Use of the Fast Antimicrobial Screen Test for Bob Veal Calves

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 310

[Docket No. 95-048DF]

RIN 0583-AC03

Use of the Fast Antimicrobial Screen Test for Bob Veal Calves

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Direct final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

Federal meat inspection regulations to permit the use of the Fast

Antimicrobial Screen Test (FAST) in its bob veal calf residue testing

program. Under FSIS' residue testing program, carcasses of bob veal

calves are subject to specific regulatory requirements for residue

testing by FSIS inspectors to assure that adulterated meat does not

enter human food channels. Until recently, the Calf Antibiotic and

Sulfonamide Test (CAST) was the only official test authorized for use

in the bob veal calf residue testing program. FSIS has now developed

FAST, which is an enhanced and equally effective version of CAST that

provides results after 6 hours of incubation, compared to 18-24 hours

of incubation for CAST. This action will permit the use of FAST in lieu

of CAST under FSIS' bob veal calf residue testing program.

DATES: This rule will be effective on February 20, 1996, unless we

receive written adverse comments or written notice of intent to submit

adverse comments on or before January 22, 1996. If FSIS receives

adverse comments or notice of intent to submit adverse comments, FSIS

will withdraw this rule and publish a proposed rule for public comment.

ADDRESSES: Send an original and two copies of written comments to: FSIS

Docket Clerk, Docket #95-048DF, Room 4352, South Agriculture Building,

Food Safety and Inspection Service, U.S. Department of Agriculture,

Washington, DC 20250.

SUPPLEMENTARY INFORMATION:

Background

In June 1984, as a result of findings of increased levels of

sulfonamide and antibiotic residues in young calves, FSIS promulgated

an interim rule (49 FR 23602; affirmed 50 FR 32162) that amended the

Federal meat inspection regulations (9 CFR parts 309, 310 and 318) by

establishing an intensified residue testing program for bob veal calves

(calves up to 3 weeks in age or 150 pounds in weight). FSIS was

concerned with findings of increased levels of sulfonamide and

antibiotic residues in young calves, and undertook an emergency

rulemaking to decrease the likelihood that adulterated meat would enter

into human food channels. FSIS determined that carcasses and parts

thereof from bob veal calves are adulterated under the Federal Meat

Inspection Act if they bear or contain sulfonamide or antibiotic

residues other than in accordance with tolerances established by the

Food and Drug Administration.

In the interim rule, FSIS stated that CAST, a swab bioassay test,

would be the official test used to screen carcasses of bob veal calves.

In trial testing, FSIS had found CAST to be extremely reliable in

detecting violative levels of antibiotics and sulfonamides in animal

tissues.

FSIS has recently developed a new test that, like CAST, is designed

to detect the presence of sulfonamide and antibiotic residues in animal

tissues. FAST is similar to and is performed in a similar manner to

CAST. The major advantage of FAST is that test results can be obtained

in 6 hours, instead of the 18-24 hour period required for CAST. FSIS'

in-plant trial testing of FAST has shown that FAST is equivalent to

CAST in detecting sulfonamide and antibiotic residues in animal

tissues.1

\1\ Results of the in-plant trial for FAST are available for

review in the Office of the FSIS Docket Clerk, Room 4352, South

Agriculture Building, Food Safety and Inspection Service, U.S.

Department of Agriculture, Washington, DC 20250.

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Therefore, FSIS is amending Sec. 310.21 to add FAST as an

alternative to CAST for use by inspectors in testing carcasses and

parts of bob veal calves for sulfonamide and antibiotic residues.

Effective Date

This rule is being published without a prior proposal because this

action is viewed as noncontroversial, and FSIS does not anticipate any

adverse public comments will be received. This rule will be effective

60 days after the date of publication in the Federal Register unless

FSIS receives written adverse comments or written notice of intent to

submit adverse comments within 30 days of the date of publication of

this rule in the Federal Register.

If FSIS receives adverse comments or notice of intent to submit

adverse comments, FSIS will withdraw this rule and publish a proposed

rule for public comment.

If no adverse comments are received, FSIS will publish a notice in

the Federal Register confirming that the rule is effective on the date

indicated.

Executive Order 12866

This rule is considered not significant and therefore has not been

reviewed by the Office of Management and Budget.

Effect on Small Entities

The Administrator, FSIS, has determined that this rule will not

have a significant impact on a substantial number of small entities.

The rule permits the use of an alternate test, which can provide

results in less than half the time than the original test. Carcasses

that test negative could be released on the day of slaughter, which

will modestly benefit the meat industry.

Executive Order 12778

This rule has been reviewed under Executive Order 12778, Civil

Justice Reform. This rule (1) preempts all State and local laws and

regulations that are inconsistent with this rule; (2) has no

retroactive effect; and (3) does not require administrative proceedings

before parties may file suit in court challenging this rule.

List of Subjects in 9 CFR part 310

Meat inspection, Residue testing.

For the reasons discussed in the preamble, FSIS is amending part

310 of the Federal meat inspection regulations (9 CFR Part 310) as

follows:

PART 310--[AMENDED]

1. The authority citation for part 310 continues to read as

follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

2. The introductory text and footnote to paragraph (c) of

Sec. 310.21 are revised to read as follows:

[[Page 66483]]

Sec. 310.21 Carcasses suspected of containing sulfa and antibiotic

residues; sampling frequency; disposition of affected carcasses and

parts.

* * * * *

(c) * * * The inspector shall perform a swab bioassay test 1

on:

\1\ The procedures for performing the swab bioassay test are set

forth in one of two self-instructional guides: ``Performing the

CAST'' or ``Fast Antimicrobial Screen Test.'' These guides are

available for review in the office of the FSIS Docket Clerk, Room

4352 South, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250.

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* * * * *

Done at Washington, DC, on: December 14, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95-31017 Filed 12-21-95; 8:45 am]

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