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National Shellfish Sanitation Program
U.S. Food and Drug Administration
Shellfish Safety Team
Division of Cooperative Programs
Office of Compliance
Model Ordinance
Reference: Chapter I@.02A(1)
NSSP Guidance Document
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Shellfish Plant Inspection Standardization Procedures
Key Words: Standardization, Limited, Officers
Question: What procedures are to be used to
standardize a State Shellfish Standardization Officer in jurisdictions
which have less than
five (5) dealers to certify for the ICSSL?
Interpretation:
OPTIONS FOR STANDARDIZING STATE
SHELLFISH STANDARDIZATION OFFICERS WITHIN JURISDICTIONS WITH FEWER THAN
5 CERTIFIED DEALERS
1.
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Determine the number of
intrastate shellfish dealers not listed on the ICSSL and include as
many as necessary to obtain the minimum 5 inspections. All
certified dealers must be included in the sample. |
2.
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Arrange to conduct
standardization inspections in another jurisdiction, using as many
certified dealers as necessary to complete the exercise. All
certified dealers within the candidate's home state must be included in
the sample. This exercise must be conducted with an FDA
Standardization Officer. |
3.
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If options 1 or 2 are possible,
they must be selected before pursuing option 3. When the Regional
Shellfish Specialist agrees that option 1 or 2 cannot be utilized, the
FDA Standardization Officer and the State Candidate will inspect all
interstate and intrastate dealers within the state. If this
number of dealers equals less than 5, the standardization exercise will
be based upon the inspection of the number of available plants.
However, the Candidate must achieve 80% agreement on EACH
inspection. The FDA Standardization Officer shall review annually
the number of dealers available within the jurisdiction and standardize
the State Shellfish Officer using 5 dealers whenever they become
available. The State Shellfish Officer shall make every effort to
achieve standardization using 5 dealers. If a State Shellfish
Standardization Officer standardized under this option relocates to
another state with five (5) or more dealers, that Officer must be
restandardized by the Regional FDA Shellfish Specialist through field
standardization using 5 dealers. |
IN ALL OF THE
ABOVE OPTION CASES, THE STATE SHELLFISH STANDARDIZATION OFFICER
CANDIDATE MUST SUCCESSFULLY COMPLETE THE FDA CLASSROOM TRAINING PORTION
OF THE STANDARDIZATION PROCESS. |
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4.
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A state may choose to contract
with another state which has a recognized State Standardization Officer
to conduct routine and pre-certification inspections. |
Rationale:
NSSP Guidance Document -
Shellfish Plant Inspection Standardization Procedures, in the Guide for
the Control of Molluscan Shellfish, establishes the procedures for
measuring the training and performance of an applicant to become a
standardized State Shellfish Officer or Plant Inspector. NSSP
Guidance Document - Shellfish Plant Inspection Standardization
Procedures requires that, during the plant inspection phase of
standardization, a minimum of 8 plants be jointly inspected by the FDA
Standardization Officer and the candidate for State Shellfish
Officer. Three of the 8 plant inspections are considered to be a
review or warm-up inspections, and 5 inspections are counted as the
official number of inspections for the standardization process. However, several states and foreign countries that participate in the ISSC and want to list firms on the ICSSL have fewer than 5 plants within their jurisdiction. Therefore, they are unable to follow the procedures set forth in NSSP Guidance Document - Shellfish Plant Inspection Standardization Procedures to standardize a State official. NSSP Guidance Document - Shellfish Plant Inspection Standardization Procedures addresses this issue vaguely, stating that, "For states that do not have 8 plants, all of the available plants must be inspected with the Standard determining the appropriate review number." To clarify this issue, FDA offers the above options. Election of any option will:
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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
Shellfish Sanitation Branch
Interstate Shellfish Sanitation Conference