Sunset 2020 Meeting 2 - Review

Livestock Substances §205.603 

October 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 2022. 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. 

Request for Comments

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

received after that date may not be reviewed by the NOSB before the meeting. 

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

Glycerin

Phosphoric acid

Lime, hydrated

Mineral oil

Sucrose octanoate esters

NOSB Oct 2018 proposals and discussion documents pg. 47 of 204
Alcohols (i) Ethanol

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

(1) Alcohols. (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 

Subcommittee Review

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 post-harvest 

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.

NOSB Oct 2018 proposals and discussion documents pg. 48 of 204
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.

Questions

1. Is ethanol still a commonly used substance in livestock? 

2. Would you be able to meet the need for non-synthetic/non-GMO and/or organic ethanol if the 

demand for it were created by eliminating the listing for synthetic ethanol?

Public Comments

Public comments support ethanol remaining on the National List for antiseptic purposes because it is 

integral for preventing infection and the spread of pathogens while cleaning wounds. However, one 

commenter suggested the NOSB investigate the availability of non-synthetic ethanol from non-GMO 

fermentation organisms and feedstock, as well as the availability of organic ethanol.

Subcommittee vote

Motion to remove ethanol based on the following criteria in the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Jessie Buie

Seconded by Harriet Behar

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

Alcohols (ii) Isopropanol

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (1) Alcohols. (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 

NOSB Oct 2018 proposals and discussion documents pg. 49 of 204
Subcommittee Review

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 that is 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).

Questions

1. Is isopropanol still essential? 

2. Would you be able to meet the need for non-synthetic/non-GMO and/or organic ethanol if the 

demand for it were created by eliminating the listing for synthetic isopropanol?

Public comments support isopropanol remaining on the National list for disinfectant use in livestock. 

NOSB Oct 2018 proposals and discussion documents pg. 50 of 204
Subcommittee vote

Motion to remove isopropanol based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Jessie Buie

Seconded by: Harriet Behar

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

Aspirin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (2) Aspirinapproved 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 

Subcommittee Review

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; Figure 2). 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. 

NOSB Oct 2018 proposals and discussion documents pg. 51 of 204
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 must be administered under written orders of a licensed veterinarian and it has a restriction 

annotation for a withdrawal time.

A second pain medication approved for pain relief in organic livestock is Butorphanol (7 CFR 

205.603(a)(5) and 21 CFR 522.246). 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. 

Public Comments:

During the Spring 2018 NOSB meeting the Livestock Subcommittee received several comments in favor 

of relisting aspirin and no comments against relisting aspirin. Some of the comments in favor of relisting 

included:

• This product is important to the humane treatment of organic animals and is commonly used to 

reduce inflammation.

• It is the only real-time responsive form for inflammation and fever management available. There 

are other products that are available but do not offer the same type of timely response to 

ensure animal health and wellbeing. This is also a proven remedy and is critical in organic 

livestock production.

This material satisfies the OFPA evaluation criteria and the Livestock Subcommittee supports the 

relisting of aspirin.

Subcommittee vote

Motion to remove aspirin from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Ashley Swaffar

Seconded by: Harriet Behar

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

NOSB Oct 2018 proposals and discussion documents pg. 52 of 204
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 

Subcommittee Review

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

other areas that address ‘biologics—vaccines” in the USDA organic regulations.

§205.200 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)

The Organic Food Production Act (OFPA) specifically allows vaccines to be used in the absence of illness, 

while prohibiting all other medications from this use.

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, and addition of other materials that 

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

vaccine.

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.

Public comment

There was universal agreement among producers, certifiers and organic advocacy groups that vaccines 

are an important health maintenance tool on the organic livestock farm, with agreement to relist with 

no other annotation. 

At the same time, there were numerous comments stating the implementation of §205.105 (e) is 

inconsistent between certification agencies, with some certifiers asking producers to determine if the 

vaccine they wish to use is genetically modified, and others not asking this of their producers. Some ask 

for the information, but allow all vaccines to be used, others prohibit the use of GMO vaccines. There 

NOSB Oct 2018 proposals and discussion documents pg. 53 of 204
was agreement, especially among certifiers and organic advocacy groups that the current wording in the 

regulation is leading to inconsistencies in certification and confusion among producers and certifiers on 

this material. 

Discussion

The Livestock Subcommittee is aware of the inconsistencies as described in public comment around the 

use of GMO vaccines. The Subcommittee also recognizes the great importance vaccines play in the 

prevention of livestock disease, and that the presence of Biologics-Vaccines on the National List is not 

the area in the regulation that is causing the confusion and inconsistency in the use of GMO vaccines. 

The Subcommittee has reviewed this material and judged it to meet the OFPA criteria for placement on 

the NL.

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 to protect the investments 

that producers have in individual animals as well as their herds or flocks.

Subcommittee vote

Motion to remove biologics, vaccines from §205.603(a)(4) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.603(b) if applicable: N/A 

Motion by: Harriet Behar

Seconded by: Jesse Buie

Yes: 0 No: 4 Abstain: 0 Absent: 2 Recuse: 0

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 

Subcommittee Review

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 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. 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 

NOSB Oct 2018 proposals and discussion documents pg. 54 of 204
the animal is at risk. Stages of life, environmental stresses, 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. 

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

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

ingredients (i.e., excipients) that enhance their properties, such as dextrose, citric acid, glucose, glycine, 

and more. The 2015 Technical Report (TR) has a detailed description of the various manufacturing 

processes. 

Public Comment

In response to the questions of essentiality of this material in organic livestock production, and if there 

were any natural alternatives that could replace it, there was universal agreement among all 

commenters to retain this material on the National List, with no changes to the annotation. Organic 

certification agencies noted they certify many organic producers who use this material to maintain 

healthy livestock, both mammals and poultry. Environmental and consumer groups also supported this 

material as well as companies that market organic livestock products.

Discussion

This subcommittee believes this material satisfies the OFPA evaluation criteria. This material is used 

regularly and found to be essential by a large number of organic livestock producers. There were no 

negative public comments noted for this material.

Subcommittee Vote

Motion to remove electrolytes from §205.603(a)(8) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.603(b) if applicable: N/A

Motion by: Harriet Behar

Seconded by: Dan Seitz

Yes: 0 No: 4 Abstain: 0 Absent: 2 Recuse: 0

Glycerin

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (11) Glycerin—

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 

Subcommittee Review

Glycerin falls under OFPA section 6517(c)(1)(B)(i) that describes livestock medicines. Glycerin is a byproduct 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 

NOSB Oct 2018 proposals and discussion documents pg. 55 of 204
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 organic criteria. However, 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.

Glycerin has over 1,000 uses; however, its use in organic is limited to an ingredient in teat dips 

(§205.603(a)(11)). 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 have detrimental chemical 

interactions with other substances, staying inert without changing the properties of whatever substance 

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

Glycerin mist can act as an inhalation irritant. It is easily digested with the same metabolism as 

carbohydrates.

Natural alternatives include castor oil and vegetable oils. There are some management tools for 

controlling mastitis, which 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. None of the management tools seem to be effective alone. 

The Livestock Subcommittee asked the following questions for the Spring 2018 meeting: (1) If there are 

non-food agricultural sources of glycerin available, should synthetic glycerin be removed from 

§205.603(a); and (2) How are certifiers tracking that the glycerin used as a teat dip is being produced 

through the hydrolysis of fats or oils? 

The public comments were supportive of continued listing of glycerin as a livestock tip dip, and there

were no responses to the questions. 

Subcommittee vote

Motion to remove glycerin from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.603(b) if applicable: N/A

Motion by: Sue Baird

Seconded by: Harriet Behar

Yes: 0 No: 5 Abstain: 0 Absent: 1 Recuse: 0

Phosphoric acid

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (19) 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

NOSB Oct 2018 proposals and discussion documents pg. 56 of 204
Subcommittee Review

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?

Public Comment

Written comments were submitted prior to the spring 2018 NOSB meeting by three organizations and 

one organic dairy farmer. All commenters support relisting the substance, as phosphoric acid is 

considered essential for the purposes for which it is allowed. One organization stated that because 

phosphoric acid is highly corrosive, it would be worthwhile to see whether EPA’s Safer Choice program 

offered any potential alternatives. Another organization recommended that an annotation be added 

that clarifies when a rinse or purge is, or is not, required.

The subcommittee recommends continued listing of the substance because it satisfies OFPA criteria. 

Subcommittee vote

Motion to remove phosphoric acid from §205.603(a) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Daniel Seitz

Seconded by: Harriet Behar

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

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 

NOSB Oct 2018 proposals and discussion documents pg. 57 of 204
Subcommittee Review

Specific Uses of the Substance

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

an external parasiticide (7 CFR 205.603(b)(5)). Regarding livestock applications, the final rule states that 

hydrated lime may not be used to cauterize physical alterations (medical treatment) 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. 

Approved Legal Uses of the Substance 

The USDA organic regulations currently permits 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)).

Discussion

The Livestock Subcommittee discussed the use of hydrated lime in both livestock and crop production, 

specifically, the relationship between crop use and livestock use and whether approval for use in one 

category affected the other. The following questions were posed to stakeholders:

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?

Public comment

The majority of public comment supported relisting. Many commenters suggested that hydrated lime 

was essential for organic production in that it prevents the spread of pests among herds. A few 

commenters said that there are no alternatives to hydrated lime. The Subcommittee requests public 

comment on revising the annotation for hydrated lime. 

Additional information requested from stakeholders

Is hydrated lime a useful tool for deodorizing animal waste?

Subcommittee vote

Motion to remove hydrated lime based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.603(b) if applicable: N/A

Motion by: A-dae Romero-Briones

Seconded by: Jessie Buie

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

NOSB Oct 2018 proposals and discussion documents pg. 58 of 204
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

 Subcommittee Review 

Approved Legal Uses of the substance

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 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 in organic production, although a proposed rule by the National Organic Program (83 FR 2498, 

March 19, 2018) would allow for this use, if finalized

Discussion

In Subcommittee discussion, there was some concern about the manufacturing process and there was 

also brief discussion about the frequency of use in the organic community. A few members reiterated 

the importance of mineral oil to organic livestock farmers. The Subcommittee seeks input on the 

following questions:

1. Is mineral oil an essential material?

2. Are organic farmers using mineral oil as a lubricant?

Public comment

The majority of commenters considered mineral oil essential for organic agriculture and suggested relisting. Most commenters indicated that they use mineral oil as a spray, and use it minimally (as little as 

one cup per animal) to control flies and mites. One commenter suggested de-listing mineral oil citing 

alternative substances to control pests

Subcommittee vote

Motion to remove mineral oil based on the following criteria in the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.603(b) if applicable: N/A

Motion by: A-dae Romero-Briones

Seconded by: Sue Baird

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

NOSB Oct 2018 proposals and discussion documents pg. 59 of 204
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

Subcommittee Review

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

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, including wild tomato and wild 

potato species and the petunia plant. The petitioned substance is a soap derived from coconut oil fatty 

acids or palm kernel oil fatty acids. EPA has registered SOEs as a biopesticide for foliar spray on 

greenhouse, nursery, and field crops; for sciarid fly control in mushroom-growing media; and for varroa 

mite control on honeybees. 

The listing at §205.603(b) specifically addresses the petitioned use for livestock (i.e., honey bees) as a 

control of varroa mites. 

Effect on the Environment 

SOEs are an effective adult miticide and also control other pests. SOEs are not harmful to fish, hazardous 

to bees, or phytotoxic. When applied according to EPA-approved label directions, no direct exposure of 

birds or aquatic organisms to SOE is expected. 

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 to insects, fish, and other nontarget 

wildlife. 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 technical report (TR) 

states that no sub-chronic, chronic, immune, or endocrine issues have been identified. An ocular risk 

exists but is unlikely if the product is used according to label. 

Status: 

The previous TR and/or NOSB recommendations do not provide sufficient information to evaluate SOEs 

relative to OFPA criteria for livestock production, specifically for varroa mite control on bees.

Public Comments

There were no substantive comments from beekeepers during the Spring 2018 public comment period 

on the continued listing of SOEs at §205.603(b); nevertheless there were comments from other livestock 

producers who stated that they were aware that SOEs are an important tool for beekeepers in 

controlling varroa mites in honey bees. 

A public health advocacy organization commented that in view of the restrictive use of SOEs, and the 

difficulty that beekeepers are experiencing in maintaining the health of honey bee colonies, they 

supported keeping SOEs on the National List.

NOSB Oct 2018 proposals and discussion documents pg. 60 of 204
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 spraying SOEs. Should there be 

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

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

do we need to keep it available to be rotated with other products?

Subcommittee vote

Motion to remove sucrose octanoate esters (SOEs) from §205.603(b) based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Sue Baird

Seconded by: Jessie Buie

Yes: 2 No: 4 Abstain: 0 Absent: 0 Recuse: 0

NOSB Oct 2018 proposals and discussion documents pg. 61 of 204