Are you subject to FDA's bioterrorism rules?

Kelly Robertson, a farmer and consultant in southern Illinois, called the other day to ask about FDA recordkeeping (bioterrorism) rules that may impact farmers beginning Dec. 11. He'd been getting a lot of sales calls from software vendors who want to sell programs that will help fulfill these recordkeeping obligations.

My first reaction was here comes a knee-jerk reaction from the government thanks to bad spinach. But in fact these rules have been in play for quite some time now. Whether or not you will be subject to new recordkeeping obligations is a little hazy. I asked my contact at the Illinois Farm Bureau to nose around a bit. "When I brought this up in casual conversation with our regulatory guys, all I got were blank stares,•bCrLf he says.

Earlier this year our sister publication Feedstuffs reported that the FDA's bioterrorism rules would go into effect for companies with 11-499 employeess, while those with 10 or fewer have until Dec. 11 to comply. The •rules' in question have to do with keeping traceback records on food you produce. Those who must comply would have to keep records of where the food was grown, who it was sold it, where it was stored — things of that nature.

"The rule applies to anyone who manufactures, processes, packs, transports, distributes, receives, holds or imports food, including grain, feed and feed ingredients and feed additives,•bCrLf we reported in Feedstuffs. "It requires companies to keep these records one step forward and one step back -- where the feed/ingredient/grain came from and where it went -- and to make those records available within 24 hours when FDA requests them.•bCrLf

There is something on the FDA website on traceability, "but it's worded very vague," says Robertson. No kidding. I tried sifting through it and it wasn't easy. But it may be worth a look if you operate a farm or farm-related business. Go to the FDA website. Section B 4 deals with farms and as I read this, for the most part, they are exempt. If you grow hay and sell it to another farm to be consumed by livestock or, for example, pleasure horses, you don't need to keep records.

However, if you grow hay and sell it to another farmer who is a broker planning to sell your hay to others, then you do need to keep records. If a farm grinds or mixes a feed and sells it to a neighbor or another business, then records would need to be kept. Another example would be farmers who dry alfalfa and sell it to others as feed (section B 4.5 Q). FDA would consider that a commercial transaction, and records are needed.

 Integrators are also generally exempt, provided that the feed is used only on farms within the same ownership.

 The National Grain and Feed Association (NGFA) has been all over this. I made a call to NGFA and discovered the recordkeeping regulations also provide partial exemptions for certain types of establishments, including commercial feed dealers and retail feed stores. To qualify for the exemption the total annual dollar value of sales by a retail store directly to final consumers must exceed the value of sales to all other buyers, including farms, livestock and poultry feeding operations and other businesses.

 For more details and information, NGFA has come up with several guidance documents at no charge at their website. You can click HERE for the PDFs. The comprehensive document at the top of the page would probably suit most farmers best.

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