 Degerminated yellow corn

tents intimately. Allow to stand for 10 meal, degermed yellow corn meal; identity. Degerminated yellow corn meal

minutes to bring to equilibrium. Equalconforms to the definition and standard

ize the pressure in the measuring tube of identity prescribed by $ 15.504 for

by means of the leveling bulb and read degerminated white corn meal except

the volume of gas from the zero point on

the tube. Deduct 20 cc. from this readthat cleaned yellow corn is used instead of cleaned white corn.

ing (this 20 cc. together with previous

allowance of 25 cc. compensates for the $ 15.506 Self-rising white corn meal; 45 cc. acid used in the decomposition). identity. (a) Self-rising white corn meal Observe the temperature of the air suris an intimate mixture of white corn meal, rounding the apparatus and also the sodium bicarbonate, and the acid-react- barometric pressure and multiply the ing substance monocalcium phosphate. number of cc. of gas evolved by the facIt is seasoned with salt. When it is tor given in Table 44.30—Reference tested by the method prescribed in para- Tables for the temperature and pressure graph (b) of this section, not less than observed. Divide the corrected reading 0.5 percent of carbon dioxide is evolved. by 100 to obtain the apparent percent The acid-reacting substance is added in by weight of carbon dioxide in the offsuficient quantity to neutralize the so- cial sample. dium bicarbonate. The combined weight

Correct the apparent percent of carbon of such acid-reacting substance and so

dioxide to compensate for varying atmosdium bicarbonate is not more than 4.5

pheric conditions by immediately assayparts to each 100 parts of white corn

ing a synthetic sample by the same methmeal used.

od in the same apparatus. (b) The method referred to in para

Prepare the synthetic sample with 16.2 graph (a) of this section is the method

grams of corn meal, 0.30 gram of monoprescribed in “Oficial and Tentative

calcium phosphate, 0.30 gram of salt, and Methods of Analysis of the Association of Oficial Agricultural Chemists,” 6th

a sufficient quantity of sodium bicarbon

ate U. S. P. (dried over sulfuric acid) to Edition, beginning on page 208 under "Gasometric Method (2) with Chittick's

yield the amount of carbon dioxide reApparatus Official", except that the

covered in assay of oficial sample. Defollowing procedure is substituted for the

termine this quantity by multiplying

weight of carbon dioxide recovered in procedure specified therein under “17.6% Determination":

assay of official sample by 1.91. Weigh 17 grams of the official sample

Divide the weight of carbon dioxide reinto flask A, add 15-20 glass beads (4-6

covered from synthetic sample by weight mm. diameter), and connect this flask

of carbon dioxide contained in sodium

bicarbonate used. with the apparatus (fig. 25). Open stopcock C and by means of the leveling

Divide the quotient into the apparent bulb E bring the displacement solution

percent of carbon dioxide in official samto the 25 cc. graduation above the zero

ple to obtain percent of carbon dioxide mark. (This 25 cc. is a partial allow

evolved from the official sample. ance for the volume of acid to be used $ 15.507 Self-rising yellow corn meal; in the decomposition.) Allow the ap- identity. Self-rising yellow corn meal paratus to stand 1–2 minutes to insure conforms to the definition and standard that the temperature and pressure of identity prescribed by $ 15.506 for selfwithin the apparatus are the same as rising white corn meal except that yellow those of the room. Close the stopcock,

corn meal is used instead of white corn lower the leveling bulb somewhat to re

meal. duce the pressure within the apparatus, and slowly run into the decomposition

$ 15.508 White corn flour; identity. flask from burette F 45 cc. of sulfuric

(a) White corn flour is the food prepared acid (1+5). To prevent the liberated by so grinding and bolting cleaned white carbon dioxide from escaping through corn that when tested by the method the acid burette into the air, keep the prescribed in paragraph (b) (2) of this displacement solution in the leveling section, not less than 98 percent passes bulb at all times during the decomposi- through a No. 50 sieve and not less than tion at a lower level than that in the 50 percent passes through No. 70 woven

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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 46 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 8S 15.510 or 15.511, except that in

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