TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Waukesha Cherry-Burrell W265/W285 FD HTST Divert Valves
The Waukesha Cherry-Burrell W265/W285 FD HTST Divert Valves have been reviewed and found to comply with the applicable provisions of the Grade 'A' Pasteurized Milk Ordinance (PMO).
This piece of equipment is a dual stem Flow Diversion Device (FDD), which has been designed to comply with Item 16p (B) of the PMO. The technical design and supporting documentation submitted to FDA for review were for the 1.5'- 4' inch FDDs.
FDA acceptance is based on compliance with the construction, installation and operation criteria cited in Waukesha Cherry-Burrell's Operations and Maintenance Manual Publication 95-03035, June 2005 and the following provisions:
- The control system utilized with the FDD shall comply with Appendix H. Pasteurization Equipment and Procedures of the PMO and shall be found acceptable to the State Regulatory Agency.
- The installation shall comply with all applicable tests cited in Appendix I. Pasteurization Controls -Tests of the PMO.
- When installed, the magnetic flowmeter sensor and transmitter shall comply with all applicable test requirements in Appendix I. Pasteurization Equipment and Controls -Tests of the PMO.
- Upon proper installation and the determination of compliance through appropriate PMO testing, regulatory seals shall be applied through the handle of the manual air shut-off valves and around the valve body. The seal shall be sufficiently tight to assure that the manual shut-off valve cannot be closed without breaking the seal.
FDA's review and acceptance of this flow diversion device does not constitute agency endorsement or approval. Any representation on a label or in printed literature citing or indicating "FDA Approval" is false and misleading.
For additional information regarding this equipment, please contact:
Waukesha Cherry Burrell
611 Sugar Creek Road
Delavan, WI 53115
Chanhassen, MN 55317, USA
Phone: (262) 728-1900
Fax: (262) 728-4904
Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies 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.fda.gov/Food at a later date.
If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.
Jonathan M. Gardner
FDA/MST Milk Sanitation Officer
Test Procedures and Sealing