Guidance for FDA Staff 
 
Compliance Policy Guide
  
Sec.  540.275  Crabmeat    Fresh and
  
Frozen   Adulteration  with Filth, 

Involving the Presence of  

Escherichia  coli  

 
Draft Guidance
   
 
This guidance is being distributed for comment purposes only.  
 
Although you can submit  comment on any guidance at any time (see 21 CFR  
10.115(g)(5)), to ensure that the agency considers your  comment on this draft document  
before it begins work on the final version of the guidance, submit either electronic or  
written comments on the draft guidance within 60 days of publication in the  Federal  
Register of the notice announcing the availability of the draft guidance.  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. 
 
For questions regarding this draft document contact the Center for Food Safety and 
Applied Nutrition  (CFSAN)  at 240-402-1421. 
 
U.S.  Department of Health and Human Services
  
Food and Drug Administration  

Center for Food Safety and Applied Nutrition 
 
 Office of Regulatory Affairs
  
December, 2014 
  Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
Table of Contents  
 
 
  I. Introduction  
 
 II. Background  
 
III. Policy  
 
IV. Regulatory Action Guidance  
 
 V.   Specimen Charges  
 
 
 
 
 
          
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    Contains Nonbinding Recommendations
  
Draft  Not for Implementation 
 
 
 
Guidance for FDA Staff
  
 
Compliance Policy Guide
  
Sec. 540.275  Crabmeat    Fresh and Frozen  
  
Adulteration with  Filth, Involving the Presence of
  
Escherichia coli  
 
This  draft guidance, when finalized, will represent the Food and Drug Administration's  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 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.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe FDAs 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 FDA  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  
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    Contains Nonbinding Recommendations
  
Draft  Not for Implementation 
 
 
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 submission to Office of 
Regulatory Affairs (ORA), Office of Enforcement and Import Operations, Division of  
Enforcement (OEIO/DE) and  for direct reference import refusal by the District  to ORA,  
Office of Enforcement and Import Operations, Division of Import Operations  
(OEIO/DIO):  
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    Contains Nonbinding Recommendations
  
Draft  Not for Implementation 
 
 
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, [insert date] 
 
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