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Little River, TX | Guidance for Industry
Questions and Answers Regarding
Establishment and Maintenance of Records
(Edition 4)*
Final Guidance
Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 1-888-SAFEFOOD, (Fax) 1-877-366-3322, or by e-mail: [email protected].
Additional copies are available from:
Office of Regulations and Policy, HFS-24
Center for Food Safety and Applied Nutrition
Food and Drug Administration, 5100 Paint Branch Parkway
College Park, MD 20740
http://www.cfsan.fda.gov/guidance.html
4.6 Q: [Added September 2006] If I sell hay that I grow on my farm to another farm, am I subject to the establishment and maintenance of records provisions in the final rule?
A: No, you do not have to establish and maintain records for the hay you grow and sell to another farmer or to a direct consumer such as a person that owns pleasure horses. Harvesting also includes releasing the crop to another person. Thus, activities associated with the selling of the crop, such as transportation of the hay by the farmer either directly or through a third-party transporter to a buyer is included within the farm exemption. As discussed in the response to Comment 67 in the final rule preamble, a farm that transports its products from the field does not cease to be a "farm" because such transportation is considered incidental to traditional farming activities. However, if you purchase hay from another farm under different ownership to resell, then you have to establish and maintain records related to the hay you receive and release in accordance with 21 CFR 1.337 and 1.345, respectively.
For example, if Abe, a farmer, grows hay on his farm and feeds it to his livestock on that farm or another farm under the same ownership, he does not need to establish and maintain records. Or, if Abe sells the hay that he grew and harvested to Betty who has another farm for her use to feed livestock on her farm, neither Abe nor Betty have to establish and maintain records regarding the hay, provided each meets the definition of farm in 21 CFR 1.328. On the other hand, if Abe sells his hay to Charlie, who runs a brokerage company and has bought the hay to resell it, then Charlie must establish and maintain records of the hay he receives and releases in accordance with 21 CFR 1.337 and 1.345, respectively. For example, if Abe sells his hay to Charlie, who in turn sells it to Betty to feed her cattle, Charlie must establish and maintain records to identify the immediate previous sources (including Abe) and immediate subsequent recipients (including Betty) of the hay. Brokering hay is not a normal farm activity and Charlie would be considered a distributor of the hay subject to the rule. Under 21 CFR 1.326(a), persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to the regulations in subpart J, unless they qualify for one of the exclusions in 21 CFR 1.327. Abe and Betty do not need to establish and maintain records as long as they meet the definition of a farm.
4.7 Q: [Added September 2006] Does a farm have to keep records of who transported hay that was bought or sold?
A: No. If the hay was transported by the farm/seller (Abe in the example in 4.6A) or farm/buyer (Betty), no transportation records are needed. Trucks used as part of a farm operation fall within the definition of farm in 21 CFR 1.328, and are exempt from all of the requirements in Subpart J. However, if the hay was transported by a person that does not meet the definition of a farm, such as commercial trucking operation, then the transporter must establish and maintain records as provided in 21 CFR 1.352.
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Partial answer on record keeping for hay sales
