Sunset 2020 Review 

Meeting 1 - Request for Public Comment

Livestock Substances §205.603, §205.604

April 2018

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the National 

List of Allowed and Prohibited Substances (National List) that are coming up for sunset review by the 

National Organic Standard Board (NOSB). The following list announces substances that are on the National 

List for use in organic livestock production that must be reviewed by the NOSB and renewed by the USDA 

before their sunset dates in 2020. This list provides the substance’s current status on the National List, use 

description, references to past technical reports, past NOSB actions, and regulatory history, as applicable. If 

a new technical report has been requested for a substance, this is noted in this list. To see if any new 

technical report is available, please check for updates under the substance name in the Petitioned 

Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the Fall 

2018 public meeting, the NOP is requesting that the public provide comments about these substances to 

the NOSB as part of the Spring 2018 public meeting. These comments should be provided through 

www.regulations.gov by April 4, 2018 as explained in the meeting notice published in the Federal Register. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were found 

to be: (1) not harmful to human health or the environment, (2) necessary because of the unavailability of 

wholly nonsynthetic alternatives, and (3) consistent and compatible with organic practices. 

Public comments should focus on providing new information about a substance since its last NOSB review. 

Such information could include research or data that may support a change in the NOSB’s determination 

for a substance. Public comment should also address the continuing need for a substance or whether the 

substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should provide 

information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic livestock production. 
For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide reasons 

why the use of the substance should no longer be allowed in organic production or handling. Specifically, 

comments that support the removal of a substance from the National List should provide new information 

since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with livestock production. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset review. 

Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could eliminate 

the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or better 

than the allowed substance, and whether you want the substance to be allowed or removed from the 

National List. Assertions about alternative substances, except for those alternatives that already appear on 

the National List, should, if possible, include the name and address of the manufacturer of the alternative. 

Further, your comments should include a copy or the specific source of any supportive literature, which 

could include product or practice descriptions; performance and test data; reference standards; names and 

addresses of producers or handlers who have used the alternative under similar conditions and the date of 

use; and an itemized comparison of the function and effect of the proposed alternative(s) with substance 

under review. 

Written public comments will be accepted through April 4, 2018 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the meeting. 
Sunset 2020 Review Summary 

Meeting 1 - Request for Public Comment

Livestock Substances §205.603, §205.604

April 2018

Note: The materials included in this list are undergoing early sunset review as part of November 18, 2016 

NOSB recommendation on efficient workload re-organization. 

Reference: 7 CFR 205.603 Synthetic substances 

allowed for use in organic livestock production

Alcohols: Ethanol, Isopropanol

Aspirin

Biologics, Vaccines

Electrolytes

Glycerine

Phosphoric acid

Lime, hydrated

Mineral oil

Sucrose octanoate esters
Alcohols 

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

 (1)(i) Ethanol-disinfectant and sanitizer only, prohibited as a feed additive

Technical Report: 1995 TAP; 2014 TR Ethanol; 2014 TR Isopropanol

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 NOSB sunset recommendation; 10/2010

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

The United States Environmental Protection Agency (US EPA) regulates all non-food applications of 

ethanol, including its use as a pesticide and plant growth regulator. According to the Reregistration 

Eligibility Decision for Aliphatic Alcohols, ethanol and isopropanol were registered in the US as early as 

1948 as active ingredients in indoor disinfectants (US EPA, 1995). Approximately 48 ethanol products 

were registered for use as hard surface treatment disinfectants, sanitizers and mildewcides as of 2012 

(US EPA, 2012a). Ethanol is also the active ingredient in certain plant growth regulator products.

Manufacture:

Both fermentation and chemical synthesis procedures are used in the commercial production of ethanol 

for the preparation of disinfectant solutions, spirits, and industrial fuel sources. A variety of methods 

are available for the fermentative production of ethanol from carbon sources such as starch, sugar and 

cellulose using natural and genetically engineered strains of yeast or bacteria. Ethanol can also be 

produced synthetically through the direct or indirect hydration of ethylene and as a by-product of 

certain industrial operations.

International Equivalency:

Several international organizations provide guidance on the application of synthetic ethanol in organic 

crop and livestock production as well as the processing of organic foods. Among these are international 

regulatory agencies (EU, Canada and Japan) and independent organic guidelines and standards 

organizations (Codex and IFOAM). 

• European Economic Community Council (EU) – Alcohols, presumably including ethanol, may be 

used for cleaning and disinfecting livestock building installations and utensils.

• Canada – Canadian organic production standards permit the use of ethanol for a number of 

agricultural applications.

• Japan – Ethanol may be used in the processing, cleaning, storage, packaging and other postharvest processes when physical or methods using naturally derived substances are insufficient.

• Codex Alimentarius – Ethanol is allowed when mechanical, physical and biological methods are 

inadequate for pest control.

• IFOAM – Synthetic ethanol is an approved additive and processing/post-harvest handling aid 

when organic and natural sources are not available.
Environmental/Health Issues:

Aside from accidental spills, the risk of environmental contamination from released ethanol is minimal. 

The release of strong acids and bases used in the production of ethanol due to improper 

handling/disposal could lead to serious environmental impairments and ecotoxicity in both terrestrial 

and aquatic environments. However, no incidents involving the release of these chemical feedstocks 

from ethanol production facilities have been reported. Further, lesser amounts of ethanol are constantly 

released to the environment from animal wastes, plants, insects, forest fires, and microbes without 

causing environmental impairment (HSDB, 2012). It is therefore unlikely that large-scale spills and 

associated environmental contamination will occur under the allowed use of ethanol as a sanitizer and 

disinfectant in organic livestock production.

Additional information requested by Subcommittee:

1. Is the substance still considered to be essential for organic livestock production? 

2. Since the material was last reviewed, have additional commercially available alternatives 

emerged?

Alcohols 

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

 (1)(ii) Isopropanol-disinfectant only

Technical Report: 1995 TAP; 2014 TR Ethanol; 2014 TR Isopropanol

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 NOSB sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Isopropanol is used for a variety of industrial and consumer purposes, ranging from chemical and 

solvent applications to medical and consumer usage. Agricultural uses of isopropanol include the 

disinfection of production tools and surfaces and topical antisepsis during medical treatments. Livestock 

producers may use alcohol (i.e., isopropanol and/or ethanol) solutions for sanitizing and disinfecting 

surfaces (e.g., production implements, troughs, and floor drains) and during medical treatments as a 

topical disinfectant (Jacob, 2013; Dvorak, 2008).

Manufacture:

Chemical synthetic procedures are used in the commercial production of isopropanol used in the 

preparation of consumer- use disinfectants, industrial solvents, and specialty chemicals. Specifically, 

indirect and direct methods for the hydration of petroleum-derived propylene are the two primary 

commercial processes to produce isopropanol. In addition, smaller amounts of industrial isopropanol 
are generated through the hydration of acetone over transition-metal catalysts (Papa, 2011; Merck, 

2006). A variety of methods are also available for the fermentative production of isopropanol from 

carbon sources, such as starch, sugar, and cellulose, using genetically engineered yeast and bacteria 

(Papa, 2011).

International Equivalency:

A small number of international organizations provide guidance on the application of synthetic 

isopropanol in organic crop and livestock production as well as the processing of organic foods. Among 

these are the Canadian General Standards Board and the International Federation of Organic Agriculture 

Movements (IFOAM).

• Canada – Canadian organic production standards permit the use of isopropanol for a number of 

agricultural applications.

• IFOAM – Isopropanol is an approved synthetic equipment cleaner and equipment disinfectant. 

Isopropanol is also an allowed synthetic substance for pest and disease control and disinfection 

in livestock housing.

Environmental/Health Issues:

Although isopropanol is a volatile organic compound and potentially contributes to the formation of 

ozone and photochemical smog, large-scale releases of isopropanol under the prescribed use pattern in 

organic crop production are unlikely. Isopropanol may enter the environment because of its 

manufacture in addition to its solvent and chemical intermediate uses. According to US EPA, 

isopropanol is slightly toxic to practically non-toxic based on acute oral and inhalation toxicity tests as 

well as primary eye and dermal irritation studies (EPA, 410

1995).

Additional information requested by Subcommittee:

1. Is the substance still considered to be essential for organic livestock production? 

2. Since the material was last reviewed, have additional commercially available alternatives 

emerged?

Aspirin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(2) Aspirin-approved for health care use to reduce inflammation

Technical Report: 1995 TAP; 2017 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 NOSB sunset recommendation; 

10/2010 NOSB recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022
Background from Subcommittee:

Manufacturing Process:

The most prevalent method of synthesizing aspirin is via an esterification. Salicylic acid is treated with 

acetic anhydride, an acid derivative, causing a quantitative chemical reaction that turns salicylic acid's 

hydroxyl group into an ester group (R-OH → R-OCOCH3). This process yields aspirin and acetic acid, 

which are considered byproducts of this reaction. Small amounts of sulfuric acid (and occasionally 

phosphoric acid) are almost always used as a catalyst. 

The chemical feedstocks for synthesizing aspirin are also manufactured through a chemical process. 

Salicylic acid is produced commercially via the Kolbe-Schmitt process. Here, phenol and sodium 

hydroxide react to make sodium phenoxide. The phenoxide comes into contact with CO2 to form sodium 

salicylate. The salicylate is acidified to give salicylic acid. The acid is usually crystallized from aqueous 

solution to give a technical grade 99.5% salicylic acid product. For a pharmaceutical grade product, 

salicylic acid is further purified by sublimation. 

The commercial process for acetic anhydride was developed by Wacker Chemie in 1922 and uses a 

chemical reaction between acetic acid and ethenone at a low temperature and pressure.

Specific Uses of the Substance: 

Aspirin (i.e. acetylsalicylic acid) is a nonsteroidal anti-inflammatory drug (NSAID) used for temporary 

relief of minor aches and pains due to headache, muscular aches, minor arthritis pain, toothache, 

backache, the common cold, and premenstrual and menstrual cramps. It is also used for temporarily 

reducing fever, the prevention of cardiovascular events, and the treatment of rheumatologic disorders. 

Approved Legal Uses of the Substance: 

Aspirin is considered a pain reliever and fever reducer in the over-the counter, tentative final 

monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter 

Human Use by the U.S. Food and Drug Administration (FDA) (53 Federal Register 46204, Nov. 16, 1988 

and 21 CFR 343). Aspirin is included under 21 CFR 343.12 and 343.13 for the prevention of 

cardiovascular events and the treatment of rheumatologic disorders. 

Aspirin is also listed at 7 CFR 205.603 as a synthetic substance allowed for the use in organic livestock 

production and is approved for health care use to reduce inflammation. Its half life is short in cattle and 

it is not as beneficial in reducing pain as flunixin. However, aspirin is usually given orally, which makes it 

easier and more usable for farmers in an emergency. Additionally, flunixin has annotation restricting its 

withdrawal time. A second pain medication approved for pain relief in organic livestock is butorphanol 

(21 CFR 603(a)(5)). Butorphanol is a synthetic opioid partial agonist analgesic; however, it also must be 

administered under a veterinarian’s written orders, and it too is restricted by annotation to a 

withdrawal time. 

Action of the Substance: 

Aspirin inhibits the biosynthesis of certain hormone-like substances called prostaglandins, which 

accounts for most of its clinical effect. Depending on where in the body these prostaglandins are 

produced, they may trigger pain, inflammation, fever, or blood clotting. Following absorption, aspirin is 

hydrolyzed to salicylic acid, which is the active metabolite for its major clinical effects. Aspirin also 

inhibits platelet aggregation by irreversibly inhibiting prostaglandin cyclooxygenase. 
Additional information requested by Subcommittee:

1. Is the substance still considered to be essential for organic livestock production? 

2. Since the material was last reviewed, have additional commercially available alternatives 

emerged?

Biologics - Vaccines

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(4) Biologics - Vaccines

Technical Report: 2011 TR (Vaccines from Excluded Methods); 2014 TR (Aquaculture)

Petition(s): 2012 Petition (Aquaculture)

Past NOSB Actions: 11/2005 NOSB sunset recommendation; 11/2009 NOSB recommendation on 

Vaccines at §205.105; 10/2010 NOSB sunset recommendation; 10/2014 recommendation on Vaccines 

from Excluded Methods; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290 Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

In addition to the allowance of this category of synthetic materials on the National List, there are other 

areas that address ‘biologics—vaccines” in the NOP Final Rule.

Terms defined:

Biologics. All viruses, serums, toxins, and analogous products of natural or synthetic origin, such as 

diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or 

immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention 

of diseases of animals.

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and 

handling.

To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients 

or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with 

§205.600(a); 

§205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients.

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National 

List of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 

U.S.C. 6517 and 6518). 

Excerpts from NOSB meeting notes of April 2013:

In the Vaccine Working Group's interim report, we see challenges with changing technology, lack of 

disclosure, and verifying supply chains. Any expectation of verifying vaccines made with excluded 

methods will need a clear and practical framework of how to determine compliance. Also, even with a 
stricter rule regarding GM vaccine use, exceptions may be needed for critical vaccines that are only 

available from GM sources. The interim report states:

.....because there's a considerable amount of manufacturer confidential business information, the 

working group could not end up with getting this list that we would like to have for producers that 

would allow them to easily identify which vaccines to use and which not. We then explored it further...

as to what in fact constitutes an excluded method.

Current situation in 2017

The NOSB has improved and clarified their working definition of what methods would be considered 

genetic modification and therefore excluded from use under the USDA organic regulation. This work 

should aid the NOSB in moving ahead in looking at the issue of use of vaccines produced through the 

use of excluded methods. 

The NOSB could propose to begin reviewing the known vaccines produced through excluded methods as 

listed in the TR from 2011, to place them individually on the National List as required in the regulation, 

2015.105 (e). The NOSB could also propose to approve all vaccines produced through excluded 

methods as a “class” of vaccines, as suggested by the National Organic Program in the April 2013 NOSB 

meeting transcript. The NOSB could also choose to do nothing and maintain the current status quo of 

not addressing this issue, at this time.

The use of vaccines as a preventative measure to promote health in livestock is a necessary tool in 

organic livestock production. The Livestock Subcommittee does not want to lessen access to vaccines, 

both for routine maintenance of health, as well as in response to emergency situations. The allowance 

or prohibition of vaccines produced through the use of genetic engineering, or excluded methods, is not 

addressed in other organic standards around the world. As a result, all types of vaccines are allowed in 

various international organic standards.

NOSB members are aware that there is a great lack of consistency between certifiers when addressing 

the issue of GMO vaccines. Some require documentation that every vaccine used is not a GMO. Others 

do not require that documentation. Some require documentation and allow the use of the GMO vaccine. 

Inconsistency in implementation of the organic regulations leads to lack of trust in the certification 

system, as well as in the marketplace. Since the NOSB is now in review of vaccines for their sunset 

listing, we believe it is the time to address this problem of regulatory inconsistency.

The NOSB understands that livestock diseases can happen anywhere in the world and can quickly 

become a problem for all types of producers. At times, a GMO vaccine may be the only available 

solution to the problem, and the NOSB does not want to constrict the options available to producers. 

The NOSB is aware of GMO vaccines that are currently being used on organic livestock operations. Some 

may not have a non-GMO equivalent and some may. The NOSB could begin review of these individual 

GMO vaccines now for placement on the national list, to bring these operations using them into 

compliance with the full regulation as currently written.

When an organic livestock producer loses one or more of their animals, there is more than just that 

animal’s production capability lost, even though that is significant. Many times, there have been many 

years, even decades of breeding and genetic selection resulting in that specific animal. When that 

animal is lost to the farm, all of those years of breeding and their unique genetics are also lost. The use 

of vaccines as a preventative can protect this long-term investment in genetic improvement, and 
vaccines remain an important tool in the organic livestock producer’s toolbox.

Manufacturing Process:

Vaccines are produced through a variety of methods that use natural pathogens grown in a culture 

(yeast, bacteria or cell), separation and purification of the vaccine, addition of other materials that may 

enhance the efficacy of the vaccine. These methods will result in a live, modified live or killed vaccine.

Specific Use:

Vaccination against bacterial or viral infections is a cost effective and efficient method or lessening 

animal suffering and disease. A vaccine contains, or produces in the vaccinated individual, an antigen 

that stimulates an immune response and enables protection from the disease and/or future infection.

Additional information requested by Subcommittee:

1. Should individual genetically modified vaccines be listed on the National List, or should all 

genetically modified vaccines be allowed as a class, perhaps with a commercial availability 

clause such as “use of GE vaccines as a class is allowed with documentation that no GE version 

of the specific vaccine is commercially available”.

2. What type of documentation are certification agencies currently requesting to determine nonGMO status for the vaccines used on organic livestock? How is this verified? Are they denying 

the use of GMO vaccines on organic livestock operations?

3. Is the current system where GMO vaccines are sometimes reviewed and either allowed or not, 

acceptable to the organic industry, and should it remain in place with no changes?

4. Are there alternative methods or materials that make vaccines no longer an essential material 

on the National List of approved synthetics?

Electrolytes

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(8) Electrolytes—without antibiotics

Technical Report: 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Electrolytes are considered animal drugs by the FDA, and in USDA organic production they may only be 

used when preventative practices are inadequate to prevent illness, and may not be given in the 

absence of illness. Electrolytes are used to restore ionic balance, treating a variety of metabolic 

conditions such as hypocalcemia, scours, milk fever, dehydration, mastitis, ketosis, acidosis and more.
Manufacturing Process:

Electrolytes are produced through industrial processes, fermentation, or they may be mined. The major 

component of electrolyte formulations are salts and would have a variety of carriers or other 

ingredients that enhance their properties, such as dextrose, citric acid, glucose, glycine and more. The 

2015 TR has a detailed description of the various manufacturing processes. 

Specific Use:

Electrolyte balance is essential to maintain normal physiology and health of livestock. When there is an 

imbalance of cations such as sodium, potassium, calcium or magnesium, either too low or high, the 

health and life of the animal is at risk. Stages of life, environmental stresses, and stages of production 

such as birthing an animal, are all conditions that can throw the electrolyte balance off and would 

necessitate the use of this material to restore health and well-being to the animal.

Additional information requested by Subcommittee:

1. Is the substance essential for organic livestock production and is it used regularly? 

2. Since the material was last reviewed, have additional commercially available natural

alternatives emerged?

Glycerine

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(12) Glycerine - Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils

Technical Report: 2010 TAP (Livestock)

Petition(s): N/A

Past NOSB Actions: 1999 NOSB recommendation; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Glycerin, or glycerol, is a by-product of the soap manufacturing process. The oldest method of 

manufacture is by hydrolysis of natural fats & oils (either animal or vegetable): heat, steam, and 

pressure “split” the glycerin from the oil. The glycerin is concentrated in multistage evaporators and 

refined. Purification is achieved through either an ion exchange process or a distillation system, but it 

can also be produced synthetically from propylene.

If only heat, steam or pressure is used to split the ester bonds to liberate free glycerol from fat (i.e. 

triglycerides), then this is a hydrolysis reaction catalyzed by physical forces and is compatible with the 

annotation for glycerin at § 205.603(a)(11) that requires production through hydrolysis of fats or oils. If 

glycerol is formed by the chemical reaction of sodium hydroxide, then glycerol is produced by a 
chemically catalyzed hydrolysis reaction and may be considered synthetic.

Specific Uses: Glycerin has over 1,000 uses; however, glycerin is limited to being used as an ingredient in 

teat dips for the addition to § 205.603(a), As an ingredient in teat dips it prevents teat irritation and 

improves skin conditioning. Glycerin does have some germicidal activity (Fox et al., 1990).

Glycerin is widely used as a carrier for other medications because it does not detrimentally affect 

chemical interactions with other substances. Glycerin remains inert and does not change the properties 

of substance in which it is used. Furthermore, it acts as an emollient, reducing moisture evaporation of 

the skin.

OFPA: Glycerin falls under section 6517(1)(B)(i) of the OFPA code that describes livestock medicines. 

INTERNATIONAL: The 2010 TAP review stated that livestock materials have not been addressed by 

Codex and that IFOAM Basic Standards do not mention glycerin, or other synthetics used as teat dips, 

but it does not appear to be prohibited.

Effects on Human Health: Glycerin mist can act as an inhalation irritant. It is easily digested with the 

same metabolism as the carbohydrates.

Effects on the Environment: Glycerol can never be sorted or come into direct contact with strong 

oxidizers such as potassium chlorate or potassium permanganate because it may produce an explosion.

Alternatives:

Synthetic Alternatives: Isopropyl Myristate, Isopropyl Palmitate, Polypropylene Glycol, Other Glycol 

Derivatives, Petroleum Fractions, High Molecular-Weight Alcohol, Allantoin, Synthetic Glycerin from 

petrochemicals. 

Natural Alternatives: Castor and Vegetable Oil.

Management tools: Some management tools for controlling mastitis include: wiping debris from the 

teats, massaging the teat to loosen debris and stimulate milk letdown, wiping off the teat dip using 

individual cloths or paper towels, and applying the milking unit without air admission. 

Additional information requested by Subcommittee:

1. In April 2015, the NOSB Handling Sub-committee recommended listing of glycerin at §205.606 

and removal of glycerin from §205.605(b) after review of the manufacturing methods and 

sources. Are there non-food grade agricultural sources of glycerin produced by microbial 

fermentation of carbohydrate substances, and/or are there sources of glycerin produced from 

hydrolysis of fats and oils using mechanical/physical methods that are readily available as an 

ingredient for teat dips?

2. If there are non-food agricultural sources of glycerin available, should synthetic glycerin be 

removed from 205.603(a)?

3. Have there been updates in the International status for approval of synthetic glycerin used as 

livestock teat dips since the 2010 TAP was published? 

4. How are certifiers tracking that the glycerin used as a teat dip is being produced through the 

hydrolysis of fats or oils?
Phosphoric acid

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable

(20) Phosphoric acid - allowed as an equipment cleaner, Provided, That, no direct contact with 

organically managed livestock or land occurs

Technical Report: 2003 TAP (Handling)

Petition(s): N/A

Past NOSB Actions: 10/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Phosphoric acid, (H3PO4), has many uses. As a cleaner, it is generally used to remove rust and mineral 

deposits found on metal equipment such as boilers and steam producing equipment. In dairy 

operations, it is used to remove calcium and phosphate salt deposits from processing equipment.

Phosphoric acid is a hazardous substance. The exact dangers of it depend on the concentration strength 

of the solution, with higher concentrations presenting greater hazards. Phosphoric acid, at 85 wt. %, is 

considered a corrosive chemical solution that can cause, through skin exposure and inhalation, severe 

skin burns, permanent eye damage, sore throat, shortness of breath, and even death—among other 

things.

Additional information requested by Subcommittee:

1. Is the substance essential for organic livestock production? 

2. Since the material was last reviewed, have additional commercially available alternatives 

emerged?

Lime, hydrated

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable

(5) Lime, hydrated—as an external pest control, not permitted to cauterize physical alterations or 

deodorize animal wastes

Technical Report: 1995 TAP; 2015 TR 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022
Background from Subcommittee:

Under the USDA organic regulations for livestock production, hydrated lime is only permitted for 

external pest control (7 CFR 205.603(b)(5)). Regarding livestock applications, the National List states that 

hydrated lime may not be used to cauterize physical alterations or deodorize animal wastes. 

Composition of hydrated or “slaked” lime consists primarily of calcium hydroxide [Ca(OH)2] and 

magnesium hydroxide [Mg(OH)2] at 50 – 95% and 0 – 50% of the substance, respectively. High purity 

forms of the substance contain greater than 90% calcium hydroxide. The USDA organic regulations 

currently permit the use of hydrated lime (calcium carbonate) for plant disease control in crop 

production (7 CFR 205.601(i)(4)) and external pest control in livestock production (7 CFR 205.603(b)(5)). 

Manufacturing Process:

According to USDA organic regulations, “synthetic” is defined as “a substance that is formulated or 

manufactured by a chemical process or by a process that chemically changes a substance extracted from 

naturally occurring plant, animal, or mineral sources...” (7 CFR 205.2). Hydrated lime [Ca(OH)2] is 

produced through two sequential reactions: thermal decomposition of ground limestone (CaCO3) to 

quicklime (CaO) followed by hydration of quicklime at elevated temperatures and/or pressures. The 

limestone starting material is a naturally derived, non-synthetic substance. However, the NOSB 

classified calcium oxide (quicklime) as a synthetic substance due to the chemical change that occurs 

during the thermal reaction of natural limestone. Hydrated lime is therefore produced through 

chemically changing a synthetic substance (quicklime). Based on the “synthetic” definition, it is 

reasonable to conclude that hydrated lime used as an external parasiticide in organic livestock 

production is a synthetic substance. The NOSB has classified hydrated lime as synthetic since initially 

recommending addition of the substance to the National List for organic livestock production.

Specific Use:

The USDA organic regulations currently permit the use of hydrated lime for plant disease control in crop 

production (7 CFR 205.601(i)(4)) and external pest control in livestock production (7 CFR 205.603(b)(5)). 

Regarding livestock applications, the final rule states that hydrated lime may not be used to cauterize 

physical alterations or deodorize animal wastes.

Additional information requested by Subcommittee:

1. Is the substance essential for organic livestock production and is it regularly used? 

2. Since the material was last reviewed, have additional commercially available natural 

alternatives emerged?

Mineral oil

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable

(6) Mineral oil - for topical use and as a lubricant

Technical Report: 2002 TAP; 2015 TR

Petition(s): 2002 Petition

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation
Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

The USDA organic regulations currently permit the use of mineral oil in organic livestock production for 

direct topical application and as a lubricant under 7 CFR 205.603(b)(6). Regarding the former use 

pattern, mineral oil acts as an external parasiticide when applied topically to animals infested with 

mites, lice and other parasites. Conventional operators orally administer mineral oil to lubricate the 

intestinal tract and dislodge intestinal obstructions in cattle and other ruminants. This medical practice

is not currently approved for organic production, but a proposed rule published by NOP on January 17, 

2018 (83 FR 2498) would add mineral oil to the National List for relief of intestinal impaction (as 

recommended by the NOSB in 2002).

Mineral oils used in organic livestock production are hydrocarbon molecules containing 15 to about 50 

carbon atoms (U.S. EPA, 2007; EFSA, 2012). Crude, untreated mineral oil mixtures consist of three major 

classes of compounds: paraffins (linear and branched alkenes), naphthenes (alkyl-substituted cycloalkanes) and aromatics (including polynuclear aromatic hydrocarbons (PAHs)), which are generally alkylsubstituted. These untreated mineral oils may also contain small amounts of nitrogen- and sulfurcontaining compounds (EFSA, 2012).

Manufacturing Process:

The composition of mineral oil is dependent upon the crude petroleum oil source (e.g., location of 

procurement) and the processing that occurs in the refinery, such as physical separations and chemical 

conversions. In the 2007 risk assessment for mineral oils, U.S. EPA indicated that most manufacturers 

are currently using modified refining and cleanup processes to remove the more toxic components and 

generate refined minerals largely devoid of PAHs as well as nitrogen and sulfur compounds (U.S. EPA, 

2007). Because of their complexity, it is not possible to resolve mineral oil mixtures into individual 

components for quantification. Indeed, an enormous number of individual components from 

compounds of varying carbon chain length to isomers of the same carbon chain length - are constituents 

of crude and refined mineral oil mixtures (EFSA, 2012).

Specific Use:

The USDA organic regulations currently permit the use of mineral oil in organic livestock production for 

direct topical application and as a lubricant under 7 CFR 205.603(b)(6). Regarding the former use 

pattern, mineral oil acts as an external parasiticide when applied topically to animals infested with 

mites, lice and other parasites.

Additional information requested by Subcommittee:

1. Is this an essential material?

2. Is mineral oil being used orally?

3. Are organic farmers using mineral oil as a lubricant?
Sucrose octanoate esters

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable

(8) Sucrose octanoate esters (CAS #s-42922-74-7; 58064-47-4)—in accordance with approved labeling

Technical Report: 2005 TR

Petition(s): 2004 petition; 05/2004 petition amendment; 09/2004 petition amendment

Past NOSB Actions: 08/2005 NOSB recommendation; 10/2010 sunset recommendation; 10/2015 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Sucrose octanoate esters (SOEs) belong to the organic chemical family sucrose fatty acid esters (SFAEs). 

SFAEs are surfactants that lower the surface tension of a liquid, allowing easier spreading and 

evaporation. SOEs are manufactured from sucrose (table sugar) and an octanoic acid ester commonly 

found in plants and animals. SOEs, marketed as biopesticides, are intended to mimic the pest control 

properties of Nicotiana gossei Domin. (wild tobacco) and other Nicotiana species. In addition to the 

tobacco plant, insecticidal sugar esters have been found in wild tomato and wild potato species and in 

the petunia plant (Chortyk et al., 1996). The petitioned substance is a soap derived from coconut oil 

fatty acids or palm kernel oil fatty acids. SOEs are listed at §205.601(e) as an insecticide (including 

acaricides or mite control), but the listing at §205.603(b) specifically addresses the petitioned use for 

livestock (i.e., honey bees).

Specific Uses of the Substance: 

Sucrose octanoate esters (SOEs) are an EPA-registered biopesticide. SOEs are permitted by EPA for use 

as a biopesticide for foliar spray in field, greenhouse, and nursery use on any type of agricultural 

commodity (including certain non-food ornamentals), as well as on mushroom growing media and on 

adult honey bees. (U.S. EPA, 2002a). 

Effect on the Environment:

SOEs are an effective adult miticide (as well as controlling other pest types); they can be used at all plant 

growth stages; is not harmful to fish; it is not a hazard to bees (it is registered for use on bees to control 

Varroa mites); and it is not phytotoxic. When applied according to EPA-approved label directions, no 

direct exposure of birds or aquatic organisms to SOE is expected (U.S. EPA, 2002a). 

In addition, SOEs biodegrade within approximately five days at approximately 68-80.6°F/20-27°C, in 

both aerobic and anaerobic conditions, so there is minimal potential for exposure exists to insects, fish, 

and other non-target wildlife. U.S. EPA, 2002a). A limited number of experiments have shown SOEs do 

not affect a range of predators and parasitoids that are killed by insecticidal soaps. Impacts on soil fauna 

have not been established.

Effect on Human Health: 

SOEs have low toxicity to humans and are produced in a closed system. The 2005 TAP review states that 

no sub-chronic, chronic, immune, endocrine issues have been identified. An ocular risk exists but is 

unlikely if product is used according to label. 
Additional information requested by Subcommittee:

1. The TR does not address the toxicity of SOEs to non-targeted organisms, including predators, 

parasitoids, soil fauna, and aquatic organisms when exposed by spray. Should there be further 

information requested about the toxicity of SOEs to non-target organisms? 

2. Is this product still being used, or are there other synthetic products that are more effective?

3. If SOEs are not being used, do we need it to keep in the livestock toolbox to be rotated with other 

products?