Technically Speaking

Mad As Hell

By Duane Gangwish

    In the movie Network, a 1976 satire on “trash TV,” the lead character, played by Peter Finch, is a news anchor who is fed up with the situation and encourages his viewers to “Go to the window and shout as loud as you can, ‘I’m mad as hell and I’m not going to take it anymore!’”

That is what came to mind when I recently read the Final Rule on the establishment and maintenance of records to enhance the security of the U.S. food supply under the “Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (the Bioterrorism Act). Sounds pretty ominous doesn’t it? Now, apply it to poor quality grass hay.

The Bioterrorism Act was passed in 2002, regulations were drafted, a public comment period followed and the Final Rule was published on December 9, 2004. I’m getting to the hay part.

During the debate, Congress exempted farms and ranches from the requirements of the Act. Unfortunately, counter to the intent of Congress, the FDA chose to re-define farms as “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” (Federal Register, December 9, 2004, Volume 69, Number 236, Rules and Regulations page 71,561-71,655). This is clearly inconsistent with the intent of Congress.

Definitions are paramount to application of state and federal regulations, so, for the record, “food” is defined by reference to section 201(f) of the Federal Food, Drug and Cosmetic Act, Section 201(f), which states “food” is “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” [emphasis added]

In every piece of good and righteous legislation or regulation there are unintended consequences. As we learned from the FMD scare at a Holton Kansas sale barn in March of 2002, more recently with BSE, and now with avian flu, even the suspicion of a disease agent can have devastating economic impact on our industry. Now, from here on out, insert the word feed, or more specifically poor quality grass hay, wherever you see “an article of food” or just “food” and you too will be at the window shouting.

These rules do not apply if the feed is grown, raised and consumed on your “farm” or another “farm” under the same ownership. However, the FDA definition above excludes virtually all farms from the exemption because if you sell, trade, barter or give away feed, excuse me, “articles used for food or drink for animals and articles used for components of any such article,” you shall prepare and maintain the required documentation on all your feedstuffs. Again, if you haul feed, or a component thereof (hay) across the road to the neighbor, you must follow federal guidelines in the establishment and maintenance of appropriate records.

According to FDA documents, when the FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records or other information to which FDA has access must be available for inspection and copying as soon as possible, not to exceed 24 hours from time of receipt of the official request. The records-access authority applies both to records required to be established and maintained by the final rule, or any other records a covered entity may keep to comply with federal, state or local law or as a matter of business practice.

This is currently federal law and if you have more than 11 employees, you should have been keeping records since June 9, 2006, and if you have 10 or fewer, you have until December 9, 2006 to comply. The Bioterrorism Act makes failure to establish and maintain the required records or failure to make them available to FDA a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; the Federal government also can bring a criminal action in Federal court to prosecute persons who commit a prohibited act.

What records must be established and maintained by non-transporters of food? (Don’t forget the definition of food.) For non-transporters, i.e., persons who own food or who hold, manufacture, process, pack, import, receive or distribute food for purposes other than transportation, the records have to:

1.  Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety (e.g., Brand X cheddar cheese, not just cheese; romaine lettuce, not just lettuce); date received; quantity and type of packaging (e.g., 12-oz. bottles); and identify the immediate transporter previous sources including the name, address, telephone number and, if available, fax number and email address. Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists.

2.  Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm; address; telephone number; fax number and email address, if available; type of food, including brand name and specific variety; date released; quantity and type of packaging; and identify the immediate transporter subsequent recipients, including the name, address, telephone number and, if available, fax number and email address. Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists. The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.

What records must be established and maintained by transporters of food?

The term transporters includes persons who have possession, custody or control of an article of food in the United States for the sole purpose of transporting the food, whether by road, rail, water or air. The term transporters also includes foreign persons who transport food in the U.S., regardless of whether the foreign persons have possession, custody or control of food for the sole purpose of transporting it. For transporters, records have to include names of the transporter’s immediate previous source and transporter’s immediate subsequent recipient, origin and destination points, date shipment received and date released, number of packages, description of freight, route of movement during the time the food was transported and transfer point(s) through which the shipment moved.

Don’t misinterpret what I am saying. I am not trashing the ban on specified risk materials (SRMs) or the ability to trace them, but it seems we have gone far beyond reason when FDA requires the documentation of every pound of feed, or component thereof, in the nation.

I don’t really suggest you go yell out the window… nobody’s going to listen anyway. I do suggest that while you are complying with the law you pick up the phone and call your elected representatives and voice your concerns.

NC is working to bring some common sense and balance to the threat of bioterrorism in the nation’s feed supply. NC Vice-President Larry Smith has taken a lead role in this matter for the association. Please give Larry or NC staff a call to lend a hand.    Duane Gangwish is NC’s vice president of technical services.

Sidebar:

Fact Sheet on FDA’s New Food Bioterrorism Regulation

Establishment and Maintenance of Records http://www.cfsan.fda.gov/~dms/fsbtac23.html

Guidance for Industry and FDA Staff http://www.cfsan.fda.gov/~dms/secgui13.html

Final Rule
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26929.htm