Document ID: FDA-2014-D-1842-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff: Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the Presence of Escherichia coli
Posted Date: 2016-04-28T04:00Z

[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Notices]
[Pages 25408-25409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09951]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1842]

Compliance Policy Guide on Crabmeat--Fresh and Frozen--
Adulteration With Filth, Involving the Presence of Escherichia coli

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a Compliance Policy Guide (CPG) relating to fresh and 
frozen crabmeat adulteration with filth involving the presence of 
Escherichia coli (E. coli). The CPG updates the previously issued CPG 
on this topic. The CPG provides guidance for FDA staff on the level of 
E. coli in crabmeat at which we may consider the crabmeat to be 
adulterated with filth.

DATES: Submit electronic or written comments on FDA's CPGs at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1842 for ``Compliance Policy Guide on Crabmeat--Fresh and 
Frozen--Adulteration with Filth, Involving the Presence of Escherichia 
coli.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office 
of Policy and Risk Management, Office of Regulatory Affairs, Office of 
Global Regulatory Operations and Policy, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857. Send two self-addressed 
adhesive labels to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT:  Mary E. Losikoff, Center for Food 
Safety and Applied Nutrition (HFC-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2300.

SUPPLEMENTARY INFORMATION:

[[Page 25409]]

I. Background

    We are announcing the availability of revised CPG Sec. 540.275 
Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the 
Presence of Escherichia coli. The CPG updates the previously issued CPG 
Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration with Filth, 
Involving the Presence of Escherichia coli. We are issuing this CPG 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The CPG represents the current thinking of FDA on this topic. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    The CPG provides guidance for FDA staff on the level of E. coli in 
fresh or frozen crabmeat (i.e., 3.6 Most Probable Number per gram (MPN/
g) of E. coli) at which FDA may consider the crabmeat to be adulterated 
with filth under section 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(4)). We revised the CPG for clarity and 
to update the format. Revisions generally include the addition of 
sections on Background and Policy, updates to the sections on 
Regulatory Action Guidance and Specimen Charges, and FDA office names. 
The CPG provides criteria that the FDA District Offices may use to 
determine whether to recommend an enforcement action. Consistent with 
our standard business process, the CPG provides guidance to the FDA 
field offices for submitting an enforcement action recommendation to 
FDA's Center for Food Safety and Applied Nutrition (CFSAN) for case 
review. The CPG also provides direct reference authority to the FDA 
field offices in certain situations. Rather than submitting the 
recommendation to CFSAN, direct reference authority allows the FDA 
field offices to submit the recommendation directly to the appropriate 
office in FDA's Office of Regulatory Affairs, thus streamlining the 
Agency's internal case review process. Specifically, in the section on 
Regulatory Action Guidance, we clarify that FDA's District Offices have 
direct reference authority for both domestic seizure and import refusal 
based on the criteria described in the CPG. We also clarify the 
specific types of legal action to which the criteria for 
recommendations apply. In addition, we provide specimen charges 
relating to domestic seizure and import refusal. The CPG also contains 
information that may be useful to the regulated industry and to the 
public.
    In the Federal Register of December 16, 2014 (79 FR 74729), we made 
available draft CPG Sec. 540.275 ``Crabmeat--Fresh and Frozen--
Adulteration with Filth, Involving the Presence of Escherichia coli.'' 
We gave interested parties an opportunity to submit comments on the 
draft CPG by February 17, 2015, for us to consider before beginning 
work on the final version of the CPG. We received no comments on the 
draft CPG. We are issuing the CPG with no changes other than for 
clarity and to update the format. The CPG announced in this notice 
finalizes the draft CPG dated December 2014.

II. Electronic Access

    Persons with access to the Internet may obtain the CPG at either 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the CPG.

    Dated: April 25, 2016.
Katherine Bent,
Assistant Commissioner for Compliance Policy.
[FR Doc. 2016-09951 Filed 4-27-16; 8:45 am]
 BILLING CODE 4164-01-P