The Food and Drug Administration‘s (FDA) Center for Veterinary Medicine released on January 10, an update on inspections conducted of rendering plants and feed manufacturing establishments for compliance with the agency’s rule that prohibits feeding of certain mammalian proteins to ruminant animals. This rule, became effective on August 4, 1997, and is intended to prevent the establishment or spread through feed of bovine spongiform encephalopathy (BSE, commonly referred to as ‘mad cow disease’) in the United States. The FDA developed an enforcement plan with the goal of 100% compliance with this rule. For the first two years it was in effect, the enforcement plan included education as well as inspections with FDA taking compliance actions for egregious actions or repeated non-compliance. As part of the enforcement plan, an assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and feed mills and some ruminant renderers to determine compliance.

To date, there have been a total of 9,947 inspections nationwide. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. Various segments of the feed industry had different levels of compliance. For renderers, who are at the ‘top of the pyramid’ since they are the first to handle rendered protein, and who send materials to feed mills and other ruminant feeders, had a total number of inspections at 239, of which 180 were handling prohibited material. Of these firms, 84% were in compliance with the requirement that prohibited protein be labeled with the caution statement "Do not feed to cattle or other ruminants." Only 72%, however, had a system in place to prevent cross contamination of prohibited and non-prohibited mammalian protein. On the positive side, 96 to 98% of these firms were in compliance with recordkeeping requirements.

For licensed feed manufacturers, FDA said inspections had been conducted of 846 of 1,240 establishments. Of those mills inspected, 347 were handling prohibited mammalian protein. FDA said that 91 percent had systems in place to prevent commingling and cross-contamination of prohibited and non-prohibited mammalian protein, while 80 percent were in compliance with the labeling requirement. Ninety-eight percent were in compliance with the recordkeeping requirements. For non-licensed feed manufacturers, FDA said 4,344 had been inspected. Of those, 1,593 were handling prohibited mammalian protein. The agency said 59 percent were in compliance with the requirement that products containing prohibited mammalian protein be labeled with the caution statement. Seventy-four percent had systems to prevent commingling and cross-contamination. And 91 percent were in compliance with the recordkeeping requirements.

There is some disagreement regarding whether the apparently low compliance percentages are accurate. In the past, many of the feed manufacturing facilities cited for not being in complete compliance with the rules for preventing commingling and cross-contamination had systems in place, but they were cited for not having the procedures in writing. In other cases, feed manufacturers have been cited for violating the labeling requirements because they affix the caution statement to tags of feeds whose formulations may switch back and forth between using prohibited and non-prohibited mammalian protein based upon least-cost formulations.

Meanwhile, the FDA is continuing its enforcement efforts to achieve the goals of 100% inspection of all renderers and feed mills and some ruminant feeders and 100% compliance with the ruminant feed regulations. FDA Field offices have an assignment to re-inspect 700 firms that were not in full compliance with the rule but have committed to implementing the regulation. In addition, FDA is seeking assistance from state feed control officials to identify non-FDA licensed feed mills and to conduct additional inspections in all categories.

You should be aware, the FDA has received some very public heat on the issue of non-compliance by feed mills and in this second round of inspections, they are not anticipated to be as lenient, as perhaps they were, with those mills in non-compliance. If you have any questions, please call the WASA office for assistance.

The USDA recently issued a letter along with a protocol recommending the sampling and testing of seed stock to insure that it does not contain adventitious presence of the Starlink^TM-specific protein. The USDA also stated they would be advising producers and other seed customers "to request verification at the time of purchase that the seed meet the minimum requirements of the USDA seed-testing plan." The USDA noted that seed companies that produced commercial corn hybrid seed in 2000 using traditional seed production techniques may have seed stock containing small amounts of the Starlink^TM protein. Since, Starlink^TM is unapproved, there is no allowable amount of Starlink^TM that can be sold as seed. It is, technically, a zero-tolerance situation.

Specifically, USDA recommended that seed corn companies: 1) sample and test all seed lots for the presence of Starlink^TM protein using the testing protocol equivalent to, or more stringent than, the one developed by USDA's Grain Inspection, Packers and Stockyards Administration (testing a total of 2,400 kernels in sub-samples of 400 kernels each); 2) provide seed corn customers, upon request, with verification that the seed stock being purchased has been sampled and tested for the presence of Starlink^TM protein; and 3) test all parent lines of corn for the presence of Starlink^TM protein prior to 2001 seed production.

So what happens, if seed grower tests his seed stock and it happens to come up positive for Starlink^TM? The first item, of which to be aware, is the stock can not be sold as seed, because of the non-approval issue discussed earlier. It must go directly into either animal feed or an approved industrial use. Secondly, Aventis, at this time, is not compensating seed companies for adventitious presence of Starlink^TM in their seed stock. Any loss in value of the seed stock is the seed producer’s responsibility. Obviously, there is nothing keeping the seedman from suing various parties, but there is no direct or indirect compensation from Aventis. Yes, Aventis is compensating both direct Starlink^TM growers and those with buffer fields, as well as grain handlers who have received Starlink^TM or who have loads that test positive for it. But not seed producers. We know the National Grain and Feed Assn., as well as the American Seed Trade Assn., have both been made aware of this issue and are in discussions with Aventis. We’ll keep you updated on any changes or updates in this policy.

We have invited attorneys from the law firm of Lindquist & Vennum to be added to the convention speaker lineup on the indirect vitamin purchasers’ settlement. They have accepted and will discuss with the convention attendees their reasons and thoughts for opting out of the settlement and for pursing a second class-action suit. We are also honored to be joined by Wisconsin Attorney General Jim Doyle, Assistant Attorney General Kevin O’Connor (who was the lead attorney in the settlement), as well as Chuck Barnhill and Bill Dixon from the Madison law firm of Miner, Barnhill & Galland (attorneys in the original suits). Following the presentations, the floor will be open for your questions to the speakers.

We are convinced this will be the most informative single session in the Midwest on this subject. We look forward to seeing you there.

The US Department of Transportation’s Research and Special Projects Administration recently announced plans to change the Haz-Mat transportation rule from Standard Industrial Classification (SIC) Codes to the North American Industry Classification System (NAICS). Incidentally, these are the same folks that are responsible for the information requests that some WASA members have received in the last few weeks.

This change could possibly change a retailer’s status from a small business to a large business, thereby increasing haz-mat fees and potentially affecting other regulatory programs at a facility. For further information on this issue, please contact the WASA office.

WASA annually provides four $1,000 scholarships to Wisconsin students. The criteria for consideration are the following:

• be a Wisconsin resident,
• have completed one year of study in an agricultural discipline at a Wisconsin university, college or vocational/technical school,
• have a minimum of a 3.0 cumulative grade point average on a scale of 4.0, and
• can demonstrate in written form qualities of leadership, academic ability and financial need.

Why should you concern yourself with this? Because it is entirely free advertising and promotion for your business! Besides, it promotes young people’s education in our industry. All you have to do is copy the enclosed form and leave it on your counter and/or mention it to any customers who may have an eligible child. If an applicant is awarded a scholarship who received their application from you, you can have a picture taken awarding the money in your local paper. It makes you look good, gets you free good publicity and doesn’t cost you a dime. And all you have to do is have the applications on your counter. Not a bad deal for you.

As part of the convention, the association is again sponsoring the Golden Bucket Award. This represents the best ‘home grown’ idea for improving safety or productivity. Your peers will choose the winner from the applicants at the convention by a majority vote. The winner will be announced at the Friday closing luncheon and will receive a $100 cash prize, as well the right to have the award displayed at their facility for the following year.

How do you enter? Just fill out the enclosed form and return it to the WASA office prior to January 24. It’s a great way to share an idea that helped you, get some recognition and cash for it and you might even learn something you can use in the process.