[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74729-74730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Crabmeat--Fresh and Frozen--Adulteration With Filth, Involving 
the Presence of Escherichia coli; Compliance Policy Guide; Draft 
Guidance for Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for FDA staff entitled ``Compliance 
Policy Guide Crabmeat--Fresh and Frozen--Adulteration with Filth, 
Involving the Presence of Escherichia coli.'' The draft Compliance 
Policy Guide (CPG), when finalized, will update the previously issued 
``CPG Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving 
the Presence of the Organism Escherichia coli.'' This revised draft 
provides guidance for FDA staff on the level of Escherichia coli (E. 
coli) in crabmeat at which we may consider the crabmeat to be 
adulterated with filth.

DATES: Although you can comment on any guidance at any time (see 21 CFR

[[Page 74730]]

10.115(g)(5)), to ensure that FDA considers your comment on this draft 
CPG before it begins work on the final version of the CPG, submit 
either electronic or written comments on the draft CPG by February 17, 
2015.

ADDRESSES: Submit written requests for single copies of the draft CPG 
to the 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 CPG.
    Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments on the draft CPG to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary E. Losikoff, Center for Food 
Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of the draft CPG entitled 
``Compliance Policy Guide Sec. 540.275 Crabmeat--Fresh and Frozen--
Adulteration with Filth, Involving the Presence of Escherichia coli.'' 
The draft CPG, when finalized, will update the previously issued ``CPG 
Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration with Filth, 
Involving the Presence of the Organism Escherichia coli,'' which 
provides guidance for FDA staff on the level of E. coli in 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 (the FD&C 
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. Specifically, in 
the section on Regulatory Action Guidance, we clarify that FDA's 
Districts have direct reference authority for both domestic seizure and 
import refusal based on the criteria described in the draft 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 draft CPG also 
contains information that may be useful to the regulated industry and 
to the public.
    We are issuing the draft CPG consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft CPG, when finalized, 
will represent our current thinking on the level of E. coli in fresh or 
frozen crabmeat at which we may consider the crabmeat to be adulterated 
with filth under section 402(a)(4) of the FD&C Act.
    The draft CPG does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternate 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
the draft CPG to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document from 
FDA's Office of Regulatory Affairs CPG history page at 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 
guidance.

    Dated: December 10, 2014.
Melinda K. Plaisier,
Associate Commissioner for Regulatory Affairs, Office of Regulatory 
Affairs.
[FR Doc. 2014-29314 Filed 12-15-14; 8:45 am]
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