U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
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IMS-a-40

October 24, 1997

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: 1997 NCIMS Proposals 135 and 319

On September 26, 1997 FDA issued IMS-a-39. This identical memorandum reported the actions of the May 1997 National Conference on Milk Shipments (NCIMS) and the FDA responses to all except two of these actions.

FDA and the NCIMS Executive Board agreed to delay final resolution on two proposals, 135 and 319, with which FDA did not concur. This delay was needed for FDA to complete scientific and technical reviews of these proposals and present alternate solutions.

The May 1997 proposal #135, as passed, would have changed the requirement that teats be sanitized as a part of milking preparation to a recommendation.

FDA did not concur with this solution as written but offered an alternate solution which was accepted by the NCIMS Executive Board on October 19, 1997.

The accepted alternate solution is to modify item 13r of the PMO as follows (added text is underlined):

This item is deemed to be satisfied when:

1. Milking is done in a milking barn, stable or parlor.

2. Brushing is completed prior to milking.

3. Flanks, bellies, tails and udders are clipped as often as necessary to facilitate cleaning of these areas and are free from dirt. The hair on the udders shall be of such length that it is not incorporated with the teat in the inflation during milking.

4. Udders and teats of all milking cows are clean and dry before milking. Teats shall be cleaned, treated with a sanitizing solution and dry just prior to milking; except that additional alternative udder preparation methods may also be used once they have been evaluated by FDA and found acceptable.

5. Wet hand milking is prohibited.

This alternative solution was developed by FDA based on a Center for Veterinary Medicine (CVM) scientific and technical review of available scientific literature on the subject.

FDA will use M-I memorandums to inform interested parties of those alternative udder preparation methods which FDA finds acceptable for use under the PMO.

During the CVM review, one such additional alternative method was identified. This method is described in M-I-97-6.

The May 1997 proposal #319, as passed, included language regarding vitamin fortification levels with which FDA did not concur.

On October 19, 1997, the NCIMS Executive Board and FDA agreed to an alternate solution.

This solution includes removing all references to vitamin fortification levels and accepting the remainder of the proposal as written.

The NCIMS Conference Chairman has appointed a committee to work with FDA to seek mutually acceptable language regarding vitamin fortification levels in milk products.

In the interim, M-I- 92-13 should be used to provide this guidance.

The accepted alternate solution is to modify the PMO, EML and "Procedures..." as follows:

PMO, pages 13 and 47:

Assays of milk and milk products to which vitamin(s) A and/or D _3â 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 methodologies which give statistically equivalent results to the FDA methods. Vitamin testing laboratories are accredited if they have one or more certified analysts and meet the quality control requirements of the program established by the FDA. Laboratory accreditation and analyst certification parameters are specified in the Evaluation of Milk Laboratories manual.

PMO, page 48 add new #7 and change numbers coming after

7. Vitamin testing shall be performed using test methods acceptable to the FDA and other official methodologies which give statistically equivalent results to the FDA methods.

PMO, Appendix G, page 200 add new vitamin section

Reference.-- Section 6.

Frequency.-- Annually for each product type, or when any doubt arises as to the adequacy of vitamin fortification (see Appendix O).

Methods.-- Vitamin testing shall be performed using test methods acceptable to the FDA and other official methodologies which give statistically equivalent results to the FDA methods.

PMO, Appendix O, page 321

TESTING METHODS

Test methods used for the detection of vitamins A and/or D _3â shall be those acceptable the Food and Drug Administration or other official methodologies which give statistically equivalent results to the FDA methods. Vitamin analysis shall be conducted in a laboratory accredited by the Food and Drug Administration and acceptable to the regulatory agency.

EML, page 2 new paragraph

2. Food and Drug Administration accreditation of vitamin testing laboratories is based on {a} submission of satisfactory quality control information, {b} use of methods acceptable the Food and Drug Administration or other official methodologies which give statistically equivalent results to the FDA methods and {c} have one or more certified analysts which are satisfactorily participating in the vitamin split sample program.

EML, Section 1, page 4

5. The vitamin testing laboratory has {a} submitted satisfactory quality control information, {b} uses methods acceptable the Food and Drug Administration or other official methodologies which give statistically equivalent results to the FDA methods and {c} have one or more certified analysts which have satisfactorily participated in the vitamin split sample program, i.e., have met performance levels of the proficiency testing program (Section 2).

EML, ACCREDITATION OF MILK LABORATORIES, page 5

3. Vitamin testing laboratories have submitted satisfactory quality control information, use methods acceptable the Food and Drug Administration or other official methodologies which give statistically equivalent results to the FDA methods and have one or more certified analysts which have satisfactorily participated in the vitamin split sample program.

EML, Section 2, page 8

5. When a vitamin testing analyst examines milk and milk products, a minimum of 4 samples shall be examined once every three months (quarterly) using those methods which are acceptable to the FDA, unless excused for due cause.

EML, Table 1, page 24

Change number of product samples analyzed to 4 for all categories, footnote to indicate that four samples will be tested each quarter for a total of 12 samples over the course of a year.

Procedures, page 2 add

D. Laboratory Procedures

Laboratory Procedures used to ... Official Methods of Analysis of the Association of Official Analytical Chemists. Vitamin testing shall be performed using test methods acceptable to the FDA and other official methodologies which give statistically equivalent results to the FDA methods.

Copies of this memorandum are enclosed for your distribution to District Milk Specialists, state milk regulatory agencies, State Laboratory Evaluation Officers (LEOS) 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, state veterinarians, state veterinary and pharmacy boards, veterinarian professional organizations, and all other interested parties.

Joseph M. Smucker