U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
November 3, 2000


A more recent version of this document issued in November 2004. Below is an earlier version.

NATIONAL SHELLFISH SANITATION PROGRAM
MODEL ORDINANCE

II. RISK ASSESSMENT AND RISK MANAGEMENT

(Table of Contents)


Requirements for the Authority
[Note: The Authority must meet the requirements of this section even if the Authority does not formally adopt this section in regulation.]

@.01 Outbreaks of Shellfish-Related Illness.

A. When shellfish are implicated in an illness outbreak involving two (2) or more persons not from the same household (or one or more persons in the case of PSP), the Authority shall determine whether an epidemiological association exists between the illness and the shellfish consumption by reviewing:
(1) Each consumer's food history;
(2) Shellfish handling practices by the consumer and/ or retailer;
(3) Whether the disease has the potential or is known to be transmitted
by shellfish;
(4) Whether the symptoms and incubation period of the illnesses are
consistent with the suspected etiologic agent.

NOTE: For additional guidance refer to the International Association of Milk, Food, and Environmental Sanitarians' Procedures to Investigate Food Borne Illness.

B. When the Authority has determined an epidemiological association between an illness outbreak and shellfish consumption, the Authority shall conduct an investigation of the illness outbreak within 24 hours to determine whether the illness is growing area related or is the result of post-harvest contamination or mishandling.

C. When the investigation outlined in §.02B. does not indicate a post-harvest contamination problem, or illegal harvesting from a closed area, the Authority shall:

(1) Immediately place the implicated portion(s) of the harvest area(s)in the closed status;
(2) Notify receiving states and the FDA that a potential health risk is associated with shellfish harvested from the implicated growing area;
(3) As soon as determined by the Authority, transmit to the FDA and receiving states information identifying the dealers shipping the implicated shellfish; and
(4) Promptly initiate recall procedures consistent with the Recall Enforcement Policy, Title 21 Code of Federal Regulations Part 7.

D. When the investigation outlined in §.02B demonstrates that the illnesses are related to post-harvesting contamination or mishandling, growing area closure is not required. However, the Authority shall:

(1) Notify receiving states of the problem; and
(2) Promptly initiate recall procedures consistent with the Recall Enforcement Policy Title 21 Code of Federal Regulations Part 7.

E. When the investigation outlined in §.02B. cannot be completed within 24 hours, the Authority shall:

(1) Follow the closure procedure outlined in § 01C; and
(2) If the investigation does not indicate a growing area problem, the area
shall be immediately reopened and product recall terminated.

F. Upon closing an implicated area for problems other than natural occuring pathogens and/ or biotoxins the Authority shall review the growing area classification and determine if a growing area classification problem exists. The review shall include at a minimum:

(1) A review of the growing area classification file records;
(2) A field review of existing pollution sources;
(3) A review of actual and potential intermittent pollution sources, such as vessel waste discharge and wastewater discharge from treatment plant collection systems; and
(4) Examination of water quality subsequent to the illness outbreak.

G. Upon closing an implicated portion(s) of the harvest area(s) for naturally occurring pathogens and/ or biotoxins, the Authority shall:

(1) Follow an existing marine biotoxin contingency plan, if appropriate.
(2) Collect and analyze samples relevant to the investigation, if appropriate.
(3) Keep the area closed until it has been determined that levels of naturally occurring pathogens and/ or biotoxins are not a public health concern.

H. When the growing area is determined the problem, the Authority shall:

(1) Place the growing area in the closed status until:
(a) The Authority verifies that the area is properly classified, using
current data, in compliance with the NSSP Model Ordinance; or
(b) Shellfish from the growing area are confirmed as the cause of
illness but it has been determined that the event which caused the contamination no longer exists;
(2) Keep the area closed for a minimum of 21 days if the illness is consistent with viral etiology; and
(3) Develop a written report summarizing the findings of the investigation and actions taken.

I. Whenever the Authority initiates a recall of shellfish products because of public health concerns, the Authority will monitor the progress and success of the recall. The Authority will monitor the progress and success of the recall. The Authority initiating the recall will immediately notify the FDA and the Authorities in other states involved in the recall. Each Authority involved in a recall will issue public warnings if necessary to protect public health. The FDA will not normally audit or issue public warnings about such a recall. If the FDA determined that the Authority in any state involved in the recall fails to implement effective actions to protect public health, the FDA may classify, publish and audit the recall, including issuance of public warnings when appropriate.

@.02 Presence of Human Pathogens in Shellfish Meats.

A. Finding. Upon determination that human pathogens are present in shellfish meats, the Authority shall investigate the harvesting, the distribution, and the processing of the shellfish.

B. Growing Area Investigation.

(1) The Authority shall review the following factors:
(a) The documentation to trace the shellfish to its source;
(b) The classification assigned to the growing area and whether the sanitary survey data supporting that classification is current; and
(c) The probability of illegal harvesting from areas classified as restricted or prohibited, or in the closed status.
(2) The Authority shall take no further action when the Authority determines that:
(a) The growing area is properly classified;
(b) No illegal harvesting is taking place; and
(c) There is no reason to believe that the growing area is the source of the pathogens.
(3) When the Authority determines that the growing area is not properly classified, the Authority shall take immediate action to;
(a) Change the existing classification to the correct classification; or
(b) Close the growing area until the correct classification can be determined.

C. Distribution and Processing Investigation.

(1) The Authority shall evaluate the distribution and processing of the shellfish. This investigation may include collection of additional meat samples.
(2) The Authority shall take no further action when the Authority determines that there is no reason to believe a problem exists in the distribution or processing of the shellfish.
(3) When the Authority determines that a problem exists in the distribution or processing of the shellfish, the Authority shall take immediate steps to correct the problem.

D. Risk Management and Tolerance Levels.

(1) Pathogen Present. When a growing area continues to demonstrate the presence of human pathogen isolates in shellfish meats in the absence of illness, the Authority shall perform a risk assessment to determine the correct classification for an area.
(2) Established Tolerance Levels.
(a) When the established tolerance level for a particular pathogen isolate is not exceeded, the Authority:
(i) Shall maintain a written summary of its finding and the data supporting its finding in its central file; and
(ii) May leave the growing area in its present classification.
(b) When the established tolerance level for a particular pathogen isolate is known and there are no known outbreaks of shellfish associated disease caused by that pathogen in a particular growing area, the Authority shall:
(i) Leave the area in the open status of its classification when the tolerance level is not exceeded; and
(ii) Place the area in the closed status of its classification when the tolerance level is exceeded.
(c) When the tolerance level is exceeded, the Authority may:
(i) Maintain the growing area in the closed status of its current classification;
(ii) Reclassify the growing area to the restricted or prohibited classification; or
(iii) Reclassify the growing area to the conditionally restricted classification and establish a management plan. (d) Any management plan based on shellstock exceeding established tolerance levels shall:
(i) Meet all appropriate requirements for a management plan for the conditionally approved or conditionally restricted classification;
(ii) Specify the additional criteria associated with the particular pathogen isolate that the growing area must meet to be in the open status of its classification;
(iii) Document the scientific basis for the additional criteria;
(iv) Provide for periodic retesting of the shellfish meats; and
(v) Provide for the growing area to be placed in the closed status if the criteria are exceeded.
(3) Established Tolerance Levels Not Known.
(a) When an established tolerance level does not exist for the particular pathogen isolated, the Authority shall assess the public health significance of the levels of the pathogen found in the growing area shellfish meats. The Authority may consider FDA recommended action levels or levels of concern in this determination. When the Authority determines that:
(i) The levels are acceptable, the growing area shall remain in the open status of its classification; or
(ii) The levels are unacceptable, the growing area shall be placed in the closed status of its classification.
(b) If a growing area is placed in the closed status, the Authority may elect to:
(i) Maintain that status indefinitely;
(ii) Reclassify the area to the restricted or prohibited classification; or
(iii) Reclassify the area to the conditionally restricted classification and establish a management plan. The management plan shall meet the requirements of §D.(2)(d).

@.03 Presence of Toxic Substances in Shellfish Meats.

A. Upon determination that toxic substances, including heavy metals, chlorinated hydrocarbons, and natural toxins are present in levels of public health significance in shellfish meats, the Authority shall investigate the harvesting, distribution, and processing of shellfish and take necessary corrective action in accordance with the procedures described in §.02.

B. When a growing area continues to demonstrate the presence of toxic substances in the absence of illness, the Authority shall perform a risk assessment to determine the correct classification of the area. The risk assessment and subsequent risk management shall follow the procedures outlined in §.02D., Risk Management and Tolerance Levels.

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