HHS: PHS: FDA: CFSAN: OC: DCP: MSB
200 C Street, SW
May 24, 2000
TO: All Regional Food and Drug Directors
Attn: Regional/District Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Clarification of Appendix N. Record Keeping Requirements at Non-Listed Milk Plants (as Requested in Proposal 257 from the 1999 NCIMS)
Proposal 257, as accepted by the 1999 NCIMS, included a request that FDA write an M-I to clarify the intent of the Methods of Making Sanitation Ratings of Milk Shippers (MMSR) Section B.1. a. (2) as modified by this proposal. This M-I is written in response to that request.
MMSR Section B.1.a. (2) establishes that non-listed milk plants receiving milk from IMS listed BTUs, must keep, and make available records of actual milk tanker drug testing. This section provides that the State Rating Officers (SROs) and FDA Milk Specialists may accept documentation gathered by the State regulatory agency that substantial compliance with Appendix N. exists. This section also provides that the SRO (or FDA Milk Specialist through the SRO) may, at their discretion, request that industry provide records to verify this compliance.
This section also requires that the manner of storage of the records be "acceptable to the rating agency". This requirement does not provide that the RO may specify a particular place where the records must be kept, only that the SRO can require the manner of their storage be such that they can be made available to the SRO (or FDA Milk Specialist) when needed. Because proposal 258 was also accepted at the 1999 NCIMS, these records must now be available "During..." rather than "Upon initiating... ", the IMS rating or FDA check rating. The SRO can request that industry make changes in the manner in which these records are stored, if the requested records are not provided during the rating or check rating.
If these records are not provided during a rating or check rating (upon request by the SRO), the rating or check rating can not be completed and the IMS certification must be immediately withdrawn as required in MMSR Section B.1.
Language was added at the end of MMSR Section B.1.a. (2) by proposal 257 to clarify what constitutes a reasonable number of records to request in order to evaluate compliance with this section adequately, without causing an undue burden on industry.
This added language states:
"If records are requested, the rating officer should chose and request to review records for no more than fifteen days unless these selected records show a problem."
It is not necessary for the days requested to be sequential. The days chosen could include holidays, weekends and other times for which record review would most likely help the reviewer detect if there is a problem in the system at the non-listed plant.
If a problem is discovered, more records, at the discretion of the SRO (or FDA Milk Specialist), may need to be requested and examined to determine whether the supply is in substantial compliance as required under MMSR Section B. 1.
If the listing of a supply is removed for lack of compliance with MMSR B. I., the number of records requested at the next rating and check rating may be increased. This increase is at the discretion of the SRO or FDA Milk Specialist and, if required, should be adequate to establish that the problem, which resulted in the previous removal, no longer exists.
Copies of this memorandum are enclosed for your distribution to Region/District Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Rating Officers in your region. This memorandum is also available on the FDA Prime Connection Computer bulletin board system (Internet address: http://www.fda.gov), and should be widely distributed to representatives of the dairy industry and other interested parties.
Joseph M. Smucker