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U.S. Department of Health and Human Services

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M-b-350: Rosemount 8721 Sanitary Flowmeter and the 8712C or 8732D Transmitters

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Rosemount 8721 Sanitary Flowmeter and the 8712C or 8732D Transmitters

In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for Evaluating Construction, FDA's Central Region Milk Specialists and CFSAN's Milk Safety Team have evaluated this piece of equipment and have validated the technical information reviewed and submitted by the Atlantic-Midwest Dairy Equipment Review Committee (AMDERC) addressing the Rosemount 8721 Sanitary Flowmeter and 8712C or 8732D transmitters. When constructed, installed and operated as described in this memorandum, the Rosemount 8721 Sanitary Flowmeter and 8712C or 8732D transmitters have been found to meet the applicable provisions of the Grade "A" Pasteurized Milk Ordinance (PMO) when used as a magnetic flow meter based timing system for HTST pasteurizers.

Compliance with the PMO is based upon construction, installation and operation as described in the Manufacturer's Manual: Technical Data Sheet 00806-0200-4901, Rev. BA, July 2005, as well as the following provisions:

  1. The Rosemount 8721 Sanitary Flowmeter with either the 8712C or 8732D transmitters shall be installed in compliance with Appendix H. Pasteurization Equipment and Procedures, Magnetic Flow Meter Based Timing Systems for HTST Pasteurizers, including the criteria for Components and Placement of Components as cited in the PMO.  
  2. Upon installation the configured values will be documented by the manufacturer and maintained so that the operator and/or Regulatory Agency can verify these values. The Regulatory Agency should maintain a copy for their files. After the configuration values have been verified, the cover of the converter is replaced. Access to the electromagnetic flowmeter transmitter shall be restricted by the application of a regulatory seal.  
  3. 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.

The technical information that was received constitutes the Rosemount Engineering Design and Technical Construction File (EDTCF) 00816-0200-9401, Rev BA, July 2005.

For additional information regarding this equipment, please contact:

Nus Azam
Compliance Engineer
Rosemount Inc., PB 04
8200 Market Blvd
Chanhassen, MN 55317, USA
Voice: (952) 949-5169
FAX: (952) 949-5147

FDA's review and acceptance of this piece of equipment does not constitute FDA endorsement or approval. Any representation on a label or in printed literature citing or indicating "FDA Approval" is false and misleading.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. The electronic version 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.

/s/

Donald R. Goldsmith
FDA Regional Dairy Specialist
 

/s/

Jonathan M. Gardner
FDA/MSB Milk Sanitation Officer

Attachments:

Equipment Literature
Regulatory Sealing Diagram
Lockout and Sealing Guide