California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 10.5 - RAW OYSTER WARNING AND TAG AND LABEL REQUIREMENTS › Section 13675 - Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For purposes of this
						article, the following definitions shall apply:
(1) "Dealer" means a person who shucks, packs,
						re-packs, processes, labels, re-labels, ships, re-ships, holds or otherwise sells
						shellfish. "Dealer" does not include persons solely engaged in retail activities as
						defined in the Health and Safety Code, Section
						113895.
(2) "FDA" means the United States Food and Drug
						Administration.
(3) "Gulf oyster" means
						any oyster harvested from the states of Alabama, Florida, Louisiana, Mississippi, or
						Texas.
(4) "Half-shell oyster" means any
						oyster from which one shell has been removed.
(5) "MPN" (Most Probable Number) means a
						statistical estimate of the number of bacteria per unit volume determined from the
						number of positive results in a series of fermentation tubes.
(6) "Offers" means making raw oysters available to
						any person, whether the raw oysters are subject to purchase, exchange, or transfer,
						or are provided without charge.
(7)
						"Orders" means requesting or selecting raw oysters for consumption on the premises
						of a retail food facility, or requesting or selecting raw oysters for consumption
						off the premises.
(8) "Oyster treatment
						process" means a process that has been determined by the state shellfish control
						authority having jurisdiction, the FDA, or a recognized process authority to
						consistently reduce the level of
Vibrio vulnificus
to less than 30
						MPN per gram and achieve a minimum 3.52 log reduction in processed oysters, as
						determined by the use of the
Vibrio vulnificus
EIA procedure of
						Tamplin et al. as described in Chapter 9 of the FDA
Bacteriological
						Analytical Manual,
7th edition 1992, which is hereby incorporated by
						reference, or another method that is at least equivalent to this method in terms of
						accuracy, precision, and sensitivity in detecting
Vibrio vulnificus
as determined by the state shellfish control authority having jurisdiction, the FDA,
						or a recognized process authority.
(9)
						"Recognized process authority" means the person(s) or organization(s) recognized by
						the state shellfish control authority or the FDA as having expert knowledge of
						oyster treatment processes, and having adequate facilities for making such
						determinations.
(10) "Retail food
						facility" means "retail" as defined in Section
						113895
						of the Health and Safety Code and "food facility" as defined in Section
						113789
						of the Health and Safety Code.
(11)
						"Shellfish Control Authority" means the State, or other regulatory authority, or its
						designated agents responsible for the enforcement of laws or regulations governing
						shellfish growing and harvesting areas, shellfish handling facilities and dealer
						activities including harvesting, transporting, storing, handling, processing,
						packing, and repacking of shellfish.
(12) "Shellstock oyster" means any oyster in both
						shells.
(13) "Shucked oyster" means any
						oyster from which both shells have been removed and which has been packed in a
						container by a dealer.
(14) "Tent cards"
						means free-standing print displays or a printed display in a supporting stand
						designed for placement on dining tables or food service
						counters.