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VIA UPS Tracking Number:

1Z19W9A03710003953

 

 

November 19^th, 2018

 

Jelliffe Dairy Farm

Jake and Debra Jelliffe

221 Cemetery Hill Road

Asbury, New Jersey 08802-1402

 

WARNING LETTER

CMS: 566246

 

Dear Mr. and Mrs. Jelliffe:

 

On July 31, 2018 and August 3 and 10, 2018, the U.S. Food and Drug Administration (FDA or “we”) conducted an investigation of your dairy operation located at 221 Cemetery Hill Road, Asbury, New Jersey.  This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation.  You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.

 

We found that you offered for sale an animal for slaughter as food that was adulterated.  Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b.  Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

 

Specifically, our investigation revealed that on or about June 5, 2018, you sold a bob veal calf, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food.  On or about June 8, 2018, (b)(4), slaughtered this animal.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 10.9 parts per million (ppm) of neomycin residue in the kidney.  FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430).  However, this tolerance does not apply to the use of (b)(4) containing neomycin sulfate and oxytetracycline hydrochloride in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of the drug (neomycin) in bob veal calves (pre-ruminating calves).  The approved labeling for (b)(4) states in part “A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL”. The presence of neomycin in edible tissues from this animal in any amount therefore causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

 

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.  You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs in edible tissues.  Specifically, you failed to identify, segregate, and quarantine treated animals because you allowed mixed-sex pens of calves to share buckets of milk treated with drugs (neomycin) that were only intended by you to be given to heifer calves. Additionally, you do not individually identify your cattle in a way that would permit you to track them through drug treatment and/or sale, you failed to maintain treatment records, and you lack an adequate inventory system for determining quantities of drugs used to medicate your animals.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

 

Our investigation found that you adulterated (b)(4), when you failed to use this medicated milk replacer in conformance with their approved labeling. (b)(4) labeling states that it cannot be used in calves to be processed for veal, but you allowed a bob veal calf identified with ear tag (b)(4) and back tag (b)(4), to be fed (b)(4).  Medicated feed may not be used in an extra-label manner.  Your use of these medicated milk replacers without following the animal class as directed by the approved labeling caused this medicated supplement to be unsafe within the meaning of section 512 of the FD&C Act (21 U.S.C. 360b(a)(2)) and adulterated within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6).

 

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 food you distribute is in compliance with the law.

 

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur.  Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 

 

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 written response should be sent to Jessica D. Weber, Compliance Officer, United States Food & Drug Administration, Human & Animal Food Division II East, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215.  If you have any questions, please contact Ms. Weber at the above physical address, by phone at (410) 779-5407, or by email at jessica.weber@fda.hhs.gov.

 

 

Sincerely,

/S/

Evelyn Bonnin

Program Division Director

District Director

Human & Animal Food Division II East

Baltimore District Office

 

 

Cc:

Mr. Christian Kleinguenther, Bureau Chief

New Jersey Department of Agriculture

Division of Marketing and Development

275 N. Delsea Drive, Suite 2F

Vineland, New Jersey 08360

 

Dr. Bruce Fry, DVM

Alpha Veterinary Care

334 3^rd Avenue

Alpha, New Jersey 08865