FDA MANUAL OF INTERPRETATIONS

Codification System

Table of Contents

Manual of Interpretations

The Manual of Interpretation Codification System consists of nine subject areas. The nine areas are Interpretation Number, Date, National Shellfish Sanitation 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: 03-III-@.02-100
01- The primary field corresponds to the last published Guide for the Control of Molluscan Shellfish revision date; in this case it is "2003."
III- The secondary field corresponds to a chapter in the Guide; in this case it is "Chapter III - Laboratory."
@.02- The third field corresponds to the chronological numerical sequence for a subparagraph under a particular section in a chapter.
100- The fourth 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

ISSC Program Interpretations

The Interpretations found in the 1997 version of the NSSP Guide have been converted to Model Ordinance language. The conversion eliminated the need for four of the original interpretations. The chart below lists the Guide Interpretations that replaced the previous Manual Interpretations.

Manual Interpretation	Guide Interpretation
II-A-2-101	03-I-@.02-100
I-B-1-100	03-III-@.02-100
I-C-1-100	03-IV-@.02-100
99-IV@.02-101	03-IV-@.02-101
II-A-2-100	Deleted
II-B-1-100	03-VIII-.03-100
II-B-1-101	03-VIII-.03-101
II-I-8-100	Deleted
II-D-20-100	Deleted
II-D-9-100	Deleted
97-XI-01.B-100	03-XI-.01-100
97-XI-02-100	03-XI-.02-100
97-XI-02.B-100	03-XI-.02-101
99-XV-03L-101	03-XV-.03-100