Authority of Expert Panel Ignored


      Amy Kenyon, 607-643-1724


    Mark Kastel, 608-625-2000

CORNUCOPIA, WI: Organic livestock farmers may soon have access to additional medicines to treat their animals for common ailments. The USDA’s National Organic Program has proposed rule changes to add thirteen new materials to the “National List” of approved substances for organic producers and is accepting public comments through September 15th.

The Cornucopia Institute applauded the USDA’s move to allow organic farmers the use of additional benign substances for treating illness in animals. “However, we cannot help but point out the unacceptable lag time between when the National Organic Standards Board (NOSB) recommended products be approved and when the USDA decided to take up the issue,” said Amy Kenyon, a farm policy analyst at the Wisconsin-based Cornucopia Institute. (Cornucopia has prepared an action alert and a sample letter for farmers and consumers interested in offering feedback to USDA).

Added Kenyon: “Even more disturbing than the USDA sitting on the recommendations from their expert Advisory panel for as many as six years is the fact that they have completely disregarded some of the panel’s requests for restrictive measures on some of the more potent medications. The USDA also rejected the panel’s recommendations to approve the use of simple, everyday, over-the-counter substances such as mineral oil.”

The Cornucopia Institute submitted comments to the USDA’s National Organic Program, and is distributing information and analysis about the proposed rule changes to organic farmers, consumers and public interest groups around the country.

The proposed draft rule would amend the National List (of approved substances in organic food and farming) to reflect some of the recommendations submitted to the Secretary of Agriculture by the National Organic Standards Board from November 15, 2000, through March 3, 2005. The NOSB recommended substances such as bismuth subsalicylate (available to humans as the major ingredient in Pepto-Bismol®), magnesium hydroxide (a naturally occurring mineral that is used as an antacid), and butorphanol, a strong painkiller. According to Jim Riddle, immediate past chairman of the NOSB who worked to get approval for these substances, “These are not materials (ingredients) that would be added to organic meat. These are health care materials, used only when needed to prevent suffering and for documented health care necessity.”

The NOSB made recommendations that some of these materials be added to the National List of approved substances as long ago as the year 2000. “These are inputs that meet the evaluation criteria of the Organic Foods Production Act, the federal law governing organic food, and are important tools for organic farmers who seek to remain economically viable and also treat their animals with the highest standard of care,” Kenyon added.”Benign remedies for common ailments are necessary tools for any farmer, and the USDA’s years of foot-dragging on these recommendations have cost organic farmers and disrespected the NOSB’s hard work to research and recommend appropriate substances for approval.”

It has been documented that although demand for organic meat and milk continues to outstrip supply, some conscientious small farmers have decided not to become certified organic dairy farms, because they feel that they would not have access to enough important health care materials to treat their animals humanely in the event of illness, while still meeting organic criteria.

The Cornucopia Institute and consumer advocates are criticizing the USDA’s disregard for increasing the withdrawal times or limiting the use of several of the more potent drugs. The USDA Secretary of Agriculture feels that organic standards cannot be more restrictive than the FDA’s, as that would “create additional label claims.”

While the USDA cannot make a policy less restrictive than the FDA’s (for instance allowing a drug expressly prohibited in livestock by the FDA), they can hold organic farmers to a higher standard than what the FDA requires of conventional farmers. “Isn’t that the whole reason for the Organic Foods Production Act?” says Kenyon. “Organic certification is certainly an additional label claim that the USDA has created. The USDA should follow the recommendations to allow these materials but require the additional recommended safety standards.”

The Cornucopia Institute claims that this and other moves by the USDA to ignore NOSB recommendations violates OFPA Section 2118(d)(2), No Additions clause, since it would be adding uses not recommended by the NOSB. “If the USDA refuses to accept the NOSB’s requirements for approving these drugs, at a minimum, the NOSB should have the opportunity to have an up or down vote as to whether to allow these substances without additional safety measures beyond what is required by the FDA,” Kenyon added

“The National List already includes three substances for livestock use, lidocaine, procaine, and ivermectin, with withdrawal times for organic use that exceed FDA requirements for conventional use,” stated Riddle. “When the NOP removes restrictions recommended by the NOSB, they are attempting to add uses not approved by the board. This does not comply with the Organic Foods Production Act, which states that the USDA can only add substances and uses recommended by the Board.”

Adding to the controversy, the USDA has declined to approve six everyday, common remedies that the NOSB petitioned to have added to the list of approved substances. The USDA rationalized rejecting these substances, even though the FDA does not currently regulate their usage, considering them to be so harmless and common that they are of “low regulatory priority.”

The Cornucopia Institute called on the USDA to reconsider this. “While these are not materials specifically approved by the FDA for use in animals, they are widely available over the counter and are widely used by both humans and on conventional livestock farms,” Kenyon explained.

“The USDA is caught in a regulatory paradox with these common substances that are considered unapproved drugs by FDA,” said Emily Brown Rosen, an organic consultant based in New Jersey. “On the one hand, organic farmers can only use substances specifically included in the National List. On the other, FDA allows these products to be used without official sanction as animal drugs but does not want them publicly listed as such. There needs to be further discussion between the USDA, NOSB, and FDA to come up with a practical solution.”

According to the Cornucopia Institute’s comments on the proposed rule changes, the USDA has an obligation both to the National Organic Standards Board and to organic farmers to act in a timely manner to give farmers additional tools for humane animal health care. Delaying the approvals, then flouting the conservative recommendations of the NOSB is not only a violation of the Organic Foods Production Act, it is disrespectful of the expertise and hard work of the citizens who sit on the National Organic Standards Board and of the members of the organic community, farmers, consumers, and advocacy groups, who engaged in the open and collaborative process that resulted in the initial recommendations.

Comments are being accepted by the USDA on the proposed rule changes until September 15, 2006. Interested parties can visit the Cornucopia Institute web site,, for full instructions on how to reply including a sample letter and other background materials.

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An example of the recommendations that the USDA disregarded is for the drug poloxalene, a treatment for bloat in cattle. The National Organic Standards Board recommended that this drug be approved for use by organic farmers, but only for bloat, in emergency situations. The Secretary of Agriculture agreed to approve it, but not to restrict its usage, allowing it to be used routinely. When the drug was recommended for approval, it was not intended that it would be used as a “routine preventative drug.”

The NOSB recommendations would have required other drugs to double the FDA required withholding period as an additional safety buffer, after administering drugs, before a farmer can sell milk or meat from an animal. All such additional safeguards were rejected when the USDA promulgated the draft rule presently being considered.

Common materials, viewed as a benign, that the National Organic Standards Board recommended for approval, and the USDA rejected, include: Activated charcoal, calcium borogluconate, calcium propionate, kaolin pectin, mineral oil, and propylene glycol.

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