Jerry Mulnick
Regional Shellfish Specialist
FDA - Northeast Region
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To: SMTP[rsardine@bangornews.infi.net],
SMTP[rsardine@bangornews.infi.net]
Cc: Jerrold Mulnick@NER@FDAORANER, Jerrold Mulnick@NER@FDAORANER
From: John Schrade@NER@FDAORANER
Date: Wednesday, February 17, 1999 at 7:39:52 am EST
Attached: None
Dear Mr. Hoelzer:
I would like to offer my opinion concerning the question you raised relative to receiving product from a processor who has previously addressed related hazards. I would like to reference a section of the preamble to 21 CFR Parts 123 and 1240 "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products." A section of page 65114 notes that "For the most part, hazards deriving from the environment (pesticides, etc.) will be controlled during the initial processing of the product (i.e., by the first processor to take possession). As a result, subsequent processors will receive products that are generally free of environmental hazards and thus will not need to establish HACCP controls for them." It goes on to say "The same principle holds true for hazards arising during processing operations that occur before storage in a warehouse. Those hazards must be controlled during the prior processing and generally not during storage."
A properly formulated and executed HACCP plan should successfully address all hazards related to that product up until the time the second buyer takes possession. If we assume a HACCP failure on the part of a supplier then in fact you are correct in saying "...we are back to the old style of inspection." However, any remanufacture of product on the part of a second processor would require a separate hazard analysis to determine if any new hazards have been introduced and based upon the products intended use, a system of hazard control should be developed.
HACCP is a system that is built upon controls; its success relies on the trust that hazards are controlled at each processing step. Trust but verify...and verification can be done by reviewing the HACCP or hazard analysis records of the previous processor.
I hope that I have been helpful.
John P. Schrade
Regional Food Specialist
FDA - Northeast Region