Sec. 540.370 - Fish and Fishery Products

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact the Center for Food Safety and Applied Nutrition (CFSAN), 5100 Paint Branch Parkway, College Park, Maryland 20740, 301-436-2022.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs

I. INTRODUCTION ..................................................................... 3

II. BACKGROUND ....................................................................... 3

III. POLICY ................................................................................ 4

IV. REGULATORY ACTION GUIDANCE ............................................. 4

V. SPECIMEN CHARGES ............................................................... 5

Compliance Policy Guide

Fish and Fishery Products - Decomposition

Sec. 540.370 - Fish and Fishery Products - Decomposition

This draft guidance, when final, will represent the Food and Drug Administration's (FDA's) current thinking on this topic.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. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

I. INTRODUCTION:

The purpose of this Compliance Policy Guide (CPG) is to provide guidance relating to FDA's direct reference enforcement policy on decomposition in fish and fishery products.

FDA's guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, guidance documents 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 guidance documents 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 [insert date and FR reference], and CPG Sec. 560.650 and CPG 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.

IV. REGULATORY ACTION GUIDANCE:

The following represent direct reference criteria for import detention or for district offices to submit seizure recommendations to the Division of Compliance Management and Operations (HFC-210):

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:

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:

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.

The article of food is subject to refusal of admission, pursuant to section 801(a)(3) of the FD&C Act in that it appears to be adulterated within the meaning of section 402(a)(3) of the FD&C Act, in that it consists in whole or in part of a decomposed substance.

Compliance Policy Guide

Guidance for FDA Staff

Sec. 540.370 - Fish and Fishery Products - Decomposition

DRAFT GUIDANCE

TABLE OF CONTENTS

Compliance Policy Guide

Fish and Fishery Products - Decomposition