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USDA proposes adding preservatives, coloring agents to national organic list
13 substances set to join roster of ingredients used in organic livestock production

by Sustainable Food News
July 17, 2006
Feds add 13 substances to approved organic list

The federal government Monday proposed adding 13 substances, including preservatives and coloring agents, to its list of allowed substances for use in organic livestock production.

The U.S. Department of Agriculture said in a Federal Register notice it was increasing the number of allowed synthetic substances for use in organic livestock production to 36 with the inclusion of the recommended ingredients.

The National List, created in 2000 and administered by the USDA’s National Organic Standards Board (NOSB), identifies synthetic substances and ingredients that are allowed and non-synthetic, or natural, substances and ingredients that are prohibited for use in organic production and handling.

The USDA denied the recommendation of the NOSB to allow an additional eight substances to be approved for use in organic livestock production.

The additions being proposed reflect recommendations submitted to the agriculture secretary by the NOSB from November 2000 through March 2005. The USDA’s list has been amended three times. A separate amendment to the list proposed in September is currently pending.

Industry and the public are invited to comment on the proposed recommendations by Sept. 15.

Among the substances recommended for approval are calcium propionate as a feed additive used as a mold inhibitor in dry formulated herbal products. However, the agriculture secretary denied the recommendation of the NOSB that the substance be allowed for use as a veterinary treatment in organic livestock production.

Also recommeded for approval by the NOSB were substances called excipients.

The U.S. Food and Drug Administration (FDA) defines excipients as inactive ingredients that are intentionally added to therapeutic and diagnostic products. The FDA also informed the USDA that not all excipients are inert substances, and that some have been shown to be potential toxicants.

Examples of excipients include fillers, extenders, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.

“Excipients are not intended to exert therapeutic effects at the intended dosage, although they may act to improve product delivery,” USDA said. “[Excipients are] not fully qualified by existing safety data with respect to the currently proposed level of exposure, duration of exposure, or route of administration.”

“Considering the practical challenges posed by the use of excipients in medications for livestock animals, the NOSB decided to develop a recommendation that would bring a balance between standard practice and strict statutory requirements concerning the use of synthetic ingredients in organic livestock production,” the agency said.

Other substances recommended for approval are:

Atropine was petitioned for use in organic livestock production as an antidote for organophosphate poisoning usually caused by reactions to pesticides. It is a white, odorless crystalline powder that causes a reduction in salivary, bronchial, and sweat gland secretions, which makes it useful as an anesthetic.

Bismuth subsalicylate was petitioned for use in organic livestock production as an adsorbent, anti-diarrhea aid, and relief for ulcers. It is a white, odorless powder that is almost insoluble in water and decomposes in boiling water.

Butorphanol was petitioned for use in organic livestock production as a pain reliever to be administered prior to surgery and under veterinary care. Butorphanol has significant pain control and sedation properties, but it does not last long. Butorphanol is a controlled drug and is only available through veterinarians with an active Drug Enforcement Administration (DEA) license.

Flunixin was petitioned for use in organic livestock production to treat inflammation and pyrexia. Flunixin is a non-narcotic, nonsteroidal analgesic agent with anti-inflammatory and antipyretic activity. It is administered intravenously and intramuscularly, quickly broken down internally, and cleared from the bloodstream in urine.

Furosemide was petitioned for use in organic livestock production as a livestock medical treatment for udder and pulmonary edema. Furosemide is a diurectic. It is a white or slightly yellow crystalline powder that is odorless. Furosemide is practically insoluble in water, sparingly soluble in alcohol, freely soluble in alkali solutions, and insoluble in dilute acids.

Magnesium hydroxide was petitioned for use in organic livestock production as an antacid and laxative for temporary relief of an upset stomach and constipation. Magnesium hydroxide is mainly used in antacid or laxative tablets. Antacids are used to relieve minor stomach pain, heartburn, and hyperacidity.

Peracetic acid was petitioned for use in organic livestock production for facility and processing equipment sanitation. Peracetic acid is primarily used to clean equipment, milking parlors, barns, stalls, and veterinary facilities. It is also used as a topical disinfectant on animals and in the handling and processing of livestock products as a dairy equipment sanitizer, meat and poultry disinfectant, and egg wash.

Poloxalene was petitioned for use in organic livestock production for the treatment of bloat in cattle. It is a non-ionic polyol surface-active agent used as a fecal softener and preventive bloat treatment in cattle. Poloxalene may be administered as a drench (orally through a tube), preventively fed in a molasses block, and as a top dressing for feed.

Tolazoline was petitioned for use in organic livestock production as a medical treatment. Tolazoline is a white to off-white crystalline powder that is freely soluble in water and alcohol. It is used as a medical treatment in both humans and animals.

Xylazine was petitioned for use in organic livestock production as a medical treatment. Xylazine is a white or almost white crystalline substance that is freely soluble in water. It is used as a sedative, analgesic, and muscle relaxant in veterinary medicine.

The USDA blocked the NOSB recommendation to approve eight additional substances for use in organic livestock production.

Epinephrine, a naturally derived hormone that is secreted from the adrenal glands as part of the sympathetic nervous system in mammals, is used as a treatment for anaphylactic shock. As a medical drug, epinephrine is used to stimulate heartbeat and to treat emphysema, bronchitis, bronchial asthma and other allergic conditions.

The secretary said the intent of the NOSB's recommendation is already satisfied through the FDA restrictions on the use of epinephrine in livestock.

“We believe that listing epinephrine … as a “nonsynthetic substance prohibited for use in organic livestock production” would be confusing to users of the National List,” the agency said in the notice.

Another substance was moxidectin. This antibiotic is used as a medical treatment for controlling internal and external parasites. Moxidectin is effective against gastrointestinal roundworms, lungworms, cattle grubs, mites, lice and horn flies.

Although moxidectin is a macrolide antibiotic, it was petitioned for use as a parasiticide. But the secretary did not recommend it citing organic production rules prohibiting the use of antibiotics.

Also not recommended for approval for use as medication in livestock production by USDA were activated charcoal, calcium borogluconate, calcium propionate, kaolin pectin, mineral oil, and propylene glycol.
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