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Dairy Products Safe and True

Part B     Standards

MRD Standard 9

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Testing of Dry Milk Products Intended for Export to the USA for Salmonella and Penicillin (SUPERCEDED)

1. Purpose
2. Scope
3. Definitions
4. References
5. Laboratory approval
6. Laboratory registration
7. Methods of approval
8. Laboratory management and approval
9. Documentation
10. Reporting to MAF
11. Audits

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1.     Purpose

1.1     The Memorandum of Understanding (MOU) requires each lot of dry milk products offered for export to the USA to be inspected by MAF for Salmonella and penicillin and certified by an official analyst.

1.2     The FDA has recently agreed that testing may be carried out at any laboratory under MAF supervision, and that certificates of analysis are no longer required to accompany each lot of dry milk product offered for entry into the USA. To satisfy the MOU, all dry milk products offered for export to the USA must still be tested for Salmonella and penicillin, the results must be negative, and MAF certificates must be available on request.

1.3     This standard specifies the conditions under which laboratories may be approved to provide a testing service for compliance with the MOU.

2.     Scope

This standard applies to all laboratories that test dry milk products offered for export to the USA for Salmonella and penicillin for compliance with the MOU.

3.     Definitions

FDA means the Food and Drug Administration, Public Health Service, Department of Health, Education and Welfare, USA.

MAF means the Ministry of Agriculture, New Zealand.

MOU means the Memorandum of Understanding between the FDA and MAF, 1974.

4.     References

• FDA Bacteriological Analytical Manual for Foods (FDA BAM). 7^th Edition. 1992.
• MAF Regulatory Authority (Dairy). Dairy Products Safe and True. June 1993.
• MRD-Stan 2. Standard for Reporting Information to MAF Regulatory Authority.
• NZCP 5: New Zealand Dairy Industry Product Safety Standards Code of Practice. October 1992.
• NZCP 14: New Zealand Dairy Industry Salmonella and Listeria Testing Code of Practice. November 1994*.
• NZTM 2: New Zealand Dairy Industry Microbiological Methods Manual. June 1993*.

5.     Laboratory Approval

5.1     The laboratory shall be approved by MAF Regulatory Authority to test dry milk products offered for export to the USA.

5.2     The conditions for approval are:

5.2.1     The laboratory shall be registered (see Section 6) and shall comply with NZCP 14* (see Section 8).

5.2.2     The laboratory shall accept MAF Regulatory Authority and FDA audits as required (Section 10).

5.3     Approved laboratories will be included in the list of "Recognised Inspection and Audit Services", Section 32, Dairy Products Safe and True.

5.4     MAF Regulatory Authority may withdraw approval at any time if a laboratory fails to meet the conditions.

6. Laboratory Registration

6.1     The testing laboratory shall be registered by MAF Regulatory Authority under the Dairy Industry Regulations 1990. The test schedule shall include testing of dry milk products for Salmonella and penicillin by the FDA BAM method.

6.2     The requirement for registration is that the laboratory must be accredited as meeting the requirements of ISO Guide 25 by a laboratory accreditation agency recognised by MAF Regulatory Authority. Currently TELARC is the only recognised agency.

7.     Methods of Testing

7.1     Salmonella

7.1.1     Samples shall be tested for Salmonella in accordance with FDA BAM.

7.1.2 To assist laboratories, the method of testing also appears in NZTM 2*, Method 58.1: Salmonella; Detection by the FDA Method. Pre-enrichment shall be carried out according to NZTM 2*, Section 58.1.8.

7.2 Penicillin

Samples shall be tested for penicillin in accordance with FDA BAM.

8.     Laboratory Management and Operation

8.1     The laboratory shall comply fully with the requirements of NZCP 14*. This includes in particular having the facilities to handle both routine samples and traceback samples; sample handling facilities appropriate to handling large numbers of high volume dry samples; environmental monitoring to minimise the risk of cross-contamination; and facilities for decontamination and disposal of pre-enrichment broths that contain a high percentage of protein material.

8.2     MAF Regulatory Authority will verify compliance to NZCP 14* in conjunction with the normal verification audit.

9.     Documentation

9.1     The laboratory shall store and retain the following information for each sample tested:

• product type,
• New Zealand Dairy Board specification number,
• manufacturer's name and address,
• factory registration number,
• batch or lot number,
• bag size,
• number of bags per batch or lot,
• test results for each test,
• date of test.

9.2     The laboratory shall make an attested statement of this information available to the Chief Dairy Officer, MAF, on request.

9.3     The Chief Dairy Officer will furnish a certificate for any lot(s) or parts of a lot if required by FDA.

9.4     These records shall be retained for at least 7 years from the date of manufacture.

10.     Reporting to MAF

10.1     The laboratory shall provide reports of test results to dairy companies or to MAF Regulatory Authority as required to satisfy MRD-Stan 2.

10.2     The laboratory shall provide a monthly report to MAF Regulatory Authority covering:

• a summary of internal and external quality control checks,
• external audit reports, action taken on non-conformances and corrective actions,
• changes to procedures, changes to personnel and changes to facilities.

11.     Audits

11.1     MAF Regulatory Authority will audit records held by laboratories and the exporter (New Zealand Dairy Board) periodically during verification audits, to verify that all product exported to the USA has been tested and complies with the MOU.

11.2     The FDA may require or conduct audits of testing facilities periodically. Laboratories testing for the purposes of this standard shall comply with the requirements of this audit.

Revision Status

Rev	Date	Status	By	Approved
1	30 June 1995	Issued for use	Chief Dairy Officer

Amendment and Control Procedure

Amendments to this standard are issued to holders of Dairy Products Safe and True, and to the MAF Reg address list for circulars and newsletters. Suggestions for improvements to this standard are welcomed. They should be sent to: The Chief Dairy Officer MAF Regulatory Authority P.O. Box 2526 Wellington

* These publications are confidential to the New Zealand Dairy Industry. Parties outside the New Zealand Dairy Industry wishing to procure these publications should contact the Quality Consultant (Industry), New Zealand Dairy Board, P.O. Box 417, Wellington.