New FDA Tracking Requirements

By Jane Fyksen - Crops Editor
Friday, November 3, 2006 4:20 PM CST

The U.S. Food and Drug Administration's new food - and animal feed - tracking requirements have been causing a lot of concern and confusion within the farm community.

UW-Madison Forage Agronomist Dan Undersander admits he doesn't have all the answers, but maintains that the new government mandates on recording sales of hay, grain, TMRs and other feeds sold off the farm aren't as burdensome as portrayed in some reports by other media.

"There has been some concern...about the need to track hay and grain sold off the farm relative to the 'Public Health Security and Bioterrorism Preparedness and Response Act of 2002,'" says Undersander of requirements that took effect June 9 for operations with more than 10 employees and which take effect Dec. 9 for all other operations.

The rules are designed to enable FDA to trace a contamination problem back to its source. FDA lumped animal feeds with food.

The National Hay Association and others have checked out the new requirements carefully with FDA officials and found that the recording requirements "have been vastly overstated in the press," says Undersander.

Basically, he says the new requirements to keep track of commodities sold off the farm - and those purchased, too, for that matter - are "one up and one down." In other words, a farmer should keep track of "who, what, where and when" commodities are sold - and purchased, according to Undersander.

He says farms are specifically exempt from "registering" their operations with the government and/or maintaining more-stringent records of processing done on the farm for on-farm use.

The FDA states: "A farm that manufactures/processes, packs, or holds food is not required to register with FDA, if all of the food used in such activities is consumed on that farm or another farm under the same ownership. For example, a farm that manufactures/processes animal feed from ingredients obtained off the farm for consumption by animals on the farm would be exempt because most farms that raise animals engage in this activity."

While government legalese can be about as clear as mud, Undersander explains that the confusion within agriculture over FDA's new anti-terrorism mandate is that the agency set forth "one set of regulations for everything, and feed stocks got included with food." The risk to the public of contaminated hay, for instance, is much less of an issue than crops directly consumed by people, like lettuce and cabbage and other vegetables and fruits, he states.

Thus, notes Undersander, "farmers who simply bale hay for sale do not have to register their facilities or maintain (very detailed) records. The FDA does not consider baling hay as 'processing.' All the FDA needs is a receipt in a receipt book showing the person (or entity) that bought the hay and the quantity that was purchased. There is no requirement that hay producers keep track of all the bales and where they go."

"Records that are maintained for tax purposes, which show that a sale was made and to whom the sale was made, should be sufficient for compliance," he says. "The new FDA rule will not require a farmer to change recordkeeping as long as details of the feed sale are recorded."

In particular, there is no need for being able to track lots of hay or grain back to individual fields as some have indicated, notes Undersander. There's no need to record the field each load came from, the truck that hauled it and the names and contact information of the driver and people who loaded and unloaded the hay.

AN FDA-released guidance addresses some commonly asked questions of producers. Here's one: "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?"

FDA considers harvesting of grains and hay to be traditional farming activities covered under the farm exemption. The final rule defines a "farm"..."as a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term 'farm' includes: 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 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."

According to FDA, "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. 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, says FDA.

Here's another question addressed by FDA: "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'? 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?"

The agency states that it "interprets harvesting as the activities traditionally performed during the removing of a crop from the field through the safe storage of the crop. 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," FDA adds.

Also addressed in the guidance is this: "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?"

"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," answers FDA. "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...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..." FDA notes.

The agency offers this example: "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...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..."

"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," FDA states. "Abe and Betty do not need to establish and maintain records as long as they meet the definition of a farm."

FDA also addresses this: "Does a farm have to keep records of who transported hay that was bought or sold?"

The agency's answer is 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'...and are exempt from all of the requirements...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.

Here's another common query FDA addresses: "I mix my corn and haylage with a commercial protein supplement to feed my cattle. Do I need to keep records?"

FDA says "no." The definition of farm 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." To ensure that FDA is fulfilling Congress's intent to exempt "farms," it 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. In other words, a TMR is sold to a neighbor.

According to FDA, "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."

Undersander suggests that farmers who take their grain to a local elevator for storage get a receipt, because they may not necessarily get the same grain back later on.

Producers are encouraged to just use commonsense in terms of getting such receipts and keeping records of crops sold and purchased. But again, Undersander, says records don't need to go beyond what they'd keep anyway for their taxes. He notes, though, to "at least get a receipt" if you sell hay and get cash from a neighbor.

The FDA requirements are stated in a "guidance to industry" issued last month. It's at www.cfsan.fda.gov/~dms/recguid4.html. Growers, custom harvesters, truckers, hay brokers and others should direct their questions to FDA's Center for Food Safety and Applied Nutrition (CFSAN) at 888-SAFEFOOD or industry@fda.gov.

The bottom line? Undersander says the regulations "sound more formidable" for agriculture than they are. Feedstuffs, he indicates, likely won't get the same level of scrutiny as human foods. FDA isn't apt to be actively visiting farms to enforce the new regulations. However, commonsense should prevail and to be in line with the law, it's wise to track transactions.

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