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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spring Grove Dairy 22-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 55401-1999

Telephone: 612-334-4100

February 22, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 27

George Kasbergen

Co-owner

Spring Grove Dairy

12400 Limonite Avenue

Mira Loma, California 91752

Cornell Kasbergen

Co-owner

Spring Grove Dairy

2174 Road 152

Tulare, California 93274

Dear Mssrs. Kasbergen:

An investigation at your dairy farm located at N1930 County Road G, Brodhead,

WI, 53520, conducted by our-investigators on January 4,2002, confirmed that you

offered an animal for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) and that you may have caused animal drugs to become adulterated within the meaning of Section 501 (a)(5).

On or about September 20, 2001, you sold a cow identified with backtag #35CR4-

991 for slaughter as human food to [redacted] U.S. Department of Agriculture (USDA) analysis of tissue samples collected from that animal identified the presence of penicillin at 0.13 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (Title 21, Code of Federal Regulations, Part 556.5 10). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that are so

inadequate that diseased animals and/or medicated animals bearing potentially

harmful drug residues are likely to enter the food supply. For example, you lack

an adequate system for assuring that drugs are used in a manner not contrary to

the directions contained in the labeling, and for assuring that animals medicated

by you have been withheld from slaughter for appropriate periods of time to permit

depletion of potentially hazardous residues of drugs from edible tissues. Foods

from animals held under such conditions are adulterated within the meaning of

Section 402(a) (4) of the Act.

You are adulterating the [redacted] brand [redacted] penicillin that your firm uses

on cows within the meaning of Section 50 l(a)(5) when you fail to use the drug in

conformance with its approved labeling. Your use of the drug at higher than

labeled dosages causes the drug to be unsafe to use.

The above is not intended to be an all-inclusive list of violations. As a producer of

animals offered for use as food, you are responsible for ensuring that your overall

operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to establish

procedures whereby such violations do not recur. Failure to do so may result in

regulatory action without further notice such as seizure and/or injunction.

It is not necessary for you to personally ship an adulterated animal in interstate

commerce to be responsible for a violation of the Act. The fact that you caused the

adulteration of an animal that was sold and subsequently offered for sale to a

slaughterhouse that ships in interstate commerce is sufficient to hold you

responsible for a violation of the Act.

You should notify this office in writing within 15 working days of the steps you

have taken to bring your firm into compliance with the law. Your response should

include each step being taken, that has been taken, or will be taken to correct the

violations and prevent their recurrence. If corrective action cannot be completed

within 15 working days, state the reason for the delay and the time frame within

which the corrections will be completed. Please include copies of any available

documentation demonstrating that corrections have been made. Your reply should

be addressed to Compliance Officer Timothy G. Philips at the address on the

letterhead.

Sincerely,

David R. Yost

Acting Director

Minneapolis District