National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2026

Meeting 1 - Request for Public Comment

Livestock Substances § 205.603 & § 205.604

April 2024

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 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, it is noted in 

this list. Substances included in this document may also be viewed in the NOP’s Petitioned Substances 

Index. 

Request for Comments

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

2024 public meeting, the NOP requests that the public provide comments about these substances to the 

NOSB as part of the Spring 2024 public meeting. Written comments should be submitted via 

Regulations.gov at www.regulations.gov on or before April 3, 2024, as explained in the meeting notice 

published in the Federal Register. 

Public 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: (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 Substances in Organic Production at § 205.603: 

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 Substances in Organic Production at § 205.603:

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: 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 1 of 267
1. harmful to human health or the environment;

2. unnecessary because of the availability of alternatives; and/or

3. inconsistent with organic livestock production.

For Comments that Support the Continued Prohibition of § 205.604 Substances in Organic Production:

If you provide comments supporting the prohibition of a substance at § 205.604, 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 Substances in Organic Production at § 

205.604: 

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 at § 205.604 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 3, 2024 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:

Atropine

Hydrogen peroxide

Iodine (a)(16)

Iodine (b)(4)

Magnesium sulfate

Fenbendazole

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 2 of 267
Moxidectin

Peroxyacetic/peracetic acid

Tolazoline

Xylazine

Oxalic acid dihydrate

DL-methionine

Trace minerals

Vitamins

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

None

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 3 of 267
Atropine

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

(3) Atropine (CAS #-51-55-8)—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; and

(ii) A meat withdrawal period of at least 56 days after administering to livestock intended 

for slaughter; and a milk discard period of at least 12 days after administering to dairy 

animals.

Technical Report: 2002 TAP; 2019 TR

Petition(s): 2002

Past NOSB Actions: 05/2003 sunset recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Atropine is a naturally occurring alkaloid (a nitrogen-containing molecule that is produced in plants and is 

physiologically active) produced by the plants in the nightshade family (EFSA 2008, Timberlake 2015). 

Atropine is primarily isolated from Atropa belladonna (also known as deadly nightshade) and is a

component in both human and veterinary medicines for a range of treatments. Although, it is most widely 

used in both human and veterinary practices as a treatment for organophosphate poisoning. [2019 TR 35-

39]

Atropine is currently allowed by the United States Department of Agriculture (USDA) organic regulations as 

a 

medical treatment for organic livestock production (7 CFR 205.603(a)). USDA organic regulations restrict

atropine to “use by or on the lawful written or oral order of a licensed veterinarian,” and it must be followed 

by

“a meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a 

milk 

discard period of at least 12 days after administering to dairy animals. [2019 TR 24-28]

Manufacture

Atropine is a naturally occurring alkaloid (a nitrogen-containing molecule that is produced in plants and is 

physiologically active) produced by plants in the nightshade family (EFSA 2008, Timberlake 2015). The

primary source of atropine is accessed by extraction from Atropa belladonna, which yields the racemic

mixture of (+)-hyoscyamine and (-)-hyoscyamine (atropine) (Figure 1). Atropine may also be synthesized in

an acid-catalyzed esterification reaction in between tropine and tropic acid, although the primary source of

atropine is from plant extracts (PubChem 174174, Karkee 1980, Merck 2001, USDA 2002, EFSA 2008). [2019 

TR 51-56]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 4 of 267
Allowed as a health care product and production aid. Botanical preparations (such as atropine, 

butorphanol, and other medicines from herbaceous plants) shall be used according to label specifications. 

Substances containing petroleum-derived formulants (such as propylene glycol) shall not be fed to 

livestock. (Table 5.3, Botanical compounds listing, CAN/CGSB-32.311-2020, page 26)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Ancillary Substances

None

Human Health and Environmental Issues

Atropine alkaloids are naturally produced by plants in the nightshade family, which exists exclusively (preextraction) as L-hyoscyamine (PubChem 174174, Bunke et al. 1996, Reist et al. 1997, EFSA 2008). Because Lhyoscyamine is the lone enantiomer that is biologically produced, atropine does not exist naturally, but

rather is formed during the racemization. [2019 TR 343-347]

There are no reported studies on the persistence or concentration of atropine (neither D-hyoscyamine nor 

L-hyoscyamine) or the metabolized products tropine and tropic acid, although tropine has been identified as 

“readily biodegradable” (Sigma-Aldrich 2018b). [2019 TR 371-373] 

Due to the limited application of atropine (for veterinary medicine, approved for use only when used or 

ordered by a veterinarian), and the small quantities administered (milligrams), atropine is unlikely to be a 

source of environmental contamination (Rinaldi and Himwich 1954, Chugh et al. 2005, Aardema et al. 2008, 

Eddleston et al. 2008, Kumar et al. 2010). Moreover, the L-hyoscyamine enantiomer is largely degraded to 

tropine and tropic acid prior to excretion, further reducing the likelihood of environmental persistence and 

concentration build-up (Sigma-Aldrich 2018b). [2019 TR 375-380] 

The metabolism of atropine in humans is like that of most animal species. Atropine is both readily 

absorbed and distributed within the human body and readily excreted in urine (EMEA 1998, Williams et al.

2000, Aardema et al. 2008, EFSA 2008). Similar to the metabolic pathways in veterinary applications, 

humans also metabolize L-hyoscyamine (one enantiomer of the racemic atropine mixture) to tropine and 

tropic acid (Equation 2), which are excreted in urine along with the non-metabolized D-hyoscyamine 

enantiomer present in atropine (EMEA 1998, EFSA 2008). The short biological half-life of atropine (2-5 

hours), and incorporation of the substance in human medical applications makes negative health effects 

from the approved usage of atropine unlikely (Williams et al. 2000, Aardema et al. 2008, Mayo Clinic 2017, 

MedlinePlus 2017). Moreover, atropine is approved for use only when used or ordered by a veterinarian 

coupled with the withdrawal restrictions placed on animals receiving atropine treatments, makes human 

health effects unlikely (Rinaldi and Himwich 1954, Chugh et al. 2005, Aardema et al. 2008, Eddleston et al.

2008, Kumar et al. 2010). [2019 TR 544-555] 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 5 of 267
Discussion 

In written comments submitted for the spring and fall 2019 NOSB meetings, all commenters supported 

relisting atropine as essential for use in organic animal production, and several commenters stated that 

atropine was included in the organic system plan of operations they certified. No commenters expressed 

opposition to relisting. This material satisfies the OFPA Evaluation criteria and the NOSB supports the 

relisting of Atropine.

Questions to our Stakeholders

None

Hydrogen peroxide

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

(15) Hydrogen peroxide.

Technical Report: 1995 TAP (Crops); 2015 TR (Crops)

Petition(s): N/A

Past NOSB Actions: 11/2005 sunset recommendation; 04/2010 sunset recommendation; 

10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Historically, agricultural disinfectants containing hydrogen peroxide have been used for the disinfection of 

livestock housing surfaces and production equipment. Synthetic hydrogen peroxide is permitted for use in 

organic livestock production as a disinfectant, sanitizer, and medical treatment [7 CFR 205.603(a)]. It is also 

permitted for use in or on processed products labeled as “organic” or made with organic (specific 

ingredient or food group(s)) per 7 CFR 205.605(b), and for various uses in organic crop production per 7 CFR 

205.601.

Manufacture

Commercially available hydrogen peroxide is industrially produced using the anthraquinone autoxidation 

(AO) process. The AO method involves initial catalytic reduction of an alkyl anthraquinone with hydrogen to 

form the corresponding hydroquinone. This is followed by the autoxidation of the hydroquinone in air to 

regenerate the anthraquinone and release hydrogen peroxide. The simplified overall reaction involves 

direct combination of gaseous hydrogen (H2) and oxygen (O2). Almost all modern production facilities 

manufacture commercial hydrogen peroxide solutions using large, strategically located anthraquinone 

autoxidation processes. [2015 TR 34-39]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as a health care product and production aid. Pharmaceutical grade hydrogen peroxide is allowed 

for external use as a disinfectant. Food-grade hydrogen peroxide is allowed for internal use (for example, 

added to livestock drinking water). (Table 5.3, CAN/CGSB-32.311-2020, page 27)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 6 of 267
European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned

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

Organically Produced Foods (CXG 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM) Norms

Allowed. (Appendix 5: Substances for Pest and Disease Control and Disinfection in Livestock Housing and 

Equipment, page 83)

Japan Agricultural Standard (JAS) for Organic Production

Allowed. (Appended Table 4: Chemicals for cleaning or disinfecting livestock or poultry house)

Ancillary Substances

Water is the primary inert ingredient in hydrogen peroxide formulations. Some product labels list salicylic, 

phosphoric acid, benzyl alcohol, acetic acid, citric acid, butoxy-propan-2-xyloxy- propan-2-ol [2015 TR 170-

173]

Human Health and Environmental Issues

Hydrogen peroxide is inherently unstable due to the weak peroxide (O–O) bond. At typical pesticide 

concentrations, hydrogen peroxide is expected to degrade rapidly to water and oxygen (US EPA, 2007). 

[2015 TR 316-317]

When used as a fungicide, hydrogen peroxide is likely to contact soils under a variety of environmental 

conditions. Hydrogen peroxide degrades with an anaerobic (without oxygen) soil half-life of four hours in 

soils containing petroleum (US EPA, 2007). [2015 TR 320-322]

Since the substance has physical properties very similar to those of water, hydrogen peroxide is unlikely to

preferentially bind to soils when used in agricultural production (US EPA, 2007). [2015 TR 325-327] 

Research data indicates that volatilization of the substance from moist soils and surface water is expected 

to be low (EC, 2003). 

When released to water, hydrogen peroxide should be rapidly consumed through biodegradation and 

photolysis. 

The half-life of hydrogen peroxide metabolism in water generally decreases with increasing size of the 

microbial populations in the receiving water. Consequently, hydrogen peroxide degradation half- lives in 

natural waters range from a few hours to several days. [2015 TR 331 -334]

Hydrogen peroxide is not expected to bioaccumulate in aquatic organisms due to its low octanol-water

partition coefficient (Kow) of 0.032 (US EPA, 2007).

Degradation of hydrogen peroxide released to the atmosphere is primarily a result of indirect photolysis 

reactions with smaller contributions from direct photolysis and chemical reaction with organic substances. 

Light, oxygen, ozone, hydrocarbons and free radicals in the atmosphere mediate hydrogen peroxide

formation and release to the 

atmosphere, likely at a significantly greater rate than the agricultural uses of the substance (Goor, 2007; Eul,

2001). Considering the various atmospheric degradation pathways, the overall tropospheric half-life of 

hydrogen peroxide is estimated to be 10–24 hours (Goor, 2007; EC, 2003). [2015 TR 342-351]

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 7 of 267
Multiple EPA terrestrial effects characterizations have evaluated the toxicity of hydrogen peroxide and 

other “peroxy compounds” to mammals and birds. Studies submitted by the registrants indicate that 

hydrogen peroxide solutions used in pesticide products are corrosive to washed and unwashed eyes, as 

well as exposed skin (i.e., Toxicity Category I for eye and skin irritation). [2015 TR 355-358 The 

environmental protection agency reported in 2009 the results of a skin sensitization study which suggests that 

Hydrogen peroxide is not likely to be a sensitizer to mammals. The compound is considered slightly toxic to 

practically non-toxic to birds on an acute oral basis. 

Hydrogen peroxide is an unstable inorganic compound and is expected to degrade rapidly to water and 

oxygen in the environment. The half-lives for aerobic and anaerobic degradation of hydrogen peroxide in 

various soils are between one and seven hours. Hydrogen peroxide is mobile in soils, but does not readily 

volatilize from moist soils and surface waters (EC, 2003; US EPA, 2007). When released to water, hydrogen 

peroxide is rapidly consumed through biodegradation and photolysis. The half-life for biodegradation of 

hydrogen peroxide in water generally ranges from minutes to several hours (Goor, 2007; US EPA, 2007). 

Light, oxygen, ozone, hydrocarbons and free radicals contribute to hydrogen peroxide formation in the 

atmosphere, likely at significantly greater rates than the agricultural uses of the substance. The overall 

tropospheric half-life of hydrogen peroxide is estimated to be 10–24 hours (EC, 2003; Eul, 2001; Goor,

2007). Under typical use conditions, diluted and pure forms of hydrogen peroxide are reactive with

transition metals (e.g., iron, copper, chromium) and organic materials (US EPA, 2007; ATSDR, 2014). [2015 

TR 480-490]

Ecological receptors are insensitive to moderately sensitive to hydrogen peroxide solutions. Hydrogen 

peroxide is considered slightly toxic to practically non-toxic to birds on an acute oral basis. Likewise, 

aquatic toxicity studies indicate that hydrogen peroxide is slightly toxic to aquatic invertebrates and 

practically non-toxic to fish on an acute exposure basis. In contrast to birds and aquatic animals, 

microorganisms are particularly sensitive to various concentrations of hydrogen peroxide. The scientific 

literature and agricultural experience have demonstrated that hydrogen peroxide is toxic to pathogen soil 

organisms, such as the downy mildew fungus Pseudoperonospora cubensis and pink rot of potato fungus 

Phytophthora erythroseptica (Kuepper, 2003; Al-Mughrabi, 2006). Considering the oxidizing mode of 

action for hydrogen peroxide, it is likely that the substance is also toxic to beneficial soil organisms,

including Mycorrhizal fungi and nitrogen-fixing bacteria. This non-target effect is most relevant for spray 

drift and soil drench scenarios, and should not present a population-level concern for controlled hydrogen 

peroxide applications.

Environmental contamination is not expected when purified forms of hydrogen peroxide are released to 

the environment. At typical pesticide concentrations, hydrogen peroxide is expected to rapidly degrade to 

oxygen gas and water (US EPA, 2007). 

The toxic solvents and reagents used in the manufacture of hydrogen peroxide are removed prior to

product formulation and, in many cases, are reused in subsequent synthetic reactions (Eul, 2001; Goor,

2007). As such, it is unlikely that these chemicals are readily introduced into the environment as a result 

of hydrogen peroxide production. 

Hydrogen peroxide is generally considered safe for human exposure at low doses. Indeed, the US Food and 

Drug Administration (FDA) affirmed hydrogen peroxide as Generally Recognized as Safe (GRAS) when used

as a direct food additive with certain limitations (see “Approved Legal Uses of the Substance” for details).

Acute irritation and systemic toxicity is possible in humans exposed to moderate to high doses of hydrogen

peroxide. Systemic effects of the substance generally result from the release of oxygen gas and water as 

the enzyme catalase decomposes available hydrogen peroxide. Specifically, venous embolism (gas bubble

in bloodstream) may occur when the amount of oxygen gas produced exceeds its blood solubility (ATSDR, 

2014).

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 8 of 267
Hydrogen peroxide is unlikely to cause chronic toxicity in humans because it is rapidly decomposed in the 

body. The available toxicity and epidemiology studies provide no evidence of reproductive or 

developmental toxicity in experimental animals and humans (ATSDR, 2014). On the other hand, hydrogen

peroxide is a known mutagen and is associated with genotoxicity in mammalian and human cell lines 

(IARC, 1999; Driessens, 2009). IARC determined that there is inadequate evidence in humans and limited 

evidence in experimental animals for the carcinogenicity of hydrogen peroxide, classifying the substance as 

Group 3 – Not classifiable as to its carcinogenicity to humans (IARC,

2014). 

Moderate spills of hydrogen peroxide to marine and estuarine environments are unlikely to adversely affect 

the receiving water bodies. On the contrary, a method describing the addition of hydrogen peroxide to 

natural waters as an oxidizing agent for oil spill remediation was published in patent literature (Hoag, 

2014). Likewise, hydrogen peroxide has been used to treat wastewater, and aids in the removal of soil 

contaminants, including creosote, polycyclic aromatic hydrocarbons (PAHs), and other inorganic and 

organic substances (Atagana, 2003; Conte, 2001; US EPA, 2007).

Toxic substances used in the manufacture of hydrogen peroxide, including alkyl anthraquinones, aromatic 

solvents and transition metal catalysts (e.g., Raney nickel and palladium), are generally removed from 

hydrogen peroxide prior to formulation of commercial pesticide products. Further, certain fractions of 

these reagents, catalysts and solvents are often returned to the reactors for use in subsequent synthetic 

reactions (Goor, 2007; Eul, 2001). Therefore, the chemicals used in the production of hydrogen peroxide 

should not be released to the environment when manufacturers adhere to standard operating procedures 

for safe handling and disposal of toxic substances. Populations of beneficial soil fungi, such as Mycorrhizal 

fungi, and nitrogen-fixing bacteria may be negatively impacted by large-scale soil treatments of fungicides 

containing hydrogen peroxide.

Overall, the available information suggests that large volumes of concentrated hydrogen peroxide solutions 

will adversely affect the viability and reproduction of non-target microorganisms, including beneficial soil 

fungi and nematodes. Hydrogen peroxide is an unstable inorganic compound and is expected to degrade 

rapidly to water and oxygen in the environment. The half-lives for aerobic and anaerobic degradation of 

hydrogen peroxide in various soils are between one and seven hours. The half-life for biodegradation of 

hydrogen peroxide in water generally ranges from minutes to several hours (Goor, 2007; US EPA, 2007). In 

contrast to birds and aquatic animals, microorganisms are particularly sensitive to various concentrations of 

hydrogen peroxide.

Considering the oxidizing mode of action for hydrogen peroxide, it is likely that the substance is also toxic to 

beneficial soil organisms, including Mycorrhizal fungi and nitrogen-fixing bacteria. This non-target effect is 

most relevant for spray drift and soil drench scenarios, and should not present a population-level concern 

for controlled hydrogen peroxide applications. Environmental contamination is not expected when purified 

forms of hydrogen peroxide are released to the environment. At typical pesticide concentrations, hydrogen 

peroxide is expected to rapidly degrade to oxygen gas and water (US EPA, 2007). The toxic solvents and 

reagents used in the manufacture of hydrogen peroxide are removed prior to product formulation and, in 

many cases, are reused in subsequent synthetic reactions (Eul, 2001; Goor, 2007). As such, it is unlikely that 

these chemicals are readily introduced into the environment because of hydrogen peroxide production.

Hydrogen peroxide is generally considered safe for human exposure at low doses. Indeed, the US Food and 

Drug Administration (FDA) affirmed hydrogen peroxide as Generally Recognized as Safe (GRAS) when used 

as a direct food additive with certain limitations (see “Approved Legal Uses of the Substance” for details). 

Acute irritation and systemic toxicity are possible in humans exposed to moderate to high doses of 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 9 of 267
hydrogen peroxide. Systemic effects of the substance generally result from the release of oxygen gas and 

water as the enzyme catalase decomposes available hydrogen peroxide. Specifically, venous embolism (gas 

bubble in bloodstream) may occur when the amount of oxygen gas produced exceeds its blood solubility 

(ATSDR, 2014). Inhalation or ingestion of hydrogen peroxide at high concentrations may lead to seizures, 

cerebral embolism or even tissue death (infarction).

The most common symptoms reported were acute symptoms based on acute corrosion and irritation 

effects. The symptoms include eye irritation, skin burns, esophageal burns, nausea, dizziness, rash, and 

headaches. Inhalation effects include chest congestion, respiratory irritation, coughing of blood, tightness 

of chest and shortness of breath. Dermal effects include edema, erythema, skin burns, blistering, and 

swelling. These cases led to hospitalization in some cases. 

Discussion 

During the Spring and Fall 2019 NOSB meetings, the Livestock Subcommittee received comments in favor of 

relisting hydrogen peroxide and no comments against relisting. One commenter stated hydrogen peroxide 

is one of the most widely used hard surface sanitizers and is generally recognized as safe (GRAS) as an 

antimicrobial agent and for other purposes by the FDA. Unlike many alternatives available to organic 

producers, it is an excellent choice as it rapidly degrades to oxygen and water, leaving no residue. Hydrogen 

peroxide has been recommended for relisting by the NOSB At each of its previous sunset reviews. 

Questions to our Stakeholders

None

Iodine—§205.603(a)(16) and §205.603(b)(4) 

Reference: § 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (16) Iodine.

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

 (4) Iodine.

Technical Report: 1994 TAP; 2015 TR; 2023 Limited Scope TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Iodine has excellent antimicrobial qualities and is widely used in organic livestock production as a topical 

treatment, disinfectant and antimicrobial, especially as a teat dip used both pre-milking and post- milking. 

Mastitis is a painful inflammation with infection. Antibiotic use is prohibited in organic agriculture so 

preventive healthcare is of critical importance. While a clean barn, clean milking parlor, and clean cows are 

a vital aspect of an organic milk production system, barns are not sterile environments and thus 

antimicrobial teat dips used in pre- and post-milking are vital preventive healthcare products. There are 

many teat dips available commercially. Iodine-based teat dips are the most commonly used in organic 

livestock production. Iodine can be in molecular form or iodophor form. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 10 of 267
Typically, molecular iodine is “complexed” into a variety of iodophors where surfactants are mixed with 

molecular iodine to enhance water solubility and sequester the molecular iodine for extended release in 

disinfectant products. There may also be several other ingredients in iodine-based teat dips, some of which 

may be excipients.

Manufacture

Molecular iodine (I2) production processes generally utilize raw materials containing iodine, including 39 

seaweeds, mineral deposits, and oil well or natural gas brines. Various chemical substances are added in 

the production of commercially available teat dip products. Many of the iodophors commonly used for 

disinfection in the dairy industry consist of iodine mixed with polymeric nonionic surfactants, such as the 

polyalkylene glycol and polyvinylpyrrolidone carriers. The nonylphenol ethoxylates (NPEs), polyoxyethylene 

nonylphenol (CAS# 9016-45-9) and ethoxylated nonylphenol (CAS# 26027-38-3), as well as 

polyvinylpyrrolidone (CAS# 9003-39-8) and other potential polymeric carriers are US EPA List 4 Inerts (US 

EPA, 2004a) when used in pesticides, including antimicrobial sanitizers. When used in animal drugs (e.g. 

teat dips), these substances are considered excipients, and are subject to restrictions at section 205.603(f). 

This rule states that a given excipient may be used in the manufacture of drugs used to treat organic 

livestock when the excipient is: (1) identified as GRAS by FDA, (2) approved by FDA as a food additive, (3) 

included in the FDA review and approval of a New Animal Drug Application or New Drug Application, or (4) 

approved by APHIS for use in veterinary biologics. 

Manufacturers commonly incorporate conditioners into iodine teat dip products to replace the protective 

oils that polymeric surfactants (i.e., detergents) used as complexing agents remove from animal skin during 

treatment. Moisturizers such as glycerin and propylene are normally added at concentrations ranging from 

two to ten percent of the product formulation (Universal, 2011; Nickerson, 2001). Further, glycerin 

produced through the hydrolysis of fats or oils is allowed as a livestock teat dip on the National List (7 CFR 

205.603(a)(12)). Lanolin may also be added to iodophor teat dip products as an emollient to replace natural 

oils lost from the affected skin of dairy cows (Nickerson, 2011).

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as a topical disinfectant. Allowed iodine sources include potassium iodide and elemental iodine. If 

used as a cleaning agent, non-elemental iodine shall be used. Iodine shall not exceed 5% solution by volume 

(example: iodophors). Use shall be followed by a hot‐water rinse. (Table 5.3, CAN/CGSB-32.311-2020, page 

27)

Substances such as alcohol, iodine, hydrogen peroxide, chlorine dioxide and ozone, can be used as 

disinfectants for a pre- or post-teat dip or udder wash if they are registered for this use by Canada’s Food 

and Drug Regulations. (Table 5.3, Teat dips and udder wash listing, CAN/CGSB-32.311-2020, page 29)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 11 of 267
Allowed. (Appendix 5: Substances for Pest and Disease Control and Disinfection in Livestock Housing and 

Equipment; iodine agent)

Japan Agricultural Standard (JAS) for Organic Production

Allowed. (Appended Table 4: Chemicals for cleaning or disinfecting livestock or poultry house)

Ancillary Substances

Excipients are almost always used in iodine sanitizing products, and the review of these substances is 

outlined above in manufacturing. One class of excipients, NPEs, has been identified as hazardous to the 

environment and potentially no longer necessary in manufacturing.

Human Health and Environmental Issues

A limited scope TR for Iodine was requested for this sunset review of the substance. One of the questions 

explored by the TR was the impact that NPEs (an excipient used in combination with iodine) has on the 

environment and human health.

NPEs have long been known to be toxic to aquatic organisms, they bioaccumulate in plants, and they have 

been shown to exhibit estrogenic properties in human studies. Their use in cleaning and sanitizing products 

has slowly been phasing out. However, they remain in use in dairy iodine teat dips, and the residues of 

these substances can find their way into milk bulk tanks, equipment, and manure lagoons where they will 

likely be applied to the soil. The TR identifies iodine teat dips as the largest potential contributing source of 

NPEs on dairy operations.

Discussion 

NOSB acknowledges that iodine sanitizers remain necessary to livestock operations as a sanitizer for 

medical procedures as well as for topical use, particularly as a teat dip for dairy animals. NOSB has also 

heard from numerous stakeholders that it is time to ensure that iodine products used on organic farms are 

free from NPEs. A limited scope TR was conducted to evaluate the availability of NPE-free iodine products 

and their suitability, the potential for NPEs contained in iodine products to contaminate organic products 

and the environment, and what detrimental effects may occur should NPEs enter the supply chain or be 

applied to soil.

The Livestock Subcomittee believes iodine continues to meet National List criteria and should not be 

removed. The LS would like to consider an annotation to prohibit NPEs in iodine products used on organic 

livestock operations, and may submit a proposal for the Fall 2024 meeting.

Questions to our Stakeholders

1. Based on the feedback received at previous reviews of iodine and the recently conducted limited scope 

TR of iodine, it appears that there is a significant supply of NPE-free iodine formulas for numerous types 

of iodine products, and a prohibition on NPE containing formulas would not have significant impact on 

the industry. Is this analysis correct? Are there specific types of iodine products where NPE-free 

formulas are not available?

2. For certifiers and MROs: Would an annotation restricting iodine formulas to those that are free of NPEs 

pose significant challenges to the review of iodine products in organic system plans?

3. What specific language should NOSB consider for a proposed annotation in order to fully restrict NPEs 

from iodine products used on organic livestock operations?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 12 of 267
 Magnesium sulfate

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

(19) Magnesium sulfate.

Technical Report: 1995 TAP; 2011 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Magnesium sulfate has a number of veterinary uses. It acts as an anticonvulsant, laxative, bronchodilator, 

electrolyte replacement aid with hypomagnesaemia, and may be used to treat cardiac arrhythmias. 

Specifically, in swine, magnesium sulfate is administered to treat malignant hypothermia. 

Magnesium sulfate can be added to livestock feed to treat conditions stemming from a magnesium 

deficiency. Lactation tetany or grass tetany occurs when ruminants graze on grasses low in magnesium or 

suffer from a low level of magnesium in their diet. The condition is often realized after cases of sudden 

death in cattle. Clinical signs include convulsions and muscular spasms, and death may occur due to 

respiratory failure. If livestock are feeding on pastures with high potassium levels, which interfere with the 

uptake of magnesium by grasses, supplemental magnesium sulfate may be needed. 

Magnesium capsules can be inserted into the rumen of livestock and after a one-week stabilization period, 

the capsule begins to release magnesium for up to 80 days. This capsule is recommended for use in highrisk or valuable animals. It is advised that, in addition to the capsule, the livestock be fed hay in order to 

increase absorption of the magnesium. If immediate treatment for magnesium deficiency is needed, 

magnesium sulfate can be administered intravenously. 

A magnesium lick can also be provided for livestock to increase the amount of magnesium in the diet. 

Because magnesium sulfate is not palatable, molasses is added to the magnesium lick to encourage cattle‘s 

use. Licks are generally 80 percent molasses and 20 percent magnesium sulfate and are considered to be 

less reliable than supplementing feed with magnesium. 

Magnesium sulfate, as Epsom salts, can be used to treat inflammation and abscesses in livestock. Soaking 

the affected area in a mixture containing Epsom salt and water can reduce signs of inflammation. 

Manufacture

Magnesium sulfate can be obtained from naturally-occurring sources or manufactured by a chemical 

process. 

Several mineral forms of magnesium sulfate are recovered from the ground. The magnesium sulfate 

generally found in nature is in the hydrated form (i.e., contains water). Specifically, magnesium sulfate 

monohydrate and magnesium sulfate heptahydrate occur in nature as the minerals kieserite and epsomite, 

respectively (Kawamura and Rao, 2007). 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 13 of 267
The synthetic form of magnesium sulfate is produced by a chemical reaction in which magnesite ore 

(containing MgCO3) or magnesium hydroxide (Mg[OH]2) is ignited to produce magnesium oxide. 

Magnesium oxide is then reacted with sulfuric acid, producing magnesium sulfate. To produce a high grade 

of purity, the magnesium sulfate is re-crystallized and separated from the parent solution (Kawamura and 

Rao, 2007).

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as an animal health care product and production aid; origin must be mined sources. Usage includes 

being a source of magnesium and sulphur. (Table 5.3, CAN/CGSB-32.311-2020, page 27)

Non-synthetic chelated or sulphated minerals are allowed for use as an animal health care product and 

production aid. Examples include oyster shell, calcium chloride and magnesium oxide. Synthetic nutrient 

minerals may be used if non-synthetic sources are not commercially available. Minerals from any source are 

allowed for medical use. (Table 5.3, CAN/CGSB-32.311-2020, page 28)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed (Annex III, Part A(1), 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned. 

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned. 

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned. 

Human Health and Environmental Issues

Magnesium and sulfur are ubiquitous in the natural environment. According to the 2011 TR, if used in 

accordance with 7 CFR 205.603, it is unlikely that magnesium sulfate will cause harm to the environment. 

Magnesium sulfate is considered by the Food and Drug Administration (FDA) as generally recognized as safe 

(GRAS) when used as a nutrient or dietary supplement (21 CFR 184.1443). The Food and Nutrition Board, an 

organization established by the Institute of Medicine that provides guidance to the public and policy 

makers on nutrition and food sciences, has recommended that cereal grain products be fortified with 

magnesium in response to the potential risk of deficiency among significant segments of the population 

(FAQS, 2010). 

Multiple products containing magnesium sulfate are approved by the FDA for medicinal use in humans. 

Magnesium sulfate can be administered via injection or can be orally ingested (U.S. FDA, 2010). In 2010, the 

FDA approved a product containing magnesium sulfate, which acts a colon cleanser in preparation for a 

colonoscopy (Braintree Laboratories, 2010). If large quantities of magnesium sulfate are ingested by or 

injected into humans, blood electrolyte balance can be disturbed, resulting in circulatory collapse and 

death. However, this is far beyond the bounds of veterinary use. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 14 of 267
Discussion 

During the previous NOSB review, the Livestock Subcommittee received several comments in favor of 

relisting magnesium sulfate and no comments against relisting. Some of the comments in favor of relisting 

included: 

• Magnesium sulfate is essential for organic livestock production. It is used when grass tetany and 

organophosphate poisoning occur. Both are acute situations, and an effective immediate treatment is 

necessary. 

• This product is administered by the intravenous or intramuscular routes as an electrolyte replenisher or 

anticonvulsant. Magnesium sulfate is used as a laxative and bronchodilator. This product is also added to 

feed to treat magnesium deficiency. Accordingly, this product is important to the humane treatment of 

organic animals. 

Subcommittee Discussion 

Magnesium sulfate satisfies the OFPA evaluation criteria, and the Livestock Subcommittee supports 

relisting. 

Questions to our Stakeholders

Are there effective non-synthetic alternatives to magnesium sulfate for this purpose? 

Parasiticides, Fenbendazole

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

(23) Parasiticides—prohibited in slaughter stock, allowed in emergency treatment for dairy and 

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

infestation. In breeder stock, treatment cannot occur during the last third of gestation if the 

progeny will be sold as organic and must not be used during the lactation period for breeding stock.

Allowed for fiber bearing animals when used a minimum of 36 days prior to harvesting fleece or 

wool that is to be sold, labeled, or represented as organic.

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

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

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

Technical Report: 1999 TAP (Fenbendazole, Ivermectin); 2015 TR; 2020 TR (Fenbendazole) 

Petition(s): 03/2007 Fenbendazole; 07/2019 (annotation request)

Past NOSB Actions: 05/2008 NOSB recommendation; 10/2015 sunset recommendation; 04/2016 

recommendation – annotation change; 10/2019 sunset recommendation; 10/2020 NOSB recommendation 

to not amend listing

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472); Renewed 

03/15/2017 (82 FR 14420); Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 FR 

66559); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

In veterinary medicine the term parasiticide refers to anthelmintic drugs (medicines used to destroy 

parasitic worms) [2015 TR 148]. Anthelmintics are medications capable of causing the evacuation of 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 15 of 267
parasitic intestinal worms. As veterinary drugs, parasiticides are articles intended for use in treatment or 

prevention of disease in animals (Section 201(g)(1)(B) & (C) of the Federal Food, Drug, and Cosmetic Act [21 

U.S.C. 321(g)(1)(B) & 234 (C)]). The use of parasiticides in organic production is strictly confined to 

emergencies and the practice of returning livestock production to a healthy steady state does not include 

the routine use of parasiticides. Parasitism may be the weakest link in organic livestock production 

(Karreman, 2004). Outbreaks of disease due to nematode parasites can happen even in well managed 

herds. When changes in a production system occur as a result of land use, weather, or transient exposure 

of susceptible animals to parasites the natural imbalance favors parasite infestation. When unnoticed, 

undetected and without treatment parasite infestation can lead to disease and potentially death 

(Stockdale, 2008) [2015 TR 394-398].

The 2020 Technical Report discussed the use of fenbendazole in chickens, which was the subject of a 2019 

petition to change the allowance on the National List. The 2020 TR summarized fenbendazole as follows:

The target organisms of the parasiticide fenbendazole are the roundworms Ascaridia galli and 

Heterakis gallinarum. These nematodes, along with Capillaria spp., are recognized as the principal 

helminthic parasites of chickens, with A. galli by far the most common. The life cycles of both target 

nematodes are simple and direct, transmitted bird-to-bird via fecal droppings. Infected chickens are 

unthrifty, weak, and emaciated, and have weight loss proportional to the parasite burden. Young 

birds are particularly susceptible. Although mature hens are less susceptible, their egg productivity 

may drop, and death may occur in severe cases. Because chickens raised as broilers have a much 

shorter lifespan than laying hens, parasiticides are generally not required to treat them. Turkeys 

have a longer grow-out than broilers and are subject to additional helminthic parasite pressure, 

particularly the roundworm parasite Ascardia dissimilis [2020 TR 25-37].

Fenbendazole is a benzimidazole veterinary anthelmintic – i.e., an antiparasitic drug (US NLM 

2020). The mode of action works at the sub-cellular level, preventing cell division. Benzimidazoles 

bind to β-tubulin, inhibiting the cell’s microtubule assembly responsible for intracellular transport 

and required for mitotic cellular division... The ultimate effect on nematodes is starvation caused by 

intestinal cell disruption and inhibition of nematode egg production. The late-stage (L5) larvae and 

adult stages of A. galli and H. gallinarum are susceptible. Efficacy studies reported that 

fenbendazole increased mortality of A. galli larvae and adult, but did not report any reduction in 

the number of viable parasite eggs [2020 TR 67-76].

Manufacture

The fenbendazole is manufactured using a condensation of o-phenylenediamine or o-nitroaniline with a 

carboxylic acid derivative. N-arylamide hydrochlorides can also be transformed to benzimidazoles with 

sodium hypochlorite and base. (Brown et al., 1961; Grenda et al., 1965; Loewe et al, 1976) [2015 TR Table 

4].

Fenbendazole is approved as a New Animal Drug Application (NADA) by the U.S. Food and Drug 

Administration’s Center for Veterinary Medicine (U.S. FDA CVM) ... The FDA has established a tolerance of 

1.8ppm fenbendazole in 93 eggs, using the predominant metabolite fenbendazole sulfone as a marker [21 

CFR 556.275]. This effectively provides a maximum residue limit (MRL) of 2.4 ppm total fenbendazole, 

including its metabolites fenbendazole sulfone and oxfendazole. In addition to poultry, the FDA has 

approved fenbendazole for use in cattle, swine, sheep, horses and turkeys, as well as zoo and wildlife 

animals [21 97 CFR 520.905, 21 CFR 558.258]. Fenbendazole is also approved for use as an anthelminthic 

for laying hens in the European Union (EMA 2011) and Canada (Health Canada 2020) [2020 TR 89-98].

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 16 of 267
International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

5.2.2(b) Shall respect requirements set out in 6.6 of CAN/CGSB-32.310 with regard to the use of internal 

parasiticides. Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and 

natural methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal 

times documented.

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

As per the 2015 TR - Parasiticides are prohibited on a routine basis. However, in the case of a sick animal 

requiring an immediate treatment, the use of chemically synthesized allopathic medicinal products is 

limited to a strict minimum. Doubling withdrawal periods after use of chemically synthesized allopathic 

medicinal products is suggested to guarantee the integrity of organic production for consumers. Because 

widespread animal diseases would seriously affect organic production, measures may be taken to ensure 

maintenance of farming or reestablishment of farming with nonorganic animals or non-organic for a limited 

period in the affected areas (2015 TR 461-467] 

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

Organically Produced Foods (GL 32-1999)

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented.

International Federation of Organic Agriculture Movements (IFOAM)

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented. IFOAM has an additional exception on the usage of parasiticides including a maximum of 

three courses of remedial treatments within 12 months, or one course of treatment if the productive 

lifecycle of the animal is less than one year

Japan Agricultural Standard (JAS) for Organic Production

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented.

Ancillary Substances

Excipients are identified in the 2015 Technical Report. No ancillary substances are identified. 

Human Health and Environmental Issues

The risks associated with chemical treatment of parasites include (1) immediate non-target effects, (2) 

obligation for repeat treatments, (3) potential risk to domestic animals and human health, (4) target 

organism resistance to the treatment, (5) potential residue buildup and (6) potential food chain 

contamination (Rudd, 1985). [1999 TAP pgs. 6-7]. All FDA livestock approved parasiticides are synthetically 

produced substances shown by experimental and clinical studies to be safe for application to food animals. 

The excipients are usually United States Pharmacopoeia (USP) grade chemicals and also subject to FDA 

approval [2015 TR 379-381].

In the 2020 Technical Report, the Subcommittee reviewed additional information on fenbendazole on the 

following evaluation questions and focus questions:

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 17 of 267
1. Evaluation Question #9: Discuss and summarize findings on whether the use of the petitioned 

substance may be harmful to the environment.

2. Evaluation Question #10: Describe and summarize any reported effects upon human health from 

use of the petitioned substance.

3. Evaluation Question #11: Describe all natural (non-synthetic) substances or products which may be 

used in place of a petitioned substance. Provide a list of allowed substances that may be used in 

place of the petitioned substance.

4. Evaluation Question #12: Describe any alternative practices that would make the use of the 

petitioned substance unnecessary.

5. Focus question – Alternatives: What agricultural practices can be used to reduce parasites (and/or 

prevent the reintroduction of these parasites) in outdoor areas for poultry?

6. Focus question – Alternatives: Are there currently allowed substances and/or practices (or 

combinations of allowed substances and practices) to eliminate or reduce parasite infestations in 

poultry and/or outdoor areas?

7. Focus question – Human Health: What are the specific human health risks associated with 

consuming eggs from poultry that are infested with parasites?

8. Focus question – Human Health: Is there any research on the human health effects of consuming 

fenbendazole or its metabolites that might be present in eggs following treatment of birds? Is there 

any research on the effects in young children, older adults, pregnant women and others with 

compromised immune systems?

9. Focus question – Human Health: Have any long-term human trials been conducted to determine 

the effects (to humans) of low doses of fenbendazole consumed over a long period of time?

10. Focus question – Human Health: Is any information available on whether human exposure to 

fenbendazole interferes with the efficacy of mebendazole, which is used for human treatment?

11. Focus question – Human Health: Do parasites develop resistance to fenbendazole? If so, does 

parasite resistance to fenbendazole diminish its usefulness as a human treatment for parasites 

(particularly outside the U.S. where its use for human treatment may be approved)?

12. Focus question – Human Health: Fenbendazole has shown some promise as a cancer treatment. Is 

any information available on whether the presence of fenbendazole in eggs consumed by humans 

could have any effect on this cancer treatment?

13. Focus question – Human Health: Does cooking eggs lessen the amount of fenbendazole or its 

metabolites in eggs?

14. Focus question – Regulatory: Are there other regulatory bodies or independent organizations 

(including international bodies) that have published findings regarding the toxicity (or lack thereof) 

of fenbendazole?

15. Focus question – Regulatory: What evidence was used to make the determination by FDA to allow 

use of fenbendazole for laying hens without an intervening period between treatment and sale of 

eggs? What studies, specifically, were used by the FDA to make their determination? Who provided 

funding for the studies?

Discussion 

Parasiticides are used in acute, emergency cases and should be administered under the care of a 

veterinarian across the spectrum of ruminant animals – sheep, goats, dairy, beef, etc. According to several 

organic focused dairy veterinarians, fecal samples should be sent to a lab to determine the parasite load 

and the farmer should accordingly develop a plan of action for the infected animal(s). Parasites are most 

common in young animals during the first grazing season. It is less common for adult animals to require 

treatment if good herd management practices are followed. It was noted that pasture height above six 

inches results in lower pest loads as the cows don’t graze low enough to where the parasites are typically 

located. Additionally, it was anecdotally noted during Subcommittee discussion that calves allowed to nurse 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 18 of 267
experience lower pest loads than calves that are bottle fed. The Board recognizes that parasiticides are not 

a preventative measure for herd health; however, the ability to use these tools in acute cases provides the 

utmost care and exemplifies animal welfare best care practices.

Questions to our Stakeholders

1. How do certifiers mitigate consistent repeat use of parasiticides?

2. Are there suggestions to improve the annotation?

3. Which age/class of animal do certifiers see their clients requesting approval for emergency 

parasiticide use?

4. How often do certifiers request copies of fecal sample test results to confirm the parasite load in a 

herd prior to allowing an emergency treatment with parasiticides?

Parasiticides, Moxidectin

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

(23) Parasiticides—prohibited in slaughter stock, allowed in emergency treatment for dairy and 

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

infestation. In breeder stock, treatment cannot occur during the last third of gestation if the 

progeny will be sold as organic and must not be used during the lactation period for breeding stock. 

Allowed for fiber bearing animals when used a minimum of 36 days prior to harvesting of fleece or 

wool that is to be sold, labeled, or represented as organic.

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

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

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

Technical Report: 2003 TAP (Moxidectin); 2015 TR

Petition(s): 2003

Past NOSB Actions: 05/2004 NOSB recommendation; 10/2015 sunset recommendation; 04/2016 NOSB 

recommendation - annotation change; 10/2019 sunset recommendation

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472); Renewed 

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 FR 

66559); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

In veterinary medicine the term parasiticide refers to anthelmintic drugs (medicines used to destroy 

parasitic worms), [2015 TR 148] although moxidectin is also effective against arthropod parasites (e.g., 

ticks, mites, fleas, lice, etc.). As veterinary drugs, parasiticides are articles intended for use in treatment or 

prevention of disease in animals (Section 201(g)(1)(B) & (C) of the Federal Food, Drug, and Cosmetic Act [21 

U.S.C. 321(g)(1)(B) & 234 (C)]).

The use of moxidectin in organic production is strictly confined to emergencies and the practice of 

returning livestock production to a healthy steady state that does not include the routine use of 

parasiticides. Routine management of parasiticides should include proper grazing management (rotating 

pastures when the grass is less than six inches tall), herbal and natural remedies, and selective breed 

genetics. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 19 of 267
Moxidectin is listed in the National List in 7 CFR 205.603(a) as a “medical treatment” under (23) 

“parasiticides”. Substances listed under 7 CFR 205.603(a)(23) may not be used in livestock intended for 

organic slaughter and can only be used for the emergency treatment of dairy and breeder stock. In addition 

to the use-restrictions listed for parasiticides, organic operations using moxidectin must observe a two-day 

milk-withhold following treatment of cattle and a 36 day withhold following treatment of goats, sheep, and 

other dairy species.

Manufacture

Moxidectin, a derivative of nemadectin, is a chemically modified Streptomyces cyanogriseus fermentation 

product (Asato and France, 1990) [2015 TR 224-225]. The synthesis of moxidectin involves protecting the 5-

hydroxy group of nemadectin with p-nitrobenzoyl chloride to give the corresponding 5-O(p-nitrobenzoyl)- 

nemadectin, which is then oxidized to give a 5-O(p-nitrobenzoyl)-23-oxo- nemadectin derivative in a 

crystalline state. The 5-O(p-nitrobenzoyl)-23-oxo- nemadectin derivative is then reacted with 

methoxylamine to give the 23-(methyloxime)5-O(p-nitrobenzoyl)- nemadectin intermediate in a crystalline 

state. This intermediate is then deprotected in the presence of base to give the desired 23-(methyloxime)- 

nemadectin. These reactions take place in the presence of various organic solvents (U.S. Patent Number 

4,988,824).

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented.

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

Parasiticides are prohibited on a routine basis. However, in the case of a sick animal requiring an immediate 

treatment, the use of chemically synthesized allopathic medicinal products is limited to a strict minimum. 

Doubling withdrawal periods after use of chemically synthesized allopathic medicinal products is suggested 

to guarantee the integrity of organic production for consumers. Because widespread animal diseases would 

seriously affect organic production, measures may be taken to ensure maintenance of farming or 

reestablishment of farming with nonorganic animals or non-organic for a limited period in the affected 

areas [2015 TR 461-467].

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

Organically Produced Foods (GL 32-1999)

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented.

International Federation of Organic Agriculture Movements (IFOAM)

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented. IFOAM has an additional exception on the usage of parasiticides including a maximum of 

three courses of remedial treatments within 12 months, or one course of treatment if the productive 

lifecycle of the animal is less than one year.

Japan Agricultural Standard (JAS) for Organic Production

Parasiticides are prohibited on a routine basis. If there is a specific disease or health issue and natural 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 20 of 267
methods are not effective, parasiticides may be used as long as there is a doubling of withdrawal times 

documented.

Ancillary Substances

Excipients are identified in the 2015 Technical Report. No ancillary substances are identified.

Human Health and Environmental Issues

The risks associated with chemical treatment of parasites include (1) immediate non-target effects, (2) 

obligation for repeat treatments, (3) potential risk to domestic animals and human health, (4) target 

organism resistance to the treatment, (5) potential residue buildup and (6) potential food chain 

contamination (Rudd, 1985). [1999 TAP pgs. 6-7]. Moxidectin is excreted in feces but is both microbially and 

photo-degraded in dung pats in the soil. It is the least toxic to dung beetles of the macrocyclic lactone 

anthelmintics. Moxidectin peaks in 2 days in feces after treatment and decreases to less than 10 ppb by 37 

days after treatment. The half-life for degradation of moxidectin in the environment may be up to 130 days 

[2015 TR Table 5 and 575-577].

Discussion 

Parasiticides are used in acute, emergency cases and should be administered under the care of a 

veterinarian across the spectrum of ruminant animals – sheep, goats, dairy, beef, etc. According to several 

organic focused dairy veterinarians, fecal samples should be sent to a lab to determine the parasite load 

and the farmer should accordingly develop a plan of action for the infected animal(s). Parasites are most 

common in young animals during the first grazing season. It is less common for adult animals to require 

treatment if good herd management practices are followed. It was noted that herds that graze on pasture 

above a height of six inches experience lower pest loads as the cows don’t graze low enough to where the 

parasites are typically located. Additionally, it was anecdotally noted during Subcommittee discussion that 

calves allowed to nurse experience lower pest loads than calves that are bottle fed. The Board recognizes 

that parasiticides are not a preventative measure for herd health; however, the ability to use these tools in 

acute cases provides the utmost care and exemplifies animal welfare best care practices.

History of moxidectin:

The NOSB recommended adding moxidectin to the National List in 2004 with the restriction that it only be 

allowed for use to control internal parasites. In a proposed rule published on July 17, 2006 (71 FR 40624), 

the USDA announced its decision to not include moxidectin on the National List because of its macrolide 

antibiotic classification. Based upon the public comments that informed NOSB recommendations sent to 

the Secretary on May 30, 2004, the NOP verified the information supplied by commenters, and 

subsequently concurred that moxidectin does not function as an antibiotic when used as a parasiticide. 

Moxidectin was then added to National List (77 FR 28472, May 15, 2012).

Questions to our Stakeholders

1. How do certifiers mitigate consistent repeat use of parasiticides? 

2. Are there suggestions to improve the annotation?

3. Which age/class of animal do certifiers see their clients requesting approval for emergency parasiticide 

use?

4. How often do certifiers request copies of fecal sample test results to confirm the parasite load in a herd 

prior to allowing an emergency treatment with parasiticides?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 21 of 267
Peroxyacetic/peracetic acid

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

(24) Peroxyacetic/peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing equipment.

Technical Report: 2000 TAP; 2016 TR

Petition(s): 2008

Past NOSB Actions: 11/2000 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Peracetic acid (PAA) is listed in the National List as allowed for use in organic livestock production for 

sanitizing facilities and processing equipment. This is consistent with the substance’s primary use in the 

food industry as a bactericide and fungicide for sanitizing and disinfecting structures, equipment, and hard 

surfaces. 2016 Technical Report (TR) line 99 states, peracetic acid may be used in livestock production in 

dairies – milking parlors, dairy production and transfer facilities and equipment – as well as in poultry 

premises, hatcheries, livestock quarters, stables, stalls, pens, cages, and on feeding and watering 

equipment.

Beginning at 2016 TR line 288: The reason for the excellent and rapid antimicrobial effects of peracetic acid 

is its specific capability to penetrate the cell membrane. Once inside the cell, peracetic acid plays a role in 

denaturing proteins, disrupting cell wall permeability, and oxidizing sulfhydryl and sulfur bonds in enzymes 

and other proteins. PAA irreversibly disrupts enzyme systems, which destroys the microorganism. The end 

products of peracetic acid oxidation are acetic acid and water.

Manufacture

Solutions of peracetic acid used as sanitizers are created by combining aqueous mixtures of two 

substances: acetic acid (the acid in vinegar) and hydrogen peroxide. At cool temperatures, acetic acid and 

hydrogen peroxide react over a few days to form an equilibrium solution containing peracetic acid, acetic 

acid, and hydrogen peroxide. This equilibrium solution is the substance sold commercially as the sanitizer 

“peracetic acid.”

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Not explicitly mentioned for livestock use. 

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed for cleaning and disinfection (Annex IV, Part D, 2021/ 1165).

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 22 of 267
Allowed. (Appendix 5: Substances for Pest and Disease Control and Disinfection in Livestock Housing and 

Equipment; peracetic acid, page 83).

Japan Agricultural Standard (JAS) for Organic Production

The Japanese Agricultural Standard for Organic Livestock Products, Table 4, lists “Agents for cleaning or 

disinfecting of housing for livestock.” Included on this list are “Hydrogen Peroxide Solution” and “Cleaning 

agents and disinfectants for milking equipment, rooms and buildings.” Peracetic acid is not specifically 

mentioned.

Ancillary Substances

Peracetic acid is a sanitizer regulated by the FDA and EPA, and a number of additional substances are 

allowed in peracetic acid formulations. These additional substances are necessary to stabilize the 

formulations and do not meet the NOSB’s definition of an ancillary substance.

Human Health and Environmental Issues

Peracetic acid is considered an environmentally friendly substance, with very little potential to cause 

contamination due to its rapid breakdown into benign substances already present in the environment. It 

has, however, been reported that peracetic acid in the atmosphere can react with photochemically 

produced hydroxyl radicals (reaction half-life of approximately 9 days) (U.S. National Library of Medicine 

2012), with a suggested role in contributing to acid rain.[2016 TR 544-547]

Both peracetic acid and hydrogen peroxide have been cited as potential contributors to acid rain. However, 

while peracetic acid and hydrogen peroxide can be involved in chemical reactions in the atmosphere that 

ultimately lead to acid rain, the literature does not cite them as being a significant contributor to or source 

of acid rain.

[2016 TR lines 615-618] Peracetic acid has been found in some instances to have beneficial effects related 

to environmental contamination. One study reports peracetic acid to be effective in degrading toxic 

compounds benzo(a)pyrene and methylnaphthalene in lake sediments through oxidation of the parent 

compound.

Discussion 

The importance of producers to have access to sanitizers in livestock operations cannot be understated. To 

maintain efficacy, producers must also have access to substances with multiple modes of action to prevent 

resistance to a single sanitizer. PAA functions as an effective sanitizer and poses little risk to human health 

or the environment. There is no new information available to the NOSB that would lead to recommending 

removal of this substance from the National List at 7 CFR 205.603(a).

Questions to our Stakeholders

None

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 23 of 267
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, and;

(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(s): 2002

Past NOSB Actions: 09/2002 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 FR 

66559); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 10/30/2029

Subcommittee Review

Use 

In organic livestock production, 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 and 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 [2019 TR 116-118].

Tolazoline is used only for veterinary applications, with no natural 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) [2019 TR 658-665].

Manufacture

Tolazoline is a synthetic substance 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 Allowed Substances List (CAN/CGSB 32.311-2020)

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

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

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 24 of 267
most commonly used substance for a reversal agent for sedatives, including xylazine) is not explicitly 

mentioned.

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Tolazoline is not explicitly mentioned.

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

Organically Produced Foods (CXG 32-1999)

Tolazoline is not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Tolazoline is not explicitly mentioned.

Japan Agricultural Standard (JAS) for Organic Production

Tolazoline is not explicitly mentioned.

Environmental Issues

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

receptors temporarily and reversibly. Tolazoline affords several physiological effects, including vasodilation 

(increasing arterial oxygenation), transient hypotension, and histaminic gastrointestinal effects. There are 

no published toxicity or carcinogenicity studies on tolazoline's toxicity or lethal dosages.

Neither xylazine nor tolazoline are listed by the EPA as an inert ingredient of toxicological concern [2019 TR 

398]. There are no studies on tolazoline's environmental toxicity, persistence, or concentration.

Discussion 

Tolazoline appears to be a critical tool for organic livestock producers. 

Questions to our Stakeholders

None

Xylazine

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

(30) Xylazine (CAS #-7361-61-7)—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, and;

(ii) 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(s): 2002

Past NOSB Actions: 09/2002 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 FR 

66559); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 25 of 267
Subcommittee Review

Use 

Xylazine is essential for use in veterinary surgical procedures for livestock, especially cattle.

Manufacture

Xylazine is synthesized by reacting 2,6-dimethylphenylisothiocyanate with 3-amino-1-propanol in a polar 

solvent (ether) to form a thiourea. Concentrated hydrochloric acid is added after the solvent is removed. 

Water is added to the cooled mixture, which is then filtered, and the filtrate is made basic to form a 

precipitate that is recrystallized as xylazine. Xylazine is used as a sedative, analgesic, and muscle relaxant in 

veterinary medicine. As a medical treatment, it can be administered intravenously, intramuscularly, 

subcutaneously, or orally, usually as a water-based injectable solution. Xylazine can also be found as a 

white crystalline powder. Xylazine sedative properties are due to its depressant mode of action on nervous 

system synaptic receptors. Sedation of animals is necessary for both planned medical procedures and 

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

performing the procedures. Xylazine is commonly used in conjunction with tolazoline, which is a reversal 

agent for sedatives such as xylazine. According to information posted on the FARAD (Food Animal Residue 

Avoidance Databank) website (http://www.farad.org/amduca-law.html), extra label use (i.e., off label use) 

of xylazine is permissible under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) only if 

such use is by or on the lawful written or oral order of a licensed veterinarian within the context of a valid 

veterinarian-client-patient relationship. According to the FARAD Digest (published in JAVMA, Vol. 223, No. 

9, Nov. 1, 2003), xylazine is used as a medical treatment in livestock intended for food production as well as 

in dairy cows. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as a health care product and production aid. (Table 5.3, Sedatives listing, CAN/CGSB-32.311-2020, 

page 28)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Human Health and Environmental Issues

Xylazine is a substance with potent hypnotic and muscle-relaxation properties. The side effects of xylazine 

include significant cardiac arrythmias, which has resulted in its lack of approval for human medical 

applications (Green et al. 1981, EMEA 1999, Reyes et al. 2012). Due to the lack of approval for use in human 

medical applications, information on the mode of action and toxicity of xylazine is limited. [2019 TR 610-

614]. Reported cases of xylazine in humans have shown physiological effects like those seen in veterinary 

applications (Samanta et al. 1990, JECFA 1998a). Upon absorption of xylazine, patients were difficult to 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 26 of 267
rouse and showed signs of confusion (indicative of central nervous system and neuropathic depression) and 

expressed symptoms of bradycardia, hypotension (respiratory depression), and hyperglycemia (Gallanosa 

et al. 1981, Spoerke et al. 1986, Samanta et al. 1990). With regard to human carcinogenicity, no studies of 

direct effects have been published; however, the International Agency for Research on Cancer (IARC) has 

designated the xylazine metabolite, xylidine, as potentially carcinogenic to humans based on studies with 

laboratory animals (NTP 1990, IARC 1993, JECFA 1998a). The lethal dosage of xylazine in humans is not well 

known and appears to vary dramatically between individuals (Spoerke et al. 1986, Ruiz-Colon et al. 2014). 

Fatal doses of xylazine recorded have been as low as 40 mg, while other individuals have survived exposure 

to levels as high as 2400 mg (Spoerke et al. 1986, Ruiz-Colon et al. 2014) [2019 TR 616-628].

Discussion 

This material appears to be a critical tool for organic livestock producers.

Questions to our Stakeholders

None

Oxalic acid dihydrate

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

(8) Oxalic acid dihydrate—for use as a pesticide solely for apiculture.

Technical Report: 2018 TR

Petition(s): 2017

Past NOSB Actions: 04/2019 NOSB recommendation to add

Recent Regulatory Background: Added to NL 07/2021 (86 FR 33479)

Sunset Date: 7/26/2026

Subcommittee Review

Use 

Oxalic acid is used as a parasiticide specifically for apiculture. Oxalic acid is currently labeled and approved 

by the EPA for use in beehives (Registration #91266-1). It is used both in the hive and during transport of 

honeybees in cages when sold as “bee packages”. It can be used in rotation with formic acid, currently on 

the National List, to control varroa mites and is a useful tool for beekeepers to manage honeybee parasites. 

Oxalic acid can be applied to a hive in two ways: In a sugar syrup to be trickled between frames, and as a 

vapor treatment. There are numerous types of equipment, both home-made and commercially available, 

that provide the beekeeper the means of heating the oxalic acid and filling the hive with this vapor. In 

addition, oxalic acid is used to treat packaged bees before they are shipped to customers. Packaged bees 

with infestations of varroa mites have been a problem for beekeepers and the use of a sugar/oxalic acid 

syrup spray is a useful method to address this issue. Varroa mites, an invasive pest, are one of the many 

production problems affecting the livelihood of beekeepers. Numerous chemical varroa mite treatments 

have been used over the years in nonorganic operations. Many of these treatments are no longer effective 

due to the development of resistance by the varroa mite. Formic acid has been used for many years in 

honeybee hives, with no varroa mite resistance. It is considered unlikely that resistance will occur. Similar 

to formic acid, it is unlikely that varroa mites will develop resistance to oxalic acid. 

The mode of action of this substance is not clearly understood, but it appears to be attributed to its acidity 

(pH near 0.9). Oxalic acid will cross the exoskeleton of the mites in a few hours of application and cause 

death. Oxalic acid vapor can enter the mite through the soft pads of its feet, enter the mite’s blood stream 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 27 of 267
and kill it. When mites parasitize and suck on the bee, it can kill the mite through this method as well. There 

is no clear research to determine if one or all of these are the main modes of action. Current research does 

indicate that the amount of oxalic acid typically applied to the honeybee hive is not toxic to the bees and is 

sufficient to kill varroa mites.

Manufacture

Oxalic acid is a dicarboxylic acid, which is in a crystalline form when solid, but loses this structure when 

dissolved in water. Commercial oxalic acid is produced through a variety of chemical reactions that include 

oxidation of carbohydrates or alkenes as well as synthesis from carbon monoxide and water. Oxalic acid 

crystals are produced through precipitation of the crystals from the mother liquor. Oxalic acid can also be 

produced through microbial fermentation of products such as citric acid, but these are not the typical 

method for commercial production.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

CAN/CGSB-32.310-2015 Clause 6.6.10: “The use of veterinary medicinal substances shall comply with the 

following: (a) if no alternative treatments or management practices exist, veterinary biologics, including 

vaccines, parasiticides or the therapeutic use of synthetic medications may be administered, provided that 

408 such medications are permitted by this standard and Table 5.3 of CAN/CGSB-32.311 or are required by 

law.” 

Allowed as a health care product and production aid for mite control in honeybee colonies. (Table 5.3, 

CAN/CGSB-32.311-2020, page 28)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed 2018/848 Annex 2, Part II 1.9.6.3 Health Care of Bees (e)

Formic acid, lactic acid, acetic acid and oxalic acid as well as menthol, thymol, eucalyptol or camphor may 

be used in cases of infestation with Varroa destructor.”

OR 2021/1165 PART D Products referred to in Article 12(1) of this Regulation The following products or 

products containing the following active substances as listed in Annex VII to Regulation (EC) No 889/2008 

cannot be used as biocidal products: — caustic soda; — caustic potash; — oxalic acid

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

Organically Produced Foods (GL 32-1999)

Allowed for pest and disease control in beekeeping. (72, B. livestock & livestock products; page 17)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed for pest and disease control in beekeeping. (5.8.7, page 52 and Appendix 5: Substances for Pest 

and Disease Control and Disinfection in Livestock Housing and Equipment, page 83)

Japan Agricultural Standard (JAS) for Organic Production

Japan does not have apiculture standards and oxalic acid is not present on their list of approved materials.

Ancillary Substances

None identified.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 28 of 267
Human Health and Environmental Issues

Since it is an acid, it is considered hazardous in cases of skin contact, eye contact, ingestion, or inhalation. 

Handling instructions include use of protective equipment, such as long sleeves and pants, chemical 

resistant gloves, goggles, and a respirator. 

There are no concerns of environmental contamination during manufacture or disposal. The amount used 

for honeybees is fairly small and does not add to concentrations of greenhouse gases in the atmosphere, 

and it would not have widespread negative impacts due to its biodegradability. Misuse of higher-thanrecommended concentrations of oxalic acid could result in killing honeybees.

Discussion 

In prior Board discussions, it was debated whether apiculture materials should be reviewed and approved 

only after there are NOP apiculture standards. It was noted that the NOP currently allows for organic 

honeybee products to be sold with the USDA organic seal, and honeybee products are certified organic by 

numerous NOP accredited certifiers. At the time, all Livestock Subcommittee members supported the 

implementation of the 2010 NOSB recommendation for organic apiculture standards.

At the October 2018 NOSB meeting, the NOSB recommended to remove sucrose octanoate esters (SOEs) 

from the National List. At the time, SOEs were not available for use by beekeepers, since they were no 

longer EPA registered. In addition, SOEs were said to be ineffective for varroa mite control. AMS did not 

remove sucrose octanoate esters from the National List as recommended by NOSB at §§ 205.601(e)(10) and 

205.603(b)(11). Following the 2018 NOSB meeting, the EPA received product registrations for sucrose 

octanoate esters (in December 2020). Subsequent comments demonstrated that the market situation had 

changed since the 2018 NOSB recommendation, with recent product registrations and increased use of 

sucrose octanoate esters. Additionally, commenters noted this substance is not harmful to the environment 

and cited the lack of alternatives approved for organic use.

Beekeepers have expressed support for oxalic acid dihydrate in prior public comments noting some 

benefits over formic acid.

Oxalic acid dihydrate is consistent with the requirements of OFPA sec. 2118(c) (7 U.S.C. 6517(c)).

Questions to our Stakeholders

What factors are weighed when determining to use sucrose octanoate esters, formic acid, or oxalic acid 

dihydrate for varroa mite control?

 DL-methionine

Reference: § 205.603(d) As feed additives.

(1) DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog calcium 

(CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic poultry production at 

the following pounds of synthetic 100 percent methionine per ton of feed in the diet, maximum 

rates as averaged per ton of feed over the life of the flock: Laying chickens—2 pounds; broiler 

chickens—2.5 pounds; turkeys and all other poultry—3 pounds.

Technical Report: 2001 TAP; 2011 TR

Petition(s): 2005; 2007; 2009; 2011

Past NOSB Actions: 10/2001 NOSB recommendation; 03/2005 NOSB recommendation; 05/2008 NOSB 

recommendation; 04/2010 NOSB recommendation on Methionine annotation; 04/2010 NOSB 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 29 of 267
recommendation on Methionine step-down annotation after October 2012; 04/2010 sunset 

recommendation; 08/2014 Organic poultry feed proposal; 04/2015 NOSB Formal recommendation to

amend; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 FR 

66559); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Methionine is an essential amino acid for poultry since it cannot be produced biologically by the birds and is 

necessary for proper cell development for the growing chicks and for proper feathering. The USDA organic 

standards require that all agricultural ingredients for livestock feed be certified organic, and prohibit 

feeding meat by-products to organic poultry. This restriction narrows the options for natural sources of 

methionine. 

Manufacture

Methionine is a sulfur-containing amino acid. The 2011 Technical Report lists these various methods of 

manufacture:

L-methionine may be isolated from naturally-occurring sources, produced from genetically engineered 

organisms, or synthesized through many processes. While methionine has been produced by fermentation 

in the laboratory, racemic mixtures of D- and L-methionine (i.e., DL-methionine) are usually produced 

entirely by chemical methods (Araki and Ozeki, 1991) [2011 TR 238-240]. Most L-methionine is produced 

from synthetic DL- methionine, and DL-methionine can be produced in following ways:

• Reaction of acrolein with methyl mercaptan in the presence of a catalyst (Fong et al., 1981);

• Reaction of propylene, hydrogen sulfide, methane, and ammonia to make the intermediates acrolein, 

methylthiol, and hydrocyanic acid (DeGussa, 1995; 1996);

• Use of the Strecker synthesis method with α-methylthiopropionaldehyde as the aldehyde (Fong et 275 

al., 1981); or

• Reaction of 3-methylmercaptopropionaldehyde with ammonia, hydrogen cyanide, and carbon dioxide 

in the presence of water in three reaction steps (Geiger et al., 1998) [2011 TR 242-248].

In general, L-methionine is produced from DL-methionine via optical resolution resulting in separation into 

the D- and Lenantiomers (Ajinomoto Corporation, 2012) or by acetylation of synthetic DL-methionine and 

subsequent enzymatic selective deacetylation of the N-acetylated L-methionine (Usuda and Kurahashi, 

2010). Because much of the DL-methionine supply is synthesized using chemical methods, the L methionine 

produced from it is also synthetic. While nonsynthetic L-methionine can be produced by fermentation, 

there are no commercial sources available that use this method (Kumar and Gomes, 2005) [2011 TR 479-

480].

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed for use in feed, feed additives, and feed supplements. Organic sources, such as fishmeal, insect 

meal, brewer’s yeast, potato protein, corn gluten and distillers’ grains, shall be the first preference. When 

these organic sources does not meet amino acid requirements to produce a balanced feed, then:

a) amino acids derived from biological sources by biofermentation and extracted/isolated by 

hydrolysis, by physical, or other non-chemical means may be used;

b) when such forms of lysine and methionine are not commercially available for use in 

monogastrics feeding, all sources of lysine and methionine may be used.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 30 of 267
This annotation will be reviewed at the next revision of the standard. ( Table 5.2, Amino acids listing, 

CAN/CGSB-32.311-2020, page 23).

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

The European Economic Community (EEC) Council Regulations state that “growth promoters and synthetic 

amino acids shall not be used” in animal feed in organic production.

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM)

Not allowed. (3.2 Organic animal management does not use any of the following synthetic feed rations: 

amino acids (including isolates), page 16).

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Human Health and Environmental Issues

Synthetic methionine used as a nutritional supplement in livestock production can enter the environment 

through waste streams from its production, use, and disposal. Methionine has a relatively low vapor 

pressure, indicating that methionine present in soil or water is not likely to evaporate into air. Methionine 

is highly mobile in soil, and research has shown that most of the methionine in soil breaks down in about 16 

days. Methionine can exist as a vapor or particulate in the air. Airborne methionine vapor will be degraded 

in the atmosphere with a half-life of about 7.5 hours. Methionine is also found naturally in water from 

metabolism of proteins. The potential for bioconcentration of methionine in aquatic organisms is 

considered low due to its high water solubility [2011 TR 729-286].

Discussion 

The Livestock Subcommittee continues to see a need for synthetic DL-methionine in the organic poultry 

diet. The feeding of synthetic methionine to organic poultry has been a contentious practice over the years, 

with some stakeholders opposed to any synthetic feed component. In contrast, comments from organic 

producers at the last review tended to strongly support the use of synthetic methionine under the current 

annotation. Research and innovation on this issue continue, but in the meantime the inclusion of DLmethionine on the National List appears warranted.

Questions to our Stakeholders

1. Given supply disruptions of soybeans and soy products experienced by the organic livestock sector 

since February 2022, what organic crops other than soy could be incorporated into poultry rations 

to supply methionine?

2. Is there a need for changes to the USDA organic regulations to align with either Canadian 

(unrestricted amino acid are allowed in organic feed) and/or EU (non-organic feeds containing 

methionine are allowed) organic regulations? If so, what changes to the USDA organic regulatory 

text should be made?

3. What other nutritional barriers to organic poultry production do producers face when formulating 

well balanced rations for all poultry in the organic sector?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 31 of 267
4. Is the current restriction on methionine in organic poultry diets necessary? What would the impact 

be on poultry nutrition and feed formulations if methionine was allowed without any restrictions?

Trace minerals

Reference: § 205.603(d) As feed additives.

(2) Trace minerals, used for enrichment or fortification when FDA approved.

Technical Report: 2013 TR (aquatic trace minerals); 2019 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB recommendation; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 09/2014 subcommittee proposal - aquatic trace minerals; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Minerals are required in animal nutrition for their vital roles in various metabolic, enzymatic, and 

biochemical reactions in the animal body. Forages and grains are good sources of calcium and phosphorus, 

respectively. Minerals may be provided through the intake of plant matter feedstuffs and through synthetic 

supplements. Several factors directly or indirectly influence the levels of minerals in plants, including 

location, nature, and chemical composition of the soil; level of fertilization; and the presence of antinutritional factors that may reduce mineral bioavailability. Bioavailability is defined as the total proportion 

of the nutrient in a feedstuff that is available for use in normal body functions. As a result, the amounts of 

minerals for animals that depend on plants as feedstuffs will vary. 

The dietary importance of each micro-mineral will depend on the animal species in question. When diet is 

insufficient to meet an animal’s nutrient requirements, supplementation of minerals is typically done 

through inclusion in the diet either as an individual substance or as part of a trace mineral premix. NOP 

Guidance 5030 Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For Organic Livestock 

Feed spells out in more detail which minerals are covered under this listing. 

It should be noted that while it is beyond the scope of this sunset review to clarify which minerals are 

included in this listing, the Livestock Subcommittee acknowledges this listing also includes macro minerals. 

The 2019 TR addresses macro minerals that are included in animal diet, though not in great detail as they 

are outside the focus of trace minerals.

Manufacture

Because this is a broad categorical listing, manufacture varies. In most cases, biologically active forms of 

trace minerals cannot be obtained by mining, so many trace minerals used as feed additives are produced 

by chemical reactions resulting in inorganic forms of the mineral. More recently, organic forms have 

become available. This would include the various chelates and complex forms. One of the limiting factors to 

the use of chelated minerals has been high cost. At the time of the 2019 review, chelated minerals cost 10 

to 15 times more per milligram of mineral supplied, compared to inorganic sources. 

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Descriptions of the common processes used to manufacture many of the trace minerals in use are included 

in the 2019 TR. This level of detail is not provided for the class of substances called metal amino acid 

chelates since the processes used to manufacture those materials are largely the same.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed for use in feed, feed additives, and feed supplements. Unprocessed rock dusts; ground animal or 

plant material (other than blood or bone meal); and seawater are preferred sources. Chelated and 

sulphated forms are allowed. If none of these sources are commercially available, other versions are 

allowed, except for forms containing or produced with EDTA or EDDHA. (Table 5.2, CAN/CGSB-32.311-2020, 

page 24)

Non-synthetic chelated or sulphated minerals are allowed for use as a health care product and production 

aid. Examples include oyster shell, calcium chloride and magnesium oxide. Synthetic nutrient minerals may 

be used if non-synthetic sources are not commercially available. Minerals from any source are allowed for 

medical use. (Table 5.3, CAN/CGSB-32.311-2020, page 28)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed for use as feed or in feed production (Annex III, Part B, 3(b), 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Allowed when used in preference to veterinary drugs or antibiotics, needs to be recognized by the 

certification body or authority, and can only be used if they are of natural origin. In case of shortage of 

these substances, synthetic substances may be used. 

International Federation of Organic Agriculture Movements (IFOAM)

Allowed. Animals may be fed vitamins, trace elements, and supplements from natural sources unless they 

are not available in sufficient quantity and/or quality. 

Japan Agricultural Standard (JAS) for Organic Production

Allowed for therapeutic purposes and mineral supplementation.

Human Health and Environmental Issues

Based on information presented in the 2019 TR, the hazards associated with the use of the trace minerals 

are primarily associated with dust irritation of the skin and eyes. 

When used as petitioned, trace minerals from unconsumed feed have the potential to be transferred to 

ground or surface waters. While trace minerals are essential dietary components for animal feeds, some 

are considered heavy metals with strong toxic potential. When included in animal feeds above required 

amounts, trace elements accumulate in urine and feces in low concentrations. In many cases, these may 

serve to increase deficient soil levels. The environmental risks of overly high micronutrient applications 

include impairment of plant production, accumulation in edible animal products, and contamination of the 

water supply. Concerns regarding specific minerals are included in the 2019 TR.

Discussion 

The NOSB received comments during the previous review cycle from a wide representation of the organic 

community supporting the continued use of trace minerals, noting their essentiality to livestock health and 

welfare and their importance in offsetting seasonal variables in forage nutrition. 

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Some commenters noted organic production should not be dependent on synthetic nutrients and that the 

current annotation is not restrictive enough to prevent reliance on synthetic materials. These commenters 

recommend adding “when forage and available natural feeds are poor quality” to the annotation. 

However, according to the 2109 TR, forages alone do not satisfy the mineral requirements of grazing cattle. 

Mineral deficiencies and imbalances in grazing ruminants have been reported in almost all regions of the 

world. The choice of forage crop; the part of the plant consumed, and the plant’s state of maturity; the soil 

type and condition; and climatic conditions and seasons when plant material is eaten/gathered are all 

factors in determining the level and availability of trace minerals.

Questions to our Stakeholders

Are there effective non-synthetic alternatives to some or all synthetic trace mineral feed supplements?

Vitamins

Reference: § 205.603(d) As feed additives.

(3) Vitamins, used for enrichment or fortification when FDA approved.

Technical Report: 1995 TAP (Folic Acid); 2013 TR (aquaculture); 2015 TR; 2023 Limited Scope TR pending

Petition(s): 2012 (aquaculture)

Past NOSB Actions: 10/1995 NOSB recommendation; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

The National Organic Program (NOP) currently allows the use of vitamins as feed additives in organic 

livestock production under 7 CFR 205.603, “Synthetic Substances Allowed for Use in Organic Livestock 

Production” for enrichment or fortification when FDA approved. Section 205.237(b)(2) prohibits the use of 

feed supplements and additives in amounts above those needed for maintenance of adequate nutrition 

and health. Further, the USDA organic regulations require producers to meet certain standards for livestock 

health care practices. As part of this requirement, livestock feed rations must meet nutritional 

requirements, including vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and 

fiber (ruminants) (7 CFR 205.238(a)(2)). 

The addition of vitamins directly or indirectly into animal food falls under the regulatory oversight of the 

U.S. Food and Drug Administration (FDA). According to FDA regulations, the addition of vitamins must be 

used according to the relevant food additive regulation, unless the substance is generally recognized as safe 

(GRAS) under 21 CFR 582/584 for that use pattern (FDA, 2014a). 

Depending on the raw nutrients available, vitamins are combined in livestock feed rations of grains, beans, 

oilseeds, and other meals along with minerals and amino acids. There are 15 essential vitamins currently 

allowed for use in organic livestock production for fortification and enrichment: Vitamin A (vitamin A 

acetate), Vitamin B1 (thiamine hydrochloride), Vitamin B2 (riboflavin), Vitamin B3 (niacin, nicotinic acid), 

Vitamin B5 (calcium pantothenate), Vitamin B6 (pyridoxine hydrochloride), Vitamin B7 (biotin), Vitamin B12 

(cyanocobalamin), Vitamin C (ascorbic acid), Choline chloride, Vitamin D3 (cholecalciferol), Vitamin E (αNational Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 34 of 267
Tocopherol acetate), and Inositol. The scope of vitamin compounds is reflective of vitamins defined as 

“required nutrients” by the National Research Council’s (NRC’s) Nutrient Requirements for cattle, sheep, 

swine and poultry. Dietary intake of these essential vitamins is essential for the health and well- being of all 

animals, including livestock. Most vitamins aid in the metabolism of proteins, carbohydrates, and fats while 

some vitamin compounds have important antioxidant properties. Common signs of vitamin deficiency 

include anorexia, poor growth, reduced feeding efficiency and, in some cases, mortality. 

Manufacture

Individual vitamin compounds are normally produced on an industrial scale by chemical synthesis or partial 

synthesis. While chemical synthesis remains the dominant industrial production method for many vitamins, 

an increasing number of fermentation processes are being developed for vitamin production. Many 

recently developed fermentation methods for manufacturing vitamins utilize genetically engineered 

microorganisms, generating concerns over the use of these vitamin sources in organic food production. The 

Technical Review conducted in 2015 stated that fermentation production using genetic modification may 

be commonly used in production of vitamins A, B2, B5, B6, C, E, and B12. 

In response to the TR information, NOP published NOP 5030 “Guidance Evaluating Allowed Ingredients and 

Sources of Vitamins and Minerals For Organic Livestock Feed” which instructs certifiers regarding the 

review of vitamins in livestock feed. Specific to excluded methods in vitamins, NOP 5030-1 (Response to 

comments) states, "The USDA organic regulations also prohibit use of excluded methods at § 205.105(e), 

and thus vitamins used in livestock feed should be reviewed for excluded methods." 

The Livestock Subcommittee has requested a limited-scope technical report, which was not received in 

time to be incorporated into this review. The TR was requested to update which vitamins are produced 

with excluded methods, and to determine the availability of other sources. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Biological and mineral sources of all vitamins are allowed. Non-biological and non-mineral sources of 

vitamins B1, C (ascorbic acid) and E are allowed. (Table 4.2, CAN/CGSB-32.311-2020, page 21)

Allowed in feed, feed additives, and feed supplements as a concentrated mixture of minerals and vitamins, 

from organic sources if commercially available. Allowed for enrichment or fortification. Vitamin formulants 

that comply with Canadian regulations are accepted. Vitamins not compliant to 5.1.2 of CAN/CGSB-32.311

are allowed. (Table 5.2, Pre-mixes listing, CAN/CGSB-32.311-2020, page 25)

Allowed for use as a health care product and production aid. Vitamin formulants that comply with Canadian 

regulations are accepted. Vitamins not compliant to 5.1.2 of this standard are allowed. Orally, topically, or 

by injection. (Table 5.3, CAN/CGSB-32.311-2020, page 29)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Vitamins, pro-vitamins and chemically well-defined substances having similar effect allowed; agricultural 

derivatives preferred (Annex III, Part B, 3(a), 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Vitamins or provitamins are allowed if they are of natural origin. In case of shortage of these substances or 

in exceptional circumstances, synthetics may be used. (page 13)

International Federation of Organic Agriculture Movements (IFOAM)

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Allowed from natural sources unless they are not available in sufficient quantity and/or quality. (3.2-page 

16; 5.5.6-page 48)

Japan Agricultural Standard (JAS) for Organic Production

Allowed for therapeutic purposes.

Human Health and Environmental Issues

In addition to being essential nutrients, vitamins are generally considered non-toxic and safe for livestock 

and human consumption at levels typically ingested through the diet and dietary supplements. When given 

according to label directions, supplementation of animal feeds with vitamins is unlikely to result in 

excessive vitamin intake for humans. 

No studies have been found indicating toxic effects of vitamins on soil-dwelling organisms. Strong acids and 

bases are used in the synthetic or extraction process of vitamin compounds. Improper use or disposal of 

these chemicals during the production of vitamins could affect both the pH and chemical composition of 

the soil, potentially resulting in physiological effects on soil organisms. Accidental release of chemical 

reagents during the production process may lead to ecological impairment. 

Discussion 

Public Comments During the Spring 2019 NOSB review the Livestock Subcommittee received limited 

comments on retaining vitamins at §205.603. The comments that were received were overwhelmingly in 

favor of relisting vitamins at §205.603(d)(3), with many of the commenters stating that the addition of 

vitamins to the livestock diet was essential for the health and well-being of the animal. One stakeholder 

questioned whether B vitamins are essential, especially in ruminants.

The LS discussed the possible increase in use of GMO fermentation for production of vitamins and would 

like stakeholder input in addition to information in the forthcoming TR.

Questions to our Stakeholders

1. What are common uses of vitamin B and K feed supplements? Are they necessary for good 

ruminant health?

2. How common are livestock vitamin products that are produced with excluded methods?

3. Are there methods to detect livestock vitamin products produced using excluded methods?

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