Table of Contents

FDA MANUAL OF INTERPRETATIONS

Interpretation Number: 03-XI-.02-100

Model Ordinance
Reference: Chapter I.@.02.H.(2).(c)-(e)
Chapter XI.02.A.(2)
Chapter XI.02.E.(4)

Key Words: Ice, sanitary quality, stored, protected, adulteration

Question: 1) What are the factors affecting the sanitary quality of ice and actions that should be taken when ice is improperly stored, protected or subject to adulteration?

Interpretation:

Ice is a regulated food which is used or intended for use on molluscan shellfish either in-shell or shucked for human consumption. Ice must be protected from adulteration as defined in the Food, Drug and Cosmetic Act §402.
In accordance with the Guide for the Control of Molluscan Shellfish any ice used in the processing, storage or transport of shellstock or shucked shellfish shall be made on-site from potable water in a commercial machine; or received from a facility sanctioned by the appropriate regulatory authority. Ice must be stored in a safe and sanitary manner to prevent its contamination.

The dealer shall use only equipment and utensils, including approved plastic ware which are: (1) constructed in a manner and with materials that can be cleaned, sanitized, maintained or replaced in a manner to prevent contamination of ice and shellfish products; and, (2) free from any exposed screws, bolts, or rivet heads on food contact surfaces. The dealer shall assure that all joints on food contact surfaces: (1) have smooth easily cleanable surfaces; and (2) for stainless steel, are welded. "Item 12 - Ice: approved source, sanitary, protected" is designated as a Swing item and identified as either a Key or Critical deficiency (NSSP Standardized Shellfish Processing Plant Inspection Form (ISSC Form 93-01(A).)

Key Deficiency: Applies when conditions may lead to adulteration of ice.
Critical Deficiency: Applies when the ice is visibly adulterated.

Key Conditions:
The following conditions are representative of Key deficiencies:

Improperly constructed, maintained, cleaned, and sanitized walk-in coolers, insulated rooms, or other storage containers;

• Improperly constructed, cleaned, sanitized and stored totes, scoops, shovels, or other utensils used in handling ice;
• Ice making machines not maintained or protected (reservoir).

Corrective Actions:
Ice storage unit:

• Discontinue the use;
• Set a correction schedule for cleaning, repair, or replacement

Ice handling equipment:

• Discontinue use, clean and sanitize; or
• Replace with approved equipment

Ice machines:

• Shut down and initiate cleaning and/or repair.

Critical Conditions:
The following conditions are representative of Critical conditions:

• Dirt or other debris such as insulation, or paint chips observed in the ice;
• Ice is observed to be exposed to mold, slime, rust, condensate from cooler evaporator units, or other sources of adulteration.
• Ice exposed to foot traffic and observed to be used in direct contact with product;
• Stored food items in the ice.

Critical deficiency corrective action:

1.      Discard ice;
2.      Repair or replace ice storage units and equipment which caused the ice to be adulterated, or obtain ice from another source;
3.      Destroy all product exposed to ice produced under conditions of adulteration

Where the dealer fails to take the appropriate corrective action as outlined above and required by Chapter I.@02.H(2)(a), the shellfish Control Authority must initiate decertification procedures, as required by Chapter I.@02.H(2)(b), and must ensure that the product is removed from commerce or is processed to eliminate the hazard, consistent with Chapter I.@02.H(2)(c).

Rationale:
Ice is considered a food when used in direct contact with shellfish. As a food ice must be stored and handled in the same sanitary manner as any other food product. No food product shall enter into commerce that is either injurious to health or is otherwise adulterated. Contaminated ice used in direct contact with shellfish will cause the shellfish to be adulterated. Each shellfish dealer must protect molluscan bivalves and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants.
All materials used in equipment, utensils, walk in coolers, or rooms used to make or store ice must meet food contact surface requirements. A preventive or corrective measure should be used to control an identified food safety hazard to ensure that no product shall enter into commerce that is either injurious to health or is otherwise adulterated.

Other References:

1. Food and Drug Administration, "Federal Food, Drug and Cosmetic Act", Government Printing Office, Washington, DC
2. Food and Drug Administration, "1997 Food Code", Washington, DC.
3. 21 Code of Federal Regulations, Part 123 - Fish and Fishery Products, Government Printing Office, Washington, DC
4. 21 Code of Federal Regulations, Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, Government Printing Office, Washington, DC

Contact:

U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway (HFS-628)
College Park, MD 20740

Distribution:

Shellfish Specialists
Regional Federal State Program Managers
Division of Federal State Relations
Office of Seafood
Interstate Shellfish Sanitation Conference