Current through Register Vol. 50, No. 9, September 20, 2024
A. Shell-stock harvested for delivery to a
steam factory for canning and thermal processing shall be landed at the factory
within 72 hours from the time harvesting begins. The time harvesting begins and
the time of arrival at the factory shall be recorded on the harvester's
invoice.
B. If a harvester elects
to fish shellstock intended for raw (half shell) consumption during the months
of March-November, it shall be unlawful to possess shellstock intended for
shucking, post-harvest processing, relaying or bedding until all shellstock
harvested for raw (half shell) consumption are off-loaded dockside. However a
harvester may fish shellstock for shucking and post-harvest processing at the
same time when fishing shellstock for raw (half shell) consumption provided
that the refrigeration and time/temperature requirements for raw (half shell)
consumption are followed for the entire harvest (i.e., all harvested shellstock
on board shall meet the time/temperature requirements of §329. A of this
Part).
C. Except for deliveries
made to a shellfish dealer certified by the Office of Public Health for
inclusion on the U.S. Food and Drug Administration's Interstate Certified
Shellfish Shippers List and located less than 30 minutes from dockside, all
land-based deliveries of shell stock shall be made aboard mechanically
refrigerated trucks with an internal air temperature of 45 degrees Fahrenheit
or less as measured 12 inches from the blower. For shipments by air, an
internal meat temperature of 45 degrees Fahrenheit or less shall be maintained
at all times. To accomplish this it shall be necessary to pre-chill shellstock
to an internal temperature of 40 degrees. Fahrenheit or less prior to being
packed into insulated containers with frozen gel packs. Land-based deliveries
of molluscan shell stock to a steam factory for thermal processing and canning
shall be exempt from these refrigeration requirements during the months
November through May provided that the shellfish are delivered to the cannery
in accordance with the requirements cited in Paragraph A of this Section and
the Department of Wildlife and Fisheries, Enforcement Division is notified via
their toll free telephone number [(800) 442-2511] prior to making each
delivery.
D. When shell-stock are
temporarily off-loaded for any reason, storage must be on pallets or on a well
graded paved surface, with direct exposure to the sun limited to no more than
30 minutes.
E.
1. A Harvester-Dealer Time/Temperature Log
Sheet (see §345) shall be completed by both the harvester and first certified
dealer to document compliance with time to refrigeration requirements during
the months January through December. Log sheets shall be maintained for a
period of one year and made readily available for inspection by agents of the
Department of Health and Hospitals, Department of Wildlife and Fisheries and
the U.S. Food and Drug Administration. Log sheets for the current and previous
15 days harvest shall be kept aboard the harvest vessel for immediate
examination. The requirement for a Harvest-Dealer Time/Temperature Log Sheet
will not apply to the West Cove Conditional Management Area or the Lower
Calcasieu Lake Conditional Management Area which are located in Cameron Parish.
Log Sheet Instructions: A Harvester-Dealer Time/Temperature Log Sheet (see
§345 formerly Table 1). Prior to the
taking of oysters the harvester shall make the following legible entries:
a. boat name/number;
b. harvester name/license number;
c. harvester signature and date;
d. harvesting area/lease number (Note: if
there is a change relating to harvesting area/lease number, the changes must be
documented on log sheet.);
e. time
harvesting begins;
f. harvester
shall declare whether oysters will be bedded, shucked, relayed or other
(explain).
2. Upon
completion of the taking of oysters and prior to the leaving of the harvesting
site, the harvester shall record the time harvesting ended and the total number
of sacks harvested.
3. If the
harvester declares sacks of oysters for both shucking and half-shell, those
oysters shall be distinguished by placing the appropriate tag on the sack prior
to leaving the harvesting area.
4.
The certified dealer information shall be completed as follows.
a. The certified dealer/agent shall legibly
document in the appropriate place on the harvester dealer time/temperature log
sheet the temperature of the cooler where oysters are being stored at the time
unloading of the harvesting vessel begins.
b. The certified dealer/agent shall legibly
document in the appropriate place the time when the last sack or container of
oysters taken from the harvest vessel is placed in the cooler. This entry must
be made immediately upon removal of the last sack or container of shellfish
from the vessel.
c. The certified
dealer/agent shall legibly document in the appropriate place the temperature of
the cooler immediately upon removal of the last sack or container of oysters
from the harvesting vessel and placement of same under refrigeration.
d. The certified dealer/agent shall
immediately sign and date the log sheet in the appropriate place.
5. Alternate designs for the
Harvester-Dealer Time/Temperature Log Sheet depicted in
§345 may be submitted for consideration
and approval to the Office of Public Health.
F. Post-Harvest Processing
1. If a dealer elects to use a process to
reduce the levels(s) of one target pathogen or some target pathogens, or all
pathogens of public health concern in shellfish, the dealer shall:
a. have a Hazard Analysis Critical Control
Point (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:
i.
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 pergram) 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;
ii. for processes
that target Vibrio parachaemolyticus, the level of
Vibrio parachaemolyticus in product that has been subjected to
the process shall be nondetectable (<30 per gram)
iii. 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;
iv. 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;
v. the HACCP plan shall
include:
(a) process controls to ensure that
the end point criteria are met for every lot; and
(b) a sampling program to periodically verify
that the end point criteria are met;
b. package and label all shellfish in
accordance with all requirements of the Model 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 and X.07 of the National Shellfish Sanitation Program
Model Ordinance;
c. keep records in
accordance with Chapter X.08 of the National Shellfish Sanitation Program Model
Ordinance.
2. A dealer
who meets the requirements of this Section may label product that has been
subjected to the reduction process as:
a.
"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;
b. "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
c. "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
d. 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 §333.
F.2 c
3. For the
purpose of product temperature the receiving and storage critical control
points of shucked product apply to shell stock prior to PHP processing.
Following PHP processing, 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 shellstock.
4. A
harvester-dealer oyster tag, blue in color, shall be used for In-Shell Product
that has undergone a Post-Harvest Treatment Process.
5. Certification number of the post-harvest
treatment facility is required on all post-harvest treated tags.
1. Certified dealers shall adopt written
procedures for conducting recalls of adulterated or misbranded shellfish
products. These written procedures for conducting recalls shall be based on,
and complementary to, the FDA Enforcement Policy on Recalls published in the
April 1, 2003 Code of Federal Regulations, Title 21, Chapter 1, Subchapter A,
Part 7-Enforcement Policy which is also contained in the 2019 NSSP Guide for
the Control of Molluscan Shellfish under Section VII (Federal Regulations)
thereof.
G.
Recalls
1. Certified dealers shall adopt
written procedures for conducting recalls of adulterated or misbranded
shellfish products. These written procedures for conducting recalls shall be
based on, and complementary to, the FDA Enforcement Policy on Recalls published
in the April 1, 2003 Code of Federal Regulations, Title 21, Chapter 1,
Subchapter A, Part 7-Enforcement Policy which is also contained in the 2019
NSSP Guide for the Control of Molluscan Shellfish under Section VII (Federal
Regulations) thereof.
2. Certified
dealers shall follow their written recall procedures to include timely
notification of the Office of Public Health of a situation requiring recall,
timely notification of consignee who received the affected product, and
effective removal or correction of the affected product.
H. A Hazard Analysis Critical Control Point
(HACCP) plan for oyster harvesters shall be required for all oyster harvesters
dredging for product intended for the half-shell market.
1. The oyster harvester must demonstrate
through record keeping that oysters harvested have met the refrigeration time
and temperature requirements of §329
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:4(A)(1),
R.S.
40:5(2)(3)(5)(7)(15)(17)(19)(20)(21),
and
R.S.
40:5.3.
