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February 17, 2004
Milk Safety References
Interpretation of Pasteurized Milk Ordinance (PMO)
Single-Service Glass Milk Containers (M-a-94)
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
http://www.cfsan.fda.gov at a later date.
CAPT Richard D. Eubanks, RS, MPH
Senior Milk Sanitation Officer |
CAPT Robert F. Hennes, RS, MPH
Chief, Milk Safety Branch |
Grade "A" Pasteurized Milk Ordinance - 2001 Revision