PART 3:

 LABORATORY SAMPLING (11/15/03)

Section 3:

 Food Chemistry Testing Program

  1. PURPOSE

Food chemical analyses of imported meat and poultry products are conducted to determine, among other things, protein, salt, sodium nitrite, total fat, total water, maximum internal temperature, and calculated Protein Fat Free (PFF). Import inspection personnel shall refer to Section 1, "Laboratory General Procedures," and the specific instructions in this section when selecting import samples for food chemistry testing.

  1. CANCELLATION

Part 3, Section 3, "Food Chemistry Testing Program," dated April 1, 2002

  1. FORMS

FSIS Form 9540-3, "Import Abnormal Container, Chemical, Species, Pathology Laboratory Analysis," (see Table 6). 

  1. IMPORTED PRODUCTS SUBJECT TO FOOD CHEMISTRY TESTING

Not all imported products are subject to food chemistry testing. However, each process category has products that are appropriate for chemistry sampling. Product standards of identity, the meat and poultry regulations, and labeling policies are used in determining if a specific product should be subjected to food chemistry sampling. The AIIS is programmed to assign any number of food chemistry analyses for a given process category/subcategory, all, some, or none of which may be applicable. Inspection personnel shall refer to the meat and poultry regulations and FSIS labeling policies in determining if a specific product should be sampled and submitted for the food chemistry analyses (TOI) assigned. TOIs for analyses not applicable to the product shall be exempted in the AIIS and a reason stated.

As an example, FSIS performs maximum internal temperature (MIT) sampling for the Animal and Plant Health Inspection Service (APHIS). This sampling is conducted to verify that fully cooked perishable pork products from countries for which APHIS has restrictions in place due to animal health diseases are cooked to a minimum internal temperature of 156o F. MIT sampling does not need to be performed on pork products originating in unrestricted countries or on thermally processed – commercially sterile items. The status of animal health restrictions has been summarized in the APHIS Disease Chart, which is maintained in the Import Public Folder in Outlook. Inspection personnel should refer to this list prior to exempting an MIT sample request.

  1. SUPPLIES

Inspection personnel shall refer to FSIS Directive 7355.1 for guidance on obtaining sampling supplies.

  1. SAMPLING PROCEDURES

    1. Obtaining Assignments

      Food chemistry assignments are generated by the Automated Import Information System (AIIS).

    2. Sample Size

      1. A food chemistry sample unit shall consist of approximately one pound of product but not less than twelve ounces. Exception: When sampling shelf-stable product or keep refrigerated product such as perishable canned hams, the whole unit--regardless of size--shall be submitted to the laboratory as the sample unit.

      2. Depending upon how product is packaged, a sample unit may consist of a single package, a portion thereof, or several packages.

        1. Example 1: When product is packaged in 12-oz units, such as frozen meatballs, then a single package shall be considered as one sample unit.

        2. Example 2: When product is packaged in 10-lb immediate containers, such as frozen frankfurters, then enough franks shall be withdrawn from the container to obtain an approximate 1-lb sample.

        3. Example 3: When product is packaged in 10-oz units such as canned hams, then two cans (20-oz) will be considered as one sample unit.

    3. Sample Selection

One sample unit shall be submitted to a laboratory regardless of the number of food chemistry assignments assigned to a lot. For example, if a lot of dried, cooked, cured beef has two food chemistry assignments, e.g., sodium nitrite and Moisture/Protein Ratio (MPR), then only one sample unit shall be randomly selected and submitted for both analyses. There are four exceptions below to the rule of only one (1) sample.

  1. Lots Subject to Maximum Internal Temperature (MIT)

    When a lot is assigned a MIT and at least one other chemistry assignment, TWO sample units must be submitted to a laboratory; one sample unit for MIT analysis and the other sample unit for all other food chemistry analyses.

  2. Lots of Cooked Sausage Sampled for Compliance with the 30% Fat Limitations

    When a lot of cooked sausage is assigned a food chemistry assignment for fat, a total of 3 one-pound samples (or the equivalent) must be submitted to the laboratory.

  3. Cured Pork Products Subject to PFF Sampling at the Intensified Level

    When a lot is sampled at the Intensified level for PFF, 5 sample units shall be randomly selected and submitted to a laboratory for separate analyses. A separate FSIS Form 9540-3 is to be completed for each sample selected. Refer to FSIS Directive 9550.1, "Protein Fat-Free (PFF) For Imported Cured Pork Products," dated April 24, 1990, for PFF sampling instructions.

  4. 3% Added Water Limitation Canned Products (e.g., Canned Luncheon Meat and Chopped Pork) –

    Further Sampling at Importer’s Request

    When the added water result of an Intensified sample exceeds 4% but is less than 5%, the importer/broker or representative has the option to request that an additional THIRTY sample units be randomly selected from the lot and submitted to an accredited laboratory for separate analyses. This sampling is at the importer’s expense. A separate FSIS Form 9540-3 is to be completed for each sample selected. If the importer does not request this option, the lot shall be refused entry.

    If further sampling was conducted and the average of the 30 sample results is 3% added water or less and none of the 30 sample results exceed 5% added water, the lot shall be released for this TOI. Otherwise, the lot is refused entry.

  5. Accredited Laboratories are non-federal chemistry laboratories accredited by FSIS to perform analyses of water, protein, salt, and fat. Inspection personnel shall refer to the Meat and Poultry Inspection Directory or in Outlook (Outlook:\\Public Folders\All Public Folders\Accredited Laboratories) for the list of accredited laboratories. Accredited labs shall fax the results (forms) to the Eastern Lab and to the Regional Import Field Office. The supervisor or designee shall determine whether the sample result is in compliance. The supervisor or designee shall write the result on the form and fax it to the Eastern Lab. In instances where there is more than one form for the same analysis for the same lot (5, 6 or 30 samples), the supervisor or designee will calculate the results for the entire set of samples and only fax one form to the Eastern lab with the final determination. The results will then be posted to Laboratory Electronic Application for Results Notification (LEARN) and reported in the AIIS.

    NOTE: When samples are submitted to an accredited laboratory, the importer/broker or representative is responsible for the laboratory and mailing charges associated with the sample.

  1. Intensified

    Lots sampled at the Intensified level must be placed on FSIS Hold pending reporting of the lab analyses. EXCEPTION: Canadian establishments with a food chemistry TOI on Intensified may sample and pre-certify the laboratory results. Inspection personnel should refer to Part 3, Section 1, "Laboratory General Procedures," for guidance.

  2. Security

    Samples must be kept properly secured at all times.

  1. SUBMITTING SAMPLES

    1.  Preparing Samples

      1. Inspection personnel shall refer to Section 1, "Laboratory General Procedures" and FSIS Directive 7355.1, "Use of Sample Seals for Laboratory Samples and Other Applications," for related procedures concerning preparing, securing, and submitting samples.

      2. Sample units shall be REFRIGERATED or FROZEN when submitted to a laboratory. NOTE: Shelf stable product is not required to be refrigerated or frozen prior to submitting it to the laboratory.

      3. Inspection personnel shall complete one FSIS Form 9540-3 for all food chemistry analyses requested from each lot sampled unless otherwise instructed. The laboratory will perform all applicable requested analyses identified on the form.

      4. FSIS Form 9540-3 shall be enclosed in a separate bag and inserted along with the sample unit in a self-sealing bag. A copy of the form must be maintained for the case file.

      5.  Inspection personnel shall send the sample unit to the designated laboratory without further preparation (e.g., grinding), unless otherwise instructed.

    2. Laboratory

      1. Except as noted in VII.B.2, all food chemistry samples shall be submitted to the Eastern Laboratory, Athens, Georgia.

      2. If requested by the importer/broker or representative, food chemistry samples may be submitted to an accredited laboratory that is accredited to test for the assigned analysis. A list of accredited labs is available in Outlook (outlook:\\Public Folders\All Public Folders\Accredited Laboratories).

    3. Mailing

      Samples shall be mailed via the FSIS contract overnight delivery/courier mailing service. Samples must be shipped Monday through Friday so that they arrive at the laboratory overnight. A sample box shipped on Friday must have a "Saturday Delivery" sticker on it and "Saturday Delivery" marked on the shipping label to avoid delays and discarded samples. Samples must not be shipped on Saturday or the day before a Federal holiday.

  1. LABORATORY RESULTS REPORTING PROCEDURES

    1. Acceptable

When a food chemistry sample is reported as "Acceptable" for all analyses, the involved lot is not subject to further testing and may be released if held, and all other reinspection criteria are acceptable.

  1. Not Acceptable

    1. Normal or Increased sample

      1. The lot may be subject to recall if it was not on Voluntary Hold and the violation is a public health/food safety issue. Inspection personnel must notify their supervisor or OIA to get further instruction.

      2. The lot is refused entry if it was held; and,

      3. The foreign establishment that produced the product is placed on Intensified for the specific TOI that was violative until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as "Acceptable".

  1. Intensified sample.

    1. The lot is refused entry.

    2. The foreign establishment that produced the product will continue on Intensified for the specific TOI that was violative until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as "Acceptable".

  1. Indeterminate or Non-Regulatory Result

When a food chemistry laboratory result is reported as "Indeterminate" or "Non-regulatory Result", inspection personnel shall e-mail ImportInspection@fsis.usda.gov and copy their supervisor with the AIIS Lot Identification Number for guidance concerning disposition of the involved product and entry of results into the AIIS.

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