CPG Sec. 540.370 Fish and Fishery Products 
- Decomposition 
You may submit written or electronic comments regarding this guidance at any time. 
Submit written comments on the guidance to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to regulations.gov. All comments should be 
identified with the docket number listed in the notice of availability that publishes in the 
Federal Register. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition (CFSAN) 
Office of Regulatory Affairs (ORA) 
January 2009 
Table of Contents 
I.  Introduction 
II. Background
III. Policy
IV. Regulatory Action Guidance
V.  Specimen Charges 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic. It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations. If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  
I. Introduction: 
The purpose of this document is to provide guidance for FDA staff on FDAs direct 
reference enforcement policy on decomposition in fish and fishery products.  FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
II. Background: 
Fish and fishery products are susceptible to degradation resulting from time/temperature 
exposure. Proper commercial handling, including adherence to Current Good 
Manufacturing Practice (21 CFR part 110), helps prevent the products from becoming 
decomposed prior to reaching consumers. Nevertheless, decomposed fish and fishery 
products are periodically detected in interstate commerce and warrant regulatory action. 
FDAs enforcement policy on decomposition in shrimp and fish was previously provided 
in part in CPG Sec. 540.575 Fish  Fresh and Frozen  Adulteration Involving 
Decomposition (CPG 7108.05), CPG Sec. 560.650 Canned and Cooked/Frozen Shrimp  
Adulterated by Decomposition (CPG 7119.13), and CPG Sec. 540.400 Shrimp - Fresh or 
Frozen, Raw, Headless, Peeled or Breaded - Adulteration Involving Decomposition (CPG 
7108.11). CPG Sec. 540.575 was withdrawn on July 18, 2008 (73 FR 41361). CPG Sec. 
560.650 and CPG Sec. 540.400 were revoked on July 5, 1995 (60 FR 35038), and 
December 24, 1996 (61 FR 67837), respectively. 
III. Policy: 
The following regulatory action guidance is applicable to all fish and fishery products, 
except scombrotoxin-forming species of fish, which are addressed in CPG Sec. 540.525 
Decomposition and Histamine Raw, Frozen Tuna and Mahi-Mahi; Canned Tuna; and 
Related Species (CPG 7108.24). The guidance also does not apply to dried fish or fish 
sauce/paste products. 
The Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), section 402(a)(3) [21 
U.S.C. 342(a)(3)], states that a food shall be deemed to be adulterated "if it consists in 
whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit 
for food." The criteria in this guidance do not establish an acceptable level of 
decomposition in food. FDA may choose to take regulatory action against adulterated 
food that does not meet the direct reference criteria. 
IV. Regulatory Action Guidance: 
The following represents criteria for direct reference import detention or for direct 
reference seizure recommendations to the *Office of Human and Animal Food  Operations (OHAFO) in consultation with the Office of Enforcement and Import 
Operations (OEIO) and CFSAN*: 
Using a two-class, pass/fail, evaluation approach, the presence of decomposition 
is detected in a minimum of two (2) subsamples from a lot when up to 24 
subsamples are examined from the lot. 
The presence of decomposition is detected in a subsample, i.e., the subsample fails the 
decomposition evaluation, when: 
1.  20% or more of the edible portion contains definite and persistent sensory 
attributes indicative of decomposition as determined by qualified FDA seafood 
sensory analysts (a current list of qualified FDA seafood sensory analysts may be 
obtained from the *Office of Regulatory Science (ORS))*; or 
 
2.  An appropriate chemical indicator of decomposition (CID) is detected by original 
and check analysis using a method approved by CFSAN. For this direct reference 
authority, indole at levels greater than or equal to 25 micrograms indole per 100 
grams sample, based on the AOAC, 18th Edition, Method 35.1.35 (981.07), is an 
appropriate CID for all shrimp products. 
Note: A sample may meet the direct reference criteria when subsamples fail for a 
combination of reasons, i.e., one due to sensory detection of decomposition and another 
due to decomposition detected by CID. 
An import shipment offered for entry may be detained if one or more lots in the shipment 
are deemed violative. A "line by line" examination or decomposition evaluation of each 
lot in the shipment is not a prerequisite to detention of the shipment. 
V. Specimen Charges: 
Domestic Seizure 
The article of food was adulterated when introduced into and while in interstate 
commerce and is adulterated while held for sale after shipment in interstate commerce 
within the meaning of the Act, 21 U.S.C. 342(a)(3), in that it consists in whole or in part 
of a decomposed substance. 
Import Detention 
The article of food is subject to refusal of admission, pursuant to section 801(a)(3) of the 
FD&C Act [21 U.S.C. 381(a)(3)] in that it appears to be adulterated within the meaning 
of section 402(a)(3) of the FD&C Act [21 U.S.C. 342(a)(3)], in that it consists in whole 
or in part of a decomposed substance.  Issued: January 2009 
Updated: 2/10/09