Issue View | Council I | 2020 Scribe Packet

This issue was submitted for consideration at a previous biennial meeting, see issue: Issue 2016 I-023 ; new or additional information has been included or attached .

CFP- ISSC Joint Committee on Shellfish; Amend Food Code

Proposed amendments to the most current edition of the FDA Food Code based on the CFP- ISSC Joint Committee on Shellfish investigating opportunities and activities to improve compliance with the Food Code Section 3-203.12. Issue :2016 I-023. These amendments will remove discrepancies in terminology, definitions, and requirements for shellstock tagging in the Food Code and the Model Ordinance that may inhibit compliance with the Food Code, increasing the ability of retail food establishments to provide complete and accurate source information

The incidence of Vibrio parahaemolyticus (Vp) illness associated with molluscan shellfish consumption is on the increase and continues to be a significant challenge to state and federal health authorities. Increased efficiency in investigation could potentially decrease preliminary growing area closures. Timely investigation of Vp cases by State and local health officials are impeded by unsuccessful efforts to determine product source. In many cases, investigation is complicated by inadequate record keeping as required by Section 3-203.12 of the 2013 FDA Food Code.

that a letter be sent to the FDA requesting that Sections 1-201.10 (B), 3-202.18, and 3-203.12 be amended to incorporate requirements from the Interstate Shellfish Sanitation Conference 2017 Model Ordinance. Specific proposed language is found below:

1-201.10 (B)
"Certification number" means a unique combination of letters and numbers assigned by a
shellfish control authority to a molluscan shellfish dealer according to the provisions of the
National Shellfish Sanitation Program. the unique identification number issued by the SHELLFISH CONTROL AUTHORITY to each dealer for each location. Each certification number shall consist of a one to five digit Arabic number preceded by the two letter State abbreviation and followed by a two letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this provision of the National Shellfish Sanitation Program using the following terms: shellstock shipper (SS), shucker-packer (SP), repacker (RP), and Depuration Processor(DP).

"Commingle" means:

1. To combine shellstock harvested on different days or from different growing areas as identified on the tag or label; or

2. To combine shucked shellfish from containers with different container codes or different shucking dates; and
3. To combine in-shell product harvested on different days or from different growing areas
as identified on the tag or label.

Add Definition "In-shell Product" means non-living, processed shellfish with one or both shells present.

"Molluscan shellfish" means any edible all species of fresh or frozen oysters, clams, mussels,
whether shucked or in the shell, raw, including post-harvest processed, frozen or unfrozen, whole or in part; and scallops or edible portions thereof in any form, except when the scallop final product form consists only of the shucked is the adductor muscle only.

"Shellstock" means raw, in-shell live molluscan shellfish in the shell.

"Shucked shellfish" means molluscan shellfish that have one or both shells removed.

3-202.18. Shellstock and In-shell Product Identification.
(A) Shellstock shall be obtained in containers bearing legible source identification tags or labels
that are affixed by a dealer that depurates, ships, or reships the shellstock, as specified in the
National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, and
that list are listed in the Interstate Certified Shellfish Shippers List. ^Pf
(1) Except as specified under (C) of this section, on the harvester's tag or label, the following
information in the following order: ^Pf
(a) The harvester's identification number that is assigned by the SHELLFISH CONTROL AUTHORITY,
(b) The date of harvesting, ^Pf
(c) most precise identification of the harvest location or aquaculture site that is practicable based on the system of harvest area designations that is in use by the SHELLFISH CONTROL AUTHORITY and including the abbreviation of the name of the state or country in which the shellfish are harvested, ^Pf
(d) The type and quantity of shellfish, ^Pf
(e) The following statement in bold, capitalized type: "This tag is required to be attached
until container is empty or retagged and thereafter kept on file for 90 days:, ^Pf and
(2)(1) Except as specified in (D) of this section, on each DEALER'S tag or label, the following
information in the following order. ^Pf
(a) The dealer's name and address, and the certification number assigned by the SHELLFISH CONTROL AUTHORITY.;^Pf
(b) The original shipper's certification number including the abbreviation of the name of the state or country in which the shellfish are harvested. If depurated the original shellstock shipper's certification number is not required. ^Pf
(c) The same information as specified for a harvester's tag under Subparagraphs (A)(1)(b)-(d) of this section, The harvest date; or if depurated, the date of depuration processing, or if wet stored, the original harvest date, and the final harvest date which is the date removed from wet storage. ^Pf and
(d) The following statement in bold, capitalized type: "This tag is required to be attached until container is empty and thereafter kept on file for 90 days. If wet stored or depurated, the wet storage or depuration cycle or lot number. The wet storage lot number shall begin with the letter "w". ^Pf
(e) The most precise identification of the harvest location as is practicable including the initials of the State of harvest, and the SHELLFISH CONTROL AUTHORITY'S designation of the growing area. ^Pf
(f) The type and quantity of shellstock. ^Pf
(g) The following statement in bold, capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS. RETAILERS: DATE WHEN LAST SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)______________" ^Pf
(h) The statement "Keep Refrigerated" or an equivalent statement. ^Pf
(B) A container of shellstock and in-shell product that does not bear a tag or label or that bears
a tag or label that does not contain all the information as specified under subsection A of this
section shall be subject to a hold order, as allowed by law, or seizure and destruction in
accordance with 21 CFR Subpart D - Specific Administrative Decisions Regarding Interstate
Shipments, Section 1240.60(d).^Pf
(C) If a place is provided on the harvester's tag or label for a DEALER'S name, address, and
CERTIFICATION NUMBER, the DEALER'S information shall be listed first.
(C) (D) If the harvester's tag or label is designed to accommodate each DEALER'S identification
as specified in Subparagraph's (A)(2)(a) and (b) of this section, individual DEALER tags or
labels need not be provided. When both the dealer and the harvester tags appear on the
container, the dealer's tag is not required to duplicate the information on the harvester's tag.
^Pf
(D) (E) In-shell product shall be obtained in containers bearing legible source identification tags or labels that are affixed by a dealer that depurates, ships, or reships the in-shell product, as
specified in the National Shellfish Sanitation Program (NSSP) Guide for the Control of
Molluscan Shellfish, and that list:that are listed in the Interstate Certified Shellfish Shippers
List.^P
(1) The dealer tag or label on in-shell product shall contain the following indelible, legible
information in the order specified below: ^Pf
(a) The dealer's name and address; ^P

(b) The dealer's certification number as assigned by the SHELLFISH CONTROL AUTHORITY; ^Pf
(c) The original shellstock shipper's certification number. If depurated the original shellstock shipper's certification number is not required. ^Pf
(d) A "SELL BY DATE" or the words "BEST IF USED BY" followed by a date when the product is expected to reach its shelf life. The date shall include month, day, and year. ^Pf
(e) If depurated, the depuration cycle number or lot number. ^Pf
(f) The most precise identification of the harvest location as is practicable including the initials of the State of harvest, and the SHELLFISH CONTROL AUTHORITY'S designation
of the growing area.
(g) The type and quantity of in-shell product; ^Pf
(h) The following statement in bold, capitalized type: "THIS TAG IS REQUIRED TO BE

ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE, IN CHRONOLOGICAL ORDER, FOR 90 DAYS. RETAILERS: DATE WHEN LAST
SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)_____________." OR "THIS LABEL IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE, IN CHRONOLOGICAL ORDER, FOR 90 DAYS" RETAILERS: DATE WHEN LAST SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)_________.^Pf
(i) The statement "Keep Refrigerated" or an equivalent statement. ^Pf

3-203.12 Shellstock and in-shell product; maintaining identification.
A. Except as specified under subdivision (C) (2) of this section, shellstock and in-shell product
tags or labels shall remain attached to the container in which the shellstock and in-shell product
are received until the container is empty.^Pf
B. The date when the last shellstock and in-shell product from the container is sold or served
shall be recorded on the tag or label.^Pf
C. The identity of the source of shellstock and in-shell product that are sold or served shall be
maintained by retaining shellstock and in-shell product tags or labels for 90 calendar days from
the date that is recorded on the tag or label as specified in subsection B of this section, by:^Pf
1. Using an approved recordkeeping system that keeps the tags or labels in chronological
order correlated to the date that is recorded on the tag or label, as specified under
subsection B of this section;^Pf and
2. If shellstock and in-shell product are removed from its tagged or labeled container:
a. Preserving source identification by using a recordkeeping system as specified under
subdivision C 1 of this section,^Pf and
b. Ensuring that shellstock, in-shell product, or shucked shellfish from one tagged or
labeled container are not commingled with shellstock, in-shell product, or shucked
shellfish from another container with different certification numbers, different harvest
dates, or different growing areas as identified on the tag or label before being ordered
by the consumer.^Pf