Medicine and health
Teat dips are classified by the Food and Drug Administration as health care products used to prevent mastitis and other prevalent diseases in milking livestock. OTCO will need to review and approve your teat dip — or equivalent material — prior to use.
For iodine-based teat dips, OTCO must determine all ingredients used to complex (e.g., keep iodine in liquid form) the iodine are compliant with organic standards. In addition, we must determine and review all excipients in the teat dip product. We will require detailed information and communications with the manufacturer to determine the specific purpose of each ingredient in the product.
Chlorhexidine is only allowed as a teat dip in accordance with the restriction: “when alternative germicidal agents and/or physical barriers have lost their effectiveness.” If requesting use for a chlorhexidine-based teat dip, first you must provide — during your material request prior to use — clear justification for its use per the restriction. For instance, you might demonstrate other teat dips applied and use issues, including attempts to address issues with after care such as clean bedding or ensuring cows remain standing after milking. Only after acceptable justification would OTCO review the proposed chlorhexidine-based teat dip.
An allowed teat dip, its restriction requires that the glycerin is “produced through the hydrolysis of fats and oils.” It is prohibited for use as an active ingredient in all other organic livestock animal products or applications. You will need to provide manufacturer confirmation in accordance with the process-based manufacturing restriction.
Excipients (e.g., inactive ingredients such as emulsifiers or preservatives) are ingredients in a medication that do not provide any therapeutic or diagnostic effects. Typically, they assist or enhance the administration and delivery of the active ingredient to maximize its effectiveness.
“Only for use in the manufacture of drugs used to treat organic livestock when the excipient is: identified by the FDA [Food and Drug Administration] as Generally Recognized As Safe; approved by the FDA as a food additive; or, included in the FDA review and approval of a New Animal Drug Application or New Drug Application.”
OTCO recommends you submit all medications for review and approval prior to use. Upon receipt of a medication request, we will review both the active ingredient and the excipients to ensure they meet the requirements for organic production. You must provide a complete ingredient statement at the time of request.
Medications often will only list active ingredients on the label, but we must review all of the ingredients, including the excipients. Just because the active ingredient in a medication may be allowed in organic livestock production, the medication may not be approved unless all of the excipients are also compliant. You can request a complete ingredient list from the manufacturer.
Approval will only be granted for medications with synthetic excipients found in the one of the FDA references. In all cases where an ingredient is not referenced in accordance with the National List’s FDA references, the medication cannot be approved.
#Restrictions and use of synthetic medications
Organic livestock operations can only use synthetic medications if they are specifically listed as allowed. Before any synthetic medications can be used, you must demonstrate all preventative practices used first. A non-synthetic medication may be eligible for use if it is not prohibited per the National List.
Approval of synthetic medications
All synthetic ingredients for a medication must be approved for use per the National List. Be sure to include a complete ingredient lists for medication — OTCO requires manufacturer-provided lists of active and inactive ingredients — with your submission. An incomplete list will result in additional review time by our staff and requests for clarification.
Restrictions for use
Several materials, despite approval for use, will also include restrictions or specific allowances for how they can be used. Per the restriction(s), any other use is prohibited. Verification for approved use will include reconciling all restrictions and manufacturing processes.
For example, glycerin is only allowed when used as the active ingredient in a livestock teat dip. Additionally, it must be produced through the hydrolysis of fats or oils. It is not allowed as an active ingredient in any other medication, or if produced by other unapproved methods.
Restrictions are shown on your approved inputs list, and can be accessed via MyOTCO.
The use of preventative practices to promote animal health is central for organic production. Only after preventative practices and veterinary biologics are inadequate means to prevent illness may an operation administer synthetic medications.
The belief that substituting an approved organic medication for a previously used conventional product in livestock management falsely assumes that the medications are equal. Additionally, it disregards holistic management practices that help ensure organic animals’ health.
The USDA National Organic Program standards name six specific preventative health care practices:
- Selection of species and types of livestock with regard to suitability for site-specific conditions and resistance to prevalent diseases and parasites
- Provision of a feed ration sufficient to meet nutritional requirements, including vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants)
- Establishment of appropriate housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of diseases and parasites
- Provision of conditions which allow for exercise, freedom of movement, and reduction of stress appropriate to the species
- Performance of physical alterations as needed to promote the animal’s welfare and in a manner that minimizes pain and stress
- Administration of vaccines and other veterinary biologics
OTCO will review your Organic System Plan during the initial review, and as necessary in subsequent years, to ensure your preventative practices are adequate to promote good animal health. If practices are inadequate, you will need to follow restrictions for medications and antibiotics.
The use of antibiotics, including ionophores, is not allowed for use in organic animal production and carries special restrictions, requirements, and subsequent actions following use. Organic livestock operations:
- Are prohibited from feeding antibiotics to livestock
- Are prohibited from selling, labeling, or representing any animal or edible animal product as organic if the animal was treated with antibiotics
Animal care and well-being
However, this does not mean that sick animals on organic farms should never be treated with antibiotics if they are necessary. Organic livestock operations are prohibited from withholding medical treatment from a sick animal in order to preserve the animal’s organic status.
It is your duty to treat any animal with appropriate medication, including antibiotics if necessary, to ensure the animal’s well-being — even though the animal may lose organic status as a result.
If livestock is treated with antibiotics or any prohibited substances, they immediately must be clearly identified so as not to be sold, labeled, or represented as organic.
You must create a comprehensive, proactive animal health and nutrition plan that focuses on preventative care. It may be of benefit to work with veterinarians and/or animal nutritionists that understand the USDA National Organic Program’s requirements.
Inspectors and certifiers will review your animal health care records to ensure that sick animals in need of antibiotics have been given treatment. They will also verify that any animals treated with antibiotics or other prohibited medications are clearly identified — segregated if necessary — and animals, offspring, or any products have not been sold or represented as organic.