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National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2003
Model Ordinance
XVI. Post-harvest Processing
Table of Contents
Post-Harvest Processing
- If a dealer elects to use a process to reduce the level(s) of
one target pathogen or some target pathogens, or all pathogens of
public health concern in shellfish, the dealer shall:
(1) |
Have a HACCP plan approved
by the Authority 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 (<30 MPN/gram), to
be determined by use of the Vibrio vulnificus FDA approved
EIA procedure of Tamplin, et al, as described in Chapter 9 of the FDA Bacteriological
Analytical Manual, 7th Edition, 1992, or other method approved for NSSP
use. |
(b) |
For processes that
target Vibrio parahaemolyticus (the O3:K6 serotype shall be used for
validation),
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 ISSC. |
(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 Authority, with the 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 this Ordinance. 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 Chapter X.05 and X.06. |
(3) |
Keep records in accordance
with Chapter X.07. |
- 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)-(3). |
- For the purposes of refrigeration, if the product is dead, the
product shall be treated as shucked product. If the product is live,
the product shall be treated as shellstock.