“Traceability in the National Shellfish Sanitation Program”

“Traceability in the National
Shellfish Sanitation Program”
American Cheese Society Conference
July 31, 2014
“Traceability in the National
Shellfish Sanitation Program”
Presented by
Maryanne Guichard, MS
Assistant Secretary
Washington State Department of Health
Michael Antee, MS, RS
Shellfish Sanitation Program Specialist
U.S. Food & Drug Administration, Office of Partnerships
Agenda
 History of NSSP and ISSC
 Discussion of Cooperative Programs
 NSSP Traceback
• What is it
• How is it conducted
Raw, fresh and on the half shell
Delicious but potentially high health risk
1
Oyster Species
Eastern Oyster
European Flat
Crassostrea virginica
Ostrea edulis
Kumamoto
Crassostrea sikamea
Olympia
Ostreola conchaphila
Pacific Oyster
Crassostrea gigas
12
Blue Mussels
Mytilus edulis
3
Manila Clam
Venerupis philippinarum
Quahog or HardShelled Clam
Mercenaria mercenaria
“Littleneck”
“Cherrystone”
“Chowder”
4
Geoduck
Panopea generosa
5
What is the National Shellfish
Sanitation Program (NSSP)
• The NSSP is based on public health principles and controls
formulated at the Conference on Shellfish Sanitation called
by the Surgeon General of the U.S. in 1925
• The program exercises control over all phases of growing,
harvesting, shucking, packing, and distribution of fresh
and fresh-frozen shellfish
6
History of the Interstate Shellfish
Sanitation Conference (ISSC)
• 1977-1979 – States concern about the application of the
NSSP
• 1979 – Organizational committee established
• 1982 – October – Formation meeting in Annapolis, MD
• 1984 – FDA entered into a MOU with ISSC recognizing
ISSC as the primary voluntary national organization of
State Shellfish regulatory officials that provides guidance
and counsel on matters involving the sanitary control of
shellfish
7
History of the ISSC
continued…
• Development of Model Ordinance (continued)
– 1996 – FDA Seafood Regulation adopted
– 1997 – FDA Seafood Regulation and HACCP principles
integrated into Model Ordinance
– 1998 – First printing of the NSSP Guide for the Control of
Molluscan Shellfish
• 1983 – 1999 – Annual Meetings
• 2001 – 2015 – Biennial Meetings
8
The ISSC
• The ISSC is a national non-profit organization
that included participation from:
–
–
–
–
–
–
–
–
States
Federal Public Health Officials
Shellfish Industry
Native American Tribes
Academia
Other countries
Consumer Representatives
Other parties interested in safe consumption of raw
molluscan shellfish
9
Conference Funding
• Membership/Registration
• USFDA Cooperative Agreement (NOAA provides
financial assistance)
• Grants
– USFDA
– NOAA
– EPA
• Contributions
10
Purpose of the ISSC
• To provide formal structure for State and Federal
regulatory authorities and the shellfish industry to
participate in establishing regulatory guidelines and
procedures for uniform State application of the National
Shellfish Sanitation Program (NSSP)
• These guidelines include the necessary control measures
to ensure a safe shellfish supply to the consuming public
11
The National Shellfish Sanitation
Program (NSSP)
• NSSP Guide for the Control of Molluscan
Shellfish
– Procedures of the NSSP used by the USFDA in
fulfillment of its obligations under the Public Health
Service Act, Food, Drug & Cosmetic Act, and the Fair
Packaging & Labeling Act
– This document contains the guidelines that states must
follow to achieve compliance with the Program. The
USFDA uses information contained in the Model
Ordinance (and supporting documents) in its evaluation
of State programs
12
Roles of Participants in the NSSP
• Shellfish Shipping States
– Adopt laws and regulations that provide state authority to
implement the requirements of the NSSP
– Sanitary surveys of shellfish growing areas
– Patrol of shellfish growing areas
– Certification and inspection of shellfish provisional plants
– Laboratory certification of labs conducting analysis tests
of water & shellfish meats
13
Roles of Participants in the NSSP
continued…
• Shellfish Industry
– Harvest shellfish only from approved growing areas
– Implement the sanitary requirements for
processing/handling and distribution of shellfish
– Labeling
– Records
14
Roles of Participants in the NSSP
continued…
• FDA
– Conducts annual evaluations of state shellfish
control programs
• Vibrio control
• classification program review
• plant certification program review
• laboratory program review
• patrol review
• special programs
15
ISSC State/County Participation
non-participating states
Canada
Mexico
Korea
Chile
New Zealand
participating / receiving states
participating / producing states
16
Foreign Programs
• MOAs have been signed between
the FDA and several foreign
nations in which they agreed to
follow and maintain parallel
programs subject to evaluations using the
same criteria as those applied to the state
shellfish programs
17
Interstate Certified Shellfish
Shippers List (ICSSL)
• A principal objective of the ICSSL is to provide a
mechanism for the state health officials, dealers
and consumers to receive information confirming
that shellfish shipped in interstate commerce meet
acceptable sanitary criteria
18
Interstate Certified Shellfish Shippers List (ICSSL)
http://www.cfsan.fda.gov/~ear/shellfis.html
29
Executive Board
• Voting Membership
– Regulatory and industry members from each of six regional
geographic groupings
– Three regulatory members-at-large from non-producing states
– One FDA member
– One NOAA/NMFS member
– One EPA member
• Non-voting Members
–
–
–
–
Executive Director
Northwest Treaty Tribe
Three Task Force Chairs
Chair of Patrol, AFDO Liaison, Consumer Representation and
Past Chairman of Executive Board
19
How ISSC Works
• Any member can submit proposals to change
the guide
• Committees
• Task forces
• General assembly
20
ISSC Webpage
www.issc.org/
21
Cooperative Programs are not
your Traditional FDA
Regulatory is through State and
Tribal Regulations
(Stronger
Regulations than
FD&C Act)
Cooperative Programs are not
your Traditional FDA
Program from Growing Area Waters
to Table
23
32
Dealer Tags
28
Interstate Certified Shellfish Shippers List (ICSSL)
http://www.cfsan.fda.gov/~ear/shellfis.html
29
35
31
Shucked Shellfish Labeling
33
Shucked Shellfish Labeling
34
SHUCKED MEAT LABELING
Shucker packer’s or repacker’s certification Number
“Sell By Date” or “Best IF USED BY”
If 64 ounces or more “DATE SHUCKED” on lid and sidewall
If frozen meat is thawed and repacked, must be labeled previously
frozen
35
36
42
43
Traceback and Recall
40
Traceback Activity
•
•
•
•
•
•
•
Consumption
Illness
Illness reported – Dr/Lab/LHJ/Complaint
Epidemiology/report to CDC
Control Authority – state agency
Local health jurisdiction
ISSC
41
Traceback at Authority
• Review of report
• Follow up with Dealer/other states/FDA
• Dealer provides harvest/purchase records
•
•
•
•
review
Review of growing area/determination
Work with LHJ for review of where served
Review of report/tag
Determination of recall
42
ISSC State/County Participation
non-participating states
Canada
Mexico
Korea
Chile
New Zealand
participating / receiving states
participating / producing states
16
Traceback at Authority
• Review of report
• Follow up with Dealer/other states/FDA
• Dealer provides harvest/purchase records
•
•
•
•
review
Review of growing area/determination
Work with LHJ for review of where served
Review of report/tag
Determination of recall
42
SHELLSTOCK RECEIVING LOG
Date
Received
Shellstock
quantity and
type
Harvest
Date or
Shuck date
Harvest
location
Harvester or
Original
Shipper Cert. #
Delivering
Shippers Cert. #
Date
Sold
Quantity & type of
shellstock sold
HACCP RECORDS MUST BE REVIEWED AT LEAST ONCE EVERY SEVEN DAYS. Sign and date after every review
Sold to
Initials
Traceback at Authority
• Review of report
• Follow up with Dealer/other states/FDA
• Dealer provides harvest/purchase records
•
•
•
•
review
Review of growing area/determination
Work with LHJ for review of where served
Review of report/tag
Determination of recall
42
44
THE GALVESTON BAY COMPLEX
(Not complete – EXAMPLE ONLY)
Restricted
Galveston
Restricted
North Approved Area
Smith Point
East Approved Area
Central Approved Area
Traceback at Authority
• Review of report
• Follow up with Dealer/other states/FDA
• Dealer provides harvest/purchase records
•
•
•
•
review
Review of growing area/determination
Work with LHJ for review of where served
Review of report/tag
Determination of recall
42
43
Facility Inspection
47
Traceback at Authority
• Review of report
• Follow up with Dealer/other states/FDA
• Dealer provides harvest/purchase records
•
•
•
•
review
Review of growing area/determination
Work with LHJ for review of where served
Review of report/tag
Determination of recall
42
Recall
• Harvest dates/amounts determined
• Follow up with Dealer
• Dealer provides harvest/purchase records
•
•
•
•
•
review
Recall ordered or volunteered
ISSC/states notified
Follow up with Dealer(s)/other states
Amounts recalled/determined
consumed/destroyed
Finalize report of recall
48
Questions
Thank You