CPG Sec 540.275 Crabmeat – Fresh and Frozen – Adulteration with Filth, Involving the Presence of Escherichia coli

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

CPG Sec. 540.275 Crabmeat – Fresh and Frozen
– Adulteration with Filth, Involving the
Presence of Escherichia coli
You may submit either electronic or written comments regarding this guidance at any time.
Submit electronic comments to http://www.regulations.gov. Submit written 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.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs
April 2016
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. If you cannot identify the appropriate
FDA staff, call the telephone number listed on the title page of this guidance.
I. Introduction:

The purpose of this document is to provide guidance for FDA staff on adulteration with filth
involving the presence of Escherichia coli in fresh and frozen crabmeat. In the remainder of this
guidance, “we” or “our” refers to FDA.
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
Escherichia coli (E. coli) has traditionally been used as a microbiological indicator of
insanitation during processing. E. coli is commonly associated with feces of warm blooded
animals. Its presence in foods and water suggests fecal contamination. In the production of
commercially processed fresh or frozen crabmeat, the cook step (boiling or steaming the in-shell
crabs) destroys nonsporeforming bacteria including E. coli, if they are present on the raw
product. Therefore, the presence of E. coli in finished product indicates that either the cook step
was inadequate or the product was recontaminated after the cook step. As applied to fresh or
frozen crabmeat discussed in this CPG, cooking is a heat treatment, usually performed before the
product is placed in the finished product container and distributed either refrigerated or frozen.
Recontamination of the crabmeat after the cook step could be a result of either insanitary
practices by the employees in the processing plant or the presence of insects in the processing
plant that may have served as vectors for the dissemination of bacteria to the food after the cook
step. Strict in-plant sanitation measures should be instituted to prevent the presence of E. coli in
the finished product. Although most strains of E. coli are harmless, some strains can cause severe
illness. The confirmed presence of E. coli at levels of 3.6 Most Probable Number per gram
(MPN/g) or greater in crabmeat indicates insanitary conditions, which may include poor
employee hygiene practices, improperly sanitized utensils and equipment, or insects or other
pests.
III. Policy
FDA may consider that crabmeat has been prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth and, thus, is adulterated under section
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4))
when, based on examination of a sample consisting of a minimum of six subsamples of fresh or
frozen crabmeat:
• E. coli at levels of 3.6 MPN/g or greater is present in two or more of six subsamples, with or
without inspectional evidence to indicate the most probable source of the E. coli, or

• E. coli at levels of 3.6 MPN/g or greater is present in only one of six subsamples, and available
inspectional evidence indicates the most probable source of the E. coli (i.e., evidence
demonstrating an inadequate cook step or likely contamination after cooking). Such inspectional
evidence may include observed insanitary conditions, such as poor employee hygiene practices,
improperly sanitized utensils and equipment, the presence of insects or other pests, and possible
routes of contamination of the cooked crabs or crabmeat (e.g., contact between raw crabmeat and
cooked crabs or crabmeat).
Under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)), FDA may refuse admission of
crabmeat that is offered for import into the United States and that appears to be adulterated
within the meaning of section 402(a)(4) of the FD&C Act.
IV. Regulatory Action Guidance
Direct Reference
The following represents criteria 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, and for direct citation by the appropriate Field
Office within the Human and Animal Food Program*:
When upon examination of a sample consisting of a minimum of six subsamples of fresh or
frozen crabmeat, E. coli at levels of 3.6 MPN/g or greater is present in two or more of six
subsamples, with or without inspectional evidence to indicate the most probable source of the E.
coli.
Recommendations
The following represent criteria for recommending seizure or import refusal to CFSAN, Office
of Compliance, Division of Enforcement (HFS-605): When upon examination of a sample
consisting of a minimum of six subsamples of fresh or frozen crabmeat, E. coli at levels of 3.6
MPN/g or greater is present in only one of six subsamples, and available inspectional evidence
indicates the most probable source of the E. coli.
Available inspectional evidence indicating the most probable source of the E. coli (i.e., evidence
demonstrating an inadequate cook step or likely contamination after cooking) should be included
in the recommendation. Such inspectional evidence may include observed insanitary conditions,
such as poor employee hygiene practices, improperly sanitized utensils and equipment, the
presence of insects or other pests, and potential routes of contamination of the cooked crabs or
crabmeat (e.g., contact between raw crabmeat and cooked crabs or crabmeat).
While assessing recommendations based on the criteria above, the Division of Enforcement will
also assess whether a charge under section 402(a)(3) of the FD&C Act (21 U.S.C. 342(a)(3)) can
be supported.

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 21
U.S.C. 342(a)(4), in that the food has been prepared, packed, and held under insanitary
conditions whereby it may have been contaminated with filth.
Import Refusal
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)(4) of the FD&C Act
in that it has been prepared, packed, or held under insanitary conditions whereby it may have
become contaminated with filth.*
*Material between asterisks is new or revised*
Issued: 10/1/82
Revised: 10/30/89, 3/95, 5/2005, 11/29/2005, 4/25/2016