Many inactive ingredients commonly used in teat dips are prohibited for use in organic production and some, that are approved, have been identified as harmful to the environment and humans. The National Organic Standards Board plans to evaluate some of these key ingredients for use in crop and livestock production between now and 2017, which may change the way certification agencies review these ingredients in the future.
Iodine and hydrogen peroxide are the most common active ingredients in teat dips. Both are currently listed as allowed synthetics for use in organic livestock production under 7 CFR 205.603(b)(3) as a topical treatment in livestock production (i.e., teat cleanser for milk-producing animals). Various surfactants, emulsifiers and other inert ingredients are used to formulate liquid antimicrobial products so they can be effectively applied to the skin to reduce microbes and replace moisture. These additional ingredients are usually identified as inactive, which may be allowed when they are approved excipients as defined in Section 205.603(f) of the National List. The FDA has a formal policy permitting the manufacture and use of teat dips and udder washes without being registered as “drugs” pending any concerns found by the Center of Veterinary Medicine’s (CVM) continual monitoring of their use. Inactive ingredients in unregistered drugs* must be evaluated for compliance with the organic livestock healthcare requirements.
Nonylphenol Ethoxylates (NPE) are a class of inexpensive nonionic surfactants commonly used in teat dips that have recently been found to be harmful to aquatic life and human health. Studies have found them to be endocrine disrupters and estrogen mimics that accumulate in waterways as well as powdered dairy products (i.e., infant formula). The use of NPE has become more heavily regulated or banned in Europe, China, Canada and Japan. The EPA issued a phase-out Action Plan in 2010 to encourage voluntary reduction of their use by manufacturers in the U.S. This has greatly effected the dairy industries ability to export dairy products from operations using teat dips with NPE as an ingredient. Manufacturers are now producing NPE-free teat dips to alleviate these exporting hurdles. These products have a whole different class of chemicals that must be evaluated for compliance as an excipient (Linear Alcohol Ethoxylates or LAE).
Only a few specific types of NPE are currently considered as allowed excipients for use in topical healthcare products used in organic livestock production. This may change when the NOSB re-evaluates the current listings for iodine on the National List when it comes up for Sunset Review in 2017. In January, a technical report for iodine used in livestock production was published in preparation for evaluating its continued listings as an allowed synthetic for use in livestock production. The NOSB has also had a technical report published in February for the use of NPE in crop production, as these ingredients are also used in anti-microbial sanitizers and pesticides. There are a few types of NPE that are allowed as EPA List 4 Inerts, which are allowed as inactive ingredients in pesticides used in organic production.
This is a good example of the nuances associated with evaluating inputs for use in organic production. Although iodine is listed as an allowed synthetic for use in livestock production, it is the other ingredients that can make it a challenge to determine if a particular product is allowed. NOSB will be taking other ingredients into consideration during their evaluation of substances up for Sunset Review or Petitioned to be listed on the National List. It will be important to see if there are any changes to how these products comply once the rule-making process is finalized for Iodine and NPE.
* A drug is defined by FDA as a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
Erin Bardagjy, Material Review Officer