Animal & Veterinary
Regulatory Activities - May/June 2003
by Karen A. Kandra
FDA Veterinarian Newsletter May/June 2003 Volume XVIII, No 3
The following firms/individuals re-ceived warning letters for offering animals for slaughter that contained illegal residues:
- Juan I. Echeverria, Owner, Echeverria Dairy, Chino, CA
- Avelino A. Vieira, Owner, Alvieira Dairy, Wendell, ID
The above violations involved illegal residues of penicillin in a culled dairy cow and tilmicosin in a downer cow.
A warning letter was issued to Ettore Alosio, President, Micelle Products, Inc., Lake Forest, CA, for violations concerning the distribution of unapproved animal drugs, including, Arthamine Advanced, Arthramine Plus, Anti-Gas, Champ Chewable Nutritional Pebbles, Calmative, Dermaplex, and Dermasol spray/gel.
Because these products are not approved under a New Animal Drug Application, they are unsafe under Section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated under Section 501(a)(5) of the Act.
Under Section 201(g) of the Act, any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or “intended to affect the structure or any function of the body of man or other animals” is regarded as a drug.
Freedom of Information
The Freedom of Information Act (FOIA) allows anyone to request copies of records not normally prepared for public distribution. FOIA pertains to existing records only and does not require agencies to create new records to comply with a request. It also does not require agencies to collect information they do not have or to do research or analyze data for a requestor. In addition, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time.
How to Make a FOI Request
All FOIA requests must be in writing and should include the following information:
- Requestor’s name, address, and telephone number.
- A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for “all information” on a particular subject. Also fees for a more specific and limited request will generally be less. Information on major information systems maintained by FDA can be obtained by using the Department of Health and Human Services Government Information Locator Service (GILS) site. This information may be useful in narrowing a request.
- Separate requests should be submitted for each firm or product involved.
- A statement concerning willingness to pay fees, including any limitations.
All FOIA requests must be in writing. FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Office of Information Resources Management
Division of Freedom of Information (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.
FOIA requestors may have to pay fees covering some or all of the costs of processing their request. Requestors may want to include the maximum dollar amount they are willing to pay. If the fees exceed the maximum amount stated, FDA will contact the requestor before filling the request. Requestors are generally billed for fees after their requests have been processed; however, if total fees are expected to exceed $250.00 FDA may require payment in advance of processing.
Effective March 26, 2003, the hourly rate for FOI search and review time has been increased as follows:
- GS-1 through GS-8 – $18.00 per hour ($1.00 increase)
- GS-9 through GS-14 – $36.00 per hour ($2.00 increase)
- GS-15 and above – $64.00 per hour ($3.00 increase)