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Signing Of Letters Of Understanding With Two (2) Third Party Certifiers Authorizing Them To Participate In The National Conference On Interstate Milk Shipments’ Voluntary International Certification Program

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-14-2

January 24, 2014

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

FROM: Dairy and Egg Branch/Milk Safety Team (HFS-316)

SUBJECT: Signing Of Letters Of Understanding With Two (2) Third Party Certifiers Authorizing Them To Participate In The National Conference On Interstate Milk Shipments’ Voluntary International Certification Program

The National Conference on Interstate Milk Shipments (NCIMS) has signed Letters of Understanding (LOUs) authorizing the following two (2) Third Party Certifiers (TPCs) to participate in the NCIMS Voluntary International Certification Program (ICP).  These are the first two (2) TPCs authorized under the ICP.

  • Milk Regulatory Consultants, LLC
  • Harold Wainess & Associates, Inc.

Letter of Understanding(LOU): A formal written signed agreement between a Third Party Certifier (TPC) and the NCIMS Executive Board that acknowledges the NCIMS’ authorization of the Third Party Certifier (TPC) to operate under the NCIMS voluntary International Certification Program (ICP).  It also states the Third Party Certifier’s (TPC’s) responsibilities under the NCIMS voluntary International Certification Program (ICP); their agreement to execute them accordingly; and their understanding of the consequences for failing to do so.  The Letter of Understanding (LOU) shall include, but is not limited to, the issues and concerns addressed in all documents involved in the NCIMS voluntary International Certification Program (ICP).

The ICP institutes a fourth (4th) option for the listing of milk companies on the Interstate Milk Shippers (IMS) List to provide a means for NCIMS member States to accept Grade “A” milk and/or milk products processed in these IMS Listed milk companies. The two (2) TPCs will implement, regulate, enforce, rate and verify compliance with the regulations contained in the most current revision of the Grade “A” Pasteurized Milk Ordinance (PMO) and related NCIMS documents for the purpose of listing milk companies in areas outside of the boundaries of the United States. Listing of milk companies on the IMS List under the NCIMS voluntary ICP will enable the importation of Grade “A” milk and/or milk products into the United States from those IMS listed milk processing plants and Bulk Tank Units (BTUs)-a single or group of dairy farms, located outside of the U.S. boundaries. 

The NCIMS Grade “A” Milk Safety Program and the PMO require that all Grade “A” milk and milk products in interstate commerce and all Grade “A” milk and milk products submitted for importation into the United States come from a source listed on the IMS List. The IMS List may be viewed at the following Web Site: http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2007965.htm.

The ICP is to be implemented, operated and maintained to:

  • Comply with all of the applicable requirements of the PMO and related NCIMS documents.  The regulation and rating of milk companies shall be in accordance with the applicable requirements of the NCIMS Grade “A” Milk Safety Program for the purpose of listing those complying on the IMS List.

  • Continue to ensure the same level of milk safety provided within the NCIMS Grade “A” Milk Safety Program.

  • Provide a means for NCIMS Member States to accept Grade “A” milk and/or milk products from NCIMS voluntary ICP IMS Listings.

Milk companies that are interested in importing Grade “A” milk and/or milk products into the United States under the NCIMS voluntary ICP, should contact the following NCIMS authorized TPCs:

  • Milk Regulatory Consultants, LLC

    56820 Highway A
    Russellville, MO 65074

    Mr. R. Lynn Young, Owner

    Phone: (573) 338-1785
    E-mail: RLynnYoung@cs.com

  • Harold Wainess & Associates, Inc.

    3335 N. Arlington Heights Road, Suite E
    Arlington Heights, IL 60004

    Mr. Kenneth Anderson, President

    Phone: (847) 259-6400
    Fax: (847) 259-6460
    E-mail: kenderson@aol.com

Please refer to the FDA Web Site, Memorandum of Information (M-I-13-8) at:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk/ucm287572.htm and the Procedures Document at:
http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk/UCM
378829.pdf
for information on the operation of the ICP.

For additional information concerning the NCIMS Voluntary ICP please contact one (1) of the following individuals:

NCIMS International Certification Program Committee (ICPC)

Ms. Claudia Coles, Co-Chair
WA Dept. Of Agriculture
111 Washington Street
P.O. Box 42560
Olympia, WA 98504-2560

Phone: (360) 902-1905
Fax: (360) 902-2087
Email: ccoles@agr.wa.gov

Mr. Thomas Ford, Co-Chair
Dairy Division
IN State Board of Animal Health
Discovery Hall, Suite 100
1202 E. 38th Street
Indiana State Fairgrounds
Indianapolis, IN 46205

Phone: (317) 544-2388
FAX: (317) 542-1415
Email: tford@boah.in.gov

U.S. Food and Drug Administration (FDA)

CAPT Robert Hennes
MST Team Leader
CFSAN/OFS/DPDFS/DEB/MST
Food and Drug Administration
HFS-316, Room 3B-008
5100 Paint Branch Parkway
College Park, MD 20740

Phone: (240) 402-2175
Fax: (301) 436-2715
Robert.Hennes@fda.hhs.gov

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, Milk Regulatory/Rating Agencies and 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 at a later date.

If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.

/s/

Robert F. Hennes, RS, MPH
CAPT U.S. Public Health Service
Dairy and Egg Branch/Milk Safety Team