October 2, 1998
FDA REQUESTS COMMENTS ON DRAFT Guidance INTERPRETING "On-farm Feed Manufacturing and Mixing Operations"
In the Federal Register of September 23, 1998, the Food and Drug Administration (FDA) announced the availability for comment of a Level 1 draft guidance entitled "Interpretation of On-Farm Feed Manufacturing and Mixing Operations.'' The draft guidance is intended to clarify the applicability of certain sections of the Animal Proteins Prohibited in Ruminant Feed regulation to ruminant feeders.
Title 21, Section 589.2000 of the Code of Federal Regulations -- Animal proteins prohibited from use in animal feed -- defines ``feed manufacturer'' to include "on-farm feed manufacturing and mixing operation." FDA’s Center for Veterinary Medicine has been asked whether ruminant producers who mix Total Mixed Rations (TMRs) are "feed manufacturers" under the rule. This draft guidance makes it clear that an operation that simply mixes pre-prepared supplements with plant material such as grains and silage is not considered a feed manufacturer for purposes of this regulation.
While all ruminant feeders are subject to the regulation, the regulation imposes significantly different requirements on ruminant feeders that are also "feed manufacturers.'' For this reason, FDA finds it necessary to clarify the phrase "on-farm feed manufacturing and mixing operations.''
Copies of this document may be obtained from CVM's Internet Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your requests.
The Agency is requesting comments on this draft guidance by November 23, 1998. Written comments on the draft guidance should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance and the Docket Number 98D-0727.
Additional information is contained in the Federal Register notice and is available from Gloria J. Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1726, E-mail: mailto:gdunnava@bangate.fda.gov
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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