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Title 21: Food and Drugs
Subpart A - General Provisions
§ 155.3 Definitions.

For the purposes of this part:

(a) The procedure for determining drained weight is set forth in the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 32.001-32.003, which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) Compliance means the following: Unless otherwise provided in a standard, a lot of canned vegetables shall be deemed in compliance for the following factors, to be determined by the sampling and acceptance procedure as provided in paragraph (c) of this section, namely:

(1) Quality. The quality of a lot shall be considered acceptable when the number of defectives does not exceed the acceptance number (c) in the sampling plans.

(2) Fill of container. A lot shall be deemed to be in compliance for fill of container (packing medium and vegetable ingredient) when the number of defectives does not exceed the acceptance number (c) in the sampling plans.

(3) Drained weight. A lot shall be deemed to be in compliance for drained weight based on the average value of all samples analyzed according to the sampling plans.

(c) The sampling and acceptance procedure means the following:

(1) Definitions - (i) Lot. A collection of primary containers or units of the same size, type, and style manufactured or packed under similar conditions and handled as a single unit of trade.

(ii) Lot size. The number of primary containers or units in the lot.

(iii) Sample size. The total number of sample units drawn for examination from a lot.

(iv) Sample unit. A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit. For fill of container, the sample unit shall be the entire contents of the container.

(v) Defective. Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.

(vi) Acceptance number (c). The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements.

(vii) Acceptable quality level (AQL). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time.

(2) Sampling plans.

Lot size (primary containers Size of container
n 1 c 2
net weight equal to or less than 1 kg (2.2 lb)
4,800 or less132
4,801 to 24,000213
24,001 to 48,000294
48,001 to 84,000486
84,001 to 144,000849
144,001 to 240,00012613
Over 240,00020019
net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
2,400 or less132
2,401 to 15,000213
15,001 to 24,000294
24,001 to 42,000486
42,001 to 72,000849
72,001 to 120,00012613
Over 120,00020019
net weight greater than 4.5 kg (10 lb)
600 or less132
601 to 2,000213
2,001 to 7,200294
7,201 to 15,000486
15,001 to 24,000849
24,001 to 42,00012613
Over 42,00020019

1 n = number of primary containers in sample.

2 c = acceptance number.

(d) Strength and redness of color means at least as much red as is obtained by comparison of the prepared product, with the blended color produced by spinning a combination of the following concentric Munsell color discs of equal diameter, or the color equivalent of such discs:

Disc 1 - Red (5R 2.6/13) (glossy finish) Disc 2 - Yellow (2.5 YR 5/12) (glossy finish) Disc 3 - Black (N1) (glossy finish) Disc 4 - Grey (N4) (mat finish) Such comparison is to be made in full diffused daylight or under a diffused light source of approximately 2691 lux (250 footcandles) and having a spectral quality approximating that of daylight under a moderately overcast sky, with a correlated color temperature of 7,500 degrees Kelvin ±200 degrees. With the light source directly over the disc and product, observation is made at an angle of 45 degrees from a distance of about 24 inches from the product. Electronic color meters may be used as an alternate means of determining the color of tomato concentrates. Such meters shall be calibrated to indicate that the color of the product is as red or more red than that produced by spinning the Munsell color discs in the combination as set out above.

(e) Tomato soluble solids means the sucrose value as determined by the method prescribed in the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed., 1980, sections 32.014 to 32.016 and 52.012, under the headings “Soluble Solids in Tomato Products Official Final Action” and “Refractive Indices (n) of Sucrose Solutions at 20°,” which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or are available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If no salt has been added, the sucrose value obtained from the referenced tables shall be considered the percent of tomato soluble solids. If salt has been added either intentionally or through the application of the acidified break, determine the percent of such added sodium chloride as specified in paragraph (f) of this section. Subtract the percentage so found from the percentage of total soluble solids found (sucrose value from the refractive index tables) and multiply the difference by 1.016. The resultant value is considered the percent of “tomato soluble solids.”

(f) Salt means sodium chloride, determined as chloride and calculated as percent sodium chloride, by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed., 1980, sections 32.025 to 32.030, under the heading “Method III (Potentiometric Method),” which is incorporated by reference.

[45 FR 43398, June 27, 1980, as amended at 47 FR 11831, Mar. 19, 1982; 48 FR 3954, Jan. 28, 1983; 54 FR 24895, June 12, 1989; 63 FR 14035, Mar. 24, 1998]
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