200 C Street, S.W.
Washington, DC 20204
IMS-a-42 (Correction #1)
November 12, 1999
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialist
FROM: Milk Safety Team (HFS - 626)
SUBJECT: Proposal 236, Grade "A" Labeling
Proposal #236 from the May 1-6, 1999 NCIMS Conference added the following (underlined) words to #4 of Section 4 of the R-5 PMO:
- The Words "Grade A" on the exterior surface. Acceptable locations shall include the principal display panel, the secondary or informational panel, or the cap/cover.
During the NCIMS Executive Board meeting on July 27, 1999, Proposal #236 was brought before the NCIMS Executive Board for reconsideration. After discussion, the Executive Board voted to extend the implementation date for Proposal #236 from August 16, 1999 to July 1, 2000.
During the next NCIMS Executive Board meeting on October 25, 1999, FDA informed the Executive Board that Section VII of the Procedures document establishes implementation dates for proposals that are passed and that the NCIMS Executive Board should not have opened Proposal #236 for reconsideration.
Therefore, the implementation date for Proposal #236 stated on page 9 of IMS-a-42 as July 1, 2000 is hereby corrected to August 16, 1999.
During the October 25, 1999 NCIMS Executive Board’s discussion of this issue, the Board passed a motion to request the FDA to issue a memo to clarify the labeling issue and that enforcement action not be taken on ratings and check ratings until July 1, 2000. In response to that request, FDA will use enforcement discretion on a case-by-case basis based on each situation’s merits for the implementation of Proposal #236. This discretion will only be extended during State milk sanitation ratings or FDA check ratings, when the following criteria have been assessed:
- A firm is in the process of using existing label supplies on-hand and new labels have been ordered before the date of this memorandum,
- A "good faith effort" was expended in obtaining new labeling that complies with the requirements of Proposal #236. A "good faith effort" includes evidence of the date when new labeling was ordered, quantities ordered and a detailed explanation of why new labeling cannot be employed on time,
- A statement is given as to the total number of units of noncomplying labeling for which the extension is requested,
- A statement is given as to the estimated date by which new labeling can be employed, and
- The firm has made arrangements with the State regulatory agency to ensure that the new labels will be used on all products as soon as they become available and that existing inventories of unused labels will be discarded when new labels are available.
Copies of this memorandum are enclosed for distribution to District 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 CFSAN World Wide Web site at http://www.cfsan.fda.gov and should be widely distributed to representatives of the milk industry and other interested parties.
Joseph M. Smucker, Chief
Milk Safety Branch, HFS - 626
Division of Cooperative Programs
Center for Food Safety and Applied Nutrition
U. S. Food and Drug Administration