National Organic Standards Board | October 2021 | Proposals & Discussion Documents 

National Organic Standards Board Meeting 

October 13 & 14 (Comment webinars), and October 19 - 21, 2021 (NOSB meeting) 

SUBCOMMITTEE/DOCUMENT PAGE 

Compliance, Accreditation, & Certification Subcommittee (CACS) 

Proposal: Letter to Secretary re: Climate Change initiatives 1 

Discussion Document: Oversight improvements to deter fraud: Modernization of 7 

organic traceability infrastructure 

Crops Subcommittee (CS) 

Proposal: Chitosan - plant disease control - petitioned 13 

Proposal: Biochar - petitioned 17 

Proposal: Ammonia Extract - petitioned 23 

Proposal: Kasugamycin - petitioned 49 

Proposal: Hydronium - petitioned 55 

Proposal: Carbon Dioxide - petitioned 59 

Proposal: Lithothamnion 63 

Proposal: Biodegradable biobased mulch film annotation change 67 

Proposal: Sodium nitrate - petitioned by NOSB 73 

2023 Crops Sunset Reviews: §205.601 & §205.602 75 

Handling Subcommittee (HS) 

Proposal: Zein - petitioned 105 

Proposal: Fish oil annotation 111 

2023 Handling Sunset Reviews: §205.605 & §205.606 117 

Livestock Subcommittee (LS) 

2023 Livestock Sunset Reviews: §205.603 155 

Materials Subcommittee (MS) 

Proposal: Research Priorities 2021 181 

Discussion Document: Excluded Methods Fall 2021 193 

Policy Development Subcommittee (PDS) 

Discussion Document: Public comment process 201 

PLEASE NOTE: 

Discussion documents, proposals, reports and/or other documents prepared by the National Organic 

Standards Board, including its subcommittees and task forces, represent the views of the National Organic 

Standards Board and do not necessarily represent the views and policies of the Department of Agriculture. 

Please see the NOP website for official NOP policy, regulations, guidance and instructions. 

TOC 1 

 

 

 

 

 

 

 

 

 

 

 

National Organic Standards Board 

Compliance, Accreditation, and Certification Subcommittee (CACS) 

Proposal - Letter to Secretary Vilsack regarding USDA Climate Change Initiatives 

August 10, 2021 

Secretary of Agriculture 

US Department of Agriculture 

Washington, DC 20250 

Subject: USDA Climate Change Initiatives 

Dear Secretary Vilsack, 

The climate focus of USDA is an encouraging step forward for the U.S., as scientific research provides 

evidence for the ability of agriculture to help mitigate climate change. As members of the National 

Organic Standards Board, the federal advisory committee to the National Organic Program, and our 

stakeholders who commented on this document during the October 2021 public meeting, we want you 

to know that we are wholly supportive of USDA engaging agriculture as a tool for mitigating climate 

change. 

Organic farming systems have significant potential to contribute to climate change solutions through 

both avenues, by emitting fewer GHGs and carbon sequestration by healthy soils under organic 

management. The 90 Day Progress report, dated May 2021, fails to mention the potential contributions 

to climate change mitigation that certified organic production systems may offer. We believe this is a 

grave omission that USDA needs to rectify as concrete plans for the department’s climate change 

strategies are developed. Furthermore, the National Organic Program is already well established at 

USDA. Rather than reinventing the wheel, we urge USDA to leverage organic agriculture as the 

department moves forward to incorporate climate smart strategies into U.S. agriculture. 

The extant body of research provides strong support that organic farming systems emit lower levels of 

GHG. Organic agriculture does not rely on synthetic inputs,1 and when paired with good organic farming 

practices, an organic farm emits fewer GHGs. Concerns have been raised that, since organic field crop 

yields are below those of conventional crop yields, the net GHG ‘footprint’ per unit production may not 

be lower than that of conventional farming (Lee et al., 2015; McGee, 2015). That said, some of the 

farmers on the NOSB report achieving yields equivalent to those realized on conventional farms, 

indicating that yield differentials are crop and location specific. Research supports the experience of the 

NOSB farmers, and finds that an overall reduction in GHG emissions, due to the widespread adoption of 

organic farming systems, is possible (Muller et al., 2017; Skinner et al., 2019; Squalli and Adamkiewicz, 

2018). 

While soils under organic management have more soil organic matter, there are numerous problems 

that make it difficult to definitively tie the higher soil organic matter to increased carbon sequestration. 

These challenges are related to measurement, testing, and understanding which types of soil organic 

1 Synthetic inputs are disallowed unless included on the National List; environmental impact is one factor 

considered prior to the inclusion of a synthetic input. Note that the majority of inputs used on a certified organic 

farm are non-synthetic. 

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carbon are best able to sequester carbon (OFRF, 2018). Other obstacles identified include the lengthy 

time period required to build soil organic carbon, the reduced yields of some organic systems,2 and lack 

of technical assistance for organic farming systems in many areas of the country. We encourage 

additional research on this important topic. 

Nevertheless, research finding that organic farms produce fewer GHG emissions, coupled with the 

research showing that regenerative organic practices build soil carbon, should lead USDA to emphasize 

organic as a climate mitigation centerpiece as research continues. Organic farms start from the vantage 

of having higher soil organic carbon, as research has consistently shown, suggesting that there is 

potential for these farms to contribute to climate change mitigation. We believe that USDA should 

support research and other efforts to improve our understanding of the potential contribution of 

organic farming systems to climate change mitigation. 

Furthermore, the higher levels of soil organic matter allow farmers to better cope with the extreme 

weather associated with climate change (Bellprat et al. 2019). Soil under organic management offers 

benefits such as higher water holding capacity, more filtration, and less erosion, which helps ensures a 

food supply amongst increasingly irregular drought and flooding conditions. Recent research is helping 

to narrow down which organic practices are better at promoting soil health (Tully and McAskill 2019). 

We have direct responses to several points made in the 90 Day Progress Report: 

● Support new and better markets (page 9): The organic market is already thriving, with organic 

food retail sales exceeding $56 billion in 2020 as reported by OTA. Prioritizing transition-toorganic market development is strongly encouraged to continue to remove barriers for 

producers choosing to convert to organic production. Overall, a greater reliance on certified 

organic products in the climate smart strategy would solve the ‘finding a market’ for 

environmentally friendly food and agricultural products, and investing federal funds into further 

developing the domestic organic market is likely to have a sizeable impact. 

● Education and technical assistance (page 8): There is just one extension agent in the US who 

works exclusively with organic producers. Increasing the number of trained organic extension 

agents, housed at land grant universities, would provide producers with important technical 

assistance and education. Better technical assistance would help organic producers manage 

their risk and help farmers identify best organic farming practices. 

● Leverage existing USDA programs to support CSAF strategies (page 6): Prioritize updating Risk 

Management Agency (RMA) programs, including adjusting actuarial data for transition and 

organic t-yields. Additionally, adjust RMA programs by allowing innovative production practices 

to be eligible for risk management insurance for those in transition, certified organic, and other 

climate-smart producers. All organic farmers, including those newly certified, need equal access 

to federally subsidized crop insurance and other incentives, on the same scale and scope as 

those available to non-organic farmers. 

● Strengthen the role of USDA climate hubs (page 8): Each USDA climate hub should have at least 

one researcher with organic production as a key part of their research portfolio. 

● Increased research Comment 1 (page 13): More research is needed to understand the organicconventional yield gap, by crop and by location. For some crops in some locations, the gap is 

nonexistent or minimal, and for others it is larger. This key area has not been adequately 

examined. Additional investment in the NASS/ERS data collection of the Agricultural Resource 

2 Depending on crop, yields may be lower on organic farms, whereas for other crops, yields are 

equivalent to those obtained via conventional production. 

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Management Survey for more complete coverage of organic crops is a great way to leverage and 

enhance existing USDA resources. 

● Increased research Comment 2 (page 13): Closing any existing organic-conventional yield gap is 

an important component of reducing GHG emissions of organic systems, particularly when 

measured in terms of pound or kilo of product grown. Historically, the US lacks a sufficient 

investment in organic agricultural research and into crop cultivars well-adapted to climatefriendly organic production systems (Hultengren et al., 2016; Ponisio et al, 2014). Thus, we 

suggest developing specific seed varieties for organic crops, improving organic farm weed 

mitigation through technology, no-till/ minimum till practices, cover cropping and other 

innovations specifically targeting organic systems can close the organic-conventional yield gap 

and reduce input dependency, leaving organic systems as better climate mitigators. This work 

should be done by ARS scientists and university researchers (through NIFA funding). 

● Supporting research and data collection (page 4): We encourage USDA to invest in data 

collection on soil organic matter and its ability to sequester carbon. The data collection needs to 

take place over long time periods, to see how carbon sequestration changes as soil health 

improves. Additionally, research identifying ‘early indicators’ of soil health would allow organic 

farmers to understand whether their soil is on an optimal trajectory for building soil health. 

Sites for this type of research are the existing long term cropping system trials and working 

organic farms. At least some of the data collected should be from farms at the beginning of the 

transition period. 

● Integrate climate smart strategies into existing conservation programs (page 9): expanding 

access of organic farmers (an existing USDA program) for conservation programs would better 

support the economic health of organic farms. 

● Transition payments, which would provide support to farmers during the critical transition 

period when risks are high, yields and revenues typically decline, would help farmers adopt 

organic farming systems. However, these payments should go to farmers who are transitioning 

into sectors that are able to support a greater number of operations, as economic viability is a 

critical aspect to a healthy organic farming sector. Any federal support via a transition payment 

should be attached to a requirement that the newly transitioned farms obtain organic 

certification. 

● At the same time, as mentioned on page (6), early adopters of organic systems need to be 

recognized. Allow eligibility for early adopters to have access to current offerings such as RCCP, 

EQIP, and other programs that are available to encourage continued deployment of these 

practices on organic farms. 

The Organic Foods Production Act (OFPA), 7 U.S.C. §§ 6501-6522, requires that organic farmers select 

and implement tillage and cultivation practices that maintain or improve the physical, chemical, and 

biological condition of soil and minimize soil erosion. Furthermore, OFPA requires that organic farmers 

Maintain or improve soil organic matter content. In other words, OFPA codifies regenerative agriculture 

through the requirements it places on organic farmers to build and maintain soil health. 

OFPA further requires investment in soil health on organic farms, which supports climate change 

mitigation: An organic plan shall contain provisions designed to foster soil fertility, primarily through the 

management of the organic content of the soil through proper tillage, crop rotation, and manuring. 

(OFPA §6513(b)(1)). 

In closing, we stress the importance of explicitly including organic production systems in the climatesmart strategy of the department. We urge you to portray organic farmers and ranchers as models for 

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climate responsible producers. Then, as the rest of the US agricultural sector moves towards adopting 

climate-mitigation practices, they can rely on the example of the organic agriculture sector, which is 

both economically viable and climate friendly in its farming practices. 

We would be happy to talk with you or any of your representatives about this important issue. 

Best regards, 

National Organic Standards Board 

Steve Ela, Chair Kim Huseman 

Sue Baird Mindee Jeffery 

Asa Bradman Nate Powell-Palm 

Jerry D’Amore Wood Turner 

Rick Greenwood Kyla Smith 

Amy Bruch Carolyn Dimitri 

Brian Caldwell Logan Petrey 

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References 

Bellprat, O., Guemas, V., Doblas-Reyes, F. and Donat, M.G., 2019. Towards reliable extreme weather and 

climate event attribution. Nature communications, 10(1), pp.1-7. 

Di Sacco, A., Hardwick, K.A., Blakesley, D., Brancalion, P.H., Breman, E., Cecilio Rebola, L., Chomba, S., 

Dixon, K., Elliott, S., Ruyonga, G. and Shaw, K., 2021. Ten golden rules for reforestation to optimize 

carbon sequestration, biodiversity recovery and livelihood benefits. Global Change Biology, 27(7), 

pp.1328-1348. 

Hayek, M.N., Harwatt, H., Ripple, W.J. and Mueller, N.D., 2021. The carbon opportunity cost of animalsourced food production on land. Nature Sustainability, 4(1), pp.21-24. 

IPCC, 2014: Climate Change 2014: Synthesis Report. Contribution of Working Groups I, II and III to the 

Fifth Assessment Report of the Intergovernmental Panel on Climate Change [Core Writing Team, R.K. 

Pachauri and L.A. Meyer (eds.)]. IPCC, Geneva, Switzerland, 151 pp. 

Lee, K.S., Y. C. Choe, and S. H. Park. 2015. Measuring the environmental effects of organic farming: a 

meta-analysis of structural variables in empirical research. J. Environ. Manag. 162, 263–274. 

McGee, J.A., 2015. Does certified organic farming reduce greenhouse gas emissions from agricultural 

production? Agric. Hum. Values 32, 255–263. 

Muller, A., Schader, C., Scialabba, N.E.H., Brüggemann, J., Isensee, A., Erb, K.H., Smith, P., Klocke, P., 

Leiber, F., Stolze, M. and Niggli, U., 2017. Strategies for feeding the world more sustainably with organic 

agriculture. Nature communications, 8(1), pp.1-13. 

Organic Farming Research Foundation. 2018. Organic Practices for Climate Mitigation, Adaptation, and 

Carbon Sequestration. Santa Cruz, CA. 

Skinner, C., Gattinger, A., Krauss, M., Krause, H.M., Mayer, J., Van Der Heijden, M.G. and Mäder, P., 

2019. The impact of long-term organic farming on soil-derived greenhouse gas emissions. Scientific 

reports, 9(1), pp.1-10. 

Squalli, J. and Adamkiewicz, G., 2018. Organic farming and greenhouse gas emissions: A longitudinal US 

state-level study. Journal of Cleaner Production, 192, pp.30-42. 

Yang, Y., Tilman, D., Furey, G. and Lehman, C., 2019. Soil carbon sequestration accelerated by restoration 

of grassland biodiversity. Nature communications, 10(1), pp.1-7. 

Tully, K.L. and McAskill, C., 2020. Promoting soil health in organically managed systems: a 

review. Organic Agriculture, 10(3), pp.339-358. 

Motion to accept the proposal on the letter to the Secretary re: climate change initiatives 

Motion by: Nate Powell-Palm 

Seconded by: Kyla Smith 

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Nate Powell-Palm, CAC Subcommittee Chair, to transmit to NOP August 10, 2021. 

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National Organic Standards Board 

Compliance, Accreditation & Certification Subcommittee (CACS) 

Oversight Improvements to Deter Fraud: 

Modernization of Organic Supply Chain Traceability Discussion Document 

August 13, 2021 

Background: 

This discussion document aims to build on two related topics: Strengthening Organic Enforcement (SOE) 

(proposed rule) and Human Capital, by seeking input from the organic community on modernizing 

supply chain traceability to best match the size and scale of today’s industry and future needs. While 

the pending SOE rule pulls the industry forward in many ways, the Compliance, Accreditation & 

Certification Subcommittee (CACS) is suggesting additional tools such as an electronic organic link 

system (OLS), which could capture business-to-business sales providing continuity across the supply 

chain. 

The Organic program is a fully traceable food system. When operating at its full potential, products are 

traceable through the supply chain back to the fields in which the ingredients were grown. It’s 

commendable that stakeholders from across organic sectors were able to collaborate to develop such a 

robust system. The CACS is seeking stakeholder input as it considers the next steps in modernizing the 

system. 

In 2021, the organic industry exceeded $60 billion in sales. While technology has drastically improved 

since the implementation of OFPA the organic community must acknowledge that the original 

infrastructure used to track fraud and provide transparency needs to be updated based on today’s 

standards and available technology. 

Human Capital and Data Management in Organics: 

Inspectors and certifiers do an incredible job maintaining a system using the tools they have. Organic 

operations undergo annual inspections, and at every annual inspection, organic inspectors test the 

integrity and traceability of an operation’s record-keeping system by conducting a trace-back and mass 

balance audit. This process ultimately tests record-keeping to see if all products are fully traceable and 

to confirm there’s no evidence of product substitution (conventional for organic). However, this 

traceability system and the tools inspectors and producers use to verify records and test integrity can be 

significantly improved with current technological systems. 

The decentralized, opt-in system that has sustained the inspection process so far and offered 

exceptional (for the food industry) transparency is impaired by its decentralization and lack of industrywide consistency. How one operation proves its system integrity versus another makes the inspection 

process inconsistent and reliant on the inspector’s information on the day of inspection. 

Currently, there is not a centralized database to track business-to-business sales and purchases. Also, 

lack of mandatory reporting to a central database, i.e., the Organic Integrity Database, restricts the 

ability to glean large, supply chain-wide insights into potential fraud in the organic system. If each 

business-to-business purchase of ingredients or sales of organic products were recorded and reported to 

a central database, instances of fraud could be easily identified and addressed. Inspectors would have a 

way to cross check and reconcile data on both sides of a transaction. In other words, inspectors don’t 

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have a tool to check that information reported to them by one operation reconciles with that 

operation’s customers or suppliers. 

To address this, the CACS would like to explore the “organic link” concept, a data point, which would 

show the date, NOP number, lot number, growing year, and quantity of organic goods processed 

through business-to-business sales. 

SOE Defines Four Integral Concepts Providing Guidance for Improvements: 

1. Organic integrity: The unique attributes that make a product organic and define its status as 

organic. A product that fully complies with the USDA organic regulations has integrity, and its 

organic qualities have not been compromised. 

2. Organic fraud: Intentional deception for illicit economic gain, where non-organic products are 

labeled, sold, or represented as organic. This may include substitutions or deliberate mislabeling, 

falsified records, and/or false statements in applications or organic system plans or during 

inspections, investigations, and audits. (Proposed added term 205.2) 

3. Audit trail: Documentation that is sufficient to determine the source, transfer of ownership, and 

transportation of any agricultural product labeled as “100 percent organic,” the organic ingredients 

of any agricultural product labeled as “organic” or “made with organic (specified ingredients)” or the 

organic ingredients of any agricultural product containing less than 70 percent organic ingredients 

identified as organic in an ingredients statement (7 CFR 205.2). 

4. Supply chain traceability: The ability to identify and track a product (including its location, history, 

and organic nature) along its entire supply chain, from source to consumption and/or “backward” 

from consumption to the source. A supply chain audit assesses supply chain traceability for specific 

products, verifying whether records show all movement, transactions, custody, and activities 

involving the products. 

The Strengthening Organic Enforcement proposed rule presents a significant step forward for the 

industry. By requiring brokers and previously exempt handlers to seek certification, SOE closes 

significant loopholes for fraud while improving overall system integrity. However, with considerable 

progress comes the need for comparably powerful tools. The CACS is exploring resiliency of the tools at 

hand. 

Continuous Improvement Exists for Supply Chain Traceability: 

The proposed SOE guidelines for improvements are helpful. However, the standard tools that certifiers, 

inspectors, and the organic community need to improve supply chain traceability are undefined. The 

SOE proposed rule challenges the organic community to answer the call for continuous improvement 

post-rule implementation. 

Increased inspections and certifications for brokers and previously exempt handlers within the organic 

supply chain will undoubtedly enhance the system’s integrity. Still, suppose these inspections, and all 

inspections, continue to occur in isolation. In that case, the increased surveillance is left impeded by the 

inability to glean deeper insights forwards and backwards throughout the supply chain. 

Many technologies exist to assist in the process. Electronic systems, digital ledger technology (DLT), 

blockchain, etc., are being tested or leveraged commercially in the food and agriculture industry. The 

current form of the proposed SOE rule points to technology as playing an essential role in entire supply 

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chain traceability, fully verifiable organic products, and near-instantaneous tracking at the item level in 

complex supply chains. Technology will ultimately enhance and support the enforcement of OFPA 

requirements. 

Organic Link System (OLS): 

To further build upon the SOE proposed rule, and import certificates, which are a requirement of the 

SOE proposed rule, the CACS is exploring ways to address the need for additional granularity to verify all 

sales at a field level and throughout the supply chain. -There can be many landing spots for shelf-stable 

products like grain, including warehouses, ports, handlers, etc., leading to higher risks of co-mingling or 

contamination that require additional verification. Therefore, the CACS is suggesting an organic link 

system (OLS), which could provide an extra level of granularity. 

OLS is best defined as an electronic tool that captures registered business-to-business transactions, 

providing continuity in verification and traceability across the supply chain. OLS could provide a bidirectional look back by certifiers and inspectors involved across the different product exchanges and 

could prevent sales duplication of a specific parcel or co-mingling organic and non-organic products. 

OLS Implementation and SOE Compatibility: 

OLS implementation requires that business-to-business transactions be electronically recorded into a 

centralized database. Specific data to be captured would include the date, NOP certificate number 

(found on the SOE standardized certificate), year product was grown, the quantity of organic goods 

exchanged, etc. This critical data would be recorded by businesses (handlers, brokers, importers, etc.) 

involved in the transactions within the organic supply chain. The information would be accessible to 

certifiers and inspectors through a variety of different permission levels. 

An organic link system allows certifiers and inspectors to conduct bi-directional traceability along the 

supply chain (source to consumer) more effectively and efficiently. As quoted in the current SOE 

proposed rule, “We (AMS) anticipate that electronic tracking technologies will allow AMS to achieve its 

goal of complete supply chain traceability and foresee incorporation of electronic tracking systems into 

future enforcement strategies.” 

Through leveraging the OLS, the amendment put forth in the SOE stating, “Certifying agents must share 

information with other certifying agents to verify supply chains and conduct investigations (§ 205.501

and § 205.504)” can more easily be accomplished.

Without an OLS, it will be challenging to execute SOE’s requirement for “certifying agents to create 

fraud prevention procedures to identify high-risk operations, conduct risk-based unannounced 

inspections, supply chain trace-back and mass-balance audits, and share information with other 

certifying agents to verify supply chains and conduct investigations.” 

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Barriers and Solutions for OLS Integration: 

In looking at an electronic organic link system (OLS), the organic stakeholder community must identify 

and help solve barriers that exist or could exist for future technology integration. Three known barriers 

are as follows: 

1. Inadequate access to technology and connectivity: 

Solutions to consider: Accessibility to technology and connectivity doesn't have to become a limiting 

factor. Specifically, the NOSB recognizes the need to not burden organic farmers, certifiers, or inspectors 

with additional paperwork. Therefore, the first documented exchange occurs at the point-of-sale from a 

farmer to their buyer and then each step following. Handlers, brokers, importers, and others involved in 

business-to-business exchanges will bear the recording responsibilities. Re-positioning the initial point of 

data capture to the first transaction will provide valuable information for a two-sided look back through 

the various business-to-business transactions in a complex supply chain. 

Since an organic link system is a business-to-business look-back system, producers who sell directly to 

consumers (i.e., CSA’s, direct meat sales, and farmer/processors packaging their goods for sale to 

customers) would be exempt from this system. 

Organic Link System Illustration Example: 

1) Handler to Farmer 2) Handler to Importer 3) Importer to Handler 

4) Importer to End User 5) End User to Importer 

Despite the potential of having various certifiers and inspectors for each of the entities listed below, an 

organic link system can provide comprehensive verification. 

2. The expense of implementing an electronic system: 

Solutions to consider: The USDA's Organic Integrity database (INTEGRITY) was designed with expansion 

in mind and will become an even more critical clearinghouse of industry-wide data with the future 

implementation of the SOE proposed rule. As stated in the SOE, "certifying agents to issue standardized 

certificates of organic operation generated from INTEGRITY and to keep accurate and current certified 

operation data in INTEGRITY. This would require an initial upload of mandatory data for each operation 

and maintenance, at lease annually, to ensure that data in INTEGRITY are current and accurate.” 

Therefore, standard operating procedures are being implemented and point to further use of 

technology. Adding additional reporting capabilities to capture transactional level exchanges is the next 

phase. 

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3. Human Capital: 

Solutions to consider: Public comments at the Spring 2021 NOSB meeting highlighted concerns that 

certifiers believe organic systems are continuously becoming more complex. In addition to increased 

numbers of certifications and inspections across the supply chain, the SOE proposed rule states “to 

facilitate trace-back audits, investigations, and verification, AMS proposes amending the organic 

regulations to clarify that certifying agents must share information with one another for the purposes of 

certification and enforcement.” 

Further developing electronic tools and centralized electronic reporting will aid in enforcement and 

oversight through more efficiency, not less. The SOE proposed rule captures this sentiment stating, 

"Standardization will simplify the verification of valid organic certificates and import certificates. It will 

also reduce reporting, by eliminating the need to provide notices of approval or denial of certification 

and annual lists of certified operations to USDA." 

Without an organic link system or a similar system, a one-way look back is achievable, however, 

complete supply chain traceability is extremely difficult. With an OLS, dual-process verification of 

complex supply chains involving multiple certifiers and inspectors can be a reality through leveraging 

universally recognized certified NOP numbers and other vital data. This data would be available for 

inspectors to use as an audit framework when conducting inspections on site. 

Summary: 

Technology integration to further modernize the organic verification and traceability system is 

fundamental. Creating a system to report transactional data to a centralized database would provide 

the most significant insights for preventing fraud. The industry can then operate in a pre-competitive 

space to create a uniform system under which all operations, foreign and domestic, will perform. 

Therefore, transitioning our current system from process-driven certification to data-driven certification 

with electronic verification is imperative. Integrating technology to identify fraud in the supply chain 

quickly is essential, ultimately ensuring a level playing field between all producers, foreign and domestic. 

Formalizing technology integration for complete supply chain traceability within the organic system 

could be incorporated into the 2023 Farm Bill. Technologically driven organic supply chain traceability 

insures an even playing field. It supports organic growers who are investing in climate-smart farming 

practices and supports developing rural America. 

As discussed in this document, it is imperative to continuously improve and modernize transparency in a 

post-SOE implementation world. Barriers always exist for continuous improvement, but with the 

collective participation of the stakeholder community, we can ensure integrity by modernizing organic 

supply chain traceability through technology integration. 

The NOSB calls on the organic community to share best practices and ideas regarding the most 

appropriate and innovative technologies that can be leveraged to execute the aims of an organic link 

system. 

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Questions for Stakeholders: 

1. How can technology efficiently and effectively be deployed to enhance supply chain traceability? 

2. What form does an organic link system (OLS) must take to be non-burdensome for organic 

stakeholders, including certifiers, inspectors, handlers, operations, importers, etc.? 

3. What challenges exist with the implementation of an organic link system (OLS)? 

4. Is there value in AMS, certifiers, and inspectors getting more granular with transaction-level 

detail to gain transparency throughout the complex supply chain? 

5. What other methods exist for enhancing transparency? 

6. Are there additional areas that need to be considered for improvement to prevent fraud or 

react to fraud? 

7. Should the industry require the registration of land 36 months before certification? 

Note: The USDA Risk Management Agency (RMA) currently tracks the organic status of the land when 

transitional land is insured. RMA also requires a registered plan on transitional acres. Domestic and 

International operations reporting the last restricted use pesticide data for land could stabilize markets 

and allow for enhanced risk assessments simply by knowing what is coming down the pipeline. 

Vote in Subcommittee 

Motion to accept the discussion document on oversight improvements to deter fraud: Modernization of 

Organic Supply Chain Traceability 

Motion By: Amy Bruch 

Seconded By: Nate Powell-Palm 

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Nate Powell-Palm, Subcommittee Chair, to transmit to NOSB, August 13, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Chitosan for Plant Disease Control 

June 1, 2021 

Summary of Petition: 

Chitosan has been petitioned for use in organic crop production for addition to the National List at 

§205.601(j)(4) for plant disease control. The NOSB requested a technical review (TR) of chitosan since 

the last one was from 2004 when there was a petition for its use as an adhesive adjuvant. Much of the 

material in the current analysis comes from the TR received by the NOP in July 2020. Chitosan is a 

copolymer composed of two different chemical subunits that repeat in particular order: glucoseamine 

and N-acetyleglucosamine. It is derived from chitin which is structurally similar to cellulose. The 

petitioner stated that chitosan is an alternative to sulfur-based pesticides, which can be phytotoxic to 

plants. The petitioner bases the request on chitosan's antimicrobial properties as well as its role in plant 

defense signaling pathways. 

Most commercial chitin, from which chitosan is derived, is produced from shrimp, prawn, and crab 

waste. Chitin forms structures that strengthen cell walls, insect skeletons, crustacean shells, and internal 

mollusk body parts. The manufacture of chitosan uses relatively large amounts of corrosive chemicals, 

notably sodium hydroxide and hydrochloric acid. That said, relatively little chitosan is produced. Only 

2000 metric tons of chitosan are produced each year while 70 million tons of sodium hydroxide are 

produced for use in all types of industrial processes. In contrast to the chemicals used to isolate and 

synthesize the material, chitosan is produced from chitin, a food related marine biowaste and is thus, 

part of a recycling process. However, as part of an industry that requires the use of sodium hydroxide 

and hydrochloric acid, considerable energy is consumed producing these products with concomitant 

production of chlorine gas, carbon dioxide, carbon monoxide, freon and mercury. 

Chitosan has a variety of potential uses. It is a registered pesticide (OPP No. 128930) that is used in crop 

production as a plant growth enhancer and plant defense booster (EPA 2003). Chitosan is applied to 

treat field crops, ornamentals, turf, home gardens, and nurseries. It is also listed as an animal feed 

component in the Official Publication of the Association of Animal Feed Control Officials. The State of 

Oregon has approved the use of chitosan in unrestricted amounts as a soil amendment (fertilizer). 

Chitosan was recommended to be added to the National List in 2005 as an adjuvant although it was 

already present on EPA List 4, and therefore would have been redundant. Chitosan also has a variety of 

other uses that include as a flocculant allowed for precipitating proteins during animal food production, 

a plant growth regulator in or on wheat, and as a seed treatment for specific crops. The FDA also allows 

chitosan produced from the fungus Aspergillus niger as a secondary direct food ingredient in alcoholic 

beverages. 

Chitosan is not toxic as demonstrated in acute toxicity studies in mice, rats and rabbits and is naturally 

occurring in the environment in large concentrations. EPA exempted chitosan from the requirement for 

a tolerance limit due to its low toxicity and abundance in the environment. As mentioned in the 

summary above, EPA states that chitosan is not expected to harm people, pets, wildlife, or the 

environment when used according to label direction. 

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Summary of Review: 

A survey of regulations for organic production from a number of countries and international 

organizations indicates that chitosan is not included within the Canadian Organic standards as an 

allowed material. CODEX Alimentarius does not include chitosan within the Codes guidelines. European 

Economic Community (EEC) Council Regulation shows that chitosan hydrochloride is allowed for pest 

and disease management under European Union organic regulations but may not be used as an 

herbicide. 

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or X Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

The petition describes the process of producing chitosan from chitin as proprietary so the exact 

process they use is unknown. Generally, however, chitosan is produced from chitin by using 

dilute sodium hydroxide to separate and extract chitin from shells or acids for demineralization, 

but a more concentrated solution is required to effectively deacetylate chitin to form chitosan at 

a range of 40 to 60% concentration. Chitin can also be converted into chitosan using a high-heat 

process or a lower temperature process using enzymatic conversion 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

The petitioner is requesting that chitosan be added to 7 CFR 205.601(j)(4) as a synthetic 

substance allowed for use in organic crop production as a plant disease control. 

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

Based on information in the 2020 Technical Report, the application of chitosan as an active 

ingredient in pesticidal products is unlikely to be harmful to the environment. It occurs naturally 

in quantities exceeding what would be used in organic crop production and it degrades into 

substances that are non-toxic and readily used as nutrients. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)] 

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Due to the variety of results found in different studies it is likely that chitosan has multiple 

antibacterial modes of action. One hypothesis is that positively charged chitosan binds to 

negatively charged cell surface molecules. Another hypothesis is that smaller chitosan 

molecules move through cell walls and inhibit gene transcription. There is also another 

thought that chitosan chelates essential nutrients making them unavailable to bacteria. 

Chitosan can also initiate systemic resistance in plants and may act directly between host 

and pathogen to block the growth of the pathogen itself. Since chitosan is used at low levels 

and is degraded by soil microorganisms the is expected to be no increase in the environment. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

Because of the low toxicity of chitosan, the misuse of the product or its disposal are expected to 

have minimal effects on the environment. Both chlorine and sodium hydroxide are used in 

production of chitosan, and are toxic in the environment if not contained in transport. 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

According to numerous sources as reported in the Technical Report chitosan is nearly non-toxic 

to humans and most other animals and its degradation products do not cause side effects in the 

body (US EPA). 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

Pesticide studies about the use of chitosan as an active ingredient have shown that there might 

be temporary changes to soil microbial communities. Being a large polymer with numerous 

reactive sites, it is difficult to characterize all possible chemical interactions involving chitosan. 

the Technical Report found studies that chitosan can limit the ability of some microorganisms to 

absorb nutrients, but it can also act as a chelator. It has been suggested because of this, it might 

be used as a material to improve the anionic exchange capacity of soils to limit the leaching of 

anionic nutrients and improve nutrient delivery to plants 

6. Are there any adverse impacts on biodiversity? (§205.200) 

At the rates this substance is applied, no adverse impacts on biodiversity are expected. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

As the Technical Report emphasizes, good farming practices, including suppressive soils, 

creating unfavorable conditions for pathogens, managing disease vectors such as aphids, 

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sterilizing soils with heat and planting resistant cultivars reduce the need to use disease control 

substances. Also, there are more than 200 products listed by OMRI for use as plant disease 

control. Some do contain synthetic active ingredients, but many contain nonsynthetic active 

ingredients such as bacteria, microorganism extracts, botanical substances, oils, and natural 

acids. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)] 

Chitosan is a relatively benign product and also has the advantage of taking a waste stream of 

seafood shells and converting them to a useful recycled product. Both chlorine and sodium 

hydroxide are energy-intensive, toxic chemicals used in the production of chitosan, and must be 

considered. Additionally, chitosan is classified as synthetic, and the Subcommittee questions 

whether there is a need for an additional synthetic plant disease control product on the National 

List. The Crops Subcommittee is divided on whether chitosan should be added to the National 

List. 

Classification Motion: 

Motion to classify chitosan as synthetic 

Motion by: Rick Greenwood 

Seconded by: Brian Caldwell 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

National List Motion: 

Motion to add chitosan to the National List at 205.601(j)(4) for plant disease control 

Motion by: Rick Greenwood 

Seconded by: Steve Ela 

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

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP June 1, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Cow Manure Derived Biochar (CMDB) 

August 3, 2021 

Summary of Petition [link]: 

A petitioner has requested an annotation to the listing at § 205.602(a) “Ash from manure burning” that 

would indicate that ash from manure burning does not include biochar derived from pyrolysis of cow 

manure. The petitioner contends that cow manure derived biochar, or CMDB, not only provides a 

solution to nutrient leaching and other adverse impacts to raw manure handling in large scale dairy 

operations but also has other benefits for organic crops that may exceed those of plant-based biochar. 

The organic use of the petitioned material falls under the OFPA category for Crop and Livestock 

Materials and is characterized as a fertilizer and carbon storage soil amendment/soil conditioner to aid 

in organic crop production. In addition to CMDB, it can also commonly be referred to as cow manure 

biochar, dairy biochar, dairy manure biochar, dairy manure sourced biochar, manure derived char, or 

dairy manure char. 

Biochar is defined in NOP guidance document 5034 “Materials for Organic Crop Production” as: "[...] 

biomass that has been carbonized or charred. Sources must be untreated plant or animal material. 

Pyrolysis process must not use prohibited additives." 

The following annotation (in bold) at § 205.602(a) has been requested relevant to CMDB: 

§ 205.602 Nonsynthetic substances prohibited for use in organic crop production. 

The following nonsynthetic substances may not be used in organic crop production: 

(a) Ash from manure burning – unless derived as part of the production of biochar from 

pyrolysis of cow manure. 

***** 

[68 FR 61992, Oct. 31, 2003, as amended at 83 FR 66572, Dec. 27, 2018] 

Subcommittee Review: 

“Ash from manure burning” has been prohibited explicitly under OFPA since 1995 and reiterated every 

five years since then through 2015. In 2016, the NOSB unanimously denied a 2014 petition to annotate 

the prohibited use of ash from manure burning at §205.602(a) “[...] where the combustion reaction does 

not involve the use of synthetic additives and is controlled to separate and preserve nutrients” or the 

basis of the fact that it reduces the carbon and nitrogen present in the feedstock and thus does not 

contribute to soil-building processes. Around the same timeframe (fall 2015 NOSB meeting), the Board 

reiterated this position during the review of substances due to sunset in 2017 (in keeping with the 

position of the NOP), stating, “ash from manure burning was placed at §205.602 based on its 

incompatibility with organic production; burning these materials is not an appropriate method to recycle 

organic wastes.” 

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In response to the current petition in early 2020, the Crops Subcommittee requested a Technical Report 

(TR) of the petitioned substance, both to understand the implications of the process of pyrolysis in the 

context of the prohibited “ash from manure burning” (in other words, is pyrolyzed manure the same 

thing as ash?) and to understand more fully the potential carbon storage benefits of crop systems that 

utilize biochar, and more specifically CMDB, given member interest in more fully evaluating the 

potential to improve the contributions of organic agriculture to climate stability. 

The Crops Subcommittee received a draft TR and requested additional information in an updated draft 

including the following questions. That draft was received in March 2021 and deemed sufficient in April 

2021. 

The substance does not appear – at least by the name referenced here – on Canadian, EU, IFOAM, 

Codex, or Japanese lists of accepted materials, although biochar is referenced indirectly on Canadian, 

CODEX and Japanese lists. 

Category 1: Classification 

1. For CROP use: Is the substance ___X____ Non-synthetic or _______ Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

CMDB derives from the manure of dairy cows and the combustion in the absence of oxygen (i.e., 

pyrolysis) of that manure. It does not undergo a chemical transformation. NOP has previously 

categorized biochar as non-synthetic and classifies transformations of “heating or burning of 

biological matter (e.g., plant or animal material)” as “a natural process that does not result in 

the classification of ash as synthetic.” 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

CMDB does not contain any active synthetic ingredients. The only related question that has 

been raised about the substance is whether there are residues from dairy cow husbandry that 

persist in manure and further into CMDB. As reported in the TR, the presence of any such 

residues has not been documented. 

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

It does not appear that detrimental chemical interactions can occur from the use of CMDB in 

organic farming. However, agronomically, some crops are appropriate for applications of 

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biochar and CMDB and others may not be. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)] 

It appears that CMDB does not meet any relevant criteria for toxic persistence in the 

environment and may even contribute to the reduction of other toxics in the soil and the 

environment. Additionally, the expectation of biochar applications is that they can remain stable 

in the environment for hundreds or thousands of years, hence their potential value as a means 

of sequestering permanent carbon. 

That said, biochar can harbor toxics such as polycyclic aromatic hydrocarbons (PAH), which are 

typically formed using high-temperature production methods and heavy metals that are 

typically carried over from the feedstock, as noted in the TR, and can vary depending on the 

temperature at which the biochar was produced. According to the TR, “there have been reports 

of bio-accumulated PAH in food crops that were grown in biochar-amended soils,” as well as 

localized accumulation of pollutants in biochar contexts over time. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

Documented evidence appears to suggest that the production of biochar and CMDB results in 

net negative carbon emissions due to slower decomposition than raw biomass sources. The 

larger question about manufacturing impacts relates to the kind of scaled dairy operation from 

which the manure derives. This raises questions about the fundamental climate/water, 

environmental, and animal welfare impacts of those operations as well as whether or not 

organic agriculture should have a role in reducing or neutralizing negative aspects of those 

operations. 

While the TR clearly asserts that carbon is sequestered through the use of biochar, it does not 

cite data on the net carbon emitted or sequestered through the use of whatever energy 

feedstock is required to achieve optimal heat for carbonization. 

The TR also points out the net positive benefits of recycling “waste” material that would 

otherwise need to be disposed of were it not being pyrolyzed into CMDB. Recycling of manurebased feedstocks, as such, could attribute to reduced impacts typically associated with the 

disposal of such waste. 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

There do not appear to be any documented human health impacts from the petitioned 

substance. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

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The TR suggests that biochar and CMDB can lead to a less dense soil structure that can promote 

root growth and that it can have mixed results related to water retention in the soil (woodbased biochar is more porous than manure and thus can support more water retention). The TR 

also suggests that biochar and CMDB can improve the Cation Exchange Capacity (CEC) of soil 

which effectively improves the retention of nutrients in the soil. Nutrient bioavailability can vary 

in biochar-amended soil, depending on the feedstock, with CMDB being more nutrient-rich than 

other forms of biochar. CEC benefits can also lead to the sequestration of heavy metals, 

effectively immobilizing or neutralizing them. 

The TR also indicates that most biochar has base pH which can be beneficial in acidic soils, with 

CMDB having a higher pH than other biochar. It can also increase the solubility of nutrients and 

other substances, for example aluminum which the TR notes is toxic to plants. 

Sources cited in the TR indicate the biochar can have a wide range of positive and negative 

impacts on soil microbial communities but is most generally thought to improve microbial 

growth: “Grass and manure feedstocks and biochar with low production temperatures (<500 °

C) 

typically result in positive priming due to their relatively high nutrient content and bioavailability 

(Verheijen et al. 2010, Zimmerman et al. 2011, Tenic et al. 2020).” (Priming is increased or 

decreased microbial activity resulting from changes to physical and chemical properties of the 

soil, “specifically the availability of nutrients.”) TR sources suggest this combination of attributes 

of biochar and CMDB are what help with its contribution to crop resilience. 

The TR also points out that biochar can sequester “pesticides, herbicides, antibiotics, and 

pharmaceutical compounds” and that there is inconsistency as to whether biochar can 

neutralize and/or degrade those substances. It reduces nutrient cycling soil and retains nitrogen 

in soils as ammonia and ammonium. This can reduce soil acidification and climate-polluting N2O 

emissions. 

6. Are there any adverse impacts on biodiversity? (§205.200) 

The substance does not appear to have any biodiversity impacts, other than the soil microbe 

considerations noted above. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

In appropriate crop applications, wood-derived biochar can be an alternative to CMDB. CMDB 

and biochar in general are petitioned as soil amendment for their potential crop benefits as a 

soil amendment and for the unique role they can play in sequestering carbon and climatepolluting substances. It is unclear from the petition or the TR that biochar or CMDB are more 

effective at soil building than other common practices, such as cover cropping, manure and 

compost applications, and reduced tillage. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)] 

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This is perhaps a more complicated petition than the history of NOSB decisions on this 

substance would indicate. The TR is quite comprehensive about the potential for all forms of 

biochar to play significant roles in storage soil-based carbon and neutralizing pollutants that 

could otherwise adversely affect the environment. At the same time, it appears the viability of 

this petitioned material at scale is contingent upon access to manure deriving from a wide range 

of dairy operations, including but not limited to conventional operations and CAFOs. 

The argument as to whether pyrolyzed manure is the same as ash produced from burning 

manure is complex. However, the presumed production of ash appears to be the primary issue 

for previous board actions on related topics. The issue with biochar is that what could be 

considered “ash” is actually part of the substance and is contained by the substance and is not a 

byproduct of the substance. So, by tightly restricting use of ash from manure burning, organic 

agriculture may be losing a useful soil amendment and may be limiting its ability to serve as a 

climate solution. Following that argument, the use of biochar – for its recycling benefit, for its 

soil building benefit, and for its stable carbon sequestration – could be considered to be not only 

compatible with sustainable agriculture but promoting it. 

Most consulted sources suggest biochar and CMDB can be produced in a net negative carbon 

emissions content, presumably relying on the source material itself to be the primary fuel. 

However, sources are clear about this, and as the TR suggests, highest heat produced biochar 

(>500°C) – coming from vegetative sources – offers many of the key soil nutrient retention 

benefits. Manure-sourced biochar typically is produced at lower temperatures. It may be 

important for the subcommittee and the Board to understand more about necessary fuel 

sources – if any – required to produce CMDB. It has been difficult to document pyrolysis fuel 

sources clearly, but the assumption is that fossil sources would be necessary to achieve the heat 

required to produce an optimal biochar/CMDB product. 

Precedent would follow that this petition should be denied, but a careful review and discussion 

is merited. The NOP has as recently as 2016, articulated a position that pyrolysis is not its own 

unique mode of processing but in fact should be viewed as analogous to burning or combustion, 

and thus a source of ash. 

Classification Motion: 

Motion to classify cow manure derived biochar (CMDB) as nonsynthetic 

Motion by: Wood Turner 

Seconded by: Rick Greenwood 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

National List Motion: 

Motion to annotate the listing of ash from manure burning at § 205.602(a) to read “Ash from manure 

burning – unless derived as part of the production of biochar from pyrolysis of cow manure.” 

Motion by: Wood Turner 

Seconded by: Steve Ela 

Yes: 5 No: 3 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP August 3, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Ammonia Extracts 

August 3, 2021 

Summary of Petition: 

Note: Throughout this document references are made to the 2020 technical report (TR). It is intended 

that the citation of the TR inherently includes the citations of the references contained within the TR. 

When the TR is quoted the citations noted in the text of the TR have been removed for clarity – for a full 

list of references, please refer to the TR. 

References to ammonia or ammonium are specifically intended to include both unless specifically stated 

otherwise. 

Use 

Ammonium extracts are used as a source of nitrogen (N) for the production of a wide range of annual 

and perennial crops. In the past, ammonia products have been produced via synthetic processes and 

have not been allowed for use in organic production. The synthetic production methods primarily use 

the Haber-Bosch process, and that process has allowed for widespread commercial use of nitrogen for 

conventional farms. From this process, urea accounts for about 50% of nitrogen fertilizers. Other 

common forms include aqueous ammonia, ammonium nitrate, ammonium sulfate, ammonium 

phosphates and other ammonium salts. Ammonia compounds can be used as bioavailable fertilizer 

sources and can be rapidly taken up by plants (2020 TR). 

More recently, non-synthetic processes for the production of ammonium fertilizers have been 

developed. These processes produce high ammonia/ammonium products that can potentially be used 

in organic agriculture since they meet the criteria for use as non-synthetic fertilizer compounds. Before 

development of these non-synthetic processes for ammonia production, other N containing fertilizers 

have been allowed for organic use. These include, but are not limited to, soy protein hydrolysate, liquid 

fish products, and sodium nitrate. 

Nitrogen is often a major limitation to crop yields and is biologically important as a macronutrient. It 

contributes to plant growth through the formation of amino acids and as the building blocks for proteins 

and can improve photosynthetic efficiency (2020 TR). 

It should be noted that there is a wide range of ammonia/ammonium products that are approved for 

use in food processing and manufacturing. These include ammonium carbonate and bicarbonate which 

appear on the National List. Several products are approved for agricultural use, such as ammonium 

carbonates and ammonium soaps, but are limited by annotation to uses that do not directly contact 

crops. 

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Manufacture 

While the Haber-Bosch process is the primary method for making nitrogen fertilizers, it is not relevant to 

organic processing and use. More recently, several methods have been developed to produce ammonia 

products non-synthetically. As noted in the 2020 technical report and through public comment on the 

two NOSB discussion papers (Fall 2020 and Spring 2021) regarding ammonium extracts, the two 

methods are defined as ammonia stripping and ammonia concentration: 

Ammonia stripping – ammonium compounds occur in a number of agricultural, biological, and 

other sewage wastes. Ammonium is commonly produced through the metabolism, hydrolysis, 

or anaerobic digestion of these feedstocks. Once the ammonium ions are converted to 

ammonia by adjusting the pH to alkaline, the ammonia is extracted from the feedstock as a gas 

by the use of a combination of pressurized air and/or heating. After further processing, the 

ammonia is reacted with an acid to re-form ammonium. This stabilizes the nitrogen at which 

point the ammonium can be isolated as an aqueous solution or slurry or isolated as a solid by 

precipitation. The direct output of the “ammonia stripping” process is a pure ammonia gas (or 

when cooled and distilled, a pure aqueous ammonia condensate) isolated from the original 

agricultural feedstock. Products produced by this method are considered novel; new products 

are only recently being approved and/or are still in development and not yet fully 

commercialized. 

Ammonia concentration – rather than isolating only the ammonia ions, ammonia concentration 

uses a physical process to remove solids from the nitrogen containing liquid waste mixture. The 

remaining filtrate includes only water-soluble components. These include ammonia and 

ammonium, as well as phosphate, potash, secondary and micronutrients, and other organic 

compounds. This liquid is subjected to pressured air and/or heat to remove water by 

evaporation. This concentrates the remaining ammonium/ammonia compounds while also 

retaining the other nutrients and organic compounds from the original feedstock. Products 

produced by this method have been Organic Materials Review Institute (OMRI) listed. 

The output of the stripping method produces a near pure ammonia that would be similar to that 

produced by the Haber-Bosch process whereas the product of ammonia concentration retains more of 

the original compounds of the feedstock. The specific quantities and types of nutrients in the remaining 

concentration vary depending on the original feedstock. 

The other aspect of these concentrated and stripped ammonia products is that the nitrogen isotope 

ratio is different than ammonia from synthetic sources. Testing for isotope ratios of nitrogen is 

common. The nitrogen isotope ratio (δ15N) of natural materials also rarely falls below five and they are 

typically greater. Any products that go beyond this threshold (i.e., show higher δ15N values) are almost 

certainly not adulterated (California Department of Agriculture, public comment, Spring 2020). 

International 

As discussed in the 2020 TR: 

Canadian General Standards Board Permitted Substances List (CAN/CGSB-32.311-2015), Organic 

Production Systems Permitted Substances List - Ammonia extract is not listed in the Canadian Standards 

Board Permitted Substances List (CAN/CGSB- 2.311-2015); however, it does include a variety of 

ammonium compounds. Copper ammonia base, copper ammonium carbonate, ammonium forms of 

micronutrients, potassium sulfate made with ammonia reactants, and ammonium stillage are prohibited 

for “soil amendments and crop nutrition” uses. Ammonium carbonate is allowed “as an attractant in 

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insect traps.” Ammonium soaps are allowed “as a large animal repellent,” with the stipulation that 

“direct contact with soil or edible portion of crop is prohibited.” Ammonium lignosulphate is prohibited 

for “crop production aids and materials.” Ammonium bicarbonate and ammonium carbonate are 

allowed “as leavening agent[s].” Dibasic ammonium phosphate (diammonium phosphate, DAP) is 

allowed as a “yeast food for use in alcoholic beverages,” with the limitation that concentrations are 

“restricted to 0.3 g/L (0.04 oz./gal.) for cider, mead and wine.” 

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

Organically Produced Foods (CXG 32-1999) Ammonia extract is not listed in the CODEX; however, 

ammonium carbonates are listed in the CODEX as a “food additive.” 

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

extract is not listed in the EEC Council Regulation EC No. 834/2007 and 889/2008. However, several 

ammonium compounds are listed in EC No. 889/2008. Ammonium stillage is prohibited for use as a 

“fertilizer and soil conditioner.” Diammonium phosphate is allowed as an “attractant” for traps in 

“pesticides and plant protection products.” Ammonium molybdate is allowed as a nutritional “trace 

element” in animal feeds. Ammonium carbonates are allowed for the “preparation of foodstuffs of plant 

origin.” Ammonium hydroxide is allowed for the “preparation of foodstuffs of animal origin” in gelatine 

production. 

Japan Agricultural Standard (JAS) for Organic Production Ammonia extract is not listed in the JAS for 

Organic Production. However, ammonium bicarbonate and ammonium carbonate are listed in 

Notification No. 1606 and allowed for use as “food additives, limited to use for processed foods of plant 

origin.” 

International Federation of Organic Agriculture Movements (IFOAM) Ammonia extract is not listed in the 

IFOAM; however, it does list several ammonium compounds. Ammonium phosphate is allowed as an 

“additive,” with the stipulation that concentrations are “restricted to 0.3gm/l in wine.” Ammonium 

sulfate is allowed as an “additive,” with the stipulation that it is only allowed for wine and is “restricted 

to 0.3 mg/l.” Ammonium carbonates are allowed as “additives,” with uses limited to “cereal products, 

confectionary, cakes and biscuits.” 

While not addressed specifically, sodium nitrate is not allowed in Canadian production and crops grown 

with sodium nitrate may not be exported to Canada. While it is unknown, comments received at the 

Spring 2021 NOSB meeting included concerns that the use of ammonia extracts in the United States 

might result in the rejection of exported products by other countries. 

Summary of Review 

The review of this petition has resulted in a wide variety of public comments and perspectives. These 

perspectives range from issues with soil health and environmental concerns, the use of multiple sources 

of highly soluble nitrogen fertilizers, and the potential for fraud. Commenters argued both pro and con 

on each of these issues. 

In general, the comments from long-time organic organizations and growers tend to be in favor of the 

petition to prohibit ammonia extracts based on the organic principles of enhancing soil biological 

processes rather than applying a nutrient that is immediately available to the plant. They also noted the 

low carbon to nitrogen ratio, the high solubility of these extracts in terms of environmental issues, and 

the potential for these materials to increase the chances for fraud. 

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Opponents of the petition cite the need for immediately available nitrogen sources to act as a shortterm nitrogen bridge. This would be needed when unusual events cause nitrogen deficits to crops and 

soil processes have not had a chance to recharge the available nitrogen. They also note that some use 

of these materials can help prevent nitrogen loss since they could allow better targeting of nitrogen 

applications to specific crop needs. In terms of fraud, they note that many organic nitrogen fertilizers 

could also be subject to fraud. Rigorous inspections, unannounced site visits, nitrogen isotope testing, 

and mass balance reviews make fraud very unlikely. 

As noted previously, there are several materials already in the organic marketplace. These materials 

have been approved by OMRI and other material review organizations, although, with the caveat that 

nonsynthetic, liquid fertilizers that have a nitrogen analysis greater than 3 percent must comply with 

additional recordkeeping and inspection requirements in accordance with NOP Guidance on the 

Approval of Liquid Fertilizers for Used in Organic Production (NOP 5012). Non-synthetic fertilizers that 

test above 3 percent ammoniacal nitrogen are considered at higher risk for violating the soil fertility and 

crop nutrient management practice standards at §205.203. OMRI attaches a note that “this product 

contains highly soluble nitrogen and must be applied in a manner that does not contribute to the 

contamination of crops, soil or water. Its use must be part of an organic system plan that maintains or 

improves the natural resources of the operation, including soil and water quality, and comply with crop 

nutrient and soil fertility requirements.” 

Soil Health 

The USDA organic regulations at § 205.203(a) requires that a producer must select and implement 

tillage and cultivation practices that maintain or improve the physical, chemical, and biological condition 

of the soil and minimize soil erosion. At §205.203(c) and (d) the organic regulations state that the 

producer must manage plant and animal materials or crop nutrients and soil fertility to maintain or 

improve soil organic matter content. 

Many commenters noted that the use of ammonia extracts runs counter to this principal by directly 

applying plant nutrients rather than applying nutrients that improve the biological condition of the soil. 

Inherently, the annotation added to high N, ammonia/ammonium containing products notes that “this 

product contains highly soluble nitrogen and must be applied in a manner that does not contribute to 

the contamination of crops, soil, or water. Its use must be part of an organic system plan that maintains 

or improves the natural resources of the operation, including soil and water quality, and comply with 

crop nutrient and soil fertility requirements.” This annotation would not be added unless there was a 

risk that the materials do not contribute to the stated OFPA criteria. Indeed, a number of oral 

commenters testifying at the Spring 2020 NOSB meeting in favor of the use of ammonia extracts 

reinforced this by stating that ammonia extracts should not be used alone, but must be used with other 

soil building practices to comply with OFPA. 

An example of a comment that refers to basic tenets of organic agriculture and prior OFPA and NOSB 

actions was submitted at the Spring 2020 meeting: 

In contrast to the reductionism of “conventional” chemical-intensive agriculture, the origins of 

organic agriculture are in holistic and ecological thinking. Historically, perhaps the most 

important principle of organic production is the “Law of Return,” which, together with the 

foundational philosophy “Feed the soil, not the plant” and the promotion of biodiversity, 

provide the ecological basis for organic production. Together these three principles describe a 

production system that mimics natural systems. The Law of Return. In an organic system, 

residues are returned to the soil by tillage, composting, or mulching. While most organic 

growers depend on some off-site inputs, most of the fertility in a soil-based system comes from 

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practices that recycle organic matter produced on-site. The cycling of organic matter and on-site 

production of nutrients—as from nitrogen-fixing bacteria and microorganisms that make 

nutrients in native mineral soil fractions available to plants—is essential to organic production. 

The Law of Return is not about feeding plants, but about conserving the biodiversity of the soilplant-animal ecological community. The Law of Return says that we must return to the soil what 

we take from the soil. Non-crop organic matter is returned directly or through composting plant 

materials or manures. To the extent that the cash crop removes nutrients, they must be 

replaced by cover crops, crop rotation, animal manures, or additions of off-site materials, when 

necessary. Feed the soil, not the plant. 

The dictum to “Feed the soil, not the plant” reminds us that the soil is a living superorganism 

that supports plant life as part of an ecological community. We do not feed soil organisms in 

isolation, to have them process nutrients for crop plants; we feed the soil to support a healthy 

soil ecology, which is the basis of terrestrial life. 

Biodiversity. Finally, biological diversity is important to the health of natural ecosystems and 

agroecosystems. Biodiversity promotes balance, which protects farms from outbreaks of 

damaging insects and disease. It supports the health of the soil through the progression of the 

seasons and stresses associated with weather and farming. It supports our health by offering a 

diversity of foods. Ultimately, holistically healthy, truly organic farms produce healthy plants 

that require far fewer applications of insecticides and fungicides (even if approved for organic 

production). 

In the case of ammonia extracts, we are particularly interested in the principle of feeding the 

soil rather than the crop. OFPA §6513(b) requires that organic operations establish a plan 

designed to “foster soil fertility, primarily through the management of the organic content of 

the soil through proper tillage, crop rotation, and manuring.” Substances of high solubility, i.e., 

those materials that provide nutrients directly to the plant because they are quickly taken up 

into the plant from the soil solution, are counter to foundational organic principles, so they 

have always been restricted. Such materials are listed in §205.602—Nonsynthetic substances 

prohibited for use in Organic Crop Production or the “prohibited naturals” section of the 

National List: 

1) Calcium chloride is limited to treating a physiological disorder; 

2) Potassium chloride must be used in a manner that minimizes chloride accumulation in the soil 

and; 

3) Sodium nitrate is restricted to no more than 20% of the crop's total nitrogen requirement. 

The organic regulations limit substances of high solubility. In the preamble to the publication of 

the NOP Final Rule on December 21, 2000, NOP discusses how it decided to agree with the 

NOSB recommendation and to put specific regulation of substances of high solubility into the 

annotations for each of these materials where they appear on the National List of Allowed and 

Prohibited Substances. NOP goes on to say, "Based on the recommendation of the NOSB, the 

final rule would prohibit use of these materials [substances of high solubility], unless the NOSB 

developed recommendations on conditions for their use and the Secretary added them to the 

National List." At the time, the discussion was about mined substances of high solubility because 

there were no concentrated, highly soluble plant nutrient materials other than mined sources 

available at that time. New materials of high solubility should be prohibited or restricted. 

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These concerns were echoed by another commenter that stated that there are significant concerns with 

the compatibility of purified natural ammonia with organic principles: their mimicry of conventional 

synthetic fertilizers and their use requires the removal of carbon value from organic waste. 

There are studies that show the addition of nitrogen to nitrogen-limited fields can increase plant 

production. Addition of N increased production yields, biomass and thus, additional carbon resources 

that can be returned to the soil. Some of these studies show that the addition of nitrogen, no matter 

what the source, can improve soil health indices (Miner, Delgado, et al., 2020). Fertilizing nutrientdeficient soils usually results in greater crop yields. Higher yields achieve greater amounts of crop 

residue—roots, stems, and leaves—resulting from larger and healthier plants (Magdoff and Van Es, 

2021). A caveat is that a number of these studies are conducted on conventionally treated soils and 

focus on nitrogen deficient systems where the addition of any nitrogen enhances plant production. If 

nitrogen were not deficient and additional nitrogen did not result in greater plant growth, then it is 

unlikely that any nitrogen addition would improve soil health indices. 

Other studies show that long-term organic fertilizer inputs enrich carbon related soil functions. Manure 

additions can strongly influence the formation, storage and cycling of soil organic carbon and nitrogen 

and soil microecology (Sharaf, Thompson, et al., 2021; Ozlu, Sandhu, et al., 2019). The total amount 

(weights) of living organisms varies in different cropping systems. In general, soil organisms are more 

abundant and diverse in systems with complex rotations that return more diverse crop residues and use 

other organic materials such as cover crops, animal manures, and composts. When crops are rotated 

regularly, fewer parasite, disease, weed, and insect problems occur than when the same crop is grown 

year after year (Magdoff and Van Es, 2021). These biotic links can also have a positive influence on the 

ability of plants to resist insect pests. Plants grown in a balanced nutrient system are less likely to be 

attacked by pests as compared to plants that have readily available nitrogen added (Phelan, Mason, et 

al., 1995). 

There were several public comments noting that the use of ammonia extracts could increase the rate of 

mineralization in soils and thus be beneficial. In a short timeframe this could be true, but this 

accelerated rate of mineralization could come at the cost of long-term soil carbon resources. Wang, 

Juliang, et al., 2018, found that long-term application of N-fertilizers causes an abundance of bacterial 

groups responsible for the denitrification process, which causes the turnover of nitrogen to increase and 

results in greater nitrogen loss over time. Essentially, adding more nitrogen fertilizer results in a longterm loss of nitrogen while altering other soil components, like decreasing soil pH and C:N ratio. When 

soil carbon and nitrogen are reduced in response to the application of chemical fertilizers, beneficial 

enzymatic activity of the soil also decreases (Ozlu, Sandhu, et al., 2019). Another study concluded: 

Annual nitrate leaching was 4.4–5.6 times higher in conventional plots than in organic plots, 

with the integrated plots in between. This study demonstrates that organic and integrated 

fertilization practices support more active and efficient denitrifier communities, shift the 

balance of N2 emissions and nitrate losses, and reduce environmentally damaging nitrate losses. 

Although this study specifically examines a perennial orchard system, the ecological and 

biogeochemical processes we evaluated are present in all agroecosystems, and the reductions in 

nitrate loss in this study could also be achievable in other cropping systems (Kramer, Reganold, 

et al., 2006). 

Of interest is that nearly all the public comments stating that ammonia extracts help prevent 

environmental damage from excess application of manures and composts neglected to mention that an 

organic systems approach uses multiple sources of crop fertility. Comparing the use of ammonia 

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extracts to a system that only uses manures focuses on only one part of an organic system. An organic 

system includes cover cropping, interplanting, and varied crops, in addition to manures and composts. 

This mix of fertility sources is used to mitigate issues of nutrient excesses. 

The incorporation of crop residues and compost [emphasis added] provides a potential longterm alternative to ammonia extract and other nitrogen fertilizers. Nitrogen content in compost 

is slowly released through mineralization processes in the soil, primarily facilitated by its 

metabolism by microorganisms in the soil. Unlike ammonia extract, the use of compost also 

contributes to soil organic matter, and available carbon, phosphorous, and micronutrients, as 

well as soil microorganism populations and activities. The incorporation of compost into the 

agro-ecosystem has been reported to improve soil characteristics, specifically water holding 

capacity and cation exchange capacity (CEC). Increased soil CEC allows it to retain cations more 

effectively, including ammonium ions and metal cations required as micronutrients (e.g., iron 

[Fe], copper [Cu], zinc [Zn]) (2020 TR) 

Public comments and scientific research publications demonstrate that much more research regarding 

the use of these materials and of the soil health, plant health, and biological interactions is needed. 

There is conflicting information from studies on conventional soils and very little research conducted on 

organic soils. For example, a study on tomatoes in California, (Bowles, Hollander, et al., 2015) found 

that the complex plant and microbial processes that affect nitrogen cycling are affected by the ecology 

of each farm as well as between fields within a farm. Most research oriented toward nitrogen cycling 

takes place at research stations with fixed factors and limited soil variation. There has been little 

research about how nitrogen cycling occurs on working organic farms. The study detailed how organic 

tomato farms can achieve high yields even though tests showed relatively low nitrogen availability. 

They attributed this to the possibility that the nitrogen cycling was tightly coupled with tomato plant 

needs. While tests showed low nitrogen with respect to conventional standards, the sustained release 

curve of the nitrogen in those plots met plant needs. They concluded that new indicators of N 

availability are needed that consider active C and N processes in organic systems. This is another 

indicator of our lack of understanding of nutrient processes and needs in organic systems. This lack of 

understanding results in conclusions about the need for fast acting nitrogen applications and is 

problematic. 

In the absence of consistent research showing overwhelming benefits from the applications of 

ammonia extracts, and with the requirement to fulfill OFPA criteria, use of ammonia compounds raises 

questions regarding soil health and the maintenance or improvement of soil organic matter. There are 

effective organic systems that pay close attention to nitrogen needs through the use of multiple 

approaches to fertility that include the basics of crop rotations and applications of manure and 

composts. By paying attention, these systems do not result in large buildups of phosphorous or in 

excessive loss of nitrogen to the environment. While there is a segment of organic stakeholders that 

express an interest in using these extracts, there is a larger segment that believes ecosystem 

management to maintain or increase soil organic matter does not include reliance on a highly soluble 

fertilizer. 

Total Use of High N Fertilizers: 

While USDA organic regulations criteria require an organic soil fertility plan to maintain or improve soil 

organic matter (§205.203), the interpretation of this requirement can be very difficult for certifiers to 

enforce. Does growing the same crop for several years, followed by a different crop, and then back to 

the first crop conform to this requirement? What level of highly soluble, low carbon-to-nitrogen ratio 

materials can be used before they are too much and do not comply with OFPA. Given the wide range of 

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organic soil fertility options available, it can be very difficult for certifiers to enforce a notice of noncompliance. 

The restriction on the use of sodium nitrate to 20% of crop needs limits the potential for overuse of that 

form of highly soluble nitrogen fertilizers. In fact, the prior vote of the NOSB to completely prohibit this 

form of nitrogen illustrates the concern the organic community has for the use of these high nitrogen 

fertilizers. One comment received at the Spring 2020, meeting demonstrates the slippery slope of using 

these types of fertilizers, including ammonia extracts: 

Fertilizing through drip irrigation systems allows for precise placement and timing of the 

fertilizer for optimum crop production. Drip irrigation has become a major method of irrigating 

crops, especially in California. The growth in drip irrigation is driven by drought, over-draft of 

aquifers, and the need for more precise fertilization... The type of crops irrigated with drip 

irrigation include all types of vegetables, tree fruit, strawberries, cane berries, and tomatoes. 

Many of these crops, such as tree fruit and berries, are only irrigated using drip irrigation 

systems. These crops often have very long cropping cycles making it impossible to apply 

nutrients by a method other than through the drip irrigation system. Any fertilizing material 

added to drip irrigation water must have little to no solids with most of the nutrients in a 

soluble form [emphasis added]. Two of the major liquid nitrogen products are made with liquid 

fish (fish solubles, fish protein, fish emulsion, hydrolyzed fish) and or corn steep liquor. These 

ingredients contain high levels of insoluble material which cause costly plugging of drip irrigation 

lines. 

This illustrates a system that utilizes a large amount of highly soluble fertilizer for the fertility program 

with little or no attention to other organic fertilizer inputs. At what point would ammonia extracts 

become the main source of nitrogen while other organic soil building practices become a minority? 

Sodium nitrate, another highly soluble, immediately available nitrogen source is approved for organic 

use with a limitation to 20% of crop nitrogen needs. Like ammonia extracts, sodium nitrate is a nonsynthetic alternative of bioavailable nitrogen for plants. Unlike other naturally derived substances that 

must undergo mineralization to be plant available, ammonia extracts and sodium nitrate act more like 

conventional fertilizers. The 2020 TR cites a number of sources that demonstrate the benefits of 

materials that need to undergo mineralization as opposed to those that are immediately available and 

states: 

Many substances derive from natural products that are allowed as organic fertilizers, including fish 

meal, liquid fish residues, feather meal, bird or bat guano, alfalfa meal, soybean meal, bone meal, 

kelp, seaweed, blood meal, and meat meal. Like crop residues and compost, organic fertilizers 

require additional mineralization processes and provide a slow release of nitrogen, which is 

primarily present in complex molecules. Like crop residues and compost, organic fertilizers also 

contribute to increased soil organic matter, CEC capacity, and other nutrients and micronutrients. 

Unlike nitrogen fertilizers used in conventional agriculture, organic fertilizers have been reported to 

have minimal negative to long-term positive effects. 

There is the potential to use multiple sources of low C:N ratio, high bioavailability fertilizers to replace 

basic soil fertility methods such as crop rotation, intercropping, and appropriate manure and compost 

use. Traditional organic materials, with the exceptions of sodium nitrate and guano, have a C:N ratio 

above 3:1 : 

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Material C:N ratio range 

Sodium nitrate 0.02: 1 

Sea bird guano 1.2 - 3.3: 1 

Blood meal 3.1 - 3.8: 1 

Fish powder 3.4 - 4.0: 1 

Feather meal 3.5 - 3.8:1 

Bone meal 3.6: 1 

Liquid food-based fertilizer 4.6-5.2: 1 

Liquid fish emulsion 5.2: 1 

Cotton seed 5.5: 1 

Poultry litters 8-12: 1 

Composts 10.7 - 99.3:1 

Soil 10-12 

Clover and alfalfa (early) 13 

Alfalfa meal 15.9: 1 

Dairy manure (low bedding) 17 

Alfalfa hay 20 

Green rye 36 

Corn stover 60 

Wheat, oat, or rye straw 80 

Oak leaves 90 

Fresh sawdust 400 

Newspaper 600 

Sources: Cassity-Duffey, Cabrera, et al., 2020; Hartz and Johnstone, 2006; Lazicki, Geisseler, et al., 2020; 

Magdoff and Van Es, 2021. 

Ammonia extracts have C:N ratios below 3:1 as compared to other liquid products: 

Type of product Ammonia-N 

(%) 

Total N (%) Ammonia-N/Total 

N (%) 

C:N 

manure tea 0.003 - 0.42 0.09 - 0.71 3.3 - 59.2 17:1 

restricted ammonia product 4.2 – 7.47 5.78 – 8.23 51.0 – 99.6 2:1 

liquid fish fertilizer 0.4 - 0.95 3.96 – 5.25 7.6 – 20.7 3.35 

anaerobic digestate 0.048 - 0.68 0.28 – 2.21 2.2 – 43.2 1.25 - 5.48 

Source: OMRI 

Any amendment that is over 40:1 can cause temporary plant nitrogen deficits since nitrogen must be 

taken from surrounding soil to enable breakdown of these materials. Conversely, amendments with 

lower C:N ratios can contribute available nitrogen to the system (Magdoff and Van Es, 2021). 

As written by one public commenter (Spring 2021): 

The prohibition of synthetic nitrogen fertilizers manufactured through the Haber-Bosch process is a 

longstanding and fundamental prohibition in organic agriculture. The proliferation of these fossilfuel based synthetic fertilizers in conventional agriculture was a primary motivator of the modern 

organic agricultural movement. The principles of organic (as described in the 2001 NOSB 

Recommendation) seek to achieve agricultural and environmental goals through the “use of cultural, 

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biological, and mechanical methods, as opposed to using synthetic materials to fulfill specific 

functions within the system.” Therefore, substances that mimic the chemistry and functionality of 

synthetic nitrogen fertilizers can understandably be considered as equally incompatible with 

traditional organic principles. Purified natural ammonia and ammonium compounds mimic 

conventional synthetic nitrogen 

Another commenter stated: 

Highly soluble sources of nitrogen cannot be addressed in a vacuum, and we cannot look at one 

material at a time. We must take a broader approach to limiting highly soluble sources of nitrogen 

as a whole. To evaluate and list each individually, even with a restriction, is a slippery slope and 

raises the concern of “stacking.” [Question #4 of the Spring 2020 Discussion document] asks: 

“Should the use of natural ammonia extract be limited to a certain percent of nitrogen use in crops 

(similar to the Chilean nitrate restriction)?” With this approach, producers could potentially “stack” 

highly soluble sources of nitrogen, using 20% of the crop’s needs from Chilean nitrate, 20% of the 

crop’s needs from another source, and 20% of the crop’s needs from yet another source. 

Products that are immediately plant bioavailable mimic conventional nitrogen sources. Products that 

require additional mineralization, such as protein sources, require soil biotic transformation to be 

bioavailable to plants. While not perfect, organic products with greater than a 3:1 C:N ratio fit into the 

category of materials that require soil biotic transformation. Non-synthetic products that are below a 

3:1 ratio tend to be those that are immediately plant available. 

Fraud potential 

While the potential for fraud is not specifically referenced in OFPA, it does affect the ability of certifiers 

and the NOP to evaluate whether organic standards are being followed by crop producers. Given 

additional emphasis on organic enforcement and that both the petitioner and public commenters are 

concerned with the potential for fraud with these ammonia extracts, it seems prudent to note the 

issues. However, commenters have noted that the potential for fraud exists with many fertilizers. 

OMRI stated in public comments that it conducts audits and inspections of high nitrogen liquid fertilizer 

(HNLF) facilities twice a year. NOP guidance states that “the material evaluation program must...Conduct 

a balance-in/balance-out analysis of all ingredients and finished products including, when appropriate, 

by nitrogen content.” A mass balance exercise should expose fraudulent uses of synthetic nitrogen. If 

concentrated ammonia products of concern are those liquid fertilizers with above 3% ammoniacal 

nitrogen, they are considered HNLF and subject to regular mass balance audits. Formulations that may 

contain less than 3% ammoniacal nitrogen would not be subject to the same requirements, so the risk of 

adulteration remains. However, that risk already exists for all liquid fertilizer products that are not 

subject to inspection. OMRI’s inspectors certainly encounter challenges in completing mass balance 

calculations for complex formulations, particularly those derived from waste stream materials. OMRI 

therefore is not suggesting that the mass balance calculation is an absolute fail-safe measure against 

fraud, but rather a risk mitigation measure. 

In terms of N15 to N14 isotope ratio testing, OMRI expressed its concerns in public comments at 

the Fall 2020 NOSB meeting. OMRI no longer requests isotope ratio testing due to the unreliability of 

test results for complex blended formulations. 

A public commenter, citing a study from the University of California presented a different perspective. 

The University determined that there is a very marked difference in N15 isotope concentration between 

natural and synthetic ammonia, and the test for determining nitrogen isotopes in products is common. 

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The nitrogen isotope ratio (δ15N) of natural materials also rarely falls below a certain threshold, with a 

few exceptions. Fish tissue and guano, for example, do not have ratios less than 5, and they are typically 

greater. Any products that go beyond this threshold (i.e., show higher δ15N values)

are almost certainly not adulterated. It is important to note, however, that plants that rely on symbiotic 

nitrogen uptake can have δ15N values as depleted, or close to atmospheric values, as nonorganic 

nitrogen sources. So, in fertilizers where biomass from nitrogen-fixing plants (e.g., legumes) has been 

added, it may be difficult to distinguish them from nonorganic sources. 

(http://californiaagriculture.ucanr.edu • OCTOBER–DECEMBER 2013) 

The California Department of Agriculture submitted public comments that state they can use isotope 

ratios and inspections to prevent fraud: 

Concerns about fraud, i.e., fraudulent use of synthetic materials to produce organic input 

materials, have prompted calls to employ stable isotope techniques to help detect 

adulteration of organic liquid ammonia products with synthetic ammonium. Therefore, 

the potential usefulness and limitations of stable isotope testing will be discussed below. 

Nitrogen-containing materials have unique isotope ratios, or “isotopic signatures.” In a 

solution, N isotope ratios [15N/(14N+15N)] are uniform and stable, and measurements by 

isotope mass spectrometers are repeatable with great precision. 

Therefore, adulteration of an organic liquid ammonia product can be detected if the 

isotopic signature of a product is different from that obtained of the same product 

analyzed earlier, for example right after its manufacture. Comparing N isotope ratios of 

finished product batches with those of products offered in the marketplace can bring 

adulteration to light. CDFA-OIM measures the isotopic signature of finished liquid 

ammonia product batches at the manufacturing sites. The N isotopic signatures of 

products in the channels of trade must match the ones in the records. 

While changes of the isotopic signature of a given product can reliably be detected, 

using stable isotopes to distinguish between organic and synthetic sources of N is more 

problematic. The differences in N isotope ratios, or isotopic signatures, occur due to 

discrimination against the heavier (15N) isotope during biochemical and physical 

processes, such as soil-to-atmosphere fluxes of N gases. The N isotopic signature of 

the atmosphere, the source of synthetic N, is generally lower than that of organic 

materials. Thus, the N isotopic signatures of ammonium from organic sources are 

slightly, but consistently, higher than those of ammoniacal-N in synthetic fertilizer... 

It is not possible to use the isotopic signature alone to verify the integrity of the OIM 

liquid ammonia manufacturing processes due to the fact that there is a wide range of N 

isotope ratios among organic sources of N that in some cases overlap those of synthetic 

fertilizer. Thus, isotopic signatures are useful for discovering fraud committed in the 

channels of trade, but not as a tool to determine whether a product has been made 

solely from non-synthetic source materials. CDFA-OIM relies on thorough inspections of 

manufacturing plants, including N mass balance audits at announced and non-announced 

visits to deter fraud by manufacturers of organic liquid ammonia products. 

Other comments received at the Fall 2020, and Spring 2020, noted that the overlap in isotopic ratios 

between synthetic and natural ratios makes using isotope ratios alone difficult. Without extensive 

sampling of the exact ratios of lots at manufacture and at use, the chance for comixing or ammonia 

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products exists. Other commenters noted that, while California is deliberate about testing, their 

purview does not extend nationally or internationally. Likewise, adulterations at the farm scale are 

possible and farm inspections are often performed after nitrogen has been applied to crops. 

A public comment from the Spring 2020 meeting notes: 

Certifiers already face an uphill battle with those clients who treat soil as merely something to hold 

plants up and do all feeding through liquid injection rather than soil building. Adding more 

successful liquid to the system is just not in keeping with the intent or spirit of organic farming. How 

to stop people from cheating is also a major hurdle. Cheating has historically been an issue in 

making similar products by spiking them with synthetic nitrogen, and it is also an issue in users 

becoming too dependent on these products at the expense of cover crops, compost, and other 

fundamental organic practices. 

Finally, several commenters stated that the potential for fraud is increased when there is a significant 

cost difference between the biological ammonia fertilizers and the synthetic materials. The cost 

differences create an economic incentive for comingling products and presenting them as products 

approved for organic use. While legal penalties deter fraudulent activity, NOP enforcement activities 

have demonstrated that economic gains continue to motivate fraudulent activities. 

Category 1: Classification 

1. For CROP use: Is the substance X Non-synthetic or Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

The processing of ammonia extracts does not change the form of the ammonia/ammonium 

product. Naturally occurring biological processes, such as anaerobic digestion and fermentation, 

can be used to produce ammonia and ammonium compounds. While the production of 

ammonia and ammonium compounds (ammonia extract) occurs through natural, biological 

processes, isolation via ammonia stripping generally utilizes acid and base reactions. The 

classification of ammonia extract as synthetic or nonsynthetic is dependent on the identity of 

the acids and bases used in the production of ammonia extract. According to NOP decision 

trees, the use of synthetic substances for pH adjustment or other processing would result in the 

classification of the ammonia extract as synthetic, while the use of natural acids and bases 

would result in the classification of ammonia extract as nonsynthetic (2020 TR). 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

Ammonium extracts do not include an active synthetic ingredient. 

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Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

To the extent that the application of ammonia/ammonium extracts can affect soil pH and other 

microbial processes, other nutrients may or may not be released based on the soil pH effects. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the 

environment? [§6518(m)(2)] 

Ammonia, ammonium, and their byproducts have short lifetimes in the environment, typically 

ranging from hours to days based on environmental conditions. The short environmental 

lifetimes of ammonia, ammonium, and their by-products are due to the bioavailability of 

nitrogen in these compounds, which are readily incorporated into amino acids and other 

biologically important molecules. The exception in the byproducts of ammonia and ammonium 

ions is the oxidation product nitrous oxide (dinitrogen oxide [N2O]), which can persist for 

approximately 120 years in the atmosphere. When excess ammonia is present in the 

environment, it is likely to volatize and move into the atmosphere as a gas (2020 TR). 

Furthermore, the TR states that the high-water solubility of ammonia, ammonium and nitrate 

ions makes them conducive to leaching into water ecosystems. While these compounds can be 

metabolized by aquatic microorganisms, if they are overabundant eutrophication can occur and 

ammonia and ammonium can be toxic to aquatic life. Algal blooms can be caused by the influx 

of high concentrations of nitrogen nutrients. Algal blooms can reduce oxygen concentrations 

and result in hypoxic and anoxic environments. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

The production of ammonia extracts can result in the release of ammonia to the environment. 

This is expected due to the inability of ammonia isolation processes to capture 100% of the 

ammonia content of feedstocks. The efficiency of capture depends on the feedstock and 

isolation conditions, but is reported to be in the range of 17-95% of total ammonia content with 

a 90% recovery considered acceptable. The remaining ammonia is lost to the environment 

either as a gas or as residual amounts that remain in the feedstock effluent (2020 TR). 

Other issues of environmental contamination are true of all ammonia compounds and are not 

specific to non-synthetic ammonias. The release of these compounds to the atmosphere can 

contribute to degradation of air quality and visibility due to the formation of ammonium 

aerosols. Additionally, the primary issue of environmental contamination is the over application 

of nitrogen products and their subsequent leaching into non-agricultural environments. 

Dramatic losses of 20-80% have been noted. (2020 TR). 

Finally, the disposal/use of the feedstock material that remains after filtration and/or ammonia 

isolation has not been mentioned in the TR or from public comments. Depending on the use of 

that feedstock there are potential environmental issues with that remaining material. 

Comments have focused on issues with phosphorous increases and issues when using 

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manures/composts. This same problem could be an issue when a feed stock is disposed of after 

ammonia has been removed. 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

FDA allows the use of a number of ammonium substances or lists them as Generally Recognized 

as safe. However, these substances differ from those used in agriculture. 

The 2020 TR refers to several human health effects. Ammonium is a positive ion and its effect on 

human health are dependent on the remaining negative portions of the ionic compound 

Ammonium ions play a critical role in the Krebs cycle. 

Ammonia is classified as a respiratory irritant – long term exposure to gaseous ammonia can 

result in bronchial or pulmonary inflammation. Repeated exposure can lead to pulmonary 

fibrosis. Direct inhalation or ingestion can cause esophageal burns. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

The 2020 TR states: 

Ammonia and ammonium compounds can readily migrate from the applied soil system into the 

atmosphere and marine environments. When ammonia and ammonium compounds remain in 

their applied soils, they also induce changes to the local environment. The acidity of ammonium 

ions is recognized as a cause of soil acidification, reducing the soil pH. These pH changes result 

in changes to the solubility and bioavailability of other nutrients, affecting both crops and soil 

organisms. Changes to soil pH may also have negative impacts on the viability of soil 

organisms, including earthworms and various microbial populations. High soil concentrations of 

ammonia and ammonium have been shown to retard the natural nitrogen fixation processes of 

plants. This shift in natural ammonia production reduces the natural efficiency of the soil, 

making it more reliant on continued nitrogen inputs. The release of ammonia to the 

atmosphere directly contributes to ozone depletion and global warming (ammonia is a 

greenhouse gas). Ammonia and ammonium compounds contribute to the degradation of air 

quality and visibility due to the formation of ammonium aerosols. The production of nitric oxide 

and nitrous oxide contribute to ozone depletion. 

6. Are there any adverse impacts on biodiversity? (§205.200) 

The use of high nitrogen available fertilizers can alter the uptake rates of nitrogen and alter 

plant nutrient production. Studies by Phelan, Mason, et al., 1995, demonstrate that these 

altered plant nutrient production cycles can lead to increased susceptibility to pests. 

Other studies show that long-term organic fertilizer inputs enrich carbon related soil functions. 

Manure additions can strongly influence the formation, storage and cycling of soil organic 

carbon and nitrogen and soil microecology (Sharaf, Thompson, et al, 2021; Ozlu, Sandhu, et al., 

2019). The total amounts (weights) of living organisms vary in different cropping systems. In 

general, soil organisms are more abundant and diverse in systems with complex rotations that 

return more diverse crop residues and that use other organic materials such as cover crops, 

animal manures and composts. When crops are rotated regularly, fewer parasite, disease, 

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weed, and insect problems occur than when the same crop is grown year after year (Magdoff 

and Van Es, 2021) 

There were several public comments noting that the use of ammonia extracts could increase the 

rate of mineralization in soils and thus be beneficial. In a short timeframe this could be true, but 

this accelerated rate of mineralization could come at the cost of long-term soil carbon 

resources. Wang, Juliang, et al., 2018, found that long-term application of N-fertilizers causes an 

abundance of bacterial groups responsible for the denitrification process, which causes the 

turnover of nitrogen to increase and results in greater nitrogen loss over time. Essentially, 

adding more nitrogen fertilizer results in a long-term loss of nitrogen while altering other soil 

components, like decreasing soil pH and C:N ratio. When soil carbon and nitrogen are reduced in 

response to the application of chemical fertilizers, beneficial enzymatic activity of the soil also 

decreases (Ozlu, Sandhu, et al., 2019). Another study concluded: 

Annual nitrate leaching was 4.4–5.6 times higher in conventional plots than in organic 

plots, with the integrated plots in between. This study demonstrates that organic and 

integrated fertilization practices support more active and efficient denitrifier 

communities, shift the balance of N2 emissions and nitrate losses, and reduce 

environmentally damaging nitrate losses. Although this study specifically examines a 

perennial orchard system, the ecological and biogeochemical processes we evaluated 

are present in all agroecosystems, and the reductions in nitrate loss in this study could 

also be achievable in other cropping systems (Kramer, Reganold, et al., 2006). 

The TR states that the incorporation of crop residues and compost provides a potential longterm alternative to ammonia extract and other nitrogen fertilizers. Nitrogen content in compost 

is slowly released through mineralization processes in the soil, primarily facilitated by its 

metabolism by microorganisms in the soil. Unlike ammonia extract, the use of compost also 

contributes to soil organic matter, and available carbon, phosphorous, and micronutrients, as 

well as soil microorganism populations and activities. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

The following statements are taken from the 2020 TR. 

There are many natural soil amendments that can be used to deliver nitrogen for crops. Manure 

is a source of nitrogen compounds, including ammonia, ammonium ions, and urea, which are 

biological waste compounds. However, manure has a relatively low level of biologically 

available nitrogen compared to ammonia extract. The biologically available forms of nitrogen in 

manures may also lead to similar issues with nutrient leaching as ammonia extract, potentially 

polluting surrounding water systems and leading to atmospheric ammonia emissions. Manure 

from both organic and conventional livestock is permitted for use in the production of organic 

crops. However, the availability of manure may be limited regionally due to the continued 

segregation of crop and animal agricultural production. 

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In addition to manure, crop residues and compost may be added as a source of bioavailable 

nitrogen. This includes the direct integration and composting of both manure and other organic 

agricultural wastes. The high protein and amino acid content of these feedstocks allows for their 

conversion to ammonia and ammonium compounds through anaerobic digestion and 

metabolism by soil microorganisms. When composts do not include manures, they are generally 

low in nitrogen containing compounds (2020 TR). 

The incorporation of crop residues and compost provides a potential long-term alternative to 

ammonia extract and other nitrogen fertilizers. Nitrogen content in compost is slowly released 

through mineralization processes in the soil, primarily facilitated by its metabolism by 

microorganisms in the soil. Unlike ammonia extract, the use of compost also contributes to soil 

organic matter, and available carbon, phosphorous, and micronutrients, as well as soil 

microorganism populations and activities. The incorporation of compost into the 

agroecosystem has been reported to improve soil characteristics, specifically water holding 

capacity and cation exchange capacity (CEC). Increased soil CEC allows it to retain cations more 

effectively, including ammonium ions and metal cations required as micronutrients (e.g., iron 

[Fe], copper [Cu], zinc [Zn]) (2020 TR). 

Chilean nitrate (mined sodium nitrate) is a natural source of bioavailable nitrate ions. Sodium 

nitrate offers a natural alternative to ammonia extract as a nitrogen fertilizer, and is the 

historical source of nitrogen fertilizer prevalent before the advent of the Haber-Bosch process. 

Nitrate has been shown to be less toxic to terrestrial and aquatic organisms than ammonium 

ions, although it is toxic to some species at high concentrations. However, nitrate is more likely 

to contribute to environmental contamination than ammonium, and is the primary nitrogen 

compound associated with leaching into aquatic systems. Sodium nitrate is highly water soluble 

and may leach into aquatic systems as run-off. Nitrate also contributes to atmospheric 

contamination in the form of various nitrogen oxide compounds that are formed through 

denitrification reactions (2020 TR). 

Many other substances derived from natural products are allowed as organic fertilizers. These 

include fish meal, liquid fish residues, feather meal, bird or bat guano, alfalfa meal, bone meal, 

kelp, seaweed, and meat meal. These materials may be more readily available to crops due to 

their low C:N ratio, but all require mineralization to be plant bioavailable. The mineralization is 

required due to the nitrogen available in these materials being present as more complex 

molecules and proteins. These materials provide a slower N release than ammonia extracts. 

They also contribute to increased soil organic matter, CEC capacity and other nutrients and 

micronutrients. Unlike conventional fertilizers, organic fertilizers have been reported to have 

minimal negative to long-term positive effects on soil health (2020 TR). 

Crop rotation and intercropping are traditional methods to ensure soil health. They can be 

especially effective if legumes are included in the rotations. Legumes have the ability to fix 

nitrogen from the atmosphere by converting atmospheric dinitrogen into bioavailable nitrogen. 

Legumes and other nitrogen-fixing plants produce higher quantities of bioavailable nitrogen 

when there are low soil concentrations of ammonia and ammonium. Intercropping offers the 

potential of direct input of bioavailable nitrogen from legumes to other crops by growing them 

alongside each other. Intercropping has been shown to increase crop yields and these yields 

have been shown to be less dependent on nutrient inputs compared to monocropping systems. 

Cover cropping also promotes increased organic matter, increases CEC properties, and prevents 

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soil erosion. Cover crops use can be limited by regional climates and require adequate soil 

temperatures to grow between agricultural seasons (2020 TR). 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)] 

To further evaluate compatibility, the Subcommittee review includes answers to the following 

12 questions as noted in the NOSB Policy and Procedures Manual 

• Does the substance promote plant and animal health by enhancing the soil’s physical 

chemical, or biological properties? 

A number of public commenters from the Spring, 2021, NOSB meeting indicated that ammonia 

extracts must be used with other soil building practices in order to comply with OFPA criteria. 

These comments would indicate that the use of ammonium extracts alone do not enhance the 

soil’s biological properties. For example: 

The Petition ignores that the use of any fertilizer, including presently approved 

ammonia extracts, can only be applied under a holistic certified organic system plan 

This is a complex issue and commenters also provided a range of responses that either indicated 

that these extracts would harm soil biological properties or that they would enhance these 

properties. However, it seems contradictory that proponents of ammonia extracts state that 

they must be used with other organic soil building materials to comply with OFPA. They then 

turn around and argue that these extracts promote soil biological properties and soil health. 

Of particular note, the comments supporting the use of ammonia extracts were often referring 

to extracts produced using the concentration method. This method simply concentrates the 

ammonia containing materials by the removal of water. The carbon and other nutrients are not 

removed and thus these materials are not the nearly pure ammonia product that is derived 

from the stripping method. Thus, from comments received it may be important to distinguish 

these two types of ammonia materials since they cause different soil effects: 

For instance, “ammonia concentration” can result in innumerable combinations and 

concentrations of ammonia salts, minerals, and organic matter depending on the 

starting feedstock used for the digestate as well as the concentration method (e.g., 

filtration versus evaporation, etc.), resulting in different types and concentrations of 

biofertilizers (e.g., liquid versus granular). Therefore, the interactions with plants, soil, 

and microbial communities will differ depending on the resulting end-use formula of the 

concentrate. In contrast, “ammonia stripping” results in specific ammonia compounds: 

some variation of ammonium salt depending on the acid used to trap (stabilize) 

ammonia gas at the end of the stripping process. Ammonia stripping from anaerobic 

digestion of animal manure, simply put, converts ammonium from organic matter (NH4) 

to ammonia (NH3) gas, which is then typically absorbed in an acid solution to create 

ammonium sulfate or ammonium nitrate 

Additionally, commenters often compared the use of all types of ammonia extracts in relation to 

the use of manures and composts. These references noted the use of manures and composts 

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can create potential for increased phosphorous levels in the soil, nitrogen leaching in seasons 

where crops are not present and other environmental issues: 

Concerns about damage to the health of the soil system are not unjustified when 

applying ammonium fertilizers. However, these problems are not any more pronounced 

with ammonium fertilizers than they are with fertilizers in general. In fact, the targeted 

use of liquid fertilizers can be less damaging to the soil ecosystem and surrounding 

water systems than the application of large amounts of manure or even compost, which 

are both commonly used in organic systems to supply nitrogen 

However, other commenters (see comments submitted by Hatfield) noted that a good organic 

soil program does not rely solely on manures and composts, but also incorporates crop 

rotations, cover crops and interplanting. In order to avoid phosphorus or calcium build up in the 

soils after manure or compost application, a complete wholistic approach is necessary for the 

organic farming system as OFPA states. Crop rotations that cycle between high and low 

consumption or nitrogen in addition to cover crops in the off-season or intercropping with cover 

crops during the season help reduce the dependency of consecutive topical applications of 

manures or compost that can leave phosphorus deposits over time. If phosphorus deposits over 

time occur, then switching to forage grasses such as alfalfa or other forms of hay can assist in 

“growing out” the soil problems over time, but the soil will need to be remediated if excesses 

exist and not ignored for long term soil health and viability. The use of these methods can limit 

the potential for environmental issues that could result from manure use alone. And, in fact 

these diverse soil fertility practices can increase soil biological activity: 

The impact of soil carbon on soil biological response was more closely related to the 

inputs of carbon due to crop rotations than fertilizer practice (Geisseler, 2014). These 

complexities have been explored by Hijbeeks et al. (2017) when they compared soil and 

crop responses to organic and inorganic fertilizers on a range of crop from long-term 

experiments across Europe. Their results showed no significant effect of the organic 

inputs on crop yield with the effects from organic additions dependent upon the clay 

content, climate, and the soil organic matter at the beginning of the experiment as 

shown from their results (Fig. 4). These findings are consistent with those from Lori et al. 

(2017) in their meta-analysis of 56 experiments across the world. They found organic 

systems exhibited 32-84% greater microbial biomass carbon, microbial biomass 

nitrogen, total phospholipid fatty acids, and dehydrogenase, urease, and protease 

activities than conventional systems. When they used subgroup analyses, they found 

that crop rotation, inclusion of legumes in the rotation, along with the organic inputs 

were all significant factors affecting the soil microbial size and activity. 

There were few comments comparing the environmental effects of any type of ammonia extract 

to a complete organic system using manures, composts, crop rotations, cover crops and 

interplanting. Several commenters wrote that this is an area where research is limited, and 

effects may largely be unknown. 

Given that the comments and citations supporting the use of ammonia extracts generally 

compare these extracts to the use of manures and composts rather than whole soil systems, 

that these materials can only be used in conjunction with other carbon contributing soil 

practices, and that some research indicates their negative effects on soil biology, a conservative 

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approach to this answer is that the use of these extracts does not positively contribute to plant 

health over the long term. 

• Does use of the substance encourage and enhance preventative techniques including cultural 

and biological methods for management of crop, livestock, and/or handling operations? 

As noted by commenters, the use of ammonia extracts must include the uses of other cultural 

and biological processes to meet the OFPA criteria for maintaining or increasing soil organic 

matter. The ammonia extracts themselves do not encourage or enhance preventative 

techniques for crop management. 

Commenters have argued that the limited use of these materials, in situations where nitrogen 

might be limited due to unusual weather events or cold soils, could “prime” the soil system to 

increase biological activity or to bridge short term nitrogen deficits. But these situations do not 

meet the criteria of the wording “encourage and enhance preventative techniques” since they 

would be a response in an unusual situation when other techniques have failed. Others have 

noted that if soils are wet or cold during planting time, this points to inefficiency of the 

mycorrhizal fungi or the root system itself. Nitrogen is not generally needed in large amounts 

early on, and it is actually phosphorus that is needed. If mycorrhizal fungi are not active due to 

weather, they cannot process the needed phosphorus to assist with early plant germination. 

Even in excess phosphorus soils, there can be a phosphorus deficit in the plants when cold / wet 

soils occur. With the viewpoint of conventional farmers, a true starter fertilizer is actually 10-

34-0, indicating more phosphorus is needed early on to charge the soil for the plant “pop-up” 

than nitrogen itself. This same issue goes for an organic soil. 

Additionally, the purified ammonia compounds require the removal of the carbon value of 

organic waste, either through filtration or by stripping. In the past, the NOSB has prohibited 

materials sourced from agricultural waste when the carbon value of the original source material 

was not retained in the final product. The prohibition of ash from manure burning is an example 

where the carbon from the manures is removed by burning and the value of the materials for 

restoring soil organic matter is destroyed. 

• Is the substance made from renewable resources? If the source of the product is nonrenewable, are the materials used to produce the substance recyclable? Is the substance 

produced from recycled materials? Does use of the substance increase the efficiency of 

resources used by organic farms, complement the use of natural biological controls, or reduce 

the total amount of materials released into the environment? 

The substance is made from renewable materials in the form of animal manures and crop 

wastes. They can increase the efficiency of use since large volumes of manure and compost do 

not have to be hauled from their source to farms. Ammonia extracts are concentrated and thus 

much easier to haul and handle. 

Ammonia extracts can be applied when needed and only in the amounts needed at that point in 

time by the crop. Arguments are made both ways as to whether the applications of these 

materials and their ready availability to plants reduces their leaching potential (since only the 

amounts needed can be applied) or whether they bypass soil systems that tie up and release soil 

nitrogen dynamically (those systems only have a small proportion of nitrogen available to leach). 

The timing of nitrogen application can be controlled with ammonia extracts and they can be 

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applied in quantities that the crop needs at that point. This could lead to a better match of 

nitrogen added to nitrogen needed by the crop. However, there is also evidence that dynamic 

soil systems that release and then reabsorb nitrogen can supply crop needs while minimizing 

free nitrogen (Bowles, Hollander, 2015). The free nitrogen would be limited and thus leaching 

potential reduced. 

One researcher (Phelan, Mason, et al., 1995) has conducted studies showing that plants are 

more resistant to insect damage when organic fertilizers are used, as opposed to readily 

available mineral materials. Thus, the use of ammonia extracts (or sodium nitrate for that 

matter), since they are readily available, can disrupt biological controls. 

• Does use of the substance have a positive influence on the health, natural behavior, and 

welfare of livestock? 

N/A 

• Does the substance satisfy expectations of organic consumers regarding the authenticity and 

integrity of organic products? 

While the answer to this question is not referenced in the TR or other research reports, one 

public commenter noted that: 

Objections to the compatibility of these substances with organic principles are serious 

enough to potentially lead to fragmentation of the organic market. Some companies 

have indicated they may be prepared to establish private standards that exclude 

products produced with this input from their supply chain. This is an indication that the 

substance could fail to align with the 2004 NOSB Recommendation which asks NOSB to 

consider whether the substance would “satisfy expectations of organic consumers 

regarding the authenticity and integrity of organic products.” 

• Does the substance allow for an increase in the long-term viability of organic farm operations? 

This is a complex question. Some commenters argue that the potential for yield increases, 

precision application of nitrogen, and reduction of environmental contamination from excess 

nitrogen or phosphorous from composts and manures will increase long-term viability of organic 

farms. 

Others argue that the use of ammonia extracts will degrade soil biological systems and interfere 

with biological processes that are important to plant and soil health. The use of these extracts 

may give short term yield increases but are not promoting long term carbon building of the soil. 

Thus, long-term resiliency and viability may be hurt by the use of these materials. 

Using OFPA and deploying a total systems approach is necessary. Precision technology is 

independent of ammonia extract and should be adopted by organic farmers that are interested 

in increasing their yields and applying the right nutrients in the right places. Excess nitrogen or 

phosphorus applications need to be currently regulated through soil samples, removal rates, 

etc., and should not be an issue if the total systems approach is applied. Also, if there are 

nutrient management problems on a particular soil, avoiding solving them and bypassing them 

with a material that mimics conventional materials should not be permitted in an organic 

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system. At a minimum, ammonia extracts should be listed as a restriction on the OMRI 

certificate that they cannot be applied if work has not been done to remediate excess 

phosphorus or calcium build up in soils due to over applications in prior years. 

• Is there evidence that the substance is mined, manufactured, or produced through reliance on 

child labor or violations of applicable national labor regulations? 

There is no evidence that these materials violate labor regulations. 

• If the substance is already on the National List, is the proposed use of the substance 

consistent with other listed uses of the substance? 

N/A 

• Is the use of the substance consistent with other substances historically allowed or disallowed 

in organic production and handling? 

This is a petition to prohibit a natural material. There are other materials currently used in 

organic production (liquid fish, soy protein hydrolysate, sodium nitrate) that are similar in use. 

Of these, only sodium nitrate has significant nitrogen in an immediately plant usable form. 

Sodium nitrate is annotated on the National List to a limit of not more than 20% of crop needs. 

It is an allowed alternative to ammonia extracts. It should be noted, however, that a previous 

NOSB voted to prohibit use of sodium nitrate due to concerns of salt buildup and similar 

concerns regarding soil biology effects. 

In general, natural substances allowed in organic production are made up of complex chemical 

structures including lignins, proteins, carbon, nitrogen and other minerals and materials. 

Ammonia extracts produced through the concentration method may be similar to these 

historically allowed substances except that the ammonia content is concentrated and 

substantially higher than these naturally occurring substances. That concentration may cause 

these ammonia extracts to behave differently these other traditional natural materials. As 

noted above, that different behavior in the soil may be beneficial or detrimental. These 

differences may be exhibited by the differing C:N ration between ammonia extracts and other 

organic inputs. With the exception of sodium nitrate, most other traditional non-synthetic 

organic fertilizers have ratios of at least 3:1 and often greater. The low C:N ratio of ammonia 

extracts would be expected to cause different soil effects than those materials with higher 

carbon amounts. 

Proponents for the use of ammonia extracts argue that they are similar to other substances 

allowed and that they are only more immediately available. When used in moderate quantities 

they enhance soil biology and can cause soil and plant ecosystems to be more productive. 

Opponents argue that ammonia extracts bypass and short circuit soil biological processes and 

do not enhance long term carbon build up in the soil. Their low C:N ration is contrary to the 

original intent of the organic regulations in that soil fertility methods should promote long term 

soil health and ecosystem stability. 

• Would approval of the substance be consistent with international organic regulations and 

guidelines, including Codex? 

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As noted in the TR, there are a number of ammonia materials listed for use in handling, but 

there are no listings regarding the use of ammonia extracts for crop production. The use of 

sodium nitrate for products exported to Canada is limited. Since ammonia extracts and sodium 

nitrate are similar in plant availability and solubility, it is possible that the use of ammonia 

extracts in products destined for Canada could also be restricted, but this is unknown at this 

point. Furthermore, Europe and Canada have systems of closed positive lists, meaning a 

material cannot be used unless it is on the allowed list. This contrasts with the United States 

where a non-synthetic material can automatically be used unless it is prohibited or annotated. 

If ammonia extracts do not appear on the Canadian or European lists, then growers in those 

countries are unable to use them. 

Inconsistencies between international certifiers reduces export market potential and creates 

additional confusion with countries that have substantially different standards that the United 

States receives imports from. 

• Is there adequate information about the substance to make a reasonable determination on 

the substance's compliance with each of the other applicable criteria? If adequate information 

has not been provided, does an abundance of caution warrant rejection of the substance? 

Given the conflicting information regarding ammonia extracts, it seems prudent to prohibit the 

use of extracts. These materials have only been developed in the last ten years and there is not 

adequate research that would demonstrate that these high nitrogen, carbon limited materials 

comply with OFPA criteria for the maintenance and increase of soil organic matter. As noted 

above, arguments can be made that these materials have a positive effect or a negative effect. 

Given that there is no clear answer and that negative effects on soil health have been 

documented, an abundance of caution warrants a prohibition of these extracts. If future 

research conclusively demonstrates that these materials comply with the OFPA criteria to 

maintain and build soil organic matter, a petition could be submitted to remove the prohibition. 

Additionally, the prohibition could be allowed to expire during future sunset reviews. 

Furthermore, an abundance of caution warrants a close look at the use of low (below 3:1) C:N 

ratio materials, such as ammonia extracts, for organic fertility. The NOSB has set precedents to 

the limitation of these types of materials. Sodium nitrate is limited to 20% of crop needs. Other 

highly soluble, non-nitrogen materials are also limited by annotation. It was noted in public 

comments that: 

In the preamble to the publication of the NOP Final Rule on December 21, 2000, NOP 

discusses how it decided to agree with the NOSB recommendation and to put specific 

regulation of substances of high solubility into the annotations for each of these materials 

where they appear on the National List of Allowed and Prohibited Substances. NOP goes on 

to say, "Based on the recommendation of the NOSB, the final rule would prohibit use of 

these materials [substances of high solubility], unless the NOSB developed 

recommendations on conditions for their use and the Secretary added them to the National 

List." At the time, the discussion was about mined substances of high solubility because 

there were no concentrated, highly soluble plant nutrient materials other than mined 

sources available at that time. 

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Another commenter in favor of the use of ammonia extracts stated: 

I also believe that there should be a limit on the amount or percent of AE Nitrogen 

applied to the crop where no more than 20 – 30% of a crops total N comes from an AE 

or any high Nitrogen product that contains less than a C:N ratio of 2. 

This long-time concern for the use of highly soluble plant nutrients and the criteria of “an 

abundance of caution” is an important aspect of this petition. With respect to this petition, 

several options are open to the NOSB. The first is to prohibit ammonia extracts that meet the 

proposed definition. The second is to reject the petition altogether and allow any use of nonsynthetic ammonia extracts. The third would be to annotate the use of these extracts to some 

maximum percent of crop needs, similar to sodium nitrate. 

If an annotation to limit the use of ammonia extracts were to be put in place, the potential 

exists for sodium nitrate and ammonia extracts to both be used up to each of their maximum 

allowed rates. This stacked rate would allow for the use of higher applications than either 

alone. The combined use would put the burden on certifiers to identify whether the total use of 

these highly soluble products violated the OFPA criteria to maintain or build soil organic matter. 

It is likely that different certifiers would have different interpretations and that notices of noncompliance would be difficult to enforce. 

Additionally, the effectiveness of a prohibition or limitation is dependent on an exact definition 

of ammonia extracts. If new products are developed that fall outside the definition, a future 

petition would have to be submitted to determine if they should or should not be allowed. This 

could create additional work loads and a perpetual cycle of review for each new product 

produced. It would seem prudent to set an additional limitation for these extracts that might 

fall outside the current definition, as well as for other highly soluble nitrogen materials. A 

limitation that would restrict the total use of highly soluble nitrogen fertilizers would prevent 

the “stacking” of multiple highly soluble fertilizer types. The NOSB should not have to be 

continually concerned about the introduction of different novel ammonia extracts or other 

novel non-synthetic nitrogen materials before a petition is submitted to restrict them. 

Sodium nitrate was prohibited in part for this same rationale. As stated by NOSB in a past review 

to justify its recommendation to prohibit, the “use and dependence on sodium nitrate also can 

tend for producers to put off the need for strong soil-building practices, consistent with 

§205.203, since it behaves similarly to conventional synthetic nitrogen fertilizers.” This is 

evidence that the substance could fail to align with the 2004 NOSB Recommendation which asks 

NOSB to consider whether “use of the substance is consistent with other substances historically 

allowed or disallowed in organic production and handling.” Highly soluble sources of nitrogen 

cannot be addressed in a vacuum, and we cannot look at one material at a time. We must take a 

broader approach to limiting highly soluble sources of nitrogen as a whole. To evaluate and list 

each individually, even with a restriction, is a slippery slope and raises the concern of “stacking”. 

• Does use of the substance have a positive impact on biodiversity? 

Some commenters argue that ammonia extracts enhance soil biological processes, many others 

argue that these materials either do not impact or decrease biodiversity. A proponent of the 

use of ammonia extracts cited Jerry Hatfield in that: 

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Bio-based fertilizers been shown to increase the characteristics related to soil 

health, e.g., organic matter, soil aggregates, enhanced biological activity, increased 

nutrient cycling because they stimulate biological activity through a balanced 

carbon:nitrogen (C:N) ratio 

Contrarily, the 2020 TR states: 

While bioavailable nitrogen is also important for the function of microorganisms, high 

concentrations of ammonia and ammonium compounds result in changes to the native 

soil communities. These changes vary based on the initial soil communities and may 

result in either an increase or decrease in total population. However, while there are 

cases of population growth in some communities, the application of nitrogen fertilizers 

is associated with decreases to the diversity of these microbial communities 

Given the conflicting information regarding biodiversity impacts, it would be very difficult to 

state unequivocally that the use of ammonia extracts has a positive impact on biodiversity. 

While there is a chance that these extracts do increase diversity, there is a very likely chance 

that they decrease biodiversity. 

References 

Bowles, T.M., Hollander, A. D., Steenwerth, K. L., Jackson, L. E.; 2015; Tightly-coupled plant-soil nitrogen 

cycling: Comparison of organic farms across an agricultural landscape. PLoS ONE 10(6): e0131888. 

Cassity-Duffey, K., Cabrera, M., et al.; 2020; Nitrogen mineralization from organic materials and 

fertilizers: Predicting N release; Soil Science Society of America Journal, March/April, 84:2, p. 522-533. 

Geisseler, D. A; 2014; Long-term effects of mineral fertilizers on soil microorganisms: A 

Review; Soil Biology & Biochemistry, 75:54-63. 

Hartz, T.K., Johnstone, P.R.; Nitrogen Availability from H-nitrogen containing organic fertilizers; 2006; 

Horttechnology, January-March 16:1, p. 39-42. 

Hijbeek, R. M.; 2017; Do organic inputs matter - a meta-analysis of additional yield effects for 

arable crops in Europe; Plant Soil, 411:293-303. 

Kramer, S. B, Reganold, J. P., Glover, J. D., et al.; 2006; Reduced nitrate leaching and enhanced 

denitrifier activity and efficiency in organically fertilized soils; Proceedings of the National Academy of 

Sciences 103, April p. 4522-4527. 

Lazicki, P., Geisseler, D., Lloyd, M.; 2020; Nitrogen mineralization from organic amendments is variable 

but predictable; Journal of Environmental Quality, March/April, 49:2, p. 483-495. 

Lori, M. S.; 2017; Organic farming enhances soil microbial abundance and activity - A meta-analysis 

and meta-regression; PLoS One, 12:e0180442. 

Magdoff, F., Van Es, H.; 2021; Building soils for better crops – ecological management for healthy soils; 

SARE Handbook Series Book 10, Fourth Edition. 

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Miner, G. L., Delagado, J. A., Ippolito, J. A., et al.; 2020; Assessing manure and inorganic nitrogen 

fertilization impacts on soil health, crop productivity, and crop quality in a continuous maize 

agroecosystem; Journal of Soil and Water Conservation, July, 75:4, p. 481-498. 

Ozlu, E., Sandhu, S. S., Kumar, S., et al.; 2019; Soil health indicators impacted by long-term cattle manure 

and inorganic fertilizer application in a corn-soybean rotation of South Dakota; Scientific Reports, 9:1, p. 

11776. 

Phelan, P. L., Mason, J. F., Stinner, B. R.; 1995; Soil-fertility management and host preference by 

European corn borer, Ostrinia nubilalis (Hiibner), on Zea mays L.: A comparison of organic and 

conventional chemical farming; Agriculture, Ecosystems and Environment, 56, p. 1-8. 

Sharaf, H., Thompson, A. A., Williams, M. A., et al.; 2021; Functional change in bacterial communities to 

fertilizer and rootstock; Soil Science Society of America Journal, July/August, 85:4, p. 1105-1121. 

Wang, X., Junliang, F., Guoce, X., et al.; 2018; The Effects of Mulch and Nitrogen Fertilizer on the Soil 

Environment of Crop Plants; Article in Advances in Agronomy, Chapter 3, October. 

The following are to be added at § 205.602 – non-synthetic substances prohibited for use in organic crop 

production as a new subsection , (j) ammonia fertilizers. Each type of ammonia fertilizer would be a 

separate subsection under ammonia fertilizers. For example: 

§205.602 

(j) ammonia fertilizers 

(i) Stripped ammonia 

(ii) Concentrated ammonia 

Stripped ammonia is intended to encompass a wide variation of novel thermo-mechanical derivations of 

steam stripping technology that result in ammonia-containing condensate, aqua ammonia, ammoniumcompound solutions, or any products thereof, such as further isolation of ammonium compounds into a 

solid by precipitation or solvent evaporation, and/or treatment with nitrifying bacteria. 

Concentrated ammonia is intended to focus on products with substantial levels of Am N and avoids 

products with minimal N. The limit on % ammoniacal nitrogen (greater than 3%) aligns with the OMRI 

category description for “Fertilizers with High Ammoniacal Nitrogen.” If both definitions are passed, the 

NOP could combine them into a single listing during rulemaking. 

Classification Motion: 

Motion to classify ammonia extracts as nonsynthetic 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

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National List Motions: 

Motion to add at §205.602, non-synthetic substances prohibited for use in organic crop production: 

Stripped Ammonia – created by separating, isolating and/or capturing ammonia or ammonium from an 

agricultural feedstock or other natural source using methods such as, but not limited to, steam stripping, 

pressurized air, heat, condensation, and/or distillation. 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Motion to add at §205.602, non-synthetic substances prohibited for use in organic crop production: 

Concentrated Ammonia – contains greater than 3% ammoniacal nitrogen and the total 

nitrogen content is predominately (i.e., >50%) in the ammonia or ammonium form. 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 7 No: 1 Abstain: 0 Absent: 0 Recuse: 0 

Motion to add at §205.203(f): Nitrogen products with a C:N ratio of 3:1 or less, including those that are 

components of a blended fertilizer formulation, are limited to a cumulative total use of 20% of crop 

needs. 

Motion by: Steve Ela 

Seconded by: Logan Petrey 

Yes: 7 No: 1 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP August 13, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Kasugamycin for Plant Disease Control 

July 20, 2021 

Summary of Petition: 

Kasugamycin is an antibiotic that inhibits bacterial protein synthesis and has been approved by the U.S. 

Environmental Protection Agency (EPA) for control of plant diseases, especially fire blight caused by 

Erwinia amylovora on apples and pears. The registered formulations are Kasumin 2L and Kasumin 4L 

containing the active ingredient kasugamycin hydrochloride hydrate. Kasugamycin is obtained by 

aerobic fermentation of the microorganism Streptomyces kasugaensis. The technical grade active 

ingredient, kasugamycin hydrochloride hydrate, was registered with the EPA in 2014 and a formulation 

Kasumin 2L containing two percent kasugamycin was registered in 2018. In 2020 Kasumin 4L containing 

four percent kasugamycin was registered with the EPA. Kasumin 2L and 4L were registered with a 

number of restrictions including those that prohibit application where animals are grazing or in areas 

where crops have been fertilized with animal or human waste. Users are also required to follow a 

resistance management plan. Applications are limited to four per year with California limiting 

applications to two per year. 

Summary of Review: 

Kasugamycin is an aminoglycoside antibiotic that is manufactured through fermentation and isolated as 

hydrochloride. Kasugamycin is a colorless solid at room temperature and is soluble in water. The 

hydrochloride has relatively low volatility and does not volatilize readily from soil into the air. 

Kasugamycin is characterized by the EPA as moderately persistent to persistent. A major source of 

degradation is aerobic microbial metabolism in soil with a half-life of 43-73 days. About 4% remains 

after a year. Hydrolysis in water is very slow and metabolites are also persistent (TR 278). Persistence 

on fruit is low and about half the amount applied to foliage ends up on the soil and non-target surface 

vegetation. Residues on fruit decrease 10-fold in 27-32 days. 

Kasugamycin has low acute toxicity to mammals and is classified EPA Category IV (least toxic, no warning 

label) for all exposures other than dermal, for which it is classified EPA Category III (next least toxic, 

requires "Caution" warning on label). It also has low chronic toxicity from rat feeding studies and there 

was no evidence of carcinogenicity in mice or was there evidence of chromosome damage. 

Normal labeled use of kasugamycin has led to field resistance in several pathogens. Kasugamycin was 

first used to control diseases of rice in Japan starting in 1965 with rice blast caused by Magnaporthe 

grisea and resistance was noticed in 1971. Field resistance in Acidovorax sp. occurred in 1990 and in B. 

glumae in 2001. In Florida, rapid field resistance to bacterial spot of tomato caused by Xanthomonas 

perforans was also seen. In orchards that had been treated at least once with kasugamycin studies 

found resistant bacteria in 401 field isolates from apple flowers, leaves and soil samples. Additionally, 

Erwinia resistance to kasugamycin has been generated in the laboratory. Kasugamycin has not been 

evaluated to determine if its use for orchard sprays would lead to kasugamycin-resistant pathogens in 

animals grazing orchard grass, but spraying orchard grass with streptomycin at concentration levels used 

for fire blight leads to an increase in antibiotic-resistant human pathogens found in sheep grazing on 

sprayed grass. (TR 805). 

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The TR contractor was asked to answer the question, “is kasugamycin susceptible to development of 

resistance with normal (labeled) use?” It was reported (TR 1152) that some level of resistance has 

occurred, and this is why the Kasumin label requires a resistance management plan. The plan includes 

use of kasugamycin as part of an IPM program and less than four applications per year (2 in California). 

The alternative to kasugamycin is an integrated organic program that attacks fire blight at every point in 

its life cycle. Cultural controls can be combined with application of fixed copper sprays in dormant and 

pre-bloom periods, application of lime sulfur for mildew control and thinning of apple blossoms, 

biological controls such as Aureobasidium pullulans products during bloom time, and bio-control 

antagonists such as Bacillus subtilis products later in the blooming period. Other organic procedures are 

also available to control fire blight, but they are more effective on the West Coast. 

Summary of Review: 

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or X Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

Kasugamycin is an aminoglycoside antibiotic that is manufactured through fermentation and 

isolated as hydrochloride. Kasugamycin is a colorless solid at room temperature and is soluble 

in water. The hydrochloride has relatively low volatility and does not volatilize readily from soil 

into the air. 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

The National Organic Standards Board (NOSB) was petitioned to add kasugamycin as an allowed 

synthetic to the synthetic substances National List at 7 CFR §205.601. Kasugamycin does 

contain an active synthetic ingredient: toxins derived from bacteria, as it is isolated from 

bacterial fermentation. 

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

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Kasugamycin is an antibiotic that inhibits bacterial protein synthesis and would not be 

expected to have chemical interactions with other materials used in organic farming. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)] 

Kasugamycin is characterized by the EPA as moderately persistent to persistent. A major source 

of degradation is aerobic microbial metabolism in soil with a half-life of 43 - 73 days. About 4% 

remains after a year. Hydrolysis in water is very slow and metabolites are also persistent (2021 

TR 278). Persistence on fruit is low and about half the amount applied to foliage ends up on the 

soil and non-target surface vegetation. Residues on fruit decrease 10-fold in 27-32 days. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

The probability of environmental contamination during manufacture is low because it is 

confined within a facility as a fermentation product. Kasugamycin is characterized as 

moderately persistent to persistent (U.S. EPA 2013). A major source of degradation is aerobic 

microbial metabolism in soil with a half-life of 43-73 days. About four percent remains after a 

year. Because laboratory studies used only one soil type, the EPA uses a 219-day soil half-life in 

persistence calculations (U.S. EPA 2013). Both aerobic and anaerobic degradation occurs. 

Aerobic degradation is faster than anaerobic. Typical aerobic half-life in water is seven days and 

half-life in sediment is 108 days. Anaerobic half-life was 32 days in water and 141 days in 

sediment (NYS 2015; U.S. EPA 2013). Hydrolysis in water is very slow, especially in acidic 

conditions (NYS 2015). Kasugamycin moves freely in sandy soil, less so in clay soils. It is likely to 

move both into surface water and ground water, but movement into ground water is less likely 

(U.S. EPA 2013). Because of soil movement, field dissipation is faster than molecular 

degradation seen in the laboratory. Field dissipation half-life in soil is 5.7 to 12.3 days. It does 

not volatilize readily from water or soil. Half-life of Kasugamycin in the gas phase is 1.6 hours 

(NYS 2015) (TR 264). 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)] 

Kasugamycin has low acute toxicity to mammals and is classified EPA Category IV (least toxic, 

no warning label) for all exposures other than dermal, for which it is classified EPA Category III 

(next least toxic, requires "Caution" warning on label). It also has low chronic toxicity from rat 

feeding studies and there was no evidence of carcinogenicity in mice or was there evidence of 

chromosome damage. 

Normal labeled use of kasugamycin has led to field resistance in several pathogens. 

Kasugamycin was first used to control diseases of rice in Japan starting in 1965 with rice blast 

caused by Magnaporthe grisea and resistance was noticed in 1971. Field resistance in 

Acidovorax sp. occurred in 1990 and in B. glumae in 2001. In Florida, rapid field resistance to 

bacterial spot of tomato caused by Xanthomonas perforans was also seen. In orchards that had 

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been treated at least once with kasugamycin studies found resistant bacteria in 401 field 

isolates from apple flowers, leaves, and soil samples. Additionally, Erwinia resistance to 

kasugamycin has been generated in the laboratory. Kasugamycin has not been evaluated to 

determine if its use for orchard sprays would lead to kasugamycin-resistant pathogens in 

animals grazing orchard grass, but spraying orchard grass with streptomycin at concentration 

levels used for fire blight leads to an increase in antibiotic-resistant human pathogens found in 

sheep grazing on sprayed grass. (2021 TR 805). 

The TR contractor was asked to answer a question about kasugamycin’s susceptibility to 

development of resistance with normal (labeled) use. It was reported (2021 TR 1152) that some 

level of resistance has occurred, and this is why the Kasumin label requires a resistance 

management plan. The plan includes use of kasugamycin as part of an IPM program and less 

than four applications per year (Two in California). 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

Up to five percent of applied amounts of kasugamycin move into surface water. Kasugamycin 

had the largest harmful effect on aquatic plants, especially blue-green algae. For duckweed, 

Lemna gibba, frond count was reduced with EC50 = 86 ppm. For green algae, 

Pseudokirchneriella subcapitata, 96-hour cell density was reduced with EC50 of 3.9 ppm. For 

blue-green algae, Anabaena flos-aquae, 96-hour cell density was reduced with EC50 of 0.65 

ppm (NYS 2015). The most sensitive plant tested was blue-green algae, Anabaena sp., with EC50 

0.65 ppm and a no-observed-adverse-effect concentration (NOAEC) of 0.08 ppm (U.S. EPA 

2013). Kasugamycin water contamination measured in rice paddy irrigation water was <2 ppm 

(Sheu et al. 2010). Huang et al. (2010) noted bacterial population changes when adding 

kasugamycin at high rates to river water microcosms in the laboratory. The EPA states that 

Kasugamycin is classified as practically non-toxic to freshwater and estuarine/marine fish and 

invertebrates on an acute exposure basis (U.S. EPA 2013). 

6. Are there any adverse impacts on biodiversity? (§205.200) 

Yes. There are subtle changes in the microbial population as some bacterial species develop 

kasugamycin resistance. As was stated in an earlier section, in orchards that had been treated 

at least once with kasugamycin studies found resistant bacteria in 401 field isolates from apple 

flowers, leaves and soil samples. It is also postulated that the microbial flora of animals that 

have grazed in orchards sprayed with kasugamycin could develop resistance as has been shown 

for other aminoglycoside antibiotics. Negative changes in the soil microflora are not in 

concordance with OPFA criteria for listing on the National List. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

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The alternative to kasugamycin is an integrated organic program that attacks fire blight at every 

point in its life cycle. Cultural controls can be combined with application of fixed copper sprays 

in dormant and pre-bloom periods, application of lime sulfur for mildew control and thinning of 

apple blossoms, biological controls such as Aureobasidium pullulans during bloom time, and biocontrol antagonists such as Bacillus subtilis later in the blooming period. Other organic 

procedures are also available to control fire blight, but they are more effective on the West 

Coast. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)] 

Kasugamycin has been in agricultural use since 1965. It has been used against a number of plant 

pathogens. In every instance, some level of resistance has occurred (Vallad et al. 2010; Yoshii et 

al. 2012). The EPA believes that resistance of the fire blight pathogen Erwinia amylovora to 

kasugamycin is possible, and the Kasumin label requires a resistance management plan. This 

plan includes use of kasugamycin as part of an IPM program and less than four applications per 

year (U.S. EPA 2018). (2021 TR 1145 

Given the history that antibiotics used in agriculture create microbial resistance, and that the 

NOSB has voted to remove other antibiotics in the same family, such as streptomycin, from the 

National List, the Crops Subcommittee finds that kasugamycin, is not compatible with a system 

of sustainable agriculture under OPFA criteria. 

Classification Motion: 

Motion to classify kasugamycin as synthetic 

Motion by: Rick Greenwood 

Seconded by: Steve Ela 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

National List Motion: 

Motion to add kasugamycin to the National List at §205.601(j)(4) for plant disease control 

Motion by: Rick Greenwood 

Seconded by: Amy Bruch 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP July 22, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Stabilized Hydronium used as a processing aid in organic crop production 

July 23, 2021 

Summary of Petition: 

Hydronium is being petitioned for use as a processing aid for pH adjustment not below 5.0 and as a 

stabilizer in the production of animal manures. It would be used to reduce malodorous properties of 

manures. 

Summary of Review: 

A survey of regulations for organic production from a number of countries and international 

organizations indicates that hydronium is not included within the Canadian Organic Standards as an 

allowed material. CODEX Alimentarius does not include a listing for hydronium nor is there a listing in 

the Japan Agricultural Standard (JAS) for Organic Production. Based on data submitted by the 

manufacturer, hydronium acts as a biocide but has not been approved by the EPA for that use. 

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or X Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

Hydronium is a mixture of sulfuric acid and calcium hydroxide. The sulfuric acid is produced from 

sulfur dioxide collected in pollution control scrubbers and the calcium hydroxide is produced by 

hydrating calcium oxide. Hydronium is a manufactured compound. 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from bacteria; 

pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock 

parasiticides and medicines and production aids including netting, tree wraps and seals, insect traps, 

sticky barriers, row covers, and equipment cleansers; or (ii) is used in production and contains 

synthetic inert ingredients that are not classified by the Administrator of the Environmental 

Protection Agency as inerts of toxicological concern? 

Hydronium was petitioned as an allowed synthetic substance for addition to the National List at 7 

CFR §205.601 (j) 7. Hydronium is used as a production aid and although it contains sulfur, very little 

sulfur is left in the final product. 

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Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

As described in the petition, hydronium would be used in small amounts as an addition to manures 

during processing and would not be expected to cause detrimental chemical interactions. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? [§6518(m)(2)] 

The compounds used to produce hydronium are listed as "food grade" and the company states that 

there are no hazardous compounds generated as by-products. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

The technology used to produce hydronium is rated as "non-hazardous" as rated by 3rd party 

testing and EPA 6-pack testing. There is no discharge waste material or air emissions during 

production. The probability of environmental contamination during production is low. 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

Based on EPA 6-pack testing hydronium is rated as non-hazardous, has a corrosivity rating similar to 

distilled water and does not induce amide hydrolysis on plant, animal, or human tissue. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including the 

salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

Hydronium is used in very small quantities and would not be expected to have any physiological 

effects on soil organisms or interact with chemicals in the agroecosystem. 

6. Are there any adverse impacts on biodiversity? (§205.200) 

Data submitted in the proposal demonstrates that hydronium has biocide properties, and the 

petitioner has requested that designation of the product from the EPA. To date, it has not been 

approved by the EPA. Because hydronium is a biocide it is expected to have an impact on the 

biodiversity of soil microorganisms with unknown effects. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

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OMRI lists over 2,000 pH adjustment aids/acidic compounds. Although many of them would 

probably not be applicable to the process of odor control of manure many organic acids could 

probably perform as hydronium is described. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)] 

No. Based on OPFA criteria and improving soil health, the biocide activity of this product and the 

lack of EPA approval make it incompatible with a system of sustainable agriculture. 

Classification Motion: 

Motion to classify hydronium as synthetic 

Motion by: Rick Greenwood 

Seconded by: Amy Bruch 

Yes: 8 No: 0 Abstain: 0 Absent: Recuse: 0 

National List Motion: 

Motion to add hydronium to the National List at 205.601(j)(7) as an organic processing aid 

Motion by: Rick Greenwood 

Seconded by: Steve Ela 

Yes: No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP July 31, 2021. 

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National Organic Standards Board 

Crops Subcommittee Petitioned Material Proposal 

Carbon Dioxide 

August 3, 2021 

Summary of Petition: 

The NOSB received a petition requesting the addition of synthetic carbon dioxide at §205.601 Synthetic 

substances allowed for use in organic crop production as (a) algicide, disinfectants, and sanitizer, 

including irrigation system cleaning systems and (j) As plant or soil amendments. 

Carbon dioxide is currently allowed for use as an ingredient in organic labeled processed food products: 

§205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products 

labeled as “organic” or “made with organic (specified ingredients or food group(s)).” (b) Synthetic 

allowed: - Carbon dioxide. 

This petition requests the allowance of carbon dioxide in organic crop production. 

Subcommittee Review: 

Carbon dioxide is understood to be a material with inherently low risk and is approved as a processing 

aid. Because carbon dioxide is a synthetic material, the Subcommittee discussions focused on the need 

and benefits of using carbon dioxide over other allowed alternatives? 

Category 1: Classification 

1. For CROP use: Is the substance _______ Non-synthetic or __X_____ Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

Carbon dioxide (empirical formula CO2, CAS Reg. No. 124-38-9) occurs as a colorless, odorless, 

noncombustible gas at normal temperatures and pressures. The solid form, dry ice, sublimates 

under atmospheric pressure at a temperature of −78.5 °C.

Carbon dioxide is prepared as a byproduct of the manufacture of lime during the “burning” of 

limestone, from the combustion of carbonaceous material, from fermentation processes, and 

from gases found in certain natural springs and wells. 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

Carbon dioxide falls under the category of production aid. 

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Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

Carbon dioxide is already allowed as an organic processing substance. It occurs naturally in the 

atmosphere, has little chemical interactions with other substances, and has no apparent 

negative effect on other materials used in organic farming systems. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)] 

The action to dissolve carbon dioxide (CO2) in water (H2O) makes carbonic acid (H2CO3): H20 + 

CO2 -> H2CO3. Carbonic acid is dissociated in water to: HCO3- + H+. This hydrogen lowers water 

pH. This is a common, naturally occurring reaction in the soil ecosystem from CO2 in the 

atmosphere. 

In soils with high pH, applying water with a reduced pH can increase nutrient availability and 

increase plant health. Additionally, the activity of carbon dioxide in water can help prevent 

clogging of irrigation systems by algae and other plant contaminants. 

CO2 can also be used for pest control in storage areas, however, that is not the subject of this 

petition. 

3. Describe the probability of environmental contamination during manufacture, use, misuse, or 

disposal of such substance? [§6518(m)(3)] 

As a basic component of the atmosphere, carbon dioxide has a high environmental persistence. 

This is not a negative, except to the overarching concern of global warming. At the rates 

occurring in the atmosphere, it is completely non-toxic and is exempt from having a lethal dose. 

The water pH adjustment process can be manually controlled, as well as automatically 

controlled, by adding a pH probe and controller that adjusts the carbon dioxide (CO2) injection 

to maintain target pH values in the water. Water cannot drop below pH 5.0 when carbonic acid 

(dissolved CO2) is used in the acidification process. This characteristic makes the use of carbonic 

acid the safer and most secure process for water pH adjustment when compared to alternatives. 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i);

§6518(m)(4)]. 

Suffocation can occur in pure carbon dioxide but is due to the lack of oxygen not toxicity of 

carbon dioxide. There are no other direct effects of human health from the substance. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

The use of dissolved carbon dioxide to reduce water pH is an acidifying method that occurs 

naturally, i.e.- atmospheric carbon dioxide from biological processes enters water through 

equilibrium. It dissolves in water, including water in soil solution, to form carbonic acid. Carbon 

acid breaks down into carbon dioxide. 

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6. Are there any adverse impacts on biodiversity? (§205.200) 

Carbon dioxide is a greenhouse gas and can contribute to climate change. Its increase in the 

atmosphere has altered the biodiversity in many ecosystems. However, the use of this product 

in accordance with the petition will not add to the increase of carbon dioxide. The petitioned 

use is for carbon dioxide produced as a byproduct of other processes. The carbon dioxide would 

be released to the atmosphere regardless of the petitioned use. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

Alternatives used in organic production to lower pH levels in irrigation water are sulfur 

“burners” and citric acid. Because water pH cannot drop below 5.0 when carbon dioxide is used 

as an acidifier, this method may be considered more secure as a pH adjustment compared to 

alternatives. 

Sulfur burners create sulfurous acid by dissolving the fumes of burning sulfur in irrigation water. 

Sulfur is an odorless, tasteless, light-yellow solid usually sold in blocks or pellets. Sulfurous acid 

is slightly irritating to the skin, and strongly irritating to the eyes of rabbits. Under acidic 

conditions, sulfurous acid may liberate sulfur dioxide, which is known to induce respiratory 

irritation in humans. 

Citric acid is a non-synthetic widely used in food processing. It is used as an ingredient, 

acidulant, pH control agent, flavoring, and as a sequestrant. It is used as a dispersant in flavor or 

color additives. Citric acid has GRAS status (generally recognized as safe) by the FDA 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Because carbon dioxide is approved as an organic processing substance, is already being 

produced, and its listing at §205.601 would be considered a recycling process, the Crops 

Subcommittee finds it compatible with a system of sustainable agriculture. 

Classification Motion: 

Motion to classify carbon dioxide as synthetic 

Motion by: Logan Petrey 

Seconded by: Rick Greenwood 

Yes: 7 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

National List Motion: 

Motion to add carbon dioxide at §205.601 

Motion by: Logan Petrey 

Seconded by: Brian Caldwell 

Yes: 7 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP August 3, 2021 

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National Organic Standards Board 

Crops Subcommittee Proposal 

NOP Request to Review Lithothamnion Classification 

August 3, 2021 

I INTRODUCTION: 

Lithothamnion is a genus of coralline marine red algae containing 103 species, some of which have 

calcareous deposits within their cell walls. It is sometimes considered a plant in the botanical 

classification Rhodophyta within Archaeplastida, but other times is not included in the stricter definition 

of “plant”, Viridiplantae [https://en.wikipedia.org/wiki/Plant]. In common usage, seaweeds such as 

lithothamnion, kelp, etc. are called plants. 

Biology and use 

According to The Seaweed Site https://www.seaweed.ie/uses_general/corallinealgae.php : 

“A number of crustose, calcareous red algae (Corallinaceae) grow detached in shallow waters and 

accumulate to form large beds of stone-like algae on the coasts of north western Europe and in the 

western Mediterranean, México (Baja California), and Brazil. These are collectively known as "maërl", 

"coral" or "coral sand" in north-western France, Britain and Ireland (Blunden, Binns & Perks 1975). 

Scientifically, they are also known as "rhodoliths". 

“The two most common species in the north-eastern Atlantic are Phymatolithon calcareum [apparently 

a synonym for L. calcareum] and lithothamnion corallioides, growing from 0-8 m (occasionally to 32 m) 

in the subtidal of quiet bays with clear Atlantic water off the coasts of Spain, France, England, Scotland, 

and Ireland, and in the Mediterranean. Similar species form such beds in clear waters throughout the 

world, such as the Gulf of Mexico, Arctic Canada, Indonesia. The algal thallus is made up of successive 

layers of calcium (and some magnesium) carbonates, which may account for up to 80% of the wet 

weight. 

Maërl is dredged off the coast of Brittany, at Falmouth in England, in Bantry Bay, Ireland, and in Iceland, 

dried, ground, and sold as a soil additive, for animal feed supplements, as a water filtration agent, and as 

a natural anti-osteoporosis remedy. Over 500,000 t are harvested each year from live and dead deposits, 

although annual amounts are declining, mainly due to the exhaustion of resources, particularly in 

France. 

In Ireland, about 20,000 tonnes of subfossil maërl is harvested from a site in Bantry Bay”. 

The species Lithothamnium calcareum is, besides tricalcium phosphate, often used as food fortification 

in plant-based milk substitutes to achieve a similar calcium content as a cow milk. 

https://en.wikipedia.org/wiki/Lithothamnion 

A U.S. Food and Drug Administration (FDA) generally recognized as safe (GRAS) notice has been 

published for seaweed-derived calcium for the intended use: “in foods in general as a source of dietary 

calcium for food enrichment and fortification purposes at various levels that range up to 4.0 percent.” 

[https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices&id=28&sort=GRN_No&order= 

DESC&startrow=1&type=column&search=GRN%20No%2E%C2%A4DECIMAL%C2%A428] 

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Harvest 

Lithothamnion superpositum [=lithothamnion crispatum] is a species found off the coast of South 

America and is used in calcium-enrichment food products and supplements. It’s typically a kiwi- or 

lemon-sized ball of purplish calcified algae that attaches to seaweed on the ocean floor. According to a 

manufacturer, “At a certain point, it’s washed onto shore in a protected eco-marine park and 

sustainably hand-harvested.” 

Certifiers that the NOP consulted provided the following additional information: 

• Lithothamnion superpositum [sic] [should be L. calcareum] algae species have life spans between 

50-100 years and appear to favor the volcanic sand/gravel deposits along the coastline shelves 

near to the shore of Iceland, most concentrated in the West Fjords. During their life span, the 

algae fronds accumulate seawater minerals, calcifying the fronds. Calcified pieces of the algae 

break off the live plants, and currents move this material to lower shelves further offshore. 

• Harvesting in Brazil is done by dredging dead calcareous skeleton sediment material of 

lithothamnion algae (algae shells), that has detached and accumulated in deposit areas by tide 

movements, from deep waters off the continental shelf of Brazil. Harvesting in Iceland is done 

by dredging calcified marine algae from (dead) lithothamnion sp. from mines in the sea (100 

yards or more offshore, avoiding the live plants) in fjords. 

• After harvest, lithothamnion is washed/heat treated, dried, milled, and packaged. 

II BACKGROUND: 

A lithothamnion product was petitioned to be added to the National List in February 2007 (see “Calcium, 

Seaweed Derived” on the USDA Petitioned Substances webpage). [The petition and NOSB 

recommendation can be found under “calcium, seaweed derived” at: 

https://www.ams.usda.gov/sites/default/files/media/Calcium%20Seaweed%20Petition.pdf] 

In 2008, the NOSB recommended that “calcium, seaweed derived” did not need to be considered for 

addition to §205.605(a) “since use of this material is currently allowed through the existing listing of 

Nutrient Minerals on the National List §205.605(b).” 

Since the 2008 NOSB recommendation, the NOP has received questions about whether USDA organic 

regulations allow the certification of lithothamnion. Organic certification allows organic handlers to use 

ingredients in organic products without the content counting as part of the 5 percent nonorganic 

ingredient component. The NOP previously informed a certifier that lithothamnion is a nonagricultural 

product and therefore cannot be certified organic. Since then, the NOP has learned that two certifiers 

certify lithothamnion under the wild crop portion of the USDA organic regulations. Additionally, seven 

operations are certified to handle organic lithothamnion, identified in the Organic Integrity Database as: 

“Lithothamnium,” “Lithothamnion superpositum,” “Lithothamnion sp.,” “Lithothamnion,” and 

“Lithothamnion calcareum.” Certifiers did not clarify how an agricultural determination was made. 

In March 2021, the NOP sent a memo to the NOSB requesting that the NOSB address the classification 

of collected lithothamnion as “agricultural” or “nonagricultural” and if it may be certified as a “wild 

crop” under the USDA organic regulations. 

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III RELEVANT AREAS OF THE RULE: 

Related definitions from section 205.2 of USDA organic regulations: 

Agricultural product. Any agricultural commodity or product, whether raw or processed, including any 

commodity or product derived from livestock, that is marketed in the United States for human or 

livestock consumption. 

Nonagricultural substance. A substance that is not a product of agriculture, such as a mineral or a 

bacterial culture, that is used as an ingredient in an agricultural product. For the purposes of this part, a 

nonagricultural ingredient also includes any substance, such as gums, citric acid, or pectin, that is 

extracted from, isolated from, or a fraction of an agricultural product so that the identity of the 

agricultural product is unrecognizable in the extract, isolate, or fraction. 

Wild crop. Any plant or portion of a plant that is collected or harvested from a site that is not maintained 

under cultivation or other agricultural management. 

According to NOP Guidance 5033, the decision tree 5033-2 should be used to determine whether a 

substance is classed as Agricultural or Nonagricultural under the NOP. In this case, the substance is 

collected lithothamnion; that is, lithothamnion as harvested, before any processing. 

IV DISCUSSION: 

The Decision Tree for Classification of Agricultural and Nonagricultural Materials for Organic Livestock 

Production or Handling (NOP 5033-2), step 1, asks, “Is the substance a mineral or bacterial culture as 

included in the definition [above] of nonagricultural substances in section 205.2 of USDA organic 

regulations?” 

The answer is not simple. Harvested lithothamnion consists of dead parts of an algae, harvested for 

their mineral content. Further, it is not a product of agriculture. Note that an example in decision tree 

5033-2 classifies kelp, which is somewhat similar, as agricultural. However, the NOSB feels that the 

classification turns on the fact that kelp is harvested live, whereas dead parts of lithothamnion are 

harvested as a mineral. Thus, the answer is yes, thereby classifying lithothamnion as nonagricultural. 

Can a nonagricultural substance be classified as organic? Perhaps, if it is a wild crop. 

Is lithothamnion a wild crop? Guidance 5022 (National Organic Program wild-crop harvesting practice 

standard) states, “Eligible species can be plant or other non-animal species, such as mushrooms, kelp, or 

seaweed, that are fixed to a defined location by a species part, such as a root, holdfast, mycelial thread, 

rhizoid, or stolon.” Based on the definition and guidance above, and allowing for common usage of the 

word, “plant”, the NOSB determines that lithothamnion is not a wild crop, because it is not a live plant 

or part of a live plant, and is not fixed to a defined location. 

Lithothamnion is similar to diatomaceous earth, peat, or limestone—originally living tissues that after 

death are accumulated into deposits that can be mechanically harvested. 

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V RECOMENDATION: 

Based on the above considerations, lithothamnion is classified as a nonagricultural substance. According 

to NOP Guidance 5022 lithothamnion is not a wild crop since it is not fixed to a defined location by a

species part, therefore it cannot be certified organic. 

Vote in Crops Subcommittee: 

Motion to classify lithothamnion as a nonagricultural substance 

Motion: Brian Caldwell 

Seconded by: Amy Bruch 

Yes:- 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Motion that lithothamnion does not meet wild crop criteria and is not eligible to be certified to the wild 

crop standard.

Motion: Brian Caldwell 

Seconded by: Steve Ela 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP August 6, 2021. 

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National Organic Standards Board 

Crops Subcommittee Proposal 

Biodegradable Biobased Mulch Film 

August 13, 2021 

I. Summary of biodegradable biobased mulch film 

The NOP rescinded policy memorandum 15-1 in October 2019, stating that it was redundant with 

current regulations. The requirement for 100% biobased feedstocks is articulated in the preamble of the 

final rule and the status quo remains. Removal of the policy memorandum provides an opportunity for 

the NOSB to revise the current definition (§ 205.2) to consider reducing the biobased content 

requirement. The Crops Subcommittee is now planning to vote on an annotation at the Fall 2021 

meeting addressing biodegradable mulch (BDM) film that is not 100% biobased. 

II. Discussion 

Biodegradable biobased mulch film has been on the National List of approved synthetic substances 

since September 30, 2014, based on an October 2012 NOSB recommendation. Historical information on 

this material is as follows: 

Reference on the National List: § 205.601(b) As herbicides, weed barriers, as applicable (2) Mulches 

(iii) Biodegradable biobased mulch film as defined in §205.2. Must be produced without organisms or 

feedstock derived from excluded methods. 

Technical Report: 2012 TR; 2015 Report; NOP Policy Memorandum 15-1; Supplemental Technical 

Evaluation Report 2016 

Petition(s): 2012 

Past NOSB Actions: 10/2012 NOSB Recommendation; Memo to the NOSB with Report on 

Biodegradable Biobased Mulch Films in Organic Crop Production (Michigan State University, September 

2019) (pdf). 

Recent Regulatory Background: Final Rule published 09/30/14 (79 FR 58655); Sunset renewal notice 

published 10/08/2019, 84 FR 53577 

Background from Subcommittee 

Biodegradable biobased mulch films were approved for placement on the National List of approved 

synthetics (Biodegradable Mulch Film Made from Bioplastics) without detailing if non-biobased content 

would be allowed. The vast majority of mulch films in this category contain 20% or less of biobased 

materials (i.e., carbon sources are ~80% petroleum derived). There are some products that might meet 

the biobased aspect of this material’s definition on at §205.2, but they are either not biodegradable or 

are not used in production due to brittleness or other production issues. 

In January 2015, the National Organic Program issued Policy Memorandum 15-1, to clarify that 

biodegradable biobased mulch film must not contain any non-biobased synthetic polymer feedstocks. 

The NOSB requested a limited scope technical report (TR) in 2016. The questions asked for this 

limited scope TR from 2016 were as follows: 

1. What is the effect on overall soil health, including soil biology, when this materialbiodegrades? 

2. What is the cumulative effect of the continued use of this biodegradable biobased mulch film, 

on soil nutrient balance, soil biological life, and soil tilth, when used in the same area of the 

field for 3-5-10 years? 

3. What effect does the breakdown of these polymers have on soil and plant life as well as 

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livestock that would graze either crop residues or forages grown the subsequent year after this 

mulch film was used? 

4. Are there different cropping systems, climate, soil types or other factors that affect the 

decomposition rate (Examples would be long cold winters, or exceptionally dry conditions, such 

as found in a desert)? 

5. Are there metabolites of these mulches that do not fully decompose, and if so, is there an effect 

upon soil health or biological life? 

The TR focused on biobased biodegradable mulches that contain polymers and the soil and crop health 

effects they may have as they biodegrade. This supplemental TR was inconclusive, since research on 

these materials is currently limited, and the questions above were not answered to the NOSB crop 

subcommittee’s satisfaction. 

An argument can be made that even though the non-biobased polymers degrading into the soil 

originate from petroleum (a nonrenewable fossil fuel), the use of this product could be considered 

environmentally friendly because: 

• Many organic production systems rely on enormous amounts of fossil fuel-derived plastic, 

mostly polyethylene (PE) films, to produce organic crops; 

• PE films likely shed micro plastics and leach chemicals into organic soil over the growing 

season; 

• Before and during removal, PE films can tear and breakdown, leaving plastic in the soils or 

migrating off-site into aquatic habitats; 

• PE films are generally not recyclable due to contamination by soils or the lack of recycling 

infrastructure; 

• Plastic used in annual production systems end up in landfills; 

• Biodegradable mulches potentially save labor and time, and likely fuel, since the mulch does 

not have to be removed from the field and transported for disposal; 

The current listing of biodegradable mulch on the National List is aspirational: there are no products on 

the market that are commercially viable made from 100% biobased carbon sources (i.e., no petroleum). 

In fact, some public commenters have recommended that BDM films be taken off the National List 

since the 100% biobased requirement essentially prohibits use of these materials. Despite the lack of 

products meeting the annotation, the NOSB reviewed this material for its five-year sunset renewal in 

2017 and decided to relist it as written, with the understanding that there were no products on the 

market that were commercially viable made from 100% biobased materials. The Crops Subcommittee 

felt more information was needed that addressed the key questions above before considering a change 

to the annotation. The Crops Subcommittee also felt that if biodegradable mulch remained on the 

National List manufacturers would be able to develop a product that met the requirement of 100% 

biobased “ingredients”, which was the preferred outcome. 

The National Organic Program also reached out to Dr. Ramani Narayan, a researcher with the 

Department of Chemical Engineering and Materials Science at Michigan State University, to provide 

more information beyond the Technical Report, which was completed in 2016, to the NOSB. The focus 

of Dr. Narayan’s report is the biodegradability of both biobased and petroleum-based mulch films with 

limited research on the effect of these products degrading into the soil over time. Section 2.7 of the 

reportstates: 

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Environmental studies have not shown any adverse impacts associated with the incorporation of 

biodegradable mulch films (BDMs) into the soil to date. More research is needed to monitor any 

potential formation of terrestrial micro and nanoplastics from biodegradable mulch films and 

ensure that there is no residual soil ecotoxicity. There is need for tuning the physicochemical 

properties of the biodegradable mulch films with the needs of specific cropping systems and 

climates .... Sintim et al. showed that there was no significant effect on soil health over two 

years of monitoring and that the soil microbial communities did not differ much either. They 

found significant enrichment in bacterial and fungal gene copies under BDM treatments over 2 

years, but no significant change under PE and no mulch. Another important observation was 

that repeated tillage of BDMs into the soil across 4 years did not impact crop yield significantly 

and had no major effect on crop quality. 

While this section points out possible negative issues with some polymers used in the biodegradable 

mulch, the majority of the report focused on the positive aspects when the mulch does biodegrade. The 

report also discussed current regulations that protect organic integrity and would not allow the use of 

excluded methods (some of the polymers are extracted from petroleum through the use of bacteria 

created through excluded methods) and do not allow materials to be used that “contribute to 

contamination crops, soil or water.” Organic producers in the European Union are allowed to use 

petroleum based biodegradable mulch with no requirement on the percentage of bio-based ingredients. 

The EU will be reviewing these mulches in 2024 with possible changes to their annotation. 

Key concerns of current and past NOSB members 

include the possibility of soil, aquatic, and other 

environmental contamination by partially 

decomposed BDM films even if the materials pass 

ASTM laboratory-based standards. Of particular 

concern to NOSB members is the possibility that 

BDM films will not decompose thoroughly in dry or 

cold environments where there is less biological activity in 

soils. A related concern is that BDM films ploughed into 

soils may be out of reach of peak biological activity to break 

it down. For example, most soil biological activity occurs in 

the top 4-6 inches, with only a small fraction below that 

level. If ploughing results in BDM film plastic mixed into soil 

7-10 inches deep, there may be fewer microbiotic fauna 

available to consume BDM carbon sources. Figures 2 and 3 

show examples of relatively complete biodegradation after less than one year and another case where 

visible material after 2 months “burial” (source: https://eorganic.org/node/8260). 

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Organic Strawberry PE Film Plasticulture (Source: 

https://ucanr.edu/blogs/blogcore/postdetail.cfm?p 

ostnum=31015&) 

Extensive public comments and up-to-date 

scientific reviews have been submitted to the 

NOSB, and in some cases submitters note 

sampling and/or other analytic methods are not 

yet developed enough to answer all questions 

about potential residues in soil. 

The Board has also weighed the merits of 

comparing the risk to soils and the environment 

from BDM films versus risk from PE films. Board 

members are torn on this issue. Use of plastic in 

organic production is increasing rapidly. Many 

small- and large-scale growing systems, 

such as organic “plasticulture” strawberry 

production, are highly dependent on PE films, with 

thousands of acres of plastic used annually to 

essentially containerize soil, resulting in enormous 

amounts of plastic waste and agricultural soil and 

general environmental contamination (see figures). 

For example, the Monterey County Regional Waste 

Management District in California receives 5,700 

tons (11.4 million lbs.) of agricultural plastic 

annually. Based on the acreage of organic 

strawberries, (approximately 20%), up to ~1-2 

million lbs. is likely from organic fields each year. 

Board members are also concerned about the 

Monterey County Agriculture 

Plastic Waste – Organic and 

Conventional. Source: P. Krone, 

NOAA 

precedent of allowing petroleum-derived products 

to be added directly to soils. The comparative risk of the two production aids leaves 

some organic community members uncomfortable. In essence, the thinking is “I don’t think the reason 

to add a new material to the National List should be because we’re trying to mitigate the harms caused 

by another NL material.” 

Precedents of Allowing the Addition of Petroleum Products to Soil 

The National List currently allows the use of petroleum-derived products on organic soils. For example, 

horticultural mineral oils used in crop production are refined from petroleum. Mineral oils are closer in 

chemistry to petroleum jellies and paraffin, versus 

other more volatile and toxic petroleum constituents. 

However, these materials pose some environmental 

and health risks, and their use on crops results in 

direct entry into soil ecosystems. 

The NOSB is also proposing allowance of paper pots 

as planting aids, with the listing to read as follows: 

Paper-based crop planting aid. A material that is 

comprised of at least 60% cellulose-based fiber by 

weight, including, but not limited to, pots, seed tape, 

and collars that are placed in or on the soil and later 

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incorporated into the soil, excluding biodegradable mulch film. Up to 40% of the ingredients can be nonsynthetic, other permitted synthetic ingredients at §205.601(j), or synthetic strengthening fibers, 

adhesives, or resins. Contains no less than 80% biobased content as verified by a qualified third-party 

assessment (e.g., laboratory test using ASTM D6866 or composition review by qualified personnel). 

Added nutrients must comply with §§205.105, 205.203, and 205.206. 

This proposal requires 80% biobased content, but allows 20% of the material to be non-biobased, 

potentially including nylon and other non-biodegradable plastics in the paper pots. The paper-pot 

proposal is notable because it allows the direct application of non-biodegradable plastics to soil, although 

the long-term hope is that future products will be 100% biobased. Paper-pot production aids are 

generally used by small farmers and their contribution to soil plastics is likely to be small compared to the 

thousands of acres of soil covered by PE films and their possible future BDM film replacements. 

Possible Use Restrictions 

The Board has considered several options to guide use of BDM films with less than 100% biobased 

content, if they are approved. Specifically: 

1. Allow BDM film use followed by ploughing into soil (with some consideration for off-site 

transport), with monitoring and assessment to determine whether there are adverse 

impacts; 

2. Restrict BDM film use based on soil types and climates where the BDM film may not 

biodegrade rapidly; 

3. Allow BDM film use but require that it be gathered up at the end of the season followed by 

on-farm or off-farm composting. 

In response to public comments, the Crops Subcommittee has concluded that Option 1, above, is the 

only reasonable option on which to vote. Soil types and climate are complex, and it is not possible to 

pre-identify regions and growing practices where use of the BDM films may or may not work (Option 2). 

Finally, Option 3 does not work because the films become brittle toward the end of the season and 

cannot be removed intact for later composting. 

Public commenters at the April 2021 meeting remain divided, although many farmers and certifiers 

agreed reducing the requirement of 100% biobased content by a small margin is reasonable. Groups 

supporting the change included, Oregon Tilth, OWPC, MOSA, PCO, QCS, VOF, NOFA. Many farmers also 

supported the change. Those opposed included NOC, BP, MOGFA, Cornucopia, and OEFFA, raising 

concerns about the product being “not ready for prime time”, the potential for environmental 

contamination, the replacement of plant-based mulches, and that use may not reduce use of PE film-based 

plasticulture on soils. 

III. Proposal 

Weighing the risks and benefits of using PE and BDM films, the Crops Subcommittee proposes to allow 

BDM films that are at least 80% biobased by weight, with the remaining 20% by weight consisting of 

materials that meet one of the following composting standards: ASTM D6400, ASTM D6868, EN 13432, EN 

14995, or ISO 17088 (all incorporated by reference; see § 205.3). The CS understands that this 

recommendation is still aspirational in the sense that no current BDM films meet the 80% biobased 

content criteria. However, several manufacturers have reported that producing 80% biobased film may be 

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feasible, and this proposal sets a realistic goal. The CS recommends that use of >80% biobased material be 

required if and when these materials become available, The CS also recommends ongoing monitoring of 

new research on BDM and other plastic films and that the NOSB should consider changes to this 

annotation as information and new products become available. 

The CS proposes the following annotation change for biodegradable biobased mulch film: 

§205.601 Synthetic substances allowed for use in organic crop production. 

(iii) Biodegradable biobased mulch film as defined in §205.2. Must be produced without organisms or 

feedstock derived from excluded methods. 

§205.2. 

Biodegradable biobased mulch film. A synthetic mulch film that meets the following criteria: 

(1) Meets the compostability specifications of one of the following standards: ASTM D6400, ASTM D6868, 

EN 13432, EN 14995, or ISO 17088 (all incorporated by reference; see § 205.3); 

(2) Demonstrates at least 90% biodegradation absolute or relative to microcrystalline cellulose in less than 

two years, in soil, according to one of the following test methods: ISO 17556 or ASTM D5988 (both 

incorporated by reference; see § 205.3); and 

(3) Must be at least 80% biobased with content determined using ASTM D6866 (incorporated by 

reference; see § 205.3). 

Vote in Crops Subcommittee 

Motion to accept the biodegradable biobased mulch film annotation recommendation. 

Motion by: Asa Bradman 

Seconded by: Brian Caldwell 

Yes: 7 No: 1 Abstain: 0 Absent: Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP August 15, 2021. 

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National Organic Standards Board 

Crops Subcommittee Proposal 

National List Technical Correction for Sodium Nitrate 

July 27, 2021 

Background: 

The NOSB seeks to make a technical correction to the listing for sodium nitrate. While sodium nitrate 

still appears on the National List of Allowed and Prohibited Substances (National List) with an annotation 

limiting its use (7 CFR 205.602(g) – prohibited nonsynthetic), the sunset review of sodium nitrate has 

been suspended. The current listing reads: 

Sodium nitrate – unless use is restricted to no more than 20 percent of the crop’s total nitrogen 

requirement; use in spirulina production is unrestricted until October 21, 2005. 

According to the sunset provision in OFPA, sodium nitrate was supposed to sunset from the National List 

on October 21, 2012. At that time, the sunset process required the NOSB to vote to relist a substance 

for it to remain on the National List. If the NOSB voted to not renew a substance, it would be referred to 

the NOP for rulemaking to remove it from the List. The current process differs in that the NOSB must 

vote to remove a substance from the list, otherwise the substance remains on the List. 

As part of the 2012 sunset review, the NOSB reviewed sodium nitrate at its April 2011, meeting and 

recommended that it be relisted, but without the annotation limiting its use. In other words, the NOSB 

voted to keep sodium nitrate on the National List with a complete prohibition on its use. During the 

rulemaking process, the NOP received comments about the economic significance of complete 

prohibition, which delayed rulemaking. While that rulemaking was supposed to be forthcoming, it was 

never developed nor passed. 

Currently the listing for sodium nitrate is in limbo. It was never renewed on the National List as a 

prohibited substance with or without the annotation limiting its use. While the wording remains on the 

National List, the listing is considered invalid. Therefore, sodium nitrate use is not restricted to 20% of a 

crop’s total N needs since the listing was not renewed during the 2012 sunset process. It can also be 

argued that at this time sodium nitrate should not even appear on the National List since it was never 

officially renewed. 

Subcommittee Review: 

In order to remedy and clarify this technical issue, stakeholders have asked the NOSB to formally 

reinstate the listing for sodium nitrate. This proposal is not intended to be a review about whether 

sodium nitrate should be listed with a 20% cap or be completely prohibited. While this Board notes that 

the previous NOSB voted for a complete prohibition, in order to ensure that sodium nitrate isn’t allowed 

for unlimited use, this Board recommends a formal motion to recognize the current listing and have it 

reviewed every five years as part of the sunset cycle. A future Board, or petitioner, can submit a petition 

for a complete prohibition and that can be debated separately from the resolution of the technical issue 

that is at currently at hand. 

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Subcommittee Vote: 

Motion to reinstate the listing of sodium nitrate at 7 CFR 205.602(g) - prohibited nonsynthetic: 

Sodium nitrate - unless use is restricted to no more than 20 percent of the crop’s total nitrogen 

requirement; use in spirulina production is unrestricted until October 21, 2005. 

Motion by: Steve Ela 

Seconded by: Brian Caldwell 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Rick Greenwood, Crop Subcommittee Chair, to transmit to NOP July 27, 2021. 

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Sunset 2023 

Meeting 2 - Review 

Crops Substances § 205.601 & § 205.602 

October 2021 

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 scheduled for sunset review by the 

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

List for use in organic crop production 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, use 

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

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

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

Substances Database. 

Request for Comments 

Written public comments will be accepted through September 30, 2021 via www.regulations.gov. 

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

§205.601 Sunsets: Synthetic substances allowed for use in organic crop production: 

• Copper sulfate (§205.601(a)(3) & §205.601(e)(4)) 

• Ozone gas 

• Peracetic acid (§205.601(a)(6) & §205.601(i)(8)) 

• EPA List 3 - Inerts of unknown toxicity 

• Chlorine materials 

o (i) Calcium hypochlorite 

o (ii) Chlorine dioxide 

o (iii) Hypochlorous acid - generated from electrolyzed water 

o (iv) Sodium hypochlorite 

• Magnesium oxide 

§205.602 Sunsets: Nonsynthetic substances prohibited for use in organic crop production: 

• Calcium chloride 

• Rotenone (CAS # 83-79-4) 

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Copper sulfate 

Reference: §205.601(a)(3) Copper sulfate - for use as an algicide in aquatic rice systems, is limited to one 

application per field during any 24-month period. Application rates are limited to those which do not 

increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited 

certifying agent; and, 

§205.601(e)(4) Copper sulfate—for use as tadpole shrimp control in aquatic rice production, is limited to 

one application per field during any 24-month period. Application rates are limited to levels which do not 

increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited 

certifying agent. 

Technical Report: 1995 TAP (Copper Sulfate and Other Coppers); 2001 TAP; 2011 TR 

Petition(s): 2001 

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 04/2011 

recommendation; 10/2016 sunset recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 11/03/2013; Sunset renewal notice 

effective 5/29/2018 (83 FR 14347) 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Copper sulfate is used as an algicide for rice crops, as the growth of algal matting in flooded fields can 

dislodge young seedlings. It is broadcast aerially into the flooded rice fields by plane. Rice farmers also 

spray copper sulfate to control a freshwater invertebrate, Triops longicaudatus, otherwise known as 

tadpole shrimp. Tadpole shrimp are only detrimental to very young seedlings, as their burrowing activities 

can disrupt the seedling roots and the first emerging leaves. 

Manufacture 

Copper sulfate is manufactured by treating copper metal with hot concentrated sulfuric acid. Copper oxides 

can be treated with a more dilute sulfuric acid to produce copper sulfate. Copper sulfate is also known as 

copper vitriol. 

International Acceptance 

While the majority of rice is grown in Asian countries, the top ten countries that contribute to global 

organic rice production include Italy and the USA, as shown in the table below. 

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Figure 1. Top producers of organic rice globally (Willer and Yuseffi 2007). 

Canadian General Standards Board Permitted Substances List 

• Permitted for use as a wood preservative, fungicide on fruit and vegetables or for disease 

control. 

• Shall be used with caution to prevent excessive copper accumulation in the soil. Copper buildup 

in soil may prohibit future use. 

• Visible residue of copper products on harvested crops is prohibited. 

• There is very little rice grown in Canada, but the organic rice grown in Abbottsford is farmed 

without copper sulfate and using the seedling transplanting method that eliminates the need 

for copper sulfate. 

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

Chemicals Agency (ECHA) 

• The EU does not permit copper sulfate for use in organic rice production. 

• ECHA states copper sulfate “is very toxic to aquatic life, is very toxic to aquatic life with long lasting 

effects, may cause cancer, may damage fertility or the unborn child, is harmful if swallowed, causes 

serious eye damage, may cause damage to organs through prolonged or repeated exposure, causes 

skin irritation and may cause an allergic skin reaction.” 

Japan Agricultural Standard (JAS) for Organic Production 

• Copper sulfate is only permitted in organic agriculture as a fungicidal spray, not for use in rice 

fields. 

Environmental and Human Health Issues 

Copper is readily dissolved and suspended in the water and is lethal to fish and other aquatic organisms at 

fairly low concentrations. In amphibians, increasing concentrations of copper can alter behavior, reduce 

growth rates and final size, and at higher concentrations can result in death. Copper also has algicidal 

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effects and can disrupt the food chain in aquatic environments. For this reason, its direct introduction into 

flooded rice fields is contentious, particularly since rice fields serve as replacement wetlands for many flora 

and fauna in agricultural areas like Northern California. Previous comments to the NOSB have highlighted 

specific concerns that the application rates in organic rice fields in California are several times higher than 

the amounts known to be toxic to native amphibian species. 

In the soil, copper concentrates heavily in the topsoil and over time, leads to resistant fungal strains, as well 

as altering the soil microbiota and killing soil-dwelling animals such as earthworms. Copper toxicity in the 

soil can reduce the growth and nutrient value of crop plants, as well as damage the integrity of root 

systems (Van Assche and Clijsters, 1990). Because it accumulates in the soil over time and eventually results 

in poor plant outcomes, its use as a sustainable practice is called into question. 

Copper sulfate has been shown to be toxic to bees, particularly in tropical environments. At sub-lethal 

levels, the heavy metal also changes behavior and movement ability of bees (Rodrigues et al, 2016). Despite 

this, there are multiples statements on the National Pesticide Information Center (NPIC) and in US 

Environmental Protection Agency Office of Pesticide Programs documents stating that copper sulfate is 

virtually non-toxic to bees. This is an important issue to clarify. The role that bees play in the pollination of 

commercial crops globally should make the use of copper sulfate a concern to farmers and the general 

public alike. 

Copper sulfate has been classified as a human carcinogen by the European Chemicals Agency (ECHA), with 

specific concern for renal cancers (Buzio et al, 2002). Chronic exposure to fungicidal sprays elevated the risk 

of renal cancers by almost 3 times. While copper binds to soils readily, copper contamination of drinking 

water sources would also be a concern. 

Discussion 

Copper sulfate is a difficult substance to evaluate, as there appears to be broad consensus throughout the 

US, EU, and Canada that it is hazardous to both human health and the environment. Despite this, its use has 

repeatedly been extended in all three jurisdictions, as there isn’t yet a viable organic alternative for copper 

in certain applications. The EU, Canada, and Japan all exclude copper sulfate for organic rice production but 

allow it as a fungicidal spray in organic orchards and vineyards. 

In terms of copper sulfate use in rice paddies to control tadpole shrimp, it appears that there may be ways 

to circumvent the need for chemical control. The tadpole shrimp emerge from eggs and most hatch within 

1-3 days of flooding. Tadpole shrimp primarily cause injury to the rice through chewing young roots and 

shoots and disrupting the roots with burrowing activities (Tindall and Fothergill, 2012). The shrimp do not 

injure older seedlings once they have reached the water surface and roots are well established in the soil. 

In fact, at this later stage in seedling development, the tadpole shrimp can be beneficial to the crop by 

controlling algae and mosquitos. 

Transplanting in older seedings eliminates any threat from algal mats to the delicate young seedling stage, 

as do practices such as dry seeding the rice or ensuring that the rice is seeded directly at the time of 

flooding. Interestingly, transplanting seedlings has been the preferred method of rice production 

throughout most of human rice cultivation. In Asian rice cultivation, the tadpole shrimp are often 

deliberately introduced as a means of controlling algae and mosquitos. The current approach of flooding 

the fields and then direct wet-seeding didn’t gain popularity until broad chemical use was implemented and 

has been demonstrated to marginally reduce costs and increase yields. 

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It may be time to research alternate algicides and other means of controlling tadpole shrimp. It appears 

that to date there is sufficient evidence to conclude that: 

1) use of copper sulfate in rice fields can cause environmental damage, 

2) alternative seeding practices could eliminate the need for copper sulfate as both algae and tadpole 

shrimp cease to be problematic once seedlings are established and 

3) international standards do not allow for spraying of copper sulfate for organic rice production. 

Despite these points, public comment, and interviews with organic rice farmers, certifying agencies, and 

former board members have all highlighted the ongoing need for copper sulfate until alternative 

herbicides/insecticides are available. According to these sources, abrupt de-listing would have a 

tremendous negative impact on US-grown organic rice. 

Subcommittee Review 

Much of the Crops Subcommittee’s review of copper sulfate centered on public comments and on 

interviewing stakeholders after the Spring 2021 NOSB meeting. There were in excess of twenty-five written 

and oral comments with the overwhelming majority in favor of keeping copper sulfate on the National List. 

Two of the organizations most opposed to the use of copper sulfate did not advocate immediate delisting, 

but rather, strongly urged the program to: Get serious about “Continuous Improvement” and to put some 

real effort into finding alternative methods or materials that would limit or end its use. 

The Crops Subcommittee recommends re-listing copper sulfate and has called for a comprehensive review 

of copper sulfate as part of its Research Priorities for 2021. 

References 

o Buzio L, Tondel M, De Palma G, et al. (2002) Occupational risk factors for renal cell cancer. An Italian 

case-control study. La Medicina del Lavoro. 93(4):303-309. 

Rodrigues C, Krüger A, Barbosa W, Guedes R (2016) Leaf fertilizers affect survival and behavior of the 

Neotropical Stingless Bee Friesella schrottkyi (Meliponini: Apidae: Hymenoptera) , Journal of Economic 

Entomology, 109(3):1001–1008. 

o Tindall K, Fothergill K (2012) Review of a new pest of rice, Tadpole Shrimp (Notostraca: Triopsidae), in 

the midsouthern United States and a winter scouting method of rice fields for preplanting 

detection. Journal of Integrated Pest Management 3 (3):B1–B5. 

o Van Assche F, Clijsters H (1990) Effects of metals on enzyme activity in plants. Plant Cell Environ. 

13:195-206. 

o Willer, Helga & Yussefi, Minou. (2007). The World of Organic Agriculture - Statistics and Emerging 

Trends 2007. 

Justification for Vote 

The Subcommittee proposes removal of copper sulfate from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove copper sulfate from the National List at 205.601(a)(3) and 205.601(e)(4) 

Motion by: Jerry D’Amore 

Seconded by: Rick Greenwood 

Yes: 2 No: 6 Abstain: 0 Absent: 0 Recuse: 0 

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Ozone gas 

Reference: §205.601(a)(5) Ozone gas—for use as an irrigation system cleaner only. 

Technical Report: 2002 TAP; 2021 TR 

Petition(s): 2001 

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation; 10/2016 sunset recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Ozone gas is a strong oxidant and works by oxidizing plant tissue and bacterial membranes. It is used as an 

antimicrobial agent to clean irrigation lines. It has been used in Europe for more than 100 years to treat 

drinking water and it has been used in the United States to disinfect water and to oxidize color and taste 

contaminants in water. Ozone is found in the atmosphere at levels of 0.05 ppm but at levels of 0.5 ppm in 

cities with smog. 

Manufacture 

Ozone is usually formed by combining an oxygen molecule with an oxygen atom in an endothermic 

reaction. Because ozone is unstable it is generated at the point of use. It can be generated by irradiating 

oxygen-containing gas with UV light and the other technologies, but the primary industrial method is by 

corona discharge. There are generally four system components to an ozone generating process; a power 

source or ozone generator, a gas source, an ozone delivery system, and an off-gas destruction system. The 

gas source may be air, high purity oxygen or a combination of the two. 

International acceptance 

The 2021 TR of ozone noted the following: 

Canadian General Standards Board Permitted Substances List - not listed 

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

- ozone not listed. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

- listed as an equipment cleanser and equipment disinfectant. 

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

Organically Produced Foods (CXG 32-1999) - not listed 

Japan Agricultural Standard (JAS) for Organic Production - ozone is not listed for water treatment. 

Human Health and Environmental Issues 

When ozone gas is used for water treatment it oxidizes or disinfects many components that impact water 

quality and could result in crop iron deficiencies. It will oxidize iron and manganese, which precipitate as 

ferric and manganese hydroxides. Ozone partially oxidizes organic matter to forms that are more easily 

biodegradable. It is also germicidal against many types of pathogenic organisms including viruses, bacteria, 

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and protozoa. It is rated as a strong irritant via inhalation, and irritating to skin, eyes, and mucous 

membranes. Ozone systems that inject directly into irrigation lines use relatively low concentrations of 

ozone and there is little potential for off-gassing. In water, ozone decomposes rapidly and the only 

decomposition product is oxygen, as opposed to chlorine, which can generate trihalomethanes. Cleaning of 

irrigation lines should not lead to problems with soil structure because most of the ozone is contained in 

the irrigation tubing. 

Discussion 

Ozone is still in active use by the organic community. One certifier indicated that ozone is listed in 50 

organic system plans (OSPs). The users include wineries, mushroom operations, and grain handlers. There 

were 17 public comments at the 2021 Spring NOSB meeting, and all were in favor of relisting ozone gas on 

the National List. 

Justification for Vote 

The Subcommittee proposes removal of ozone gas from the National List based on the following criteria in 

the Organic Foods Production Act (OPFA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove ozone gas from the National List 

Motion by: Rick Greenwood 

Seconded by: Amy Bruch 

Yes: 0 No: 6 Abstain: 0 Absent: 2 Recuse: 0 

Peracetic acid 

Reference: §205.601(a)(6) Peracetic acid—for use in disinfecting equipment, seed, and asexually 

propagated planting material. Also permitted in hydrogen peroxide formulations as allowed in §205.601(a) 

at concentration of no more than 6% as indicated on the pesticide product label; and, 

§205.601(i)(8) Peracetic acid - for use to control fire blight bacteria. Also permitted in hydrogen peroxide 

formulations as allowed in §205.601(i) at concentration of no more than 6% as indicated on the pesticide 

product label. 

Technical Report: 2000 TAP; 2016 TR 

Petition(s): 2008 

Past NOSB Actions: 11/2007 recommendation; 11/2009 annotation change; 12/2011 sunset 

recommendation; 10/2016 sunset recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset Review 

10/09/2008 (73 FR 59479); Annotation change 05/28/2013 (78 FR 31815); Sunset renewal notice effective 

5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

In organic crop production, peracetic acid, or PAA, is used to disinfect equipment. It can also be used as a 

disinfectant to treat seeds or asexually propagated planting material. It can be used to disinfect pruning 

equipment to help prevent the spread of the fire blight bacterium and is also used in one of the hydrogen 

peroxide formulations for control on the tree canopy of this same disease. PAA is also used in formulations 

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of hydrogen peroxide, allowed at a concentration of no more that 6%, for use in organic crop production. 

Peracetic acid was relisted during the 2016 sunset review for Handling and the 2017 sunset review for 

Livestock. Peracetic acid is an unstable oxidizing agent, which makes it an effective sanitizer. 

First industrially developed in 1950, it has historically been used to treat fruits and vegetables to reduce 

spoilage from bacteria and various fungi. It is used to treat bulbs, to disinfect potting soil, clean irrigation 

equipment, and as a seed treatment to inactivate fungi or other plants diseases. Additionally, in organic 

crop production it is also used as a bactericide/fungicide in wash waters to help decrease Escherichia coli 

O157:H7 on some fruit and vegetable crops. With the removal of two antibiotics previously allowed for use 

in organic crop production to assist in fire blight reduction, use of this substance as part of a rotational 

control and fire blight prevention program has increased in recent years, according to information provided 

by some organic stakeholders during public comment periods. 

Manufacture 

According to the 2016 Technical Report (TR), solutions of peracetic acid, hydrogen peroxide, acetic acid, 

and water are produced by reacting glacial acetic acid with hydrogen peroxide, frequently in the presence 

of a catalyst such as a mineral acid (e.g., sulfuric acid). Most commercially available PAA solutions contain a 

synthetic stabilizer and chelating agent such as HEDP (1-hydroxyethylidene-1, 1-diphosphonic acid) or 

dipicolinic acid (2, 6-dicarboxypyridine) to slow the rate of oxidation or decomposition. 

PAA appears to be a straightforward material in that it is made from, and decomposes back to, acetic acid, 

oxygen, and water. PAA is a very strong oxidizing agent and can be produced by the interaction between 

methyl (or acetaldehyde) and air, or by mixing acetic acid and hydrogen peroxide (methyl itself derives 

from plants, commonly coffee, bread grains, and ripe fruit). It can also be produced within laundry 

detergents and is considered a more effective bleach than hydrogen peroxide. 

International Acceptance 

Canadian General Standards Board Permitted Substances List- permits the use of peracetic (peroxyacetic) 

acid at paragraph 4.3 (Crop Production Aids and Materials) with the following annotation: “Permitted for: a) 

controlling fire blight bacteria; and b) disinfecting seed and asexually propagated planting material”. This 

allowance is consistent with NOP regulations. 

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

not listed in Annex II – Pesticides – plant protection products. Nonetheless, as of June 1, 2012, the 

European Union and the United States have an equivalency agreement whereby organic products certified 

to the USDA or European Union (EU) organic standards may be sold and labeled as organic in both the 

U.S.A. and the EU. 

Codex - Not listed. 

Japan Agricultural Standard (JAS) for Organic Production - Not listed in the Japanese Agricultural Standard 

for Organic Production. However, the United States entered into an equivalency agreement with Japan, 

effective on January 1, 2104. The scope of the arrangement is limited to plants and plant-based products 

which undergo final processing, packaging, or labeling within the boundaries of those two countries. 

IFOAM - The IFOAM norms permit the use of peracetic acid for cleaning equipment and/or disinfecting 

equipment with no final rinse (IFOAM Appendix 4, Table 2), for pest and disease control, and for 

disinfection of livestock housing and equipment (IFOAM Appendix 5). 

Human Health and Environmental Issues 

If misused, peracetic acid can irritate eyes, skin, and breathing. 

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Discussion 

Peracetic acid was registered by the EPA for indoor antimicrobial use in 1985. In the December 2, 2011 

NOSB recommendation for the 2013 sunset review of peracetic acid for the two Crops listings at § 

205.601(a)(6) and § 205.601(i)(8), the Board clarified the annotation change from the 2009 

recommendation and supported it. 

The original recommended annotation change was: 

§205.601(a)(6) Peracetic acid—for use in disinfecting equipment, seed, and 

asexually propagated planting material. Permitted in hydrogen peroxide 

formulations at concentration of no more than 5%. 

§205.601(i)(8) Peracetic acid—for use to control fire blight bacteria. Permitted in 

hydrogen peroxide formulations at concentrations of no more than 5%. 

This annotation was later implemented by the NOP with a slight change. The recommended 5% limit was 

changed to a 6% limit, based on information provided during public comment stating the recommended 5% 

limit was too low compared to percentages in use at the time. This point of concern was discussed at the 

Spring which year? NOSB meeting and it was decided that this slight increase in the percentages was 

necessary to adequately accommodate use rates. 

While there do appear to be other materials that could be used as possible alternatives, peracetic acid is 

selected for use by many organic crop producers for many reasons: it is a strong oxidizing compound, it 

works well in cold conditions, it does not give off chlorine into the environment, it is used as part of a 

rotation process in fire blight disease control, and it is the more benign of the sanitizers and disinfectants, 

since it reverts back to acetic acid, oxygen, and water in the environment. It has also been described as a 

no-rinse material. This information was provided during public comment and can be found in the 2016 TR. 

Concerns about the various forms of peracetic acid mentioned in the 2016 TR were raised during public 

comment submitted for the Spring 2016 NOSB meeting. The NOSB determined the majority of those other 

sources (that were raising a concern) would not be allowed for use in organic crop production or other 

currently allowed uses, as currently shown on the National List. Several commenters mentioned that all 

sanitizers and disinfectants should be looked at to determine need and to prioritize allowed uses. The NOSB 

determined this request was outside of the scope of this specific sunset review and would need to be 

addressed as a separate issue/topic. 

Other public comments mentioned that the implementation of the Food Safety Modernization Act (FSMA), 

which oversees an enhanced approach to food safety at the farm and handling levels, places an even higher 

degree of necessity in having this material and/or other sanitizers available for use in organic crop 

production. 

There was overwhelming support for the continued (relisting) of peracetic acid for use in organic crop 

production. While a few commenters took a neutral position, there were no commenters, either during the 

written or oral public comment periods, that were specifically opposed to the relisting of peracetic acid. 

Based on the information provided (comments, new TR, etc.), discussion during public comment periods 

(in-person, webinar, and written), and Subcommittee review and discussion, the NOSB determined this 

material satisfies the OFPA Evaluation criteria and the Crops Subcommittee supported the relisting of 

peracetic acid. Additionally, peracetic acid was relisted during the 2016 Sunset review for Handling and the 

2017 Sunset review for Livestock. 

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–

Summary of Public Comments 

There is widespread use of peracetic acid by many stakeholders, and it is generally considered to be critical 

to the sanitizer, cleaner, and disinfectant toolkit as one of the most benign and effective materials available 

for crop-specific uses. Many certifiers report that it is a sanitizer in increasingly widespread use. 

Organic producers consider peracetic acid essential to ensure food safety and compliance with food safety 

regulations under FSMA. Stakeholders broadly support the need for a comprehensive technical review of 

sanitizers and listing of sanitizers on the National List itemized “by specific use or application” with clear 

identification of the hazards to humans and the environment (NOC, 2020). Further, restructuring the 

National List so that cleaners, sanitizers, and disinfectants have a designated category would help to ensure 

certified operations understand which cleaners, sanitizers, and disinfectants may be used, and it would 

facilitate better organic education. Overall, a unique category on the National List could help the NOSB in 

its review of cleaners, sanitizers, and disinfectants, and it could support the use of alternative, less toxic 

materials, when their use can meet strict food safety standards (OTA, 2021). Establishing a separate 

sanitizer listing on the National List is beyond the scope of this sunset review but the Crops Subcommittee – 

in coordination with the Handling Subcommittee -- will recommend a work agenda item to advance these 

suggestions. 

Justification for Vote 

The Subcommittee proposes removal of peracetic acid from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove peracetic acid from the National List 

Motion by: Wood Turner 

Seconded by: Jerry D’Amore 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

EPA List 3 Inerts of unknown toxicity 

Reference: §205.601(m)(2) EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone 

dispensers. 

Technical Report: N/A 

Petition(s): N/A 

Past NOSB Actions: 10/2002 meeting minutes and vote (see pheromones); 11/2007 recommendation; 

05/2012 recommendation; 08/2015 recommendation to change annotation at 7 CFR §205.601(m); 10/2016 

sunset recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset Review 

10/09/2008 (73 FR 59479); Sunset Review 10/03/2013 (78 FR 61154); Sunset renewal notice effective 

5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

The annotation for EPA List 3 inerts limits their use in organic crop production to passive pheromone 

dispensers. The dispensers are generally manufactured as either tubes that contain pheromones or as an 

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impregnated substance containing the pheromone. Passive pheromone dispensers may be used to trap and 

monitor insect populations, or they may be used for control of a pest through pheromone mating 

disruption. For trapping, the pheromone-impregnated dispenser is placed in a trap and the insect catch is 

monitored to determine when an economic threshold is reached, and the particular insect needs to be 

controlled. For pheromone mating disruption, the dispensers are tied to branches of trees or placed in such 

a manner that they are distributed throughout an area being covered by the pheromones. Throughout the 

season, the design of the pheromone dispensers regulates the volatilization of pheromones into the air. 

Once in the air of the production area, the pheromones act to disrupt mating by interfering with the insect 

communication systems. A wide variety of insects, mostly Lepidoptera, can be managed with pheromones 

including codling moth, peach twig borer, peach crown borer, leafrollers, pink bollworm, boll weevil, gypsy 

moth, and others. When they are placed in the production area, the pheromone dispensers are not in 

contact with the organic product being grown but are instead suspended from the trees or plants. Since the 

pheromone dispensers do not contact the product grown, there is no movement of the pheromones into 

the product. Passive pheromone dispensers are different from other forms of dispensers such as 

microencapsulated products, which are sprayed throughout the production area and could be in direct 

contact with the fruit or other product being grown. 

Manufacture 

Manufacture varies based on which List 3 inert is being used, so will not be addressed. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Synthetic and non-synthetic pheromones and semiochemicals are permitted. For pest control. Use in 

pheromone traps or passive dispensers. 

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

Pheromones, Attractant; sexual behaviour disrupter; only in traps and dispensers. 

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

Organically Produced Foods (GXG 32-1999) 

Pheromone preparations for traps. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Pheromones – in traps and dispensers only. 

Japan Agricultural Standard (JAS) for Organic Production 

Limited to the agent containing sex pheromone activity for pest as active ingredient. 

Human Health and Environmental Issues 

Passive pheromone dispensers used to monitor insects are crucial to integrated pest management 

programs in that they help to determine the size and impact of insect populations. The use of passive 

pheromone dispensers for mating disruption often precludes the need for other chemical controls. When 

used with adequate sanitation practices, monitoring, biocontrol methods, and environmental controls, 

pheromones can be effective in controlling certain Lepidoptera insects. Without pheromone use, and 

despite the other natural controls listed, insecticides may be needed for control of a specific pest insect. 

Insecticides may be either natural or synthetic but would most often be applied directly to the product 

being grown and might require preharvest intervals. While pheromones are very specific to individual insect 

species, other insecticides may be broader spectrum and affect more species than those requiring control 

and may have more detrimental environmental impacts. 

NOSB Proposals and Discussion Documents October 2021 85 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other potential environmental issues relate to the number of pheromone dispensers containing List 3 inerts 

used per acre. Often maximum applications are in the range of 400 dispensers per acre. Information from 

the package of one manufacturer lists 8% other ingredients which may include List 3 inerts, and that the 

total amount of pheromone applied per acres is 50 grams. Given the small amount of pheromone applied, 

there is a very small volume of List 3 inerts applied to any given acre. This application rate is very low when 

compared to the amounts of allowed List 4 inerts applied in spray materials or the amount of synthetics 

applied in allowed newspaper mulch. While application of any material to organic acreage should be 

considered, it is also important to consider the scale of the application. In addition, the ingredients other 

than pheromones are heavier than the pheromone itself and remain inside the dispenser. Thus, the List 3 

inerts are not dispersed into the atmosphere and do not have direct crop contact. 

The manufacture of pheromones may have possible environmental impacts, but because these materials 

are grouped together as List 3 inerts, these impacts cannot be independently categorized. 

Discussion 

For reference, the old EPA lists can be found at: https://www.epa.gov/pesticide-registration/categorizedlists-inert-ingredients-old-lists. 

As noted in the 2020 review of List 4 inerts, the List 3 inerts listing is also outdated because EPA no longer 

maintains these lists. Thus, the process to review materials for addition or removal is broken. The listing for 

List 3 inerts is more specific than that for List 4 inerts in that it is limited to only those materials needed for 

and used in passive pheromone dispensers. These dispensers do not come into direct contact with the 

agricultural product being produced, whether they be used for trapping or mating disruption. 

During the previous review the NOSB supported the recommendation that inerts be moved into a separate 

listing, containing all inert ingredients, with a subheading for inert ingredients used in passive pheromone 

dispensers. However, the process recommended by the NOSB in that review was not initiated, therefore 

the current review of these materials is similar to the previous review. As with List 4 inerts, the NOSB 

strongly recommends and asks the National Organic Program to develop an alternative to the List 4/List 3 

references that would allow for review (and addition or removal) of inerts and that would not rely on an 

antiquated list. Public comments from prior reviews supported moving quickly with an annotation change 

so that the List 3 inerts could be systematically and thoroughly reviewed. 

However, NOSB, in prior reviews, found that these materials are an essential component of passive 

pheromone dispensers, have a history of use in organic farming, and have reduced the use of many other 

pest control products. The specificity of the annotation leads to limited use in very controlled situations. 

There was no new information that caused the NOSB to question the safety to human health or the 

environment. In prior reviews, public commenters supported moving quickly with the annotation change so 

that the List 3 inerts, as well as the other inerts, could be systematically and thoroughly reviewed. The 

continued need for pheromones in organic production was a common theme in the public comments. 

Subcommittee Review 

Comments received at the Spring 2021 NOSB meeting were similar to the comments received for the List 4 

inerts review in 2020. The prohibition of List 3 inerts prior to establishment of a new system would cause 

significant disruption to the availability of essential pest control tools for organic production. Removing List 

3 inerts from the National List would severely limit the ability of organic growers to control and monitor a 

number of crop-threatening pests. There are no natural control alternatives to control these pests. 

Comments noted that only the pheromones, not the List 3 inerts, are released from the dispensers and that 

the pheromones themselves do not have direct contact with the organic crop. 

NOSB Proposals and Discussion Documents October 2021 86 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–

While these pheromone products with their accompanying List 3 inerts are critical to organic growers, 

strong concern was expressed by stakeholders regarding the reference to a defunct EPA list. As with List 4 

inerts, a new, current, reference system must be developed for the List 3 inerts. This is critical so that the 

inerts can be reviewed, new materials can be added to this category, and problematic materials can be 

removed. Stakeholders and the NOSB implore the NOP to move forward on a current method of listing 

these inerts in a parallel process to List 4 inerts. 

Other stakeholders had concerns about possible health effects from some List 3 inerts and that it is difficult 

to establish what inerts are being used. One group suggested that it is quite likely that at least some of the 

List 3 substances would be found to be acceptable if they were individually reviewed by the NOSB, but the 

broad listing does not the support the integrity of the organic label. 

Justification for Vote 

The Subcommittee proposes removal of EPA List 3 from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove EPA List 3 from the National List 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 1 No: 7 Abstain: 0 Absent: 0 Recuse: 0 

Chlorine materials Calcium hypochlorite 

Reference: §205.601(a) - As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. (2) Chlorine materials -For pre-harvest use, residual chlorine levels in the water in direct crop 

contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual 

disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible 

sprout production according to EPA label directions. 

(i) Calcium hypochlorite 

Technical Report(s): 1995 TAP; 2006 TR; 2011 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 NOSB sunset recommendation; 04/2011 

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547), Sunset renewal notice 

3/21/2017 (82 FR 14420); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 10/30/2024 

Subcommittee Review 

Use 

Calcium hypochlorite is an Environmental Protection Agency (EPA)-registered pesticide (PC Code 014701). 

Calcium hypochlorite is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (SDWA) 

(currently 4mg/L expressed as Cl2). 

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Calcium hypochlorite is an "indirect" food additive approved by the Food and Drug Administration (FDA). 

Calcium hypochlorite may be used as a final sanitizing rinse on food-processing equipment (21 CFR 

178.1010). Calcium hypochlorite also can be used in postharvest, seed, or soil treatment on various fruit 

and vegetable crops (EPA, 1991). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the FDA or the EPA for such purposes. Rinsing with potable water 

that does not exceed the maximum residual disinfectant limit for the chlorine material under the SDWA 

must immediately follow this permitted use. Certified operators should monitor the chlorine level of the 

final rinse water, the point at which the water last contacts the organic product. The level of chlorine in the 

final rinse water must meet limits as set forth by the SDWA. Water used as an ingredient in organic food 

handling should not exceed the maximum residual disinfectant limit for the chlorine material under the 

SDWA, as required by the Organic Food Production Act (7 U.S.C. 6510(a)(7)). 

In water, calcium hypochlorite separates into calcium and hypochlorite ions, and hydrochlorous acid 

molecules. Hypochlorous acid molecules are neutral and small in size. As a result, when hypochlorous acid 

molecules exist in equilibrium with the hypochlorite ions, they easily diffuse through the cell walls of 

bacteria. This changes the oxidation-reduction potential of the cell and inactivates 3-phosphate 

dehydrogenase, an enzyme which is essential for the digestion of glucose. Inactivation of this enzyme 

effectively destroys the microorganism's ability to function. 

Manufacture 

Calcium hypochlorite is produced by passing chlorine gas over hydrated (slaked) lime. It is then separated 

from the coproduct, calcium chloride, and air dried or vacuum dried. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

International Federation of Organic Agriculture Movements (IFOAM) Norms - Equipment 

cleaner/disinfectant 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposures occur or from chronic lower-level exposures – especially in 

occupational environments when these materials are used on a daily basis. Chlorine compounds are 

dermal, respiratory, ocular, and mucous membrane irritants. In addition, sodium hypochlorite (bleach) can 

cause asthma, as classified by the Association of Occupational and Environmental Clinics 

(http://www.aoecdata.org/ExpCodeLookup.aspx Code 332.10). Given the similar chemical properties and 

mechanisms of action, other chlorine-based oxidant sanitizers are also likely to cause asthma. Chlorine 

compounds are toxic to fish and other aquatic organisms. Strict adherence to the label is required when 

used, including the use of personal protective equipment when appropriate. Use of chlorine compounds in 

organic processing and crop production have been reviewed in 2006 and 2011 Technical Reports (TR) 

(referenced above). 

NOSB Proposals and Discussion Documents October 2021 88 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been deemed essential to ensure food safety and to comply with food safety regulations under the Food 

Safety Modernization Act (FSMA). The Crops Subcommittee (CS) generally supports continued listing of 

chlorine materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for 

post-harvest handling and processing. The CS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic materials, when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Many organic stakeholders commented that chlorine materials are essential to ensure food safety and 

compliance with food safety regulations under the FSMA. Public comment and Board discussions reflect 

concerns about the use of chlorine materials in organic crop production due to potential impacts on human 

health and the environment. Some public comments outline the need for a comprehensive technical review 

of sanitizers and listing of sanitizers on the National List itemized “by specific use or application” with clear 

identification of the hazards to humans and the environment (NOC, 2020). Further, restructuring the 

National List with a designated category for cleaners, sanitizers and disinfectants would help to ensure 

certified operations understand which cleaners, sanitizers and disinfectants may be used, and would 

facilitate better organic education. Overall, a unique category on the National List could help the NOSB in 

its review of sanitizers, cleaners, and disinfectants, and could support the use of alternative, less toxic, 

materials when their use can meet strict food safety standards (OTA, 2021). Establishing a separate 

sanitizer listing on the National List is beyond the scope of this sunset review but the Crops Subcommittee – 

in coordination with the Handling Subcommittee -- will recommend a work agenda item to advance these 

suggestions. 

Justification for Vote 

The Subcommittee proposes removal of calcium hypochlorite from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove calcium hypochlorite from the National List 

Motion by: Wood Turner 

Seconded by: Logan Petrey 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

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Chlorine materials – Chlorine dioxide 

Reference: §205.601(a) - As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. (2) Chlorine materials - For pre-harvest use, residual chlorine levels in the water in direct crop 

contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual 

disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible 

sprout production according to EPA label directions. 

(ii) Chlorine dioxide 

Technical Report(s): 1995 TAP; 2006 TR; 2011 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 NOSB sunset recommendation; 04/2011 

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547), Sunset renewal notice 

3/21/2017 (82 FR 14420); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 10/30/2024 

Subcommittee Review 

Use 

Chlorine dioxide is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (currently 

4mg/L expressed as Cl2). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the Food and Drug Administration (FDA) or the Environmental 

Protection Agency (EPA) for such purposes. Rinsing with potable water that does not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA must immediately follow this permitted 

use. Certified operators should monitor the chlorine level of the final rinse water, the point at which the 

water last contacts the organic product. The level of chlorine in the final rinse water must meet limits as 

set forth by the SDWA. Water used as an ingredient in organic food handling should not exceed the 

maximum residual disinfectant limit for the chlorine material under the SDWA, as required by the Organic 

Food Production Act (7 U.S.C. 6510(a)(7)). 

Chlorine dioxide is a strong oxidant. It is likely a better bactericide than hypochlorous acid. In general, the 

disinfection efficiency of chlorine dioxide decreases as temperature decreases. 

Manufacture 

To form chlorine dioxide, sodium chlorate (NaClO3) and sulfuric acid (H2SO4) are reacted with sulfur 

dioxide (SO2), or chloric acid (Cl-H-O3) is reacted with methanol (CH3OH) (HSDB, 2005). Alternatively, 

chlorine dioxide can be formed with chlorine (Cl2) and sodium chlorite; sodium hypochlorite with 

hydrochloric acid; potassium chlorate with sulfuric acid; or by passing nitrogen dioxide through a column of 

sodium chlorate. 

NOSB Proposals and Discussion Documents October 2021 90 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

International Federation of Organic Agriculture Movements (IFOAM) Norms - Equipment 

cleaner/disinfectant 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposures occur or from chronic lower level exposures – especially in 

occupational environments when these materials are used on a daily basis. Chlorine compounds are 

dermal, respiratory, ocular, and mucous membrane irritants. Sodium hypochlorite (bleach) can cause 

asthma, as classified by the Association of Occupational and Environmental Clinics 

(http://www.aoecdata.org/ExpCodeLookup.aspx Code 332.10). Given the similar chemical properties and 

mechanisms of action, other chlorine-based oxidant sanitizers are also likely to cause asthma. Chlorine 

compounds are toxic to fish and other aquatic organisms. Strict adherence to the label is required when 

used, including the use of personal protective equipment when appropriate. Use of chlorine compounds in 

organic processing and crop production have been reviewed in 2006 and 2011 Technical Reports (TR) 

(referenced above). 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been deemed essential to ensure food safety and to comply with food- safety regulations under the Food 

Safety Modernization Act (FSMA). The Crops Subcommittee (CS) generally supports continued listing of 

chlorine materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for 

post-harvest handling and processing. The CS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic, materials when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Many organic stakeholders commented that chlorine materials are essential to ensure food safety and 

compliance with food safety regulations under the FSMA. Public comment and Board discussions reflect 

concerns about the use of chlorine materials in organic crop production due to potential impacts on human 

health and the environment. Some public comments outline the need for a comprehensive technical review 

of sanitizers and listing of sanitizers on the National List itemized “by specific use or application” with clear 

identification of the hazards to humans and the environment (NOC, 2020). Further, restructuring the 

National List with a designated category for cleaners, sanitizers and disinfectants would help to ensure 

certified operations understand which cleaners, sanitizers and disinfectants may be used, and would 

facilitate better organic education. Overall, a unique category on the National List could help the NOSB in 

its review of sanitizers, cleaners and disinfectants, and it could support the use of alternative, less toxic, 

materials when their use can meet strict food safety standards (OTA, 2021). Establishing a separate 

sanitizer listing on the National List is beyond the scope of this sunset review but the Crops Subcommittee – 

in coordination with the Handling Subcommittee -- will recommend a work agenda item to advance these 

suggestions. 

Justification for Vote 

The Subcommittee proposes removal of chlorine dioxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

NOSB Proposals and Discussion Documents October 2021 91 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

– –

Subcommittee Vote 

Motion to remove chlorine dioxide from the National List 

Motion by: Wood Turner 

Seconded by: Logan Petrey 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Chlorine materials Hypochlorous acid generated from electrolyzed water 

Reference: §205.601(a) - As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. (2) Chlorine materials -For pre-harvest use, residual chlorine levels in the water in direct crop 

contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual 

disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible 

sprout production according to EPA label directions. 

(iii) Hypochlorous acid - generated from electrolyzed water. 

Technical Report(s): 1995 TAP (Chlorine materials); 2006 TR (Chlorine materials); 2011 TR (Chlorine 

materials); 2015 TR (Hypochlorous acid) 

Petition(s): 2015 

Past NOSB Actions: 04/2016 recommendation to add 

Recent Regulatory Background: Added to NL 12/27/2018 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Hypochlorous acid is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (currently 

4mg/L expressed as Cl2). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the Food and Drug Administration (FDA) or the Environmental 

Protection Agency (EPA) for such purposes. Rinsing with potable water that does not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA must immediately follow this permitted 

use. Certified operators should monitor the chlorine level of the final rinse water, the point at which the 

water last contacts the organic product. The level of chlorine in the final rinse water must meet limits as 

set forth by the SDWA. Water used as an ingredient in organic food handling should not exceed the 

maximum residual disinfectant limit for the chlorine material under the SDWA, as required by the Organic 

Food Production Act (7 U.S.C. 6510(a)(7)). 

Hypochlorous acid molecules are neutral and small in size. As a result, when hypochlorous acid molecules 

exist in equilibrium with hypochlorite ions, they easily diffuse through the cell walls of bacteria. This 

changes the oxidation-reduction potential of the cell and inactivates 3-phosphate dehydrogenase, an 

NOSB Proposals and Discussion Documents October 2021 92 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

enzyme which is essential for the digestion of glucose. Inactivation of this enzyme effectively destroys the 

microorganism's ability to function. 

Manufacture 

Electrolyzed water (EW) is the product of the electrolysis of a dilute sodium chloride solution in an 

electrolysis cell containing a semi-permeable membrane that physically separates the anode and cathode 

but permits ions to pass through. In the process, hypochlorous acid, hypochlorite ion, and hydrochlorite 

acid are formed at the anode, and sodium hydroxide is formed at the cathode. The solution formed on the 

anode side is acidic EW (pH 2 to 6), and the solution formed on the cathode side is basic EW (pH 7.5 to 13). 

Neutral EW, with a pH of 6 to 7.5 is produced by mixing the anodic solution with hydroxide, or by using a 

single-cell chamber for electrolysis. (TR lines 48-68). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

International Federation of Organic Agriculture Movements (IFOAM) Norms - Equipment 

cleaner/disinfectant 

Japan Agricultural Standard (JAS) for Organic Production 

Human Health and Environmental Issues 

Hypochlorous acid, generated from electrolyzed water, is present in solutions of two chlorine sanitizers 

(sodium hypochlorite and calcium hypochlorite) currently allowed at §205.601(a)(2)(i, ii). Like other 

chlorine compounds, hypochlorous acid is also an oxidant and can pose risks to human health. Strict 

adherence to the label is required when used, including the use of personal protective equipment when 

appropriate. Use of chlorine compounds in organic processing and crop production have been reviewed in 

2006 and 2011 Technical Reports (TR) (referenced above). 

When formulated via electrolyzed water, hypochlorous acid is effective as a sanitizer at lower chlorine 

concentrations and is likely safer for health and the environment than other currently listed chlorine 

sanitizers. 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been deemed essential to ensure food safety and to comply with food safety regulations under the Food 

Safety Modernization Act (FSMA). The Crops Subcommittee (CS) generally supports continued listing of 

chlorine materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for 

post-harvest handling and processing. The CS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic, materials when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Many organic stakeholders commented that chlorine materials are essential to ensure food safety and 

compliance with food safety regulations under the FSMA. Public comment and Board discussions reflect 

concerns about the use of chlorine materials in organic crop production due to potential impacts on human 

health and the environment. Some public comments outline the need for a comprehensive technical review 

of sanitizers and listing of sanitizers on the National List itemized “by specific use or application” with clear 

NOSB Proposals and Discussion Documents October 2021 93 of 205
 

 

 

 

 

 

 

 

 

 

 

 

–

identification of the hazards to humans and the environment (NOC, 2020). Further, restructuring the 

National List with a designated category for cleaners, sanitizers and disinfectants would help to ensure 

certified operations understand which cleaners, sanitizers and disinfectants may be used, and would 

facilitate better organic education. Overall, a unique category on the National List could help the NOSB in 

its review of sanitizers, cleaners, and disinfectants, and could support the use of alternative, less toxic, 

materials when their use can meet strict food safety standards (OTA, 2021). Establishing a separate 

sanitizer listing on the National List is beyond the scope of this sunset review but the Crops Subcommittee – 

in coordination with the Handling Subcommittee -- will recommend a work agenda item to advance these 

suggestions. 

Justification for Vote 

The Subcommittee proposes removal of hypochlorous acid from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove hypochlorous acid from the National List 

Motion by: Wood Turner 

Seconded by: Logan Petrey 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Chlorine materials Sodium hypochlorite 

Reference: §205.601(a) - As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. (2) Chlorine materials -For pre-harvest use, residual chlorine levels in the water in direct crop 

contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual 

disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible 

sprout production according to EPA label directions. 

(iv) Sodium hypochlorite 

Technical Report(s): 1995 TAP; 2006 TR; 2011 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 NOSB sunset recommendation; 04/2011 

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547), Sunset renewal notice 

3/21/2017 (82 FR 14420); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 10/30/2024 

Subcommittee Review 

Use 

Sodium hypochlorite is an Environmental Protection Agency (EPA)--registered pesticide (PC Code 014703). 

Sodium hypochlorite is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

NOSB Proposals and Discussion Documents October 2021 94 of 205
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (currently 

4mg/L expressed as Cl2). 

Sodium hypochlorite is an "indirect" food additive approved by Food and Drug Administration (FDA). 

Sodium hypochlorite may be used as a final sanitizing rinse on food processing equipment (21 CFR 

178.1010); sodium hypochlorite may be used in washing and lye peeling of fruits and vegetables (21 CFR 

173.315). Sodium hypochlorite also can be used in postharvest, seed, or soil treatment on various fruit and 

vegetable crops (EPA, 1991). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the FDA or the EPA for such purposes. Rinsing with potable water 

that does not exceed the maximum residual disinfectant limit for the chlorine material under the SDWA 

must immediately follow this permitted use. Certified operators should monitor the chlorine level of the 

final rinse water, the point at which the water last contacts the organic product. The level of chlorine in the 

final rinse water must meet limits as set forth by the SDWA. Water used as an ingredient in organic food 

handling should not exceed the maximum residual disinfectant limit for the chlorine material under the 

SDWA, as required by the Organic Food Production Act (7 U.S.C. 6510(a)(7)). 

In water and soil, sodium hypochlorite separates into sodium and hypochlorite ions and hydrochlorous acid 

molecules. Hypochlorous acid molecules are neutral and small in size. As a result, when hypochlorous acid 

molecules exist in equilibrium with the hypochlorite ions, they easily diffuse through the cell walls of 

bacteria. This changes the oxidation-reduction potential of the cell and inactivates 3-phosphate 

dehydrogenase, an enzyme which is essential for the digestion of glucose. Inactivation of this enzyme 

effectively destroys the microorganism's ability to function. 

Manufacture 

Generally, sodium hypochlorite is produced by reacting chlorine with a solution of sodium hydroxide 

(NaOH, also called lye or caustic soda). This method is used for most commercial productions of sodium 

hypochlorite. A more active, but less stable formulation of sodium hypochlorite can be produced by 

chlorinating a solution of soda ash (Na2CO3). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

International Federation of Organic Agriculture Movements (IFOAM) Norms - Equipment 

cleaner/disinfectant. An intervening event or action must occur to eliminate risks of contamination. 

European Economic Community (EEC) Council Regulations 834/2007 and 889/2008 

Products for cleaning and disinfection referred to in Article 23 (4). 

Japan Agricultural Standard (JAS) for Organic Production 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposure occurs or from chronic lower-level exposures – especially in 

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occupational environments when these materials are used on a daily basis. Chlorine compounds are 

dermal, respiratory, ocular, and mucous membrane irritants. Sodium hypochlorite (bleach) can cause 

asthma, as classified by the Association of Occupational and Environmental Clinics. Given the similar 

chemical properties and mechanisms of action, other chlorine-based oxidant sanitizers are also likely to 

cause asthma. Chlorine compounds are toxic to fish and other aquatic organisms. Strict adherence to the 

label is required when used, including the use of personal protective equipment when appropriate. Use of 

chlorine compounds in organic processing and crop production have been reviewed in 2006 and 2011 

Technical Reports (TR) (referenced above.). 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been deemed essential to ensure food safety and to comply with food-safety regulations under the Food 

Safety Modernization Act (FSMA). The Crops Subcommittee (CS) generally supports continued listing of 

chlorine materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for 

post-harvest handling and processing. The CS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic, materials when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Many organic stakeholders commented that chlorine materials are essential to ensure food safety and 

compliance with food safety regulations under the FSMA. Public comment and Board discussions reflect 

concerns about the use of chlorine materials in organic crop production due to potential impacts on human 

health and the environment. Some public comments outline the need for a comprehensive technical review 

of sanitizers and listing of sanitizers on the National List itemized “by specific use or application” with clear 

identification of the hazards to humans and the environment (NOC, 2020). Further, restructuring the 

National List with a designated category for cleaners, sanitizers and disinfectants would help to ensure 

certified operations understand which cleaners, sanitizers and disinfectants may be used, and it would 

facilitate better organic education. Overall, a unique category on the National List could help the NOSB in 

its review of sanitizers, cleaners, and disinfectants, and could support the use of alternative, less toxic, 

materials when their use can meet strict food safety standards (OTA, 2021). Establishing a separate 

sanitizer listing on the National List is beyond the scope of this sunset review but the Crops Subcommittee – 

in coordination with the Handling Subcommittee -- will recommend a work agenda item to advance these 

suggestions. 

Justification for Vote 

The Subcommittee proposes removal of sodium hypochlorite from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove sodium hypochlorite from the National List 

Motion by: Wood Turner 

Seconded by: Logan Petrey 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

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Magnesium oxide 

Reference: §205.601(j)(5) Magnesium oxide (CAS # 1309-48-4)—for use only to control the viscosity of a 

clay suspension agent for humates. 

Technical Report(s): 2021 TR 

Petition(s): 2013 

Past NOSB Actions: 5/2014 NOSB recommendation to add 

Recent Regulatory Background: Added to NL 12/27/2018 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Magnesium oxide (MgO) is a synthetic substance approved for organic crop production to control the 

viscosity of a clay suspension agent for humates. MgO occurs as the mineral magnesia and in its hydrated 

form – magnesium hydroxide - as the naturally occurring mineral periclase. Magnesium oxide appears to be 

a fairly benign compound with a wide range of uses, including as an antacid and laxative (milk of magnesia) 

and in lots of industrial processes such as in producing cement, abrasive materials, and furnace linings. 

MgO is neither a strong acid nor a strong base. Instead, it acts as a buffering agent when in an aqueous 

solution. Buffering agents are materials that create an effective resistance to change in pH of an aqueous 

solution when a strong acid or base is added. 

Manufacture 

Magnesium oxide is a naturally occurring compound that is found in the mineral periclase. There are 

several manufacturing processes used to produce MgO. However, most commercially available magnesium 

oxide is formed by calcinating magnesium carbonate–containing minerals (e.g., magnesite, hydromagnesite). 

Magnesium can also be sourced from other mineral sources in the form of magnesium chlorides and 

silicates, which can be converted to magnesium hydroxide via acid-base and metathesis reactions. 

Magnesium hydroxide sourced as brucite or by the chemical processing of other magnesium-containing 

minerals is calcined to form magnesium oxide. 

Magnesium oxide is also produced from seawater and salt lake brine sources. While magnesium is a 

common elemental component of brine, magnesium oxide is not present in brine sources due to its water 

insolubility. Magnesium chloride is the primary source of magnesium within brine and is converted to 

magnesium hydroxide using the same reactions used to process mineral sources of magnesium chloride. 

Additionally, brine may be treated with sulfuric acid to remove carbonates, reducing calcium in the final 

product. Magnesium oxide from brine is also obtained by calcination of magnesium hydroxide. 

NOP guidelines classify substances produced by the “heating or burning of non-biological matter (e.g., 

minerals) to cause a chemical reaction” as synthetic (NOP 5033). Based on this classification, all commercial 

sources of magnesium oxide are considered synthetic, formed by calcination (heating) to liberate carbon 

dioxide (Equation 3) or water (Equation 8). (TR 2021) 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

The CAN/CGSB-32.311-2015 lists magnesium oxide as a “mineral” for use in “feed, feed additives, and feed 

supplements” and in “health care products and production aids.” (TR 2021) 

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

Magnesium oxide is listed in ED No. 889/2008 as a “feed material of mineral origin.” Magnesium oxide is 

not listed in EC. No 834/2007. 

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

Organically Produced Foods (GL 32-1999) 

There are no current references to synthetic magnesium oxide for use in crop production. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

There are no current references to synthetic magnesium oxide for use in crop production. 

Japan Agricultural Standard (JAS) for Organic Production 

There are no current references to synthetic magnesium oxide for use in crop production. 

Environmental Issues 

TR2021 states that, at the time of publication, the author found no studies on magnesium oxide’s 

environmental persistence or toxicity. The insoluble nature of magnesium oxide makes it unlikely to 

contaminate water systems, and its insolubility results in low bioavailability within terrestrial environments. 

Moreover, when used as approved within organic agriculture, magnesium oxide is applied in limited 

quantities as a viscosity control additive, making environmental contamination unlikely (NOSB 2013). 

The code of federal regulations (CFR), title 21, Part 184-Direct food substances affirmed as generally 

recognized as safe lists magnesium oxide at § 184.1431 as an ingredient used in food with no limitation 

other than current good manufacturing practice and affirms the ingredient as generally recognized as safe 

(GRAS) as a direct human food ingredient. 

The original petitioner noted that magnesium oxide is safely used in numerous applications for other 

materials because it is considered nonhazardous, environmentally safe, and nontoxic. Some of the 

applications include: 

• wastewater treatment 

• toxic metal removal 

• adsorption of dyes and excess phosphorus from industrial wastewater 

• odor control 

• treatment of acid mine drainage 

• nontoxic flame retardant for clothing 

• flue gas desulfurization 

• hazardous spill clean up 

Magnesium oxide and the hydrated form magnesium hydroxide have been used safely for over a century as 

a laxative and antacid (milk of magnesia). 

Discussion 

This is the first sunset review for magnesium oxide since it was added to the National List. A previous 

technical report covered the uses of magnesium oxide in livestock production, and the petitioner noted 

that aspects from that report were relevant to the listing for crop use. In addition, the NOSB requested and 

received a technical report in the summer of 2021 specifically for this material to be used in crops. 

According to the original petition, natural humic substances stimulate biological activity, foster cycling of 

resources by making fertilization more efficient, conserve water, promote ecological balance, conserve 

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biodiversity, and improve soil and water quality. Non-synthetic humic substances are used in organic 

agriculture to improve soil structure and fertility, increase plant nutrient uptake, and improve root 

architecture. 

The petitioner further stated that magnesium oxide is used to: 

modify clays in such a manner to effectively suspend humic substances while simultaneously 

preventing recrystallization of any fertilizer or micronutrient salts that may be in solution. Reducing 

the growth of crystals is necessary to prevent the plugging of spray nozzles during spray 

applications. The use of the magnesium oxide-modified clay also increases the viscosity of aqueous 

suspensions of humates, which in turn delays settling and keeps the solids from forming a hard 

cake when settling eventually occurs. 

Alternatives to magnesium oxide include periclase and brucite, dolomitic limestone, phlogopite, wood ash, 

and pelletized non-synthetic humates. The petitioner states that these are either not commercially 

available or do not meet chemical or physical specifications for suspending humates in the solution. 

In the review to add magnesium oxide to the National List, the NOSB determined that magnesium oxide, as 

petitioned, satisfied all three evaluation criteria - minimal impact on humans and environment, essentiality 

for use in organic agriculture, no commercial availability of non-synthetic material, and compatibility & 

consistency with organic agriculture. They found that magnesium oxide appeared to be a fairly benign 

compound with a wide range of uses. The petitioned use is for a very low level and specific use. The NOSB 

chose to add the restrictive annotation to clarify the language in the petition, which they felt was too 

broad. 

In advance of the Spring NOSB meeting, stakeholders submitted a few comments, primarily in favor of 

permitting magnesium oxide for this particular use. Based on the current review, and stakeholder support, 

the Subcommittee proposes magnesium oxide remain on the National List. 

Justification for Vote 

The Subcommittee proposes removal of magnesium oxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove magnesium oxide from the National List 

Motion by: Amy Bruch 

Seconded by: Logan Petrey 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

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Calcium chloride 

Reference: §205.602(c) Calcium chloride, brine process is natural and prohibited for use except as a foliar 

spray to treat a physiological disorder associated with calcium uptake. 

Technical Report: 2001 TAP; 2021 TR 

Petition(s): 2005; 2015 

Past NOSB Actions: 09/1996 minutes and vote; 11/2006 annotation change (failed); 11/2007 sunset 

recommendation; 12/2011 sunset recommendation; 10/2016 sunset recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Calcium chloride is used to manage almost three dozen physiological disorders on crops. These include a 

reduction of cork spot on pears, bitter pit in apples, fruit cracking on developing figs, rain cracking in 

cherries, blossom end rot on tomatoes, and tipburn on Chinese cabbage (TAP lines 156-175). “Application 

of foliar calcium sprays relieves calcium physiological disorders because these are local deficiencies due to 

calcium transport problems. Local availability of calcium in new shoots and fruits can help solve the 

problem” (lines 197-98). Application of nonsynthetic calcium chloride in organic crop production is limited 

to foliar sprays to treat a physiological disorder associated with calcium uptake. 

Manufacture 

According to the 2007 TAP, “calcium chloride can be produced from a number of sources by various 

methods. Some of these are naturally occurring, some require extraction and beneficiation that is not 

considered by most reviewers to be a chemical reaction, and some are entirely synthetic. Those extracted 

from brine are generally considered nonsynthetic, although certain steps to purify the brine may be 

considered synthetic (lines 8-11).” The TAP goes on to explain that “calcium chloride can be obtained by 

extraction of nonsynthetic brines. When calcium chloride is extracted from a nonsynthetic source, its 

molecular structure is not changed during extraction and thus should be classified nonsynthetic. However, 

Dow (the major supplier) and other producers use synthetic chemicals during the purification of the brine 

(lines 62-4).” Industrial production of calcium chloride occurs mainly through 1) the hydrochloric acid 

method, 2) the Solvay process, and 3) the Dow process. “Productions by the Solvay process and by reaction 

of a calcium source with hydrochloric acid are both clearly synthetic” (lines 11-12). The 2001 TAP explains 

that: 

Calcium chloride can be obtained by extraction of nonsynthetic brines. When calcium chloride is 

extracted from a nonsynthetic source, its molecular structure is not changed during extraction and 

thus should be classified nonsynthetic (lines 62-3). 

Calcium chloride from naturally occurring brine is nonsynthetic as long as there are no manufacturing steps 

(see NOP 5033 4.6 Extraction of Nonorganic Materials) that change the classification to synthetic. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

States “non-synthetic calcium chloride may be used to address nutrient deficiencies and physiological 

disorders”. 

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

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Allows for calcium chloride as a “foliar treatment of apple trees, after identification of deficit of calcium” 

with the limitation that the need be “recognized by the inspection body or inspection authority”. 

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

Organically Produced Foods (GL 32-1999) 

Lists calcium chloride for “leaf treatment in case of proven calcium deficiency”. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Permits calcium chloride under Appendix 2, Fertilizers and Soil Conditioners of mineral origin with no 

restrictions on use. 

Japan Agricultural Standard (JAS) for Organic Production 

Lists calcium chloride under Fertilizers and Soil Improvement Substances. 

Environmental Issues 

The 2007 TAP describes that, when used as a foliar spray, calcium chloride “probably has low potential for 

interaction or interference with other materials used in organic farming” (lines 295-96). It has a low toxicity 

to mammals, though it can be a skin, eye, and breathing irritant. When used in foliar applications, “it should 

not affect beneficial insects. It should not persist on foliage. Any not absorbed by the plant should be 

washed off with rain. Calcium chloride is extremely soluble in water, and low concentrations from foliar use 

should not build up in soil, unless it is used in low rainfall areas with minimal irrigation. Any water-soluble 

calcium or chloride not absorbed by plant roots would drain into surface waters or be leached into 

groundwater (lines 304-08).” Additionally, during manufacture from brines, the liquid brines are pumped 

out from underground, and do not present the kind of problem usually seen with strip mining. The only 

toxic chemicals involved are chlorine and bromine, and they are handled so that environmental 

contamination is low. The chlorine is recycled, and bromine is isolated as bromide or bromine and is sold as 

a chemical product. Excess lime added in processing is isolated as part of the final calcium chloride. The 

magnesium hydroxide produced is used to prepare other magnesium salts and magnesium metal by 

electrolysis. It is not dumped into the environment. The sodium chloride isolated in the process is sold as 

table salt or for chemical production. Spent solutions are recycled and pumped back underground to isolate 

a new concentrated brine (lines 311-319). Finally, “calcium chloride obtained from natural salt brines has a 

significant amount of sodium chloride, usually about 3-4%. Sodium chloride has a high salt index and should 

not be applied to soil (Rader, et al., 1943)... Application to soil could lead to chloride phytotoxicity 

(Greenway and Munns, 1980) (TAP lines 355-58). 

Discussion 

This is a unique §205.602 material in that while not completely prohibited for use, the listing serves to 

annotate or the restrict use of this nonsynthetic. Since it is only allowed for a very specific use (foliar 

application to treat a calcium uptake disorder), Material Review Organizations list it with the restriction to 

reflect the very narrow permitted use. Certifiers are responsible for verifying that growers use it in a 

manner consistent with the restriction. 

In 1996, the NOSB originally voted to allow calcium chloride for use to control bitter pit in apples and as an 

emergency defoliant for cotton; the material was categorized as nonsynthetic and was not included on 

sections 205.601 or 205.602. In 2003, calcium chloride was subsequently added to National List at § 

205.602 as a non-synthetic substance prohibited for use in organic crop production with the current 

annotation. The annotation states: “brine process is natural and prohibited for use except as a foliar spray 

to treat a physiological disorder associated with calcium uptake.” In 2005, the NOSB rejected a petition to 

remove the prohibition for use as a soil-applied nonsynthetic substance due to high chloride and solubility 

concerns. The board received another petition in 2015 to remove the prohibition on direct soil applications 

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but determined it to be ineligible as no new substantive information was presented to warrant 

reconsideration of the petition. 

The NOSB has consistently concluded that brine process calcium chloride is a mined substance of high 

solubility, and as such, its use is subject to the conditions established on the National List of non-synthetic 

materials prohibited for crop production. The foundational principle for placing high solubility materials 

such as calcium chloride on the prohibited non-synthetic materials list is elaborated in §205.203(d) – Soil 

fertility and crop nutrient management practice standard: “A producer may manage crop nutrients...in a 

manner that does not contribute to contamination of crops, soil, or water by plant nutrients...” The NOSB 

has established that the potential for overuse of this natural substance resulting in subsoil, surface water, 

and ground water contamination, warrant continued limitation through the annotation restrictions. 

Summary of Public Comments: 

Relisting calcium chloride as a prohibited non-synthetic material was widely supported in the public 

comments. Calcium chloride is a material needed to combat physiological disorders of many commodities 

that typically cannot be resolved with other calcium products. Many commenters stated that calcium 

chloride is necessary to ensure quality of many crops and significant losses would occur if the substance 

were not relisted. The current annotation restricting the use to “foliar sprays to treat a physiological 

disorder associated with calcium uptake” is also supported to prevent soil buildup of chloride. 

Justification for Vote 

The Subcommittee proposes removal of calcium chloride from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove calcium chloride from the National List 

Motion by: Logan Petrey 

Seconded by: Brian Caldwell 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Rotenone 

Reference: §205.602(f) Rotenone (CAS # 83-79-4). 

Technical Report(s): N/A 

Petition(s): N/A 

Past NOSB Actions: 10/2012 NOSB recommendation to add 

Recent Regulatory Background: Added to NL 12/27/2018 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Rotenone is a potent non-synthetic botanical pesticide that is also used as a piscicide. 

Manufacture 

Rotenone is commonly derived from the roots of various tropical plants native to Southeast Asia, South 

America, and East Africa. Historically, farmers have used this extract as a foliar spray to control pests on 

vegetables, berries, tree fruit, nuts, and forage crops. 

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International acceptance 

In the U.S. rotenone is only registered for piscicidal (fish killing) purposes. Since it is no longer registered by 

the EPA as a pesticide, it is not available for purchase as an insecticide in the U.S. although it might be 

available for purchase in other countries. In the December 27, 2018 Federal Register rotenone was added 

to §205.602 as a non-synthetic substance that is prohibited for use in organic crop production. The UK 

banned the sale of rotenone in 2009 and it is also banned in the EU. 

Human Health and Environmental Issues 

Adverse health effects from rotenone have been well documented since the NOSB reviewed botanicals in 

1994. In 2004 the EPA required an inhalation neurotoxicity study to investigate the possibility of rotenone 

leading to Parkinson's Disease-like symptoms at high-dose exposure in animals. Instead, the companies 

distributing and selling rotenone products voluntarily cancelled all food-use registrations, except for 

piscicidal uses. 

Discussion 

Rotenone was found to have adverse environmental and health impacts, a lack of essentiality, and an 

incompatibility with organic principles, and therefore, the NOSB unanimously passed a recommendation in 

October 2012 to add rotenone to the National List at §205.602 as a non-synthetic substance prohibited for 

use in organic crop production. 

There were only five public comments at the 2021 Spring meeting about rotenone and all were in favor of 

the continued listing as a prohibited natural substance in organic crop production. 

Justification for Vote 

The Subcommittee proposes removal of rotenone from the National List based on the following criteria in 

the Organic Foods Production Act (OPFA) and/or 7 CFR 205.600(b): Not recommending removal from the 

prohibited list, based on adverse environmental and health impacts, a lack of essentiality, and an 

incompatibility with organic principles. 

Subcommittee Vote 

Motion to remove rotenone from the National List 

Motion by: Rick Greenwood 

Seconded by: Amy Bruch 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

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National Organic Standards Board 

Handling Subcommittee 

Petitioned Material Proposal 

Zein 

August 3, 2021 

Summary: 

This document reviews the petitioned use of zein, or corn protein, as a “Nonorganic agricultural 

substance[s] allowed in or on processed products labelled as organic,” as well as the recently submitted 

2021 technical review. While the petitioner asked for the material to be allowed as a nonorganic 

agricultural substance, the NOSB disagrees with this classification. In reviewing the petition, TR, NOP 

Classification of Materials guidance decision tree (NOP 5033), and past NOSB decisions, it was 

determined that this is a nonagricultural substance and that it should be classified as non-synthetic. 

Introduction: 

The NOSB was petitioned in February of 2020 to consider zein, otherwise known as “maize protein”, 

“protein coating” or “confectioner’s glaze”, as an addition to the National List. The full petition may be 

found here. The petitioner, Flo Chemical Corporation, asked for inclusion of zein under “Nonorganic 

agricultural substance[s] allowed in or on processed products labeled as “organic” (§ 205.606).” The 

NOSB asked for a technical report which was produced in January 2021 and deemed sufficient in 

February 2021. 

Regulatory background: 

This is the first time that zein has been petitioned for inclusion on the National List. 

The TR states, “Zein is a food substance generally recognized as safe (GRAS) by FDA [21 CFR 184.1984] as 

a direct human food ingredient, for use as a surface-finishing agent, and for technical effects (i.e., as an 

anticaking agent or free-flow agent, a drying agent, and a humectant). Zein also is allowed as an indirect 

food additive used as a component of adhesives [21 CFR 175.105]. A major use of zein is for coating 

foods and pharmaceutical products. The most common production process for zein uses corn gluten, also 

known as corn gluten meal, as the starting material. Corn gluten itself is a GRAS food ingredient [21 CFR 

184.1321].” 

As zein has not been previously considered for addition to the National List, there are no current NOP 

policy memos that relate to zein or its category of proposed use. Despite this, the rulings that have been 

made on corn steep liquor (CSL) are directly relevant to any review of zein. The corn gluten meal (CGM) 

that zein is made from is a different product created during the same wet-milling process used to make 

CSL. The bulk of the corn gluten meal is produced via wet-milling with sulfur dioxide. Dry-milling 

produces very little of the desired zein protein in the end product. 

In determining whether or not to allow corn steep liquor as a non-synthetic product, OMRI reported the 

following decision-making process: 

“For technical questions such as these, OMRI relies on our Advisory Council, an independent body made 

up of experts in their fields, to determine the status of a substance. The Advisory Council was provided 

with peer-reviewed literature, patents, manufacturing processes and a copy of the 2006 NOSB 

synthetic/nonsynthetic decision tree catered to CSL to help inform their votes. In May 2009, the Advisory 

Council voted 8-2 that corn steep liquor is synthetic. 

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Later, OMRI received additional information that lent to the argument that it was not synthetic; mainly 

that lactic acid is the driving force for the chemical change rather than sulfurous acid. Lactic acid is 

produced naturally in the steeping process through the conversion of dissolved sugars. The Advisory 

Council was asked to vote again, taking into account the new information. Again, the council voted that 

CSL was synthetic, 7-3. This comment from an Advisory Council member summarizes the prevailing 

argument: “As long as any of the active species [Sulfurous acid] is present, it can react with the proteins. 

Breaking of disulfide bonds is an irreversible reaction that goes to completion. Once the sulfite ion reacts, 

more of it is produced by the ionization process to maintain equilibrium conditions. The suboptimal pH of 

the industrial process does not stop breaking of disulfide bonds by sulfite ion. It only slows it down. In the 

industrial process some of the bonds are probably broken by lactic acid, but it is unreasonable to assume 

that the entire degradation process is due to unilateral action of lactic acid produced in the fermentation 

reaction.” 

In a memo on November 12, 2009, the NOP asked the organic industry to consider CSL nonsynthetic and 

allowed for use in organic agriculture until the NOSB can discuss it at the Spring 2010 meeting. Although 

the OMRI Advisory Council voted twice that CSL is synthetic, OMRI has followed the NOP directive and 

currently lists products with CSL.” 

In 2011, the NOSB reviewed corn steep liquor and through a similar rationale, came to the same 

conclusion. 

“Recommendation: The Crops Committee recommends that Corn Steep Liquor produced via the 

traditional countercurrent corn wet milling process be considered as non-synthetic and allowed 

for use in organic crop production. 

Committee Vote Motion: Consider CSL to be non-synthetic when produced via the traditional 

countercurrent corn wet milling process only. 

Motion: Jeff Moyer Second: Tina Ellor Yes: 4 No: 3 Abstain: 0 Absent: 0” 

Use: 

Zein is the protein component of corn, which has the useful quality of being hydrophobic, but easily 

dissolved in an alcohol solution. This allows zein to be dissolved into the solution and then sprayed or 

otherwise applied on the food item. The alcohol then evaporates and leaves behind a thin layer of zein 

that acts as a protective coating. This zein layer serves as a moisture barrier and effectively extends the 

shelf life of dried nuts and fruits, candies, and fresh fruits and vegetables much in the same way plastic 

wrap would. In contrast to plastic sheeting, the zein layer is fully edible and adds nothing but a small 

amount of protein of poor nutritional quality to the consumed product. 

Manufacture: 

According to the petitioner, “Flo Chemical Corporation manufactures (isolates) zein utilizing a 

proprietary process (Freeman Process), which was developed in 1976 by the company’s founders. The 

process starts with the following raw materials: non-GMO CGM, water and ethanol.” 

While it would be possible to manufacture organic zein with organic starting products, the manufacturer 

states that sourcing certified organic corn gluten meal for the production of organic zein is not currently 

possible. 

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International use: 

Canadian General Standards Board Permitted Substances List 

Zein is not included in the Canadian General Standards Board—CAN/CGSB-32.311-2020, Organic 

Production Systems Permitted Substances List. 

CODEX Alimentarius Commission 

Zein does not appear in the CODEX Alimentarius Commission—Guidelines for the Production, 

Processing, 130 Labelling and Marketing of Organically Produced Foods (GL 32-1999). 131 132 

European Economic Community (EEC) Council Regulation 

Zein does not appear in the European Economic Community (EEC) Council Regulation—EC No. 834/2007 

135 and 889/2008. 

Japan Agricultural Standard (JAS) for Organic Production 

Zein is not listed in Table 1 “Additives” of the JAS for Organic Processed Foods Notification No. 1606. 

International Federation of Organic Agriculture Movements (IFOAM) Norms Zein is not included in the 

IFOAM Norms 

Summary of review: 

As this is the first time zein has been considered, there are no previous public comments or reviews to 

draw upon. For questions of whether or not the product should be allowed and/or how to classify it, 

referencing the relevant discussions surrounding corn steep liquor is useful. The NOSB determination 

on how to categorize corn steep liquor can be found here. 

Combining both written and oral stakeholder comments from the 2021 Spring Meeting, there were 

about ten total responses with none in favor of adding zein to the National List. With that said, there 

were only two comments against the material itself with the remainder simply challenging the need of 

“another coating” or “preservatives” on fresh fruits and vegetables. During three subsequent Handling 

Subcommittee meetings this question of “need” was thoroughly debated with the eventual consensus 

being that the petitioned substance should be limited to very specific uses where its “unique” 

hydrophobic properties appear to be “preferred”. The petition is therefore annotated as follows: 

Annotation of zein for inclusion on the National List at §205.606: “Only for use in nutraceuticals or 

pharmaceuticals as a micro encapsulation acting as a moister barrier and taste masker.” 

Category 1: Classification 

1. Substance is for: X Handling _______ Livestock 

2. For HANDLING and LIVESTOCK use: 

a. Is the substance ___ Agricultural or X Non-Agricultural? 

b. If the substance is Non-agricultural, is the substance ____X_ Nonsynthetic or Synthetic? 

There has been ongoing debate about whether the end products of the corn wet-milling process 

can be considered non-synthetic. Wet-milling steeps the corn for 24-48 hours in a hot water 

solution that is 0.1% - 0.2% sulfur dioxide, allowing the sulfur dioxide to break protein bonds and 

add itself to the resulting molecule. This means that a chemical reaction has occurred. 

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According to the Decision Tree for Classification of Agricultural and Nonagricultural Materials 

for Organic Livestock Production or Handling (NOP 5033-2), an agricultural substance that 

undergoes a chemical change becomes non-agricultural. This then brings up the question as to 

whether zein should be considered nonsynthetic or a synthetic. As the NOSB has evaluated this 

question previously for corn steep liquor, the precedent has been established to consider these 

end products non-synthetics. 

3. For LIVESTOCK: Reference to appropriate OFPA category 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern? 

N/A 

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)] 

The substance will be used solely as a coating for nutraceutical and pharmaceutical capsules and 

as an inert, hydrophobic substance, will have no potential for detrimental chemical reactions. 

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the 

environment? [§6518(m)(2)] 

Zein has been deemed GRAS since 1960 and is fully biodegradable and edible. It contributes no 

toxicity or detrimental breakdown products to the environment. 

3. Describe the probability of environmental contamination during manufacture, use, misuse, or 

disposal of such substance? [§6518(m)(3)] 

There are legitimate concerns regarding the environmental impacts of the corn wet-milling 

process. Corn wet-milling is the primary means used to create the corn gluten meal that is the 

starting product for zein. As evidence that it is a concern to the regulatory agencies, from 1999-

2004 the Agricultural Research Service Southern Regional Research Center received a grant from 

the USDA titled, “Development of environmentally acceptable technologies for processing 

corn.” A specific aim of the research was to reduce the use of sulfur dioxide in wet-milling of 

corn as it was determined to be environmentally detrimental. (Full text of the grant report can 

be found here.) If and when sulfur dioxide is released into the air through the drying process, it 

reacts with air and water to form sulfuric acid and becomes one of the major contributors to 

acid rain. While there are steps that can be taken to remove the sulfur dioxide before exhaust is 

released into the environment, the potential for negative environmental effects exists. 

The previous decision-making on that point is outlined above. Having summarized that, it is 

important to note that there does seem to be an effective pathway to avoiding the wet-milling 

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process entirely in the production of zein. Researchers out of the University of Illinois have 

developed another zein product that is created directly from whole corn. They plan to market 

this product under the name Amazein and point to the fact that direct production from corn 

bypasses need for sulfur dioxide or the other caustic chemicals that are used during the wet 

milling process. This method of direct extraction from whole organic corn may also allow for the 

creation of a truly organic zein product as organic ethanol is available in the US. 

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

Zein is a fully edible protein layer that contributes an incomplete amino acid profile to the 

consumer. While it therefore should not be a major protein source in the human diet, its 

proposed use as a coating for pills represents no impact to human health. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt and solubility of the soil), crops and livestock. [§6518(m)(5)] 

In its proposed role as a coating in organic nutraceuticals and pharmaceuticals, zein will have no 

role in the agroecosystem. As previously mentioned, the only environmental concerns come 

from the corn-wet milling process that is used to create the corn gluten meal that is the starting 

material for zein production. 

6. Are there any adverse impacts on biodiversity? (§205.200) 

The TR states: “ Zein is extracted from CGM. In its evaluation of CGM as an herbicide ((Office of 

Pesticide Programs 2003)), stated: 

“All required toxicology data for this biochemical pesticide are waived. No additional 

toxicological data are needed. The decision to waive these data are based on: 1) the product is 

naturally occurring, 2) possesses a non-toxic mode of action, 3) corn gluten meal is considered 

GRAS (Generally Recognized As Safe) by FDA under 21 CFR §184.1321, and can be used without 

limitations, other than current Good Manufacturing Practices, and 4) under 40 CFR §180.1164, 

corn gluten is exempted from the requirements of a tolerance on food when used as a herbicide; 

and under 40 CFR §180.1001 (d), corn gluten meal is exempted from the requirement of a 

tolerance when used as an attractant on crops. Further, the registrant’s request for data waivers 

was appended with abstracts from scientific journals discussing the use of corn gluten meal as a 

food and/or feed for dairy and beef cattle, cats, minks, foxes, sheep, horses, swine, poultry, 

trout, salmon, catfish, guinea pigs, hamsters, monkeys, mice, rats, rabbits, and dogs.” 

Zein itself has been considered GRAS (generally recognized as safe) since about 1960 and this 

status was confirmed in 1981 (Select Committee of GRAS Substances (SCOGS) 1981). 

Zein is a fully biodegradable, edible protein extracted from corn milling byproducts (primarily 

corn gluten, a GRAS substance) with an alcohol and applied to food as an alcoholic solution. The 

alcohols involved are isopropyl alcohol (a major ingredient in hand sanitizers) and ethyl alcohol 

(grain alcohol). Zein manufacturing processes are designed to recover and reuse the alcohol for 

both economic and environmental reasons. An analogous substance is the purified protein 

gelatin, extracted from animal processing waste products. 

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Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)] 

There are products currently on the National List that can serve a similar role to zein in forming 

a protective coating around foodstuffs. Examples of this include beeswax, shellac, vegetable 

proteins, and carnauba wax. Zein’s unique functionality comes in because it offers a 

vegan/vegetarian option to replace shellac and beeswax as coatings. As opposed to other 

vegetable proteins (such as wheat), zein is a hypoallergenic option. The final other option, 

carnauba wax, can be sourced and grown only in Brazil, making it outside of the US jurisdiction 

for regulating how its grown and produced. However, for the annotated use in microencapsulation for pharmaceuticals and nutraceuticals, it appears to be the preferred option. 

2. For Livestock substances, and Nonsynthetic substances used in Handling: In balancing the 

responses to the criteria above, is the substance compatible with a system of sustainable 

agriculture? [§6518(m)(7)] 

The substance is compatible with a system of sustainable agriculture, as it would serve solely as 

an encapsulation method for organically produced substances being made into pills. It would 

therefore have no impact on the sustainability of the agriculture that produced the substance. 

Zein itself would be both created and applied in a laboratory setting. 

Zein is created from a renewable resource (corn gluten meal), it is fully biodegradable, and it 

presents no threat to human health. As the substance is created and applied in the laboratory, it 

has no impact on the agroecosystem beyond serving as a vehicle for ingesting organic 

pharmaceutical and nutraceutical products. 

Classification Motion: 

Motion to classify zein as nonsynthetic 

Motion by: Jerry D’Amore 

Seconded by: Steve Ela 

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

National List Motion: 

Motion to add zein at §205.605(a), annotated as: “Only for use in nutraceuticals or pharmaceuticals as a 

micro encapsulation acting as a moisture barrier and taste masker.” 

Motion by: Jerry D’Amore 

Seconded by: Steve Ela 

Yes: 4 No: 3 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Jerry D’Amore, Handling Subcommittee Chair, to transmit to NOP August 18, 2021. 

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National Organic Standards Board 

Crops Subcommittee 

Fish Oil Annotation Proposal 

August 13, 2021 

Summary: 

In May 2019, the NOSB requested a work agenda to annotate fish oil to address environmental 

concerns. Specifically, The NOSB request stated: 

During the sunset review of Fish Oil at the Spring NOSB 2019 meeting the NOSB asked for comment 

on how to address environmental and conservation concerns raised about the manufacturing of Fish 

Oil. Public comment was received validating these concerns as well as suggesting annotative 

language to address this area of concern. These annotations were proposed by industry and trade 

associations as well as interest groups. The Handling Subcommittee (HS) would like to request a 

work agenda item to propose an annotation to Fish Oil to address environmental concerns. 

In August 2019, the NOP agreed to add this item to the NOSB work agenda. Specifically, the NOP 

stated: 

You have requested to review the current listing of fish oil and develop recommendations to 

address the environmental impact of harvesting of fish directly for their oil. Please limit your 

work to this topic; this work agenda item does not include the organic certification of fish (i.e. 

aquaculture or wild seafood standards). In your review, please consider how your 

recommendations would align with other Federal regulations addressing fish harvesting. 

Citations: 

OFPA § 6517. National List 

(c) Guidelines for prohibitions or exemptions 

(1) Exemption for prohibited substances in organic production and handlingoperations The 

National List may provide for the use of substances in an organic farming or handling 

operation that are otherwise prohibited under this chapter only if— 

(A) the Secretary determines, in consultation with the Secretary of Health and 

Human Services and the Administrator of the Environmental Protection Agency, 

that the use of such substances— 

(i) would not be harmful to human health or the environment; 

OFPA § 6518. National Organic Standards Board 

(l) Requirements 

In establishing the proposed National List or proposed amendments to the National List, the 

Board shall— 

(1) review available information from the Environmental Protection Agency, the National 

Institute of Environmental Health Studies [sic (National Institute of Environmental Health 

Sciences)], and such other sources as appropriate, concerning the potential for adverse 

human and environmental effects of substances considered for inclusion in the proposed 

National List; 

OFPA § 6518. National Organic Standards Board 

(m) Evaluation 

In evaluating substances considered for inclusion in the proposed National List or proposed 

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amendment to the National List, the Board shall consider— 

... 

(6) the alternatives to using the substance in terms of practices or other available 

materials; and 

(7) its compatibility with a system of sustainable agriculture. 

7 CFR 205.606 Nonorganically produced agricultural products allowed as ingredients in or on 

processed products labeled as “organic.” 

Only the following nonorganically produced agricultural products may be used as ingredients in or 

on processed products labeled as “organic,” only in accordance with any restrictions specified in this 

section, and only when the product is not commercially available in organic form. 

... 

(e) Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8)—stabilized with organic 

ingredients or only with ingredients on the National List, §§205.605 and 205.606. 

Summary of Review: 

Fish oil was added to the National List in 2007, based on a petition from a manufacturer. At that time the 

NOSB did not request a Technical Report (TR) or Technical Advisory Panel Report (TAP). The 2007 NOSB 

recommendation indicated that the OFPA criteria were met in all categories but provided no scientific 

rationale or citations to support such findings. However, the final NOSB recommendation from May 9, 2007, 

stated ...”pursuant to the judgment in Harvey v. Johanns, the NOSB was instructed to develop criteria for 

determining commercial availability, an essential tool in evaluating whether or not petitioned materials 

could be listed at § 205.606.” These criteria were finalized in the NOSB “Recommendation for the 

Establishment of Commercial Availability Criteria National List § 205.606” of October 19, 2006. “That 

recommendation allows for pro-active listing on § 205.606 of materials that may currently be available in an 

organic form, but the supply of which has a history of fragility due to factors such as limited growing 

regions, weather, or trade-related issues. “.... After discussion, the Board decided to add an annotation to 

the recommendation to list fish oil to the National List. The annotation is “stabilized using only allowed 

ingredients on the National List.” The Board felt that this annotation was not overly prescriptive since a 

nonorganic material that falls within the annotation exists on the market.” The NOSB (2007) further noted 

that “There were no public comments specifically opposing the listing of fish oil on §205.606....” 

While the NOSB has submitted several recommendations on organic aquaculture standards, the NOP has 

not proceeded with rulemaking on these recommendations. At this time organic fish and therefore organic 

fish oil cannot be produced under the USDA organic regulations. If fish oil is to be used by organic food 

manufacturers it must remain on the National List. 

In subsequent sunset reviews in 2015 and 2019, public comment indicated that the listing as is left room for 

concern based on how the fish for the fish oil were harvested. Sustainability of fishing is a key 

environmental concern and the U.S. has been a leader in managing sustainable fishing. The management of 

U.S. Fisheries is primarily governed by the Magnuson-Stevens Fishery Conservation and Management Act of 

1976. This act recognized the need to manage fisheries to ensure fish stocks would be able to continually 

produce without depletion. Specifically, it sought to prevent overfishing, rebuild overfished stocks, increase 

long-term economic and social benefits, and ensure a safe and sustainable supply of seafood. NOAA 

fisheries manages this program for federal waters (extending 200 miles offshore but excluding state 

managed water within 3 miles of the shoreline) and states “U.S. fisheries are scientifically monitored, 

regionally managed, and legally enforced under 10 national standards of sustainability. Managing 

sustainable fisheries is a dynamic process that requires constant and routine attention to new scientific 

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information that can guide management actions. According to the World Wildlife Fund, “seven of the 

world’s top ten fisheries (by volume) target forage—also known as low trophic level—fish, 90 percent of 

which are processed into fishmeal and fish oil.” Fish and shellfish are renewable resources—they can 

reproduce and replenish their populations naturally. Because of this, we can sustainably harvest fish within 

certain limits without depleting the resource. Fishery management is the process of using science to 

determine these limits—some fish are caught while some are left to reproduce and replace the fish that are 

caught.” As part of its regulatory duties, NOAA maintains a Fish Stock Sustainability Index. In this index fish 

stocks by region are described as: 

• Maximum sustainable yield (MSY): The largest long-term average catch that can be taken from a stock 

under prevailing environmental and fishery conditions. 

• Overfishing: A stock having a harvest rate higher than the rate that produces its MSY. 

• Overfished: A stock having a population size that is too low and that jeopardizes the stock’s ability to 

produce its MSY. 

• Rebuilt: A stock that was previously overfished and that has increased in abundance to the target 

population size that supports its MSY. 

In the U.S., NOAA data shows a slight decreasing trend in the number of fish 

stocks that are not overfished or subject to overfishing. 

The United Nations Food and Agricultural Organization (FAO) similarly 

recognizes concerns about over exploitation of fish. In its 2016 report, FAO 

recognized that worldwide overfished stocks had increased from 10% of total 

stocks in 1974 to 33.1% in 2015. The FAO classifies fish stocks fisheries around the 

world in terms of population stability. The FAO categories include: 

1. Over-exploited 

2. Fully exploited. 

3. Non-fully exploited. 

Proposed Annotation Discussion 

Significant U.S. regulation and International regulation exists to address the environmental concerns of 

overfishing. In addition, there are numerous private standards established to monitor fishing, including, but 

not limited to, voluntary third-party organizations that certify fishery practices to sustainability standards 

such as the Marine Stewardship Council (MSC), Friends of the Sea, Global Standard for Responsible Supply 

(IFFO RS), and Sustainable Fisheries Partnership. In contrast to third-party certifiers, there are groups like 

Seafood Watch (https://www.seafoodwatch.org/) that grade fish products by environmental criteria (i.e., 

red, yellow, green) but do not certify products on a fee basis. Thus, fish producers have no choice as to 

whether their products are assessed against environmental criteria by Seafood Watch. 

Previously, the Handling Subcommittee presented a discussion document for the April 2020 NOSB meeting 

that argued that while private third-party standards may be sufficient to address potential environmental 

concerns related to fishing, the use of sufficient and recognized U.S. Government national standards and 

United Nations international standards may be preferred because legal definitions have been defined and 

are potentially more enforceable compared with third-party private entities. 

Public Comment Summary 

Several dairy and other producers reported using fish oil in milk and other products and projected lost sales 

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if fish oil was not allowed as part of the non-organic 5% of USDA Organic labeled products. 

The Handling Subcommittee originally suggested adding three elements to the current fish oil annotation. 

The first element would state that fish oil should be sourced from fishing industry by-product only. This 

annotation would prevent the use of fish caught solely for oil production. Note, krill are not recognized as 

fish. Because the National List specifically identifies “fish oil”, oils derived from krill are not allowed in 

organic products and are not the subject of this annotation. 

In public comment in 2019 and 2020, it was noted by industry and trade associations that fish oil is always a 

byproduct due to economics, but environmental groups remain concerned that fisheries may be exploited 

exclusively for fish oil production. Overall, public comment supported restricting fish oil production only as 

a byproduct. 

Earlier discussion documents proposed an annotation limiting fish oil production from fisheries that were 

harvested such that, when the fisheries were within National Oceanic and Atmospheric Administration 

(NOAA)’s or Food and Agriculture Organization (FAO)’s jurisdiction, they must not be unsustainably 

exploited. 

These suggested annotations received substantial public comment which raised concerns by some certifiers 

and fish-oil industry representatives. Certifiers were concerned about their lack of expertise to ensure 

compliance with either NOAA or FAO standards, and recommended a simple affidavit by processors 

verifying compliance. Others were concerned that while NOAA and FAO standards were similar in 

objectives, they were not directly comparable because they used different timeframes and population 

assessment methods, including different data sources and populations modeling techniques. Thus, 

application of standards based on NOAA and FAO classifications would likely not be uniform across 

producers or verifiable by organic certifiers and would introduce regulatory inconsistency, and therefore 

would not be a practical bar to set for fishery sustainability standards. Other limitations to these 

governmental standards include: 

• There are state managed marine fisheries where NOAA doesn’t have jurisdiction and thus doesn’t 

assess the populations. In these cases, there may be specific populations that are overfished while 

the species as a whole may not be; 

• Many fisheries in foreign waters are not necessarily tracked by FAO but may, in fact, meet 

sustainability standards, or be over-exploited; 

• Many fisheries in international waters are not tracked by governmental or international agencies 

but may, in fact, meet sustainability standards, or be over-exploited; 

• For some species, some populations may be at risk of over-exploitation, whereas other local 

populations may be sustainable, without clear market demarcation of fish origin. 

In response to these concerns, the HS reached out to scientists at NOAA, Seafood Watch, and MSC. These 

individuals and groups recommended annotation language consistent with public comments suggesting 

certification of environmental sustainability “by a third-party certifier” as more likely to achieve OFPA goals. 

This suggested reliance on third part certification for National List annotation raises several concerns, 

including: 

1. Organic environmental sustainability standards would be sourced outside USDA and other U.S. 

government agencies; 

2. There is potential for “greenwashing” if an unscrupulous third-party certifier did not meet 

environmental sustainability standards; 

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3. Requiring third–party certification could exclude smaller-scale producers that cannot afford third 

party certification even though their fishery meets sustainability standards. 

However, there are also advantages to relying on third-party certification programs for non-agricultural 

products that derive from natural resources. According to MSC and other scientists consulted, “certification 

schemes are complex and, within seafood, cover varying issues related to environmental sustainability and 

social responsibility ... the question on which certifications meet the requirements laid out by the NOSB for fish 

oil will undoubtedly come up. It would be a challenge for the NOSB to create and maintain a list of acceptable 

certification schemes for fish oil in organic products and would require constant vetting of the changes of each 

certification...” 

Three examples of a possible annotation 

were discussed at the April 2021 NOSB 

meeting (see box). Overall, public comment 

leaned to Option 2. Fish oil producers 

generally preferred Option 1 but would 

accept Option 2. Dairy and other groups 

producing products containing fish oil leaned 

toward Option 2 and were not concerned 

about impacts product availability. Option 3 

utilizing the Seafood Watch program was also 

supported, but concerns were raised about 

the size and reach of the program. 

Option 2 in particular has several advantages 

according to MSC because the “... International Social and Environmental Accreditation and Labeling (ISEAL) 

and Global Seafood Sustainability Initiative (GSSI)... [are]... global membership organization for ambitious 

collaborative, and transparent sustainability systems. One of their core work streams is defining credible 

practice of programs based on emerging global consensus...” These “... organizations ... are highly respected 

globally as leaders in science-based sustainability certifications. There are established processes, quality 

controls and quality assurances already in place for GSSI recognized and ISEAL compliant certification 

programs. GSSI and ISEAL help to define and ensure programs demonstrate their continual compliance in 

upholding best practice for seafood sustainability certifications and sustainability systems at a global level. 

Further information on the rigor and process of becoming GSSI benchmarked or an ISEAL Code Complaint 

member can be found on the respective organizations’ website” and the requirements would be clear and 

enforceable. 

Based on public comments and consultation with MSC, the Handling Subcommittee modified Option 2 and 

recommends adoption of the following annotation. 

Fish oil annotation: §205.606 (e) Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8) - stabilized with 

organic ingredients or only with ingredients on the National List, §§205.605 and 205.606. Sourced from 

fishing industry by-product only and certified as sustainable against a third-party certification that is 

International Social and Environmental Accreditation and Labeling (ISEAL) Code Compliant or Global 

Seafood Sustainability Initiative (GSSI) recognized. 

In the future, listing of fish oil at §205.606 and the annotation can be reevaluated when organic aquaculture 

standards are approved. 

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Subcommittee Vote: 

Motion to accept the proposed fish oil annotation 

Motion by: Asa Bradman 

Seconded by: Kyla Smith 

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

Citations: 

• Fish oil annotation discussion document, April 2021 NOSB meeting 

• https://www.worldwildlife.org/industries/fishmeal-and-fish-oil 

• 2019 Fall Sunset Review – Fish Oil, NOSB Public Comments Fall 2019 NOSB meeting 

• https://www.fishwatch.gov/sustainable-seafood/managing-us-fisheries 

• https://www.fisheries.noaa.gov/national/2018-report-congress-status-us-fisheries 

• https://www.fisheries.noaa.gov/national/population-assessments/status-us-fisheries 

• https://www.fisheries.noaa.gov/national/sustainable-fisheries/status-stocks-2019 

• http://www.fao.org/3/I9540EN/i9540en.pdf 

• http://www.fao.org/newsroom/common/ecg/1000505/en/stocks.pdf 

• https://www.msc.org/ 

• https://friendofthesea.org/ 

• https://www.iffors.com/ 

• https://ivopure.org/ 

• https://www.sustainablefish.org 

Approved by Jerry D’Amore, Handling Subcommittee Chair, to transmit to NOP August 14, 2021. 

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Sunset 2023 

Meeting 2 - Review 

Handling Substances § 205.605(a), § 205.605(b), § 205.606 

October 2021 

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 scheduled for sunset review by the 

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

List for use in organic crop production 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, use 

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

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

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

Substances Database. 

Request for Comments 

Written public comments will be accepted through September 30, 2021 via www.regulations.gov. 

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

§205.605(a) Sunsets: Nonagricultural (Nonorganic) substances allowed as ingredients in or on processed 

products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’: 

• Agar-agar 

• Animal enzymes 

• Calcium sulfate-mined 

• Carrageenan 

• Glucono delta-lactone 

• Tartaric acid 

§205.605(b) Sunsets: Nonagricultural (Nonorganic) substances allowed as ingredients in or on processed 

products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’: 

• Cellulose 

• Chlorine materials 

o (i) Calcium hypochlorite 

o (ii) Chlorine dioxide 

o (iii) Hypochlorous acid—generated from electrolyzed water 

o (iv) Sodium hypochlorite 

• Potassium hydroxide 

• Silicon dioxide 

• Potassium lactate 

• Sodium lactate 

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Agar -agar 

Reference: §205.605(a) 

Technical Report: 1995 TAP; 2011 TR 

Petition(s): N/A 

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal notice 

effective 11/03/13 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Agar-agar has been used as a food additive for over 350 years. Current uses in food include: stabilizer, 

thickener, gelling agent, texturizer, moisturizer, emulsifier, flavor enhancer, and absorbent. Agar-agar can 

be found in bakery products, confections, jellies and jams, dairy products, canned meat and fish products, 

and vegetarian meat substitutes. A useful characteristic of agar-agar is its ability to withstand high 

temperatures. Since agar-agar is practically tasteless and does not require the addition of cations to form 

gels, it doesn’t interfere with taste profiles. Agar-agar can be used in foods in combination with other 

thickening or gelling agents. Agar-agar is classified as generally recognized as safe (GRAS) by the FDA. 

Manufacture 

Agar-agar is derived from red algae, the main genera harvested being Gelidium and Gracilaria, the second 

of which can be cultivated. After harvesting, the algae are cleaned with water, dried in the sun, pressed into 

bales, and shipped to processors for agar-agar extraction. Prior to extraction, the Graciliara species are 

usually subjected to alkaline pretreatment (heated in a sodium hydroxide solution) followed by rinsing with 

water and sometimes a weak acid to neutralize the alkali. Alkaline pretreatment is used to bring about a 

chemical change in the polysaccharides. This chemical change produces agar-agar with increased gel 

strength. Without this pretreatment, the gels extracted from Graciliara species would be too weak for most 

food applications (2011 TR lines 165-176). After pretreatment, the algae are placed in tanks for extraction 

via hot water and pressure, followed by filtration. Water is removed from the gel through a freeze-thaw 

process or by mechanical pressure. The gel is then dried with hot air resulting in a finished product of 

flakes, strips, or powder. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Agar-agar is permitted for use in organic production. 

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

Agar-agar is permitted for use in organic production. 

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

Organically Produced Foods (GL 32-1999) 

Agar-agar is permitted for use in organic production. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Agar-agar is permitted for use in organic production. 

Japan Agricultural Standard (JAS) for Organic Production 

Agar-agar is not permitted for use in organic production in Japan. 

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Environmental Issues 

The current world demand for agar-agar is reportedly increasing, which has placed pressure on the 

overharvested natural sources. There were no studies found to indicate if the harvesting of agarophytes, in 

particular, is harmful to the biodiversity of nearby beaches or algae beds. Agar-agar manufacture produces 

alkaline wastewater, but there were no documents found that show this to be a current problem to the 

environment. 

Discussion 

Based on the different manufacturing processes, and the 2011 TR, there does appear to be a question as to 

whether two forms of agar-agar exist. While there are extraction processes that are natural (non-synthetic) 

and without chemical modifications, there are others that can be considered synthetic. An example of the 

synthetic method would be when Graciliara species are subjected to an alkaline pretreatment (heated in 

sodium hydroxide solution) to modify the polysaccharides in the algae. This process brings about a chemical 

change in the polysaccharides (L-galactose-6-sulfate groups are converted to 3,6-anhydro-L-galactose), 

increasing the gel strength of the agar-agar. Data indicate that without this treatment, the gel extracted 

would be too weak for most food applications. While the 2011 TR lists several methods of extraction, it 

states that only 1 -2% of the agar-agar supply is from the natural form of extraction. Furthermore, the 

product from the natural extraction method does not appear to be readily available in the U.S. market. 

Agar-agar is currently listed on the National List at §205.605(a) Nonagricultural (nonorganic) substances 

allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).” (a) Nonsynthetics allowed. During the 2018 sunset review it was suggested 

that based on the manufacturing process, agar-agar could also be listed at §205.605(b) Synthetics allowed. 

There were several comments during the Spring 2021 meeting supporting the relisting of agar-agar. It is an 

essential tool in the development and innovation of organic foods. Several commentors noted there is a 

distinct difference between synthetic and non-synthetic forms based on species of red algae. However, 

commercial availability of non-synthetic agar-agar is insufficient and may not be effective for some 

applications. 

Justification for Vote 

The Subcommittee proposes removal of agar-agar from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove agar-agar from the National List 

Motion by: Kim Huseman 

Seconded by: Jerry D’Amore 

Yes: 0 No: 7 Abstain: 0 Absent: 0 Recuse: 0 

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Animal enzymes 

Reference: §205.605(a) Animal enzymes - (Rennet - animals derived; Catalase - bovine liver; Animal lipase; 

Pancreatin; Pepsin; and Trypsin). 

Technical Report: 2000 TAP; 2011 TR; 2015 Limited Scope TR (ancillary substances in enzymes) 

Petition(s): NA 

Past NOSB Actions: 11/2000 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Enzymes are naturally occurring proteins that act as highly efficient catalysts in biochemical reactions. They 

are used to carry out naturally occurring biological processes that are useful in the processing of food 

products or ingredients (Enzyme Technical Association 2001) (2011 TR, lines 140- 142). Animal enzymes, 

such as rennet, are used as a coagulant to curdle milk to be made into cheese or sour cream. Enzymes are 

used in very small amounts to achieve the desired effect. For example, the amount of animal-derived 

rennet used to clot milk is 0.036 percent (2011 TR, lines 727-728). 

Manufacture 

Traditionally, the fourth stomach of calves or goat kids is dried, cleaned, and then sliced into pieces, before 

being stored in either whey or saltwater. Vinegar or wine can be added to lower the pH. After allowing the 

solution to sit for a few days, it is filtered repeatedly. A small amount of boric acid is added to the filtrate. In 

industrial production, the stomach is minced, and the pH adjusted by adding hydrochloric acid and sodium 

phosphate (2011 TR, lines 444-458). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

The use of enzymes is permitted in organic processing in Canada. 

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

The use of enzymes is permitted in organic processing in the EU. 

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

Organically Produced Foods (GL 32-1999) 

The use of enzymes is permitted in organic processing in CODEX. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

The use of enzymes is permitted in organic processing by IFOAM. 

Japan Agricultural Standard (JAS) for Organic Production 

The use of enzymes is permitted in organic processing in Japan. 

Ancillary substances 

Explained in the 2015 Limited Scope TR: 

“Enzyme products used in food processing may be single ingredient, stand-alone preparations of 

the enzyme, or formulated with other ingredients (OMRI, 2015). In many cases the enzyme product 

which results from a fermentation process is not effective in food applications without further 

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formulation (Whitehurst & Van Oort, 2009). Enzyme preparations therefore commonly contain 

other substances, not only as incidental secondary metabolites and residual growth media from the 

enzyme production, but also intentionally added ingredients, which function as diluents, 

preservatives, stabilizers, antioxidants, etc. (FDA, 2010). These additives must be generally 

recognized as safe (GRAS), or be FDA approved food additives for this use (FDA, 2014).” 

To prevent the loss of enzyme activity, ancillary substances, such as stabilizers, are added. This is especially 

true for liquid enzyme preparations due to the destabilizing effect of water. Stabilizers are also used to 

combat the degradation of enzyme structures due to autolysis or proteolysis. To control microbial 

contamination of enzyme preparations, preservatives are added. The development of alternatives to 

preservatives (plant extracts, peptides, compounds from herbs and spices) is increasing but there are 

microbial resistance challenges and the need for continued research. Currently it is unknown if natural 

preservatives are being used in any enzyme formulations. 

Ancillary Substances by Food Additive Functional Class 

Anti-caking & 

anti-stick agents 

Magnesium stearate, calcium silicate, silicon dioxide, calcium stearate, 

magnesium silicate/talc, magnesium sulfate. 

Carriers and fillers Lactose, maltodextrins, sucrose, dextrose, potato starch, non-GMO soy oil, rice 

protein, grain (rice, wheat, corn, barley) flour, milk, autolyzed yeast, inulin, 

cornstarch, sucrose, glycerol, potassium chloride, ammonium sulfate, calcium 

phosphate, calcium acetate, calcium carbonate, calcium chloride, calcium 

sulfate, dextrin, dried glucose syrup, ethyl alcohol, glucose, glycol, lactic acid, 

maltose, mannitol, mineral oil, palm oil, purity gum (starch), saccharose, 

sorbitol, soy flour, sunflower oil, trehalose, vegetable oil, microcrystalline 

cellulose, propylene glycol, stearic acid, dicalcium phosphate. 

Preservatives Sodium benzoate, potassium sorbate, ascorbic acid, alpha (hops) extract, 

benzoic acids and their salts, calcium propionate, citric acid, potassium chloride, 

potassium phosphate, sodium acetate, sodium chloride, sodium propionate, 

sodium sulfate, sorbic acid and its salts, stearic acid, tannic acid, trisodium 

citrate, zinc sulfate. 

Stabilizers Maltodextrin, betaine (trimethylglycine), glucose, glycerol, sodium chloride, 

sodium phytate, sorbitol, sucrose. 

pH control, buffers Acetic acid, citric acid anhydrous, sodium citrate, sodium phosphate, trisodium 

citrate. 

Environmental Issues 

The manufacture or use of animal enzymes is not found to be harmful to the environment or biodiversity. 

Enzymes are used in small amounts, are biodegradable, and the release of enzymes into the environment is 

not an environmental concern. 

Discussion 

There are no true alternatives to animal enzymes. Enzymes can only be substituted with another enzyme 

with the same function. One alternative to animal derived rennet for the production of cheese is genetically 

engineered chymosin, which is incompatible with organic food handling due to the use of excluded 

methods to produce it. The 2000 TAP for animal derived enzymes indicated that animal derived enzymes 

could be produced from organic livestock. 

There was overwhelming support during the comment period of the 2021 Spring meeting to relist animal 

enzymes on the National List. Comments addressed the non-existence of organic animal enzymes and the 

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-

inability to achieve a reliable organic supply; cost was listed as a barrier as well. Several mentioned the lack 

of adequate alternatives in order to produce the type(s) of cheese being manufactured. There was one 

opposing comment suggesting more research needs to be done regarding the essentiality of catalase, 

animal lipase, pancreatin, pepsin, and trypsin. 

Justification for Vote 

The Subcommittee proposes removal of animal enzymes from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove animal enzymes from the National List 

Motion by: Kim Huseman 

Seconded by: Jerry D’Amore 

Yes: 0 No: 7 Abstain: 0 Absent: 0 Recuse: 0 

Calcium sulfate mined 

Reference: §205.605(a) 

Technical Report: 1996 TAP; 2001 TAP 

Petition(s): 2000 

Past NOSB Actions: 09/1996 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

• Coagulate in tofu manufacturing. Calcium sulfate is essential to soft and silky tofu types. 

• Yeast food and dough conditioner, water conditioner. 

• Firming agent (in canned foods). 

• Jelling ingredient. 

• Baking powder. 

• Dentistry (bone regeneration). 

Manufacture 

Calcium sulfate can be obtained from natural sources or synthetic sources. The listing restricts calcium 

sulfate to mined sources, and mined gypsum is the primary source. After crude gypsum is mined in opencast quarrying or via deep mining, it is ground and separated. It is normally sold in pure form but may 

contain impurities of calcium carbonate and natural occurring silica. It can form as a by-product from many 

different kinds of processes, including from emissions from fossil fuel power stations. The material is 

generally recognized as safe (GRAS) by the FDA. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Restricted to “as a carrier for cakes and biscuits; for soybean products; and for bakers’ yeast” and source is 

restricted to “sulfates produced using sulfuric acid are prohibited.” 

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

Restricted to use as a coagulation agent and carrier only but is not restricted to mined sources. Mexico – 

restricted to acidifiers, acidity, anti-caking agent, antifoam, filler, and coagulant but not restricted to mined 

sources. 

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

Organically Produced Foods (GL 32-1999) 

Restricted to “Cakes & biscuits/soybean products/baker’s yeast. Carrier” but not restricted to mined 

sources. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Restricted “For soybean products, confectionery and in bakers’ yeast” but not restricted to mined sources. 

Japan Agricultural Standard (JAS) for Organic Production 

Restricted to ”Limited [use] as coagulating agent or used for confectionary, the processed beans products 

or bread yeast” but not restricted to mined sources. 

Ancillary substances 

None reported in the 2001 TAP. 

Environmental Issues 

Mining of calcium sulfate (as gypsum or alabaster) has exposed several public land areas, including Grand 

Staircase-Escalante National Monument in Utah, to extractive impacts. It is unclear the full extent of these 

activities to date, or landscape and critical area damage that could occur in the future. This question could 

potentially be addressed more fully in more current Technical Report (TR), as the most recent report on 

calcium sulfate is a 2001 Technical Advisory Panel (TAP), especially given that the sunset under 

consideration is the mined version. 

Discussion 

The Handling Subcommittee received several comments during the previous sunset review in 2016. 

Manufacturers and trade associations emphasized its use in tofu production. Several companies noted it 

was critical to production of tofu and soy cheese. One manufacturer noted they would like it retained but 

they currently use magnesium chloride instead. Another manufacturer noted magnesium chloride 

produced a softer tofu than calcium sulfate. It was also noted that calcium sulfate was used in the brewing 

industry to adjust the mineral content of water. One interest group asked that its use be limited to 

coagulation of bean curd noting evidence was not available for its use in other food applications. Another 

interest group raised concerns about the environmental and human health concerns of mining and noted a 

toxicological review completed by the National Toxicology Program in 2006. This review noted: “None of 

the long-term studies can be considered adequate tests of chronic toxicity or carcinogenicity by modern 

standards.” Furthermore, it focused more on exposure from the 2001 World Trade Center attacks, and the 

limited information from mine workers was from a 1976 study that was available during the original 1996 

TAP. While the previous sunset review considered the renewal of calcium sulfate valid, a previous NOSB 

noted that future sunset reviews should consider if a new TR could help in a review of current data on 

alternative manufacturing methods, environmental or human health concerns, and/or whether an 

annotation should be recommended. 

In 2016, the subcommittee agreed this material satisfies the OFPA evaluation criteria and the Handling 

Subcommittee supported the relisting of calcium sulfate, which subsequently was upheld by the full Board. 

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Subcommittee review 

At the Spring 2021 NOSB meeting, the Subcommittee heard from several certifiers about somewhat limited 

use of the material among their members, although despite limited use, their support for relisting was 

clear. One non-profit stakeholder shared concern flagged by the Subcommittee about potential negative 

impacts from mining for the substance in sensitive areas. That group also asked that the material be 

annotated to limit its use as a coagulant only. 

Questions to our Stakeholders 

1. Is there clear evidence of unacceptable environmental impacts from the mining of calcium sulfate? 

2. Is there clear evidence of unacceptable human health impacts from calcium sulfate mining? 

Justification for Vote 

The Subcommittee proposes removal of calcium sulfate-mined from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not 

recommending removal. 

Subcommittee Vote 

Motion to remove calcium sulfate-mined from the National List 

Motion by: Wood Turner 

Seconded by: Jerry D’Amore 

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

Carrageenan 

Reference: §205.605(a) 

Technical Report: 1995 TAP; 2011 TR; 2016 Limited Scope TR 

Petition(s): N/A 

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987 – misspelled as 

‘carageenan’); Sunset renewal notice effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 

5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Carrageenan is a food additive used as an emulsifier, thickener, and gelling compound primarily in meat 

and dairy products. It is often used as a vegan alternative to animal sourced gelatin. It is listed as generally 

recognized as safe (GRAS) on the FDA list of food additives. 

Manufacture 

Carrageenan is made through a fairly simple process of heating edible red algae in a hot alkali solution, 

typically using potassium hydroxide. The cellulose from the plant is then removed through centrifugation 

and the remaining gel-like solution is the carrageenan, which can be evaporated and dried into a powder 

for addition to foods. 

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There are three main kinds of carrageenan (kappa, iota, and lambda carrageenan) which are primarily 

extracted from different seaweed species (or different life stages) and are distinguished chemically by the 

number and position of ester sulphates on the carbohydrate units in the molecules. This information is 

relevant, as the different types have different properties and uses in the food industry: 

• Kappa-carrageenan – forms strong gels in combination with potassium ions and is used primarily in 

dairy products. 

• Iota-carrageenan – forms soft gels in the presence of calcium ions. 

• Lambda-carrageenan – does not gel and is used to thicken dairy products. 

Figure 1. Most of the global production is of kappa-carrageenan (Source 

www.grandviewresearch.com) 

Most of the seaweeds used in carrageenan production are sourced from the Philippines and China and are 

grown in seaweed farms. 

International Acceptance 

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

The EEC allows carrageenan as an additive to organic dairy foods. The joint FAO/WHO Expert Committee on 

Food Additives (JECFA) determined in 2015 that carrageenan is a safe additive for infant formula at doses 

up to 1000mg/L. 

Canadian General Standards Board Permitted Substances List 

Canada allows carrageenan as a food additive under their organic standard with no limits on usage. 

Japan Agricultural Standard (JAS) for Organic Production. JAS allows carrageenan as an additive to organic 

dairy products. 

International Federation of Organic Agriculture Movements (IFOAM) Norms IFOAM allows carrageenan as a 

food additive with no annotations. 

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

Organically Produced Foods (CXG 32-1999) 

Carrageenan is listed as a food additive permitted for use in plant-based foods, dairy products, and dairy 

analogues (excluding fats, oils, and fat emulsions) within the guidelines for organically produced foods 

(Matthee, 2007). 

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The East African Organic Product Standard and the Pacific Organic Standard both list carrageenan as an 

additive allowed in organic food processing. 

Environmental Issues 

Farming of seaweed used to extract carrageenan raises several environmental issues. Seaweed farms can 

be a lucrative business for small scale aquaculture as the overhead is low, requiring at the most basic level 

nylon strings or netting in shallow coastal waters. The turnover to harvest is quite short, at only 6 weeks. 

However, increased demand for seaweed has resulted in the establishment of some farms that involve first 

destroying important nearshore habitats like mangrove swamps or eelgrass beds to provide growing 

environments. Drifting mats from the established farms can also smother other nearby habitats, such as 

coral reefs. For example, when seaweed farming was introduced to India, to promote aquaculture for 

carrageenan, the seaweed rapidly invaded and smothered coral reefs in a nearby marine reserve (Baglar, 

2008). 

Research into the ecological effects of seaweed farming indicates that the diversity of fish is reduced in and 

around the seaweed farms. Proximity to seaweed farming reduces the size and growth rates of sea grass 

beds. A proposed environmental mitigation strategy is to move seaweed farming to deeper, sandybottomed areas and ensure that the farms are a safe distance from vulnerable habitats like coral reefs 

(Kelly, Cannon and Smith, 2020). 

The impacts of seaweed aquaculture can be positive. It has been hypothesized that carefully placed 

seaweed aquaculture can help increase oxygenation in near-shore waters, remove impurities from the 

water, buffer against wave action, help stabilize marine pH and otherwise help mitigate against some 

effects of climate change (Duarte, Wu, Xiao, Bruhn and Kraus-Jenson, 2017). In addition, it is a food source 

that requires no freshwater or chemical inputs, making it an attractive alternative to terrestrial-based 

crops. Lastly, seaweed farming can provide a viable alternative to fishing in areas where overfishing has 

depleted fish populations. 

Discussion 

Carrageenan has a long history of use as a food additive, used to make dairy-based puddings in Ireland for 

nearly 1500 years and found in soups in China since 600 BC. It did not become broadly used in industrial 

food preparation until the 1930s. It is currently a $500 million dollar industry. 

Figure 2. Carrageenan production in 2018 (Taylor, 2019) 

Due primarily to their role as thickening and emulsifying agents, carrageenan and other algae-based foods 

represent one of the fastest growing segments of the food sector. Seaweed production is projected to grow 

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an additional 12.6% a year over the 5 year period from 2020-2025 as the demand for processed foods 

continues to grow. 

Despite this extensive history of human consumption, there have been concerns in the United States that 

carrageenan can cause a myriad of health problems as part of the human diet (Bixler, 2017). Most of this 

controversy stems from research led by Dr Joanne Tobacman (Tobacman, Bhattachayya, Borthakur, and 

Dudeja, 2008). Her research has suggested that carrageenan promotes intestinal ulcers, contributes to 

irritable bowel syndrome, and could be carcinogenic. 

Critics of Dr Tobacman and associates’ work believe that Tobacman has been conducting experiments using 

not carrageenan, but a degraded form of carrageenan, poligeenan, that is a known inflammatory agent and 

not considered safe for consumption. Poligeenan is only produced from carrageenan under high heat and 

extreme acid conditions, and is therefore not created during the process of human digestion. Poligeenan is 

distinct from food-grade carrageenan. In fact, poligeenan is well-known for producing an inflammatory 

response and is used to provoke edema for study in rats when injected under the skin. The results from 

Tobacman’s studies have not been replicated when independently assessed. 

Further muddying the waters, much of the early work on carrageenan and poligeenan do not distinguish 

between the intact and the degraded form, calling both carrageenan. Therefore, older scientific papers 

need careful reading to determine whether the researcher used poligeenan or carrageenan. Intact 

carrageenan, like cellulose and other fibre, is a large molecule that passes through the human digestive 

tract without being broken down or absorbed. Despite the lack of replication of this work, there are 

numerous anecdotal reports from people who find relief from digestive complaints when they remove 

carrageenan from their diet. Currently, changes in perceived health must therefore be considered 

correlative and not demonstrative of causation. 

In 2007, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered it “inadvisable to use 

carrageenan or processed eucheuma seaweed in infant formulas,” but then partially reversed this position 

in 2014, concluding that “these new studies allay the earlier concerns that carrageenan, which is unlikely to 

be absorbed, may have a direct effect on the immature gut.” The Committee also took account of the 

previous toxicological database on carrageenan, which “did not indicate other toxicological concerns” and 

“that the use of carrageenan in infant formula or formula for special medical purposes at concentrations up 

to 1000 mg/L is not of concern.” Infants are considered to be the most sensitive population to the potential 

effects of carrageenan. The 2011 Technical Report (TR) reports that “the group acceptable daily intake 

(ADI) for carrageenan and processed Eucheuma seaweed was categorized as “not specified” by JECFA, ... 

[which] means that the total dietary intake of the substance arising from its use at the levels necessary to 

achieve the desired effect in food and from its acceptable background levels in food does not...represent a 

hazard to health”. 

As part of the 2016 NOSB sunset review, “an extensive list was prepared of all the food product categories 

in which carrageenan is used. In most of the product types there are versions that are currently being sold 

that do not contain carrageenan. These often contain other types of gums such as gellan, guar, or xanthan.” 

At that time, products for vegetarians and vegans where carrageenan is used in place of gelatin were 

singled out as difficult to produce without carrageenan. 

Eliminating carrageenan may be achievable through the elimination of many processed foods where it is 

considered essential by manufacturers. Most international organic standards permit use of carrageenan, 

including the EU, Canada, Japan, and IFOAM (see the International Acceptance section above). During the 

last sunset review, the NOSB recommended removal of carrageenan from the National List based on lack of 

essentiality (Yes: 10 No: 3 Abstain: 1 Absent: 1 Recuse: 0). The basis of this decision largely reflected the 

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intense consumer controversy associated with this substance, as well as concerns about its compatibility 

with a system of sustainable agriculture. Also invoked was the NOSB Guidance on Compatibility from the 

Appendix of the NOSB Policy and Procedures Manual that poses this question for consideration, “Does the 

substance satisfy expectations of organic consumers regarding the authenticity and integrity of organic 

products?” 

It is important to note that the NOP did not implement the NOSB recommendation to remove carrageenan 

from the National List, and carrageenan is currently allowed in organic production. 

Stakeholder Input 

There were fourteen stakeholder thoughts and/or concerns (both oral and written) registered during the 

2021 Spring NOSB meeting. Eight were in favor of keeping carrageenan on the National List and four were 

opposed. The remaining two indicated that carrageenan was not used within their community. While there 

was general support within the stakeholder community to keep carrageenan on the National List, it was 

deemed an unnecessary addition by the NOSB as there are alternative products that serve the same 

functionality. 

Justification for Vote 

The Subcommittee proposes removal of carrageenan from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Availability of alternatives. 

Subcommittee Vote 

Motion to remove carrageenan from the National List 

Motion by: Jerry D’Amore 

Seconded by: Kyla Smith 

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

References: 

Bagla, P. (2008) Seaweed invader elicits angst in India. Science. 320:1271 

Bixler, HJ (2017) The carrageenan controversy. Journal of Applied Phycology 29:2201–2207 

Duarte CM., Wu J, Xiao X, Bruhn A, Krause-Jensen D (2017) Can seaweed farming play a role in climate 

change mitigation and adaptation? Frontiers in Marine Science 4 

Kelly EL, Cannon AL, Smith, JE (2020) Environmental impacts and implications of tropical carrageenophyte 

seaweed farming. Conservation Biology 34(2): 326-337 

Matthee, M. (2007) The Codex Alimentarius Commission and its standards. Maastricht University. 

Taylor, A (2019) Seaweed farming for food and fuels. Chemical and Engineering News, 97(34) 

Tobacman JK, Bhattacharyya S, Borthakur A, Dudeja PK. (2008) The carrageenan diet: not recommended. 

Science 321(5892):1040-1041. 

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Glucono delta -lactone 

Reference: §205.605(a) Glucono delta-lactone—production by the oxidation of D-glucose with bromine 

water is prohibited. 

Technical Report: 2002 TAP; 2016 TR 

Petition(s): 2002 

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347) 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Glucono delta-lactone (GDL) is primarily used in the production of tofu, particularly in the production of 

silken tofu, and is generally thought to be the only material that can produce the physical and sensory 

components favored in that product. In tofu production, GDL serves as a coagulant. GDL can also be used as 

a curing or pickling agent, leavening agent, pH control agent and sequestrant. It is also used in feta cheese 

in place of lactic acid bacteria to reduce pH. Less tangy than citric acid, GDL slowly undergoes hydrolysis in 

water and converts to gluconic acid to produce a tangy flavor in food applications. GDL is generally 

recognized as safe (GRAS) by the FDA. 

Manufacture 

Glucono delta-lactone (GDL) is produced by crystallization from an aqueous solution of gluconic acid. There 

are a variety of ways gluconic acid can be produced. The most common method to produce gluconic acid is 

called the Blom process, where gluconic acid is produced by fermentation of glucose syrups by Aspergillus 

niger. Sodium hydroxide or calcium carbonate is added to the fermentation process to produce gluconate 

salt. The gluconate salt is then isolated via evaporation, crystallization and then conversion to acid via ionexchange. This process produces GDL via fermentation and acid base reactions (2016 TR, pg. 10-11). Other 

processes to make GDL involve oxidation of D-glucose with bromine water (which is not allowed by the 

National List annotation) and the use of purified enzymes (TR 281-282). 

GDL is >99% pure and has no ancillary substances present. GDL is often sold in formulation with other 

additives specifically designed for the application. These substances should be reviewed separately as they 

are not ancillary substances. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

GDL is not listed on the permitted substances list of Canada. 

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

GDL is not listed on the permitted substances list of the EU. 

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

Organically Produced Foods (CXG 32-1999) 

GDL is not listed on the permitted substances list of CODEX. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

GDL is not listed on the permitted substances list of IFOAM. 

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Japan Agricultural Standard (JAS) for Organic Production. 

GDL is not listed on the permitted substances list of Japan. 

Environmental Issues 

The Handling Subcommittee was unable to document any environmental or human health issues associated 

with the production or consumption of GDL. Some sources have indicated it may cause minor bladder 

discomfort and/or back pain. 

The 2016 technical review examined human health and environmental impacts of GDL use and production 

but found low to no risk. The TR did raise the question of classification, given the substance is produced via 

fermentation and acid-base reactions similar to the production of citric acid, which is also listed as 

nonsynthetic at §205.605(a). The TR also raised concerns about the potential for GMO enzymes used in the 

production of GDL via the oxidation with enzymes production method (not the most common form of 

production). 

Discussion 

The original petition and primary use of GDL is for the coagulation of tofu. Other coagulants for tofu include 

magnesium chloride, calcium chloride, calcium sulfate, and magnesium sulfate. Acids such as citric or lactic 

acid can be used as well. Each of these substances produce a different type of tofu texture and flavor 

making distinctly different products. Calcium salts produce firmer tofu, sulfate salts produce soft tofu and 

GDL produces silken tofu. Citric and lactic acids produce acidified tofu that is often undesirable. Precise 

control of temperature and processing environments may allow different coagulants to produce different 

types of tofu. 

The Handling Subcommittee requested public comment regarding the use of GDL in organic processed 

foods other than tofu production. One comment was received stating its use was necessary for a dairy 

product and another noted its use in a cosmetic product. Further, the Handling Subcommittee asked if 

alternative tofu coagulants such as calcium and sulfate salt would be sufficient to produce all forms of tofu 

if GDL were removed from the national list. In response, companies commented that alternatives on the list 

result in distinctly different and firmer tofu and that GDL is critical for silken, jelly-like tofu. Several tofu 

manufacturers commented in favor of retaining GDL. 

Lastly, the Subcommittee asked stakeholders whether GDL produced from enzymes should be prohibited or 

further restricted due to concerns about GMOs, an issue that is referenced in the 2002 TAP and noted as an 

issue for ongoing monitoring. Interest groups expressed concern that enzymatic GDL could possibly be 

produced via GMO substrates or enzymes and recommended the listing be annotated if renewed at all. As 

annotation changes are not possible during sunset review, this would require separate action from the 

Board. Another commenter questioned the necessity of GDL stating it could be produced via alternative 

means, however, no information was presented on the commercial viability of this approach. 

Subcommittee review 

At the Spring 2021 NOSB meeting, the Subcommittee received limited commentary from stakeholders 

about GDL. However, one commenter did indicate that the misalignment between the current annotation – 

which prohibits GDL made from bromine water and ensures only nonsynthetic GDL is used in organic – and 

the 2016 TR which suggests GDL can be made from a variety of different chemical means leaves the listing 

exposed to synthetic GDL production and some excluded methods. That comment suggests a clarification of 

the annotation may be needed. 

The Handling Subcommittee heard from several certifiers about somewhat limited use of the material 

among their members, although despite limited use, support for relisting was clear. One non-profit 

stakeholder shared a concern flagged by the subcommittee about potential negative impacts from mining 

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for the substance in sensitive areas. That group also asked that the material be annotated to limit its use as 

a coagulant only. Another stakeholder suggested GDL is nonessential, though several certifiers reported 

that a number of their members and clients are currently using GDL. 

At this time, this material satisfies the OFPA evaluation criteria, and the Handling Subcommittee supports 

the relisting of glucono delta-lactone. 

Questions to our Stakeholders 

1. How widespread is the use of GDL in organic applications? 

2. Is there evidence that GDL being used in organic applications may derive from genetic modification 

of any kind? 

3. Have alternatives to GDL emerged in recent years that deliver the same product quality and 

functionality? 

4. Is the lack of International acceptance significant? 

5. How is organic silken tofu produced in the EU, Japan, etc. without the use of GDL? 

Justification for Vote 

The Subcommittee proposes removal of glucono delta-lactone from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not 

recommending removal. 

Subcommittee Vote 

Motion to remove glucono delta-lactone from the National List 

Motion by: Wood Turner 

Seconded by: Jerry D’Amore 

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0 

Tartaric acid 

Reference: §205.605(a) Tartaric acid - made from grape wine. 

Technical Report: 2011 TR 

Petition(s): 2011 Petition to remove from §205.605(b) - made from malic acid 

Past NOSB Actions: NOSB meeting review 11/1995; 11/2005 recommendation; 12/2011 recommendation; 

11/2016 recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

According to the 2011 TR, tartaric acid naturally occurs in many plants, especially grapes, bananas, and 

tamarinds. Tartaric acid can be used to create several different salts, including tartar emetic (antimony 

potassium tartrate), cream of tartar (potassium hydrogen tartrate), and Rochelle salt (potassium sodium 

tartrate). The primary uses of tartaric acid are associated with its salts. 

The 2011 TR further notes that tartaric acid and its salts have a very wide variety of uses. These include use 

as an acidulant, pH control agent, preservative, emulsifier, chelating agent, flavor enhancer and modifier, 

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stabilizer, anti-caking agent, and firming agent. It has been used in the preparation of baked goods and 

confectionaries, dairy products, edible oils and fats, tinned fruits and vegetables, seafood products, meat 

and poultry products, juice beverages and soft drinks, sugar preserves, chewing gum, cocoa powder, and 

alcoholic drinks. 

Tartaric acid and its immediate byproducts are particularly useful in baking. Due to its acidic properties, 

tartaric acid is used in baking powder in combination with baking soda (sodium bicarbonate). When tartaric 

acid reacts with sodium bicarbonate, carbon dioxide gas is produced, causing various baking products to 

‘rise’ without the use of active yeast cultures. This action alters the texture of many foods. Tartaric acid and 

its salts are used in pancake, cookie, and cake mixes because of these properties. Cream of tartar is used to 

make cake frosting and candies. 

Although tartaric acid is isolated from wines, it may also be used in winemaking to alter acidity. For nongrape wines, it may be added to increase acidity or to help prevent degradation of the flavor from 

unwanted microorganisms (TR, 2011). 

Tartaric acid and its salts (i.e., potassium acid tartrate, sodium potassium tartrate acid) are classified by FDA 

as generally recognized as safe (GRAS). 

Manufacture 

The 2011 TR details the production of tartaric acid: 

The nonsynthetic form of tartaric acid is isolated from the undesirable wastes created during the 

winemaking process. These unwanted materials include grape pomace, grape stalks, grape seeds, and vine, 

which naturally contain a significant amount of tartaric acid. An excess of tartaric acid is generally 

unwanted in winemaking because it creates a sour and undesirable taste. The available excess tartaric acid 

is precipitated using potassium hydroxide or calcium hydroxide in order to create a wine with the desired 

taste. Then the resulting waste mixture is evaporated. This process produces a powder containing calcium 

or potassium tartrate and additional substances including polyphenols and tannins. The powder is then sold 

to facilities that purify tartaric acid. The process for extracting tartaric acid from waste materials is similar 

to the processing of excess tartaric acid, in that potassium hydroxide is added to the waste mixture. 

Activated carbon is also added to remove unwanted pigmentation. The potassium tartrate is precipitated 

by adding saturated pure tartaric acid solution and then the precipitate is redissolved with acidic water at 

70° C. Potassium and sulfate ions must be removed from the remaining solution, so cation exchanges are 

performed followed by evaporation. The solution is then crystallized at 4° C. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

The use of tartaric acid (C4H6O6; INS 334) is permitted for organic processing by the Canadian General 

Standards Board as a non-organic ingredient classified as a food additive in beverages. Use of the synthetic 

form is allowed only if the nonsynthetic form of tartaric acid is not commercially available. Tartaric acid 

derived from nonsynthetic sources is also permitted for use as a processing aid in beverages (the Canadian 

General Standards Board, 2020). 

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

The European Economic Community (EEC) permits the use of tartaric acid as a food additive in organic food 

if derived from a plant source, which is presumably grapes (EEC 889/2008, 2008). 

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

Organically Produced Foods (CXG 32-1999) 

The CODEX Alimentarius Commission describe the functions of tartaric acid as an acidity regulator, 

adjuvant, anticaking agent, antioxidant, bulking agent, emulsifier, flour treatment agent, humectant, 

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preservative, raising agent, sequestrant, and stabilizer. Tartaric acid from a plant source (i.e., nonsynthetic L 

(+) tartaric acid) is permitted for use as a food additive in organic food production (although exclusions of 

the GFSA still apply). Tartaric acid is listed as an acceptable acidity regulator in the Codex General Standard 

for Food Additives (CODEX STAN 192-1995; CODEX Alimentarius Commission, 2011). 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Allows the use of tartaric acid only for wine. 

Japan Agricultural Standard (JAS) for Organic Production. 

Limited to be used for processed foods of plant origin. 

Environmental Issues 

If appropriate use patterns and disposal recommendations are followed, it is unlikely that tartaric acid 

would cause harm to the environment. The biodegradability of tartaric acid is 95% after 3 days and the 

substance is considered readily biodegradable. No bioaccumulation is to be expected (TR 2011). 

Discussion 

Tartaric acid is a critical component in several areas of food handling. While baking powder can be replaced 

with baking soda, cream of tartar must be added to maintain the baking powder properties. While tartaric 

acid is made from grapes, it is also an important component in winemaking and there are no organic 

alternatives. Other natural components of grapes, such as malic acid, can be used to alter the acidity of 

wine and possess preservative characteristics, but they often impart a different taste than tartaric acid 

(2011 TR). 

For pH adjustment, citric acid and malic acid can be used, however, they impart certain flavors to the 

product. If a grape flavor is needed, tartaric acid would be the first choice. 

Due to low impacts on human health and the environment and the advantageous qualities that tartaric acid 

lends to baked goods, wines, and other products, tartaric acid is a good candidate for relisting. 

Subcommittee Review 

A number of public comments supported relisting of this material. Commenters highlighted that tartaric 

acid is essential in wine production and that organic wines rely on this material. However, several 

stakeholders questioned whether there could be an adequate supply of tartaric acid made from organic 

grape wine. The listing could discourage the development of an organic tartaric acid. The sale of tartaric 

acids made from organic wines could also provide additional revenue for organic vintners. This is an openended question and the answer to it was not resolved in public comments. Since the question is not 

resolved, relisting at this point in time is prudent. However, as the organic wine market continues to grow, 

the Board encourages the inclusion of an analysis of the availability of tartaric acid from organic grapes 

during the next sunset review, and also encourages the organic wine industry to move towards production 

of tartaric acid from organic grapes. 

Justification for Vote 

The Subcommittee proposes removal of tartaric acid from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

NOSB Proposals and Discussion Documents October 2021 133 of 205
 

 

 

 

 

 

 

 

 

 

Subcommittee Vote 

Motion to remove tartaric acid from the National List. 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0 

Cellulose 

Reference: §205.605(b) Cellulose (CAS #9004-34-6)—for use in regenerative casings, powdered cellulose as 

an anti-caking agent (non-chlorine bleached) and filtering aid. Microcrystalline cellulose is prohibited. 

Technical Report: 2001 TAP; 2016 TR 

Petition(s): 2001 

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal notice 

effective 11/03/2013 (78 FR 61154); Sunset renewal notice effective 5/29/2018 (83 FR 14347); Annotation 

change effective 12/27/2019 (83 FR 66559). 

Sunset Date: 11/03/2023 

Subcommittee Review 

Use 

Cellulose is used as a processing aid for filtration of juices; as an anti-caking agent ingredient for use in 

shredded cheese; and as a processing aid in the form of peelable/non-edible hot dog and sausage casings. 

Some of these uses in organic handling have been around since before the enacting of OFPA, with cellulose 

allowed by certifiers in organic cheeses since 1994 and for use in organic meat products since 1999. 

Manufacture 

Cellulose is available in several different forms, each with varying functional qualities used for multiple 

purposes in organic handling. There are two specific forms of cellulose currently permitted for use in 

organic processing and handling: amorphous powdered cellulose and inedible cellulose casing. 

Cellulose in its natural form is the main structural component of higher plant cell walls and one of the most 

abundant organic substances on earth (EMBL, 2015)(TR 2-11-2016). Most commercially available cellulose 

(powdered) is produced from wood pulp or other plant sources, e.g., corn cobs, soybean hulls, oat hulls, 

rice hulls, sugar beet pulp, etc. The plant material goes through a delignification process that results in a 

chemically changed synthetic substance. The original process for making regenerated cellulose casing, the 

viscose method, dates to the 1890’s and converts cellulose fibers into regenerated fibers and films. With 

some minor changes to the process, it is still in use today. Cellulose is considered Generally Regarded as 

Safe GRAS under 21 CFR 121.101 (LSRO 1973). 

The 2016 TR and public comments submitted in previous sunset reviews of cellulose provided the following 

list of ancillary substances that are sometimes used in the production of cellulose. The 

TR was very clear that there are well defined sources of commercially available cellulose that do not include 

any ancillary substances, as well as those that might use ancillaries listed in the chart below. During the 

2018 Sunset review, public comment identified additional ancillary substances used in the production of 

cellulose. The review noted the Handling Subcommittee would develop a follow-up proposal to include 

these ancillaries, however it is not clear if this progressed. 

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Functional Class Ancillary Substance Name 

Carriers and fillers, agricultural or nonsynthetic Potato starch, dextrose 

Carriers and fillers, synthetic Propylene glycol 

Preservatives Polysorbate 80, enzymes 

Binder/Plasticizer Lecithin, propylene glycol, mineral oil 

Anti-caking & anti-stick agents Mineral oil, animal oil, vegetable oil, resin 

Releasing agents Mineral oil 

International Acceptance 

The 2016 TR notes the following international allowances: 

Canadian General Standards Board Permitted Substances List 

Allowed as a filtering aid (non-chlorine bleached) and for use in inedible regenerative sausage casings 

(CAN/CGSB 2015). 

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

Cellulose is authorized for use in the wine sector only for use as an inert filtering aid (EU Commission 2008). 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

in Appendix 4, Table 1 “List of approved additives and processing/post-harvest handling aids” as a 

processing and post-harvest handling aid with no annotation (IFOAM 2014). 

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

Organically Produced Foods (CXG 32-1999). No specific listing 

Japan Agricultural Standard (JAS) for Organic Production. 

No specific listing 

Environmental Issues 

During previous reviews, public comment, as well as the 2016 TR, raised concerns regarding the use of 

wood pulp as a source for cellulose and the environmental impact that logging of primary forests and 

replacement with monoculture plantations may have. Concerns were also raised about environmental 

problems caused by waste cellulose generated from food processing. The 2016 TR states that conversion of 

cellulosic food wastes, as well as cellulose waste from filtration aids and/or spent casings, into useful 

products is the subject of research. The research is based more on seeking to add value, but is also driven 

by environmental concerns, rising disposal costs, and governmental regulations. 

Discussion 

Cellulose remains essential to organic handling for a few products. The NOSB asked the stakeholders 

whether there were other ancillary substances (beyond those listed above) that might be used in the 

production of cellulose. In the April 2021 meeting comments, stakeholders identified glycerin/glycerol as 

another ancillary substance. 

A notable comment by a stakeholder was that sourcing cellulose should be done in a way that minimizes 

environmental impact. This concern echoes public comments from earlier sunsets of cellulose, as 

mentioned in the previous section (Environmental Issues) of this document. 

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–

Overall, based on the written and oral comments prior to the April 2021 meeting, there continues to be 

support for relisting cellulose. 

Justification for Vote: 

The Subcommittee proposes removal of cellulose from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote: 

Motion to remove cellulose from the National List at §205.605(b) 

Motion by: Kyla Smith 

Seconded by: Jerry D’Amore 

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

Chlorine materials Calcium hypochlorite 

Reference: §205.605(b) Chlorine materials - disinfecting and sanitizing food contact surfaces, equipment 

and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or 

food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is 

followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine 

material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food 

handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe 

Drinking Water Act. 

(i) Calcium hypochlorite

Technical Report: 2006 TR (Chlorine materials- Handling); 2011 TR - Crops 

Petition(s): N/A 

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

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547); Amendment to 

annotation effective 1/28/2019 (83 FR 66559); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Calcium hypochlorite is an Environmental Protection Agency (EPA)-registered pesticide (OPP Nos. 014701). 

Calcium hypochlorite is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (SDWA) 

(currently 4mg/L expressed as Cl2). 

Calcium hypochlorite is an "indirect" food additive approved by Food and Drug Administration (FDA). 

Calcium hypochlorite may be used as a final sanitizing rinse on food processing equipment (21 CFR 

178.1010). Hypochlorites also can be used in postharvest, seed, or soil treatment on various fruit and 

vegetable crops (EPA, 1991). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

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chlorine materials at levels approved by the FDA or the EPA for such purposes. Rinsing with potable water 

that does not exceed the maximum residual disinfectant limit for the chlorine material under the SDWA 

must immediately follow this permitted use. Certified operators should monitor the chlorine level of the 

final rinse water, the point at which the water last contacts the organic product. The level of chlorine in the 

final rinse water must meet limits as set forth by the SDWA. Water used as an ingredient in organic food 

handling should not exceed the maximum residual disinfectant limit for the chlorine material under the 

SDWA, as required by the Organic Food Production Act (7 U.S.C. 6510(a)(7)). 

In water, sodium and calcium hypochlorite separate into sodium, calcium, and hypochlorite ions and 

hypochlorous acid molecules. Hypochlorous acid molecules are neutral and small in size. As a result, when 

hypochlorous acid molecules exist in equilibrium with the hypochlorite ions, they easily diffuse through the 

cell walls of bacteria. This changes the oxidation-reduction potential of the cell and inactivates 

triosphosphate dehydrogenase, an enzyme which is essential for the digestion of glucose. Inactivation of 

this enzyme effectively destroys the microorganism's ability to function. 

Manufacture 

Calcium hypochlorite is produced by passing chlorine gas over slaked lime. It is then separated from the 

coproduct, calcium chloride, and air dried or vacuum dried. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Allowed for wash water in direct contact with crops or food; b) in flush water from cleaning irrigation 

systems, equipment, storage, or transport units—application to crops or fields is permitted. 

European Commission Directorate-general for Agriculture and Rural Development 

Production Rules - The current EU regulation on organic production does not state a specific list of 

substances authorised in the cleaning of food processing facilities dealing with organic food (the only 

exception concerns milking facilities: Annex VII of Regulation 889/2008). However, operators have to 

comply with the rules set out in Article 26(4) (b) of Regulation 889/2008, notably, they have to implement 

suitable cleaning measures, monitor their effectiveness and record these operations. In addition, any food 

processing operator has to comply with the “hygiene package” regarding products that are allowed for 

cleaning and disinfection of food processing facilities and equipment. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Equipment cleaner/disinfectant: An intervening event or action must occur to eliminate risks of 

contamination. 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposures occur or from chronic lower-level exposures – especially in 

occupational environments when these materials are used on a daily basis. These compounds are dermal, 

respiratory, ocular, and mucous membrane irritants. Sodium hypochlorite (bleach) and can cause asthma, 

as classified by the Association of Occupational and Environmental Clinics 

(http://www.aoecdata.org/ExpCodeLookup.aspx Code 332.10). Given the similar chemistries and 

mechanisms of action, other chlorine-based oxidant sanitizers, already known to be respiratory irritants, 

also likely cause asthma. Chlorine compounds are toxic to fish and other aquatic organisms. Strict 

adherence to the label is required when used, including the use of personal protective equipment when 

appropriate. Use of chlorine compounds in organic processing and crop production have been reviewed in a 

2006 and 2011 Technical Reports (TR) (referenced above). 

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–

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been judged essential to ensure food safety and to comply with food safety regulations under the Food 

Safety Modernization Act (FSMA). The Handling Subcommittee (HS) generally supports continued listing of 

these materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for postharvest handling and processing. The HS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic materials, when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Public comment and Board discussions reflect concerns about the use of chlorine materials in organic food 

processing and handling because of their potential impacts on human health and the environment, but as 

noted above, many organic stakeholders judge these materials essential to ensure food safety and 

compliance with food safety regulations under FSMA. Very thoughtful public comments outline the need 

for a comprehensive technical review of sanitizers and listing of sanitizers on the National List itemized “by 

specific use or application” with clear identification of the hazards to humans and the environment (NOC 

2020). Further, “Restructuring the National List so that cleaners, sanitizers and disinfectants have a 

designated section... would generally help certified operations understand the cleaners, sanitizers and 

disinfectants that may be used, and it would help organic outreach and education... Overall, a designated 

list could help NOSB in its review of sanitizers, cleaners and disinfectants and it could support the use of 

alternative, less toxic materials, when their use can meet strict food safety standards (OTA 2021).” 

Establishing a separate sanitizer listing on the National List is beyond the scope of this sunset review but 

the HS will recommend a work agenda item to advance these suggestions. 

Justification for Vote 

The Subcommittee proposes removal of calcium hypochlorite from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove calcium hypochlorite from the National List 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

Chlorine materials Chlorine dioxide 

Reference: §205.605(b) Chlorine materials - disinfecting and sanitizing food contact surfaces, equipment 

and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or 

food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is 

followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine 

material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food 

handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe 

Drinking Water Act. 

(ii) Chlorine dioxide 

Technical Report: 2006 TR (Chlorine materials); 2011 TR - Crops 

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Petition(s): N/A 

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

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547); Amendment to 

annotation effective 1/28/2019 (83 FR 66559); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Chlorine dioxide is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (SDWA) 

(currently 4mg/L expressed as Cl2). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the Food and Drug Administration (FDA) or the Environmental 

Protection Agency (EPA) for such purposes. Rinsing with potable water that does not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA must immediately follow this permitted 

use. Certified operators should monitor the chlorine level of the final rinse water, the point at which the 

water last contacts the organic product. The level of chlorine in the final rinse water must meet limits as set 

forth by the SDWA. Water used as an ingredient in organic food handling should not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA, as required by the Organic Food 

Production Act (7 U.S.C. 6510(a)(7)). 

Chlorine dioxide is a strong oxidant. It is likely a better bactericide than hypochlorous acid. In general, the 

disinfection efficiency of chlorine dioxide decreases as temperature decreases. 

Manufacture 

To form chlorine dioxide, sodium chlorate (NaClO3) and sulfuric acid (H2SO4) are reacted with sulfur 

dioxide (SO2), or chloric acid is reacted with methanol (CH3OH) (HSDB, 2005). Alternatively, chlorine 

dioxide can be formed with chlorine (Cl2) and sodium chlorite; sodium hypochlorite with hydrochloric acid; 

potassium chlorate with sulfuric acid; or by passing nitrogen dioxide through a column of sodium chlorate. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Allowed for wash water in direct contact with crops or food; b) in flush water from cleaning irrigation 

systems, equipment, storage, or transport units—application to crops or fields is permitted. 

European Commission Directorate-general for Agriculture and Rural Development 

Production Rules - The current EU regulation on organic production does not state a specific list of 

substances authorised in the cleaning of food processing facilities dealing with organic food (the only 

exception concerns milking facilities: Annex VII of Regulation 889/2008). However, operators have to 

comply with the rules set out in Article 26(4) (b) of Regulation 889/2008, notably, they have to implement 

suitable cleaning measures, monitor their effectiveness and record these operations. In addition, any food 

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processing operator has to comply with the “hygiene package” regarding products that are allowed for 

cleaning and disinfection of food processing facilities and equipment. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Equipment cleaner/disinfectant: An intervening event or action must occur to eliminate risks of 

contamination. 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposures occur or from chronic lower-level exposures – especially in 

occupational environments when these materials are used on a daily basis. These compounds are dermal, 

respiratory, ocular, and mucous membrane irritants. Sodium hypochlorite (bleach) can cause asthma, as 

classified by the Association of Occupational and Environmental Clinics 

(http://www.aoecdata.org/ExpCodeLookup.aspx Code 332.10). Given the similar chemistries and 

mechanisms of action, other chlorine-based oxidant sanitizers, already known to be respiratory irritants, 

also likely cause asthma. Chlorine compounds are toxic to fish and other aquatic organisms. Strict 

adherence to the label is required when used, including the use of personal protective equipment when 

appropriate. Use of chlorine compounds in organic processing and crop production have been reviewed in 

2006 and 2011 Technical Reports (TR) (referenced above). 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been judged essential to ensure food safety and to comply with food-safety regulations under the Food 

Safety Modernization Act (FSMA). The Handling Subcommittee (HS) generally supports continued listing of 

these materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for postharvest handling and processing. The HS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic materials, when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Public comment and Board discussions reflect concerns about the use of chlorine materials in organic food 

processing and handling because of their potential impacts on human health and the environment, but as 

noted above, many organic stakeholders judge these materials essential to ensure food safety and 

compliance with food safety regulations under FSMA. Very thoughtful public comments outline the need 

for a comprehensive technical review of sanitizers and listing of sanitizers on the National List itemized “by 

specific use or application” with clear identification of the hazards to humans and the environment (NOC 

2020). Further, “Restructuring the National List so that cleaners, sanitizers and disinfectants have a 

designated section... would generally help certified operations understand the cleaners, sanitizers and 

disinfectants that may be used, and it would help organic outreach and education... Overall, a designated 

list could help NOSB in its review of sanitizers, cleaners and disinfectants and it could support the use of 

alternative, less toxic materials, when their use can meet strict food safety standards (OTA 2021).” 

Establishing a separate sanitizer listing on the National List is beyond the scope of this sunset review but 

the HS will recommend a work agenda item to advance these suggestions. 

Justification for Vote 

The Subcommittee proposes removal of chlorine dioxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

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– –

Subcommittee Vote 

Motion to remove chlorine dioxide from the National List 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

Chlorine materials Hypochlorous acid generated from electrolyzed water 

Reference: §205.605(b) Chlorine materials - disinfecting and sanitizing food contact surfaces, equipment 

and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or 

food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is 

followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine 

material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food 

handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe 

Drinking Water Act. 

(iii) Hypochlorous acid - generated from electrolyzed water. 

Technical Report: 2006 TR (Chlorine materials - Handling); 2011 TR - Crops; 2015 TR 

Petition(s): 2015 

Past NOSB Actions: 2016 NOSB Recommendation to add 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Hypochlorous acid is an antimicrobial disinfectant and pesticide used to control harmful microorganisms 

including bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It 

is allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in 

direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or 

fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (SWDA) 

(currently 4mg/L expressed as Cl2). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the Food and Drug Administration (FDA) or the Environmental 

Protection Agency (EPA) for such purposes. Rinsing with potable water that does not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA must immediately follow this permitted 

use. Certified operators should monitor the chlorine level of the final rinse water, the point at which the 

water last contacts the organic product. The level of chlorine in the final rinse water must meet limits as set 

forth by the SDWA. Water used as an ingredient in organic food handling should not exceed the maximum 

residual disinfectant limit for the chlorine material under the SDWA, as required by the Organic Food 

Production Act (7 U.S.C. 6510(a)(7)). 

Hypochlorous acid molecules are neutral and small in size. As a result, when hypochlorous acid molecules 

exist in equilibrium with hypochlorite ions, they easily diffuse through the cell walls of bacteria. This 

changes the oxidation-reduction potential of the cell and inactivates triosphosphate dehydrogenase, an 

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enzyme which is essential for the digestion of glucose. Inactivation of this enzyme effectively destroys the 

microorganism's ability to function. 

Manufacture 

Electrolyzed water (EW) is the product of the electrolysis of a dilute sodium chloride solution in an 

electrolysis cell containing a semi-permeable membrane that physically separates the anode and cathode 

but permits ions to pass through. In the process, hypochlorous acid, hypochlorite ion, and hypochlorite acid 

are formed at the anode, and sodium hydroxide is formed at the cathode. The solution formed on the 

anode side is acidic EW (pH 2 to 6), and the solution formed on the cathode side is basic EW (pH 7.5 to 13). 

Neutral EW, with a pH of 6 to 7.5 is produced by mixing the anodic solution with hydroxide, or by using a 

single-cell chamber for electrolysis. (TR lines 48-68). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Allowed for wash water in direct contact with crops or food; b) in flush water from cleaning irrigation 

systems, equipment, storage, or transport units—application to crops or fields is permitted. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Not listed 

Human Health and Environmental Issues 

Hypochlorous acid, generated from electrolyzed water, is present in solutions of two chlorine sanitizers 

(sodium hypochlorite and calcium hypochlorite) currently allowed at §205.601(a)(2)(i, ii). Like other 

chlorine compounds, hypochlorous acid is also an oxidant and can pose risks to human health. Strict 

adherence to the label is required when used, including the use of personal protective equipment when 

appropriate. Use of chlorine compounds in organic processing and crop production have been reviewed in 

2006 and 2011 Technical Reports (TR) (referenced above.). 

As formulated via electrolyzed water, hypochlorous acid is effective as a sanitizer at a lower chlorine 

concentration and is likely safer for health and the environment than other currently listed chlorine 

sanitizers. 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been judged essential to ensure food safety and to comply with food safety regulations under the Food 

Safety Modernization Act (FSMA). The Handling Subcommittee (HS) generally supports continued listing of 

these materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for postharvest handling and processing. The HS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic materials, when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Public comment and Board discussions reflect concerns about the use of chlorine materials in organic food 

processing and handling because of their potential impacts on human health and the environment, but as 

noted above, many organic stakeholders judge these materials essential to ensure food safety and 

compliance with food safety regulations under FSMA. Very thoughtful public comments outline the need 

for a comprehensive technical review of sanitizers and listing of sanitizers on the National List itemized “by 

specific use or application” with clear identification of the hazards to humans and the environment (NOC 

2020). Further, “Restructuring the National List so that cleaners, sanitizers and disinfectants have a 

NOSB Proposals and Discussion Documents October 2021 142 of 205
 

 

 

 

 

 

 

 

 

 

 

 

–

designated section... would generally help certified operations understand the cleaners, sanitizers and 

disinfectants that may be used, and it would help organic outreach and education... Overall, a designated 

list could help NOSB in its review of sanitizers, cleaners and disinfectants and it could support the use of 

alternative, less toxic materials, when their use can meet strict food safety standards (OTA 2021).” 

Establishing a separate sanitizer listing on the National List is beyond the scope of this sunset review but 

the HS will recommend a work agenda item to advance these suggestions. 

Justification for Vote 

The Subcommittee proposes removal of hypochlorous acid from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove hypochlorous acid from the National List 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

Chlorine materials Sodium hypochlorite 

Reference: §205.605(b) Chlorine materials - disinfecting and sanitizing food contact surfaces, equipment 

and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or 

food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is 

followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine 

material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food 

handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe 

Drinking Water Act. 

(iv) Sodium hypochlorite 

Technical Report: 2006 TR (Chlorine materials); 2011 TR - Crops 

Petition(s): N/A 

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

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

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547); Amendment to 

annotation effective 1/28/2019 (83 FR 66559); Sunset renewal notice effective 10/30/2019 (84 FR 53577). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Sodium hypochlorite is an EPA-registered pesticide (OPP No 014703). Sodium hypochlorite is an 

antimicrobial disinfectant and pesticide used to control harmful microorganisms including bacteria, viruses, 

and fungi on inanimate objects and surfaces primarily in indoor environments. It is allowed for disinfecting 

and sanitizing food contact surfaces. Residual chlorine levels for wash water in direct crop or food contact 

and in flush water from cleaning irrigation systems that is applied to crops or fields cannot exceed the 

maximum residual disinfectant limit under the Safe Drinking Water Act (SDWA) (currently 4mg/L expressed 

as Cl2). 

Sodium hypochlorite is an "indirect" food additive approved by FDA (http://www.cfsan.fda.gov/~dms/opaindt.html). Sodium hypochlorite may be used as a final sanitizing rinse on food processing equipment (21 

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CFR 178.1010); sodium hypochlorite may be used in washing and lye peeling of fruits and vegetables (21 

CFR 173.315). These hypochlorites also can be used in postharvest, seed, or soil treatment on various fruit 

and vegetable crops (EPA, 1991). 

For organic food handling facilities and equipment, chlorine materials may be used up to maximum- labeled 

rates for disinfecting and sanitizing food contact surfaces. Rinsing is not required unless mandated by the 

label use directions. Water used in direct post-harvest crop or food contact (including flume water to 

transport fruits or vegetables, wash water in produce lines, egg or carcass washing) is permitted to contain 

chlorine materials at levels approved by the FDA or the EPA for such purposes. Rinsing with potable water 

that does not exceed the maximum residual disinfectant limit for the chlorine material under the SDWA 

must immediately follow this permitted use. Certified operators should monitor the chlorine level of the 

final rinse water, the point at which the water last contacts the organic product. The level of chlorine in the 

final rinse water must meet limits as set forth by the SDWA. Water used as an ingredient in organic food 

handling should not exceed the maximum residual disinfectant limit for the chlorine material under the 

SDWA, as required by the Organic Food Production Act (7 U.S.C. 6510(a)(7)). 

In water and soil, sodium and calcium hypochlorite separate into sodium, calcium, and hypochlorite ions 

and hydrochlorous acid molecules. Hypochlorous acid molecules are neutral and small in size. As a result, 

when hypochlorous acid molecules exist in equilibrium with the hypochlorite ions, they easily diffuse 

through the cell walls of bacteria. This changes the oxidation-reduction potential of the cell and inactivates 

triosphosphate dehydrogenase, an enzyme which is essential for the digestion of glucose. Inactivation of 

this enzyme effectively destroys the microorganism's ability to function. 

Manufacture 

Generally, sodium hypochlorite is produced by reacting chlorine with a solution of sodium hydroxide 

(NaOH, also called lye or caustic soda). This method is used for most commercial productions of sodium 

hypochlorite. A more active, but less stable formulation of sodium hypochlorite can be produced by 

chlorinating a solution of soda ash (Na2CO3). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Allowed for wash water in direct contact with crops or food; b) in flush water from cleaning irrigation 

systems, equipment, storage, or transport units—application to crops or fields is permitted. 

European Commission Directorate-general for Agriculture and Rural Development 

Production Rules - The current EU regulation on organic production does not state a specific list of 

substances authorised in the cleaning of food processing facilities dealing with organic food (the only 

exception concerns milking facilities: Annex VII of Regulation 889/2008). However, operators have to 

comply with the rules set out in Article 26(4) (b) of Regulation 889/2008, notably, they have to implement 

suitable cleaning measures, monitor their effectiveness and record these operations. In addition, any food 

processing operator has to comply with the “hygiene package” regarding products that are allowed for 

cleaning and disinfection of food processing facilities and equipment. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Equipment cleaner/disinfectant: An intervening event or action must occur to eliminate risks of 

contamination. 

Human Health and Environmental Issues 

Chlorine sanitizing compounds currently on the National List are strong oxidants and can pose serious risks 

to human health if acute high exposure occurs or from chronic lower-level exposures – especially in 

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occupational environments when these materials are used on a daily basis. These compounds are dermal, 

respiratory, ocular, and mucous membrane irritants. Sodium hypochlorite (bleach) can cause asthma, as 

classified by the Association of Occupational and Environmental Clinics 

(http://www.aoecdata.org/ExpCodeLookup.aspx Code 332.10). Given the similar chemistries and 

mechanisms of action, other chlorine-based oxidant sanitizers, already known to be respiratory irritants, 

also likely cause asthma. Chlorine compounds are toxic to fish and other aquatic organisms. Strict 

adherence to the label is required when used, including the use of personal protective equipment when 

appropriate. Use of chlorine compounds in organic processing and crop production have been reviewed in 

2006 and 2011 Technical Reports (TR) (referenced above.). 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been judged essential to ensure food safety and to comply with food safety regulations under the Food 

Safety Modernization Act (FSMA). The Handling Subcommittee (HS) generally supports continued listing of 

these materials but encourages ongoing discussion about the listing of sanitizers and disinfectants for postharvest handling and processing. The HS supports research priorities that investigate alternatives to 

chlorine compounds and encourages the use of alternative, less toxic materials, when their use can meet 

strict food safety standards. 

Summary of Public Comments 

Public comment and Board discussions reflect concerns about the use of chlorine materials in organic food 

processing and handling because of their potential impacts on human health and the environment, but as 

noted above, many organic stakeholders judge these materials essential to ensure food safety and 

compliance with food safety regulations under FSMA. Very thoughtful public comments outline the need 

for a comprehensive technical review of sanitizers and listing of sanitizers on the National List itemized “by 

specific use or application” with clear identification of the hazards to humans and the environment (NOC 

2020). Further, “Restructuring the National List so that cleaners, sanitizers and disinfectants have a 

designated section... would generally help certified operations understand the cleaners, sanitizers and 

disinfectants that may be used, and it would help organic outreach and education... Overall, a designated 

list could help NOSB in its review of sanitizers, cleaners and disinfectants and it could support the use of 

alternative, less toxic materials, when their use can meet strict food safety standards (OTA 2021).” 

Establishing a separate sanitizer listing on the National List is beyond the scope of this sunset review but 

the HS will recommend a work agenda item to advance these suggestions. 

Justification for Vote 

The Subcommittee proposes removal of sodium hypochlorite from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove sodium hypochlorite from the National List 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

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Potassium hydroxide 

Reference: §205.605(b) Potassium hydroxide - prohibited for use in lye peeling of fruits and vegetables 

except when used for peeling peaches. 

Technical Report: 2001 TAP; 2016 TR 

Petition(s): 2001 petition; 2011 petition to amend annotation 

Past NOSB Actions: 10/1995 meeting minutes and vote; 11/2005 recommendation; 12/2011 

recommendation; 11/2016 recommendation 

Recent Regulatory Background: Added to the National list 12/21/2000 (65 FR 80548); National List 

amended 11/03/2003 (68 FR 62215); National List amended 05/28/2013 (78 FR 31815); Sunset renewal 

notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

Subcommittee Review 

Use 

Potassium hydroxide is a synthetic, inorganic compound produced by the electrolysis of potassium chloride. 

Also known as potash, it is a strong base, and alkaline in solution. Much of its utility in food processing is 

based on its function as a caustic strong base. Potassium hydroxide is widely used in food processing as a 

pH adjuster, cleaning agent, stabilizer, thickener, and poultry scald agent (2016 TR). 

Potassium hydroxide in poultry chill water increases the shelf life of broilers and other meat birds by killing 

various spoilage organisms, particularly when used in combination with lauric acid. To a limited extent, 

potassium hydroxide will also act as a preservative in the curing of certain foods, such as olives. 

The 2016 TR notes that potassium hydroxide is also used in the lye peeling of fruits and vegetables. The FDA 

lists potassium hydroxide as generally recognized as safe (GRAS) for humans (21 CFR 184.1631), which is 

allowed under 21CFR 173.315(a)(1) - Chemicals used in washing or to assist in the peeling of fruits and 

vegetables. According to the TR, peaches peeled for canning or pickling use a 1.5% solution of lye at a 

temperature slightly below 145°F (<62°C) for about 60 seconds, followed by a wash and dip into a solution 

of 0.5 - 3.0% citric acid. Because hot water cannot be used for freezing peaches, they require a higher 

solution - about 10% - and a treatment time of about 4 minutes to be peeled. Lye is removed by thorough 

washing, and again citric acid is used to neutralize the pH of the fruit. 

For certain grains and legumes potassium hydroxide is used to remove tannins that interfere with nutrient 

uptake. For example, it increases solubility of protein in soybeans. It can be also be used as a solvent to 

determine protein quality and total soluble protein in assays. Potassium hydroxide can be used as a 

substitute for the traditional calcium hydroxide (lime water) used to remove the pericarp of corn, a process 

known as ‘nixtamilization’ - part of the process to make masa from corn. Furthermore, the removal of the 

pericarp or bran from corn, sorghum, and other grains increases the nutritional quality and digestibility of 

those grains (2016 TR). 

Manufacture 

The 2016 TR notes that the FDA specifies that food grade potassium hydroxide is made by the electrolysis 

of potassium chloride (KCl) and water in the presence of a porous diaphragm [21 CFR 184.1631(a)]. 

Potassium chloride, also known as muriate of potash, is a naturally occurring mineral, with the main global 

source being Canada. Most U.S. production occurs in New Mexico and Utah. Potassium chloride is put into 

aqueous solution and is electrolyzed by various processes. Diaphragm cells will produce a liquor that 

contains 10 - 15% by weight of KOH and about 10% KCl. Most of the KCl crystallizes by evaporation and 

subsequent cooling during concentration. The concentrated KOH is about a 50% solution with about 0.6% 

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KCl. Potassium hydroxide is regarded by the chemical industry as a by-product of the process for producing 

hydrochloric acid. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Allowed for pH adjustment only. Prohibited for use in lye peeling of fruits and vegetables (C CAN-CGSB32.311-2015E). 

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

Caustic potash is on Annex VII, “Products for cleaning and disinfection” (EU Commission 2008). However, it 

does not appear in Annex VIII, “Certain products and substances for use in production of processed organic 

food, yeast and yeast products.” 

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

Organically Produced Foods (CXG 32-1999). 

Permitted for use in cereals and cereal products, derived from cereal grains, from roots and tubers, pulses, 

and legumes, excluding bakery wares of food category 07.007.1.1.1 yeast leavened. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Not found. 

Japan Agricultural Standard (JAS) for Organic Production. 

“Limited to be used for processing sugar as pH adjustment agent” (Japan MAFF 2000). 

Environmental Issues 

The amount of fresh water used in the lye peeling process and the release of effluent that increases 

biological oxygen demand are two key environmental concerns about the lye peeling process. The release 

of potassium hydroxide in untreated or improperly treated wastewater will raise the pH and potassium 

levels of the body of water receiving it. Soap manufacturing can also threaten environmental health in the 

immediate vicinity of the soap manufacturing facility, as nutrient loading of potassium may result in algal 

blooms and eutrophication (2016 TR). 

Human health toxicity mainly involves the risk of ingestion of concentrated potassium hydroxide. Ingestion 

of lye inevitably leads to esophagus damage, with over 90% of the cases also involving stomach damage. 

Discussion 

In 1995, the NOSB approved the addition of potassium hydroxide to § 205.605(b), with an annotation 

prohibiting its use in the lye peeling of fruits and vegetables. This restriction was based on concerns about 

the environmental effects of the waste products of the lye peeling process, and the fact that mechanical 

and non-chemical alternatives were available for most fruits and vegetables. 

In 2001, a petitioner sought to expand the use of potassium hydroxide by amending the annotation to read 

―prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the 

Individually Quick Frozen (IQF) production process. The 2001 TAP review for that expansion noted that 

―The stone fruit (peaches, nectarines, and apricots) do not appear to currently have alternative methods 

available on a commercial scale to achieve peeling without the use of caustic substances. The 2001 TAP 

review also noted that the environmental effects that had originally resulted in the restrictive annotation 

could be mitigated with the use of good wastewater management practices. Peach processing plants are 

generally restricted by state and local wastewater treatment requirements, and the natural acidity of the 

fruit and additional pH adjustments buffer the alkalinity of the wastewater. Because no commercially viable 

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alternatives are available, and processing practice mitigates the potential environmental effects, the NOSB 

approved the expanded annotation. 

A new petition from the same petitioner was filed in 2011, seeking to expand the annotation again to allow 

the use of potassium hydroxide for the peeling of fresh peaches to be canned. The petition confirms the 

lack of commercially viable alternatives for this use, and the mitigation of potential environmental impact. 

The processing of peaches for canning and freezing is identical up until the freezing or canning step. Based 

on the petition, the 2001 TAP review, and the rationale of the 2001 NOSB, the Handling Subcommittee 

supported the expansion of this annotation to allow potassium hydroxide to be used in the peeling of both 

IQF and canned peaches. Accordingly, since canning and freezing are the primary commercial processing 

methods used for peaches, the NOSB favored removing the language regarding IQF methods so that the 

exception to the prohibition on lye peeling applies to all peach peeling. 

During previous reviews, a number of stakeholders commented about the use of potassium hydroxide as a 

cleaning and sanitizing agent. As such, it provides a different mode of action as compared to chlorine 

materials. 

Alternatives to potassium hydroxide include naturally occurring alkali substances such as sodium carbonate 

and sodium bicarbonate. The drawbacks of these natural materials are that they are less soluble than 

potassium hydroxide and they may not be effective in raising the pH. For fruit peeling, mechanical, steam, 

or hand peeling is an alternative. As noted above, while potassium hydroxide was not initially allowed for 

peeling in organic processing, subsequent petitions and NOSB decisions allowed for its limited use for the 

peeling peaches. 

Subcommittee Review 

Stakeholder comments on potassium hydroxide were mixed, with some supporting relisting and others 

asking for a more thorough review and a possible annotation change for this listing. 

Proponents of relisting noted that there are no management practices that would eliminate the need for 

this material, that it is needed for pH adjustment and potassium fortification, and there are differences in 

solubility as compared to possible alternatives. Delisting of this material would lead to difficulties with 

product stability and increased manufacturing losses. One commenter noted that if this product were 

delisted they would leave the organic category. 

Opponents to relisting noted the human health hazards from the corrosivity of potassium hydroxide, the 

environmental concerns from the disposal of large amounts of water with soluble potassium and alkali ions, 

and whether it continues to be essential for organic peach processing. Others noted that the annotation is 

problematic in that it lists uses that are not allowed rather than uses that are allowed. Annotations that list 

allowable uses are very specific in that other uses are definitively prohibited. Annotations that only list 

methods that are prohibited allow for any other uses, including those that were not anticipated at the time 

of listing. However, annotation changes cannot be done during the sunset review and would need to be the 

reviewed as a separate work agenda item. 

While the Subcommittee recognizes the arguments of the opponents to this material, the removal of this 

material would be disruptive to organic handlers and at this point in time it is still essential for organic 

handling. 

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Justification for Vote 

The Subcommittee proposes removal of potassium hydroxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove potassium hydroxide from the National List. 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0 

Potassium lactate 

Reference: §205.605(b) Potassium lactate - for use as an antimicrobial agent and pH regulator only. 

Technical Report: 2015 TR 

Petition(s): 2004; 2014 NOP memo to NOSB 

Past NOSB Actions: 4/2016 recommendation 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Potassium lactate comes as a liquid and may be added to meat as an antimicrobial ingredient. It is affirmed 

as generally recognized as safe (GRAS) at 21 CFR 184.1639. The FDA does not authorize its use in infant 

foods and formulas. 

Manufacture 

Potassium lactate is generally produced from natural (fermented) lactic acid, which is then reacted with 

potassium hydroxide. Lactic acid is produced from the fermentation of natural food sources such as 

dextrose (from corn) and sucrose (from sugar cane or sugar beets) or starch. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Sodium lactate and potassium lactate are not listed for use in processing. Lactic acid is allowed. 

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

Potassium lactate is not permitted for use in organic food processing in the European Union. Lactic acid, the 

precursor substance, is allowed. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Sodium and potassium lactates are not specifically listed on any of the appendices in the IFOAM, but the 

precursor, lactic acid, is allowed. 

Japan Agricultural Standard (JAS) for Organic Production 

Sodium lactate and potassium lactate are not listed in the JAS standard and therefore are not permitted. 

The JAS standard specifically states, “The use of any materials except for those described as below is 

prohibited.” 

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Environmental Issues 

There do not appear to be any human health concerns associated with potassium lactate as provided by the 

2015 TR. There was an environmental issued raised about the amount of gypsum created in the 

manufacturing of lactic acid, the necessary precursor of potassium lactate. However, according to a report 

published by the EPA, lactic acid and its salts are readily biodegradable and have low potential to persist in 

the environment (Environmental Protection Agency 2008). 

Discussion 

Many stakeholders view this listing as “enormously complicated” saying that it is the procedural history 

that is complicated and not the material itself. Potassium lactate has been allowed for use in organic 

handling since its approval in January of 2004. The decision to not require a petition for this material for 

inclusion to the National List was based on the fact that both of the materials used to produce potassium 

lactate (lactic acid and potassium hydroxide) were already approved on the National List. It was later 

determined that this decision was not consistent with previous NOSB recommendations on classification of 

materials and that the material needed to go through the petition process. Potassium lactate was added to 

the National List effective January 28, 2019. The Handling Subcommittee finds significant merit to keep 

potassium lactate on the National List at § 205.605 (b) with the annotation: for use as an antimicrobial 

agent and pH regulator only. 

Summary of Public Comments 

A majority of public commenters was in support of relisting potassium lactate. A review of the “use tables” 

supplied by several associations indicate that potassium lactate is a widely used material. Some 

stakeholders asked why both potassium and sodium lactates are on the National List as they appear to be 

used nearly interchangeably. It was noted that there are certain uses, such as “low sodium” meat 

alternatives, that require potassium lactate specifically. 

Justification for Vote 

The Subcommittee proposes removal of potassium lactate from the National List based on the following 

criteria in the Organic Foods Production Act (OPFA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove potassium lactate from the National List 

Motion by: Jerry D’Amore 

Seconded by: Steve Ela 

Yes: 0 No: 7 Abstain: 0 Absent: 0 Recuse: 0 

Silicon dioxide 

Reference: §205.605(b) Silicon dioxide - Permitted as a defoamer. Allowed for other uses when organic rice 

hulls are not commercially available. 

Technical Report: 1996 TAP; 2010 TR 

Petition(s): 2010 petition to remove 

Past NOSB Actions: 09/1996 minutes and vote; 11/2005 recommendation; 12/2011 recommendation; 

11/2016 recommendation 

Recent Regulatory Background: Added to NL 12/21/2000 (65 FR 80548); National list amended 05/28/2013 

(effective 11/03/2013) (78 FR 31815); Sunset renewal notice effective 5/29/2018 (83 FR 14347). 

Sunset Date: 5/29/2023 

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Subcommittee Review 

Use 

Synthetic amorphous silicon dioxide is used as a food additive for various functions including as: 

• An anticaking agent in foods. 

• A stabilizer in beer production, and filtered out of the beer prior to final processing 

• An adsorbent in tableted foods. 

• A carrier. 

• A defoaming agent. 

Manufacture 

Synthetic amorphous silicon dioxide can be manufactured by three methods: a vapor-phase hydrolysis 

process, a wet process, or a surface-modified treatment. According to FDA regulations, silicon dioxide (as a 

food additive) is manufactured by vapor phase hydrolysis or by other means whereby the particle size is 

such as to accomplish the intended effect. Silicon dioxide can be produced as a nanomaterial, but for use in 

organic production such a material would have to be petitioned and placed on the National List. As stated 

in NOP Policy Memorandum from March 2015: 

As with other substances, no engineered nanomaterial will be allowed for use in organic production 

and handling unless the substance has been 

1) petitioned for use; 

2) reviewed and recommended by the NOSB; and 

3) added to the National List through notice and comment rulemaking. 

Currently there is no silicon dioxide produced with nanotechnology on the National List. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Silicon dioxide is listed in Table 6.3 Ingredients Classified as Food Additives, and Table 6.5 Processing Aids. 

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

Silicon dioxide is listed in Annex VIII of the Commission Regulation, Section A Food Additives, Including 

Carriers for use in preparation of foodstuffs of plant origin as an anticaking agent for herbs and spices. Also 

listed as a gel or colloidal solution in Section B Processing Aids and Other Products, Which May Be Used for 

Processing of Ingredients of Agricultural Origin from Organic Production. 

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

Organically Produced Foods (CXG 32-1999) 

Silicon dioxide (Amorphous) is listed in Annex 2 Permitted Substances for the Production of Organic Foods, 

Table 3 Ingredients of Non-Agricultural Origin as an additive in foods of plant origin permitted for use in 

herbs, spices, seasonings, and condiments (e.g., seasonings for instant noodles). Also allowed as a 

processing aid in gel or colloidal solution. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Silicon dioxide (amorphous) is listed in Appendix 4, Table 1 List of Approved Additives and Processing/PostHarvest Handling Aids. 

Japan Agricultural Standard (JAS) for Organic Production 

Silicon dioxide listed in Attached Table 1 Food Additives, limited to be used for processed foods of plant 

origin as gel or colloidal solution. 

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Ancillary Substances 

None reported in the 2010 TR and none noted in public comment during the 2016 sunset review. 

Environmental Issues 

The 2010 TR stated silica dust is produced during its manufacture and use, however at the time of writing 

there was no data on ambient air concentrations of amorphous silica and ambient levels are not well 

quantified for crystalline silica. Exposure levels are considered the highest in occupations involved with 

packing, weighing, reprocessing, and cleaning. While the Subcommittee recognizes the risk of exposure to 

crystalline silica dust during the mining, manufacture and processing of silica, there does not appear to be a 

great deal of study on the effects of amorphous silica as is used in the manufacture of silicon dioxide. 

Studies that have explored exposure to amorphous silica dust suggest such exposure may not lead to 

silicosis or fibrosis as can result from crystalline silica exposure. These existing studies point to the need for 

further work in this area (Merget R, Bauer T, Küpper HU, Philippou S, Bauer HD, Breitstadt R, Bruening T. 

Health hazards due to the inhalation of amorphous silica. Arch Toxicol. 2002 Jan;75(11-12):625-34. doi: 

10.1007/s002040100266. PMID: 11876495; McLaughlin JK, Chow WH, Levy LS. Amorphous silica: a review 

of health effects from inhalation exposure with particular reference to cancer. J Toxicol Environ Health. 

1997 Apr 25;50(6):553-66. doi: 10.1080/15287399709532054. PMID: 15279029). 

The 2010 TR noted the EPA concluded that silicon dioxide and silica gel do not pose unreasonable risks to 

the environment, including non-target organisms, when used at their registered levels. This conclusion is 

based on the belief that silicon dioxide and silica gel are chemically unreactive in the environment, occur 

naturally in various forms, and are practically non-toxic to non-target organisms. 

Discussion 

A 2010 petition to remove silicon dioxide was put forward by RIBUS, the manufacturer of a commercially 

produced rice-based certified organic alternative to silicon dioxide. In 2011, the NOSB did not move the 

petition to remove forward, and silicon dioxide remained on the list. Data was presented in the petition 

claiming that a reformulation of the rice-based alternative could be substituted for silicon dioxide at nearly 

1:1 ratio. However, the Handling Subcommittee felt the data was limited, not published from a third-party 

source, and did not conclusively demonstrate its applicability in all products and processes. 

The Subcommittee did however wish to acknowledge the availability of a natural alternative. Even though 

the Subcommittee did not vote to remove silicon dioxide, it passed a recommendation in 2011 to amend 

the annotation of silicon dioxide, resulting in its current listing which requires the use of organic rice hulls 

when commercially available. In its recommendation, the Subcommittee noted that additional information 

and clarification of processors’ needs regarding silicon dioxide is needed for future deliberations by the 

NOSB. 

In its last sunset review in 2016, public comment indicated that organic rice hulls are not a viable 

alternative for all current uses: 

• As an anticaking agent in organic powders, including organic cheese powders. 

• In organic dry flavors in which rice hulls have not adequately or evenly disbursed flavor actives and 

have taken up moisture. 

• As an anticaking agent at a recommended 2% application rate, when instead the rice hull rate has 

been 15-50%. 

• As a flow agent for rice syrup solids. 

• As a clarifier in the production of beer. 

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Summary of Public Comment 

Most stakeholders were in favor of relisting based on essentiality. Public comments noted that alternatives, 

such as organic rice hulls, are not able to be used to achieve suitable functionality in all applications. There 

were a few comments that suggested the NOSB review the current annotation against the original 

annotation passed by the Board to ensure the intent of the original annotation is accurately conveyed. 

Justification for Vote 

The Subcommittee proposes removal of silicon dioxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove silicon dioxide from the National List 

Motion by: Kyla Smith 

Seconded by: Kim Huseman 

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

Sodium lactate 

Reference: §205.605(b) Sodium lactate - for use as an antimicrobial agent and pH regulator only. 

Technical Report: 2015 

Petition(s): 2004; 2014 NOP memo to NOSB 

Past NOSB Actions: 4/2016 recommendation 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Sodium lactate comes as a liquid and may be added to meat as an antimicrobial ingredient. It is affirmed as 

generally recognized as safe (GRAS) at 21 CFR 184.1639. The FDA does not authorize its use in infant foods 

and formulas. 

Manufacture 

Sodium lactate is generally produced from natural (fermented) lactic acid which is then reacted with 

sodium hydroxide. Lactic acid is produced from the fermentation of natural food sources such as dextrose 

(from corn) and sucrose (from sugar cane or sugar beets) or starch. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Sodium lactate and potassium lactate are not listed for use in processing. Lactic acid is allowed. 

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

Sodium lactate is allowed for use in processing foodstuffs of animal origin only and is listed for use in: 

“Milk-based and meat products.”. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Sodium and potassium lactates are not specifically listed in any of the appendices in the IFOAM, but the 

precursor, lactic acid, is allowed. 

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Japan Agricultural Standard (JAS) for Organic Production 

Sodium lactate and potassium lactate are not listed in the JAS standard and therefore are not permitted. 

The JAS standard specifically states, “The use of any materials except for those described as below is 

prohibited.” 

Environmental Issues 

There does not appear to be any human health concerns associated with sodium lactate as provided by the 

2015 TR. There was an environmental issue raised about the amount of gypsum created in the 

manufacturing of lactic acid, however, according to a report published by the EPA, lactic acid and its salts 

are readily biodegradable and have low potential to persist in the environment (Environmental Protection 

Agency 2008). 

Discussion 

Many stakeholders view this listing as “enormously complicated” saying that it is the procedural history 

that is complicated and not the material itself. Sodium lactate has been allowed for use in organic handling 

since its approval in January of 2004. The decision to not require a petition for this material for inclusion to 

the National List was based on the fact that both of the materials used to produce sodium lactate (lactic 

acid and sodium hydroxide) were already approved on the National List. It was later determined that this 

decision was not consistent with previous NOSB recommendations on classification of materials and that 

the material needed to go through the petition process. Sodium lactate was added to the National List 

effective January 28, 2019. The Handling Subcommittee finds significant merit to keep sodium lactate on 

the NL at § 205.605 (b) with the annotation: for use as an antimicrobial agent and pH regulator only. 

Summary of Public Comments 

A majority of public comments were supportive of relisting sodium lactate. A review of the “use tables” 

supplied by several associations indicate that sodium lactate is a widely used material. Some stakeholders 

asked why both sodium and potassium lactates are on the National List as they appear to be used nearly 

interchangeably. It was noted that there are certain uses, such as “low sodium” meat alternatives that 

require potassium lactate specifically. 

Justification for Vote 

The Subcommittee proposes removal of sodium lactate from the National List based on the following 

criteria in the Organic Foods Production Act (OPFA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove sodium lactate from the National List 

Motion by: Jerry D’Amore 

Seconded by: Kim Huseman 

Yes: 0 No: 7 Abstain: 0 Absent: 0 Recuse: 0 

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Sunset 2023 

Meeting 2 - Review 

Livestock Substances § 205.603 & § 205.604 

October 2021 

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 scheduled for sunset review by the 

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

List for use in organic crop production 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, use 

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

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

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

Substances Database. 

Request for Comments 

Written public comments will be accepted through September 30, 2021 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: 

• Activated charcoal 

• Calcium borogluconate 

• Calcium propionate 

• Chlorine materials 

o (i) Calcium hypochlorite 

o (ii) Chlorine dioxide 

o (iii) Hypochlorous acid—generated from electrolyzed water 

o (iv) Sodium hypochlorite 

• Kaolin pectin 

• Mineral oil 

• Nutritive supplements (Injectable trace minerals, vitamins, and electrolytes) 

• Propylene glycol 

• Sodium chlorite, acidified §205.603(a)(28); and Sodium chlorite, acidified §205.603(b)(9) 

• Zinc sulfate 

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

• None 

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Activated charcoal 

Reference: §205.603 (a)(6) Activated charcoal (CAS # 7440-44-0) - must be from vegetative sources. 

Technical Report: 2002; 2021 TR 

Petition(s): 2002 

Past NOSB Actions: 2002 recommendation/vote 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

The principal veterinary use for activated charcoal is as an antidote to toxic substances—and analogous 

medical applications include use as a detoxifier. According to the 2002 TAP Review, it is regarded as the 

poison antidote of choice and the universal antidote to toxic substances. There is no reported overdosage 

or acute toxicity. Activated charcoal is highly effective against both natural and synthetic toxins. Studies 

show activated carbon to be effective in removing various mycotoxins, such as aflatoxin, fumonisins, 

ochratoxin A, trichothenes, and zearalenone. Natural toxins from plants are also removed or attenuated by 

activated charcoal treatment or supplementation. 

Activated carbon can also be used to remove synthetic pesticides from animals that might contaminate milk 

or meat. Treatment with activated carbon when using certain parasiticides can help reduce the residual 

levels in flesh and fatty tissue. However, it should be noted that use of such substances and withdrawal 

from milk or meat production is subject to the applicable USDA organic regulations. 

Activated charcoal is used to treat animals for drug overdoses, with efficacy established on pigs, dogs, and 

rabbits. 

Manufacture 

Activated charcoal of vegetative origin can be made from a large variety of sources such as hardwoods, 

grain hulls, corn cobs, and nut shells. The material undergoes pyrolysis at a very high heat. The resulting 

charcoal may be chemically activated using a variety of acids, bases, and salts, usually under pressure and 

elevated temperature. Activation agents include acetic acid, hydrochloric acid, potassium hydroxide, 

sodium hydroxide, zinc chloride, and several others. According to the 2021 TR, these chemical activation 

agents are usually collected and reused. The charcoal may also be activated through exposure to 

oxygenated gas or steam. Activated charcoal can also be produced from animal by products or coal, but 

these sources are not allowed under this listing. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Table 5.3 of the Permitted Substances List includes activated charcoal, stating “shall be of plant origin.” 

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

Organically Produced Foods (GL 32-1999; Part B, Section 22) 

While there is no specific listing for activated charcoal (carbon), the Guidelines state the following: 

The use of veterinary medicinal products in organic farming shall comply with the following principles: 

a) where specific disease or health problems occur, or may occur, and no alternative permitted 

treatment or management practice exists, or, in cases required by law, vaccination of livestock, the 

use of parasiticides, or therapeutic use of veterinary drugs are permitted; 

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b) phytotherapeutic (excluding antibiotics), homeopathic or ayurvedic products and trace elements 

shall be used in preference to chemical allopathic veterinary drugs or antibiotics, provided that 

their therapeutic effect is effective for the species of animal and the condition for which the 

treatment is intended; 

c) if the use of the above products is unlikely to be effective in combating illness or injury, chemical 

allopathic veterinary drugs or antibiotics may be used under the responsibility of a veterinarian; 

withholding periods should be the double of that required by legislation with, in any case, a 

minimum of 48 hours; 

d) the use of chemical allopathic veterinary drugs or antibiotics for preventative treatments is 

prohibited. 

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

While there is no specific listing for activated charcoal, Article 14 notes that “suffering shall be kept to a 

minimum during the entire life of the animal, including at the time of slaughter.” The regulation further 

notes “disease shall be treated immediately to avoid suffering to the animal; chemically synthesized 

allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict 

conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In 

particular restrictions with respect to courses of treatment and withdrawal periods shall be defined.” 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

While activated charcoal is not specifically listed, the general principles state management practices should 

be directed to the well-being of animals, achieving maximum resistance against disease, and preventing 

infections. Sick and injured animals must be given prompt and adequate treatment. Further, the standards 

note the well-being of the animals is the primary consideration in the choice of illness treatment. The use of 

conventional veterinary medicines is allowed when no other justifiable alternative is available. Withdrawal 

periods shall not be less than double of that required by legislation. 

Japan Agricultural Standard (JAS) for Organic Production 

While activated charcoal is not specifically listed, the standard states that when veterinary drugs are used, 

the withholding period shall be twice the period of conventional standards. 

Environmental Issues 

Activated charcoal has minimal impact on human health and the environment. It may cause respiratory 

problems for those who handle it, especially as the particle size decreases. Its use in processing doesn’t 

generally have an effect or chemical interaction in the agroecosystem. 

Because of concern regarding the use of certain acids in manufacture, during a sunset review for activated 

charcoal listed at §205.605(b), some stakeholders commented that they would like to see use limited to 

sources derived solely from steam activation. The recent TR indicates that this concern is lessened by reuse of the activation agents. 

Discussion 

This substance was among 35 NOSB recommendations on amendments to the National List, made from 

November 2000 to November 2016, that were acted upon in a final rule published in December 2018. 

Because of this recent addition, this is the first sunset review of activated charcoal at this listing. 

Comments on activated charcoal received for the Spring 2021 NOSB meeting were strongly in favor of its 

continued listing as an approved synthetic substance for use in livestock care. It is used infrequently in 

relatively small amounts and has little environmental impact. Furthermore, its use can reduce or prevent 

livestock distress and death. 

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Justification for Vote 

The Subcommittee proposes removal of activated charcoal from the National List based on the following 

criteria in the Organic Foods Production Act (OPFA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove activated charcoal from the National List 

Motion by: Brian Caldwell 

Seconded by: Kim Huseman 

Yes: 0 No: 3 Abstain: 0 Absent: 2 Recuse: 0 

Calcium borogluconate 

Reference: §205.603 (a)(7) Calcium borogluconate (CAS # 5743-34-0) - for treatment of milk fever only. 

Technical Report: 2000 TAP 

Petition(s): N/A 

Past NOSB Actions: 2000 recommendation/vote 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Calcium borogluconate is used for the treatment of hypocalcemia (also called parturient paresis or milk 

fever) in cattle, sheep, and goats. 

Milk fever is the result of metabolic stress occurring only at or near parturition (giving birth). The mother 

mobilizes large amounts of calcium to produce milk to feed newborn, and blood calcium levels can drop 

below the point necessary for impulse transmission along the nerve tracts. There are three discernable 

stages of milk fever for cows: in stage one, cows are able to stand but show signs of hypersensitivity and 

excitability. In stage two, cows are unable to stand. In stage three, cows lose consciousness progressively to 

the point of coma. 

Manufacture 

Calcium borogluconate is prepared by the reaction of five parts calcium gluconate to one-part boric acid in 

an aqueous solution. Boric acid esterifies the alcohol groups on the gluconate. Excess boric acid is removed 

by distillation with ethanol. 

Calcium gluconate is prepared by a number of methods, including the reaction of gluconic acid with calcium 

hydroxide. Calcium hydroxide was also reviewed by the NOSB for processing and was voted synthetic and 

allowed. Gluconic acid is most commonly produced in the U.S. by fermentation. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Table 5.3 of the Permitted Substances List includes calcium borogluconate “[f]or milk fever. No withdrawal 

period required.” 

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

Organically Produced Foods (CXG 32-1999) Part B, Section 22) 

While there is no specific listing for calcium borogluconate, the Guidelines state the following: 

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The use of veterinary medicinal products in organic farming shall comply with the following principles: 

a) where specific disease or health problems occur, or may occur, and no alternative permitted 

treatment or management practice exists, or, in cases required by law, vaccination of livestock, the 

use of parasiticides, or therapeutic use of veterinary drugs are permitted; 

b) phytotherapeutic (excluding antibiotics), homeopathic or ayurvedic products and trace elements 

shall be used in preference to chemical allopathic veterinary drugs or antibiotics, provided that 

their therapeutic effect is effective for the species of animal and the condition for which the 

treatment is intended; 

c) if the use of the above products is unlikely to be effective in combating illness or injury, chemical 

allopathic veterinary drugs or antibiotics may be used under the responsibility of a veterinarian; 

withholding periods should be the double of that required by legislation with, in any case, a 

minimum of 48 hours; 

d) the use of chemical allopathic veterinary drugs or antibiotics for preventative treatments is 

prohibited. 

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

While there is no specific listing for calcium borogluconate, Article 14 notes that “suffering shall be kept to 

a minimum during the entire life of the animal, including at the time of slaughter.” The regulation further 

notes “disease shall be treated immediately to avoid suffering to the animal; chemically synthesized 

allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict 

conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In 

particular restrictions with respect to courses of treatment and withdrawal periods shall be defined.” 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

While calcium borogluconate is not specifically listed, the general principles state management practices 

should be directed to the well-being of animals, achieving maximum resistance against disease, and 

preventing infections. Sick and injured animals must be given prompt and adequate treatment. Further, the 

standards note the well-being of the animals is the primary consideration in the choice of illness treatment. 

The use of conventional veterinary medicines is allowed when no other justifiable alternative is available. 

Withdrawal periods shall not be less than double of that required by legislation. 

Japan Agricultural Standard (JAS) for Organic Production 

Calcium borogluconate is not specifically listed. 

Environmental Issues 

The TAP review did not discuss environmental issues related to the manufacture of calcium borogluconate. 

The review noted, “[t]he material is metabolized by the animal, with the calcium entering the blood stream 

and some being expressed as milk. The animal’s urine and feces may contain higher levels of boron as a 

result, but none of the literature reviewed partitioned the fate. Some claim that introduction of boron and 

sugar is either unnecessary or causes complications, but these are not specified.” 

Discussion 

This substance was among 35 NOSB recommendations on amendments to the National List, made from 

November 2000 to November 2016, that were acted upon in a final rule published in December 2018. This 

is the first sunset review of calcium borogluconate at this listing. 

Calcium borogluconate is also classified on the National List under electrolytes which are currently listed at 

§205.603 as synthetic substances allowed for organic livestock production when they do not contain 

antibiotics. Due to the listing of calcium borogluconate as a stand-alone substance and the inclusion of the 

substance under the listing for electrolytes, the Subcommittee sought feedback on the separate listings and 

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clarity from the FDA on the status of the substance as a livestock treatment. The NOP conferred with the 

FDA on the proposed additions and amendments to § 205.603. During this conference, the FDA indicated

that their process involves reviewing formulated products for medical treatment approval. FDA indicated 

they do not review for medical treatment approval of generic materials, as included in this rule. Therefore, 

individual substances cited in this rule would not be reviewed as medical treatments under the FDA 

process. Based upon this consultation, NOP believes these substances are not in conflict with FDA 

regulations. 

Stakeholders reflected a general acceptance of calcium borogluconate under separate listings to facilitate 

consistency amongst certifiers. One comment noted that the majority of certifiers would allow calcium 

borogluconate as an injectable electrolyte but having the separate listing assures this is the case. One 

certifier commented the listing is redundant, another certifier adding that having the separate listings does 

not cause differences in decision making. 

Producers support the re-listing of calcium borogluconate, stating that it is a common, inexpensive, and 

traditional treatment for ketosis in ruminates. A producer group noted that a variety of treatments for 

ketosis are necessary for organic producers as they perform and are administered in different ways. Two 

veterinarians commented that the substance is essential for livestock treatment. 

Justification for Vote 

The Subcommittee discussed stakeholder feedback, the additional listing of the substance on the National 

List as an electrolyte and the regulatory clarity established by NOP with the FDA. As the substance provides 

relief from unnecessary animal suffering, it is compatible with a sustainable system of agriculture. 

The Subcommittee proposes removal of calcium borogluconate from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not 

recommending removal. 

Subcommittee Vote 

Motion to remove calcium borogluconate from the National List 

Motion by: Kim Huseman 

Seconded by: Mindee Jeffery 

Yes: 0 No: 3 Abstain: 0 Absent: 2 Recuse: 0 

Calcium propionate 

Reference: §205.603 (a)(8) Calcium propionate (CAS # 4075-81-4) - for treatment of milk fever only. 

Technical Report: 2002 TAP; 2015 TR (Electrolytes) 

Petition(s): 2002 

Past NOSB Actions: 2002 recommendation/vote; 2002 position paper 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Calcium propionate is an electrolyte that is used in organic livestock to treat metabolic conditions such as 

hypocalcemia, scours, dehydration, milk fever, erratic heartbeat, loss of muscle control, mastitis, ketosis, 

alkalosis, acidosis, and difficulty in labor and prostration. Lack of treatment often results in death. Although 

the FDA considers electrolyte formulations to be animal drugs, many of the formulations have not been 

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formally approved by the FDA; often because they are non-proprietary, general use materials. No company 

has applied for a New Animal Drug Approval (NADA) for calcium propionate. 

Milk production is very closely related to the total glucose supply at the udder. Propionate is used by the 

liver to make the glucose used by the cow to make lactose, the sugar in milk. Propionate's second function 

involves the cow's fat metabolism. When the cow's energy demands for milk production exceed the 

amount of energy she is eating, she begins to break down some of her body fat. The fats are broken down 

into smaller pieces, called non-esterified fatty acids (NEFA's), and carried to the liver. At the liver, they are 

broken down to form acetate to generate energy. Acetate is broken down to carbon dioxide and water to 

yield more energy; however, this process requires propionate. If there is not enough propionate available 

(which is often the case when cows are making a lot of milk sugar), the excess acetate builds up in the liver, 

creating acetone, acetoacetate, and beta-hydroxybutyrate. These products are released from the liver into 

the cow's bloodstream, causing ketosis symptoms. 

When lactation starts, milk fever can be treated by intravenous administration of electrolytes containing 

calcium to the animal. Calcium can be added by oral boluses, pastes, or drenching if the animal is still 

standing, but when the animal is down, an intravenous injection is needed. Oral doses of calcium chloride 

can be effective, but it is caustic, causing ulcerations and acidosis. Calcium propionate is less caustic, does 

not cause acidosis, and the propionate fatty acid is glucogenic. One dose of calcium propionate is given at 

calving, and another 24 hours later. 

Manufacture 

Electrolytes are mostly synthetic materials produced by chemical processes. Since many are salts, they are 

often produced by acid-base reactions. Calcium propionate is produced by reacting propionic acid with an 

aqueous solution of calcium hydroxide. It is also produced by reacting calcium hydroxide with propionitrile. 

International Acceptance 

Canadian General Standards Board Permitted Substances List In Canada, the Permitted Substances List for 

Organic Animal Production allows electrolytes as part of Table 5.3 ‘Health Care Products and Production 

Aids.’ Electrolytes without antibiotics are permitted, and electrolyte solutions ‘with no added active 

ingredients’ are permitted (Canadian Standards 2011). No withdrawal period required. 

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

Organically Produced Foods (CXG 32-1999) Part B, Section 22) 

Electrolytes are not specifically mentioned. However, under Health Care, Section 22 “where specific disease 

or health problems occur, or may occur, and no alternative permitted treatment or management practice 

exists, or, in cases required by law, vaccination of livestock, the use of parasiticides, or therapeutic use of 

veterinary drugs are permitted.” 

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

Electrolytes are not mentioned specifically in 834/2007. However, Annex V, Feed Materials of Mineral 

Origin (EU EEC 2008, Article 14 Section 1 (e) (ii) states “chemically synthesised allopathic veterinary 

medicinal products including antibiotics may be used where necessary and under strict conditions” (EU EEC 

2007). In 889/2008 many of the electrolyte salts are permitted as feed additives. 

While there is no specific listing for calcium propionate, Article 14 notes that “suffering shall be kept to a 

minimum during the entire life of the animal, including at the time of slaughter.” The regulation further 

notes “disease shall be treated immediately to avoid suffering to the animal; chemically synthesized 

allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict 

conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In 

particular restrictions with respect to courses of treatment and withdrawal periods shall be defined.” 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

In the IFOAM Norms for organic production and processing version 2012, electrolytes are not specifically 

mentioned for organic animal production. In Section III (5) on Animal Husbandry, only natural sources are 

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permitted for vitamins, trace elements, and supplements. Use of synthetic allopathic veterinary drugs or 

antibiotics will cause the animal to lose its organic status (IFOAM 2012). But many of the electrolyte 

substances are mentioned in Appendix 4 as additives and processing aids (IFOAM 2012). 

While calcium propionate is not specifically listed, the general principles state management practices 

should be directed to the well-being of animals, achieving maximum resistance against disease, and 

preventing infections. The use of conventional veterinary medicines is allowed when no other justifiable 

alternative is available. Withdrawal periods shall not be less than double of that required by legislation. 

Japan Agricultural Standard (JAS) for Organic Production 

The Japanese Agricultural Standard (JAS) for Organic Production originally considered only crops and 

processing (JAS 2005). Later revisions included livestock. A summary in 2007 mentions that organic 

livestock must be fed organic feed, have exercise and access to pasture, and must not be fed antibiotics or 

GMOs. Electrolytes for organic animal production were not mentioned; therefore, it is unknown whether 

they are specifically allowed or prohibited (JAS 2007). 

Soil Association Standards, United Kingdom 

The Soil Association Standards at Section 10.10.22 specifically allow calcium borogluconate, magnesium 

and phosphorus salts for milk fever. Section 10.10.34 specifically allows glucose/electrolytes as oral 

rehydration therapy for scours. Antibiotics and other non-allowed substances cannot be used (Soil 

Association 2005). 

Environmental Issues 

Electrolytes are used in animal production situations. Since electrolytes are usually added to correct 

deficiencies, concentrations in the environment due to excretion would be no more than a normal 

untreated animal with normal electrolyte balances. Most of these materials are produced by acid-base 

reactions. Environmental contamination from production of calcium propionate is unlikely, as reactions are 

simple neutralizations, producing the needed salt and water. Any problems would come from excess 

stocking rates. Excess stocking rates could lead to an excess of metabolic by-products in the immediate 

environment, plus extra stress on the animals. 

Discussion 

The 2015 TR on electrolytes, including calcium propionate, discussed whether there were alternative nonsynthetic materials or alternative practices that would make the use of calcium propionate unnecessary. 

The TR concluded that the electrolytes are on the list of allowed synthetics, and non-synthetic sources of 

electrolyte formulations are typically not commercially available. 

Alternative practices that would make the use of calcium propionate less necessary for treatment of 

hypocalcemia and the prevention of milk fever are low calcium prepartum diets, Dietary Cation Anion 

Difference (DCAD) diets (prior to parturition), and administration of oral electrolytes. Sometimes 

combinations of these treatments are used. DCAD diets involve adding electrolytes to food to provide an 

excess of strong anions or choosing food that will have this effect. Body condition should be managed in 

late lactation to prevent cows from becoming too fat which adds to the risk of milk fever. Modifying diets 

of late lactation cows to increase the energy supply from digestible fiber and reduce the energy supply 

from starch may aid in partitioning dietary energy toward milk and away from body fattening. 

Public comments on calcium propionate received for the Spring 2021 NOSB meeting were generally in favor 

of continuing its listing on the National List as an approved synthetic substance for use in livestock care. A 

majority of livestock dairy producers, veterinarians, and the organic industry at large stated it was an 

essential treatment for milk fever. It was noted that calcium propionate products present little opportunity 

for environmental or human health issues, stating that the calcium propionate is metabolized by the 

livestock to achieve normal electrolyte balances. One commenter stated that they have not seen new, nonsynthetic products available for the treatment of milk fever. 

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– -

There were a few commenters who noted that the listing for calcium propionate is redundant, as the 

listings for electrolytes at §205.603(a)(11) and nutritive supplements at§205.603(a)(21) together allow for 

calcium propionate for the treatment of milk fever, but other commenters stated that having the separate 

listings does not cause differences in decision making. 

Justification for Vote 

The Livestock Subcommittee proposes removal of calcium propionate from §205.603(a) based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.603(a) if applicable: N/A. 

Not recommending removal. 

Subcommittee Vote: 

Motion to remove calcium propionate from the National List 

Motion by: Kim Huseman 

Seconded by: Sue Baird 

Yes: 0 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

Chlorine materials Calcium hypochlorite, chlorine dioxide, Hypochlorous acid generated from 

electrolyzed water, sodium hypochlorite 

Reference: §205.603 (a)(10) Chlorine materials—disinfecting and sanitizing facilities and equipment. 

Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the 

Safe Drinking Water Act. 

(i) Calcium hypochlorite 

(ii) Chlorine dioxide 

(iii) Hypochlorous acid - generated from electrolyzed water 

(iv) Sodium hypochlorite 

Petition(s): 2016 (Hypochlorous Acid) 

Technical Report: 2006 TR (Chlorine materials); 2017 Limited Scope TR (Hypochlorous Acid) 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 05/2006 NOSB sunset recommendation; 10/2010 

NOSB recommendation; 10/2015 sunset recommendation; 04/2016 Recommendation to add hypochlorous 

acid; 11/2017 sunset recommendation 

Recent Regulatory Background: Added to National List 2/20/2001 (65 FR 80547); Sunset renewal notice 

3/15/2017 (82 FR 14420); Hypochlorous acid added to NL effective 1/28/2019 (83 FR 66559); Sunset 

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

Sunset Date: 1/28/2024 (hypochlorous acid); 10/30/2024 (Calcium hypochlorite, chlorine dioxide, sodium 

hypochlorite) 

Subcommittee Review 

Use 

Sodium and calcium hypochlorite are chlorinated inorganic disinfectants used to control bacteria, fungi, and 

slime-forming algae that can cause diseases in people and animals (EPA, 1991, 1992). These disinfectants 

also are used in cleaning irrigation, drinking water, and other water and wastewater systems. Chlorine 

dioxide is an antimicrobial disinfectant and pesticide used to control harmful microorganisms including 

bacteria, viruses, and fungi on inanimate objects and surfaces primarily in indoor environments. It is also 

used in cleaning water systems and disinfecting public drinking water supplies (Agency for Toxic Substances 

and Disease Registry (ATSDR), CDC, 2004a). It also is used as a bleaching agent in paper and textile 

manufacturing, as a food disinfectant (e.g., for fruit, vegetables, meat, and poultry), for disinfecting food 

processing equipment, and treating medical wastes, among other uses (EPA, 2003a). Chlorine materials are 

currently used for disinfection of livestock facilities (NOP Guidance 5026). 

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Hypochlorous acid, as formulated via electrolyzed water, is effective as a sanitizer at a much lower chlorine 

concentration and is safer for health and the environment than the currently listed chlorine sanitizers. 

Manufacture 

Calcium hypochlorite, sodium hypochlorite, and chlorine dioxide are all synthetic materials that are 

manufactured by chemical processes. Calcium hypochlorite is produced by passing chlorine gas over 

hydrated (slaked) lime. It is then separated from the coproduct, calcium chloride, and air dried or vacuum 

dried. Generally, sodium hypochlorite is produced by reacting chlorine with a solution of sodium hydroxide 

(NaOH, also called lye or caustic soda). This method is used for most commercial productions of sodium 

hypochlorite. A more active, but less stable formulation of sodium hypochlorite can be produced by 

chlorinating a solution of soda ash (Na2CO3). Chlorine dioxide is formed by reacting sodium chlorate 

(NaClO3) and sulfuric acid (H2SO4) with sulfur dioxide (SO2), or chloric acid is reacted with methanol 

(CH3OH) (HSDB, 2005). Alternatively, chlorine dioxide can be formed with chlorine (Cl2) and sodium 

chlorite; sodium hypochlorite with hydrochloric acid; potassium chlorate with sulfuric acid; or by passing 

nitrogen dioxide through a column of sodium chlorate. 

Hypochlorous acid: Electrolyzed water (EW) is the product of the electrolysis of a dilute sodium chloride 

solution in an electrolysis cell containing a semi-permeable membrane that physically separates the anode 

and cathode but permits ions to pass through. In the process, hypochlorous acid, hypochlorite ion, and 

hydrochlorite acid are formed at the anode, and sodium hydroxide is formed at the cathode. The solution 

formed on the anode side is acidic EW (pH 2 to 6), and the solution formed on the cathode side is basic EW 

(pH 7.5 to 13). Neutral EW, with a pH of 6 to 7.5 is produced by mixing the anodic solution with hydroxide, 

or by using a single-cell chamber for electrolysis. (TR lines 48-68). 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Bleach (not exceeding drinking water standards) is permitted in packaging and sanitation. 

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

Sodium hypochlorite (e.g., as liquid bleach) is authorized for the clearing and disinfecting of livestock 

buildings and installations. 

Environmental Issues 

Information available from EPA and FDA on chlorine dioxide, sodium, and calcium hypochlorite, and 

hypochlorous acid indicates that there is no environmental contamination resulting from proper 

manufacture, use, or disposal. 

Discussion 

Protecting food from contamination by human pathogens is essential to safeguard organic integrity. 

Despite the potential for significant risks to human health and the environment, chlorine compounds have 

been judged essential to ensure food safety and to comply with food safety regulations. The Livestock 

Subcommittee (LS) generally supports continued listing of these materials but encourages ongoing 

discussion about the listing of sanitizers and disinfectants for livestock handling and processing. The LS 

supports research priorities that investigate alternatives to chlorine compounds and encourages the use of 

alternative, less toxic materials, when their use can meet strict food safety standards. However, at this 

point in time, chlorine materials are an essential part for maintaining hygiene in livestock facilities. 

Public comment was consistently in favor of relisting chlorine materials including (i) Calcium, hypochlorite, 

(ii) Chlorine dioxide, (iv) Sodium hypochlorite. Due to its efficacy as a sanitizer and the overall lack of 

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suitable alternatives, livestock producers and other stakeholders in the livestock product supply chain cited 

chlorine materials as a critical tool to maintain hygiene. 

Justification for Vote 

The Subcommittee proposes removal of chlorine materials from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove chlorine materials from the National List 

Motion by: Kim Huseman 

Seconded by: Nate-Powell-Palm 

Yes: 0 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

Kaolin pectin 

Reference: §205.603 (a)(17) Kaolin pectin - for use as an adsorbent, antidiarrheal, and gut protectant. 

Technical Report: 2002 TAP; 2021 TR Pending 

Petition(s): 2002 

Past NOSB Actions: 2002 recommendation/vote; 2002 Position Paper 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Kaolin pectin is used in livestock for the same reasons that it is administered to humans: as an adsorbent, 

anti-diarrheal, and gut protectant. It may also be combined with vitamin A to treat bacterial diarrhea in 

calves. 

Status 

According to the 2002 Technical Advisory Panel (TAP), the FDA has declared kaolin to be generally 

recognized as safe (GRAS) as an indirect food additive, and pectin to be GRAS as a direct food additive, both 

with the limitation that the levels in food are consistent with good manufacturing practices. 

In addition to kaolin pectin having been placed on the National List as an allowed synthetic substance, 

kaolin and pectin are also separately allowed for use in organic systems. 

In the 2002 TAP, there was some disagreement about whether kaolin pectin should be categorized as a 

synthetic or non-synthetic substance. 

Manufacture 

Kaolin pectin is a formulated mixture of kaolin and pectin. Both kaolin and pectin occur naturally. Kaolin is 

a mineral dust formed by weathering of aluminum silicates. Pectin may be obtained from appropriate 

edible plant material, usually citrus fruits or apples, by extraction into an aqueous medium. No organic 

precipitants are used other than methanol, ethanol, and isopropanol. In some pectin products, a portion of 

the methyl esters are converted to primary amides by treatment with ammonia under alkaline conditions. 

The commercial product is normally standardized with sugars and may be buffered with suitable food grade 

salts. 

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International Acceptance 

Canadian General Standards Board Permitted Substances List. Kaolin pectin not listed. 

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008. Kaolin pectin not 

listed. 

Note that while there is no specific listing for kaolin pectin, the use of this substance is consistent with 

Article 14, which states that “suffering shall be kept to a minimum during the entire life of the animal, 

including at the time of slaughter.” The regulation further notes “disease shall be treated immediately to 

avoid suffering to the animal; chemically synthesized allopathic veterinary medicinal products including 

antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, 

homeopathic and other products is inappropriate. In particular restrictions with respect to courses of 

treatment and withdrawal periods shall be defined.” 

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

Organically Produced Foods (GL 32-1999). Kaolin pectin not listed. 

Note that while there is no specific listing for kaolin pectin, the use of this substance is consistent with the 

Guidelines, which state the following: 

The use of veterinary medicinal products in organic farming shall comply with the following principles: 

a) where specific disease or health problems occur, or may occur, and no alternative permitted 

treatment or management practice exists, or, in cases required by law, vaccination of livestock, the use 

of parasiticides, or therapeutic use of veterinary drugs are permitted; 

b) phytotherapeutic (excluding antibiotics), homeopathic or ayurvedic products and trace elements shall 

be used in preference to chemical allopathic veterinary drugs or antibiotics, provided that their 

therapeutic effect is effective for the species of animal and the condition for which the treatment is 

intended; 

c) if the use of the above products is unlikely to be effective in combating illness or injury, chemical 

allopathic veterinary drugs or antibiotics may be used under the responsibility of a veterinarian; 

withholding periods should be the double of that required by legislation with, in any case, a minimum of 

48 hours; 

d) the use of chemical allopathic veterinary drugs or antibiotics for preventative treatments is 

prohibited. 

International Federation of Organic Agriculture Movements (IFOAM) Norms. Kaolin pectin is not listed. 

Note that while there is no specific listing for kaolin pectin, the use of this substance is consistent with 

IFOAM’s general principles that state that “management practices should be directed to the well-being of 

animals, achieving maximum resistance against disease, and preventing infections. Sick and injured animals 

must be given prompt and adequate treatment. Further, the standards note the well-being of the animals is 

the primary consideration in the choice of illness treatment. The use of conventional veterinary medicines 

is allowed when no other justifiable alternative is available. Withdrawal periods shall not be less than 

double of that required by legislation.” 

Japan Agricultural Standard (JAS) for Organic Production 

Kaolin pectin in not listed. 

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Environmental Issues 

According to the 2002 TAP: 

• There is no evidence that kaolin and pectin will contaminate the environment. 

• In the manner in which kaolin is to be used, in kaolin pectin, there is an unlikely chance of 

environmental contamination. However, if workers are to be exposed to kaolin dust during 

manufacture, they must take appropriate precautions. 

Discussion 

Under §6509 of OFPA “Animal production practices and materials”, Section (d) “Health care” states: 

(1) Prohibited practices 

For a farm to be certified under this chapter as an organic farm with respect to the livestock 

produced by such farm, producers on such farm shall not— 

(A) use subtherapeutic doses of antibiotics; 

(B) use synthetic internal parasiticides on a routine basis; or 

(C) administer medication, other than vaccinations, in the absence of illness. 

To the degree to which kaolin pectin is used to address actual livestock illnesses in the context of organic 

livestock production, its allowance is consistent with OFPA Section 6509. 

Public comment during the 2021 spring meeting overwhelmingly supported the relisting of kaolin pectin; it 

is a vital tool used for gastrointestinal disorders in livestock production. Kaolin pectin does not seem to be 

overused, but rather being used on an as-needed basis. The TAP on kaolin pectin is from 2002, and the 

Livestock Subcommittee requested a new TR in 2021. The TR was not available before the Subcommittee 

voted on this document. 

Justification for Vote 

The Subcommittee proposes removal of kaolin pectin from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove kaolin pectin from the National List 

Motion by: Sue Baird 

Seconded by: Mindee Jeffery 

Yes: 0 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

Mineral oil 

Reference: §205.603 (a)(20) Mineral oil—for treatment of intestinal compaction, prohibited for use as a 

dust suppressant. 

Technical Report: 2002 TAP; 2015 TR; 2021 Limited Scope TR 

Petition(s): 2002 Petition 

Past NOSB Actions: 11/1995 NOSB minutes and vote; 2002 recommendation/vote; 5/2003 

recommendation. 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Mineral oil was petitioned in 2002 to be used for treatment of intestinal compaction and topical 

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application, and as a dust suppressant. After reviewing the 2003 TAP review, NOSB recommended adding 

mineral oil for treatment of intestinal compaction only. The scope of this sunset review is for mineral oil, 

approved in 205.603(a)(20) for administering internally to lubricate the intestinal tract and dislodge 

intestinal obstructions in cattle and other ruminants. The National Organic Program (NOP) final rule 

currently permits the use of mineral oil in organic livestock production for treatment of intestinal 

compaction, prohibited for use as a dust suppressant in 7CFR 205.603(a)(20). 

Mineral oil is used as an internal lubricant in livestock production. In the case of “omasal impaction”, the 

ruminant’s third stomach (omasum) becomes tightly bound and compacted, resulting in severe pain for the 

affected animal. Omasal impaction is related to failure of omasal transport, which develops because of a 

condition that prevents ingested material from passing through the omasal canal into the abomasum, the 

fourth and final stomach compartment in the ruminants’ stomachs. In general, impactions in various 

segments of the gastrointestinal tract may develop in pregnant beef cows during cold winter months when 

cattle consume less water and are fed lower-quality roughage. Mineral oil may be applied as an oral drench 

until the viscous mineral oil treatment lubricates the impaction. 

Mineral oil is also commonly used to control bloat. Bloat generally occurs in animals after grazing young, 

lush pasture, particularly if the pasture contains significant amounts of legume species (clover, medics, or 

lucerne). Ruminants such as cattle produce large volumes of gas during the digestive process, and natural 

foaming agents in legumes and some rapidly growing grasses cause stable foam to form in the rumen. The 

animal is therefore unable to pass the gas trapped as small bubbles in the foam. Severe cases may require 

insertion of a wide-boar trocar and cannula into the rumen to relieve the pressure followed by direct 

addition of an anti-bloat preparation (e.g., mineral oil, vegetable oils, or dioctyl sodium sulfosuccinate) into 

the rumen through the cannula. Sudden death is commonly observed in cattle that are not closely 

observed. As a preventative measure, veterinary specialists suggest that cattle producers drench each 

animal twice daily with an anti-bloat preparation when the pasture is considered risky. 

Manufacture 

The industrial production of highly refined, food-grade mineral oils involve chemical processing and 

refinement using various chemical reagents and/or catalysts. To produce mineral oil, the chemical 

composition of natural crude oil is altered through physical separation (distillation) followed by 

reactions/combination with synthetic substances and reagents (aromatic solvents, strong acids, and/or 

catalysts). 

Crude oil is desalted, distilled, and subjected to solvent extraction, de-aromatization with fuming sulfuric 

acid or sulfur trioxide, and/or catalytic hydrocracking treatments to reduce the concentration of polar 

constituents containing heteroatoms (nitrogen, oxygen, and sulfur atoms) as well as polynuclear aromatic 

hydrocarbons (PAHs) and other aromatic compounds. 

Because of the complexity of the mineral oil mixtures, refined mineral oils are identified using several CAS 

numbers depending on the treatment processes utilized and the intended use pattern of the mineral oil 

product. Mineral oils used in organic livestock production are hydrocarbon molecules containing 34 carbon 

atoms. These untreated mineral oils may also contain small amounts of nitrogen- and sulfur containing 

compounds. As such, the NOSB classified mineral oil as “synthetic” since initially recommending addition of 

the substance to the National List. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Canadian regulations permit numerous uses for mineral oils of varying purity. Mineral oils are allowed for 

external application only under Section 5.3 (health care products and production aids) of the permitted 

substances list for livestock production (CAN, 2011). 

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

Organically Produced Foods (GL 32-1999; Part B, Section 22) 

The Codex Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced 

Foods (CAC/GL 32-1999) indicate that mineral oil is only permitted for use in traps for organic crop 

production. Mineral oils are not specifically mentioned for livestock applications. However, under Health 

Care, Section 22 “where specific disease or health problems occur, or may occur, and no alternative 

permitted treatment or management practice exists, or, in cases required by law, vaccination of livestock, 

the use of parasiticides, or therapeutic use of veterinary drugs are permitted.” 

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

According to Annex II of the European Organic Regulation (EC) No 889/2008, mineral oil may be used as an 

insecticide and/or fungicide only in fruit trees, vines, olive trees and tropical crops (e.g., bananas). Mineral 

oils are not mentioned specifically in 834/2007 for the use in livestock. However, Annex V, Feed Materials 

of Mineral Origin (EU EEC 2008, Article 14 Section 1 (e) (ii) states “chemically synthesized allopathic 

veterinary medicinal products including antibiotics may be used where necessary and under strict 

conditions” (EU EEC 2007). While there is no specific listing for mineral oils in livestock, Article 14 notes 

that “suffering shall be kept to a minimum during the entire life of the animal, including at the time of 

slaughter.” The regulation further notes “disease shall be treated immediately to avoid suffering to the 

animal; chemically synthesized allopathic veterinary medicinal products including antibiotics may be used 

where necessary and under strict conditions, when the use of phyto-therapeutic, homeopathic and other 

products is inappropriate. In particular restrictions with respect to courses of treatment and withdrawal 

periods shall be defined.” 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

The IFOAM Norms permit the use of “light mineral oils (paraffin)” under Appendix 3 (crop protectants and 

growth regulators). There are no approved uses for mineral oils or related substances in organic livestock 

production under the IFOAM Norms (IFOAM, 2014). 

Japan Agricultural Standard (JAS) for Organic Production 

The Japanese Agricultural Standard (JAS) for Organic Production originally considered only crops and 

processing (JAS 2005) with later revisions including livestock. Japanese regulations for the organic 

production of livestock only mentions the use of “petroleum oil aerosol” and “petroleum oil emulsion” for 

plant pest and disease control (Table 2). Otherwise, it does not appear that Japanese organic regulations 

permit the use of mineral oil or related products in organic livestock production (JMAFF, 2012). 

However, on July 16, 2020 USDA and Japan signed an Organic Livestock Equivalency. Livestock products 

include beef, eggs, etc., and processed products of animal origin include ham, cheese, chocolate milk, etc. 

The arrangement is limited to domestic animals (cattle, horses, sheep, goats, and pigs) or domestic poultry 

(chickens, quails, ostriches, ducks, and wild ducks. Due to this equivalency agreement, livestock treated 

with Mineral Oil would be allowed for export to Japan. 

Human Health and Environmental Issues 

Because of their complexity, it is not possible to separate mineral oil mixtures into individual components 

for quantification. Indeed, an enormous number of individual components are constituents of crude and 

refined mineral oil mixtures. Mineral oils may be classified as highly refined or mildly treated/untreated. 

Testing in laboratory animals has demonstrated that mineral oils are slightly to practically non-toxic to 

mammals on an acute exposure basis. Mineral oils are mild irritants, classified as Toxicity Category IV 

(lowest toxicity) for skin irritation and Category III for eye irritation. Highly refined “white” mineral oils 

produced no sensitization reactions in guinea pigs repeatedly exposed to the substance. 

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The carcinogenicity and genotoxicity potential for mineral oils is generally dependent upon the degree of 

refinement and presence of PAHs in the mixture. White mineral oils, which have undergone the most 

severe acid, solvent, or hydrocracking treatment, showed no activity in a series of skin-tumor bioassays. 

Much like the mammalian studies, the results of avian and honeybee studies suggest that refined mineral 

oils are practically non-toxic to birds and honeybees via acute oral and contact exposure, respectively. 

Refined mineral oils are generally characterized as minimally toxic to aquatic organisms on an acute 

exposure basis. 

The white mineral oils that are likely to be used for lubrication and external parasite control in organic 

livestock production are highly refined oils that contain negligible quantities of toxic contaminants 

compared to untreated and mildly treated oils. 

Discussion 

During the 2015 review of mineral oil some livestock producers indicated that failure to regularly treat for 

omasal impaction often results in the need for surgery. Mineral oil products are considered unapproved 

animal drugs according to FDA regulations. Animal drugs containing mineral oils are currently marketed for 

relief of obstruction or impaction of the intestinal tract in cattle, sheep, goats, swine, and horses. Because 

these animal drugs are not FDA approved, the labels carry the disclaimer: “this drug has not been found by 

FDA to be safe and effective, and this labeling has not been approved by FDA.” 

Accordingly, the NOP was unable to accept the 2015 NOSB recommendation to allow the use of mineral oil 

as a livestock medication. Mineral oil remains prohibited for use in organic livestock production as an orally 

administered treatment of constipation in cattle and other ruminants. The NOP currently permits the use of 

mineral oil in organic livestock production for topical use and as a lubricant at §205.603(b)(6)). 

Best management practices may prevent the development of omasal impaction and parasite infestation in 

cattle, sheep, and other livestock under certain conditions. Omasal impaction generally occurs when the 

feed provided to cattle is tough and fibrous, particularly alfalfa stalks and cuttings from fodder trees, or 

under drought feeding conditions in sheep that are fed on the ground. The latter form of impaction in 

sheep is typically due to the accumulation of soil in the omasum. 

In healthy animal stock, providing the necessary nutritional requirement for wintering pregnant beef cattle 

can prevent abomasal impaction. Producers using low-quality roughage should augment the ration with 

grain to meet energy and protein requirements, especially if laboratory analyses indicate these key nutrient 

parameters are low in the roughage alone. Adequate drinking water should be supplied continually for 

animal welfare, and to encourage proper digestion of feed and pasture materials. Like bloat, omasal 

impaction may be prevented through provision of rations containing 10–15% cut or chopped roughage 

mixed into the complete feed to ease the digestion of fibrous materials. The roughage should be a cereal, 

grain straw, grass hay, or equivalent, and grains should be rolled or cracked as opposed to finely ground. 

Public comments received during the Spring 2021 NOSB meeting overwhelmingly supported relisting 

mineral oil. Commenters stated that mineral oil is used infrequency but when it is needed, there is no 

alternative that is sufficient because natural oils do not work, as they get digested and do not move or 

break up the compaction. Other commenters stated that other than invasive surgery, mineral oil was the 

best option. One livestock producer stated that you can take good care of your animals, but compaction 

can still happen in rare cases. If the material were prohibited, there would be huge negative effects on cow 

health. Animal welfare would be impacted, because the animal would either die, or would have to be sold if 

nonorganic treatments are used. One livestock veterinarian commented that, “Mineral oil has the property 

of not being absorbed by the gut and thus can coat the gut so there is no absorption and possible 

reabsorption downstream of toxins. It can be used for frothy bloat. It is indispensable to me as a 

practitioner to quickly reverse digestive upsets.” 

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–

Subcommittee Justification 

The Subcommittee proposes removal of mineral oil from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove mineral oil from the National List 

Motion by: Kim Huseman 

Seconded by: Brian Caldwell 

Yes: 0 No: 3 Abstain: 0 Absent: 2 Recuse: 0 

Nutritive supplements injectable trace minerals, vitamins, and electrolytes 

Reference: §205.603 (a)(21) Nutritive supplements - injectable supplements of trace minerals per 

paragraph (d)(2) of this section, vitamins per paragraph (d)(3), and electrolytes per paragraph (a)(11), with 

excipients per paragraph (f), in accordance with FDA and restricted to use by or on the order of a licensed 

veterinarian. 

Technical Report: 1995 TAP ((a)(11) electrolytes); 2015 TR ((d)(3) vitamins); 2015 TR ((a)(11) electrolytes); 

2019 TR ((d)(2) trace minerals) 

Petition(s): 2009 

Past NOSB Actions: 05/2009 recommendation to add to NL 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Nutritive supplements (Injectable trace minerals, vitamins, and electrolytes) are allowed to treat livestock 

ailments when administered or ordered by a licensed veterinarian. 

Manufacture 

Trace minerals used as feed additives are produced by chemical reactions resulting in inorganic forms of the 

mineral. Organic compounds are used for some of the trace minerals. 

Vitamins can be extracted from foods or synthesized by chemical or fermentation processes. Regarding the 

former, certain vitamins can be obtained from natural dietary sources in varying quantities. For example, 

Vitamin C (ascorbic acid) is a major nutritional component of citrus fruits and Vitamin D is a natural 

constituent nutrient of cold-water fish. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

From the Permitted Substances List (CAN/CGSB-32.311- 459 2006), vitamins may be used for enrichment or 

fortification of livestock feed, and synthetic vitamins may be used if non-synthetic sources are not 

commercially available (CAN, 2011b). Under no circumstances should vitamins be used to stimulate growth 

or production (CAN, 2011b). 

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

EC No. 834/2007 and 889/2008, state that “feed of mineral origin, trace elements, vitamins or provitamins 

shall be of natural origin. In case these substances are unavailable, chemically well-defined analogic 

substances may be authorized for use in organic production.” Specifically, vitamins are allowed nutritional 

additives for use in animal production under the following conditions: (1) Vitamins derived from raw 

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materials occurring naturally in feedstuffs; (2) Synthetic vitamins identical to natural vitamins for 

monogastric animals and aquatic animals; (3) Synthetic vitamins A, D, and E identical to natural vitamins for 

ruminants with prior authorization of the Member States based on the assessment of the possibility for 

organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations. 

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

Organically Produced Foods (GL 32-1999) 

The Codex Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced 466 

Foods (CAC GL 32-1999) provides criteria for feedstuffs and nutritional elements. Specifically, section 467 of 

these guidelines pertaining to livestock production states that “feedstuffs of mineral origin, trace minerals, 

vitamins, or provitamins can only be used if they are of natural origin. In case of shortage of these 

substances, or in exceptional circumstances, chemically well-defined analogic substances may be used” 

(Codex, 2013). 

United Kingdom Soil Association 

Nature identical synthetic vitamins may be used in the production of non-herbivores without permission, 

while producers of herbivores must seek approval to use nature identical synthetic vitamins A, D and E. 

Regarding the latter group, the operator must demonstrate nutritional deficiency of the animals’ feed. Soil 

Association standards do not permit the use of concentrated vitamins and minerals to encourage early 

maturity or high levels of production (Soil Association, 2014). 

Japan Agricultural Standard (JAS) for Organic Production 

The Japan Agricultural Standard (JAS) for Organic Production does not specify the allowed or prohibited 

status of vitamins in organic livestock feed materials. However, the standard permits 493 natural feed 

additives: Feed additives (except for those produced by using antibiotic and recombinant DNA technology), 

which are natural substances or those derived from natural substances without being chemically treated. In 

case of a difficulty to obtain feed additives listed in 8, the use of similar agents to the described food 

additives are permitted only for supplementing nutrition and effective components in feeds. This statement 

suggests that synthetic vitamins may be allowed if naturally derived substitutes are not available (JAS, 

2012). 

Environmental Issues 

The potential exists for environmental contamination resulting from the industrial production of several 

vitamin compounds. In particular, materials safety data sheets (MSDS) for several feedstock chemicals and 

other chemical reagents used in the synthesis of calcium pantothenate (vitamin B5) and biotin (vitamin B7) 

indicate the potential for ecological damage if accidentally released into the environment. 

Isobutyraldehyde and cyanide salts used in the synthesis of calcium pantothenate as well as ethylene oxide 

used for choline chloride generation have shown toxicity toward fish and aquatic invertebrates. Further, 

hydrogen sulfide, which is used in the synthesis of biotin, is toxic to fish at low doses, and is therefore listed 

as very toxic to aquatic life. Strong acids (e.g., nitric acid, hydrochloric acid) used in the syntheses of 

numerous vitamins may alter the pH of aquatic systems if accidentally released to the environment. Strong 

acids and bases are also utilized in the extraction of tocopherols from vegetable oils and may lead to 

environmental impairment if accidentally released or improperly handled. Many of the vitamins 

synthesized for supplements and feed fortification are derived from petroleum products or genetically 

modified crop materials. 

Discussion 

There can be times of stress when certain individual animals need high amounts of vitamins and minerals 

delivered to target tissues in a rapid manner. If for whatever reason animals are not eating, then they are 

not taking in the oral forms of vitamins and minerals. They may need nutritive supplementation best 

delivered by injection. Additionally, with the prohibition of the use of antibiotics in certified organic 

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livestock, farmers and veterinarians need as many of the remaining tools as possible to prioritize animal 

health. Injectable forms of vitamins and minerals, allowed strictly on an as-needed basis, provide valuable 

support to an animal's immune system and work to assist livestock health, well-being, and animal welfare. 

Public comments consistently highlighted the need for effective health supplements that can address acute 

illnesses in livestock. Overall, commenters agreed that the removal of nutritive supplements would hobble 

organic livestock producers’ ability to effectively manage their stock and provide the best care in acute 

illness scenarios. 

Justification for Vote 

The Subcommittee proposes removal of nutritive supplements from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not 

recommending removal. 

Subcommittee Vote 

Motion to remove nutritive supplements from the National List 

Motion by: Nate Powell-Palm 

Seconded by: Brian Caldwell 

Yes: 0 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

Propylene glycol 

Reference: §205.603 (a)(27) Propylene glycol (CAS #57-55-6) - only for treatment of ketosis in ruminants. 

Technical Report: 2007 TAP; 2021 TR 

Petition(s): 2002 

Past NOSB Actions: 2002 Position Paper; 9/2002 recommendation to add to NL 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559) 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Propylene glycol is allowed for use in organic production only as a treatment for ketosis in ruminants [21 

CFR 205.603(a)(27)]. Propylene glycol is typically administered in an oral drench to animals showing signs of 

clinical ketosis or to animals that a producer suspects of having subclinical ketosis. Propylene glycol is 

generally recognized as safe (GRAS) by the U.S. FDA (21 CFR 184.1666). 

Ketosis is a metabolic disease that can result from energy imbalance in early lactation. According to the 

most recent technical report, the majority of a dose of propylene glycol is not fermented in the rumen. 

Instead, it is directly absorbed and metabolized by the liver to form glucose. 

Manufacture 

Propylene glycol is commercially produced through the hydrolysis of propylene oxide. The original source of 

the propylene oxide is typically propylene, generated either through the steam cracking of hydrocarbons or 

through the dehydrogenation of propane, both of which are non-renewable sources. 

The 2021 technical report notes that researchers and manufacturers are improving methods to produce 

propylene glycol on a commercially viable scale via two additional routes: 

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• Catalytic hydrogenolysis of glycerol, a method that is becoming more economically feasible 

with the increased production of glycerol through biomass-produced ethanol. 

• Microbial fermentation through a number of different microorganisms. 

Many of the fermentation methods in development rely on genetically modified microorganisms for the 

efficient production of propylene glycol. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

The Canadian General Standards Board includes propylene glycol on CAN/CGSB 32.311-2020 Table 5.3 

(Health Care Products and Production Aids) with the annotation, “May only be used as an ingredient in foot 

baths.” Table 5.3 also includes a listing for “Formulants (inerts, excipients),” allowing propylene glycol as an 

excipient used along with a permitted active ingredient. 

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

Organically Produced Foods (GL 32-1999) 

The CODEX guidelines state in Annex 1, Part B “Health Care” clauses that producers must first prevent 

disease through species selection and management approaches. If prevention practices are insufficient to 

keep an animal healthy, a producer may use allopathic veterinary drugs if other homeopathic or 

phytotherapeutic products are insufficient. Propylene glycol is not explicitly mentioned for livestock health 

care input materials, but it would fall into the category of “veterinary drug” as defined in Section 2.2 of the 

261 Guidelines. 

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

Title II, Chapter 2, Section 4 of the EC No. 889/2008 focuses on disease prevention and veterinary 

treatment in organic livestock production. Article 24, paragraph 3 indicates that if preventive methods and 

phytotherapeutic and homeopathic products are not effective at combating illness, a producer may use 

chemically synthesized veterinary medical products. In this case, propylene glycol would be considered a 

“veterinary medicinal product” under the definition at Article 1(2) of Directive 2001/82/EC of the European 

Parliament and of the Council concerning the Community code relating to veterinary medicinal products. A 

48-hour withdrawal period between the last administration and the production of organically produced 

milk or meat is noted. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Section 5.6 of the IFOAM Standard for Organic Production and Processing describes the requirements for 

the use of veterinary medicine in organic livestock production. Section 5.6.1 requires that producers 

establish preventive practices, including good quality feed and access to the outdoors, to avoid illness in 

their livestock before using synthetic allopathic veterinary medical products. Propylene glycol, when used 

to address ketosis symptoms in livestock, would be considered a synthetic allopathic veterinary medical 

product, and Exception (c) would allow its use under veterinary supervision with a minimum withdrawal 

period of at least 14 days. Prophylactic use of synthetic allopathic veterinary drugs is prohibited. 

Japan Agricultural Standard (JAS) for Organic Production. 

Article 4 of the Japanese Agricultural Standard for Organic Livestock, last revised in April 2018, includes the 

“Health control” section, specifying practices for organic livestock production. The Standard requires that 

producers implement preventive practices before using veterinary drugs, and veterinary drugs may only be 

used for therapy purposes. A withdrawal period of 48 hours between last use and milking or slaughter is 

noted. 

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Environmental Issues 

The technical report on propylene glycol notes that the substance is widely used throughout many U.S. and 

global economic sectors, with most of the production capacity through propane as part of the 

petrochemical reduction process. Production of propane can lead to significant environmental impacts, 

including greenhouse gas emissions, pollution of waterways, water use issues, and petrochemical spills. 

In the treatment of ketosis, propylene glycol is used in small volumes and is virtually non-toxic to 

vertebrates and invertebrates (with the exception of cats). Its use on organic dairy farms presents a very 

low risk for environmental contamination. Beyond mishandling or leakage from packages, less than 1 

percent of the propylene glycol used in a dose is excreted in milk, manure, or urine when used to treat 

ketosis. Contamination resulting from on-farm use is likely to be minimal. 

Based on currently available information, propylene glycol is: 

• Not acutely toxic and it has a high lethal concentration in both mammals and aquatic species. 

• Readily decomposed into carbon dioxide and water by microorganisms in water and soil, and 

breaks down in air through reaction with hydroxyl radicals. 

• Able to move rapidly through the environment with water and shows little to no bioaccumulation. 

• Efficiently retained and consumed as energy for animals so that it will not be applied to soils 

through manure incorporation. 

Discussion 

Propylene glycol was among 35 NOSB recommendations on amendments to the National List, made from 

November 2000 to November 2016, that were acted upon in a final rule published in December 2018. This 

is the first sunset review of propylene glycol at this listing. 

Public comments were received for the Spring 2021 meeting in written formats. One industry group 

reported that propylene glycol is a sensible replacement for the administration of bottles of dextrose 

intravenously, which is a subpar treatment and can be dangerous for the farmer and the cow. According to 

the written submission, propylene glycol is the easiest route to rehabilitating ruminants suffering from 

ketosis, as cows can be aggressive when ketotic, making IV administration difficult and dangerous. 

Dairy producers noted that there are natural alternatives like oral administration of apple cider vinegar and 

molasses. In addition to natural and preventative solutions to ketosis, producers provided information that 

propylene glycol is commonly available in farm stores and veterinary clinics and supported the continued 

listing of the substance. Additionally, a large animal veterinarian commented that propylene glycol is the 

gold standard for treatment of ketosis in ruminants. 

The USDA organic regulations specify that producers shall not administer any drug in the absence of illness 

[7 CFR 205.238(c)(2)], limiting the use of propylene glycol to after the onset of ketosis symptoms, both 

clinical and subclinical, in ruminants. 

According to the technical report, many of the available fermentation methods rely on genetically modified 

microorganisms for the efficient production of propylene glycol. These new methods offer the potential to 

produce propylene glycol without relying on petrochemical byproducts but are not economically 

competitive or available at commercial scale at the time of this review. 

Subcommittee Recommendation 

Despite concerns about the environmental impacts from the manufacturing practices identified in the 

technical report, and the potential future risk of excluded methods in the manufacture of propylene glycol, 

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the Subcommittee has determined that the limited use of the substance as a medical treatment for ketosis 

is necessary and recommends relisting. 

Justification for Vote 

The Subcommittee proposes removal of propylene glycol from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending 

removal. 

Subcommittee Vote 

Motion to remove propylene glycol from the National List 

Motion by: Mindee Jeffery 

Seconded by: Nate Powell-Palm 

Yes: 0 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

Sodium chlorite, acidified 

Reference: §205.603 (a)(28) Sodium chlorite, acidified - allowed for use on organic livestock as a teat dip 

treatment only; and 

§205.603 (b)(10) Sodium chlorite, acidified - allowed for use on organic livestock as a teat dip treatment 

only. 

Technical Report: 2013 TR 

Petition(s): 2012; 2014 Addendum #1; 2014 Addendum #2 

Past NOSB Actions: 4/2015 recommendation 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Acidified sodium chlorite is used as a disinfecting teat dip for organic livestock producers. Acidified sodium 

chlorite breaks down in the environment to water and salt and is more benign than other teat dip materials 

currently listed on the National List. 

Manufacture 

Acidified sodium chlorite solutions are made by mixing an aqueous solution of sodium chlorite with a foodgrade acid, such as citric acid. Several industrial synthetic procedures are utilized in the production of 

sodium chlorite. As examples, the treatment of chlorine dioxide, sodium hydroxide, and a reducing agent 

(e.g., sodium sulfite) or reaction of chlorine dioxide with sodium peroxide (i.e., Na2O2 or an alkaline solution 

of hydrogen peroxide, H2O2) are commercially utilized methods for the synthesis of sodium chlorite. 

Generally recognized as safe (GRAS) acids, such as citric and lactic acids, are typically produced through 

fermentative means; however, these naturally occurring compounds may also be extracted from plantbased sources or generated using chemical synthetic methods. 

International Acceptance 

Canadian General Standards Board Permitted Substances List 

Acidified sodium chlorite is not specifically listed. 

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

While there is no specific listing for acidified sodium chlorite, Article 14 notes that “suffering shall be kept 

to a minimum during the entire life of the animal, including at the time of slaughter.” The regulation further 

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notes “disease shall be treated immediately to avoid suffering to the animal; chemically synthesized 

allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict 

conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In 

particular restrictions with respect to courses of treatment and withdrawal periods shall be defined.” 

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

Organically Produced Foods (CXG 32-1999) While there is no specific listing for acidified sodium chlorite, 

the Guidelines state the following: 

The use of veterinary medicinal products in organic farming shall comply with the following principles: 

a) where specific disease or health problems occur, or may occur, and no alternative permitted 

treatment or management practice exists, or, in cases required by law, vaccination of livestock, the 

use of parasiticides, or therapeutic use of veterinary drugs are permitted; 

b) phytotherapeutic (excluding antibiotics), homeopathic or ayurvedic products and trace elements 

shall be used in preference to chemical allopathic veterinary drugs or antibiotics, provided that 

their therapeutic effect is effective for the species of animal and the condition for which the 

treatment is intended; 

c) if the use of the above products is unlikely to be effective in combating illness or injury, chemical 

allopathic veterinary drugs or antibiotics may be used under the responsibility of a veterinarian; 

withholding periods should be the double of that required by legislation with, in any case, a 

minimum of 48 hours; 

d) the use of chemical allopathic veterinary drugs or antibiotics for preventative treatments is 

prohibited. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

While acidified sodium chlorite is not specifically listed, the general principles state management practices 

should be directed to the well-being of animals, achieving maximum resistance against disease, and 

preventing infections. Sick and injured animals must be given prompt and adequate treatment. Further, the 

standards note the well-being of the animals is the primary consideration in the choice of illness treatment. 

The use of conventional veterinary medicines is allowed when no other justifiable alternative is available. 

Withdrawal periods shall not be less than double of that required by legislation. 

Japan Agricultural Standard (JAS) for Organic Production 

Acidified sodium chlorite is not specifically listed. 

Environmental Issues 

While the manufacture and use of acidified sodium chlorite solutions have resulted in releases to the 

environment, the risk of environmental contamination from released acidified sodium chlorite is minimal. 

Certain manufacturing facilities have reported releases of chlorine dioxide, a portion of which was 

generated through reaction of chlorite with a strong acid, to air, water, and soil (ATSDR, 2004). Strong acids 

(e.g., hydrochloric acid) and bases (sodium hydroxide) are used in the commercial production of sodium 

chlorite, and their release due to improper handling/disposal could lead to serious environmental 

impairments. Likewise, the release of strong oxidizing agents in large quantities may lead to ecotoxicity in 

both terrestrial and aquatic environments. This is true of both the chemical feedstocks (e.g., hydrogen 

peroxide) used in the manufacture of acidified sodium chlorite precursors and the chemicals in acidified 

sodium chlorite solutions (i.e., chlorous acid, chlorine dioxide, chlorite). Regarding the former, several lower 

reactivity sulfur-containing and carbonaceous substances have been evaluated for the conversion of 

chlorine dioxide to sodium chlorite. 

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Discussion 

Acidified sodium chlorite was among 35 NOSB recommendations on amendments to the National List made 

between November 2000 and November 2016 that were acted upon in a final rule published in December 

2018. Because of this recent addition, this is the first sunset review of acidified sodium chlorite at this 

listing. 

Preventive health care is an essential part of organic farming, and mastitis prevention through clean milking 

parlors and clean animals is always of paramount importance on a dairy farm. Organic farmers cannot use 

antibiotics and thus the use of pre-milking and post-milking teat dips is a normal practice and may be the 

most critical factor in preventing mastitis. Acidified sodium chlorite satisfies the criteria related to impact 

on humans and the environment and is compatible with organic agriculture. Iodine is widely used in teat 

dips. The technical report (TR) on iodine, received on January 7, 2015, provides recent research information 

and comparative data on iodine-based teat dips and on teat dips whose primary ingredient is acidified 

sodium chlorite. The following is excerpted from the iodine TR in its discussion of alternatives to iodine in 

teat dips: “Information regarding the availability of natural, non-synthetic agricultural commodities or 

products that could substitute for iodine and iodophor disinfectants is limited.” Acidified sodium chlorite 

thus appears to be a potentially important ingredient in teat dips. 

Public comments during the 2021 spring meeting were supportive of relisting sodium chlorite, acidified 

(ASC) as an approved teat dip for livestock. It was stated a few times that it is not used frequently but key 

when necessary to prevent mastitis. During the subcommittee review, there was discussion about the two 

listings at §205.603(a) and §205.603(b), and whether they were redundant. It appears the listings are not 

redundant. At §205.603(a) Sodium chlorite is allowed as a pre-milking sanitizer while at §205.603(b) it is 

used for post-milking as a preventative topical treatment. 

Justification for Vote 

The Subcommittee proposes removal of sodium chlorite, acidified from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not 

recommending removal. 

Subcommittee Vote 

Motion to remove sodium chlorite, acidified from the National List 

Motion by: Kim Huseman 

Seconded by: Nate Powell-Palm 

Yes: 0 No: 3 Abstain: 0 Absent: 2 Recuse: 0 

Zinc sulfate 

Reference: §205.603 (b)(12) Zinc sulfate - for use in hoof and foot treatments only. 

Technical Report: 2015 TR 

Petition(s): 2014 

Past NOSB Actions: 4/2015 recommendation 

Recent Regulatory Background: Added to NL effective 1/28/2019 (83 FR 66559). 

Sunset Date: 1/28/2024 

Subcommittee Review 

Use 

Zinc sulfate is allowed for use in organic livestock as a footbath for control of foot rot in livestock-- primarily 

dairy cattle, sheep, and goats. 

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Manufacture 

Zinc sulfate is produced synthetically by combining zinc ash with aqueous sulfuric acid (TR line 53). Zinc ash 

is produced from zinc ore mined from underground or open pit mines (TR line 60). 

International Acceptance 

Canadian General Standards Board Permitted Substances ListOperators of organic livestock production 

facilities must establish a provision for prompt treatment for animals with detectable disease, lesions, 

lameness, injury, and other physical ailments. Where preventive practices and vaccines are inadequate to 

prevent sickness or injury and where disease and health problems require treatment, the use of biological, 

cultural, and physical treatments and practices is permitted, in accordance with CAN/CGSB-32.311, Organic 

Production Systems — Permitted Substances Lists, but may be relaxed under veterinary supervision if listed 

substances fail to work. TR lines 216 – 221. 

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

Disease shall be treated immediately to avoid suffering to the animal; chemically synthesized allopathic 

veterinary medicinal products may be used where necessary and under strict conditions, when the use of 

phytotherapeutic, homeopathic and other products is inappropriate. Restrictions with respect to courses of 

treatment and withdrawal periods are defined (EU, 2007); Animal health is based on prevention of disease, 

but treated livestock may not be sold as organic products if treatment involves an unapproved medication. 

Treated livestock must be submitted to the defined conversion periods. Zinc sulfate may be used as a trace 

element in the production of organic livestock. TR lines 231-238. 

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

Organically Produced Foods (GL 32-1999) 

Where specific disease occurs, and no management practice exists, therapeutic use of veterinary drugs is 

permitted; zinc can be used as a trace element supplement when the need is recognized by the certification 

body or authority. The use of zinc sulfate for control of foot rot in cattle sheep and goats has not been 

specifically addressed (Codex, 2007). TR lines 226-230. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

Organic animal management systems follow the principle of positive health, which consist of a graduated 

approach of prevention (including vaccinations and anti-parasite treatments only when essential), then 

natural medicines and treatment, and finally if unavoidable, treatment with allopathic chemical drugs. 

Organic animal management never withholds medical treatment considered necessary for the welfare of an 

animal to maintain the organic status of the animal (IFOAM, 2014). TR lines 245-250. 

Japan Agricultural Standard (JAS) for Organic Production 

Veterinary Drugs specified by Article 1. 1 of the Ministerial Ordinance for Handling by the Ministry of 

Health, Labor and Welfare (No.4 of 1961) are permitted. Zinc sulfate use is limited to the case where 

livestock is unable to grow normally because of its shortage as a trace element (MAFF, 2012). TR lines 241-

244. 

Environmental Issues 

Production of zinc sulfate results in significant local production of tailings in large volumes and lesser 

amounts of particulates, heavy metals, and gases, which can be filtered out or captured, but may not be 

depending on where the zinc is mined and processed. The amount of zinc sulfate used for foot rot control 

is a small proportion of its total use. However, its disposal on farm fields with manure can result in soil zinc 

buildups beyond desirable levels. 

It should also be noted that the use of zinc sulfate should decrease the use of copper sulfate in treating foot 

diseases. The buildup of persistent copper in agricultural soils is a serious issue. While zinc sulfate can 

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accumulate in soils, its persistence is less certain due to its mode of attachment to soils. Zinc sulfate is 

therefore considered a more benign material compared to copper sulfate. 

Excess applications of zinc sulfate could disrupt essential nutrient balances in soils and in extremes could 

become toxic to plants or animals. Zinc sulfate is toxic to fish and aquatic invertebrates. Direct application 

to water where these exist should be avoided. 

Discussion 

According to the 2015 TR, “Peracetic acid and hydrogen peroxide foams are also used in the treatment and 

control of footrot, although the efficacy of these treatments is controversial (Bergstein et al., 2006). It is 

important to note that antibiotics are increasingly used in treatment of pododermatitis, due to the bacterial 

nature of its etiology. However, good evidence is available for increased microbial antibiotic resistance in 

Dichelobacter nodosus and other bacteria present during infection (Lorenzo, et al., 2012). Antibiotics are 

prohibited in organic livestock production (7CFR §205.237, §205.238).These same bacteria have not 

demonstrated resistance to zinc sulfate treatment.... Some vaccines have been shown to be effective in 

treating footrot. Because several bacteria are involved in the infection and these are represented by 

multiple serogroups, the effectiveness of using a monovalent vaccine in treating another serogroup is likely 

to be limited. Programs are ongoing to address vaccination, but a complete vaccine has not yet been 

described for footrot in cattle or sheep (Bennett and Hickford, 2010).” 

Copper sulfate and zinc sulfate are two of the most accepted treatments and are comparable in efficacy. 

Formalin can also be used for this purpose but is not approved for use on organic farms. Zinc sulfate has 

proven particularly effective at controlling the bacteria associated with foot rot, and is sometimes used in 

combination with other materials, including copper sulfate. The combination of zinc sulfate with sodium 

lauryl sulfate (as an excipient) has proven to be more effective than zinc sulfate with copper sulfate. 

Copper compounds are toxic to sheep and goats, so the presence of zinc sulfate on the National List allows 

for its use for these species as an alternative to copper sulfate. 

Comments from stakeholders were strongly in favor of retaining zinc sulfate on the national list as an 

approved synthetic material. Some proposed adding an annotation specifying that its use be curtailed if 

soil zinc levels become excessive. Zinc sulfate is considered less environmentally damaging than copper 

sulfate, which is on the National List for the same use. Since zinc sulfate has only been on the National List 

for a short time, it is not clear whether its presence there will reduce the use of copper sulfate for hoof 

disease. 

Based on this information, including stakeholder comments, the Livestock Subcommittee proposes that zinc 

sulfate be retained on the National list. 

Justification for Vote 

The Subcommittee proposes removal of zinc sulfate from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. Not recommending removal. 

Subcommittee Vote 

Motion to remove zinc sulfate from the National List 

Motion by: Brian Caldwell 

Seconded by: Kim Huseman 

Yes: 0 No: 3 Abstain: 0 Absent: 2 Recuse: 0 

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National Organic Standards Board 

Materials Subcommittee Proposal 

2021 Research Priorities 

August 12, 2021 

Executive Summary 

Overall: The National Organic Standards Board (NOSB) presents an annual list of research priorities for 

organic food and agriculture. The NOSB requests that integrated research be undertaken with 

consideration of the whole farm system, recognizing the interplay of agroecology, the surrounding 

environment, and both native and farmed species of plants and animals. 

Livestock 

1. Determine the efficiency of natural parasiticides and methodologies, including but not limited to, 

nutritional programs, use of herbs, essential oils, homeopathic remedies, diatomaceous earth, and 

the genetic pool of laying hens in controlling A. galli and H. gallinarum in laying and replacement 

chickens intended to become hens. 

2. Evaluate natural alternatives to DL-Methionine in a systems approach for organic poultry feed 

program. 

3. Evaluate ways to prevent and manage parasites in livestock, examining breeds, geographical 

differences, alternative treatments, and pasture species. 

4. Research and develop livestock breeding programs resulting in livestock that are adapted to outdoor 

life and living vegetation. 

Crops 

1. Examination of decomposition rates, the effects of residues on soil biology, and the factors that 

affect the breakdown of biodegradable bio-based mulch film. 

2. Conduct whole farm ecosystem service assessments to determine the economic, social, and 

environmental impact of farming systems choices. 

3. Organic no-till practices for diverse climates, crops, and soil types. 

4. Develop cover cropping practices that come closer to meeting the annual fertility demands of 

commonly grown organic crops. 

5. Development of systems-based plant disease management strategies are needed to address existing 

and emerging plant disease threats. 

6. The demand for organic nursery stock far exceeds the supply. Research is needed to identify the 

barriers to expanding this market, then develop and assess organic methods for meeting the 

growing demand for organically grown nursery stock. 

7. Strategies for the prevention, management, and control of invasive insects and weeds. 

8. Factors impacting organic crop nutrition, and organic/conventional nutrition comparisons. 

9. Side-by-side trials of organic synthetic materials, natural materials, and cultural methods, with a 

request for collaboration with the IR4 project. 

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10. Impartial evaluation of microbial inoculants, soil conditioners, and other amendments is needed as 

there is little objective evidence upon which to assess their contribution to soil health. 

11. More research, extension, and education are needed to fully understand the relationship between 

on-farm biodiversity and pathogen presence and abundance. 

12. Elucidate practices that reduce greenhouse gas emissions and that contribute to farming systems 

resilience in the face of climate change. 

Food Handling and Processing 

1. Evaluation of alternatives to chlorine materials in processing: impact mitigation, best management 

practices, and potential for chlorine absorption by produce. 

2. Suitable alternatives to BPA (Bisphenol-A) for linings of cans used for various products. 

3. Chlorine sanitizers pose potential occupational health risks in food handling and processing 

environments. Given anecdotal reports of health problems associated with exposure to chlorine 

sanitizers by food workers, the Handling Subcommittee recommends additional research, including 

monitoring for chlorine breakdown products, chlorine gas, and chloroform in organically certified 

food handling and processing facilities to quantify worker exposures and health risks. 

Coexistence with GE and Organic Crops 

1. Outcome of genetically engineered (GMO/GE) material in organic compost. 

2. Evaluation of public germplasm collections of at-risk crops for the presence of GE traits, and ways to 

mitigate small amounts of unwanted genetic material in breeding lines. 

3. Develop, then implement, methods of assessing the genetic integrity of crops at risk to quantify the 

current state of the organic and conventionally produced non-GMO seed. 

4. Techniques for preventing adventitious presence of GE material in organic crops, and evaluation of 

the effectiveness of current prevention strategies. 

5. Testing for fraud by developing and implementing new technologies and practices. 

General 

1. Examination of the factors influencing access to organically produced foods. 

2. Production and yield barriers to transitioning to organic production to help growers successfully 

complete the transition. 

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National Organic Standards Board 

Materials Subcommittee Proposal 

2021 Research Priorities 

August 12, 2021 

Introduction 

The National Organic Standards Board (NOSB) presents an annual list of research priorities for organic 

food and agriculture. The NOSB’s Livestock, Crops, Handling, and Materials/GMO Subcommittees 

proposed an updated set of priorities at the Fall 2020 board meeting. That substantially updated list 

arose from public comments received by the NOSB and by concerns raised during the course of the 

Board’s work in the preceding year. The Board requests input from stakeholders on the 2021 research 

priorities and will review those comments for the Fall 2021 proposal. 

Background 

The list of priorities is revisited each year by the NOSB. The list is made meaningful by input through the 

written and oral public comments shared with the Board, through the expertise of the Board itself and 

through interactions throughout the year with those engaged in some dimension of the organic farm to 

fork continuum. When the NOSB has determined that a priority area has been sufficiently addressed, it 

is removed from the list of priorities. Priorities are also edited each year to more accurately reflect the 

existing need for new knowledge. 

The NOSB encourages collaboration with and between laboratories, federal agencies, universities, 

foundations and organizations, business interests, organic farmers, and the entire organic community to 

seek solutions to pressing issues in organic agriculture and processing/handling. 

The NOSB encourages integrated, whole farm research into the following areas: 

Livestock 

1. Efficiency of Natural Parasiticides and Methodologies – Nutritional programs, use of herbs, essential 

oils, homeopathic remedies, diatomaceous earth, and the genetic pool of laying hens in controlling A. 

galli and H. gallinarum in laying and replacement chickens intended to become hens – among other 

interventions – may be helpful in ensuring flock health. Ongoing research into the usefulness and 

viability of such innovations is consistent with NOSB action. 

2. Evaluation of Methionine in the Context of a Systems Approach in Organic Poultry Production -

Methionine is an essential amino acid for poultry. Prior to the 1950’s, poultry and pigs were fed a plant 

and meat-based diet without synthetic amino acids such as methionine. One former NOSB member 

stated, in §205.237(5) (b), “We have seemingly made vegetarians out of poultry and pigs”. As the 

organic community moves toward reducing, removing, or providing additional annotations to synthetic 

methionine in the diets of poultry, a heightened need exists for the organic community to rally around 

omnivore producers to assist in marshaling our collective efforts in finding viable alternatives to 

synthetic methionine and to help find approaches for making them more commercially available. 

Continued research on the use of synthetic methionine in the context of a systems approach (nutrition, 

genetic selection, management practices, etc.) is consistent with the NOSB unanimous resolution passed 

at the La Jolla, California, Spring 2015 board meeting. A systems approach that includes industry and 

independent research by USDA/ARS, on farms, and by agricultural land grant universities is needed for 

(1) evaluation of the merits of natural alternative sources of methionine such as herbal methionine, high 

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methionine corn, and corn gluten meal in organic poultry production systems; (2) evaluation of poultry 

breeds selection that could be adaptive to existing organic production systems – inclusive of breeds 

being able to adequately perform on less methionine; (3) assessment of management practices for 

improving existing organic poultry welfare under different conditions; and (4) and with the European 

Union as a case study, assess how it is that EU farmers manage the methionine needs of their flocks in 

the absence of synthetic methionine use. Research findings and collaborations under various climates, 

housing types, geographical regions, and countries should be noted and researched, where applicable. 

Certainly, the fruition of these types of research topics could take years to achieve the expressed NOSB 

resolution; however, an aggressive and/or heightened research focus could lead to findings that can 

positively impact the organic poultry industry and the organic brand. The continued focus on 

methionine with a systems approach is imperative and necessary. The key research areas should include 

the efficacy and viability of alternatives such as: herbal methionine, corn gluten meal, potato meal, 

fishmeal, animal by-products, and other non-plant materials. Additional research on the more promising 

alternatives to bring them into commercial production is also encouraged. Additionally, management 

practices impacting the flock’s demand for methionine should be included, such as flock management 

practices, access to pasture, and pasture management. 

3. Prevention and Management of Parasites - Livestock production places large numbers of cattle, 

sheep, goats, poultry etc. into relatively close contact with each other on fields and in barns. Organic 

production does not allow antibiotic use and requires that livestock be raised in a manner which 

approximates the animal’s natural behavior. The organic farmer can use synthetic parasiticides in an 

emergency but not prophylactically. Synthetic parasiticides have many limitations. Even if prophylactic 

treatment with parasiticides were possible, it is clear that parasite immunity to chemical control will 

inevitably occur. Thus, prevention of parasites is critical. 

The research question on prevention and management of parasites must be systems based. What farm 

systems, bird and animal breeds, herd or flock management systems have shown the best results with 

parasite control over the last twenty years? What regional differences are there in the US in parasite 

prevention? Are there specific herbal, biodynamic, diatomaceous earth, or other treatments that have 

been proven to work overtime? What are the parasite-resistant breeds? Are there plant species in 

pastures, hayfields, and scrublands that could be incorporated into the annual grazing system to reduce 

the spread of parasites or to provide prevention through the flora, fauna, and minerals ingested? Which 

pasture management systems appear to be best for parasite prevention in various parts of the country? 

Are pasture mixes being developed that include plants known to prevent parasites in various breeds? 

4. Organic Livestock Breeding - Organic rules require livestock products originate from animals that are 

not confined and are adapted to outdoor living as well as obtaining feed from living vegetation. A 

current FAO report states that globally one third of pigs, half of all egg layers, two thirds of milk animals, 

and three quarters of meat chickens are produced with breeds more suited to confinement or 

“industrial” production systems than a typical organic farm or ranch. Similar to plant breeding, the 

organic community sees a great need for regionally adapted and publicly available livestock breeds that 

can thrive in organic systems. Heritage, native regional breeds, and breeds used in the EU and other 

areas of the world that are typically more adapted to organic systems are still present but in small 

numbers. Increased research on the breeding, production needs, and improvement of these breeds is 

needed. Traits for good conversion rates from grazing and foraging to eggs, milk or meat, meeting 

consumer expectations for quality, as well as having the constitution and temperament to thrive 

outdoors would increase both the profitability and resiliency of organic livestock operations. Animal 

breeds that may have immunity to a variety of diseases and parasites would be useful traits to research 

and incorporate in a breeding program. 

Crops 

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1. Biodegradable Bio-based Mulch Film - Biodegradable mulch was recently approved by the NOSB but 

did not specify a required percentage of biologically derived (i.e., bio-based) content. In 2015, NOP 

issued a Policy Memo that states that certifiers and material organizations should review biodegradable 

mulch film products to verify that all (100%) of the polymer feedstocks are bio-based. This requirement 

makes bio-based mulches unavailable to organic producers because petroleum-based polymers are 

present in these mulch films. In order to provide a recommendation to the NOP addressing the 

presence of petroleum-based polymers in these mulches, the answers to the following questions are 

important to develop more clarity on mulch films and possibly develop an additional annotation to 

address producer needs for biodegradable mulch films even if petroleum-based polymers are used: 

• How rapidly do these mulches fully decompose, to what extent does cropping system, soil type, 

and climate mediate decomposition rates, and does the percentage of the polymers in the 

mulch film affect the decomposition rate? 

• Are there metabolites or breakdown products of these mulches that do not fully 

decompose? Do any of these mulches fully decompose? 

• Do breakdown byproducts influence the community ecology and ecosystem function of soils, 

plants, and the livestock that graze on crops grown in these soils? 

• As fragments degrade, do they pose a problem to terrestrial and aquatic wildlife? What are the 

environmental fates of micro- and nano-plastic fragments resulting from biodegradable mulch 

film degradation, and what hazards do they present to organisms that they interact with on the 

way to that fate? 

• Do the residues of these films accumulate after repeated use? 

• Are the testing protocols in place to insure decomposition standards? 

2. Ecosystem service provisioning and biodiversity of organic systems - How do organic systems impact 

ecosystem service provisioning, both on-farm and off-farm through the materials and inputs sourced 

and used for production? For example, life-cycle analysis of environmental costs and benefits of inputs 

used for organic production, such as manure, seaweed, and fish-based soil amendments, would be 

beneficial. Additionally, what is the impact of diversified and agroecologically designed organic farming 

systems on biodiversity and ecosystem services within the farm and in its surroundings? Can farmmapping be performed to quantify the impact of the location of a farm (in a broader landscape) and the 

arrangement of fields and non-crop habitat to enhance biodiversity and ecosystem service provisioning? 

3. Organic No-Till and Minimum Tillage - Organic no-till can increase soil health and provide for 

increased biodiversity. Organic no-till preserves and builds soil organic matter, conserves soil moisture, 

reduces soil erosion, and requires less fuel and labor than standard organic row crop farming. 

Farmers are employing several different approaches to organic no-till. Some are using a roller-crimper 

to terminate cover crops for in-place mulching. They then transplant or seed directly into the cover crop 

mulch. Others are utilizing polyethylene sheets (silage tarps) to prepare land for no-till planting. This 

approach often involves termination of a cover crop, as with the roller-crimper systems, but seemingly 

as often, or more frequently, is utilized to prepare fallow ground (for stale seed bedding, termination of 

crop residue and subsequent incorporation via soil fauna), or in conjunction with large applications of 

compost or other sources of organic matter. 

Increased research is needed to develop organic no-till systems that function for a wide variety of crops 

in diverse climates and soil types. Annual crops such as commodity row crops and specialty crops, as 

well as perennial crops such as tree fruits, berries, and grapes would all benefit from these organic notill practices. Research areas that could be covered include: 

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• Development of plant varieties that have specific characteristics, such as early ripening, to aid in 

the effectiveness and practicality of organic no-till. 

• What combination of mulch crops and cultural systems sustain crop yields, provide soil health 

benefits, and suppress weeds? 

• How does organic no-till influence pest, weed, and disease management? 

• What potential pest problems can be caused or exacerbated by cover crops used as mulches, 

and how can those problems best be managed? 

• In perennial cropping systems, such as fruits, what are the benefits or drawbacks of using this 

mulching system on weed, pest, and disease management, as well as soil fertility? 

• What are the biodiversity benefits to living and/or killed mulches, and how does this contribute 

to pest, weed, and disease management? 

• Do these systems affect the nutrient balance of the soil and subsequent fertilization practices, 

including use of outside inputs? 

• Based on the improved soil health, when there is less soil disturbance and more plant 

decomposition resulting in higher organic matter, how does this system affect soil microbial life 

and nutrient availability, and does this then result in crops that are less susceptible to disease 

and pests? 

• Research is needed on seeds, specifically for good cold germination, rapid emergence and 

establishment, seedling vigor, nutrient uptake efficiency, and overall weed competitiveness to 

crop cultivar development goals for organic conservation tillage systems. 

• How can reduced tillage weed management be improved, including development of new tools 

and techniques that provide greater weed control for less soil disturbance? 

Finally, organic farmers use whole-farm planning when deciding what will be done in each of their 

fields. Research that assesses the ecosystem benefits of reducing tillage in patches (field-level) across a 

farm is also needed. For example, the relative benefits of reducing tillage are greater in areas prone to 

surface water runoff. Research is needed to “inform” where reduced tillage practices are likely to have 

their greatest impact. 

4. Managing Cover Crops for On-Farm Fertility - Growing cover crops and green manures is a 

foundational practice on many organic farms. In addition to conserving soil, increasing water holding 

capacity, and providing weed suppression, cover crops supply important plant nutrients and increase 

soil organic matter. As farmers seek to grow their own fertility, more research is needed on the efficacy 

of relying primarily on cover crops to meet production needs, particularly for horticultural crops. At 

present, there is inadequate data on the nutrient benefits of different cover crop mixes and how those 

benefits vary according to species mix, mowing practices, tillage regimes, subsequent planting time of 

the cash crops, and importantly the preceding practices that define the legacy of individual fields. 

5. Disease Management - Disease management in organic fruit and vegetable production relies on a 

systems approach to succeed, but even with current systems plans in place, growers frequently struggle 

to manage commonly occurring blights and citrus greening. The NOSB underscores the need for 

systems research that addresses solutions to these and related diseases that are workable for farmers, 

that reduces adverse health effects on farmers and fieldworkers, and that also limits adverse effects on 

the soil and water in which the crops grow. To this end, we call for systems research that identifies 

disease resistant material while at the same time identifying biological controls that limit the use of 

copper-based compounds where possible. 

Specifically, targeted research is needed to identify management practices and less toxic alternative 

materials for a wide range of crops. More research is needed on many of the crop/disease 

combinations, including: 

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• Comprehensive, systems-based approaches for managing individual crops in a way that 

decreases the need for copper-based materials, including researching crop rotations, sanitation 

practices, plant spacing, and other factors that influence disease. 

• Breeding plants that are resistant to the diseases that copper controls. 

• Developing alternative formulations of materials containing copper so that the amount of 

elemental copper is reduced. 

• Developing biological agents that work on the same diseases that copper is now used on. 

• Evaluating plant nutritional strategies to mitigate the impacts of plant diseases. 

• Research on scum and algae control in rice and whether sodium carbonate peroxyhydrate or 

other materials are suitable alternatives in an aquatic environment. 

• Soil management and crop cultivar development for enhanced beneficial crop-root microbe 

partnerships that protect organic crops from soil borne and foliar pathogens. 

• Alternatives to antibiotics (tetracycline and streptomycin) for fire blight control, particularly in 

pears and apples. 

6. Identify Barriers and Develop Protocols for Organic Nursery Stock Production 

The demand for organic nursery stock far exceeds the supply. Research is needed to identify the 

barriers to expanding this market, then develop and assess organic methods for meeting the growing 

demand for organically grown nursery stock. That work could include but is not limited to assessing 

phytosanitary rules for shipping plants and quantifying the production and demand for organic 

rootstock. Research has shown that application of the correct ectomycorrhizal inoculants to roots can 

substantially (50% or more) enhance establishment and early growth of woody perennial horticultural 

crops. How can fine tuning the use of mycorrhizal inoculants to make organic nursery stock production 

easier and more profitable, thereby helping to close the demand/supply gap? Research centered on 

development of practical organic methods for the nursery industry to implement is needed, including: 

• Disease and insect control materials that are allowed under organic standards and may be 

accepted under specific phytosanitary regulatory requirements. 

• New materials for controlling pests addressed by phytosanitary rules that show promise of 

compatibility with National List review criteria. 

• Alternative protocols for phytosanitary certification of nursery stock that are based on 

outcomes (such as testing or inspection) rather than requirements for use of synthetic materials 

during production. 

7. Management and Control of Invasive Insects and Weeds - There is a large pool of research on the 

control of insects and diseases using organic methods. Many controls use a systems approach and are 

quite effective. The introduction of new invasive species into cropping systems threatens these systems 

approaches, and in several cases the organic control options are very limited or nonexistent. For 

example, spotted wing drosophila is a relatively recent invasive insect that infests soft fruits, such as 

berries, and many other fruits as well. Infestation renders fruit unusable since insect larvae feed inside 

the fruit and may reach critical levels before fruit is harvested. This insect is particularly problematic in 

that it has the ability to oviposit in green fruit, and it has multiple generations throughout the summer, 

creating an extensive control period. There is only one control material available, and it is in danger of 

overuse. The control period may also extend so long that maximum label rates are used before the 

season ends. A second invasive insect is brown marmorated stinkbug, and currently there are no 

organic control measures beyond attempts at mass trapping. Research into organic control options for 

both these invasive pests, and others, is critical so that organic growers can integrate controls into their 

organic systems. Prevention is critical. Because invasive insect species lack native predators, the 

organic community needs more information on their biology in order to implement prevention 

strategies before they become established and are more difficult to control. 

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Weeds pose one of the greatest barriers to successful organic crop production. Invasive weeds include 

exotic species that aggressively displace both crops and native plant species, as well as creeping 

perennial species (exotic or native) that are difficult to control without repeated, intensive tillage. The 

NOP standards require certified organic producers to use tillage and cultivation practices that maintain 

or improve soil conditions. Development of integrated, organic management strategies that effectively 

control invasive weeds without excessive tillage continues to emerge as a top research priority for 

organic producers. 

8. Nutritional Value of Organic Crops - How do organic soil health and fertility practices—crop 

rotations, cover crops, compost and other organic or natural mineral amendments, etc. — affect the 

nutritional value or “nutrient density” of organically produced crops? How do organic production and 

shipping methods (including methods of production, handling, and time in transport) influence the 

nutritional quality, taste, palatability, and ultimately preference for organic vegetables and fruits? There 

is a lack of sound, rigorously conducted studies of this kind. How can growers and handlers retain 

nutrition through post-harvest handling and transportation? Additionally, can providing organic 

producers information on soil biology and soil nutrient composition help improve nutrition? Finally, 

more studies are needed examining how organic crops compare to conventional crops with regards to 

nutritional value. 

9. Side-by-Side Efficacy Comparisons Between National List Allowed and Petitioned Synthetic Inputs 

Versus Non-synthetic Alternative Inputs or Practices - During its five-year review of sunset materials on 

the National List and in the evaluation of newly petitioned materials, the NOSB often lacks sufficient 

information of the effectiveness of these materials as compared with other synthetics on the National 

List, natural materials, and cultural methods. Side-by-side trials with approved organic inputs, both 

synthetic and natural, and cultural methods to evaluate efficacy would strengthen the review process 

and provide growers with valuable information in pest and disease management decisions. The NOSB 

specifically requests collaboration with the Minor Crop Pest Management Program Interregional 

Research Project #4 (IR4) to include materials on the National List in their product trials. Such studies 

would help inform the NOSB review process of sunset materials and to determine if materials are 

sufficiently effective for their intended purpose, particularly when weighed against the natural and 

cultural alternatives. It should be noted that growers commonly rely on a mix of cultural practices and 

both non-synthetic materials and materials from the National List to produce crops of marketable 

quality and sufficient yield for profitability; it is understood that such studies would serve as a starting 

point and would form part of the comprehensive material review process. 

10. Evaluation of Microbial Inoculants, Soil Conditioners, and Other Amendments – Vendors of organic 

amendments now offer a large and growing array of microbial inoculants, organic soil conditioners, and 

other materials claimed to improve soil health, crop vigor and quality, and combat weeds, pests, and 

diseases. There is an urgent need for impartial evaluation of these materials to help producers decide 

which products to use and to avoid unnecessary expenditures on products that are unlikely to yield 

benefits. 

11. Pathogen Prevention - Third-party food safety auditors believe that some biodiversity-maintenance 

strategies employed by organic farmers may increase the risk for introduction of human pathogens on 

the field. While some research has been conducted disproving this hypothesis, more research, 

extension, and education are needed to fully understand the relationship between on-farm biodiversity 

and food safety – and this research must be communicated to third-party food safety auditors and 

incorporated into their audits. 

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12. Climate Change (Reducing Greenhouse Emissions and Sequestering Carbon) - A growing body of 

research demonstrates that organic farming can help prevent anthropomorphic climate change, and 

some strategies employed by organic farming can also help with resilience to current climate challenges 

such as drought and flooding. Although a number of researchers are examining this issue, additional 

work is needed to pinpoint specific strategies that organic farmers can take to reduce greenhouse gas 

emissions and respond to current climate challenges threatening the future of our food security. 

Handling 

1. Chlorine Materials and Alternatives - Chlorine materials currently allowed for use in organic 

agriculture are widely used in farming and handling to clean and disinfect equipment, surfaces, and 

produce. There have been some concerns raised about these materials and their impact on the 

environment and human health when/or if they form trihalomethanes and other toxic 

compounds. Chlorine materials are also acutely toxic to workers. New sanitizers and disinfectants are 

regularly petitioned to the NOSB for addition to the National List. FDA regulations on food safety (Food 

Safety Modernization Act) and best management practices for cleaning in handling operations both 

require a suitable level of cleanliness and disinfection to prevent pathogens from entering the food 

supply. 

Producers and handlers are looking for alternatives to chlorine while continuing to provide a safe 

end-product to their customers and the consumer. Addressing food safety while adhering to the 

fundamental organic principles involving human health and environmental impact is a concern. 

The organic industry needs better information on how either alternative materials or appropriate 

chlorine materials are best suited for a specific use and control measure. This is especially important in 

determining if the industry can move away from the use of chlorine compounds in the future. 

Points of consideration for future research activities: 

• Comparison of alternatives to chlorine such as: citric acid, hydrogen peroxide, ethanol, 

isopropanol, peracetic acid, and ozone. How would each compare to the different 

chlorine materials for specific uses? The strengths and weaknesses would need to be 

considered. 

• Potential human health and environmental impacts of each chlorine material versus the 

possible alternative materials listed above. Are there ways that these impacts can be mitigated 

and still allow the material to work as needed? 

• Determination of which of the above-mentioned alternatives would NOT be a suitable 

substitute for chlorine. What specific uses and/or conditions would this apply to? 

• Identification of practices that could be used to help reduce the formation of trihalomethanes 

in those specific situations where chorine is the best material to use. 

• Could the rotation of materials for cleaning and disinfecting help lower the risks from 

chlorine materials and still be effective in providing the desired control of pathogens? 

• Research on the absorption of chlorine by produce from its use in wash tanks, including 

information about the amount of time of exposure, would help inform understanding of 

human exposure to chlorine and health risks. Are residues from produce washing a 

persistent residual effect or temporary (if temporary – how long is it a viable residue), and 

would it be harmful if consumed at these levels? 

2. Alternatives to Bisphenol A (BPA) - The Handling Subcommittee is examining the issue of whether to 

prohibit BPA in packaging materials used for organic foods in light of direct evidence that these uses 

result in human exposures and mounting evidence that these exposures may be harmful. There is a 

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need for increased research about alternatives for the linings of cans and jars used for organic products 

that do not result in human exposures and health risks. 

3. Occupational Health Risks of Chlorine Sanitizers - Chlorine sanitizers pose potential occupational 

health risks in food handling and processing environments. Given anecdotal reports of health problems 

associated with exposure to chlorine sanitizers by food workers, the Handling Subcommittee 

recommends additional research, including monitoring for chlorine breakdown products, chlorine gas, 

and chloroform in organically certified food handling and processing facilities to quantify worker 

exposures and health risks. 

Materials/GMO 

In previous years, the Materials Subcommittee has prioritized the Reduction of Genetically Modified 

Content of Breeding Lines (2013) and Seed Purity from GMOs (2014), issues which are currently being 

addressed through a comprehensive stream of work on Excluded Methods. The following research 

priorities are among the areas that the Excluded Methods work continues to elevate: 

1. Fate of Genetically Engineered Plant Material in Compost - What happens to transgenic DNA in the 

composting process? Materials such as cornstalks from GMO corn or manure from cows receiving rBGH 

are often composted, yet there is little information on whether the genetically engineered material and 

traits break down in composting process. Do these materials affect the microbial ecology of a compost 

pile? Is there trait expression of Bt (bacillus thuringiensis) after composting that would result in 

persistence in the environment or plant uptake? 

2. Integrity of Breeding Lines and Ways to Mitigate Small Amounts of Unwanted Genetic Material -

Are public germplasm collections that house at-risk crops threatened by transgenic content? Breeding 

lines may have been created through genetic engineering methods such as doubled haploid technology, 

or they may have had inadvertent presence of GMOs from pollen drift. The extent of this problem needs 

to be understood. 

3. Assess the Genetic Integrity of Organic Crops At Risk - Develop then implement methods of 

assessing the genetic integrity of crops at risk to quantify the current state of the organic and 

conventionally produced non-GMO seed. Such assessments are needed on the front (seed purchased by 

farmers) and back end (seed harvested from a farmer’s field) of the production chain as well as on 

points of contamination in the production chain. 

4. Prevention of GMO Crop Contamination: Evaluation of effectiveness - How well are some of the 

prevention strategies proposed by the NOSB working to keep GMOs out of organic crops? For instance, 

how many rows of buffer are needed for corn? How fast does contamination percentage go up or down 

if there are more or fewer buffer rows? Other examples could be whether cleanout of combines and 

hauling vehicles reduces contamination using typical protocols for organic cleaning, whether situating 

at-risk crop fields upwind from GMO crops can reduce contamination, and what the role may be of 

pollinators in spreading GMO pollen. Lastly, research is needed on a mechanism to provide conventional 

growers incentives to take their own prevention measures to prevent pollen drift and its impact on 

organic and identity-preserved crops. This is policy research rather than field research but is equally as 

important. 

5. Testing for Fraud: Developing and implementing new technologies and practices New technologies, 

tests, and methodologies are needed to differentiate organic crop production from conventional 

production to detect and deter fraud. Testing to differentiate conventional and organic livestock 

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products, for example omega 3 or other indicators, is also needed. Additional tools to identify 

fraudulent processed and raw organic crops require research to combat this problem. Current 

methodologies include pesticide residue testing, in field soil chemical analysis, and GMO testing. Areas 

in need of further testing methodology include phostoxin residues, fumigant residues, carbon isotope 

rations for traceability, validating nitrogen sources using nitrogen isotope rations, or other experimental 

testing instruments that can be utilized to distinguish organic raw and/or processed crops from 

conventional items. Additionally, there is a need to develop rapid detection technologies for adaptation 

to field-testing capacities. 

General 

1. Increasing Access to Organic Foods - What factors influence access to organically produced foods? 

Individual-based studies are needed to assess the constraints to accessing to organic food. Research 

should be funded that builds on an understanding of constraints by asking what community, market, 

and policy-based incentives would enhance access to organic foods. 

2. Barriers to Transitioning to Organic Production - What are the specific production barriers and/or 

yield barriers that farmers face during the three-year transition period to organic? Statistical analysis of 

what to expect economically during the transition is needed to help transitioning growers prepare and 

successfully complete the transition process. 

Questions to Our Stakeholders 

During the Fall 2020 comment period, stakeholders identified several additional items for consideration 

as research priorities, on which, the Materials Subcommittee is seeking further input from the 

community. Comments were limited in the previous two comment cycles. 

Should the following items be considered by the NOSB for inclusion in its proposal on 2021 research 

priorities? 

• Research into the economics of organic livestock more broadly as producers continue to 

face difficult economic circumstances, including challenges with access to meat processing, 

varying price premiums, and high cost of feed 

• Research into the effects of organic crop production on water 

• Research into novel ammonia inputs, their field-level impact in organic systems, and their 

traceability and vulnerability to fraud 

• Benefits and risks of livestock integration into crop rotations 

• Nutritional value of organic animal products (such as dairy, meat, and eggs) 

• Comparisons of pesticide, antibiotic, and synthetic growth hormone residues in organic and 

conventional products 

Subcommittee Vote: 

Motion to accept the 2021 NOSB Research Priorities proposal 

Motion by: Wood Turner 

Seconded by: Steve Ela 

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

Approved by Wood Turner, Materials Subcommittee Chair, to transmit to NOSB, August 13, 2021 

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National Organic Standards Board 

Materials/GMO Subcommittee Discussion Document 

Excluded Methods Determinations 

August 12, 2021 

Introduction and background 

Cell fusion and protoplast fusion have a nuanced history in the context of the USDA’s National Organic 

Program and the work of the National Organic Standards Board. Cell fusion is included under terms 

defined at §205.2 as an excluded method. In 2013, the NOP clarified its position on both techniques in 

Policy Memo 13-1 allowing for both techniques to be used solely within taxonomic plant families. As 

work by the NOSB progressed in this area, cell fusion and protoplast fusion continue to be included as 

techniques to be evaluated on the excluded methods “TBD list” with notes indicating follow-up work by 

the NOSB. 

Goals of this document 

The Materials Subcommittee is seeking feedback on the TBD list terms ‘cell fusion’ and ‘protoplast 

fusion.’ This document will outline the history and explore context towards determining if more 

discussion is necessary on the issues of cell fusion and protoplast fusion as excluded methods in organic 

systems. 

Definitions and Criteria 

Under the NOP organic regulations, methods that employ genetic engineering techniques are excluded 

from use in organic production. The current regulation defines an excluded method at §205.2 Terms 

defined: 

A variety of methods used to genetically modify organisms or influence their growth and development 

by means that are not possible under natural conditions or processes and are not considered compatible 

with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, 

and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, 

and changing the positions of genes when achieved by recombinant DNA technology). Such methods do 

not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, 

or tissue culture. 

The NOSB previously recommended the use of the following definitions to determine whether or not 

a method should be/is excluded. 

Genetic engineering (GE) – A set of techniques from modern biotechnology (such as altered and/or 

recombinant DNA and RNA) by which the genetic material of plants, animals, organisms, cells, and other 

biological units are altered and recombined. 

Genetically Modified Organism (GMO) – A plant, animal, or organism that is from genetic engineering 

as defined here. This term will also apply to products and derivatives from genetically engineered 

sources. (Modified slightly from IFOAM Position) 

Modern Biotechnology – (i) in vitro nucleic acid techniques, including recombinant DNA and direct 

injection of nucleic acid into cells or organelles, or (ii) fusion of cells beyond the taxonomic family, that 

overcomes natural, physiological reproductive or recombination barriers, and that are not techniques 

used in traditional breeding and selection. (From Codex Alimentarius) 

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Synthetic Biology – A further development and new dimension of modern biotechnology that combines 

science, technology, and engineering to facilitate and accelerate the design, redesign, manufacture 

and/or modification of genetic materials, living organisms and biological systems. (Operational 

Definition developed by the Ad Hoc Technical Expert Group on Synthetic Biology of the UN Convention 

on Biological Diversity) 

Non-GMO – The term used to describe or label a product that was produced without any of the 

excluded methods defined in the organic regulations and corresponding NOP policy. The term "nonGMO" is consistent with process-based standards of the NOP where preventive practices and 

procedures are in place to prevent GMO contamination while recognizing the possibility of inadvertent 

presence. 

Classical/Traditional plant breeding – Classical (also known as traditional) plant breeding relies on 

phenotypic selection, field-based testing, and statistical methods for developing varieties or identifying 

superior individuals from a population, rather than on techniques of modern biotechnology. The steps 

to conduct breeding include: generation of genetic variability in plant populations for traits of interest 

through controlled crossing (or starting with genetically diverse populations), phenotypic selection 

among genetically distinct individuals for traits of interest, and stabilization of selected individuals to 

form a unique and recognizable cultivar. Classical plant breeding does not exclude the use of genetic or 

genomic information to assess phenotypes more accurately, however the emphasis must be on whole 

plant selection. 

Criteria 

Below are the criteria listed in the 2016, 2017, 2018, and 2019 NOSB recommendations to determine if 

methods should be excluded. 

1. The genome is respected as an indivisible entity, and technical/physical insertion, deletions, or 

rearrangements in the genome is refrained from (e.g., through transmission of isolated DNA, 

RNA, or proteins). In vitro nucleic acid techniques are considered to be an invasion into the 

plant genome. 

2. The ability of a variety to reproduce in a species-specific manner has to be maintained, and 

genetic use restriction technologies are refrained from (e.g., Terminator technology). 

3. Novel proteins and other molecules produced from modern biotechnology must be prevented 

from being introduced into the agro-ecosystem and into the organic food supply. 

4. The exchange of genetic resources is encouraged. In order to ensure farmers have a legal 

avenue to save seed and plant breeders have access to germplasm for research and developing 

new varieties, the application of restrictive intellectual property protection (e.g., utility patents 

and licensing agreements that restrict such uses to living organisms, their metabolites, gene 

sequences, or breeding processes) are refrained from. 

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The NOSB has voted on the following and determined them to be excluded methods: 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Targeted genetic 

modification 

(TagMo) syn. 

Synthetic gene 

technologies syn. 

Genome engineering 

syn. 

Gene editing syn. 

Gene targeting 

Sequence-specific nucleases 

(SSNs) 

Meganucleases Zinc finger 

nuclease (ZFN) 

Mutagenesis via 

Oligonucleotides 

CRISPR-Cas system (Clustered 

regularly interspaced short 

palindromic repeats) and 

associated protein genes 

TALENs (Transcription activatorlike effector nucleases) 

Oligonucleotide directed 

mutagenesis 

(ODM) Rapid Trait Development 

System 

YES 1, 3, 4 Most of these new 

techniques are not 

regulated by USDA and are 

currently difficult to 

determine through testing. 

Gene Silencing RNA-dependent DNA 

methylation (RdDM) Silencing 

via RNAi pathway RNAi 

pesticides 

YES 1, 2, 4 

Accelerated plant 

breeding techniques 

Reverse Breeding 

Genome Elimination 

FasTrack 

Fast flowering 

YES 1, 2, 4 These may pose an 

enforcement problem for 

organics because they are 

not detectable in tests. 

Synthetic Biology Creating new DNA sequences 

Synthetic chromosomes 

Engineered biological functions 

and systems 

YES 1, 3, 4 

Cloned animals and 

offspring 

Somatic nuclear transfer YES 1, 3 

Plastid 

transformation 

YES 1, 3, 4 

Cisgenesis The gene modification of a 

recipient plant with a natural 

gene from a crossable-sexually 

compatible-plant. The 

introduced gene includes its 

introns and is flanked by its 

native promoter and terminator 

in the normal-sense orientation. 

YES 1, 3, 4 Even though the genetic 

manipulation may be within 

the same species; this 

method of gene insertion 

can create characteristics 

that are not possible within 

that individual with natural 

processes and can have 

unintended consequences. 

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Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Intragenesis The full or partial coding of DNA 

sequences of genes originating 

from the sexually compatible 

gene pool of the recipient plant 

and arranged in sense or 

antisense orientation. In 

addition, the promoter, spacer, 

and terminator may originate 

from a sexually compatible gene 

pool of the recipient plant. 

YES 1, 3, 4 Even though the genetic 

manipulation may be within 

the same species, this 

method of gene 

rearrangement can create 

characteristics that are not 

possible within that 

individual with natural 

processes and can have 

unintended consequences. 

Agro-infiltration YES 1, 3, 4 In vitro nucleic acids are 

introduced to plant leaves 

to be infiltrated into them. 

The resulting plants could 

not have been achieved 

through natural processes 

and are a manipulation of 

the genetic code within the 

nucleus of the organism. 

TransposonsDeveloped via use of 

in vitro nucleic acid 

techniques 

YES 1,3,4 Does not include 

transposons developed 

through environmental 

stress such as heat, drought 

or cold. 

Induced Mutagenesis YES 1 Developed through in vitro 

nucleic acid techniques 

does not include 

mutagenesis developed 

through exposure to UV 

light, chemicals, irradiation, 

or other stress-causing 

activities. 

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The following genetic engineering methods were found by the NOSB NOT to be excluded methods: 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Marker Assisted 

Selection 

NO 

Transduction NO 

Embryo rescue in 

plants 

NO IFOAM’s 2018 position 

paper on Techniques in 

Organic Systems considers 

this technique compatible 

with organic systems. 

Embryo transfer, or 

embryo rescue, in 

animals 

NO *use of hormones not 

allowed in recipient 

animals. 

Transposons NO Developed through 

environmental stress, such 

as heat, drought, or cold. 

The following TBD methods will continue to be researched in future NOSB proposals: 

Terminology 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Used 

Notes 

Protoplast Fusion TBD There are many ways to 

achieve protoplast fusion, 

and until the criteria about 

cell wall integrity are 

discussed and developed, 

these technologies cannot 

yet be evaluated. 

Cell Fusion within 

Plant Family 

TBD Subject of an NOP memo in 

2013. The Crops 

Subcommittee will 

continue to explore the 

issue. 

TILLING Eco-TILLING TBD Stands for “Targeted 

Induced Local Lesions in 

Genomes.” It is a type of 

mutagenesis. 

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Doubled Haploid 

Technology (DHT) 

TBD There are several ways to 

make double haploids, 

and some do not involve 

genetic engineering while 

some do. It is difficult or 

impossible to detect DHT 

with tests. 

Induced 

Mutagenesis 

TBD Induced mutagenesis 

developed through 

exposure to UV light, 

chemicals, irradiation, or 

other stress. 

Transposons TBD Produced from chemicals, 

ultraviolet radiation, or 

other synthetic activities. 

Discussion 

Under the NOP organic regulation, cell fusion is by definition an excluded method at §205.2. In 2013, 

NOP Policy Memo 13-1 provided further context for the use of cell fusion in organic systems which 

included protoplast fusion. Both were deemed to be excluded methods except when either technique 

was employed within taxonomic plant families. The policy memo defends this assertion that this limited 

use mimics natural phenomenon and is therefore allowed. 

In February 2013, the NOSB discussion document on Excluded Methods Terminology references the 

policy memo explaining “that cell fusion techniques are considered an ‘excluded method’ when the 

donor cells/protoplasts do not fall within the same taxonomic family. Cell fusion is also an ‘excluded 

method’ when the donor or recipient organism is derived using techniques of recombinant DNA 

technology and techniques involving the direct introduction into the organism of hereditary materials 

prepared outside of the organism.” 

As the NOSB continued its work around issues of excluded methods, both cell fusion and protoplast 

fusion were included on a list of techniques that needed consideration for allowance/prohibition (see 

Appendix for NOSB proposal and discussion document April 2016). This “TBD list” included cell fusion 

with the note column giving the explanation “[s]ubject of an NOP memo in 2013. The Crops 

Subcommittee will continue to explore the issue.” Protoplast fusion was included in the TBD list with the 

note “[t]here are many ways to achieve protoplast fusion, and until the criteria about cell wall integrity 

are discussed and developed, these technologies cannot yet be evaluated.” The Materials 

Subcommittee is exploring whether its work is complete with cell/protoplast fusion, and by extension, 

the need for additional criteria to approach future TBD list determinations. 

NOSB Proposals and Discussion Documents October 2021 198 of 205
 

 

 

 

Questions for our Stakeholders 

1. Should the NOSB prioritize developing additional criteria for excluded methods determinations 

before continuing to work on the remaining TBD list techniques? 

2. Is Policy Memo 13-1 complete and applied consistently in organic systems, i.e., do cell fusion 

and protoplast fusion need to remain on the TBD list or can they be moved to the excluded 

method section with the notes that allowance is made for these techniques when employed 

within taxonomic plant families? 

3. As the NOSB makes excluded methods determinations on the remaining TBD list techniques, 

should this organic system include allowance for historical use and a time frame for phasing out 

excluded uses? 

Appendix 

National Organic Program (February 2013). 

Policy Memorandum Cell Fusion Techniques used in Seed Production. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/NOP-PM-13-1-CellFusion.pdf 

National Organic Standards Board. Materials/GMO Proposals. (April 2013). 

Discussion Document on Excluded Methods Terminology. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/GMOSCTrmnlgyExclddMthdsApril%202013.pdf 

National Organic Standards Board. Materials/GMO Proposals. (April 2016). 

Excluded Methods Terminology – Third Discussion Document. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/MSDDExcludedMethodsApr2016.pdf 

National Organic Standards Board Materials/GMO Proposals. (April 2016). 

Excluded Methods Terminology – Proposal. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/MSPrpslExcldMethTerminologyApr2016.pdf 

Motion to accept the Fall 2021 excluded methods discussion document 

Motion by: Mindee Jeffery 

Seconded by: Brian Caldwell 

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

Approved by Wood Turner, Materials Subcommittee Chair, to transmit to NOP August 12, 2021. 

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National Organic Standards Board 

Policy Development Subcommittee Discussion Document 

Oral and Written Comment Submissions 

August 10, 2021 

Introduction and background 

The National Organic Standards Board is bound by regulation to conduct open meetings in accordance 

with the Federal Advisory Committee Act (FACA) along with the provisions of the Policy and Procedures 

Manual (PPM). Stakeholder submissions of written and oral comments are the backbone of community 

engagement, providing invaluable perspectives on the many issues that arise in organic systems. In the 

interest of maintaining fair and equal access to the Board by the stakeholder community, the Policy 

Development Subcommittee (PDS) is reviewing procedures on written and oral comments. PDS seeks to 

review the framework for written and oral comment submissions through engaging the organic 

community in a dialogue on best practices. 

Goal of this Document 

The Policy Development Subcommittee seeks to hear feedback on how it might modify established 

procedures to maximize community engagement practices that facilitate fair and equal access to 

National Organic Standards Board members by all stakeholders. 

Discussion 

The Policy Development Subcommittee is considering the submission process of oral and written 

comments to the Board for in person and/or virtual meetings. Governing policies and procedures from 

FACA, Federal Register Notices, and the PPM are listed and linked in the Appendix of this document. 

Written Comments: 

In regard to written comments in advance of NOSB meetings, the PPM states, “All members of the 

public are encouraged to submit public comment in writing according to the Federal Register Notice. 

Written submissions allow NOSB members the opportunity to read comments in advance, eliminate or 

decrease the need for paper copies to be distributed during the meeting, and allow each NOSB member 

to review and analyze data and information well ahead of the public meeting and possible voting.” 

The NOSB has an established 30-day comment period prior to each of its public meetings. The comment 

period opens approximately 45 days prior to the meeting, and closes 30 days later, giving Board 

members approximately 2 weeks to read, analyze, and incorporate written comments into their 

proposals. The Federal Register Notice states that written comments submitted after the deadline may 

not be considered by the Board before they deliberate and vote during the meeting. The PDS is 

strengthening the language to indicate that the NOSB will not consider comments submitted after the 

deadline. 

Written comments are sometimes submitted to NOP and/or individual Board members after the 

comment period closes, along with the urgent request that the information be forwarded to the entire 

Board. Balancing the need to engage with stakeholders and ensuring all stakeholders have equal access 

to the Board creates pressure on Board members’ attention during meetings. PDS sees the forwarding 

of written comments to the Board after the closure of the comment period as an issue of fairness. 

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Stakeholders should not expect written comments submitted after the deadline to be posted to the 

Federal Register or forwarded to the Board during the public meeting. The defined comment period 

exists for a reason. 

Oral Comments: 

Announcements in the Federal Register illuminate the process and deadline for submitting oral 

comment requests before each meeting. Given the sea change in meeting processes as informed by the 

pandemic, oral comments are under consideration in two areas. In the first, the Policy Development 

Subcommittee is considering the importance of in-person oral comments during in-person Board 

meetings versus moving to an all-virtual pre-meeting oral comment process. Further, PDS is exploring 

access/fairness issues that can arise when organizations schedule multiple individuals for oral comments 

that can effectively advantage that organization over other commenters. 

Oral comments are foundational to the NOSB’s informed decision-making process. The NOSB receives 

feedback that the scheduling of NOSB meeting in the Spring and Fall conflicts with the planting and 

harvest schedules for some stakeholders and is a barrier to attendance at the in-person meetings. 

Virtual oral comments allow those without time or resources to travel, the opportunity to engage in the 

process and provide information to the Board. Given the shift and emergence of virtual resources, the 

PDS is considering making the virtual, pre-meeting format for oral comments the standard. Board 

members have noted that oral comments received the week before the meeting allow more 

consideration before deliberation and voting. Alternatively, Board members do not want to discourage 

in-person attendance by stakeholders, acknowledging the value of stakeholder information presented 

orally during the context of the in-person meeting. The PDS is trying to balance the need to provide 

opportunity for expansive participation by the stakeholder community within a framework that also 

aides the Board’s digestion of information. 

Oral comment registration procedures are outlined in the Federal Register Meeting Notice and the 

Policy and Procedures Manual. Oral commenters are generally scheduled in the order in which they 

register. The NOP makes an effort to accommodate scheduling requests for special circumstances if 

possible. Scheduling accommodations, while possibly increasing engagement, can lead to a lack of 

fairness in time given to a single organization or subject, and also increases the workload of the NOP. 

The PDS does not intend to be overly prescriptive when it comes to scheduling oral comments but does 

want to explore best practice for remaining open and flexible while maintaining a level playing field for 

all stakeholders. 

Questions 

1. Should the Board move to an entirely virtual format for oral comments the week before inperson meetings or maintain the pre-pandemic format of hearing oral comments, both virtually 

prior to the in-person meeting as well as in-person at the public NOSB meeting? 

2. If NOSB meetings move to a model wherein all oral comments are heard virtually the week 

before the meeting, would it reduce the attendance of stakeholders at the Board meeting? 

3. Restrictions due to the pandemic aside, would the availability of a live-stream meeting 

discourage in-person attendance? 

4. Is the practice of scheduling multiple oral comments by a single organization (such as a 

business/company/non-profit/trade group) inherently unfair? Is there a path by which the 

Board can field multiple areas of expertise from a single organization, while balancing the limits 

of time, fairness, and the importance of receiving a wide range of stakeholder feedback? 

NOSB Proposals and Discussion Documents October 2021 202 of 205
 

 

 

 

 

 

 

 

 

 

 

Appendix: 

A. Policy and Procedure Manual (PPM) rev. October 25, 2019 

(https://www.ams.usda.gov/sites/default/files/media/NOSB-PolicyManual.pdf) 

VIII. NOSB PROCEDURES 

E. PUBLIC COMMENT 

The NOP and NOSB encourage public comment and work collaboratively to increase opportunities 

for greater participation by a broad range of people, employing various modes of communication 

and modern technology whenever possible. Individuals may present oral comment at either a premeeting electronic webinar or at the in-person NOSB meeting. 

Before Public Meetings: 

Written comment: All members of the public are encouraged to submit public comment in writing 

according to the Federal Register Notice. Written submissions: allow NOSB members the 

opportunity to read comments in advance, eliminate or decrease the need for paper copies to be 

distributed during the meeting and allow each NOSB member to review and analyze data and 

information well ahead of the public meeting and possible voting. 

Oral Comments 

Oral comments: May be received via a virtual meeting/webinar. Public notice of such electronic 

meetings will be included in the Federal Register notice announcing the public meeting. Such 

electronic pre-meetings may allow individuals more time to present their data or information, 

reduce the need to attend the public meeting in person, reduce our carbon footprint, and give the 

NOSB more time to absorb the information. Such electronic meetings shall be recorded and made 

available to the public and to NOSB members. 

Comments at In-Person Public Meetings: 

• All persons wishing to comment at NOSB meetings during public comment periods must, in 

general, sign-up in advance per the instructions in the Federal Register Notice for the meeting. 

Persons requesting time after the closing date in the Meeting Notice, or during last minute 

sign-up at the meeting, will be placed on a waiting list and will be considered at the discretion 

of the NOP working closely with the NOSB Chair and will depend on availability of time. 

• All presenters are encouraged to submit public comment in writing according to the Federal 

Register Notice. Written submissions allow NOSB members the opportunity to read comments 

in advance electronically, and decreases the need for paper copies to be distributed during the 

meeting. 

• Persons will be called upon to speak according to a posted schedule. However, speakers should 

allow for some flexibility. Persons called upon who are absent from the room could potentially 

miss their opportunity for public comment. 

• Time allotment for public comment per person will be four (4) minutes, with the options of 

reducing to a minimum of three (3) and extending to a maximum of five (5) minutes at the 

discretion of the NOP, working closely with the NOSB Chair in advance of the meeting. 

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• Persons must give their names and affiliations for the record at the beginning of their public 

comment. 

• Proxy speakers are not permitted. 

• Public comments may be scheduled according to topic. 

• Individuals providing public comment shall refrain from making any personal attacks or 

remarks that might impugn the character of any individual. 

• Members of the public are asked to define clearly and succinctly the issues they wish to 

present before the Board. This will give NOSB members a comprehensible understanding of the 

speaker’s concerns. 

Policy for Public Communication between NOSB Meetings (Adopted April 11, 2013) 

• The NOSB and NOP seek public communication outside of Board biannual meetings and public 

comment periods to inform the NOSB and NOP of stakeholders’ interests, and to comment on 

the NOSB’s and NOP’s work activities year around. 

• The NOSB may post draft discussion documents and proposals between public meetings for 

review and public comment. Timely submission of comments will assist the NOSB and its 

Subcommittees in revising such documents for subsequent NOSB review. 

B. Federal Register Notice Example: https://www.regulations.gov/document/AMS-NOP-20-0089-0001 

C. Requirements regarding FACA meetings: (https://www.gsa.gov/policy-regulations/policy/federaladvisory-committee-management/advice-and-guidance/the-federal-advisory-committee-act-facabrochure) 

Open Access to Committee Meetings and Operations 

Under the provisions of the Federal Advisory Committee Act, federal agencies sponsoring advisory 

committees must: 

• Arrange meetings that are reasonably accessible and at convenient locations and times; 

• Publish adequate advance notice of meetings in the Federal Register; 

• Open advisory committee meetings to the public (with some exceptions-see the section on 

"Government in the Sunshine Act" below); 

• Make available for public inspection, subject to the Freedom of Information Act, papers and 

records, including detailed minutes of each meeting; and 

• Maintain records of expenditures. 

D. Sample and Example of FACA Bylaws (https://www.gsa.gov/policy-regulations/policy/federaladvisory-committee-management/advice-and-guidance/sample-and-example-of-faca-bylaws) 

NOSB doesn’t have bylaws – we instead have a combination of OFPA and the PPM. 

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Open Meetings. Unless otherwise determined in advance, all meetings of the Government 

Procurement Advisory Board (GPAB) will be open to the public. Once an open meeting has begun, it 

will not be closed for any reason. All materials brought before, or presented to, the Board during the 

conduct of an open meeting, including the minutes of the proceedings of an open meeting, will be 

available to the public for review or copying at the time of the scheduled meeting. 

Members of the public may attend any meeting or portion of a meeting that is not closed to the 

public and may, at the determination of the Chairman, offer oral comment at such meeting. The 

Chairman may decide in advance to exclude oral public comment during a meeting, in which case the 

meeting announcement published in the Federal Register will note that oral comment from the 

public is excluded and will invite written comment as an alternative. Members of the public may 

submit written statements to the PAB at any time. 

Subcommittee Vote: 

Motion to accept the discussion document on Public Comments 

Motion: Jerry D’Amore 

Seconded: Nate Powell-Palm 

Yes: 4 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Mindee Jeffery, Policy Development Subcommittee Chair, to transmit to NOSB August 

10, 2021 

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