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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Addresses Questions Under Bioterrorism Rule About Recordkeeping for Hay Sales

FDA Veterinarian Newsletter 2006 Volume XVII, No IV

The Food and Drug Administration (FDA) recently addressed questions raised by farmers and livestock feeders concerning the requirements for keeping records under Federal bioterrorism rules relating to sales of hay.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorized FDA to issue regulations that require persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States to establish and keep records identifying the immediate previous sources and the immediate subsequent recipients of the food.

The provisions of the recordkeeping rule are intended to ensure that, in the event of an outbreak of foodborne illness, FDA and other authorities will be able to determine the source and cause of the event as quickly as possible. In addition, the information will improve FDA’s ability to quickly notify the consumers or facilities and transporters that might be affected by the outbreak.

The regulation requires persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records identify the immediate previous source of all food received, as well as the immediate subsequent recipient of all food released. Records for animal food, including pet food, must be retained for one year.

Records must be retained at the establishment where the activities covered in the records occurred or at a reasonably accessible location. Companies may keep the required information in any format, paper or electronic.

The text of the final rule and information about recordkeeping and other aspects of the rule are available at http://www.fda.gov/oc/bioterrorism/bioact.html.
The definition of “food” includes animal feed, such as hay, and the recordkeeping requirements can apply to persons who handle hay. However, persons involved in operations that meet the definition of a “farm” are exempt from all of the recordkeeping requirements in the final rule. (Commodity brokers and commercial trucking operations that ship commodities, for example, are required to keep records, because they do not fall within the farm exemption.) The final rule defines a farm to include not only the growing of crops or animals, but also includes traditional farming activities that are incidental to the growing of crops and animals, such as harvesting and transporting the food to buyers. The definition of farm, as it is presented in 21 CFR 1.328 is presented below, in the answer to question 4.2.

Questions about the rule

Hay is widely produced and sold throughout the United States. When FDA released the rule about recordkeeping, it heard questions from farmers and ranchers about the rule.

The rule affects many entities and all food and animal feed under FDA’s jurisdiction. Thus, FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which has the overall lead for developing the bioterrorism regulations under the Act, has posted a “Question and Answer” guidance document on its Web site that explains all of the bioterrorism rules as they apply to food. -CFSAN worked closely with FDA’s Center for Veterinary Medicine in formulating answers to the questions involving animal feed, including questions involving hay distribution. The guidance document has been updated four times, and the most recent update, issued in September, includes a full explanation of the recordkeeping requirements as they apply to hay.

Below is an excerpt of the questions and answers in the guidance document that pertain to hay. The entire question and answer document is available at http://www.cfsan.fda.gov/~dms/-recguid4.html

4.2 A farm grows, dries, and chops alfalfa before releasing it to another person for use as animal feed. Is the farm still exempt from this regulation?

A: FDA considers harvesting of grains and hay to be traditional farming activities covered under the farm exemption. The final rule defines a “farm” in 21 CFR 1.328 as a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling produce are considered part of harvesting. The term “farm” includes: (1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (2) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. (Emphasis added.)

The answer to the question depends on whether the drying and chopping of the alfalfa is part of traditional harvesting activities that is within the farm exemption, or a post-harvest manufacturing/processing activity that is subject to the rule. FDA considers “harvesting” as encompassing those activities traditionally performed during the removing of a crop from the field through the safe storage of the crop. Thus, drying and chopping activities that are an essential part of the harvest process and which are traditional farming operations for a particular crop are activities covered by the “farm” definition, as long as all other conditions of the “farm” definition are met. For example, the harvesting of hay typically includes the cutting in the field, drying, baling, and storage of the hay. (With hay, drying is particularly important to prevent spontaneous combustion from occurring.) If, however, a farmer were to remove cut hay from storage and chop the hay to make hay cubes to sell, then establishment and maintenance of records would be required, as FDA considers this activity manufacturing/processing of the already stored hay. (This is similar to chopping carrots into 3-inch slices after they are harvested for sale as snack foods; such activity is not integral to harvesting the carrots and is a post-harvest manufacturing/processing activity subject to the rule, unless the carrots are consumed on the farm on which grown or another farm under the same ownership.)

“Manufacturing/processing” as defined in Sec. 1.328 means “making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.” As stated above, under Sec. 1.328 of the final rule, a farm can manufacture/process food and retain its exemption under the rule, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

4.5 I am a hay grower that will bale some of my hay and make ensilage out of the rest. What does FDA consider as “harvesting” as it is used in the definition of “farm” in 21 CFR 1.328? Does drying my hay naturally in the field versus drying my baled hay artificially with blower fans in my barn prior to storage make a difference in whether I am considered exempt as a farm under the final rule?

A: FDA interprets harvesting as the activities traditionally performed during the removing of a crop from the field through the safe storage of the crop. As stated in the answer to Question 4.2, the harvesting of hay includes the cutting, drying, baling, and storage of the hay. Whether the hay is dried naturally in the field or on racks in front of fans before being placed in storage does not change the status of a “farm” since the harvesting of hay requires proper drying before it can be safely stored. However, if you were to remove the hay from storage and chop the hay to make hay cubes to sell, then establishment and maintenance of records for the hay cubes would be required for this activity (but not the growing and harvesting of the hay), since this activity is considered manufacturing/processing of the already stored hay. Further, the ensiling process of cutting grass off the field and blowing the wet grass into a silo for preservation is a traditional harvesting activity that falls within the farm exemption.

4.6 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 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 above) 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 a commercial trucking operation, then the transporter must establish and maintain records as provided in 21 CFR 1.352.

4.8 I mix my corn and haylage with a commercial protein supplement to feed my cattle. Do I need to keep records?

A: No. The definition of farm, 21 CFR 1.328, includes “facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.” As discussed in the response to Comment 67 in the preamble to the final rule, to ensure that FDA is fulfilling Congress’s intent to exempt “farm,” FDA revised the definition of a farm in the final rule to include manufacturing/processing activities as long as all food used in such activities is consumed on that farm. Therefore, establishment and maintenance of records is not required for this on-farm mixed feed, as long as the mixture is fed to animals on the farm or another farm under the same ownership. However, records would need to be kept if the mixed feed is released to someone other than a farm under the same ownership. Mixing the corn and haylage with a commercial supplement constitutes manufacturing/processing and falls outside the traditional farming activity once the feed is distributed to anyone other than another farm under the same ownership.