| (a) If a dealer elects to use a process to reduce the level(s) of one target pathogen, some target pathogens, or all target pathogens of public health concern in shellfish the dealer shall: (1) have a HACCP plan approved by the SSD for the process that ensures that the target pathogen(s) are at safe levels for the at risk population in product that has been subjected to the process: (A) for processes that target Vibrio vulnificus , the level of Vibrio vulnificus in product that has been subjected to the process shall be non-detectable (<3 MPN/gram), to be determined by use of the Vibrio vulnificus FDA approved EIA procedure of Tamplin, et al, as described in the FDA Bacteriological Analytical Manual, 7th Edition, 1992, Chapter 9. (B) for processes that target Vibrio parahaemolyticus , the level of Vibrio parahaemolyticus in product that has been subjected to the process shall be non-detectable (<1 CFU/0.1 gram). (C) for processes that target other pathogens, the level of those pathogens in product that has been subjected to the process shall be below the appropriate FDA action level, or in the absence of such a level, below the appropriate level as determined by the Interstate Shellfish Sanitation Conference. (D) the ability of the process to reliably achieve the appropriate reduction in the target pathogen(s) shall be validated by a study approved by the SSD, with concurrence of FDA. (E) the HACCP Plan shall include: (i) process controls to ensure that the end point criteria are met for every lot; and (ii) a sampling program to periodically verify that the end point criteria are met. (2) package and label all shellfish in accordance with all requirements of §§241.65 - 241.67 of this title. This includes labeling all shellfish which have been subjected to the process but which are not frozen in accordance with applicable shellfish tagging and labeling requirements in §§241.65 - 241.67 of this title; and (3) keep records in accordance with §241.69 of this title (relating to Shipping Documents and Records). (b) A dealer who meets the requirements of this section may label product that has been subjected to the reduction process as: (1) "Processed for added safety," if the process reduces the levels of all pathogens of public health concern to safe levels for the at risk population; (2) "Processed to reduce (name of target pathogen(s)) to non-detectable levels", if the process reduces one or more but not all pathogens of public health concern to safe levels for the at-risk population and if that level is non-detectable; or (3) "Processed to reduce (name of target pathogen(s)) to non-detectable levels for added safety", if the process reduces one or more but not all pathogens of public health concern to safe levels for the at-risk population and if that level is non-detectable; or (4) a term that describes the type of process applied (e.g. "pasteurized", individually quick frozen", "pressure treated") may be substituted for the word "processed" in the options contained in (b)(1), (2) or (3) of this section. (c) For the purpose of refrigeration, if the end product is dead, the product shall be treated as shucked product. If the end product is live, the product shall be treated as shell stock. |
