[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Rules and Regulations]
[Page 42451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 500

[Docket No. FDA-2013-N-0253]


Animal Feeds Contaminated With Salmonella Microorganisms

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; removal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is revoking 
an advisory opinion on animal feeds contaminated with Salmonella 
microorganisms. This action is being taken because that advisory 
opinion is being superseded by the current FDA enforcement strategy 
articulated in a final compliance policy guide (CPG) on Salmonella in 
food for animals.

DATES: This rule is effective July 16, 2013.

FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary 
Medicine (HFV-230), 7519 Standish Pl., MPN-4, Rm. 106, Rockville, MD 
20855, 240-276-9207, kim.young@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 15, 1967, 
(32 FR 4058), FDA issued an advisory opinion (the 1967 advisory 
opinion) codified at Sec.  500.35 (21 CFR 500.35), which found that 
processed fish meal, poultry meal, meat meal, tankage, or other animal 
byproducts intended for use in animal feed may be contaminated with 
Salmonella bacteria, an organism pathogenic to man and animals. FDA 
found in the 1967 advisory opinion that contamination of these products 
may occur through inadequate heat treatment of the product during its 
processing or through recontamination of the heat-treated product 
during a time of improper storage or handling subsequent to processing. 
FDA also found in the 1967 advisory opinion that Salmonella 
contamination of such animal feeds having the potential for producing 
infection and disease in animals must be regarded as an adulterant 
within the meaning of section 402(a) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)).
    FDA then articulated its intention to regard as adulterated within 
the meaning of section 402(a) of the FD&C Act shipments of the 
following when intended for animal feed and encountered in interstate 
commerce and found upon examination to be contaminated with Salmonella 
microorganisms: Bone meal, blood meal, crab meal, feather meal, fish 
meal, fish solubles, meat scraps, poultry meat meal, tankage, or other 
similar animal byproducts, or blended mixtures of these.
    Elsewhere in this issue of the Federal Register, FDA announced a 
final guidance for FDA staff entitled ``Compliance Policy Guide Sec. 
690.800 Salmonella in Food for Animals'' (the CPG), that revises the 
criteria FDA staff should consider in deciding whether to recommend 
seizure or import detention of an animal feed or feed ingredient due to 
adulteration resulting from contamination with Salmonella. Because the 
policy in the 1967 advisory opinion is being superseded by the CPG, the 
1967 advisory opinion codified at 21 CFR 500.35 is hereby revoked.
    FDA is removing Sec.  500.35 without prior opportunity for comment 
in accordance with 21 CFR 10.85(g), which states ``An advisory opinion 
may be amended or revoked at any time after it has been issued. Notice 
of amendment or revocation will be given in the same manner as notice 
of the advisory opinion was originally given or in the Federal 
Register. . .'' As the advisory opinion at Sec.  500.35 was published 
and codified on March 15, 1967, without prior opportunity for comment, 
this removal of Sec.  500.35 is published in the Federal Register in 
the same manner.

List of Subjects in 21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCBs).

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 500 is 
amended as follows:

PART 500--GENERAL

0
1. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.


Sec.  500.35  [Removed]

0
2. Remove Sec.  500.35.

    Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16971 Filed 7-15-13; 8:45 am]
BILLING CODE 4160-01-P