[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Page 67837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0427]


Compliance Policy Guide; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of Compliance Policy Guide (CPG) Section 540.400, ``Shrimp--
Fresh or Frozen, Raw, Headless, Peeled or Breaded--Adulteration 
Involving Decomposition (CPG 7108.11),'' because it no longer reflects 
agency policy. This action is being taken to ensure that FDA's CPG's 
accurately reflect agency policy and to limit misinterpretation and 
confusion.

FOR FURTHER INFORMATION CONTACT: Mary I. Snyder, Center for Food Safety 
and Applied Nutrition (HFS-415), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3160.

SUPPLEMENTARY INFORMATION: FDA is revoking CPG Section 540.400, 
``Shrimp--Fresh or Frozen, Raw, Headless, Peeled or Breaded--
Adulteration Involving Decomposition (CPG 7108.11),'' because it no 
longer reflects agency policy. This CPG provides regulatory guidance on 
when shrimp is determined to be decomposed. Section 540.400 sets out 
criteria for deciding whether to initiate regulatory action based on 
the results of organoleptic and indole analyses of shrimp.
    FDA's experience with this CPG as guidance has shown that the CPG 
is subject to misinterpretation by those within and outside the agency. 
To correct this problem, FDA has decided to revoke this CPG. Until such 
time as the agency develops appropriate new guidance, it intends to use 
any appropriate method of analysis for examining shrimp and to review 
recommendations for regulatory action against decomposed shrimp on a 
case-by-case basis.
    FDA publishes its CPG's to present the agency's current thinking on 
issues that are before the agency. CPG's do not create or confer any 
rights for, or on, any person and do not operate to bind FDA or the 
public.

    Dated: December 13,1996.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 96-32548 Filed 12-23-96; 8:45 am]
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