HHS:PHS:FDA:CFSAN:OC:DCP:MSB
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200 C Street, SW Washington DC M-a-93 Revised and issued: November 12, 1999 |
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Sampling Related Questions and Answers
This interpretation is issued in accordance with the Guidelines for Issuing Interpretations of the Grade A Pasteurized Milk Ordinance and Related Documents.
Comments to the initial draft of this memorandum were received by the Executive Secretary of the NCIMS Executive Board. Those comments were considered during the NCIMS Executive Board meeting on October 26, 1999, and it was agreed to issue this memorandum as follows:
Over the last year, several questions relating to sampling criteria, evaluation, and responsibilities have been generated at FDA Regional Seminars. We have used as references the Pasteurized Milk Ordinance (PMO), the Standard Methods for the Examination of Dairy Products (SMEPD), and related coded Memorandums to answer those inquiries. The questions, the available references, and the answers to these questions are included for information and guidance by all NCIMS participants.
Question 1. What minimum standards must be met by samplers who collect samples that will be used to test milk and milk product for chemical, bacteriological, and temperature standards as defined in the Pasteurized Milk Ordinance (PMO)?
Reference - The PMO addresses this issue in Section 6. The Examination of Milk and Milk Products.
"All sampling procedures and required laboratory examinations shall be in substantial compliance with the most current edition of Standard Methods for the Examination of Dairy Products of the American Public Health Association, and the most current edition of Official Methods of Analysis of the Association of Official Analytical Chemists. Such procedures, including the certification of sample collectors and examinations shall be evaluated in accordance with the Evaluation of Milk Laboratories, United States Public Health Service/Food and Drug Administration."
Answer 1. Only a sampler who has been evaluated to be in substantial compliance with the SMEDP shall collect any sample that will be analyzed using the protocols of the SMEDP. Those samplers shall be evaluated in accordance with the PMO Appendix B, the Methods for Making Sanitation Ratings, and the Evaluation of Milk Laboratories (EML).
Question 2. The PMO requires permitting/licensing of haulers/samplers. Does that requirement apply to all samplers who collect dairy products?
References- The PMO addresses this issue in Section 3. Permits. It is also referenced in IMS-a-18.
The PMO states that "Every milk producer, milk distributor, bulk milk hauler/sampler, bulk milk pickup tanker and each milk plant, receiving station and transfer station operators shall hold a valid permit. Milk producers who transport milk or milk products, only from their own dairy farms; employees of a milk distributor or milk plant operator who possesses a valid permit; and employees of a milk transportation company that possesses a valid permit and transports milk from a milk plant, receiving station or transfer station shall not be required to possess a bulk milk hauler's/sampler’s permit."
IMS-a-18 gives direction for the computation of enforcement ratings specific to approved PHS/FDA sampling procedures. That document covers the issue by asking, "Are all producer milk samplers licensed or permitted?"
Answer 2. The PMO excludes some samplers from being permitted directly. Those samplers are covered by the milk plants’, receiving stations’, or transfer stations’ permits. The PMO does not exclude those samplers (including Appendix N samplers) from being evaluated to be in substantial compliance with the SMEDP and covered under the Sample Collection Surveillance Program. Industry representatives/fieldmen who collect official producer samples must be licensed/permitted and evaluated as samplers in accordance with the PMO.
Question 3. What are the regulatory agency responsibilities for collecting, analyzing, and meeting the criteria of Section 6 of the PMO regarding producer samples (3a) and plant samples (3b)?
Reference - The PMO addresses this issue in Section 6. The Examination of Milk and Milk Products.
(Producer samples) -
"It shall be the responsibility of the bulk milk hauler/sampler to collect a representative sample of milk from each farm bulk tank prior to transferring milk from a farm bulk tank, truck or other container. All samples shall be collected and delivered to a milk plant, receiving station, transfer station or other location approved by the regulatory agency.
.....These samples shall be obtained under the direction of the regulatory agency or shall be taken from each producer under the direction of the regulatory agency."
Answer 3a. Producer samples shall be collected and analyzed under the direction of the regulatory agency. The delivery to and analysis of these samples by an official laboratory, independent laboratory or an officially designated laboratory must maintain a proper chain of custody and shall be at the direction of the state regulatory agency.
(Plant samples) –
"During any consecutive six months, at least four samples of raw milk for pasteurization, ultra-pasteurization or aseptic processing, at least four samples of heat-treated milk products, at least four samples of pasteurized milk, flavored milk, flavored reduced or lowfat milk, flavored nonfat (skim) milk, each fat level of reduced fat or lowfat milk and each milk product defined in this Ordinance, except aseptically processed, shall be collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days, from every milk plant, by the regulatory agency."
"Assays of milk and milk products to which vitamin(s) A and/or D have been added, shall be made at least annually in a laboratory which has been accredited by the U.S. Food and Drug Administration and which is acceptable to the regulatory agency, using test methods acceptable to the FDA and other official program established by the FDA."
Answer 3b. All plant sampling for regulatory purposes shall be by the regulatory agency, except samples for vitamin analysis taken under the direction of the regulatory agency. This requirement does not apply to sample collection for screening bulk milk tankers for Appendix N. Appendix N industry samplers shall be evaluated according the requirements specified in Section 6.
Question 4. Does this also apply to single service container samples?
Reference - The PMO addresses this issue in Section 7. Items 11p. & 12p.
Item 11p. - "The manufacture, packing, transportation and handling of single-service containers, closures, caps, gaskets and similar articles comply with the requirements of Appendix J – Standards for the Fabrication of Single Service Container and Closures for Milk and Milk Products. Inspections and tests shall be made by the regulatory agency or any agency authorized by them."
Item 12p. - "When single-service containers are fabricated in another plant which conforms to the Standards of Appendix J, and the regulatory agency has information that they do comply, the regulatory agency may accept the containers as being in conformance without additional tests. If there is reason to believe that containers do not conform to the bacteriological standards, additional tests may be required. If containers are fabricated in the dairy plant, the regulatory agency shall collect at least 4 sets of containers, each 6 months, and determine conformance."
Answer 4. For container’s fabricated in a dairy plant, the regulatory agency must collect these samples as they would any other plant sample. Samples from the stand alone single service manufacturers could be collected under the direction of the regulatory agency. In many states, these plants are not under the direction of the regulatory agency. They are only surveyed by rating officers who may not direct any action because they do not have regulatory authority. All single-service containers shall be collected and tested in accordance with the latest addition of the SMEDP.
Question 5. What are the regulatory agency responsibilities for sample collection and analysis of water samples for both producer dairies and plants?
Reference - The PMO addresses this in the administrative procedures of Items 7p., 17p., & 8r. of Section 7.
Items 7p. & 17p. "Samples shall be taken by the regulatory agency and examinations shall be conducted in an official laboratory."
Item 8r. "Bacteriological examinations shall be in a laboratory acceptable to the regulatory agency."
Answer 5. All water sampling from plants, receiving and transfer stations shall be taken by the regulatory agency and examinations shall be conducted in an official laboratory. The producer water samples shall be analyzed at a laboratory acceptable to the regulatory agency and collected as directed by the regulatory agency.
Question 6. What responsibility do regulatory agencies have to prevent pre-notification of PMO required samples and to adhere to the criteria for "Universal Sampling"?
Reference - The PMO addresses this issue in Section 6. and Appendix B. Milk Sampling, Hauling and Transportation.
Section 6. - "SAMPLING PROCEDURES—The Standard Methods for the Examination of Dairy Products contains guidance for sampling of products. See Appendix G for a reference to drug residues in milk and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream. See Appendix B for reference to farm bulk milk hauling programs regarding training, licensing/permitting, routine inspection and the evaluation of sampling procedures."
Appendix B. - "Universal Sampling System. It is required that if haulers/samplers collect raw milk samples, the "universal sampling system" be employed, whereby milk samples are collected every time the milk is picked up at the farm. This system permits the enforcement agency, at its discretion, at any given time and without notification to the industry, to analyze samples collected by the hauler/sampler. The use of the "universal sample" puts more validity and faith in samples collected."
Answer 6. For a regulatory agency to use samples collected under a universal sampling program, samples must be available for analysis at any given time and without notification to the industry. Regulatory agencies shall give direction for the collection and analysis of producer samples. The delivery to and analysis of these samples by an official laboratory, independent laboratory or an officially designated laboratory must maintain a proper chain of custody and shall be at the direction of the state regulatory agency.
The FDA has always maintained that "routine" inspections, state ratings, federal ratings, sample analysis, and most regulatory activities must be accomplished without notification. We have reinforced the position that "unannounced inspections" and sampling are necessary to have integrity in the program. Every effort must be made to discourage sampling pre-notification.
Samples must be randomly selected.
Question 7. Asked, "What minimum criteria must be met for sampling bulk milk pickup tankers for Appendix N samples?"
This question is still the subject of discussion between the NICMS Executive Board and FDA. This memorandum will be revised and reissued when those issues are resolved.
Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, state milk regulatory agencies, State Laboratory Evaluation Officers and State Milk Rating Officers in your region. This memorandum is also available on the FDA Web site at http://www.cfsan.fda.gov and should be widely distributed to representatives of the dairy industry and other interested parties.
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Joseph M. Smucker, Chief Milk Safety Program |