Cal. Code Regs. Tit. 17, § 13675 - Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements
(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.
(b) Every
retail food facility that offers raw Gulf oysters shall provide a written
warning to any person who orders raw oysters, as provided in this section.
(1) The written warning shall be worded in
English and Spanish as follows:
WARNING
THIS FACILITY OFFERS RAW OYSTERS FROM THE GULF OF MEXICO. EATING THESE OYSTERS MAY CAUSE SEVERE ILLNESS AND EVEN DEATH IN PERSONS WHO HAVE LIVER DISEASE (FOR EXAMPLE ALCOHOLIC CIRRHOSIS), CANCER OR OTHER CHRONIC ILLNESSES THAT WEAKEN THE IMMUNE SYSTEM. If you eat raw oysters and become ill, you should seek immediate medical attention. If you are unsure if you are at risk, you should consult your physician.
AVISO IMPORTANTE
ESTA FACILIDAD OFRECE OSTRAS CRUDAS DEL GOLFO DE MEXICO. A COMER ESTAS OSTRAS CRUDAS PUEDEN CAUSAR UNA ENFERMEDAD GRAVE Y HASTA LA MUERTA EN LAS PERSONAS QUE PADECEN DE ENFERMEDADES DEL HIGADO (POR EJEMPLO, CIRROSIS ALCOHOLICA), CANCER U OTRAS ENFERMEDADES CRONICAS QUE DEBILITAN EL SISTEMA INMUNOLOGICO. Si usted come ostras crudas y se enferma, debe buscar atenciͳn medica inmediatamente. Si usted cree estar en peligro, debe consultar a un médico.
(2) Where raw oysters are purchased by a
consumer over a counter, or where they are offered for sale by a sign, tag, or
menu board, the sign bearing the warning set forth in subsection (b)(1) shall
be prominently placed so that it is likely to be read by consumers prior to
ordering raw oysters. The warning signs shall meet the following
specifications:
(A) Be square in shape and no
smaller than 10 inches on a side (100 square inches) or be rectangular in shape
and no smaller than 11 inches high by 8.5 inches wide (93.5 square
inches).
(B) Be printed in black
ink on a white background, dark blue ink on a yellow background or other ink
that is of high contrast from the color of the background material.
(C) At least 1/3" space shall be maintained
around the notice.
(D) The word
"Warning" and the words "Aviso Importante" shall be in all bold, upper case
letters and underlined and be no smaller than 35 point type face.
(E) The first two sentences of the English
and the Spanish version shall be in bold letters and be no smaller than 30
point type face. The remaining sentences of the English and the Spanish version
shall be no smaller than 25 point type face.
(3) Where raw oysters are ordered directly
from a server, at a dining table, or where a warning sign posted pursuant to
subsection (b)(2) is not clearly legible from any location where the consumer
orders raw oysters, the warnings shall be printed on all menus in which raw
oysters are listed, or on tent cards located on each dining table. For menus,
the warning may be shortened to contain the headers and the first two sentences
of the English and Spanish statements as set forth in subsection (b)(1) and
shall be prominently placed on the menu so that it is likely to be read by
consumers prior to ordering raw oysters. Tent cards shall contain the complete
warning statements as set forth in subsection (b)(1) and be prominently placed
on the dining tables so that they are likely to be read by consumers prior to
ordering raw oysters. Both menu warning statements and tent card warning
statements shall meet the following specifications:
(A) Be printed in black ink on a white
background, dark blue ink on a yellow background or other ink that is of high
contrast from the color of the background material.
(B) The word "Warning" and the words "Aviso
Importante" shall be in all bold, upper case letters and
underlined.
(4) Menu
warning statements shall meet the following additional specifications:
(A) Be no smaller than 10 point type
face.
(B) Be enclosed by a box rule
with no less than 1/8" of space around the notice.
(5) Tent card warning statements shall meet
the following additional specifications:
(A)
Be square in shape and no smaller than 4 inches on a side (16 square inches) or
be rectangular in shape and no smaller than 3 inches high by 5 inches wide (15
square inches).
(B) The word
"Warning" and the words "Aviso Importante" and the first two sentences of the
English and Spanish version shall be in no smaller than 12 point medium or bold
type face, and the remaining sentences shall be no smaller than 10 point type
face.
(C) Be enclosed by a box rule
with no less than 1/8" of space around the
notice.
(c)
Every dealer or retail food facility that offers raw oysters from any source
shall do all of the following:
(1) Refuse to
accept any container of raw shellstock oysters, half-shell oysters, or shucked
oysters, if the container does not have a tag or label affixed that prominently
and clearly bears the statement "Harvested in __________", "Product of
__________", or words of similar meaning (to be filled in with the name of the
state or foreign country in which the raw oysters were harvested). For
containers of raw oysters that have any oyster harvested from a state bordering
on the Gulf of Mexico, this paragraph is satisfied when the container bears a
tag or label affixed that prominently and clearly bears the statement
"Harvested from the Gulf of Mexico", or "Product of the Gulf of
Mexico".
(2) Refuse to accept raw
shellstock oysters unless each container contains a tag or label that
prominently and clearly bears all of the following:
(A) The harvest date of the
oysters.
(B) The bed name or lease
number assigned by the shellfish control authority to the harvest
area.
(C) The state abbreviation
and certification number assigned by the shellfish control authority to the
harvester, or original dealer.
(3) Refuse to accept raw shucked oysters
unless each container of oysters bears a label that prominently and clearly
states all the following:
(A) The
sell-by-date, date-shucked, date-packed, or similar date of the shucked
oysters.
(B) The state abbreviation
and certification number assigned by the shellfish control authority of the
state or foreign country to the harvester or original dealer.
(C) The harvest date of raw Gulf oysters.
This requirement is satisfied when each shipment of raw oysters is accompanied
by an invoice that specifies the harvest date of the oysters.
(D) That raw Gulf oysters, which have not
been subjected to an oyster treatment process, be cooked before
eating.
(4) Refuse to
accept any container of raw half-shell oysters unless each container of oysters
bears a tag or label that prominently and clearly states the information
required in subparagraphs (c)(3)(A), (B), and (C).
(5) Refuse to accept any container of raw
shellstock, half-shell, or shucked Gulf oysters harvested during April through
October, and such oysters shall be deemed adulterated, unless:
(A) The oysters have been subjected to an
oyster treatment process and are prominently and clearly tagged or otherwise
labeled with the information required by subsection (i); and
(B) The dealer or retail food facility has on
file a current copy of the letter from the department verifying the use of an
oyster treatment process in accordance with subsection
(h).
(d)
Warnings under subsection (b) are not required for raw shellstock, half-shell
or shucked Gulf oysters whenever the retailer has received a copy of a current
verification letter from the dealer pursuant to subsection (h) and tags or
labels as required by subsection (i) demonstrating that the oysters have been
subjected to an oyster treatment process.
(e) In order to be eligible to receive
verification by the department that oysters supplied by the dealer are
subjected to an oyster treatment process, a dealer shall submit a written
request for verification pursuant to Section
13676. A verification issued by
the department shall be valid for two years from the date of issue unless
revoked or suspended.
(f) A dealer
who has received a verification pursuant to Section
13676 shall notify the department
in writing prior to making any changes to the oyster treatment process, or any
changes to the Hazard Analysis and Critical Control Point (HACCP) plan required
by Title 21, Code of Federal Regulations, Part 123.
(g) A dealer who has received a verification
pursuant to Section
13676 shall notify the department,
within seven days, of any new information known to the dealer pertaining to the
effectiveness of the oyster treatment process.
(h) A dealer who has received verification
pursuant to Section
13676 shall provide a copy of the
letter from the department granting the current verification to every dealer
and retail food facility in California to whom the dealer sells or provides
shellstock, half-shell, or shucked raw Gulf oysters. Every dealer and retail
food facility that offers shellstock, half-shell, or shucked raw Gulf oysters
for which verification pursuant to Section
13676 has been granted, shall
retain and make available for inspection by the department and local health
agencies a copy of the current verification letter provided by the dealer. A
retail food facility shall retain the copy of the verification for one year
after the date that the verification expires.
(i) A dealer who has received verification
pursuant to Section
13676 shall affix to each
container of raw Gulf oysters subjected to an oyster treatment process
described in subsection (a)(8), a tag or label pursuant to subsections (c)(2),
(c)(3), and (c)(4), as required. In addition to requirements of subsections
(c)(2), (c)(3), and (c)(4), such tag or label shall clearly and prominently
bear the phrase "PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE
LEVELS", followed by a lot number traceable to the dealer's processing records.
Use of the phrase "PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE
LEVELS", or words of similar meaning on tags or labels of raw unprocessed
oysters, or on tags or labels of processed raw oysters from other than a dealer
who has a current verification from the department is unlawful, and causes the
oysters to be misbranded.
Notes
2. Repealer and new section filed 3-1-91 as an emergency, operative 3-1-91 (Register 91, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-1-91 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-1-91 order including amendment of section transmitted to OAL 7-1-91 and filed 7-23-91 (Register 91, No. 45).
4. Editorial correction of printing errors in section (Register 91, No. 45).
5. Amendment of section heading, section and NOTE filed 6-6-97 as an emergency; operative 6-6-97 (Register 97, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-6-97 or emergency language will be repealed by operation of law on the following day.
6. Editorial correction of HISTORY 3 (Register 97, No. 46).
7. Certificate of Compliance as to 6-6-97 order, including amendment of subsection (g)(1), transmitted to OAL 10-1-97 and filed 11-13-97 (Register 97, No. 46).
8. Amendment of section heading, section and NOTE filed 4-14-2003 as an emergency; operative 4-14-2003 (Register 2003, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-12-2003 or emergency language will be repealed by operation of law on the following day.
9. Certificate of Compliance as to 4-14-2003 order transmitted to OAL 8-11-2003 and filed 9-23-2003 (Register 2003, No. 39).
10. Amendment of subsections (a)(1)-(5), (a)(8)-(10) and (i) and amendment of NOTE filed 2-27-2015; operative 4-1-2015 (Register 2015, No. 9).
Note: Authority cited: Sections 110065, 110105, 110430, 112165, 113707, 131050, 131051, 131052, 131055, 131056 and 131200, Health and Safety Code. Reference: Sections 110175, 110545, 110560, 110565, 110660, 110705, 112195, 112200, 113980, 114029, 114039, 114039.1, 114039.2, 114039.3 and 114039.4, Health and Safety Code.
2. Repealer and new section filed 3-1-91 as an emergency, operative 3-1-91 (Register 91, No. 14). A Certificate of Compliance must be transmitted to OAL by 7-1-91 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-1-91 order including amendment of section transmitted to OAL 7-1-91 and filed 7-23-91 (Register 91, No. 45).
4. Editorial correction of printing errors in section (Register 91, No. 45).
5. Amendment of section heading, section and Note filed 6-6-97 as an emergency; operative 6-6-97 (Register 97, No. 23). A Certificate of Compliance must be transmitted to OAL by 10-6-97 or emergency language will be repealed by operation of law on the following day.
6. Editorial correction of History 3(Register 97, No. 46).
7. Certificate of Compliance as to 6-6-97 order, including amendment of subsection (g)(1), transmitted to OAL 10-1-97 and filed 11-13-97 (Register 97, No. 46).
8. Amendment of section heading, section and Note filed 4-14-2003 as an emergency; operative 4-14-2003 (Register 2003, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-12-2003 or emergency language will be repealed by operation of law on the following day.
9. Certificate of Compliance as to 4-14-2003 order transmitted to OAL 8-11-2003 and filed 9-23-2003 (Register 2003, No. 39).
10. Amendment of subsections (a)(1)-(5), (a)(8)-(10) and (i) and amendment of Note filed 2-27-2015; operative
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