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Newsletter of Penn Dutch Cow Care August 2006

Hi Folks,

Here is some major news for the humane treatment of organic livestock - 10 new materials are being proposed by the USDA to be added as allowed synthetics to the National List (7CFR205.603). It has been four long years since any action has been taken on the livestock materials that the National Organic Standards Board voted to recommend as livestock healthcare materials in 2002. The delay was due to the vast governmental apparatus and official procedures which include these materials being reviewed by the FDA and EPA. Due to an act of congress in 1994 called AMDUCA (Animal Medicinal Drug Use Clarification Act) which allows flexibility by veterinarians to use medicines in species other than those officially allowed on a label, many of the NOSB recommendations have now been accepted by Secretary Johanns of the USDA. This means that animals treated with these particular medicines will not have to be removed from organic production. Please note that these are for emergency use and not to be used routinely (I don't think any of these would have a routine use anyway).

These medicines are included under an Advanced Notice of Proposed Rulemaking (ANPR) issued by the USDA on Monday July 17th. There is an official comment period up to September 15th for the general public to speak out in favor or against any of the medicines. While there does indeed need to be some fine-tuning (specifically on withholding times for organic livestock), when an ANPR is finally issued there usually are no major changes to it unless there is widespread public discontent. Part of the reason that it took four whole years for this current ANPR to be issued is that the various government agencies went over these medical materials with a fine tooth comb. Thus, there really shouldn't be too much in the way of significant changes. Keep in mind that these materials are not yet technically allowed by certifiers until there is issued a final Rule change, which shouldn't be too long after the comment period closes. I would guess that by the end of this calendar year there will be a Final Rule change posted.

The following underlined medicines are to be officially allowed as active ingredients by the USDA for organic livestock (names in parentheses are some examples, not all, of commercial names that contain the active ingredient): atropine; bismuth subsalicylate (Bismukote®, Bismusal®); butorphanol (ex: Torbugesic®, Dolorex®); epinephrine; flunixin (Banamine®, Flunixamine®); furosemide (Lasix®, Disal®); magnesium hydroxide (Magnalax®, Rumalax®); poloxalene (TheraBloat®); tolazoline (Tolazine®); xylazine (Rompun®, Anased®).

As important as the active materials becoming allowed, the excipients used in these formulations are also to be allowed. Excipients are those inactive materials that help to stabilize a formula, adjust the pH, act as a preservative or simply act as a carrier to allow solubility of all the ingredients. The USDA has proposed less excipients to be allowed than the NOSB did four years ago, but I believe the following ones will work out just fine. Excipients that are officially known as food additives, GRAS substances or substances included in official FDA drug reviews will be allowed. Trade names which include the active ingredients listed above and their associated excipients will be allowed. Also, peroxyacetic / peracetic acid was allowed as an equipment sanitizer. Additionally, calcium propionate only to be used as a preservative for herbal compounds was also proposed to be allowed.

On the basis of improving animal welfare and humane treatment, I was personally involved in petitioning the USDA for the atropine, butorphanol, epinephrine, flunixin, furosemide, tolazoline and xylazine; however, none of this could have been accomplished without Horizon Organic and Organic Valley working together for the betterment of their farmers' animals. I will continue working with both of these companies in the next few months to fine-tune the withholding times of these medicines if used on organic livestock. One potential method is to reference the Food Animal Residue Avoidance Database (FARAD) which is composed of scientists that know the details of these medicines and how long it is before they are fully metabolized by various animal species.

While all this news is very good for humane treatment of organic livestock, some materials that were petitioned did not get recommended by Secretary Johanns for inclusion on the National List. This is solely due to the materials never having been allowed for livestock at all. While you may be surprised at the following list, these are still readily available since the FDA allows them by "regulatory discretion". In other words, these products are of low enough regulatory concern that the FDA allows them to be used even though they have never given them official approvals. But since these are not technically allowed by FDA for use in any animals, it is impossible for the USDA to insert them as "allowed". (The FDA trumps all other government agencies in the area of medicines.) The following were recommended by the NOSB, but for the reasons stated above, are not being proposed to be added to the National List by Secretary Johanns: activated charcoal, calcium borogluconate, calcium propionate, kaolin pectin, mineral oil and propylene glycol. Fortunately, two of these are natural (non-synthetic) and have been reviewed and allowed by various certifiers already. These are activated charcoal (if made from vegetable sources only) and kaolin pectin. Calcium borogluconate (the type of calcium given IV for milk fever) is technically an electrolyte and electrolytes are already allowed on the National List. Therefore if a cow has milk fever and is given IV calcium, mark it down in the animal's health record as being given "electrolytes". This is being totally honest and also legal. Other electrolytes include CMPK, hypertonic saline, lactated ringers solution, sodium iodide, etc.

Finally, while my patience wore thin in waiting for the USDA to take action regarding all these substances, I have come to respect the federal regulatory process and understand it more fully. While the process is a long and daunting one, no stone is left un-turned. Therefore, I believe the USDA has issued an ANPR which will remain overwhelmingly intact and a Final Rule change to add the mentioned medicines will look extremely similar.

NOTE: Levi S. King, 523 Valley Rd. Quarryville, PA 17566 has a proven Jersey bull for sale $950 or best offer. Can call 717-786-9183 between 7:00-7:15 Monday evenings.

For Bovinity Health, information on functional alternatives to antibiotics see:

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