M-a-94: Single-Service Glass Milk Containers
Milk Safety References
Single-Service Glass Milk Containers
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Single-Service Glass Milk Containers
Following the "Procedure for Issuing Interpretations of the Grade "A" PMO and Related Documents" from the Procedures document, the following interpretation was passed by a simple majority of the returned ballots of the NCIMS voting delegates and; therefore, will have an implementation date of February 1, 2005. PHS/FDA at the next duly convened Conference will submit a Proposal incorporating the requirements of M-a-94 into the appropriate document(s).
The following guidelines shall be applicable for single-service glass containers used in the packaging of Grade "A" milk and milk products in IMS listed plants.
Since single-service glass bottles meet the definition of a "single-service container" as defined in Appendix J. of the Pasteurized Milk Ordinance (PMO), and they must be manufactured, packaged, transported and handled in accordance with the requirements of Appendix J., and meet all other applicable requirements of the PMO.
The following requirements are for NCIMS listed milk plants choosing to use single-service glass bottles for the packaging of Grade "A" milk and milk products:
- Single-service glass containers shall be manufactured in a facility that has been evaluated and is currently certified and IMS Listed by either a State Milk Sanitation Rating Authority, if located within the United States, or an acceptable Sanitation Consulting Firm, if manufactured in a facility located outside the United States.
- Single-service glass containers shall be manufactured from non-toxic materials and packaged and shipped in a manner that protects them from contamination, i.e., shrink-wrapped in plastic or other methods acceptable to the Regulatory Agency. All containers shall be identified (coding is acceptable) as to the plant of manufacture. Closures for the containers shall be single-service, designed to protect the pouring lip of the container and from an IMS listed fabricator.
- These containers shall be inspected prior to filling to determine general condition, damage, and/or the presence of foreign materials, broken glass, other contaminates, etc.
- Single-service glass containers shall be sanitized immediately prior to filling. Sanitizing solutions must be removed from the container prior to filling. Inverted draining, sterile air evacuation or other effective methods acceptable to the Regulatory Agency may accomplish this.
- As determined by the Regulatory Agency, single-service glass containers that are received at the processing plant in an unclean and/or unprotected state, shall be properly cleaned and sanitized immediately prior to packaging. This cleaning/sanitizing operation shall be conducted in a room separate from case washing operations and rooms used for the pasteurization, processing, cooling and packaging of milk and milk products. Equipment and procedures used for the cleaning of single-service glass bottles shall meet all the requirements of Item 12p of the PMO, including recommended sanitization efficiency tests by the Regulatory Agency.
- Single-service glass containers must be labeled with wording to designate "single-service use only".
Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web site at a later date.
CAPT Richard D. Eubanks, RS, MPH
Senior Milk Sanitation Officer
CAPT Robert F. Hennes, RS, MPH
Chief, Milk Safety Branch