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The milliliter reading at the top of the layer of "insoluble solids," after centrifuging 3 minutes, is multiplied by two to obtain the percentage of “insoluble solids."

(c) If the quality of canned pineapple juice falls below the standard prescribed in paragraph (a) of this section, the label shall bear the general statement of substandard quality specified in § 10.7 (a) of this subchapter, in the manner and form therein specified.

§ 27.56 Canned pineapple juice; fill of container; label statement of substandard fill

(a) The standard of fill of container for canned pineapple juice is a fill of not less than 90 percent of the total capacity of the container, as determined by the general method for fill of container prescribed in § 10.6(b) of this chapter.

(b) If canned pineapple juice falls below the standard of fill of container prescribed in paragraph (a) of this section, the label shall bear the statement of substandard fill specified in § 10.7 (b) of this chapter, in the manner and form therein specified.

§ 27.57 Artificially sweetened canned pineapple; identity; label statement of optional ingredients

(a) Artificially sweetened canned pineapple is the food that conforms to the definition and standard of identity prescribed for canned pineapple by § 27.50, except that in lieu of a packing medium specified in § 27.50(b), the packing medium used is water artificially sweetened with saccharin, sodium saccharin, or a combination of both. Such packing medium may be thickened with pectin. (b) (1) The specified name of the food is "artificially sweetened the blank being filled in with the name prescribed by § 27.50 for canned pineapple having the same optional pineapple ingredient.

(2) The artificially sweetened food is subject to the requirements label statement or optional ingredients used, as prescribed for canned pineapple by § 27.50. If the packing medium is thickened with pectin, the label shall bear the statement "thickened with pectin." [26 F.R. 12564, Dec. 28, 1961, as amended at 35 F.R. 11178, July 11, 1970]

§ 27.60 Canned prune juice; identity; label statement of optional ingredients (a) Canned prune juice is the food prepared from a water extract of dried prunes and contains not less than 18.5 percent by weight of water-soluble solids extracted from dried prunes. The quantity of prune solids may be adjusted by the concentration, dilution, or both, of the same water extract, or extracts made. Such food may contain one or more of the optional acidifying ingredients specified in paragraph (b)(1) of this section, in a quantity sufficient to render the

food slightly tart; it may contain honey added within the quantitative limits prescribed by paragraph (b) (2) of this section; and it may contain added vitamin C in a quantity prescribed by paragraph (b)(3) of this section. Such food is sealed in a container and so processed by heat, before or after sealing, as to prevent spoilage.

(b) The optional ingredients referred to in paragraph (a) of this section are: (1) One or any combination of two or more of the following acidifying in. gredients:

(i) Lemon juice. (ii) Lime juice.

(iii) Citric acid.

(2) Honey, in a quantity not less than 2 percent and not more than 3 percent by weight of the finished food.

(3) Vitamin C, in a quantity such that the total vitamin C in each 6 fluid ounces of the finished food amounts to not less than 30 milligrams and not more than 50 milligrams.

(c) (1) The name of the food is “Prune juice—A water extract of dried prunes." For the purposes of the Federal Food, Drug, and Cosmetic Act concerning the label declaration of the name of the food, the explanatory statement “A water extract of dried prunes" may appear immediately below the words "prune juice," but there shall be no intervening written, printed, or graphic matter, and the type used for the words "A water extract of dried prunes" shall be of the same style and not less than half the point size of the type used for the words "prune juice."

(2) (i) When one or more of the acidifying ingredients specified in paragraph (b) (1) of this section are used, the label shall bear the statement " added" or "with added "the blank being filled in with the name or names of the optional ingredients used.

(ii) When honey, as specified in paragraph (b) (2) of this section is used the label shall bear the statement "With ---honey" or

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honey

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To reduce the incidence of substandard canned pineapple offered for importation into the United States.

Background

Current standards of identity and qualify for canned pineapple are described in 21 CFR 27.50, 27.51 and 27.52. Spot checks made several years ago by the Pineapple Growers Associations indicated that except for Hawaiian and Philippine pineapple, approximately 20% of over 100 samples examined did not conform to standards. An FDA survey of imported canned pineapple conducted in FY 70 found deviations from the standards in 11.3% of the codes sampled. Following FDA's FY 70 survey the industry conducted additional spot checks and claimed that there was still a problem with substandard quality pineapple and that it was increasing; especially for imports from Taiwan and Malaysia. In FY 73 the FDA surveyed both domestic and imported canned pineapple and found that, indeed, the greatest portion of substandard pineapple offered for importation was from Taiwan and Singapore/Malaysia. The survey revealed that 14.2% of the pineapple sampled from these two countries was substandard

for trim, core material or blemishes. Consequently, the FY 74 program is designed to reduce the incidence of the importation of substandard pineapple from Taiwan and Singapore/Malaysia.

In addition, the FY 73 survey revealed that the participating districts were collecting excessively high sample sizes. Both the FY 73 and FY 74 programs were statistically designed to accomplish the required task with a minimum amount of inspectional and analytical effort. To achieve the purpose of this program in FY 74, supervisory personnel are encouraged to review the attached sampling schedule and multiple stage analytical plan with field personnel participating in the program to prevent excessive sampling or examination of more cans than necessary to statistically determine the condition of the lot. Objective

To prevent the importation of canned pineapple that does not comply with the standards.

Approach

1. Inspectional.-This program does not impose any headquarters directed workload for establishment inspections.

2. Sample Collection.-During FY 74 those districts identified will collect a specified number of imported canned pineapple samples as shown below. This sampling plan is based on canned pineapple volume of entry from the identified country through the ports of entry of the districts indicated.

TABLE 1.-SAMPLING PLAN FOR IMPORTED CANNED PINEAPPLE FISCAL YEAR 1974
[Number of samples to be collected]1

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1 Number of samples: Approximately 70 percent of the samples collected should consist of retail size containers; the remaining 30 percent institutional size. However, if sufficient numbers of one size container are not available to meet district obligations under this program, another size may be substituted. Sample Collection emphasis should be placed on "crushed" pineapple.

TABLE II.-SAMPLING SCHEDULE FOR IMPORTED CANNED PINEAPPLE FISCAL YEAR 1974

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1 Total sample size: Collect the sample size specified as district sample size in the above table. Also collect an additional number of cans equivalent to 24 lb of product, e.g., 3 No. 10 cans or 12 No. 2%1⁄2 cans, for headquarters analysis.

The number of cans collected from each lot should be randomly sampled from throughout the entire lot to best reflect the condition of the lot. If a six can sample is called for, one unopened case will not suffice. The six cans should be individually collected from the entire lot.

Example: A lot to be sampled contains 30,000/8 lb. cans. From Table II we see the sample size should be 30 cans for the district sample plus 3 cans for headquarters check analysis. The total 33 can sample should be randomly selected from throughout the entire lot. The collection of intact cases will not be satisfactory as it will not best reflect the condition of the lot.

3. Sample Analysis.-Methods of analysis for canned pineapple are listed in the 21 CFR, Parts 27.50, 27.51 and 27.52. Samples collected for this program will be examined specifically for:

(a) excessive trim

(b) core material

(c) blemishes

(d) drained weight

Determine drained weight according to 21 CFR 27.51 (b) (1). Facilitate draining by inclining the seive at an angle of 17-20°.

If examination for the above factors reveals an additional problem area where the product is suspected to be substandard, examine for that problem also. Double check the collection report with Table II to insure that the sample submitted reflects the correct sample size. Where the laboratory receives a larger sample than required for analysis, the required number of cans may be selected at random from the total. Any conclusions drawn from that sample will apply to the whole lot. If the required sample size is 6 cans and the laboratory receives 6 cases for analysis, it should be assumed the inspector collected 6 cases at random from the lot. The correct procedure would be to select one can from each case for analysis.

Examine samples submitted as illustrated in the following table.

TABLE III.-MULTIPLE STAGE ANALYTICAL PLAN FOR IMPORTED CANNED PINEAPPLE FISCAL YEAR 1974

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1 See table II, Sampling Schedule.

2 For example, if 4 containers are examined and none are defective accept the lot, if 1 or more are defective for a single quality factor reject the lot; if 1 is defective examine 2 more and accept if 1 of the 6 is defective or reject if 2 or more are defective for a single quality factor.

The "reject" number is the number of cans defective in the same quality factor, e.g., trim, core or blemishes, not a combination of any factors. For example, to reject a lot based on the examination of 4 cans, 2 cans must be found substandard for trim, or 2 cans substandard for blemishes, or 2 cans substandard for core. Likewise, rejection of a lot based on examination of 120 cans requires 13 cans to be substandard for trim, or 13 cans substandard for blemishes, or 13 cans substandard for core.

Example: A lot to be sampled contains 30,000/8 lb. cans. From Table II we see the sample size should be 30 cans for the district sample plus 3 cans for headquarters check analysis. From Table III we find, for a district sample size of 30, we should start by analyzing 15 cans (stage 1). If one or no defective cans are found, the lot can be accepted and the remaining 15 cans of the sample can be discarded. If we obtained 4 or more defective cans in stage 1, the lot would be rejected and the remaining 15 cans discarded. If we obtained 2 or 3 defective cans, then we proceed to stage 2 and analyze the extra 15 cans. Then on the basis of the number of defective cans out of the cumulative sample size of 30, we reject the lot if there were 5 or more defectives and accept if there were 4 or less defectives.

For any lot rejected for substandard quality factors and against which regulatory action is being considered forward that portion of the sample identified as Headquarters Sample Size, Table II, Sampling Schedule (approx. 24 lbs., e.g., 3-No. 10 cans or 12-No. 2 1⁄2 cans) for a check analysis to:

U.S. Food and Drug Administration

Division of Food Technology

Fruit and Vegetable Products Branch (BF-414)

200 "C" Street, S.W.

Washington, D.C. 20204

Submit copies of the collection report and the analyst's worksheet with each sample.

The Division of Food Technology will notify the analyzing district by TWX or telephone of the headquarters results of analysis. The districts may prepare the necessary legal paperwork to take action against any substandard lot but should not proceed against the lot until notified of the results of the check analysis by the headquarters laboratory.

Refer to the Inspector Operations Manual, Sections 454, Sample Shipment and 454.3, Notifying Receiving Laboratories.

4. Imports.-Coverage of imported pineapple is discussed under the headings "Sample Collection" and "Sample Analysis."

Follow-up

Refer to the Administrative Guidelines, Canned Pineapple, Misbranding-Food Standards.

Reporting

Each district involved in this survey will submit their program results by duplicating and completing Attachment A for each sample collected and analyzed. Completed reports should be submitted on a monthly basis to:

U.S. Food and Drug Administration

Division of Compliance Programs

Program Development Branch, BF-323

200 "C" Street, S.W.

Washington, D.C. 20204

When no samples are reportable, submit a negative memorandum, except in that case when a district has completed its programmed obligations, then no report will be required.

The Foods Standards Program Manager, in cooperation with the Division of Mathematics, will provide the Bureau of Foods Director, with a copy to the Division of Compliance Programs, an evaluation of this program by September 1, 1974.

References

1. "Code of Federal Regulations," Title 21, Section 27.50-52, "Canned Pineapple ***"

2. Bureau of Foods, Division of Regulatory Guidance, "Administrative Guidelines."

3. Office of the Executive Director of Regional Operations, Division of Field Operations, "Inspector Operations Manual."

4. Office of the Executive Director of Regional Operations, Division of Field Operations, "Inspector Programs Manual.”

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1. Type pack e.g., slices, chunks, etc.

2. Total number of cans in lot sampled. (Do not report

the number of cases or cartons.)

3. The total number of cans collected as a sample.

4. The labeled net weight of the cans sampled.

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