National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2007

FDA MANUAL OF INTERPRETATIONS
Codification System

Guide Contents

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Manual of Interpretations

The Manual of Interpretation Codification System consists of nine subject areas. The nine areas are Interpretation Number, Date, and National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, reference hereon known as "Model Ordinance Reference," Key Words, Question, Interpretation Rationale, Other References, and Contact.


Interpretation Number: The interpretation number consists of four fields:

(1)   primary
(2)   secondary
(3)   tertiary and
(4)   quaternary.

Each identified field is related to a particular section of the Model Ordinance and a chronological number is assigned for the interpretation. The following is an example:

For example: Interpretation Number: 05-III-@.02-100
05 - The primary field corresponds to the last published Guide for the Control of Molluscan Shellfish revision date; in this case it is "2005."
III- The secondary field corresponds to a chapter in the Guide; in this case it is "Chapter III - Laboratory."
@.02- The tertiary field corresponds to the chronological numerical sequence for a subparagraph under a particular section in a chapter.
100 - The quaternary field is a chronological number for each interpretation issued under a particular section. Note: All interpretations issued for the first time for each Guide section will start with the number 100.

Date:	This is the actual date when the interpretation was issued.
Model Ordinance Reference	This refers to the particular chapters, paragraphs and subparagraphs in the guide. For example "Chapter III, Section @.02A"
Keywords:	These are words that serve to provide significant or memorable statements for systematic index entry.
Question:	This is the particular question of concern that needs to be interpreted.
Interpretation:	The FDA written response to clarify the particular area of concern in a specific chapter or section of the NSSP Guide for the Control of Molluscan Shellfish.
Rationale:	This explains the reason for the interpretation. This area will cover existing policy, regulations, laws, and public health reasons.
Other References:	This includes other documents used to issue the interpretation such as laws, regulations, model codes, scientific literature, etc.
Contact:	This is the office responsible for issuing the interpretation. Any questions or comments should be in writing and addressed to: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway (HFS-628) College Park, MD 20740