CPG Sec 540.370 Fish and Fishery Products - Decomposition

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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 FDA’s 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.
FDA’s 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