Sunset 2024 

Meeting 1 - Request for Public Comment

Livestock Substances § 205.603 

April 2022 

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 which must be reviewed 

by the NOSB and renewed by the USDA before their sunset dates. This document provides the substance’s current 

status on the National List, annotation, 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 2022 public 

meeting, the NOP is requesting that the public provide comments about these substances to the NOSB as part of the 

Spring 2022 public meeting. Comments should be provided via Regulations.gov at www.regulations.gov on or before 

April 1, 2022, 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 (see 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: (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 clearly indicate the commentor’s position on the allowance or prohibition of substances on the 

National List and explain the reasons for the position. Public comments should focus on providing relevant 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 (e.g., scientific, environmental, manufacturing, industry 

impact information, etc.). Public comment should also address the continuing need for a substance or whether the 

substance is no longer needed or in demand.

For Comments that Support the Continued Use of §205.603 Substances in Organic Production: 

If you provide comments supporting the allowance of a substance at §205.603, 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 the Continued Use of §205.603 Substances in Organic Production: 

If you provide comments that do not support a substance at §205.603, you should provide reasons why the use of the 

substance should no longer be allowed in organic production. 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/or

3. inconsistent with organic livestock production.

NOSB Proposals and Discussion Documents April 2022 Page 1 of 152
For Comments that Support the Continued Prohibition of §205.604 Substances in Organic Production:

If you provide comments supporting the prohibition of a substance on the §205.604 section of the National List, you 

should provide information demonstrating that the substance is:

1. harmful to human health or the environment; 

2. unnecessary because of the availability of alternatives; and 

3. inconsistent with organic livestock production. 

For Comments that Do Not Support the Continued Prohibition of §205.604 Substances in Organic Production:

If you provide comments that do not support the prohibition of a substance at §205.604, you should provide reasons 

why the use of the substance should no longer be prohibited in organic production. Specifically, comments that support 

the removal of a substance from the §205.604 section of the National List should provide new information since its last 

NOSB review to demonstrate that the substance is:

1. not harmful to human health or the environment; and/or

2. consistent with organic livestock production. 

For Comments Addressing the Availability of Alternatives: 

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

alternatives include, but are not limited to:

• Alternative management practices that would eliminate the need for the specific substance; 

• Other substances that are on the National List that are better alternatives, which could eliminate the need for 

this specific substance; and/or

• 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 organic operations 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 1, 2022, via www.regulations.gov. Comments received after 

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

§205.603 Sunsets: Synthetic substances allowed for use in organic livestock production: 

• Chlorhexidine

• Glucose

• Tolazoline

• Copper sulfate

• Elemental sulfur

• Lidocaine

§205.604 Sunsets: Nonsynthetic substances prohibited for use in organic livestock production: 

• None 

NOSB Proposals and Discussion Documents April 2022 Page 2 of 152
Chlorhexidine

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

(6) Chlorhexidine—Allowed for surgical procedures conducted by a veterinarian. Allowed for use 

as a teat dip when alternative germicidal agents and/or physical barriers have lost their 

effectiveness. 

Technical Report: 2010 TR; 2015 TR. 

Petition: N/A

Past NOSB Actions: 10/1999 minutes and vote; 11/2005 sunset recommendation; 11/2009 Annotation 

change/clarification; 04/2010 sunset recommendation; 10/2015 sunset recommendation; 11/2017 

sunset recommendation.

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

renewal notice effective 3/15/2017 (82 FR 14420); Annotation amendment effective 1/28/2019 (83 FR 

66559)

Sunset Date: 01/28/2024

Subcommittee Review

Use 

Used as an antimicrobial during surgery for cleansing wounds, skin, and equipment. Also used as a pre 

and post teat dip to aid in controlling bacteria that cause mastitis. There are numerous synthetic 

disinfectants currently on the National List for organic livestock production, including iodine, ethanol, 

isopropanol, sodium hypochlorite, and hydrogen peroxide. Not all alternatives to chlorhexidine are 

useful in both a surgical environment and as a teat dip, as allowed under the chlorhexidine annotation. 

Chlorhexidine reportedly kills mastitis-causing pathogens faster than iodine and is more persistent in its 

disinfection activity. Chlorhexidine is gentler on the skin than iodine, which is especially useful in 

northern climates where an irritated udder and teats can be especially problematic for the animals in 

cold winter months. Approved legal uses of the substance include disinfection during livestock surgery, 

on teats pre and post milking, and on milking equipment. Chlorhexidine is also used in food processing 

as a hard surface disinfectant and in human dentistry as a mouth wash and to disinfect equipment.

Manufacture

Limited information is available regarding the manufacture of chlorhexidine for use in commercially 

available disinfectants, sanitizers, bactericides, and virucides. The general procedure for industrial-scale 

chlorhexidine production involves initial synthesis of the 1,6-hexamethylenebis(dicyandiamide) 

intermediate, followed by reaction of the intermediate with 4-chloroaniline hydrochloride. Once 

purified, chlorhexidine is combined with acetic acid or D-gluconic acid to generate the commercially 

relevant diacetate or digluconate salts of chlorhexidine.

International Acceptance

Canadian General Standards Board Permitted Substances List

The Canadian General Standards Board allows the use of chlorhexidine under Section 5.3 (Health Care 

Products and Production Aids) of the Permitted Substances Lists for Livestock Production (CAN, 2011). 

Specifically, the rule states that chlorhexidine may be used in the following ways: (1) for surgical 

procedures conducted by a veterinarian, and (2) as a post-milking teat dip when alternative germicidal 

agents and physical barriers have lost their effectiveness.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

According to Article 23 (4) of the Commission Regulation concerning organic production and labeling of 

organic products, Housing, pens, equipment, and utensils shall be properly cleaned and disinfected to 

NOSB Proposals and Discussion Documents April 2022 Page 3 of 152
prevent cross-infection and the build-up of disease carrying organisms. Feces, urine and uneaten or split 

feed shall be removed as often as necessary to minimize smell and to avoid attracting insects or rodents.

The list of approved substances for cleaning and disinfection of building and installations for animal 

production includes “cleaning and disinfection products for teats and milking facilities.” However, the 

rule does not explicitly describe the restrictions of use for available teat dip substances (EC, 2008). It is 

therefore uncertain whether European regulations allow the use of chlorhexidine as a topical 

disinfectant (e.g., teat dip) in organic livestock production.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999) 

Chlorhexidine is not listed in CODEX.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Appendix 5 of the IFOAM Norms, which provides a list of “substances for pest and disease control and 

disinfection in livestock housing and equipment,” includes iodine and “cleaning and disinfection 

products for teats and milking facilities.” However, the standard does not explicitly describe the 

restrictions of use for available teat dip substances (IFOAM, 2014). It is therefore uncertain whether 

IFOAM guidelines permit the use of chlorhexidine as a topical disinfectant (e.g., teat dip) in the organic 

production of dairy animals.

Japan Agricultural Standard (JAS) for Organic Production

According to Table 4 of the Japanese Agricultural Standards for Organic Livestock Products, 

chlorhexidine is an allowed synthetic agent for cleaning and disinfecting livestock housing (JMAFF, 

2012). However, chlorhexidine is not explicitly allowed for use in pre- or post-milking teat dips under 

Japanese organic regulations.

Environmental Issues

The 2015 TR indicates that although data is limited, chlorhexidine is readily biodegradable in the 

atmosphere, with limited biodegradation in the terrestrial and aquatic compartments [TR 275-277] . 

However, chlorhexidine is not considered to be persistent, bioaccumulative, or toxic to humans. 

Production and use of chlorhexidine as an antiseptic and disinfectant will result in releases to the 

environment through waste streams and spills. Chlorhexidine exists primarily in protonated (cationic) 

form in the environment, and thus is expected to adsorb strongly to organic carbon and clay despite its 

predicted high mobility in soil. Likewise, chlorhexidine is expected to adsorb to suspended solids and 

sediments when released to water [TR 433 - 436]. Despite the relatively low risk associated with 

chlorhexidine, environmental hazards cannot be excluded for improper handling and disposal of 

chlorhexidine products. Specifically, chlorhexidine salts are highly toxic to aquatic life with long lasting 

effects [TR 438 - 439]. Registrant-submitted studies indicate that concentrations as low as 60 parts per 

billion are toxic to half of the freshwater water fleas in an acute toxicity test [TR 439 - 441](. Further, 4-

chloroaniline used in the synthesis of chlorhexidine is highly toxic to red blood cells and DNA, and 

exposure to residues of this substance in contaminated chlorhexidine solutions may lead to toxic effects 

in terrestrial organisms [441 – 443]. As a general antimicrobial agent, chlorhexidine is potentially toxic to 

beneficial soil organisms, including nitrogen fixing bacteria and mycorrhizal fungi.

Discussion

When other products have lost their efficacy, chlorhexidine is used to treat mastitis. It is also used by 

veterinarians as an antimicrobial during surgery. Both uses are seen to be effective and safe, and 

chlorhexidine is not seen as an overused product.

NOSB Proposals and Discussion Documents April 2022 Page 4 of 152
Questions to our Stakeholders

1. How often is chlorhexidine used as an aid in controlling bacteria that causes mastitis?

2. Are naturally derived substances, as well as other approved synthetic substances, sufficient to 

remove chlorhexidine as a disinfectant or sanitizer from this listing?

Glucose

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

(13) Glucose.

Technical Report: 1995 TAP.

Petition: N/A

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

recommendation; 10/2015 sunset recommendation; 11/2017 sunset recommendation. 

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420); Sunset 

renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 10/30/2024

Subcommittee Review

Use 

Glucose is a synthetic substance allowed in organic livestock production for medical treatment. For 

animal health purposes, glucose is used primarily as an aid in the treatment of ketosis in cattle. 

Additionally, glucose is an important remedy for dehydration, neonatal hypoglycemia, as an ingredient 

in formulated electrolyte solutions, and as an excipient.

Manufacture

An updated TR for 2021 notes that glucose is made through the hydrolysis of starches, mostly 

originating from corn, but could be sourced from wheat, rice, potato, barley, sago, or sorghum. In the 

process of hydrolysis, glucose can be formulated with enzymes or acids as the catalyst.

International Acceptance

Canadian General Standards Board Permitted Substances List

Glucose is permitted for use under section 5, Table 5.3 as a Health Care Product and Production Aide 

with no annotations or restrictions.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Article 14 addresses Livestock production rules.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999) 

Annex 1, Principles of Organic Production, Section B, subsections 20 thru 24 address Health Care in 

Livestock. 

International Federation of Organic Agriculture Movements (IFOAM) Norms

Section 5.6 addresses General Principles for use of Veterinary Medicines for Livestock.

NOSB Proposals and Discussion Documents April 2022 Page 5 of 152
Environmental Issues

According to the 2021 TR, glucose is abundant in the environment and is easily metabolized. It is not 

expected to accumulate in the environment, but as excreted in the urine of ruminants after treatment, 

is expected to be consumed by microbes in soil systems. As an important biomolecule, glucose has very 

low toxicity. Environmental concerns with glucose are associated with the agricultural production of 

starch-containing-crops used to produce glucose and the energy and materials consumed during 

manufacture. The TR goes on to describe the starch industry as causing very little waste due to the 

effective use of all side streams as economically valuable products, noting that very little waste is sent to 

a landfill or incineration. Glucose is not expected to negatively impact environmental or human health 

from chemical interactions in organic crop, livestock, or handling systems. The use of glucose in organic 

systems is not expected to threaten water or soil systems.

Discussion 

Glucose is an essential animal health remedy in organic systems. It is typically used to treat ketosis and 

dehydration when preventative measures have failed. While ketosis is a concern in most dairy herds, 

some producers note that due to an elevated risk of ketosis, it is necessary to maximize pre-parturition 

confinement in order to prevent ketosis through a low potassium diet. With glucose in the “toolbox”, 

producers can proceed with grazing pasture closer to parturition with the confidence that they will be 

able to address ketosis, should it arise. Previous sunset reviews have reflected low levels of glucose 

usage, but farmers and inspectors have consistently commented that glucose is an essential treatment 

and there is a high degree of support for keeping glucose on the National List. Since glucose is used as an 

excipient and in electrolyte formulations (for example), retaining glucose on the National List of allowed 

synthetics also maintains this important tool in formulations.

Questions to our Stakeholders

1. The National List does not currently place any use restriction on glucose other than the 

placement of the listing for use as a disinfectant, sanitizer, or medical treatment as applicable. Is 

further clarification or annotation needed for this substance on the National List?

2. The National List references multiple substances for the treatment of ketosis, including 

propylene glycol, calcium propionate, calcium borogluconate, and electrolytes. Is glucose 

equally necessary and effective as a tool for organic farmers for treatment of all stages of the 

development of this condition?

Tolazoline

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

(29) Tolazoline (CAS #-59-98-3)—federal law restricts this drug to use by or on the lawful written 

or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 

530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the 

NOP requires:

(i) Use by or on the lawful written order of a licensed veterinarian;

(ii) Use only to reverse the effects of sedation and analgesia caused by xylazine; and

(iii) A meat withdrawal period of at least 8 days after administering to livestock intended for 

slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

Technical Report: 2002 TAP; 2019 TR. 

Petition: 2002.

Past NOSB Actions: 9/2002 recommendation; 10/2010 sunset recommendation; 10/2015 sunset 

recommendation; 11/2017 sunset recommendation. 

NOSB Proposals and Discussion Documents April 2022 Page 6 of 152
Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420); Sunset 

renewal notice effective 10/30/2019 (84 FR 53577).

Sunset Date: 10/30/2024

Subcommittee Review

Use 

Tolazoline is limited to use only by a veterinarian prescription and is further restricted for “use only to 

reverse the effects of sedation caused by xylazine.” Xylazine is primarily used in veterinary medicine as a 

sedative, tranquilizer, and analgesic. Sedation of animals is necessary for both planned medical 

procedures and emergency procedures to prevent pain and suffering, well as injury to the veterinarians 

performing the procedures. Tolazoline is commonly used as a reversal agent for xylazine, by competing 

for the α2-adrenergic receptors, blocking binding events for xylazine. Structural similarities with xylazine 

allow tolazoline to compete with xylazine for biological binding sites, providing the mode of action for its 

approved use in organic livestock production as a reversal agent for xylazine.

Tolazoline is used only for veterinary applications, with no natural alternatives or USDA-approved 

synthetic alternatives. There are no alternative practices that would make the anesthetic agent 

unnecessary. Tolazoline may be made unnecessary by allowing the veterinary subject to recover from 

the effects of xylazine by natural metabolism of the substance, rather than its active reversal. However, 

the rate of xylazine metabolism is species-dependent; therefore, this may prove problematic in species 

with slower metabolic rates (e.g., cattle).

Manufacture

Tolazoline is a synthetic substance that is produced by a one-pot process (i.e., no intermediates are 

isolated) by the reaction of phenylacetaldehyde with ethylene diamine, with the incorporation of an 

iodine-based oxidation process.

International Allowance

Canadian General Standards Board Permitted Substances List

Although xylazine is listed in the CAN/CGSB-32.311-2015 — Organic production systems - permitted 

substances list in Table 5.3 “health care products and production aids,” as a “sedative”, tolazoline (the 

most commonly used substance for a reversal agent for sedatives, including xylazine) is not listed in the 

CAN/CGSB-32.311-2015.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Tolazoline is not listed in the EEC EC No. 834/2007 or 889/2008.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999)

Tolazoline is not listed in the CODEX.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Tolazoline is not listed in IFOAM.

Japan Agricultural Standard (JAS) for Organic Production

Tolazoline is not listed in the JAS for Organic Production.

Environmental Issues

Tolazoline is a synthetic α2-adrenergic antagonist that also interacts with histamine and cholinergic 

receptors in a temporary and reversible manner. Tolazoline affords several physiological effects, 

including vasodilation (increasing arterial oxygenation), transient hypotension, histaminic 

gastrointestinal effects. There are no published toxicity or carcinogenicity studies on the toxicity or 

lethal dosages of tolazoline.

NOSB Proposals and Discussion Documents April 2022 Page 7 of 152
Tolazoline is listed by the EPA as an inert ingredient of toxicological concern. There are no reported 

studies on the environmental toxicity, persistence, or concentration of tolazoline. 

Questions to our Stakeholders

Tolazoline is a synthetic substance that is limited to use only by prescription from a veterinarian to 

reverse the effects of the sedative xylazine. Are there any new non-synthetic substances that can be 

used to reverse the effect of the sedative xylazine as effectively as tolazoline?

Copper sulfate

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

(1) Copper sulfate.

Technical Report: 1995 TAP; 2015 TR. 

Petition: N/A

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

recommendation; 10/2015 sunset recommendation; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420); Sunset 

renewal notice effective 10/30/2019 (84 FR 53577).

Sunset Date: 10/30/2024

Subcommittee Review

Use 

Copper sulfate is listed on the National List of allowed synthetic substances for use in organic livestock 

production at § 205.603 as a topical treatment, external parasiticide or local anesthetic. Copper ions 

have been reported to have antimicrobial activity against a wide range of aerobic and anaerobic bacteria 

and fungi. The exact mechanisms by which copper sulfate exerts its biocidal effect is a source of 

numerous ongoing investigations in the scientific literature. Copper sulfate has been used as a footbath 

antiseptic to help control and prevent infectious hoof disease problems that affect the skin adjacent to 

the claw horn of dairy cattle and sheep i.e., digital dermatitis (DD) (hairy heel warts), foot rot lesions 

(interdigital area and invading the subcutaneous tissue), and heel erosions. Depending on the severity of 

the infection, the impact on managed cattle and or sheep ranges from minor discomfort to severe 

debilitating lameness, reproductive problems and in the dairy industry a reduction of milk production 

ranging from 20 to 50 percent [2015 TR, 93 – 98].

Manufacture

Copper sulfate is a synthetic compound produced by a chemical process. Copper sulfate is produced 

commercially by reacting various copper minerals and or metal with sulfuric acid [2015 TR 293 - 294.

International Acceptance

Canadian General Standards Board Permitted Substances List

Allowed as an essential nutrient (source of copper and sulfur) and for topical use (foot baths).

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Not listed.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999) 

Not listed.

NOSB Proposals and Discussion Documents April 2022 Page 8 of 152
International Federation of Organic Agriculture Movements (IFOAM) Norms

Not listed.

Japan Agricultural Standard (JAS) for Organic Production

Not listed.

Environmental Issues

See 2015 TR for references.

Walk-through footbaths are used to help control and prevent hoof related diseases in dairy cattle and 

sheep. A five-to-ten percent copper sulfate solution is commonly used as the antimicrobial agent in the 

footbath and is considered effective for 150 to 300 animal passes. Spent solution is mixed with manure 

waste and ultimately disposed by land application. Regulators in several states (Ippolito et al., 2013, 

Rankin, 2012) have expressed concern that soil copper could be increased to an unhealthy level by this 

practice and have established maximum (lifetime) loading rates of copper. An 8 ft. x 2.5 ft. x 5-inch foot 

footbath will contain approximately 62 gallons of water and 26 pounds of copper sulfate (charged at the 

5% concentration). Since copper sulfate is 25% copper, each time the footbath is dumped, 6.5 pounds of 

copper is added to the disposal burden. The environmental effect of this copper depends on the volume 

of footbath solution disposed (a function of the number of animals and intensity of footbath use), 

concentration of copper sulfate, and the land area of application. Without careful attention, maximum 

soil copper loading rates may be exceeded in relatively short times (5 to 30 years) (Epperson et al., 

2007). Depending on the agricultural crop, the annual removal rate for copper is less than 0.5 

pound/acre per year. Federal, state, and local environmental regulations require the development of 

manure management plans to protect water resources and soil quality. The EPA has specific guidelines 

for copper loading to agricultural land when sewage sludge or biosolids are applied. The EPA §503.13 

standard limits annual loading of copper from biosolids to 66 pounds copper per acre and limits lifetime 

loading to 1,339 pounds copper per acre (limits are based on biosolids land application) (EPA, 2014). 

Reaching these limits is almost impossible with dairy waste applications and would devastate most 

agricultural crops long before the lifetime loading limits were met. Some states have lower limits for 

copper application. New York and Illinois have set lower lifetime loading limits for copper at 75 and 250 

pounds per acre, respectively, in order to avoid the potential of irreversible toxic accumulations of 

copper in the soil (Socha et al., 2007, Ippolito et al., 2013, Rankin, 2012). While more studies are 

needed, Ippolito et al. recommended that alkaline soils with greater than 50 ppm extractable copper 

should not have additional copper load added to soil. This value is advisable for producers raising alfalfa 

for dairy cow consumption in order to avoid copper accumulation above the NRC 2005 

recommendations for the maximum tolerable Cu level for cattle and sheep. Ippolito et al. suggested that 

soil samples be tested for extractable copper every two to three years from an accredited soil testing 

laboratory to determine if a copper accumulation problem exists.

Discussion 

The Livestock subcommittee noted that while copper sulfate use in livestock appears to be essential as 

of this review, there are environmental impacts associated with its use. The subcommittee discussed 

whether zinc sulfate could be a reasonable replacement for copper sulfate on livestock operations and 

generally encourage organic industry stakeholders to help identify new research on alternatives. 

Questions to our Stakeholders

1. Can the consistent use of foot trimming allow for the elimination of copper sulfate on dairy 

farms?

2. Have other foot bath treatments of similar efficacy come on to the market?

NOSB Proposals and Discussion Documents April 2022 Page 9 of 152
Elemental sulfur

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

(2) Elemental sulfur—for treatment of livestock and livestock housing.

Technical Report: 2017 TR. 

Petition: 2016. 

Past NOSB Actions: 11/2017 recommendation to add. 

Recent Regulatory Background: Added to National List on 5/30/2019 (84 FR 18133). 

Sunset Date: 05/30/2024

Subcommittee Review

Use 

Elemental sulfur is currently allowed for use in organic production as an insecticide, for plant disease 

control, as a plant or soil amendment, and as a pesticide for domestic livestock.

Elemental sulfur is granulated to a fine powder (325 mesh) for use as a pesticide (control for mites, 

insects, fungi, and rodents) in livestock production. The particle size for this powder is 44 microns 

(0.0017 inches) or less. Sulfur is dusted liberally and rubbed into feathers or hair. Sulfur dusting and or 

spraying is used for both the animals and their respective accommodations. Livestock species include 

chickens, turkeys, ducks, geese, game birds, pigeons, equine species, cattle, swine, sheep, and goats.

Manufacture

Sulfur is an abundant element on the earth. Elemental sulfur is found in volcanic sites and salt domes. 

Sulfur was classically mined from these using the Frasch process in the U.S. as late as the 1920s, but this 

is not a major source today.

Sulfur is also found in petroleum, natural gas, and fossil products from which it must be removed as a 

legal mandate to avoid the production of sulfur dioxide, a contaminant of the air. Hydrogen sulfide from 

petroleum refining and fossil fuels is converted to pure sulfur by the Claus process. The Claus process is 

used to produce the majority of sulfur available today. In a heating and cooling cycle, hydrogen sulfide 

recovered from fossil products is combusted to form water and elemental sulfur:

16 H2S + 10 O2 → 2 SO2 + 7 S2 + 16 H2O

The addition of an aluminum or titanium catalyst permits the reaction of SO2 formed during combustion 

with additional molecules of H2S to yield sulfur and water:

2 H2S + SO2 → 3 S + 2 H2O

In 2015, recovered elemental sulfur and its byproduct sulfuric acid were produced at 103 operations in 

27 States. Total shipments were valued at about $933 million. Elemental sulfur production was 8.7 

million tons; Louisiana and Texas accounted for about 52% of domestic production. Elemental sulfur was 

recovered, in descending order of tonnage, at petroleum refineries, natural-gas-processing plants, and 

coking plants by 39 companies at 96 plants in 26 States. Domestic elemental sulfur provided 64% of 

domestic consumption. About 11 million tons of sulfur were used in the US in 2015 (USGS, 2016; for 

references, please see the 2017 technical report for Elemental Sulfur: Livestock).

International Acceptance

Canadian General Standards Board Permitted Substances List

Sulfur is allowed for control of external parasites.

NOSB Proposals and Discussion Documents April 2022 Page 10 of 152
European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Commission Regulation (EC) No 889/2008 permits the use of elemental sulfur (98% pure) as a fertilizer 

or soil amendment and as a fungicide, acaricide and repellent in organic farming. Sulfur is not permitted 

for use as an insecticide in livestock.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999) 

Codex Alimentarius guidelines (GL 32-2013) permit the use of sulfur for livestock and livestock products 

in bee husbandry for pest and disease control. With recognition by the certification body or authority, 

GL 32-2103 permits the use of sulfur in soil fertilizing and conditioning, and plant pest disease control.

International Federation of Organic Agriculture Movements (IFOAM) Norms

The IFOAM norms allow the use of sulfur as a fertilizer and soil conditioner and as a crop protectant in 

organic crop production. IFOAM allows the use of sulfur for pest and disease control in beekeeping. 

Sulfur is not permitted for use as an insecticide in livestock.

Japan Agricultural Standard (JAS) for Organic Production

The Japan Agriculture Standard for Organic Production permits the use of sulfur as a fertilizer or soil 

improvement. Sulfur is not permitted for use as an insecticide in livestock.

Environmental Issues

Elemental sulfur seems benign unless being handled or administered in very large amounts, for instance 

in transport in molten form or when stored in open piles. It can also be overfed in unusual cases.

Consumption by ruminants of a high dietary percentage (>0.3%) of sulfur as elemental sulfur or sulfate 

can cause toxic effects. Sulfur bacteria in the rumen produce the poisonous gases, hydrogen sulfide and 

sulfur dioxide that eructate from the rumen and are absorbed through the lungs. Diets rich in sulfate can 

depress feeding. In spite of the liver’s capability for detoxifying sulfide in the blood, extreme cases of 

sulfur toxicity can lead to death (Kandylis, 1984).

In livestock production, hydrogen sulfide can be a hazard to human health. This colorless toxic gas with a 

rotten egg odor is produced during the degradation of liquid manure stored in anaerobic conditions 

within agricultural livestock operations. However, the contribution of elemental sulfur to the hydrogen 

sulfide livestock production hazard for workers is negligible (EPA, 2013a).

Current available U.S. Environmental Protection Agency toxicity studies and literature searches for 

elemental sulfur do not indicate any systemic human toxicity associated with elemental sulfur exposure 

and no endpoints of toxicological concern have been identified. The acute toxicity of sulfur is low. Only 

the word caution or no signal word is required on the label for elemental sulfur for acute toxicity, 

inhalation, and dermal exposure. Sulfur is an eye and skin irritant (category III, moderate irritation

(erythema) at 72 hours), but is not a skin sensitizer. The EPA’s review of incident data indicates that both 

the relative number of reported incidents and the severity of reported health effects are low.

Discussion 

In 2017, public comments indicated that producers, especially poultry producers, supported the listing 

of this substance on the National List to help control mites. Producers also indicated that alternatives 

were not effective. The NOSB voted to add elemental sulfur to the National List based on public 

comment, and its compatibility with a system of sustainable agriculture.

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However, the EEC, IFOAM, and Japan do not allow sulfur use on livestock. Evidently, their farmers use 

other practices or products for this purpose.

According to the 2017 TR, extracts of neem seeds diluted with water or soap have been shown to be 

effective treatments for mites, ticks, fleas, flies, and some insects for livestock (Schmahl et al., 2010). 

Pest control in poultry production depends upon the production system. In cage free production, where 

chickens can partake in dustbathing behaviors, both kaolin and diatomaceous earth in the dust bath can 

serve as a good treatment for mites and lice (Martin and Mullens, 2012). Several essential oils have been 

shown to be effective against lice and ticks (Rossini et al., 2008; Jaenson et al., 2005)). 

Questions to our Stakeholders

Are alternatives sufficient to control external livestock pests?

Lidocaine

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

(5) Lidocaine—as a local anesthetic. Use requires a withdrawal period of 8 days after 

administering to livestock intended for slaughter and 6 days after administering to dairy 

animals.

Technical Report: N/A

Petition: N/A

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

recommendation; 10/2015 sunset recommendation; 2016 annotation change recommendation; 

11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice 2017 (82 FR 14420). Annotation change effective 

1/28/2019 83 FR 66559

Sunset Date: 01/28/2024

Subcommittee Review

Use 

Lidocaine is a local anesthetic used to reduce or prevent pain during de-budding horns in livestock, or 

general minor surgery on mature livestock. They numb only the area to be worked on. Humane 

treatment of animals is critically important, and the public expects high standards of animal welfare for 

organic livestock. A lengthy withholding period after treatment may result in animals not being treated 

in a timely manner, or not being treated at all. Section 205.238 establishes a livestock healthcare 

practice standard permitting physical alterations needed to promote animal welfare in a manner which 

minimizes stress, and further that a producer must not withhold medical treatment in an effort to 

preserve its organic status.

Manufacture

Lidocaine, 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide (2.2.2), is synthesized from 2,6-

dimethylaniline upon reaction with chloroacetic acid chloride, which gives α-chloro-2,6-

dimethylacetanilide, and its subsequent reaction with diethylamine.

International Acceptance

Canadian General Standards Board Permitted Substances List

NOSB Proposals and Discussion Documents April 2022 Page 12 of 152
Use of pharmaceutical local anesthetics shall be followed by withdrawal periods of 90 days for livestock 

intended for slaughter, and seven days for dairy animals.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Not listed.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999)

Not listed.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Not listed.

Japan Agricultural Standard (JAS) for Organic Production

Not listed.

Environmental Issues

Lidocaine is extensively and rapidly metabolized in the liver of mammals, followed by excretion via 

urine. No more than 10% of the dose is excreted as parent lidocaine. There is no excretion via feces.

Lidocaine is not readily biodegradable and is not predicted to bioaccumulate in aquatic organisms. The 

Predicted Environmental Concentration (PEC) / Predicted No Effect Concentration (PNEC) ratio is 6.5 x 

10-2 , which means use of lidocaine is predicted to present an insignificant risk to the environment.

Discussion 

The subcommittee notes that animal welfare is an innate aspect of organic livestock production, and 

lidocaine has been a consistent tool to minimize livestock pain.

Questions to our Stakeholders

1. Since lidocaine was last reviewed have alternative anesthetic substances emerged?

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