National Organic Standards Board

Livestock Subcommittee Proposal

Clarifying “emergency” for use of synthetic parasiticides in organic livestock production

August 29, 2017

I. INTRODUCTION

The use of parasiticides in organic production is strictly confined to emergencies under the current 

regulation. Parasiticides cannot be used routinely, but animals in need of medical attention cannot be 

ignored in favor of retaining organic status. Typically farmers perform preventative practices such as 

introducing clean animals into their herds or flocks, selecting breeds which have high resistance to 

parasites, and managing their land, especially pastures, in a manner that reduces the presence of 

parasites that might infect their animals. If an increased parasite load, for example, is noted in fecal egg 

counts, farmers have a broad array of alternative treatments available. But when all else fails and 

animals are not doing well, a farmer, perhaps working with a veterinarian, may need to use one of the 

synthetic parasiticides on the National List.

A discussion document was circulated in Spring 2017 which sought public comment from a broad cross 

section of stakeholders to determine if any changes should be made to § 205.238, Livestock Healthcare 

Practice Standard, as it pertains to parasite prevention plans, use of approved synthetic parasiticides, 

and if clarification of the term “emergency” was needed 

II. BACKGROUND

In October 2015 the NOSB recommended continued listing of three parasiticides, ivermectin, moxidectin 

and fenbenzadole, as part of its sunset review. In April 2016 the NOSB unanimously approved 

annotations amending the use of fenbenzadole and moxidectin, and in November 2016 the NOSB 

unanimously (with one absence) approved removal of ivermectin from the National List. These 

recommendations are presently pending rulemaking by the USDA. 

During the two years these changes to the annotations for these approved synthetic parasiticides were 

being considered, the NOSB received considerable public comment. In addition to providing factual, 

technical and scientific information in support of the changes, some stakeholders suggested the term 

emergency was not sufficiently well defined and use of synthetic parasiticides may be abused with the 

proposed shorter timeframe between use of the parasiticide and the sale of organic livestock products. 

Some stakeholders supported removal of ivermectin from the National List and the annotation changes 

to the other two parasiticides but urged clarification of what constitutes an “emergency”. 

This proposal addresses the concerns of NOSB members and the organic stakeholder community to 

clarify when approved synthetic parasiticide use is performed as an emergency treatment. This 

proposal describes when the use of the synthetics to treat parasites would be seen as an emergency 

treatment. Included in the proposal is the monitoring of parasite threshold levels and examples of 

various organic production practices that would have been ineffective in controlling the parasite 

problems. Having this clarity on what circumstances constitute an emergency treatment provides 

operators and certifiers a consistent and clear standard. Organic stakeholders including livestock 

producers, certifiers consumers, handlers and others expect use of synthetics are overseen as part of a 

comprehensive organic system plan. The NOSB recommended change to greatly lessen the withdrawal 

time between the use of the parasiticides and sale of organic products, has taken away a strong 

disincentive for the use of these synthetics. 

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III. RELEVANT AREAS OF THE RULE

The language below reflects the recommendations unanimously approved by the NOSB and presently 

in Rulemaking.

§205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, including: 

(1) Selection of species and types of livestock with regard to suitability for site-specific 

conditions and resistance to prevalent diseases and parasites; 

(2) 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); 

(3) Establishment of appropriate housing, pasture conditions, and sanitation practices to 

minimize the occurrence and spread of diseases and parasites; 

(b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a 

producer may administer synthetic medications: Provided, that, such medications are allowed 

under §205.603. Parasiticides allowed under §205.603 may be used on: 

(1) Breeder stock, when used prior to the last third of gestation but not during lactation for 

progeny that are to be sold, labeled, or represented as organically produced; and 

(2) Dairy animals as allowed under §205.603.

(3) Fiber bearing animals, as allowed under §205.603.

§205.603 Synthetic substances allowed for use in organic livestock production. 

(a) As disinfectants, sanitizer, and medical treatments as applicable.

(18) Parasiticides—prohibited in slaughter stock. Allowed in emergency treatment for dairy and 

breeder stock, when organic system plan-approved preventive management does not prevent 

infestation. Allowed in fiber bearing animals, when used a minimum of 90 days prior to production 

of fleece or wool that is to be sold, labeled, or represented as organic. In breeder stock, treatment 

cannot occur during the last third of gestation if the progeny will be sold as organic and must not be 

used during the lactation period for breeding stock. 

(i) Fenbendazole (CAS #43210-67-9)— Milk or milk products from a treated animal cannot be 

labeled as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days 

following treatment of goats, sheep, and other dairy species.

(ii) Ivermectin (CAS #70288-86-7)—Milk or milk products from a treated animal cannot be 

labeled as provided for in subpart D of this part for 90 days following treatment.

(iii) Moxidectin (CAS #113507-06-5)— Milk or milk products from a treated animal cannot be 

labeled as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days 

following treatment of goats, sheep, and other dairy species. 

IV. Public comment

The NOSB asked the following questions in our discussion document for the April 2017 meeting:

1. Does the term “emergency“ need to be defined? 

2. If so, how should the term “emergency” be defined?

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3. Should there be more specific guidelines, such as specific tests for parasite levels as part of the

producer’s parasite prevention plan, before it is determined that emergency treatment with an 

approved parasiticide might be needed?

4. What are the challenges for producers, inspectors and certifiers in verifying the documentation 

and implementation of a parasite management plan in organic operations, and how might these 

be addressed? 

Numerous certifiers and organic stakeholders stated they agreed with the necessity of providing further 

clarification for the term “emergency” when reviewing the use of the synthetic parasiticides present on 

the National List of approved substances. Commenters asked for improved transparency of how these 

synthetics are used, and that use is restricted to times when all other methods have failed and the 

health of the animal is at risk, Some stated that describing expectations of what constitutes an 

“emergency” provides a consistent standard for all producers of organic livestock, as well as what the 

certification agency will review when verifying their operation for compliance to the organic regulation.

Below is a sampling of responses to our questions: 

A livestock emergency is an urgent, non-routine situation in which the organic system plan’s 

preventive measures and veterinary biologics are proven, by laboratory analysis and visual inspection, to 

be inadequate to prevent life-threatening illness or to alleviate pain and suffering. In such cases, a 

producer must administer the emergency treatment (§205.238(c)(7)). Organic certification will be 

retained provided, that, such treatments are allowed under § 205.603 and the organic system plan is 

changed to prevent a similar livestock emergency in individual animals or the whole herd/flock in future

years as required under §205.238(a).

The proposal should include specific methods and practices as well as define “emergency” use to 

ensure consistency among producers and certifiers. “Emergency” should be defined as a situation that 

significantly jeopardizes the well-being of the animal treated and/or threatens to undermine the overall 

preventative practices protecting the rest of the herd or operation. An emergency should be 

demonstrated by a recommendation from a veterinarian, fecal tests, or other specific, measurable

methods to ensure consistent enforcement.

“Emergency” with respect to the use of synthetic parasiticides is defined as a serious parasite 

load that effects the immediate welfare of an individual animal, where the use of parasiticides is the only 

way to protect that animal’s welfare after other documented methods of treatment have failed.

The term “emergency” should mean the animal is infested and sick. If the health of the animal is

compromised, the animal needs to be tested to validate the emergency. If validated, then it should be

prescribed treatment. All of this should be done by a licensed veterinarian. Parasiticides shouldn’t be 

used as a preventative method or as a regular routine to maintain a healthy animal. The veterinarian 

should approve any prescribed parasiticides before the farmer administers any medicine to the animal.

There should also be specific preventative practices implemented to minimize the use of parasiticides.

These include such things as not overgrazing the pastures; placing the feed in troughs instead of on the

ground; and not overstocking the pastures with too many animals. 

A definition of “emergency”- A sudden, irregular or unexpected situation that requires urgent 

attention.” 

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Clarifying the hierarchy defined at §205.238(a-b), perhaps drawing from the structure of the 

Facility pest management standard at §205.271.

A livestock emergency is an urgent, non-routine situation in which the organic system plan’s 

preventive measures and veterinary biologics are proven, by laboratory analysis and visual inspection, to 

be inadequate to prevent life-threatening illness or to alleviate pain and suffering. In such cases, a 

producer must administer the emergency treatment (§205.238(c)(7)). Organic certification will be 

retained provided that such treatments are allowed under §205.603 and the organic system plan is 

changed to prevent a similar livestock emergency in individual animals or the whole herd/flock in future 

years as required under §205.238(a). For further clarification, the organic system plan’s preventive 

measures should be defined through a hierarchy of management practices first, natural materials 

second, and approved synthetics third.

Further clarification will assist certifiers in enforcing these regulations consistently.

We support a definition of emergency that clarifies the following:

• That the procedure is not routine.

• That preventative measures have failed.

• That identifies testing or procuring the recommendation of a veterinarian to determine

infestation and whether the animal’s life is at risk.

• Steps are taken to prevent a reoccurrence.

This clarification will help certifiers with enforcement by having a specific area of the rule to cite that 

prevents routine use and requires a plan to prevent a similar issue from reoccurring.

Certifiers need to ensure that producers engage in a number of preventive measures, such as 

rotational grazing, providing healthy herd rations, and keeping susceptible animals on clean pastures, to 

manage parasites in their livestock herds.... Certifiers should enforce the use of parasiticides for 

emergency use only and ensure that the organic system plan is changed to prevent further use in future 

years. NODPA asks the NOSB livestock subcommittee to develop an “emergency use” definition as it 

relates to a livestock operation in the final regulation. It is essential for operators and certifiers to have 

clarification of this “emergency” term..... Certifiers interpret the current regulations differently with some 

producers using a more routine use of these materials as a preventative when there is an historical 

problem with parasites. Different cultures and communities have different standards for emergency use 

and as the NOP organic standards are used internationally, definitions within regulation are increasingly 

important. Providing a hierarchy of activities, similar to what is used in crop production when 

approaching pest management, is one way to provide direction, and we believe with input from the 

organic community, the development of this definition need not be an onerous task..... the term 

“emergency use” must be clearly defined through regulation as soon as possible to balance the lowering 

of the withdrawal time, provide clear standards for use internationally and retain the integrity of the 

organic seal.”

The Organic Livestock and Poultry Practices (OLPP) Final Rule (82 FR 7042, December 19, 2017)

addresses in a general way how internal parasite problems should be addressed on an organic livestock 

operation. Public commenters asked the NOSB to consider the OLPP requirements and the NOSB 

livestock subcommittee believes this proposal further enhances the requirements of the OLPP.

Organic livestock operations must have comprehensive plans to minimize internal parasite problems in 

livestock. The plan will include preventive measures such as pasture management, fecal monitoring, and 

emergency measures in the event of a parasite outbreak. Parasite control plans shall be approved by the 

certifying agent.”

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V. Discussion 

Public commenters and the NOSB agree that clarification is needed, both for what constitutes an 

emergency, and what should be required of an operator to lessen reliance on routine use of approved 

synthetic parasiticides. The Livestock Subcommittee recommends additional rulemaking at §205.238. 

Both the crops and handling sections of the final rule contain a pest management hierarchy requiring 

methods of control first, use of natural materials second and use of approved synthetics as a last resort. 

This proposal follows a similar hierarchy, offering a clear and verifiable system for both operators and 

certifiers. 

Each age and type of livestock has differing parasite threshold levels that could result in the use of a 

synthetic parasiticide. These scientifically identified threshold levels can be found within University 

Extension publications, or by speaking with a veterinarian and other livestock health professionals. The 

use of monitoring and fecal testing provides both the operator and the certifier tools they can use to 

judge if the situation is approaching an emergency. Based upon monitoring, each operation’s unique 

organic system plan should be modified to improve livestock living conditions as well as other practices 

that might lessen parasite loads before they reach the threshold levels. The use of the synthetic 

parasiticides is a last resort after other activities have been shown to be ineffective in parasite control. 

The short wait time proposed by the NOSB between use of these synthetic parasiticides and the sale of 

organic livestock products, should only be performed when there is a documented need for an 

emergency treatment. This proposal provides a framework to aid operators in understanding what is 

required for parasite management in their organic system plan as well as information that will result in 

consistency between certifiers when implementing this rule.

Examples of practices and monitoring are listed in the proposed rule below. Rather than providing a list 

that states the only methods of parasite monitoring and management, the proposal below provides 

examples which can allow producers and certifiers the flexibility to develop and approve other methods 

that perform the same function.

The proposal below would be sufficient in providing the needed clarification, and would not require a 

further definition of the term “emergency” in §205.200 Terms Defined. Since the word “emergency” is 

used in numerous places throughout the final rule, adding a definition that mostly relates to synthetic 

parasiticide use could result in unintended effects on other areas of the organic regulation. 

This proposal strengthens the language within the Organic Livestock and Poultry Practices rule, and does 

not contradict it.

VI. PROPOSAL

Below is the current standard: 

§205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, including: 

(1) Selection of species and types of livestock with regard to suitability for site-specific 

conditions and resistance to prevalent diseases and parasites; 

(2) 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); 

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(3) Establishment of appropriate housing, pasture conditions, and sanitation practices to 

minimize the occurrence and spread of diseases and parasites; 

(4) Provision of conditions which allow for exercise, freedom of movement, and reduction of 

stress appropriate to the species; 

(5) Performance of physical alterations as needed to promote the animal’s welfare and in a 

manner that minimizes pain and stress; and 

(6) Administration of vaccines and other veterinary biologics. 

(b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a producer 

 may administer synthetic medications: Provided, That, such medications are allowed under 

 §205.603. Parasiticides allowed under §205.603 may be used on: 

(1) Breeder stock, when used prior to the last third of gestation but not during lactation for 

progeny that to be sold, labeled, or represented as organically produced; and 

(2) Dairy stock, when used a minimum of 90 days prior to the production of milk or milk 

products that are to be sold, labeled, or represented as organic. 

(c) The producer of an organic livestock operation must not: 

(1) Sell, label, or represent as organic any animal or edible product derived from any animal 

treated with antibiotics, any substance that contains a synthetic substance not allowed under 

§205.603, or any substance that contains a nonsynthetic substance prohibited in §205.604. 

(2) Administer any animal drug, other than vaccinations, in the absence of illness; 

(3) Administer hormones for growth promotion; 

(4) Administer synthetic parasiticides on a routine basis

This is the additional language to be added to §205.238(c)(4) [new text in italics]:

(4) Administer synthetic parasiticides on a routine basis. The producer must first use 

management practices to prevent scientifically identified threshold levels of parasites in their 

livestock, and secondly use nonsynthetic products to manage parasites. When these two 

approaches are not effective, this could lead to the emergency treatment and use of National List 

approved synthetic parasiticides. Examples of materials, management activities and goals used 

could include: 

i) Grazing systems and living conditions that prevent livestock parasite infestations by 

keeping livestock out of paddocks or pens until the parasites are no longer viable in that 

area. 

ii) Maintaining forage diversity, height and grazing frequency to lessen transference of 

parasites during grazing.

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iii) Use of allowed non-synthetic botanicals, biologics and minerals, both internally and 

externally, to maintain parasite levels in the livestock well below the treatment 

threshold. 

iv) Use various monitoring and documentation methods through the season which inform 

the operator of the efficacy of their parasite management practices such as fecal 

sampling and FAMACHA.

v) When the practices provided for in paragraphs (1) through (4) of this section are 

insufficient to prevent or control parasites within the accepted threshold of that parasite, 

and for that age of animal and species of animal, a parasiticide included on the National 

List of synthetic substances allowed for use in organic livestock production may be used 

as an emergency treatment. Provided, That, the conditions for using the substance are 

documented in the organic system plan, and the organic operator documents proposed 

improvements to their organic system plan to lessen the need for these National List 

approved synthetic parasiticides.

(5) Administer synthetic parasiticides to slaughter stock; 

(6) Administer animal drugs in violation of the Federal Food, Drug, and Cosmetic Act; or 

(7) Withhold medical treatment from a sick animal in an effort to preserve its organic status. All

appropriate medications must be used to restore an animal to health when methods acceptable 

to organic production fail. Livestock treated with a prohibited substance must be clearly 

identified and shall not be sold, labeled, or represented as organically produced. 

Subcommittee vote:

Motion to approve the proposal on clarifying “emergency” for use of synthetic parasiticides in organic 

livestock production. 

Motion by: Harriet Behar

Seconded by: Dan Seitz

Yes: 6 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Ashley Swaffar, Subcommittee Chair, to transmit to NOSB August 29, 2017

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