La. Admin. Code tit. 51 § IX-333

Current through Register Vol. 50, No. 9, September 20, 2024

Section IX-333 - General Provisions [formerly paragraph 9:052-3]

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.

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

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

La. Admin. Code tit. 51, § IX-333

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1309 (June 2002), amended LR 28:1592 (July 2002), repromulgated LR 29:173 (February 2003), amended LR 34:2176 (October 2008), LR 38:97 (January 2012), LR 40:1009 (May 2014), Amended LR 481854 (7/1/2022), Amended LR 482143 (8/1/2022).

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.